Mar Issue 17 65 App

Suresh Vedantham: Pill that shrinks uterine Profile fibroids gathers early data Page 26 Ulipristal acetate has become the first oral therapy to show positive phase III esultsr for the treatment of uterine fibroids. In early 2017, it demonstrated efficacy and safety in the Michael Dake: treatment of uterine fibroids in two US pivotal studies. TEVAR’s dirty secret hree prominent physicians Page 28 who are strong advocates Tfor treating uterine fibroids using embolization: gynaecologist Bruce McLucas (California, USA) Lutonix AV results and interventional radiologists Jim Spies (Washington, DC, USA) provide tailwind for and Jon Moss (Glasgow, UK) tell Interventional News about how drug-coated balloons drugs will constantly nip at the heels of interventional treatments, and in dysfunctional how it is their side-effect profile that will determine whether patients will arteriovenous fistula tolerate their use. Ulipristal acetate is an treatment investigational drug for the medical treatment of uterine fibroids. It is Scott Trerotola presented the first release a selective progesterone receptor of eight-month data from the Lutonix AV modulator that acts directly on the trial at the Leipzig Interventional Course progesterone receptors in three target (LINC; 24–27 January, Leipzig, Germany) tissues: the endometrium; uterine Uterine fibromyoma and showed that the drug-coated balloon fibroids; and the pituitary gland. (Lutonix 035 AV from Bard) is linked with a Mclucas, who is founder of the In fact, leuprolide now markets a Richter announced positive results significantly higher target lesion patency Fibroid Treatment Collective and three month injection, rather than a from Venus II, the second of two and far fewer reinterventions to maintain whose team performed the first monthly one. We, who treat myoma pivotal phase III clinical trials the opening in a wide variety of failing fibroid embolization in the USA in patients know the reason. [With this evaluating the efficacy and safety arteriovenous fistulas than standard 1994, says: “Ulipristal acetate, a drug] Patients were forced into a of ulipristal acetate in women with angioplasty. Nine-month data from the drug marketed in the USA to prevent menopausal state, similar to patients abnormal bleeding due to uterine trial will be presented at the Society of implantation and pregnancy, is the whose ovaries are abruptly removed. fibroids. A new drug application Interventional Radiology’s annual scientific latest of several medical therapies They would simply refuse to come filing for ulipristal acetate is planned meeting (4–9 March Washington, DC, USA) to be touted for control of uterine back for a second injection. And so for the second half of 2017, a press and 12-month data will be presented at the myomata. Historically, we have it is with ulipristal. Amenorrhea, release states. Charing Cross International Symposium seen progesterone implants, or hot flushes and headaches are all Venus II was a multicentre, (25–28 April, London, UK). intrauterine devices reported to reported side-effects in the current randomised, double-blind, impede, if not shrink, myomata. series. And once patients stop taking placebo-controlled clinical trial in ommenting on fistulas in a prospective, Progesterone, a balancing hormone their medication, their myomata, premenopausal women in North the significance randomised, multicentre to oestrogen, might logically rebound and grow. Most of our America between 18 and 50 years of C of the data, fashion. A lot of things perform that function. More patients have tried, and given up age who had cyclic abnormal uterine Trerotola (University of [different technologies] recently, leuprolide, an injectable on hormonal therapies, before bleeding and one or more discrete Pennsylvania Medical have been tried; this oestrogen agonist, showed promise presenting to our practice. When uterine fibroids of any size and Center, Philadelphia, is the first one that has as a treatment to reduce myomata a medical therapy comes along location observable by transvaginal USA) said: “This is worked.” by as much as 35%. So why even without the crippling side-effects ultrasound. Patients also had to have the first trial in the 51 The Lutonix AV study promote a procedure such as uterine of current options, I will be there to follicle-stimulating hormone ≤20 years since fistulas have is a prospective, global, artery embolization when we have recommend it over even minimally mIU/mL, and uterine volume ≤20 been created to look multicentre, randomised, a pill? In a word, the side-effects of invasive treatments. That day has not weeks by exam. Eligible patients at an intervention for controlled study de- all of these treatments, and more, come with ulipristal.” were randomised to ulipristal acetate lesions within native Continued on page 8 are intolerable to most patients. In January, Allergan and Gedeon Continued on page 2 2 Embolization March 2017 Pill that shrinks uterine fibroids gathers early data Continued from page 1 5mg, 10mg or placebo for two separate 12-week treatment courses followed by a 12-week treatment-free follow-up period. The study randomised 432 patients so that 162 patients received ulipristal acetate 5mg, 157 patients received 10mg of the oral therapy, and 113 patients received a placebo. The average age of patients enrolled was 41 years and 67% of enrolled patients were black/African Americans. The study met all the co- primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo Bruce McLucas Jon Moss Jim Spies (p<0.0001). The co-primary efficacy endpoints were percentage of patients with Greater Glasgow and Clyde and a term eg. with respect to cardiovascular given cyclically? What is the impact of the absence of uterine bleeding and time to lead investigator on the randomised health and cancer? Will women be medication on future fertility? It will be absence of uterine bleeding on treatment controlled FEMME (embolization vs. happy to take this drug long term? We important to have a better understanding of during course one (12-week duration). myomectomy) and REST (embolization now need to compare this interesting its safety and side-effect profile in a larger Significantly more patients in the 10mg vs. surgery) trials, has encountered drug with the existing invasive option population. Finally, what will be the cost group (54.8%) and the 5mg group (42%) patients who have been treated with so that women can make an informed of the drug in the United States, where new achieved absence of bleeding compared to this potential new treatment for uterine choice. Finally, any new treatment must drug costs are typically very steep. High those in the placebo group (0%). fibroids. “As an interventional radiologist prove to be cost-effective in the UK costs may cause insurance companies to More patients in the 10mg group I have used ulipristal acetate usually as and will not receive National Institute deny coverage, limiting the number of (55.4%) and the 5mg group (34.6%) a temporary stopgap for patients who for Health and Care Excellence (NICE) women who may benefit from it.” achieved absence of bleeding within 10 are awaiting embolization. It shrinks the approval without it.” What about the larger picture of drugs days after treatment initiation in the first fibroids and usually stops menstruation. Ulipristal acetate exerts a direct effect being developed for conditions that course of treatment compared to placebo In the UK, we can now prescribe three on the endometrium (suppressing uterine are currently treated by intervention. (0%). Significantly more patients in the 12 week courses each separated by two bleeding) and direct action on fibroid Is this the way medicine is likely to 10mg group (57.3%) and the 5mg group break through bleeds, so approximately size by decreasing the formation of go? “Without a shadow of doubt,” says (40.5%) achieved absence of bleeding a one-year course. Obviously for women new fibroid cells and promoting fibroid Moss. “Years ago, a physician once told compared to placebo (8%) in the second approaching menopause it might prove cell death. The safety and efficacy of me his job was to put the surgeon out course of treatment. The improvement to be a definitive treatment,” he told ulipristal acetate has been evaluated in of business. The demise of peptic ulcer from baseline in the UFS-QOL revised Interventional News. two phase III US studies of more than surgery is a perfect example of how a activities subscale was significantly Moss outlined some of the questions 589 adult women of reproductive age. drug (antibiotics in this case) can totally greater in the 10mg group (56.7%) and that he would like to see answered Spies, chairman and chief of service, replace surgical treatment. Of course, it the 5mg group (48.3%) compared to regarding ulipristal acetate: “The data Georgetown University Medical Center, is never completely clear-cut and some placebo (13%). are interesting and support similar and a past president of the Society of women may still prefer an invasive The most common adverse events findings previously published in the Interventional Radiology reiterates Moss’ procedure (hysterectomy, myomectomy (≥5%) on ulipristal acetate treatment New England Journal of Medicine by concerns about the ulipristal acetate’s safety or embolization) rather than take a pill were hot flush, headache, fatigue, and Donnez et al. The main question is: profile. “Selective progesterone receptor until menopause,” he adds. nausea in the combined period of first what is the role of this drug? Other modulators have been under development Spies says: “I think all medical course of treatment and first off-treatment questions are: is it going to be a long- for many years and this appears to be the technologies leapfrog each other— interval. The most common adverse event term option for women? What are the first to have sufficient data for consideration interventions have supplanted (≥5%) on ulipristal acetate treatment was long-term safety issues? What effect by the US FDA for approval. What is medications and medications will headache in the combined period of the does it have on the endometrium? known about the class of medications is supplant interventions. There second course of treatment and second Histological changes have been that it may cause structural changes to the are limits to the applicability of off-treatment interval. reported (Williams et al) but their endometrium and therefore may only be medications, so I suspect all these In the UK, Jon Moss, professor significance is unclear. Are there other suitable for intermittent use. So is this drug therapies will play complementary of interventional radiology at NHS unknown systemic effects if used long- safe for long-term use? Does it have to be roles in treating patients.”

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4 New developments March 2017

New data show bariatric News in brief embolization safe for First presentation of ATTRACT Faster recovery and shorter results at SIR meeting fluoroscopy: Go radial for radioembolization morbidly obese individuals A study awarded as the best abstract at A novel interventional radiology technique for weight loss— the Symposium on Clinical Interventional bariatric embolization—is safe and well tolerated in morbidly Oncology (CIO; 4–5 February, Hollywood, obese individuals, according to a new study appearing in the USA) found that when transradial access was online edition of Radiology. Though the results are preliminary, used to carry out radioembolization to treat the technique has the potential to be a new weapon in the war hepatocellular carcinoma, it resulted in faster on obesity. recovery time, shorter fluoroscopy time, Graphic courtesy: SIR and lower contrast volumes than when the ransarterial embolization of transfemoral approach was used. the gastric fundus, also known The National Institutes of Health (NIH)- “Higher radiation dose and longer fluor- Tas bariatric embolization, has sponsored ATTRACT study—the first major oscopy time have been reported with access emerged in recent years as a potential US trial of a catheter-based treatment for through the wrist in cardiology literature, weight-loss tool. The technique itself deep vein thrombosis will be presented on 6 however, no similar findings have been has been used for decades to stop March at the Society of Interventional Radi- reported for body interventional procedures,” bleeding in the gastric artery, but the ology’s (SIR’s) annual scientific meeting. “I said Jian Zhang, University of Maryland idea of using it to treat obesity arose do believe the ATTRACT trial achieved its Medical Center, Baltimore, USA. more recently based on observations main objective of telling us which acute deep The study was a retrospective review of of hormonal changes in patients who venous thrombosis patients should, or should data from 66 hepatocellular carcinoma pa- underwent bariatric surgery. not, receive endovascular intervention,” tients who underwent 96 radioembolization Obesity—defined as a body mass national principal investigator of the trial, procedures. Of these, 34 patients underwent index (BMI), or measure of body fat Suresh Vedantham, St Louis, USA, tells In- 49 procedures that used the radial artery based on weight and height, of 30 terventional News. ATTRACT was designed approach. The other 32 patients underwent or more—is a major public health to evaluate the use of clot-dissolving drugs 47 procedures using the femoral artery problem that affects more than in combination with clot removal devices to approach. Seven patients in the transradial one-third of Americans, according prevent post-thrombotic syndrome in patients group and six patients in femoral access to the National Institute of Diabetes Clifford R Weiss with deep vein thrombosis. group had significant past medical history and Digestive and Kidney Diseases. Commenting on the importance of multidis- of coronary artery disease. There were no Traditional approaches like a low- 17.5%, on average, at three months. ciplinary collaboration in the trial, Vedantham significant differences in terms of the age, calorie diet, behaviour modification, There was a trend toward improve- said: “Internists view deep venous thrombo- gender, functional status between the groups. exercise and medication have shown ment in quality-of-life parameters. sis as basically an imbalance in the clotting There were no major complications in the limited effectiveness. One of the more There were no major adverse events in system; whereas we view it from anatomical radial approach group, and one pseudoaneu- successful interventions has been the study group. and physiological perspectives. Only when we rysm requiring further intervention in the bariatric surgery, but its invasiveness Weiss, along with co-principal in- share these camera angles with each other can femoral group. can result in significant complications. vestigator, Aravind Arepally, Piedmont we see a fuller picture.” More transradial access news on “A number of research papers in Healthcare, used embolic beads that Vedantham’s profile and more news page 13. Interventional oncology the 1990s found signs of hormonal were approximately 10 times larger on ATTRACT on pages 26 and 27. updates on pages 16 to 24. changes after bariatric surgery,” said than the beads used in the preclinical the study’s lead author, Clifford R studies, as smaller beads are thought to Weiss, Johns Hopkins University increase the risk of gastric ulceration. School of Medicine, Baltimore, USA. However, performing gastric artery Constantin Cope (1927–2016) “In particular, there was a pretty rapid embolization with smaller beads may reduction in ghrelin, the most potent produce a greater reduction in ghrelin, onstantin “Stan” Cope, who retired hunger-stimulating hormone we know. so future studies may be needed to ex- as professor emeritus from the The hormone is produced in an area of amine the clinical benefits of smaller- CRadiology Department, Hospital the stomach called the fundus, which calibre spheres. of the University of Pennsylvania in 2004, is fed primarily by the left gastric “These are very promising and died on 6 November 2016 of heart failure. artery.” exciting results,” Weiss said. “I think He helped to advance and develop the field In bariatric embolization, very this paper and the additional data of interventional radiology as a creator of small, bead-like particles are intro- we are compiling show that bariatric procedures (he is credited with develop- duced into the left gastric artery, using embolization is very well tolerated ment of the first lymphatic interventional imaging guidance and minimally by patients, and there are signs that it procedure, the thoracic duct embolization), invasive techniques. Once in place, could have medium- and long-term inventor and teacher. they obstruct the circulation of blood, efficacy for weight loss.” Dr Cope was born in Paris, France, on leading to ischaemia and a reduction Weiss and colleagues will complete 3 June 1927. He and his family escaped to in ghrelin production. Researchers at the study in the Autumn and have all London, UK, during World War II. He re- widespread approval and is of clinical use I the Johns Hopkins University School the data collected by the end of the ceived his Bachelor of Science and Bachelor think that is the best reward one can receive of Medicine have developed and stud- year. They can then do a more defini- of Medicine degrees at London Univer- for one’s work. I am especially gratified that ied the technique for weight loss over tive study on efficacy, he said, with a sity, and his Medical Degree at New York early techniques for transhepatic bile duct the last 10 to 12 years, Weiss said. larger number of patients and a focus Medical College in 1951. Cope became a catheterisation, micropuncture vascular cath- This phase of the study (June 2014 on the long-term results. US citizen and was drafted into the Army eterisation, for anchoring abdominal hollow to August 2015) included results from He emphasised that bariatric during the Korean War. During his career, viscera, for percutaneous gall-bladder stone the first five patients, four of whom embolization is not intended to be he began collaborating with Cook Medical extraction and for thoracic duct emboliza- were women. Prior to intervention, a first-line treatment for obesity or to get many Cope devices (such as the Cope tion have received widespread clinical the patients were morbidly obese, a replacement for bariatric surgery. loop drainage catheter, Cope gastrostomy acceptance. I was also interested in the early with a mean BMI of 43.8. Using “Obesity is a complicated disease that set, Cope mandril wire guide and the Cope stages of transjugular intrahepatic portosys- fluoroscopic guidance, interventional takes many different therapies to treat, nephroureterostomy stent) manufactured. temic shunt (TIPS).” radiologists were able to embolize the including psychological counselling, When profiled in Interventional News in The SIR has instituted the Dr Constantin left gastric artery in all five patients diet, medication and, in extreme cases, 2004 on the occasion of his having received Cope Medical Student Research Award with 300–500μm beads. The patients surgery,” he said. “If we can provide the SIR Foundation’s Leaders in Innova- in his honour. Its purpose is to introduce experienced an average weight loss one more piece to the armamentarium, tion Award, he said: “I am, of course, a interested medical students to the greater of 5.9% at one month and 9% at three that would be an exciting next step in gadgeteer. When a medical gadget gets interventional radiology community. months. Serum ghrelin levels dropped the treatment of obese patients.”

6 Embolization March 2017 Lymphatic embolization leads to successful treatment of plastic bronchitis in adults

Researchers who developed a safe and effective procedure to immediate and complete resolution of remove thick clogs in children’s airways are now reporting similar symptoms, and the sixth patient reported success in adult patients. In this rare condition, called plastic significant partial improvement. Four pa- bronchitis, patients develop thick, caulk-like casts that form in the tients had minor abdominal pain, which branching paths of their airways. resolved after treatment with painkillers. The average follow-up was 11 months he researchers developed new and Interventions. They collaborated on after initial treatment. imaging tools and a minimally the current study with pulmonologist Earlier this year, Itkin and Dori Tinvasive catheterisation technique Francis X McCormack, of the University reported a retrospective case study of 18 to treat a form of plastic bronchitis of Cincinnati, in a paper in the October children who had plastic bronchitis as caused when abnormally circulating 2016 issue of the Annals of the American a complication of palliative surgery for lymphatic fluid dries into solid casts. “In Thoracic Society. single-ventricle heart disease. While rare, some cases, the cause of this condition The study reports on seven adults with plastic bronchitis can cause life-threat- is unknown, but this new study suggests a mean age of 50 years old who present- ening respiratory distress in children. In that most adult patients with plastic bron- ed with branching bronchial casts, associ- adults, the condition may go undiagnosed chitis have abnormal pulmonary flow of ated with chronic cough and/or asthma. for years in patients who may initially be lymphatic fluid that we can safely treat,” Using a customised type of magnetic diagnosed with asthma or chronic cough. said Maxim G Itkin, an interventional resonance imaging called dynamic con- Plastic bronchitis has a long medical radiologist at Children's Hospital of trast-enhanced MR lymphangiography pedigree—the Greek physician Galen de- Philadelphia (CHOP) and the Perelman (DCMRL), the team found that six of the scribed a form of it in the second century. School of Medicine at the University of seven patients had abnormal lymphatic Maxim Itkin “This was a small study, and a first Pennsylvania, USA. flow, which they now propose designat- report of this treatment in adults with Itkin and his co-author Yoav Dori, a ing as pulmonary perfusion syndrome, as lymphatic embolization, which involves lymphatic plastic bronchitis,” said Dori. paediatric cardiologist at CHOP and Penn distinct from idiopathic plastic bronchi- inserting a combination of glue and coils “Longer follow-up will be needed to Medicine, co-lead a specialised team tis, in which the cause is unknown. through catheters to halt the flow of confirm the long-term risks and benefits at the Center for Lymphatic Imaging The team treated the six patients with lymphatic fluid. Five patients reported of this procedure.” New endovascular biomaterial to replace coil embolization Researchers at Mayo Clinic, Harvard Medical School and the Massachusetts Institute of Technology (all USA) are developing a rapidly deployable hydrogel that has potential to protect patients at high risk for bleeding.

he November 2016 cover article, “An injectable shear-thinning biomaterial for endovascular Tembolization,” in the journal Science Translational Medicine reports on a universal shear- thinning biomaterial that may provide an alternative for treating vascular bleeding. To treat an aneurysm, gastrointestinal bleeding or other forms of uncontrolled haemorrhaging, clinicians often use metallic coils, which can be permanently inserted into a blood vessel to prevent further bleeding. But such coils come with limitations. Patients on blood thinning medications or who cannot form blood clots for other reasons can experience dangerous break- through bleeding, with rebleeding occurring in as many as 47% of patients. Biomaterial The study’s lead co-author Rahmi Oklu, a vascular CREDIT: Ali Khademhosseini, Brigham and Women’s Hospital interventional radiologist at Mayo Clinic’s Arizona campus, explains that the shear-thinning biomaterial pressure within the blood vessel, remain at the site of offers many advantages over metallic coils, the current injection and naturally degrade over time. In addition, gold standard. the team found that the material attracted cells to “Coils require your body’s ability to create a clot migrate and deposit themselves at the site of the in order to create that occlusion. Our shear-thinning Rahmi Oklu material, helping to block the vessel. The individual biomaterial, regardless of how anticoagulated the component materials that make up the new biomaterial patient may be, will still create that occlusion,” says The shear-thinning biomaterial has a consistency have been previously used in humans making their Oklu, who began researching the shear-thinning similar to toothpaste and is made up of both gelatin, subsequent regulatory process and clinical use easier. biomaterial three years ago while working at which gives it gel-like properties, and nanoparticles. “This work is an example of how bioengineering can Massachusetts General Hospital, Harvard Medical The material is able to maintain its shape once inside help address the challenges that clinicians and patients School, in collaboration with his colleague, Ali the vessel, obstructing the vessel or aneurysm without face,” said Khademhosseini. “Our work thus far has Khademhosseini of Brigham and Women's Hospital relying on the formation of a blood clot. Mechanical been in the lab, but we are on a translational path to in Boston. testing in the lab was initially performed and bring this new biomaterial for embolization to the The shear-thinning biomaterial, which can be monitored the material’s changes over time to optimise clinic to improve patient care.” injected through an endovascular catheter, creates an its properties in animal models. The team then tested Research on the shear-thinning biomaterial impenetrable cast of the vessel and can hold its shape the new biomaterial in both rodent and porcine models, continues. The goal is to address unmet patient within a blood vessel, preventing further bleeding. the latter of which have blood vessels of similar needs, including possible treatment of vascular This shear-thinning biomaterial is easier to deliver and dimensions to human blood vessels. malformations, varicose veins, aneurysms and see on a CT and on MRI, enabling physicians to better Some of the beneficial properties of the shear traumatic vascular injuries, as well as a drug delivery assess the outcomes of the procedure, says Oklu. thinning biomaterial include its ability to withstand device in cancer treatment.

8 Arteriovenous access March 2017 Lutonix AV results provide tailwind for drug-coated balloons in dysfunctional arteriovenous fistula treatment

Continued from page 1 the effect of the drug, was 61.6% signed to evaluate the safety and for the drug-coated balloon as effectiveness of the Lutonix 035 compared to 49.4% for percuta- AV drug-coated balloon catheter neous transluminal angioplasty compared to a standard percuta- (p=0.02). The number of interven- neous transluminal angioplasty tions required to maintain target catheter in treating patients lesion patency at 240 days was 66 presenting with clinical and in the drug-coated balloon group haemodynamic abnormalities and 94 in the plain angioplasty in native arteriovenous fistulas group (p=0.024) meaning that located in the upper extremity. there were 29.8% fewer interven- The investigators randomised tions required to maintain target 285 patients at 23 clinical sites lesion patency in the drug-coated and Trerotola noted that this balloon arm than the control trial incorporated a wide variety arm,” Trerotola told delegates. Scott Trerotola The trial treated upper extremity fistulas of lesions and fistula types. Interestingly, the 180-day The primary safety endpoint target lesion primary patency 240 days for the drug-coated bal- between the two groups being in the group treated with drug- was freedom from any serious was not significantly different loon compared to the control arm. similar. There were over 95% in coated balloon and 27.1 de novo adverse events involving the between the two treatment groups In addition to that, the number of both groups being hypertensive lesions and 7% tandem lesions arteriovenous access circuit and a convergence of curves was interventions to maintain target and around 60–65% being dia- in the group treated with plain through 30 days. The primary seen at that point. As this was the lesion patency was significantly betic. Fistulas that were treated balloon angioplasty. The target effectiveness endpoint was primary endpoint, Trerotola noted fewer than in the control arm,” reflected an American popula- lesion length was 28.4±15.09mm target lesion primary patency at that it was not met, but clarified Trerotola added in an interview tion and were in the upper arm, in the drug-coated balloon group six months. that this was a “statistical blip” with Interventional News. antecubital fossa and forearm. and 29.5±18.69 in the plain bal- The results at 240 days as the curves continue to clearly There were 141 patients who The treated vessel locations in- loon angioplasty group. demonstrated that the procedure, diverge by the 240-day mark. were treated with the drug- cluded the cephalic vein, basilic The Lutonix AV study is a when the drug-coated balloon was “The most important finding coated balloon and 144 who vein, median cubital vein and two-year study and data will be used, was as safe as the control is that starting at about 60 days, were treated with plain balloon subclavian vein. accrued for this period. procedure, percutaneous trans- there is a divergence in the curves angioplasty. The patients were With regard to lesion character- Highlights and reminders luminal angioplasty. “The target with a sustained benefit that evenly matched in both groups istics, there were 30.5% de novo from the SIR meeting will be lesion primary patency, showing reaches statistical significance at with baseline demographics lesions and 2.8% tandem lesions available on sirtoday.org

Randomised study for drug-coated New dialysis access balloon in end-stage renal disease products to preserve fistulas Medtronic has received an investigational device exemption (IDE) from the and grafts launched recently US FDA to initiate a study of the In.Pact Admiral drug-coated balloon for a potential new indication in patients with end-stage renal disease. Merit Medical Systems has announced the launch of the proprietary Super Hero and Hero Ally products, he randomised study will evaluate the additions to the company’s expanding portfolio of drug-coated balloon as a treatment dialysis access products. Tfor patients with failing arteriovenous fistulas in comparision to plain balloon hese products are designed to assist clinicians in preserving angioplasty. The IDE approval enables the existing fistulas or grafts that are in the process of failing because company to initiate the study and gain safety Tof central venous stenosis. These first-of-a-kind technologies and effectiveness data for the device in this expand upon the clinically-proven Hero graft by allowing vascular investigational indication. surgeons to expand their repertoire of graft options to include early “In the past, when the arteriovenous cannulation grafts to bypass central venous stenosis. By continuing to access site became narrowed, the only invest in innovative research and development in the field of dialysis, option was use of a standard percutaneous Merit continues to show its commitment to improving the clinical transluminal angioplasty balloon to re- outcomes of dialysis patients. open and regain access for dialysis. This would often result in restenosis and high The Super Hero and Hero Ally have been introduced in the USA, with rates of reintervention,” says Andrew European release scheduled following receipt of the CE mark. Holden, director, Interventional Radiology, Auckland Hospital and associate professor, “During the last several months, we have relocated Radiology, Auckland University, Auckland, Andrew Holden manufacturing of the Hero product line to our South Jordan New Zealand. “Patients on dialysis need facility, and now we have expanded options for physicians and alternatives to help reduce and manage Supply Chain, Mount Sinai Healthcare patients,” said Fred P Lampropoulos, Merit’s chairman stenoses of their arteriovenous access sites. System, New York City, USA, and Hiroaki and chief executive officer. It is important to effectively evaluate options Haruguchi, clinic director, Haruguchi The products were highlighted at the annual meeting such as this drug-coated balloon, which Vascular Clinic, Tokyo, Japan. of Controversies in Dialysis Access (CiDA; 20-21 already has clinical evidence in patients with The study will aim to enrol 330 patients October 2016, Austin, USA). peripheral artery disease in the upper leg.” with a 1:1 randomisation to either treatment Think Hero Graft is an immersive hands- The IDE study will evaluate the safety with In.Pact Admiral drug-coated balloon or on training experience using cadavers and efficacy of the In.Pact drug-coated standard balloon angioplasty. The primary to prepare surgeons to implant the balloon for up to two years at approximately efficacy endpoint is patency of dialysis Hero graft in dialysis patients with 30 sites in USA, Japan, and New Zealand. fistulas through six months and the primary central venous stenosis, and Principal investigators include: Holden, safety endpoint is major adverse events is designed for vascular Robert Lookstein, professor of radiology through 30 days. Additional endpoints surgeons, transplant Hero Ally and surgery, vice-chair, Interventional include reducing access circuit related events surgeons, and Services, and medical director, Clinical including repeat procedures. general surgeons.

March 2017 Arteriovenous access 11 An update on the key results of the NEAT trial venous stenosis; or ineligibility for a procedures (0.6 per patient year vs. 3.4), distal forearm fistula. Patients were with fewer event rates for angioplasties, followed for 12 months with duplex thrombectomies, catheter placements, ultrasound and physical exam. Key arteriovenous graft creations, new outcomes included procedural success, surgical AVF creations, and vascular DHEERAJ RAJAN percentage suitable for dialysis by access-related infections. physiologic criteria (brachial artery The NEAT study demonstrates the flow >500ml/min and vein diameter possibility of the endoAVF as a first-line >4mm), functional usability (received reliable AVF creation option for patient COMMENT & ANALYSIS dialysis with two-needle cannulation without the need for open surgery. Given of endoAVF for at least 2/3 of the cutoff 2mm vessel sizes and unique The NEAT (Novel endovascular access trial) study demonstrates sessions over four weeks), primary, locations of the endoAVF, more patients the possibility of using a catheter-based system to create an secondary and functional patency, may be candidates for the procedure endovascular arteriovenous fistula (endoAVF) in patients requiring and adverse events (as adjudicated compared to those meeting surgical haemodialysis as a first-line reliable option, without the need for by an independent Clinical Events criteria. Furthermore, the roll-in patient open surgery, writes Dheeraj Rajan, Toronto, Canada. Committee). group demonstrated that a physician Eighty patients were enrolled at nine with endovascular skills can easily ith around three million (venae comitantes) in the ulnar artery/ centres in Canada, Australia and New learn the procedure. Most importantly, patients receiving ulnar vein or radial artery/radial vein. Zealand (20 roll-in and 60 participants outcomes of endoAVF are higher when Whaemodialysis annually, When the catheters are inserted, the in the evaluable cohort). EndoAVF compared to other reported studies for reliable vascular access is mandatory magnets align the catheters holding the was created in 98% of participants; surgically created fistulas: maturation to facilitate adequate therapy. An vessels together. Then, radiofrequency 91% were physiologically suitable for (91% vs. 53–76%) and patency (83.5% arteriovenous fistula is the preferred energy is delivered from the venous dialysis within three months with mean vs. 68–72%) with a statistically lower vascular access for these patients. catheter in the vein to the artery, brachial artery flow of 918ml/min and post creation intervention rate. These However, high thrombosis rates, creating a side-to-side anastomosis vein diameters 5.2mm in cephalic, clinical outcomes may translate into access maturation failure with multiple and the catheters are removed. As 5.9mm in median cubital and 6mm lower long-term costs, improved patient interventions, and patient refusal plague a final step, the entry brachial vein in basilic veins. EndoAVF functional acceptance and a fundamental change in access usability. Failing access is the is embolised to divert flow to the usability was 67% in participants current standards of practice. leading cause of hospitalisation for superficial veins, which are later who received dialysis, with only patients undergoing haemodialysis and cannulated for haemodialysis. 12% of usable endoAVF requiring an Dheeraj Rajan is head and professor, is responsible for US$2.9 billion in NEAT is a prospective, single-arm, intervention to achieve usability. The Division of Vascular and Interventional annual costs. multicentre study designed to evaluate 12-month primary and cumulative Radiology, Department of Medical Imaging, The everlinq endoAVF system (TVA the safety and efficacy of the everlinQ patencies were 68.6% and 83.5%, University of Toronto, Toronto, Canada. He Medical) creates a fistula without open endoAVF system to create an endoAVF respectively, with functional patency of is an equity holder at TVA Medical. surgery or vessel dissection, eliminating in patients with end-stage renal disease 89.4%. There was one serious device- trauma to the vessels to minimise the who require haemodialysis vascular related event that occurred in one patient References 1. Liyanage, et al. Lancet. Epub March 2015;10.1016/ neointimal hyperplasia responsible access. The main inclusion criteria were: (1.7%). When compared to a propensity- S0140–6736. for failures with surgical fistulas. The target vein and artery diameters ≥2mm; score matched Centers for Medicare and 2. US Renal Data System. USRDS 2010 Annual Report. 3. Robbin et al. Radiology, 2016; 279:620–9. procedure uses two magnetic catheters life expectancy >1 year; absence of Medicaid cohort of surgical AVF, the 4. McGrogan, D. et al. J Vasc Surg 2015;62:1652–7 placed in an artery and adjacent vein central or ipsilateral upper extremity endoAVF required fewer post-creation 5. Al-Jaishi, et al. Am J Kidney Dis. 2014; 63(3):464–478 Positive results for endovascular arteriovenous fistula creation presented at LINC 2017 TVA Medical has provided clinical updates for its everlinq endoAVF system at the 2017 Leipzig Interventional Course (LINC; 24–17 January, Leipzig, Germany).

cientific data for the with end-stage renal disease revascularisation, without everlinq endoAVF showed high fistula maturation stents, couplers or other Swere presented at (91%); high patency (84%); foreign material. LINC including a main low thrombosis (10.5%); and Results were also presented arena discussion by Tobias low interventions (0.46 per from a study evaluating the Steinke, chief of Vascular patient year). everlinq 4 endoAVF system, and Endovascular Surgery, At two centres in Germany which is designed to enable Schoen Hospital, Dusseldorf, reporting real-world experience other access sites like the wrist, Germany. with the everlinq endoAVF using a 4F (vs. 6F) catheter everlinq endoAVF “The promise of the system, physicians achieved system. The prospective, single everlinq endoAVF system 100% procedural success; arm, single-centre trial showed Langone Medical Center, three million people as a viable alternative to dialysis initiation in 86% of 97% procedural success and New York City, USA.The worldwide with end stage surgical arteriovenous fistulae patients within 56 days; and a fistula maturation in 81% of everlinq endoAVF System renal disease are treated with procedures, demonstrated in low rate of interventions. patients within 30 days. has the European CE mark haemodialysis. However, the clinical trials and real-world Additionally, data were “This technology has the and Health Canada Medical first step, creating a viable cases, is very exciting,” reported from a preclinical potential to revolutionise Device License for end-stage access in the arm, is often a said Steinke. “Patients feasibility study using the dialysis access. The clinical renal disease patients who significant clinical challenge. deserve more options, and everlinq endoAVF system for results using the 4F everlinq need haemodialysis, and The current standard approach an endovascular solution is peripheral artery disease. The endoAVF System, which may commercialisation has begun (ie., surgical arteriovenous extremely appealing.” cadaver study demonstrated benefit additional dialysis at select centres in Europe. It is fistula) is associated with One-year data presented the feasibility of creating patients, are consistent with not commercially available in high failure rates, often as from the single-arm, an endovascular in situ positive clinical results the USA and is currently under high as 60%, and it requires prospective, multicentre vein bypass—in place of a seen with the innovative 6F review by the US Food and frequent revisions, resulting NEAT(Novel Endovascular surgical distal autologous vein system,” said Todd L Berland, Drug Administration. in increased morbidity and Access Trial) study in patients bypass—for below-the-knee vascular surgeon, NYU Each year, approximately unnecessary costs.

March 2017 Radial access 13 Ringing in the radial revolution There is an explosion of interest in transradial access within interventional radiology. With the twitterverse For operators doing many peripheral abuzz with hashtags such as #radialfirst and #transradial and physicians stating that the best way to a vascular procedures, the argument person’s heart is through their radial artery, Interventional News spoke to two proponents of the radial of percutaneous brachial is not an revolution, Darren Klass and Aaron Fischman, about what we need to know in 2017. argument. Performing a procedure on a patient with a complication rate of lass is an interventional 12% (of which 50% require surgery) is radiologist at Vancouver unforgivable. It is 2017—use the radial KImaging, Vancouver, Canada and artery. Fischman is an interventional radiologist AF: All femoralists should consider with the Department of Radiology, Icahn this: interventional radiology has always School of Medicine at Mount Sinai, New been about innovation, creative thought York, USA. and high technical skill. Many of the “Radial intervention is not a religion; procedures we do are not unique to us. the patient is central, not the procedure. What can differentiate us from other [But] This is a technique that should specialties is the desire to make our be practiced by all interventional procedures less invasive, more patient radiologists, because it is better for friendly, low cost and low morbidity. patients,” Klass said. The data support radial access over femoral access in all of those categories. What is the most interesting As we create more data on the radial piece of research you have access technique in interventional come across recently about Darren Klass Aaron Fishcman radiology, I am confident that we radial access? will be able to easily demonstrate the DK: The most interesting research in What is the most interesting am asked all the time if it is necessary value of radial access. Even the most my opinion is within the cardiology radial access research that to attend a course before offering this staunch femoralists realise that there are literature; however, the findings are you are carrying out? service; I think it is absolutely necessary. situations where radial access is needed extremely important and pertinent DK: We have just completed data The training provides not only access regardless of operator preference. It to our specialty. PROPHET II was a analysis of a rapid haemostasis protocol and haemostasis, but also addresses will only serve us well in the future to randomised controlled trial of 3,000 named PROTEA (Percutanous radial complications, pitfalls and inventory make sure our trainees are well versed in patients comparing patent haemostasis haemostasis using a truncated deflation needed for complex cases. You can learn both techniques allowing for optimised with and without ipsilateral ulnar algorithm), which will be presented at this yourself but I do not believe if you patient care. artery compression. The rates of SIR 2017. This protocol uses a proprietary have access to training, that patients radial artery occlusion at 30 days haemostasis pad (Statseal, Biolife) to should be put at risk while you work Are there any devices were significantly lower in the group aid with haemostasis during deflation of things out for yourself when you can be missing from the market where patent haemostasis and ulnar the balloon. The protocol decreases the provided all the tools to do this. currently? artery compression was used. This has haemostasis time to 25 minutes (from I have given advice to many DK: The biggest current issue is the lack changed my practice and although our an hour, or more) in patients undergoing interventionists once they begin using of guiding catheters longer than 100cm. centre, after over 1,200 cases, has an procedures with a 7F sheath or less and this approach. The most common We need at least 115cm or 120cm guiding extremely low asymptomatic occlusion no more than 5000IU heparin. This has questions are often around difficult cases catheters to allow for more complex visceral rate, my aim with every access is dramatically improved patient discharge or non-specific symptoms after the case, work. The stent and balloon delivery to ensure, as much as possible, that times, and our centre now has an 85% where patients may present with pins systems need to be at least 150cm to allow the vessel is spared for subsequent TACE out-patient service where patients and needles in the hand and operators are for work through 120cm Sheathless guiding interventions. The theory of ulnar artery are discharged within 90 minutes of unsure as to the approach to deal with catheters and either rapid exchange systems compression during patent haemostasis coming off the angiography table. these issues. The answer is often a simple or longer wires. Lower profile balloons allows increased flow through the radial AF: Right now, we are designing a one, but you need the tools to be able to and stents with technology acquired from artery thus decreasing occlusion rates. randomised trial for interventional manage these issues and the courses and coronary devices would be beneficial and The ulnar artery is not accessed and, oncology patients. Specifically, quality workshops provide them. important to allow work through as small therefore, temporary compression does of life (QOL) and patient satisfaction is AF: I have organised and co-ordinated delivery systems as possible. not cause occlusion. of great interest to me. We plan to take many hands-on workshops regarding AF: We are beginning to see longer Within the interventional radiology a patient population that has multiple radial access over the years. They are diagnostic catheters ranging from space, Marcelo Guimaraes (Medical procedures in a short period of time such often well attended and of great interest 110–125cm in our labs. Microcatheter University of South Carolina) is as Y-90 and randomise them to femoral to the interventional community. The systems are generally well suited at the conducting an extremely interesting or radial access and then use the opposite radial approach is not a new concept 150cm lengths. However, guiding catheters prospective study assessing technique for their second procedure. but for interventional radiologists it can typically max out at 100cm length and this patient preference for transarterial Using validated survey mechanisms, be intimidating if the tips and tricks are can be a problem when planning more chemoembolization (TACE), and I we are going to determine if patients unfamiliar. When I teach these courses complex interventions. Also, guiding eagerly await the result. are more satisfied with radial or femoral I tend to focus proper technique. If sheaths are not typically hydrophillic AF: The PROPHET II study by access. QOL is something that is proper technique is followed from the all the way to skin entry point and this Pancholy et al. was very interesting provable in interventional radiology with beginning, success rates are much higher. is as huge safety problem when using because in a randomised fashion smaller numbers of patients. them in complex interventions requiring they were able to show a significant What would be your most covered stents or distal peripheral arterial decrease in radial artery occlusion Within the interventional compelling argument to a disease interventions. These are currently with prophylactic ipsilateral ulnar radiology world, what is staunch femoralist about in development. Newer closure bands compression during radial artery the response to hands-on radial access? taking into account the findings of the haemostasis. The primary endpoint learning and workshops in DK: This is a procedure that is better PROPHET II study and others would be of of 30-day radial artery occlusion was this area? for patients. It allows them to ambulate tremendous value. Lastly, distal peripheral 0.9% with ulnar compression vs. 3% DK: The response has been excellent much faster and is more comfortable. arterial disease interventions are not yet in the control arm. Despite the fact and I believe this is echoed by all of For oncology procedures, keeping a ready for primetime. Longer stent, balloon that this is a cardiology study, I think my colleagues who train interventional patient in overnight just because of a and atherectomy delivery systems would this has implications for interventional radiologists in this technique. The most femoral puncture is not good patient be extremely valuable in developing the radiology. Radial artery occlusion is not important message is that this is not care. These patients often have a few peripheral arterial disease radial technique. very common in my practice, but does just an access procedure and it involves months to live and taking away a night This is currently underway and is something occur in small numbers. This technique the training of paramedical staff and from their loved ones just because I am very excited about. could virtually eliminate that in certain having tools to be able to complete you do not think radial access is worth See “Radial MasterKlass” with high risk cases. cases and tips for challenging cases. I learning is doing the patient a disservice. Darren Klass on page 15

March 2017 Vascular access 15 Achieving haemostasis in radial artery access The VasoStat (Forge Medical) is a haemostasis device designed for radial, sary amount of force based on the haemostasis in upper extremity brachial and transpedal procedures. The device is placed over the puncture site patient’s body habitus, residual access was just over 20 minutes, to achieve haemostasis by maintaining precise alignment over the radial artery heparin activity and sheath size. and the median time haemostasis across the needed range of pressure, without causing complete occlusion. The VasoStat device consists of following transpedal interven- Interventional News spoke to Timothy Clark, director of Interventional Radiology a central compressive plunger tion was just over 40 minutes, at Penn Presbyterian Medical Center, Philadelphia, USA, and cofounder and chief (similar to a person’s finger or which was attributed to heparin executive officer of Forge Medical, about how the VasoStat was conceived and thumb) which is aligned and an- doses being double in the lower the clinical experience with the device so far. chored within an outer footplate. extremity access group. Only A unique ratcheting mechanism a single event of radial artery What is the VasoStat How did you first allows the operator to precisely occlusion (1/72, 1.7%) was seen, device? conceive of the control the degree of compression which, although symptomatic, The use of radial access for cor- VasoStat device? in a uniform fashion according to was successfully managed with onary and peripheral interven- Relatively long times to achieve the needs of the individual patient. mechanical thrombectomy. This tions has been rapidly growing haemostasis are seen follow- When sufficient time has elapsed study will be presented in more in the USA, and within the next ing radial procedures. This has to achieve haemostasis, the ratch- detail at the Society of Inter- five years is expected to ap- been attributed to the fact that eting mechanism is released to ventional Radiology meeting in proach rates seen in many parts the arteriotomy and sheath are uncouple the compressive plunger March 2017. of Europe, Canada, and Asia. In substantially larger proportional from the footplate. The device is In another study of 314 pa- those and many other regions, to the size of the access artery then peeled off the patient’s skin tients with Rutherford class 2–5 radial access has supplanted compared to femoral access. to remove it. disease undergoing transpedal femoral access as the dominant What our practice has observed revascularisation, Kwan et al vascular access technique for in the last decade of performing Timothy Clark What is the clinical compared the performance of most coronary and many periph- radial and transpedal procedures experience of the the VasoStat device with the TR eral (such as visceral emboliza- is that the most effective haemo- volar aspect of the wrist. These VasoStat device? Band (Terumo). Both devices tion) procedures. Brachial access stasis can be obtained with highly balloon-type radial bands do not In the USA, we are now just showed equivalent performance continues to be widely used for focused pressure precisely aligned provide a high degree of preci- starting to see published out- in terms of time to haemostasis a variety of niche applications, over the arteriotomy site, similar sion and can be very uncomfort- comes with encouraging data on and a low rate of complications. including complex endovascu- to holding a thumb or finger over able for patients. Because of their very low rates of access artery However, the two groups were lar aneurysm repair. Increasing the radial artery for the required lack of precision, longer times occlusion and other complica- quite dissimilar in that almost all numbers of patients with critical length of time for successful to haemostasis are required and tions, while achieving haemosta- of the patients in the VasoStat limb ischaemia has resulted in haemostasis. Holding manual a variety of complications have sis in substantially shorter times group underwent complex, wider use of transpedal access pressure for one to two hours been observed, including arterial than balloon-type radial bands. multilevel orbital atherectomy during lower extremity revascu- is simply not feasible in a busy occlusion, nerve injury, venous In a study from our own centre and angioplasty compared to larisation procedures, both for clinical environment, so an array congestion and skin injuries, ie. at the University of Pennsyl- simple balloon angioplasty in the crossing/rendezvous techniques of dedicated radial haemostasis “handcuff syndrome”. We saw an vania, in a cohort of patients majority of the TR Band group. and even standalone access. The devices have been introduced to unmet need for a different type undergoing a total of 72 radial, Mean access artery diameter VasoStat is designed to have the the market. Current radial com- of radial haemostasis device, and brachial, ulnar and transpedal in- was also significantly smaller in versatility of achieving haemo- pression devices typically consist ideally one that could also be terventions during embolization the VasoStat group than the TR stasis in each of these anatomic of one or more inflatable bladders used for brachial and transpedal or revascularisation procedures, Band group. VasoStat substan- locations. From a regulatory tightly opposed to the arterial haemostasis. VasoStat achieved successful tially improved clinic workflow standpoint, the device has US access site with a circumferential We took an entirely different haemostasis in 100% of cases. through a reduction in puncture Food and Drug Administra- band encircling the wrist and approach with the design of the VasoStat produced substantially site assessments and a stream- tion clearance and CE mark for fixated with overlapping Velcro. VasoStat by emulating the physics shorter times to haemostasis lined removal protocol by nurs- upper extremity and pedal/tibial As the bladders are progres- of a human thumb or finger hold- compared with previous stud- ing personnel, which enabled arterial puncture site haemo- sively inflated, greater compres- ing precise pressure aligned over ies employing balloon-type more cases to be performed on stasis. sive force is achieved over the the radial artery with the neces- radial bands. The median time busy clinical days. Radial “MasterKlass” with Darren Klass Klass’ top tips for beginners Essential devices 45-degree, 150cm cath- access, given the anatomy „„Attend a course; the vessel and ensure you Always use a sheath de- eters on the shelf for taller of the dorsal radial artery. it is invaluable for do not cause unnecessary signed for the radial artery, patients for pelvic work as setting up a service and spasm or complications there are multiple options well as proximal superficial Radial access in making sure your nurses due to a missed radial and all come with an access femoral artery work. A five years and technologists are loop or aberrant anatomy. needle and wire, a femoral 150cm microcatheter is also I hope it will have the same engaged. „„Always remove the sheath cannot be used. I use an essential. trajectory as radial access „„Take time to make sure catheter over a wire; a single catheter for all of An indispensible piece of in cardiology in Europe and the room set-up is optimal although it may be my visceral work (Ultimate equipment is the sheath- New radial access Asia. If 50% of centres are for you and your team. unnecessary in many 1; Merit Medical) and a less guide catheter range technique doing radial that will be a „„Plan complex cases situations, removing 45-degree angled catheter (Asahi-INTECC), which I am working on a new huge achievement. I would well so you have the a catheter with an for everything else. allows the operator to use technique of accessing like to qualify that by saying correct inventory unprotected tip through The Ultimate 1 shape is large bore guiding catheters the dorsal branch of the radial intervention is not a available. A common the radial artery can mirrored by other manufac- for complex procedures radial artery, proximally in religion; the patient is cen- misconception with cause discomfort for turers and is essential for without having to use large the anatomical snuffbox. tral, not the procedure. What inexperienced operators is the patient, or worse visceral work. The more sheaths. This allows for up This technique has been I mean is this should be a thinking 100cm catheters (spasm, dissection and important aspect is catheter to 8.5F guiding catheters well-described in Russian technique practiced by all are long enough; they thrombosis). length. I have both 110cm to be used in the radial literature, and appears to interventional radiologists, more often are not. „„Engage with your and 125cm 4F and 5F radial artery and opens a platform be more comfortable for because it is better for pa- „„Always perform an cardiology colleagues; catheters on my shelf which for stenting using covered patients with an even lower tients. However, the femoral ultrasound of the radial they have tremendous I use for all my cases includ- self-expanding and balloon rate of haematoma and artery is still essential in artery to assess size and experience and are a great ing pelvic work (trauma, expandable stents, as well as bleeding than conventional our everyday work. I still anatomy. This will ensure resource (you will not gastrointestinal bleeds and complex balloon occlusion radial artery access. The access the femoral artery all you do not overstretch spontaneously combust!). uterine fibroid embolization) or multicatheter embolic haemostasis is simpler and the time, but if I have the and also keep a 4F and 5F protection techniques. faster than conventional choice, I choose radial. 16 Interventional oncology March 2017 MIRACLE I demonstrates high tumour control rate for drug-eluting microspheres Goetz Richter, Clinic for Diagnostic and Interventional Radiology, Stuttgart, Germany, presented breaking data from the Miracle 1 multicentre hepatocellular carcinoma trial at The Symposium on Clinical Interventional Oncology (CIO, 4–5 February, Hollywood, Florida). He spoke to Interventional News on the role of drug-eluting particles in interventional oncology.

What are the key findings from the spheres. Additionally, these small microspheres loaded MIRACLE 1 trial? with doxorubicin provided good local tumour control. We MIRACLE I study results demonstrated a high tumour never encountered pulmonary complications indicating that control rate and few serious adverse events among patients choosing a size of 75µm for drug-eluting particle emboli- with locally or clinically unresectable hepatocellular carci- zation does not entail systemic (shunt) risk as compared to noma treated with Embozene Tandem (Boston Scientific) Y-90 therapy. microspheres loaded with 150mg doxorubicin. Specifically, complete response was achieved in nearly half of the patients What is the role of drug-eluting particles Goetz Richter (48%) treated; 19% had a partial response; 29% had stable in interventional oncology? disease; and disease progression was observed in only one The role of drug-eluting particles is growing. As the body sizes for drug-eluting bead embolization in hepatocellular patient (5%). No specific safety concerns were associated of evidence demonstrating procedural safety, tumour carcinoma. This was not tested in this study. with the small 75µm microsphere size used in the study, and response, and a lack of systemic effects grows, it builds systemic toxicities were minimal with no myelosuppression support for drug-eluting embolic therapy as an option for In general, what are the trends you and only one patient developing mild alopecia. patients with hepatocellular carcinoma and other cancers see with regard to embolic particles in Although the study was relatively small with 25 patients that have few or no other treatment alternatives. interventional oncology? enrolled, it was fairly representative of a “real world” situ- Embolic particles are very versatile and the ability to ation of hepatocellular carcinoma interventional treatment: What were some of the limitations of load drugs further adds to their therapeutic potential. This around 40% of the patients had ascites and, furthermore, MIRACLE 1? potential will not be restricted to its use in hepatocellular almost 40% had an advanced stage of liver disease besides The study sample size was small with 25 patients and, as carcinoma alone. Research is ongoing to test the safety the tumour burden (Child B and C stage). with many studies of hepatocellular carcinoma treatment, and efficacy of particle embolization in liver metastastic These study results support the safety of transarterial patient characteristics such as tumour burden and severity disease. There is also interest in combining the use of em- chemoembolization (TACE) procedures using drug-eluting of liver disease varied widely. Furthermore and theoreti- bolic particles with thermal ablation in a variety of organs beads performed with small (75µm) calibrated micro- cally, it would be conceivable to use 40µm or 100µm to enhance safety and efficacy.

ADVERTORIAL International guidelines endorse Lipiodol® TACE “with strongest force of recommendation”

Thierry de Baère, Department of Interventional Radiology, Gustave different groups treating these patients. Roussy, Villejuif, France, tells Interventional News that the safety The advantage of TACE is that there and efficacy of conventional transarterial chemoembolization is no needle stick to the tumour, thus (cTACE, also known as Lipiodol TACE) is supported by 30 years avoiding potential bleeding or seeding of publication data. These data come from randomised controlled complications,” de Baère said. trials and meta-analyses, enabling European guidelines to endorse Lipiodol TACE with “the strongest force of recommendation” (1A) Lipiodol TACE is “standard due to level one evidence from the literature. of care” treatment in European and international 2016 publication in Hepatology MEDLINE and EMBASE databases. We guidelines (Lipiodol transarterial reviewed 1,564 articles and selected 101 “The European Association for the Study of A chemoembolization for to analyse the efficacy and 217 to assess the Liver (EASL) – European Organisation hepatocellular carcinoma: a systematic the safety. A total of 10,108 patients treated for Research and Treatment of Cancer review of efficacy and safety data from with Lipiodol TACE were analysed for effi- (EORTC) clinical practice guidelines Lencioni et al) recognised that TACE cacy and and a total of 15,351 patients were Thierry de Baère for the management of hepatocellular using lipiodol-based regimens, including analysed for safety. Notably, the review un- carcinoma are an important joint effort in the administration of an anticancer- derscored that the results obtained in more ment that has demonstrated superiority to between the two organisations to assist in-oil emulsion followed by embolic recent studies show improved overall sur- supportive care in two randomised trials physicians, patients, healthcare providers, agents, is widely used in the treatment of vival with Lipiodol TACE compared with and several meta-analyses in the treatment and health policy makers from Europe hepatocellular carcinoma. Findings from the overall survival rates seen in the 2002 of hepatocellular carcinoma. Consequently, and worldwide in the decision-making the paper suggest no new safety concerns Lo and Llovet randomised trials. In the it is today the treatment of intermediate process according to evidence-based data with the procedure and that current results Kudo et al study from 2014, there is a 26.1 stage hepatocellular carcinoma according on epidemiology, surveillance, diagnoses are in line with previous randomised month median and 54% two-year survival to Barcelona Clinic Liver Cancer (BCLC) and treatment of hepatocellular carcinoma. controlled trials. in 253 prospectively enrolled patients and classification, which accounts for roughly Lipiodol TACE is recommended with “We performed a systematic review to in the JIVROSG/KIVROSG Cooperative 20% of the hepatocellular carcinoma popu- the strongest force of recommendation understand the current safety and efficacy Group (Ikeda et al from 2013) prospective lation. It is noteworthy that the GIDEON (1A) due to a level one evidence from the data of Lipiodol TACE in treatment of trial of Lipiodol chemoembolization in 99 study looking at treatments received by pa- literature,” de Baère told Interventional hepatocellular carcinoma,” the authors, who patients with unresectable hepatocellular tients before they receive sorafenib, reports News. Lipiodol is also endorsed by include de Baère, write. carcinoma, there is a 37-month median that 47.2% of patient receive TACE before the American, Chinese and Japanese Commenting on the findings from the survival and a 75% two-year survival.” sorafenib, he added. international clinical practice guidelines. paper, he said: “This review clearly under- “Lipiodol TACE also has a role to play De Baère delivered the Josef Roesch lines the safety and efficacy of Lipiodol Current role of Lipiodol in in the bridge to transplantation situation, Honorary Lecture at CIRSE 2016 (10–14 TACE. It is noteworthy that the study ex- hepatocellular carcinoma but the choice between TACE and ablation September, Barcelona, Spain) on the topic amined the literature published on Lipiodol treatment depends on the patient’s status as well “Interventional radiology evolution in TACE between 1980 and 2013 using the “In 2017, Lipiodol TACE is the only treat- as different therapeutic algorithms from oncology: tools, treatments, guidelines”.

18 Interventional oncology March 2017 MAVERRIC to compare microwave ablation to surgery for resectable colorectal liver metastases The Karolinska Institute-sponsored, prospective, observational MAVERRIC study aims to demonstrate that a strategy of first line local microwave ablation of colorectal liver metastases is not inferior to liver resection in terms of survival rates at three years.

acob Freedman, principal Danderyd University Hospital, investigator of the study Division of surgery, Sweden. Jtold Interventional News: The study has set out to enroll “The lack of data that compare a cohort of 100 patients who local ablative treatment with will be treated with CT-guided resection for liver metastases microwave ablation (performed prompted us to undertake this with any generic microwave ab- study. Ablative treatment has, lation system cleared for clinical Jacob Freedman CAS-One system for many years, been used as an use). In order to be eligible for adjunct to resection and as an enrolment patients should have pancreaticobiliary units in for further interventions; and can be ablated with a single alternative when major surgery one to five metastases of less Stockholm (Sweden), Bern health-economic analysis. antenna. is contraindicated because of than 31mm in size. All lesions (Switzerland) and Groningen Commenting on the choice “All procedures are CT guid- comorbid conditions. It has been need to be amenable to CT- (the Netherlands). of ablation modality, Freed- ed with computer assisted guid- clearly shown that ablative treat- guided percutaneous microwave “The study is in full swing man said, “We chose micro- ance using the CAS-One system ment is easier for the patient, ablation, and the patient also recruiting patients from all three wave because it has clearly (CAScination). We are not using resulting in far fewer complica- needs to be deemed “resect- centres since December 2016. been shown that it has benefits, ultrasound because we want to tions and a much shorter length able” and be so evaluated at a We now have 40 of the planned although these are small, have optimal documentation of hospital stay, but whether multidisciplinary tumour board 100 patients treated and hope to compared to radiofrequency of each antenna placement for survival, the most important meeting. The outcomes of abla- close the study in early 2018,” ablation. The energy is deliv- future reference, if there are variable, is on par with surgery tive treatment will be followed Freedman explained. ered faster which reduces heat- recurrences. I am convinced that has not been shown despite a and compared with matched The secondary endpoints out- sink problems and shortens fused ultrasound would have decade of speculation.” controls from the Swedish liver lined are: survival at five and 10 anaesthesia times. There is no been as good in most situations, Freedman is associate profes- surgery registry (Sweliv). years; interventional complica- charring of tissue and no prob- but retrospective review is much sor, Karolinska Institutet, De- The study is a multi-insti- tion rates; length of stay; precise lems with conductivity [with more difficult with ultrasound partment of Clinical Sciences, tutional effort by the hepato- measurements of ablation; need microwave]. Larger lesions images,” he concluded.

Navigation opens new perspectives for percutaneous interventions

target accuracy, to reduce procedure time, The system uses four to six reflective to reduce procedure cost and if possible to spheres that are positioned in a predefined reduce radiation exposure. array in the line of sight of the infrared The main system categories that have camera. The patient is positioned in a been developed for interventional radiol- vacuum fixation system in order to limit MILTIADIS KROKIDIS ogy navigation are computed tomography potential movement. A CT scan of the tar- (cone-beam CT [CBCT]) systems, elec- get region with 1mm slice reconstruction tromagnetic tracking systems and optical is obtained and the images are fused with navigation devices. the registration information obtained from COMMENT & ANALYSIS CBCT systems may be used alone or the optical markers. The position of the in a hybrid setup with fluoroscopy. In the markers is confirmed on fusion imaging. Navigation systems have been developed to increase target latter, the needle trajectory is planned after Three further optical markers are placed in accuracy, reduce procedure time, reduce procedure cost and, if, CT pictures are obtained and the path is a mechanical arm that is used for needle possible to reduce radiation exposure, writes Miltiadis Krokidis, fused onto real time fluoroscopy pictures. placement. When the needle trajectory Cambridge, UK. Such systems appear to increase technical is defined, the mechanical arm is locked success rates of needle placement proce- and the needle can be potentially inserted he overall concept behind naviga- ventional radiology applications? dures. The main drawback is the radiation without image guidance, significantly tion systems is to localise an object The quintessence of interventional exposure that is required for real time reducing radiation exposure. Tand the exact relationship that the radiology is accurate device manipulation needle placement and the fact that patient The system was recently introduced in object has with its surrounding struc- under image guidance to target spe- respiratory motion may impair registration the UK and the first two cases were per- tures. Navigation systems in medicine cific tissue. Percutaneous image-guided and decrease accuracy. Significant reduc- formed in Cambridge University Hospitals were initially introduced in neurosurgery interventions offer a minimally invasive tion of radiation may be achieved with for the ablation of two kidney tumours and orthopaedics and their use has been solution for a variety of conditions and the use of electromagnetic systems. These with excellent results. considered a significant milestone, com- their number has exponentially increased are based on the use of sensor coils with Navigation systems inevitably come parable to the use of general anaesthesia in the last decades. Image-guided biopsies, differential magnetic fields and offer a sig- with an added initial cost that is not or the use of microscopes as they offered drainages and tumour ablation have an es- nificant advantage in ablation procedures negligible. Nevertheless, in the long term, surgeons the possibility to reach targets tablished role in the management of com- and lung biopsy. the standardisation of procedures, the pre- that were otherwise not visible, to avoid plex patients. Accurate needle placement Optical navigation devices use a stereo- dictability of the result, the reduction of adjacent organs and to be oriented in the is of paramount importance to achieve scopic camera that emits infrared light and procedure time and the lower morbidity/ absence of anatomical landmarks. treatment and to avoid complications. can determine a 3D position of reflective mortality are expected to offer a reduction In interventional radiology, imaging In the past, tissue targeting depended marker spheres. This allows for real-time of the overall cost. More precise needle offers all that. Tissue targets are visible, exclusively on the talent, the stereotac- tracking of the position of the marker placement will lead to more accurate adjacent organs can (mostly) be avoided tic perception and the experience of the spheres. A free line of sight is required tissue sampling for biopsies; increase the and there is always perception of needle operator. As the complexity of percutane- between the camera and the markers. Sys- range of lesions that may be considered position in relationship with the surround- ous interventions increased the necessity tems that use fusion imaging combined as suitable for drainage; and permit the ing anatomical organs. So what could be for accuracy and reproducibility has also with optical navigation have been also de- placement of multiple ablation electrodes the added value of navigation systems and increased. Navigation systems have been veloped. The CAS-One navigation system with specific distance and array configura- why have they been developed for inter- therefore developed aiming to increase (Cascination) is based on this principle. Continued on page 19 March 2017 Interventional oncology 19

Continued from page 18 tion. Furthermore, with the use of fusion imaging, lesions that are not visible on standard imaging modalities may be detected and targeted, therefore, increasing the range of lesions that may be treated percutaneously. As technology evolves, navigation systems will be further integrated into interven- tional radiology procedures. The use of optical navigation systems with integrated fusion imaging and no requirement for continuous screening appears to open new perspectives for percutaneous interventions.

Miltiadis Krokidis is a consultant vascular and interventional radiologist, Cambridge University Hospitals, Cambridge, UK. He has reported no disclosures pertaining to this article.

Early data suggest ablation has favourable outcomes for selected small cell lung cancer patients A preliminary analysis suggests that thermal ablation may be effective in selected patients with local small cell lung cancer without adjuvant therapy. The research from Brown University, Providence, USA, was published in the Journal of Vascular and Interventional Radiology (JVIR).

aron WP Maxwell and colleagues, including Damian E Dupuy, Afrom The Warren Alpert Medi- cal School of Brown University set out to evaluate outcomes in a small cohort of patients with local or disseminated small- cell lung cancer who received percutane- ous thermal ablation. About 12% of lung cancers diagnosed are small cell lung cancer and this type of cancer is usually caused by smoking. Small cell lung cancer often spreads early on and chemotherapy, rather than surgery might be recommended for it. Percutaneous ablation has become an Targeting tumours accepted treatment option for patients with non-small cell lung cancer and lung tumours. The study set out to deter- published literature has shown it to be mine the long-term safety and efficacy of both feasible and safe in nonsurgical microwave ablation in the treatment of candidates. lung tumours at a single academic medi- In this study, the investigators retro- cal centre and was published in JVIR in spectively evaluated 10 biopsy-proven February. small cell lung cancer tumours in nine Terence Healey and colleagues re- consecutive patients. As reported in JVIR, viewed data from 108 patients who under- the average tumour sizes were 1.8±0.5cm went CT-guided percutaneous microwave in patients with local disease and ablation for a single lung malignancy. 2.6±1.2cm among patients with dissemi- Eighty-two were primary non-small cell nated disease. The physicians treated five lung carcinoma and 24 were metastatic tumours with microwave ablation and five tumours. The mean maximum tumour with radiofrequency. None of the patients diameter was 29.6±17.2mm. The investi- received adjuvant therapy following ther- gators reviewed clinical and imaging data mal ablation. Median follow-up duration and performed statistical analysis. was 16 months (range 2–48 months). They found that the odds of primary When Maxwell and colleagues technical success were 11.1 times higher compared median and one-year overall for tumours smaller than 3cm (original tu- survival for patients in the local and mour maximal diameter; OMD) vs. those disseminated disease groups, they found larger than 3cm. Healey et al reported that that both these measures were better for every millimetre increase in OMD, the among patients treated for local small cell odds of not attaining success increased by lung cancer compared with disseminated 7%. Further, for every millimetre increase disease. Further, they found that pneumo- in OMD, the odds of complications thorax occurred in five patients (55.6%), increased by 3%. They also found that and three patients received successful median time to tumour recurrence was 62 outpatient thoracostomy tube placement. months. Recurrence rates were estimated No patients were hospitalised, and there at 22%, 36%, and 44% at one, two, and were no major complications. three years, respectively. Recurrence rates were estimated at 31% at 13 months for Microwave ablation safe and tumours >3cm and 17% for those <3cm. effective for lung tumours Complications included pneumothorax New data from a retrospective review (32%), unplanned hospital admission from the same group supports the use of (28%), pain (20%), infection (7%), and microwave ablation for the treatment of postablation syndrome (4%). 20 Interventional oncology March 2017 The role of Y-90 radioembolization for cholangiocarcinoma

single-centre reports. The majority of survival between these two therapies in these patients were treated in a salvage this retrospective review. situation following progression on These data have prompted NCCN to systemic chemotherapy. Overall re- include locoregional therapy as one of WILLIAM RILLING sponse rates to Y-90 radioembolization the treatment options for unresectable show progressive disease in the liver in and recurrent intrahepatic cholangio- only 15–25% of patients with disease carcinoma. The ESMO guidelines also control obtained (combination of partial endorse locoregional therapy including COMMENT & ANALYSIS response and stable disease) in 75–80% Y-90 radioembolization for second line of patients. Another clear advantage of treatment of locally advanced or meta- Y-90 radioembolization is a promising locoregional therapy for Y-90 radioembolization is the excellent static intrahepatic cholangiocarcinoma. a devastating disease with few available treatment options. tolerance of the therapy and low toxic- Based on the reported success of Ongoing and future clinical trials will help to determine if Y-90 ity. The incidence of high-grade adverse these early studies, a prospective phase radioembolization can safely be integrated with systemic events in all published series is rare. II trial has been initiated to study the chemotherapy, writes William Rilling, Milwaukee, USA. Most patients require only one or two safety and efficacy of combining Y-90 treatment sessions, preserving quality radioembolization with gemcitabine and ften overshadowed by hepatocel- does not play a role, at this time, in the of life in this patient population with cisplatin for unresectable intrahepatic lular carcinoma, cholangiocarci- treatment of extrahepatic cholangiocar- limited survival. cholangiocarcinoma. The study will be Onoma is frequently referred to as cinoma, but there is growing evidence of A recent pooled analysis of Y-90 using Y-90 resin microspheres and is “the other liver cancer”. This is a rare but its benefit in the treatment of intrahepatic radioembolization for intrahepatic chol- currently enrolling and additional phase devastating malignancy with poor five- cholangiocarcinoma. angiocarcinoma was published in the III studies are planned. year overall survival rates of <5%. Surgi- Despite its aggressive nature, chemo- European Journal of Surgical Oncol- In summary, Y-90 radioembolization cal resection is the only standard curative therapy for cholangiocarcinoma has had ogy in 2015. The analysis included 298 is a promising locoregional therapy for treatment. However, only 20–30% of limited success. Current standard of care patients in 12 studies. Overall median a devastating disease with few available patients present with resectable disease chemotherapy includes gemcitabine and survival was 15.5 months. Tumour treatment options. Ongoing and future and intrahepatic recurrence is common cisplatin with reported median survival of response rates were partial response in clinical trials will help to determine if even after an R-0 surgical resection. 12 months and progression free survival of 28% and stable disease in 54% at three Y-90 radioembolization can safely be Transplant is performed in very highly eight months in a phase III trial published months post treatment. integrated with systemic chemotherapy. selected patients who undergo a rigorous in the New England Journal of Medicine Other liver-directed therapies, primar- Future research is needed to further pretransplant protocol and the long-term in 2010. Both National Comprehensive ily chemoembolization, have also been define the role of different locoregional results of liver transplant for this disease Cancer Network (NCCN) and European shown to be effective in intrahepatic therapies in this disease, which is in- are still somewhat uncertain. Society of Medical Oncology (ESMO) cholangiocarcinoma. In a recent multi- creasing in incidence worldwide. The overall management of intrahepat- guidelines do not endorse any specific centre review, 198 patients with unresect- ic cholangiocarcinoma and extrahepatic second line chemotherapy regimen. able intrahepatic cholangiocarcinoma William Rilling is professor of Radiology cholangiocarcinoma differ significantly. Multiple retrospective single centre reviewed were treated at five institutions and Surgery, Vascular and Interventional Extrahepatic cholangiocarcinoma is man- series have been published reporting the over 20 years in the USA. The majority Radiology and vice chair, Clinical aged surgically when possible, occasion- safety and efficacy for Y-90 radioem- of patients in this review (128) have been Operations, Department of Radiology, ally aided by transhepatic biliary stents bolization in unresectable intrahepatic treated with conventional chemoem- Medical College of Wisconsin, for hilar cholangiocarcinoma. Adjuvant cholangiocarcinoma. Median overall bolization and with 46 patients treated Milwaukee, USA. He is a consultant for chemoradiation is sometimes employed survival ranging from nine to 22 months with Y-90 radioembolization. There was BTG and receives research support from post-resection. Y-90 radioembolization were reported in some of the initial no significant difference in the overall Sirtex for clinical trials.

Prevention and management of complications of Y-90 therapy of prior coil/plug embolization), and young patient age. We no longer routinely embolize the gastroduodenal and right gastric RIPAL GANDHI artery for both glass and resin microspheres as the development of collateral vessels can often complicate subsequent radioem- COMMENT & ANALYSIS bolization. A paper from the Stanford group demonstrated that Figure 1: A patient Most complications related to Y-90 therapy may be prevented or mitigated 34% of patients required 31% ad- with hepatocellular with appropriate patient selection, careful pretreatment planning, meticulous junctive embolization procedures carcinoma presenting with procedural technique, and optimisation of dose with use of dose reduction for hepaticoenteric vessels at time radioembolization-induced strategies when appropriate, writes Ripal T Gandhi, Miami, USA. of Y-90 administration even when liver disease six weeks after all hepaticoenteric vessels were radioembolization. The patient ransarterial yttrium-90 complications. nephropathy). embolized at mapping angiog- developed jaundice and ascites radioembolization is an Toxicities can be divided into Gastrointestinal ulcers occur in raphy. Despite re-embolization, with elevated bilirubin and Taccepted modality for three main categories: those <5% of cases due to inadvertent 7.1% of patients still developed a alkaline phosphatase without treatment of both primary and related to non-target deposition of delivery of radiomicrospheres to gastric or duodenal ulcer. tumour progression. metastatic liver malignancies and the radiomicrospheres (gastric or the gastroduodenal artery (GDA), Patients who develop gastro- has become incorporated into duodenal ulceration, oesophageal right gastric artery, left gastric intestinal ulcers typically present to heal due to injury arising several National Comprehen- injury, pancreatitis, skin damage, artery, or supraduodenal artery. hours to days after radioembo- from the serosal surface. In our sive Cancer Network (NCCN) and cholecystitis; compromised Ulcers can be prevented with lization with abdominal pain, practice, we prophylactically pre- guidelines. Although radioem- liver function due to radiation meticulous planning angiography anorexia, nausea, vomiting, and/ scribe proton pump inhibitors at bolization is generally a safe induced parenchymal damage and utilisation of cone beam or gastrointestinal bleeding. In the time of mapping angiography and effective procedure, adverse (radioembolization-induced liver CT. Factors that increase risk of one study, mean time to diagnosis and continue for three months. events may occur and it is critical disease); technical complica- ulcers include stasis during deliv- was 3.2 months. Suspicion for Patients who develop ulcers are that the procedural physician is tions related to angiography and ery, distal origin of the gastroduo- ulcer should be confirmed with treated with proton pump inhibi- familiar with strategies to both embolization (groin haematoma, denal artery, proximal administra- endoscopy and aggressively tors, sucralfate, sodium bismuth, prevent and manage potential dissection, contrast-induced tion of Y-90 (even in the setting treated as they can be difficult Continued on page 21 March 2017 Interventional oncology 21

Continued from page 20 and motility agents. Pentoxifylline and al- pha-tocopherol (vitamin E) have also been shown to be beneficial. Chemotherapy and especially biologic agents may have to be temporarily withheld as these may interfere with ulcer healing. Ulcers refractory to medical management may require surgery. Radiation-induced cholecystitis is rare, oc- curring in <2% of patients. When feasible, it is our approach to deliver the Y-90 distal to the cystic artery. In patients with a par- ticularly large cystic artery in whom distal delivery is not possible, distal split dosing may be considered. We do not typically coil embolize the cystic artery given the Figure 2: High lung shunt (30%) low incidence of radiation-induced chol- demonstrated on planar scan following ecystitis, however, we do use prophylactic Tc-MAA administration in patient with antibiotics following radioembolization hepatocellular carcinoma and hepatic if the gallbladder is in the radiation field. vein invasion. Most cases of cholecystitis can be managed conservatively with antibiotics, hydration, occurs one to six months after radioembo- and pain control. Surgery or cholecystos- lization with non-productive cough, low tomy may be necessary in severe cases. grade fever, and progressive exertional Radioembolization-induced liver disease dyspnoea. Classic imaging feature is (REILD) occurs in <4% of patients and patchy consolidation with peripheral can be potentially fatal. Patients typically sparing (aka bat-wing appearance). present one to two months after radioem- Radiation pneumonitis is managed with bolization with jaundice and ascites with steroids and bronchodilators. Pentoxi- elevated bilirubin and alkaline phosphatase fylline may also be considered as it is (aspartate transaminase/alanine transami- radioprotective and prevents early and nase may be normal) in the absence of late pulmonary toxicity. tumour progression or biliary obstruction Hepatobiliary infection (liver abscess (Figure 1). Risk factors include patients or cholangitis) may occur after radi- with abnormal liver function, cirrhosis, ex- oembolization, typically in patients with posure to multiple lines of chemotherapy, biliary-enteric anastomosis, sphincter- prior radioembolization or external beam otomy, or biliary stent/drain across the radiation, and single session whole liver ampulla. The risk is significantly lower Y-90 administration. Biopsy of normal with Y-90 than with chemoembolization, liver may be needed to confirm diagnosis; likely due to the less embolic nature of pathologic hallmark is veno-occlusive dis- radioembolization. Liver abscess is treated ease. Steroids are the mainstay of therapy. with antibiotics and percutaneous drainage. Since the underlying pathophysiology Given the significant morbidity of infection, involves veno-occlusion, defibrotide and patients with prior biliary instrumentation anticoagulation may be considered. Radio- should be prophylactically treated with protectants such as ursodeoxycholic acid an aggressive antibiotic protocol (with or and pentoxifylline may also be beneficial. without bowel preparation) before and after Radiation pneumonitis is extremely rare Y-90 administration to decrease the risk. with an incidence of <1%. It is important Most complications related to Y-90 that dose to the lungs is <30Gray in a therapy may be prevented or mitigated single Y-90 administration and <50Gray with appropriate patient selection, careful cumulative during lifetime to minimise pretreatment planning, meticulous proce- risk. It is reasonable to be more conserva- dural technique, and optimisation of dose tive in patients with chronic obstructive with use of dose reduction strategies when pulmonary disease, prior lung resection or appropriate. other disease with compromised pulmo- nary function. High lung shunts are typical- Ripal T Gandhi is an associate clinical ly seen in tumours with vascular invasion professor, FIU Herbert Wertheim College (such as hepatocellular carcinoma), large of Medicine, Miami Cardiac & Vascular tumour burden, and infiltrative disease Institute, Miami, USA. He is a consultant (Figure 2). Clinical presentation typically to Sirtex and BTG.

SIRT access “under threat” from Commissioning through Evaluation process Selective internal radiation therapy (SIRT) has been available since December 2013 to a defined group of patients with liver metastases in England on the National Health Service (NHS) via a special Commissioning through Evaluation scheme from NHS England. However, NHS England has now decided to stop funding SIRT at the end of March 2017 while it analyses the data obtained so far.

he British Society of Interventional Radiology (BSIR) and many interventional oncologists believe that this decision is unfair to patients who will be unable to Taccess SIRT on the NHS during the data analysis period and fear that the hiatus might result in the de-skilling of SIRT multidisciplinary teams that include interven- tional radiologists. There is also growing concern that referral networks for the treat- Continued on page 22 22 Interventional oncology March 2017 New NCCN guidelines recommend Y-90 resin microspheres for metastatic colorectal cancer treatment Sirtex has announced that Sir-spheres Y-90 resin microspheres have been Sirtex Americas. prolonged quality of life,” included as a Category 2A recommended treatment in the latest National These findings are also said lead investigator of Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology supported by the landmark the MORE study, Andrew S for colon cancer and rectal cancer. MORE study, a large Kennedy, director, Radiation retrospective analysis Oncology Research, Sarah his designation denotes milestone for Sir-spheres in conducted in the USA Cannon Research Institute, that there is uniform microspheres and provides with Sir-spheres Y-90 resin Nashville, USA. “We look Tconsensus among the further validation for the microspheres in more than forward to expanding access NCCN panel that selective role of our medical device 600 metastatic colorectal to this outpatient procedure, internal radiation therapy as an important treatment cancer patients. The MORE which has demonstrated (SIRT) with yttrium-90 option for unresectable, liver study helped to increase the minimal side-effects, to microspheres is an appropriate dominant metastatic colorectal understanding of SIRT as a improve outcomes for this option in patients with liver cancer. We also have positive treatment option for patients population of patients and dominant, chemotherapy signals in the first-line setting who have failed multiple advance the standard of care.” resistant colorectal disease. through the results to date of lines of chemotherapy while Sir-spheres Y-90 resin This recommendation the pivotal SIRFLOX study highlighting the positive microspheres are currently places Sir-spheres Y-90 and eagerly anticipate the aspects of the safety and the only microspheres with resin microspheres at the overall survival results in efficacy of the protocol for US FDA premarket approval same designation as the more than 1,100 patients from patients of all ages. for colorectal cancer that has recommended mCRC systemic the SIRFLOX, FOXFIRE Sir-spheres “Clinical research has metastasised to the liver, a chemotherapeutic regimens. and FOXFIRE Global studies shown that SIRT brings press release from Sirtex adds. “The 2A designation which we expect to be 2017,” said Kevin Richardson, patients with colorectal liver The new NCCN Guidelines represents a very important available in the first half of chief executive officer for metastases improved and are available online.

SARAH study results to be presented SIRT access “under threat” from commissioning as oral abstract at April conference through evaluation process Continued from page 21 The SARAH (Sorafenib vs. radioembolization in advanced ment could be lost in the analysis period when hepatocellular carcinoma) randomised controlled study SIRT will be unavailable to patients. results will be presented at the upcoming European Materials available at the BSIR annual meet- Association for the Study of the Liver (EASL), International ing (15–17 November 2016, Manchester, UK) Liver Congress (ILC) in Amsterdam, the Netherlands (19–23 note that according to the Health Minister, the April 2017). data analysis, which includes a cost-effective- ness analysis, “could take up to two years”. he study will be presented in the treatment of hepatocellular Many interventional radiologists maintain on Saturday, 22 April 2017. carcinoma, the release adds. that there is already substantial evidence T SARAH is a phase III mul- supporting the benefits of SIRT in patients ticentre prospective randomised SARAH and SIRveNIB with liver metastases from bowel cancer and open-label study for patients in investigators to undertake that the planned gap in provision is unfair Brian Stedman France that directly compared the combined prospective to patients. “In the light of the evidence, a efficacy and safety of Sir-spheres meta-analysis conclusion that NHS patients should not have If there is a positive analysis from the data, we Y-90 resin microspheres with the It was announced in October access to SIRT from April 2017 on the basis of will then have to re-skill these centres and this current standard-of-care systemic 2016 that liver cancer researchers insufficient evidence appears inconsistent with will be at a significant cost to the NHS. We are therapy, sorafenib (Bayer) in pa- from France (SARAH trial) and the published studies,” the material from BSIR seeking some form of interim funding so that tients with advanced non-resect- Singapore (SIRveNIB trial) will further adds. patients are not disadvantaged, and skills are able primary liver cancer. Unless collaborate on a prospective meta- Interventional oncologists emphasise that maintained, while the data is analysed.” embargoed, the study abstract will analysis of two studies of Y-90 it will cost the NHS both in terms of time and Stedman added: “In this scenario, we are be released on 5 April, a press resin microspheres vs. sorafenib in money to decommission services and then re- talking about patients who have failed two or release from the company states. patients with unresectable hepato- skill clinicians at a later date, if SIRT funding more lines of chemotherapy and these patients Patients with advanced hepatocel- cellular carcinoma. is lost for 12–18 months while the data is ana- are looking at few, or no, treatment options lular carcinoma (Barcelona Clinic Researchers from Assistance lysed. All these factors have led to the BSIR despite having a good quality of life. These Liver Cancer [BCLC] stage C) with Publique–Hôpitaux de Paris (AP- asking NHS England, as a matter of urgency, patients are not going to be cured by SIRT, but or without portal vein thrombosis and HP) and the Asia-Pacific Hepato- to allow for continuity of service provision our aim is to prolong life and maintain quality no extrahepatic spread, or patients cellular Carcinoma Trials Group from April 2017 onwards. of life. I strongly believe that liver-directed with early/intermediate hepatocel- (AHCC), National Cancer Centre Brian Stedman, consultant interventional therapies have a real benefit for our patients. lular carcinoma (BCLC stage A or Singapore (NCCS) and Singapore radiologist at University Hospital of South- Unlike with drugs, when it comes to innova- B) whose disease has progressed or Clinical Research Institute (SCRI) ampton, Southampton, UK, and chair of the tive device technologies, we are struggling to recurred after previous therapies; and announced that they will col- BSIR communications committee told Inter- get clear funding pathways. Prior to the Com- who are ineligible for surgical resec- laborate to combine the impending ventional News: “SIRT is a complex treatment missioning through Evaluation scheme, SIRT tion, ablation or liver transplantation results of two large, randomised that needs collaboration between interventional was regionally available through the Cancer were recruited to participate. controlled studies of Y-90 resin radiology and nuclear medicine and centres Drugs Fund. My issue is with the slightly ad The primary endpoint of the microspheres vs. sorafenib. The need to invest in equipment and staffing to get hoc funding of these technologies and this is a SARAH study is overall survival. two studies, which have completed this treatment underway. It took about a year difficulty that we need to address as an inter- Secondary endpoints include safety, patient recruitment, enrolled ap- to get the 10 centres who were delivering SIRT ventional oncology community.” progression-free survival at six proximately 800 patients with treatments in England up and running. Over In June 2013, NHS England agreed to fund months, quality of life, and health- advanced primary liver cancer. the last 18 months, most of these have been 660 NHS patients who had failed, or were care costs. They use similar research designs running at the level of activity that we have intolerant to chemotherapy, to receive SIRT for SARAH is the largest randomised to compare the efficacy, safety been expecting. Having developed this service the treatment of liver metastases from bowel study ever to compare selective profiles and quality of life of and expertise, our anxiety is that we are going cancer and biliary tract tumours in the liver internal radiation therapy using selective internal radiation therapy to be left with no funding mechanism for these at 10 NHS hospitals in England. The funding Sir-spheres microspheres against the (SIRT) with liver-directed Y-90 patients. If there is an 18-month hiatus, we are is scheduled to stop after an estimated 520 standard-of-care systemic therapy resin microspheres and sorafenib. going to lose the skill base in these 10 centres. patients will have been treated.

24 Interventional oncology March 2017 WCIO establishes Society of BTG and SIO to explore role Interventional Oncology of minimally invasive therapies In January 2017, WCIO announced that the board of directors of the in immuno-oncology organisation, a non-profit association that supports and promotes the field of interventional oncology (IO), has established the Society of BTG has announced a collaboration with the Society of Interventional Oncology (SIO). The establishment of the new society Interventional Oncology (SIO; a global organisation working was effective 17 January and its annual IO conference will continue to to nurture and support interventional oncology worldwide) to maintain its name of WCIO. explore the role of interventional oncology alongside immuno- oncology. s an established society, SIO This has led to the genesis of diseased- serves as the only membership- centered subspecialty societies for arterial ewly approved treatments, such as checkpoint inhibitors, have been “Abased organisation dedicated diseases (see “Barry Katzen announces new shown to prolong overall survival but only for a limited proportion wholly to the emerging field of IO working global society for critical limb ischaemia” Nof cancer patients, and only in certain tumour types. Combining to further promote the mission originally put on page 30 in this issue), acute and chronic immuno-oncology agents with the minimally invasive, locoregional therapies of forth by WCIO,” the press release adds. venous diseases, dialysis, spine, and stroke, interventional oncology has the potential to expand the number of cancer patients Further, it notes: “SIO benefits vary by where interventional radiologists join with who could benefit. Further research is needed to understand the potential of these membership level within the organisation. other specialists to advance care for specific combinations. Primary benefits include discounts on the patient populations.” SIO and BTG have established a working group to determine how best to WCIO conference, access to online educa- Soulen added: “SIO serves the same explore the role of interventional oncology alongside immuno-oncology in the tion through IO University, the opportunity mission for image-guided cancer therapies. fight against cancer. This group, which includes interventional radiologists and to apply for research grants, and voting The leaders in SIO wear many hats in immuno-oncologists, will identify unmet clinical needs and the critical areas of rights (contingent on level). several other professional societies in the science that require further dedicated research. The working group plans to pub- Michael C Soulen, board of directors wider oncology world, fostering collabo- lish a white paper to guide research and clinical practice later this year. and founding member, SIO told rations with these larger organisations to This collaboration also establishes an independent research fund that will en- Interventional News: “At our core, promote IO. In addition, SIO offers unique able SIO to offer grant funding to independent investigators to address the critical interventional oncologists are interventional benefits including the IO University, a unanswered questions for this combination therapy. SIO plans to fund collabora- radiologists. We are all members of the US$1.3 million online oncology educa- tive research ranging from exploratory pilot projects to prospective clinical trials. Society of Interventional Radiology tion platform that will support both the “SIO was founded to provide an optimal and necessary vehicle to nurture and (SIR), Cardiovascular and Interventional new interventional radiology/diagnostic support interventional oncology as the fourth pillar of cancer therapy worldwide. Radiological Society of Europe (CIRSE), radiology training pathway in the USA and This research collaboration with BTG will help provide the resources necessary Asia Pacific Society of Cardiovascular and CIRSE’s new IO curriculum in Europe; to further uncover how interventional oncology procedures may work synergisti- Interventional Radiology (APSCVIR), or a US$500,000 research grant programme cally when combined with another of the most cutting edge oncologic strate- similar societies as the primary professional for immuno-interventional oncology; gies—immunotherapy,” stated S Nahum Goldberg, vice-chair for Research and organisations of our specialty. IO-Central.org and IO Insights for news Head of the Interventional Oncology Unit, Hadassah Hebrew University Medical But optimal patient care is no longer the and online interactivity, and, of course, the Center in Jerusalem, Israel and SIO Interventional/Immuno-oncology Working province of solitary specialists; rather it is WCIO scientific meeting for interventional Group Chair. provided by multidisciplinary care teams. oncology, now in its twelfth year. See Melanie Lee’s (chief scientific officer, BTG) article on page 25.

Thermal drug activation using focused ultrasound could help utilise “very effective but very toxic” chemotherapy drugs site rather than to all areas of the body this further recipe of repeated focused which potentially can greatly decrease ultrasound short hyperthermia pulses the morbidity and complications seen we have found that there is a new, huge WLADYSLAW with many types of chemotherapy which increase in the overall concentration of are such a problem for many patients. the activated chemotherapeutic agent GEDROYC We have demonstrated this approach released from the thermally sensitive clearly in small animals showing that liposomes at the target site. In some tumours can be rapidly treated with instances we were able to increase COMMENT & ANALYSIS this combined focused ultrasound and the concentration of active current liposomal drug nanoparticle approach. chemotherapeutic agents at the site of Most drugs that we use are only required to work at one specific The advantages of this approach therapy by several hundredfold. point in the body and yet we administer them in a completely however do not stop at this point. We The potential of this type of approach systemic manner so that they affect all sites within the body, writes have discovered that the uptake of to allow treatment with few side-effects Wladyslaw Gedroyc, London, UK. the chemically engineered liposomes but with much greater local action is from the circulation is much greater very exciting. Not only will we be f a drug is quite toxic, or has engineer nanosized liposomal particles when the area in question is heated able to decrease side-effects from a very narrow therapeutic to encapsulate and carry a variety of than would otherwise be expected conventionally utilised chemotherapy, Iwindow, as with, for instance, drug payloads around the body without suggesting that this mild hyperthermia but we may be able to utilise very chemotherapeutic compounds, many the drugs having an action in the during this process opens up blood effective but very toxic drugs which are undesirable side-effects can be circulation. The liposomal drug particles vessel permeability allowing a much otherwise unusable to now treat just the experienced alongside the beneficial can be further engineered to be heat greater concentration of the circulating designated target lesions. effects at the site of concern due to sensitive so that when the temperature liposomes to be delivered into the We have also combined MR contrast drug distribution in healthy tissues. is raised by a controlled amount, the target site with a very large increase agents with the chemically engineered Methods of giving drugs that are only liposomes become porous and release in overall tumour concentration of the liposomes so that the area of deposition activated at the desired site of action their drug contents. Controlled non- drug. This is exciting in itself but we can potentially be visualised with MR are therefore highly desirable to interventional heating of a deep area of have managed to further engineer our imaging to further control and follow minimise side-effects (which may in the body where we require a therapeutic focused ultrasound pulse delivery so the therapeutic effect. some cases be very severe) and allow effect can be achieved using high that we not only heat the target site patients to remain relatively well whilst intensity focused ultrasound which can with non-invasive focused ultrasound Wladyslaw Gedroyc is consultant receiving maximum therapeutic effect be either ultrasound- or MR-guided. at the time of the drug circulation in its radiologist at St Marys Hospital, from the drug. Using this combination, it is possible to 1st pass but repeat this thermal mild Imperial College Healthcare NHS Trust, It is now possible to chemically deliver chemotherapy just to the cancer hyperthermia 30 minutes later. Using London, UK March 2017 Interventional oncology 25 Interventional oncology should identify “unmet immunotherapy needs” Daniel Sze, speaking at the ninth annual Hodgkin lymphoma, and system promotes attacking of Symposium on Clinical Interventional Oncology urothelial carcinoma. cancers throughout the body. (CIO; 4–5 February 2017, Hollywood, USA), noted Sze emphasised the high cost “Sorafenib taught medical that immunotherapy is a “huge opportunity” for of immunotherapy agents and oncologists to keep their interventional oncology. noted that health agencies in patients, avoid referral to some countries had halted their tertiary care, and avoid referral ze, professor of Radiology, sending in more US marines, routine use in the healthcare to interventional radiology. Stanford University, teach the local militia to expel system on the basis that they We cannot allow systemic SUSA, was speaking on the the insurgents,” he said alluding have not been shown to be cost- immunotherapies to repeat this potential role of immunotherapy to how immunotherapy works. effective. In addition, systemic history. We must re-establish in interventional radiology. As reported in the June 2016 administration may result in interventional radiology as a key “The immune system is cover story in Interventional life-threatening autoimmune player in cancer care. This will the natural defense against News, experts now believe that Daniel Sze toxicity, leading to warnings not be handed to us—we must cancer and plays a role in there could be a time when from the US FDA, he noted. generate the data,” urged Sze. surveillance, recognition, interventional radiologists no monoclonal antibody may result There are also other types “Interventional radiology attack and vigilance. It is longer perform procedures in autoimmune toxicity and of immunotherapies such must identify the unmet needs important to understand at least to destroy tumour tissue costs around US$150,000 for as cell-based therapy which within immunotherapy: many the checkpoints cytotoxic T alone—they might be ablating four infusions. PD-1/PD-L1 involves the introduction therapies are systemically toxic lymphocyte-associated protein or embolizing to provoke the inhibitors pembrolizumab and of new components of the and some cannot penetrate 4 (CTLA-4), programmed cell patient’s immune system to nivolumab were approved in immune system which tumour microenvironments. death protein 1 (PD-1) and its powerfully destroy cancer cells. 2014 and have both gone on to have been engineered or The response rates are still low ligand (PD-L1),” he said. Sze then drew attention to see huge sales. Pembrolizumab manipulated outside of the and cancers are a biochemical Immunotherapy involves a variety of immunotherapy has US FDA indication for late body, taught to recognise moving target. We must devise stimulating the cancer patient’s agents such as ipilimumab, stage melanoma and added cancer, and reintroduced interventional radiology immune system so that it can pembrolizumab, nivolumab, indications for non-small cell into the patient. In addition, solutions and administer these robustly fight the disease. Sze and atezolizumab. Ipilimumab lung carcinoma (NSCLC) with oncolytic immunotherapy uses locoregionally. We must disrupt used the analogy of a military was US FDA approved in overexpression of PD-L1 and engineered viruses to selectively tumours and uncloak antigens. defense strategy to counter 2011 and saw US$1 billion for head and neck squamous infect cancer cells. Infected We must select patients based insurgencies to elaborate sales in 2015. Indicated for cell carcinoma. Nivolumab cells undergo lysis, releasing on tumour genetics and track on the rationale behind late stage melanoma, or as is approved for melanoma, antigens, and the ensuing changes in biochemistry,” he immunotherapy: “Instead of an adjuvant therapy, this NSCLC, renal cell carcinoma, stimulation of the immune concluded.

Adding interventional oncology to immuno-oncology ing, use beads to embolize specific blood make immunotherapy more successful for vessels that feed a tumour, or use radioactive a broader patient population. microspheres to give a localised dose of Safety and cost are also important radiation to a tumour. considerations when selecting an agent MELANIE LEE Some research data suggest there could be or treatment to combine with checkpoint a synergistic effect between immunotherapy inhibitors that are known to have immune- and these minimally invasive procedures. A mediated side effects and are relatively COMMENT & ANALYSIS number of clinical trials are already under- expensive. As locoregional therapies are way to study the safety and effectiveness of generally well tolerated, combining them Some research data suggest there could be a synergistic effect immune checkpoint inhibitors in combina- with a checkpoint inhibitor is unlikely to between immunotherapy and minimally invasive procedures. tion with locoregional therapies. substantially add to the side-effect burden Tumour types that do not respond to checkpoint inhibitors—so Tumours use a variety of mechanisms to and their cost-effectiveness may ease adop- called “cold tumours”—could “turn hot” after treatment with suppress the patient’s immune system and tion of this combination approach. locoregional therapies, writes Melanie Lee. evade attack from T cells. The goal of check- point inhibitors is to take the brakes off the Multidisciplinary approach ecent advances in cancer immuno- which differ from the known toxicities of cancer-immunity cycle by turning off signals BTG has a growing portfolio of minimally therapy have led to an explosion traditional chemotherapy, further complicat- that can inhibit the ability of T cells to kill invasive therapies used by interventional Rof interest in the field. Commenta- ing their use. cancer cells. But some tumours are more radiologists across a variety of tumour tors have described it as a revolution in the It is now thought that immunotherapy immunogenic than others, and other factors types, including tumours in the liver and treatment of cancer and some even see it will need to be used in combination with in the local tumour microenvironment may kidney. The therapies represent different as possibly offering a cure for a portion of other agents or therapies to expand the pro- affect whether or not a patient will respond modalities that could potentially have a cancer patients. Although using the immune portion of cancer patients who could ben- to treatment with a checkpoint inhibitor. synergistic effect if used in combination system to fight disease is not a new concept, efit. Researchers are therefore turning their How could using locoregional therapies with immune checkpoint inhibitors. the excitement has been driven by regula- attention to combining different check- help? First, these therapies debulk the BTG has announced a partnership with tory approvals of monoclonal antibodies point inhibitors, or combining checkpoint tumour, which makes it easier for the the Society of Interventional Oncology against immune system checkpoints, such as inhibitors with other cancer treatments, like immune system to tackle what remains. (SIO), organisers of the annual WCIO con- cytotoxic T lymphocyte-associated protein radiation therapy. Second, there is also evidence that some ference, to fund new research in this area. 4 (CTLA-4), programmed death ligand 1 locoregional therapies may induce a Image-guided, minimally invasive thera- (PD-L1) and its receptor (PD-1). Soon, we Jump-starting the immune tumour-specific immune response, or pies already bring many benefits to physi- will also have data about chimeric antigen system in situ vaccination, by releasing tumour cians and their patients, and their use as a receptor T cells (CART). While very excit- Combining immuno-oncology therapies antigens. Further evidence indicates they treatment approach for cancer is growing. ing, none of these therapies on its own can with image-guided, minimally invasive induce cytokine production, stimulating We are hopeful that by better understand- offer a silver bullet. therapies is one approach that is starting to the immune system and helping to create ing the science of how these locoregional These new agents have only been shown attract interest from oncology physicians. an antitumour microenvironment. If com- therapies could work in combination with to be effective in certain tumour types, Sometimes called locoregional therapies, bined with a checkpoint inhibitor, these immuno-oncology agents, we can help such as melanoma, renal cell carcinoma these procedures deliver a treatment pre- effects could enhance overall outcomes. expand the number of cancer patients who and non-small cell lung cancer. Even in cisely where it is needed, aiming to destroy There is even the possibility that tumour might benefit from the immuno-oncology these indications, many patients treated tumour cells without causing damage to types that do not respond to checkpoint revolution. with checkpoint inhibitors do not respond healthy tissue. For example, interventional inhibitors—so called “cold tumours”— to monotherapy. These therapies are also radiologists may insert a cryoprobe directly could “turn hot” after treatment with Melanie Lee is the chief scientific officer associated with immune-related side-effects into an area to destroy a tumour with freez- locoregional therapies, perhaps helping of BTG 26 Interview March 2017 Profile Suresh Vedantham

“I do believe the ATTRACT trial achieved its main objective of telling us which acute deep venous thrombosis patients should, or should not, receive endovascular intervention,” Suresh Vedantham, professor of Radiology and Surgery, Mallinckrodt Institute of Radiology, Washington University School of Medicine in St Louis, USA, the national principal investigator of the trial and the 2017 incoming president of the Society of Interventional Radiology (SIR) tells Interventional News. The ATTRACT (Acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial was designed to evaluate the use of thrombolytics in combination with clot removal devices to prevent post-thrombotic syndrome in patients with deep venous thrombosis. Vedantham is due to present its results on 6 March at the SIR annual scientific meeting.

When did you first decide on a career Which innovations in interventional We also need to start judging each innovation, not in medicine and why did you choose radiology have most influenced your by its technological ingenuity, but by the number of interventional radiology? career? patients it is proven to impact. That involves a signifi- I recall being attracted to the social-emotional aspects There is no field in medicine where you can see such a cant change in the “culture” of interventional radiology. of patient care as far back as high school, undoubtedly breadth of innovation across so many disease domains. My belief is that we have chronically under-invested in influenced by my mother who was a very kind and The kind I am most interested in is the human brain interventional radiology-specific research and education, empathic person. I recall neither an “epiphany” nor any creativity that interventional radiologists show every and that our relationship with our diagnostic radiology active exhortation, but I am sure that my father played day. No one interacts with the human body the way we and other subspecialty colleagues must undergo a posi- a role in my choices too; he was a radiologist who did do—and no one is more capable of making chicken tive recalibration to revitalise our future. We also need a little angiography, and had a partner who was a very soup using both glamorous and mundane technology. to better leverage the power of patient advocates on active interventional radiologist. In 1991 or so, as a I continue to believe that whoever invented the stiff our behalf—I am continually amazed at all that we do, third-year medical student, I heard about Dr Ernie Ring angled glidewire should get the Nobel Prize—we have yet we we receive very little recognition for it. As I see performing the first transjugular intrahepatic portosys- changed the world with it. In my own career, the devel- it, the basic answer to this is to “double down” on the temic shunt (TIPS) procedure. The elegance, boldness opments in thrombolytic and vascular technology have clinical model we have pushed for two decades now; it and impact of this was such that I was sold! To this day, been most important. has served us well, but we need to be willing to go much I cannot imagine anything else in medicine that I would further. Achieving this change in a way that respects the rather be doing. As the incoming president of the broad diversity of clinical practice that is encompassed Society of Interventional Radiology (SIR) within interventional radiology is its own challenge. Who were your mentors and what for 2017, what are your goals for the wisdom did they impart to you? organisation in your term? Could you comment on the importance Clinically, I learned so much from the interventional SIR does so many wonderful things that produce a net of multidisciplinary collaboration and radiology faculty at University of California, Los benefit for patient care. In 2017, SIR will be conduct- its value in the running of large-scale Angeles (UCLA) where I did my residency, Stanford, ing formal strategic planning to redefine its forward clinical trials such as the ATTRACT trial? where I did my fellowship and Mallinckrodt where I path, and I look forward to guiding that process. The First, interacting with other providers enables one to was faculty. work of SIR is done by so many excellent volunteers understand the I had great research mentors early on—Drs Gail and staff members; as a leader for a limited term, your disease in a Prins (a renowned infertility researcher), Haim best hope for real impact is to try to shape Gamliel (leukemia researcher), and David Lu (UCLA people’s thinking so that the collective will abdominal radiologist)—all of whom sharpened my be comfortable in embarking in new and scientific mind. productive directions. From my many interactions with Dr Mahmood I think helping our membership see how Razavi, my strategic thinking improved around how evidence-based medicine can be a potent to overcome real-world impediments to translate my enabler of the kind of innovative, forward- “potential” into actual accomplishments. Dr Timothy looking clinical practice that interventional Murphy at Brown University does not get enough radiologists love is one area where I can credit for showing how an interventional radiologist contribute. can effectively engage the National Institutes of Health Strengthening our collaborations with (NIH); he provided tremendous guidance to me during other organisations, and getting interven- the genesis of ATTRACT. By osmosis, I learned from tional radiologists invited to the influen- Dr Michael Dake the value of sharing inspiration, not tial forums where healthcare decisions are just information, to help achieve a worthy goal. made, is another priority. To a system that But many of my mentors are not interventional desires to improve quality, reduce costs, radiologists and actually, I do believe that multidis- and enhance patient satisfaction, our ciplinary mentorship is a worthy development model value proposition is absolutely compel- that we should explore further. Dr Clive Kearon, the ling, but it is up to us to show it. renowned thrombosis trial methodologist, increased my professionalism as a clinical researcher. Cardiolo- What are the biggest gist Dr Samuel Goldhaber is a soulmate in sharing “go challenges for interventional big or go home” and “big tent” sensibilities. I greatly radiology in 2017? admire his rock-solid dedication to his patients, his We need to amass facts ie., we need inclusiveness, his seriousness of purpose, and his to rapidly transform our ability to willingness to dispense advice that, even when it was objectively demonstrate the value of not what I wanted to hear, was always what I needed interventional radiology services to pa- to hear to succeed. Vascular surgeon Dr Anthony Com- tients, providers, payors, hospitals, and erota is a model of selflessness—a shining light in the health systems. SIR staff and volunteers venous world himself, he leads by example in showing have worked very hard to advocate for us all how to collaborate. our practice, but we need to continue to I have not always been the best protégé, so these improve in marshalling the facts into a people deserve a lot of credit. I am uncomfortable with compelling case for the value of inter- authority and patronage, hardwired to challenge con- ventional radiology services. Nothing ventional thinking, overly idealistic, and have always will prove better and more patient-cen- wanted to turn the world upside down NOW. The best tred than targeted care and interventions advice to them would have been “run away!” that champion patient safety and choice. March 2017 Interview 27

Fact File broader context that goes beyond one procedure or Blood Institute (NHLBI) and collaboration with its category of intervention. It pushes you to challenge your Clinical Trial Development Resource, which enabled us own groupthink. We tend to forget that our view on a to convene a robust multidisciplinary group of experts to disease is shaped by many factors: the clinical setting aid in its planning. A grant application for the C-TRACT in which we see patients; the mindset of our colleagues; clinical trial has been submitted to the NHLBI, and will and (both for better and for worse) the effect of industry be reviewed within the next few months. The leader- (the drug industry for internists and the device industry ship of the C-TRACT study includes many leaders for endovascular physicians) upon all of it. Training from ATTRACT, and benefited from the latter trial’s matters too—internists view deep venous thrombosis as partnerships, infrastructure, and lessons learned. We are basically an imbalance in the clotting system; whereas very excited about the idea of extending the success of we view it from anatomical and physiological perspec- the ATTRACT clinical trial consortium to address this tives. Only when we share these camera angles with major unmet clinical need. each other can we see a fuller picture. Second, collaborating recruits skills that one would What are the most interesting research not have otherwise. What I have learned from AT- questions that you would like to see TRACT is pretty humbling. Despite being considered answered in interventional venous Education (selected) a “research leader”, the truth of the matter is that I am disease? first and foremost a well-trained clinician who does I think it is crucial for us to attain a better understand- 1992–93 Internship in internal medicine, research on the side. But many of the other leaders in the ing of the biology of deep venous disease. Veins are Hospital of the University of ATTRACT trial are professionally trained researchers, not metal pipes in need of plumbing—they are living, Pennsylvania, Philadelphia, USA and believe me it shows. The trial could never have been breathing organs. Much more needs to be known about 1993–97 Residency in diagnostic radiology, designed, funded, and completed without all kinds of what happens within the blood, within the vein wall, and University of California, Los Angeles, different expertise being brought to bear on it. around the vein when thrombosis develops and evolves. Los Angeles, USA Third, your potential to have real clinical impact, And our understanding of the effects of endovascular 1997–98 Fellowship in interventional radiology, and stave off challenges to your study, is multiplied intervention upon these components is in its infancy. It Stanford University Medical Center, manyfold by collaborating. My best advice to young re- would be great to see interventional radiologists partner Stanford, USA searchers would be that you need to be able to speak the with basic scientists, medical thrombosis experts, and language of multiple subspecialties around the condition other researchers to answer these fundamental questions. Employment you are studying. That means knowing their literature, 1997–98 Clinical instructor of Radiology, guidelines, and culture. Only when they see that you ap- Which early technologies in Stanford University Medical School preciate their perspectives can they reach beyond them interventional radiology are you keeping 1998–present Attending radiologist, Barnes- to understand yours. And, do not be put off by bumps in an eye on? Jewish Hospital & St. Louis the road; they are inevitable. The amazing thing I have There is extensive work ongoing to develop bioabsorb- Children’s Hospital, St Louis, USA seen with ATTRACT is that over 10 years, our steering able scaffolds for vascular reconstruction, and I would 1998–2004 Assistant professor of Radiology and committee members have actually grown together in be excited to see this kind of product reach clinical trial Surgery (General), Washington their individual perspectives on deep venous development for chronic venous disease. The potential University School of Medicine, St thrombosis, learning from each for mobile technology, robotics, and nanotechnology Louis, USA other along the way. to transform patient care and research in interventional 2005–08 Associate professor of Radiology & radiology fascinates me. I hope some of our young aca- Surgery (General), Washington What are the demic interventional radiologists grab these opportuni- University School of Medicine clinical findings ties by the horns. 2009–present Professor of Radiology and Surgery from the (General), Washington University ATTRACT trial? Could you describe an unforgettable School of Medicine At the time this publica- case? tion goes to print, I am I recall an aortic dissection case a few months after I Honours and awards (selected) not yet free to discuss the started as a faculty member. It was billed “aortogram” 1997 Roentgen resident/fellow research trial’s findings, but I do on our schedule, which, at Mallinckrodt in those days, award, Radiological Society of North believe this trial achieved meant that if you were still in there after 10 minutes eve- America its main objective of tell- ryone would be wondering what was wrong with you. 2015 Distinguished fellow, American ing us which acute deep We started at 6.30 in the evening and ended at one in Venous Forum (AVF) venous thrombosis patients should, or should the morning. The patient had presented with acute renal, not, receive endovascular intervention. mesenteric, and leg ischaemia—I fenestrated the aorta Society leadership (selected) and stented branch vessels. During the case, the tech- 2014–16 Curriculum Advisory Council, At what research stage is the nologist started crying, and I think she even called my American Board of Phlebology C-TRACT trial? boss; this was the first such case there, and she thought 2012–14 Post-Thrombotic Syndrome Guide The C-TRACT (Chronic venous thrombo- the new doctor was crazy. In truth, I was improvising lines Writing Group, AHA sis: relief with adjunctive catheter-directed with the benefit of my fellowship training. Of course, the 2015–2017 Venous Thromboembolism Guide therapy) trial is a multicentre randomised patient’s ischaemia resolved dramatically. The next day, lines Committee, American Society clinical trial that will address the large physicians from three departments called to congratulate of Hematology population of patients who suffer with me. This case helped me to see the unique interventional 2012–2016 Executive Council-Board of already-established, moderate- radiology skill set as a real “gift” that could impact pa- Directors, AVF to-severe post-thrombotic tients’ lives and transform the potential of a multidisci- 2016–2017 Chair, annual meeting, AVF syndrome. This study will plinary patient care team (and, 10 years later, this patient 2007–2010 Venous Thromboembolism determine if the addition was still alive). Guidelines Development Panel, of endovascular therapy to National Comprehensive Cancer standard medical and com- What are your interests outside of Care Network pression therapies reduces medicine? 2016 Co-chair, NHLBI Panel, Design- the severity of post-throm- First and foremost, the dynamic duo of my wife and ing Trials for Uncommon Diseases, botic syndrome and improves 10-year-old son. Both are beautiful and charismatic. National Institutes of Health health-related quality of Beyond them, I will move mountains to attend sport- 2016–17 President-elect, Society of Interven- life. This study benefited ing events and rock concerts of my choosing, and I still tional Radiology (SIR) from a planning grant from glow from the Cubs’ World Series victory (and specifi- 2017–18 President, SIR (expected) the National Heart Lung and cally, from seeing Game 5 at Wrigley Field). 28 Expert opinion March 2017 TEVAR’s dirty little secret “There is no easy fix with current endovascular tools and strategies—a default but it is very difficult to achieve can move ahead and truly create realisation is that it is easier and more definitive to treat aortic dissection good results in a chronic state. a more definitive solution without early,” Michael D Dake, Stanford, USA, told Interventional News referring to the Even experts who have a lot of constant surveillance and the Achilles’ heel of thoracic endovascular aortic repair (TEVAR) management for experience using branched grafts risk that there is going to be late uncomplicated type B dissection. in chronic dissections understand progression.” that endoleaks still exist and that t present we are for uncomplicated type B aortic branch vessel grafts still occlude. The challenge of armed with a tool dissection: medical management There has got to be a way to deal undertaking dissection “Abox of largely alongside a “wait and watch” with this upfront and definitively trials unproven and often complicated approach for complications to so as not to have a long tail of “Because dissections are relatively multi-step therapies and a ‘wait occur, after which treatment is potential complications and so as rare, in order to obtain data from a and see’ approach that satisfies no undertaken; early endovascular not to have the false lumen being a large number of patients, any trial one. Future success will require treatment for all patients; and bad actor in the chronic state. With will need to have a large number new ideas and creative thinking,” early endovascular treatment the current tools that we have, we of participating centres who are he said referring to TEVAR’s only for patients at high-risk of just do not have the opportunity interested in aortic disease and “dirty little secret”. The paradigm complications. to do that. People have tried many experienced in both open and for treatment might need to be “In all initially uncomplicated Michael Dake kinds of gizmos and gadgets to endovascular treatments. When radically re-thought, he added. type B dissections, should we plug the false lumen, but these you have that many institutions Dake received the British So- look for high-risk features that tive treatment for dissection. In seem to only work in the acute participating, there are going to ciety of Interventional Radiology predict early progression or just some fraction of patients after TE- setting when the lamella is thin be expenses and the issue is who (BSIR)’s Honorary Fellowship at plan to treat all except those in VAR, we know that there is going and weak. In the chronic setting is going to foot the bill. Trials that the society’s 2016 annual meeting whom the procedure may be dif- to be persistent false lumen perfu- some combination of technolo- are being reported are basically and the 2017 Career Achieve- ficult or at risk of complication?” sion from abdominal branches that gies such as the use of extreme industry-sponsored. Industry has ment Award from ISET. Dake is Dake questioned. can, not only continue to provide tapers and reverse tapers with to do these trials to get approval the Thelma and Henry Doelger The clinical course of type B a risk for the patient in terms of distal cutting that seek to rupture for their devices so funding these Professor (III), Department of uncomplicated aortic dissection is rupture, but also lead to dilatation the dissection septum could be trials is part of a business strat- Cardiothoracic Surgery, Stanford not entirely benign. Early TEVAR and false lumen aneurysm forma- risky. I think we need to think of a egy. However, once approval is University School of Medicine, will benefit some high-risk patients tion. Trying to really excommuni- new paradigm that will probably obtained, industry really does not Falk Cardiovascular Research who can be identified by predictive cate the false lumen aneurysm in include stent grafts at some level, have the same motivation or incen- Center. He delivered a lecture on factors. Accumulating evidence a chronic state is really difficult to but it may have to be radically tive to fund the trials that we need aortic dissection, speaking on the may favour even more liberal early do with our current toolbox,” Dake rethought. First, there needs to be to have done for the doctors and topic “Endovascular management TEVAR in type B dissection, but informed Interventional News. the understanding that what we patients. In the climate of decreas- of aortic dissection: what we the timing of the intervention and “I think we need to think about are providing in a subgroup of ing resources for research, it takes know, think we know and need to its cost-effectiveness still remain this differently. Yes, we now have patients, is inadequate. With that a lot of coordination to muster the know” at the BSIR meeting. questions, Dake told attendees. stent grafts in the tool box and we realisation, which shows that that resources to carry out these trials,” There are three main strategies “We are not providing a defini- can use these even in the branches, stent grafts are not a panacea, we Dake concluded. Venous embolization for patients with pelvic congestion syndrome Romaric Loffroy, professor of Radiology and chief, Vascular ness, has a variable intensity and duration, and Interventional Radiology Department, François-Mitterrand and often worsens premenstrually. Associ- University Hospital, Dijon, France, gives Interventional News a ated symptoms are fatigue, urinary urgency, refresher on the data and interventional radiology options. constipation, and dyspareunia. Most patients also present with lower limb varices and What do the latest data of adverse events. some also have associated vulvar or inner show? thigh varices that can communicate with the A systematic review including twenty-one How durable are the results long saphenous vein system. Patients with prospective case series and one poor- of embolization? a medical history compatible with pelvic quality randomised trial of embolization of Pooling rates of complete, excellent, or congestion syndrome first need to undergo incompetent pelvic veins (involving a total moderate improvement from main studies transabdominal or transvaginal ultrasound, of 1,308 women) was recently published give an overall improvement rate of 75% and are then referred to the interventional by Daniels et al in JVIR, representing the at 4–8 weeks after the procedure. Although radiology department for ovarian venogra- Romaric Loffroy latest interesting data on this topic. Early follow-up is heterogeneous, substantial relief phy and eventual embolization. Venographic substantial relief from pain was observed in from pain generally increases over time and criteria in favour of pelvic congestion syn- a more thorough and extensive thrombosis, approximately 75% of women undergoing is usually sustained as reported by two stud- drome are: minimum ovarian vein diameter and its low price compared with coils. embolization. Significant pain reductions ies with relief rates greater than 80% at an of 6mm, uterine venous engorgement, con- following treatment were observed in all average of 45 months of follow-up. gestion of the ovarian plexus, filling of the What important studies that measured pain on visual analog Complications of embolization appear to pelvic veins across the midline, and/or filling considerations has your scale. Repeat intervention rates were gener- be limited to short-term pain and fever in a of vulvovaginal and thigh varicosities. experience taught you? ally low. reasonable proportion of cases in which a Lower limb varicosities are partly or entirely Notwithstanding the difficulty of making sclerosant agent is used, or an uncommon What embolic agents are of pelvic venous origin. Selective venog- the diagnosis clinically and radiologically, incidence of coil migration, easily man- used in this procedure? raphy is mandatory as it can potentially outcomes are also difficult to assess, and aged percutaneously. Coil placement is a Different embolic agents can be used alone show communication between incompetent there remains a lack of level 1 evidence to relatively straightforward procedure but may or in combination to embolize ovarian veins: pelvic veins (ovarian and/or internal iliac) robustly assess clinical efficacy. Medical be subject to recanalisation or development coils, sclerosing agents, and glue are used. and lower limb varicosities. The pudendal therapy with anti-inflammatory medica- of collateral vessels. Venous puncture related Although coils are effective in occluding branches of the internal iliac veins, includ- tion and/or analgesics raises the question complications and perforation are very rare. the ovarian veins, recurrences related to ing their most distal branches, must be of long-term potential adverse events. To recanalisation of coils or development of adequately treated, and occluding the entire date, there remains just a single randomised What is the ideal patient collaterals can probably occur. venous segment of the refluxing trunk and controlled trial comparing embololotherapy profile for embolization? The procedure may be improved by using its distal branches is probably essential. with pelvic surgery, where embolization was Women who report intermittent or continu- Glubran cyanoacrylate glue because of its Good preprocedural noninvasive CT or significantly more effective than the other ous pelvic pain and have no apparent disease liquid state, which enables it to reflux into MR imaging is essential, not only to exclude treatment arms in reducing pelvic pain. So, have to be considered potential candidates various branches of any eventual longitudinal nonthrombotic iliac vein lesions, but par- embolization remains acceptable to women for pelvic congestion syndrome. The pelvic collaterals, its local inflammatory effect on the ticularly to direct treatment, appropriately in terms of efficacy given the low incidence pain is often described as fullnessor heavi- veins themselves, which potentially provides reducing time, cost, and radiation dose.

30 Peripheral arterial disease March 2017 Amputation and mortality: It is time to discuss the obvious

J A MUSTAPHA

COMMENT & ANALYSIS Figure 1: Critical limb ischaemia Figure 2: Critical limb ischaemia timeline timeline after revascularisation without after revascularisation with frequent sur- An amputation due to critical limb ischaemia is directly frequent surveillance. With a post- veillance. With a post-revascularisation associated with loss of function and death, writes J A Mustapha, revascularisation unadjusted course of adjusted course of therapy that includes Wyoming, USA. therapy that includes minimal or irregular frequent and regular surveillance ( in- surveillance, patients tend to do well for cludes secondary and assisted patency), mputation. A common term we that have 10% of the mortality in compari- the first three months and then decline the problem is identified before regres- have been using for centuries to son to critical limb ischaemia, including rapidly. sion in the critical limb ischaemia patient. Adescribe the loss of a limb. When breast cancer and colon cancer. A patient This approach is critical to achieve people most think of amputation, they envi- diagnosed with breast cancer has an al- the course that critical limb ischaemia sustainable positive outcomes. sion young patients who have undergone most 90% chance of surviving five years. tends to run through. Due to this aggressive a traumatic amputation due to accident or A patient who is diagnosed with colon course, frequent and regular surveillance whose awareness and advocacy efforts are war that are rehabilitated and go on to live cancer has a 65% chance of surviving five must occur to achieve sustainable amputa- aimed at raising public, patient and health a functional life. But ischaemic amputation, years.2 Critical limb ischaemia patients tion-free survival. As shown in Figure 1, the professional awareness of treatments to which is a major epidemic today, lends a who undergo amputation have a less than majority of patients diagnosed with critical prevent unnecessary amputations. different perspective to the patient and his/ 20% chance of five-year survival. So let limb ischaemia without their course of her family. us discuss the obvious. There is a clear therapy adjusted are likely to either receive J A Mustapha is director of Cardiovascular An amputation due to critical limb and present lack of critical limb ischaemia a major amputation within 12 months or, Research, Metro Health University of ischaemia is directly associated with loss of awareness among all healthcare provid- worse yet, die. Whereas, in Figure 2 the Michigan Health, Wyoming, USA. He is also function and death. The TASC II update in ers. A disturbing 2012 publication by same patients, but with an adjusted course clinical associate professor of Medicine, 2007 showed that after amputation, 25% of Goodney et al showed that 54% of major of critical limb ischaemia therapy, can Michigan State University College of patients are dead within one year and 20% ischaemic amputations were performed on experience completely different outcomes. Osteopathic Medicine, East Lansing, USA. of those patients who survive continue to patients without a prior diagnostic angiog- The majority of them are alive and without struggle with the disease.1 The majority of raphy or intervention during the year prior a major amputation at 12 months. It is time References et al. 3 1. Jaff MR An update on methods for revascularization patients over 75 years of age who receive to the amputation. for us to take action, educate others and our- and expansion of the TASC lesion classification to include an amputation do not ever walk again. I feel strongly that patients and their selves about the seriousness of this illness, below-the-knee arteries: a supplement to the inter-society consensus for the management of peripheral arterial disease Amputation is a very traumatic event that families need to learn there are options today and not allow a single amputation to take (TASC II): The TASC Steering Committee. Ann Vasc Dis. 2014; 8(4): 343–57. impacts the life of the patient and family in that can prevent amputation. Avoiding am- place without a detailed vascular work up 2. The surveillance, epidemiology, and end results (seer) a profound and critical way. putation, in most cases, can delay or prevent and exhaustive attempts at revascularisation. program of the national cancer institute (http://seer.cancer. gov/statfacts/ Historically, much awareness has fo- death. Because of the serious consequences Consider joining the Critical Limb Ischemia 3. Goodney PP et al. Circ Cardiovasc Qual Outcomes. 2012; cused on many other less deadly diseases of amputation, I feel compelled to describe Global Society (www.cliglobalsociety.org) 5(1): 94–102.

Barry Katzen announces new global DISRUPT PAD III planned as “largest society for critical limb ischaemia ever” calcified peripheral artery Barry Katzen, Miami, USA, announced the establishment of a new society, the Critical Limb Ischaemia (CLI) Global Society, whose disease study mission is to improve quality of life by preventing amputations and death due to the condition. hockwave Medical to 300 patients at 45 has announced global centres in the e made the has a commitment to raise Splans for DIS- USA, Europe and New announcement at public, patient and health RUPT PAD III—what Zealand. The In.Pact Hthe International professional awareness it claims is the “larg- Admiral drug-coated Symposium on of critical limb ischaemia est ever” multicentre Lithoplasty balloon will be used in Endovascular Therapy treatments to prevent randomised study to ex- both treatment arms. (ISET; 4–8 February, unnecessary amputations,” clusively enrol patients to assess short- and Drug-coated balloons Hollywood, USA). Katzen the website notes. with calcified peripheral long-term outcomes have historically been is founder and chief Katzen told Interventional artery disease. Previous compared to those shown to be effective medical executive of News: “The announcement DISRUPT PAD studies achievable using tradi- in non-calcified lesions, Miami Cardiac & Vascular Barry Katzen also focused on the direction utilised Lithoplasty as tional balloon angioplas- but results are far less Institute, and one of the of resources towards the primary therapy, dem- ty prior to drug-coated favourable as calcifica- course directors of ISET. will serve as an alliance creation of a true definition onstrating safe, effective balloon in a calcified tion levels of increase. “We are the only and advocacy for the around critical limb and consistent revascu- patient population. The DISRUPT PAD professional membership- prevention of unnecessary ischaemia from a regulatory larisation of calcified le- DISRUPT PAD III, III study is designed based medical society amputation, according to and payment point of sions while maintaining which begins enrolment to assess the impact of focused on advanced the society’s website view. In the USA, and future treatment options. in early 2017, will com- Lithoplasty on out- peripheral arterial (www.cliglobalsociety.org). most countries, there is no To date, the potential pare the safety and effec- comes of drug-coated disease and critical limb “In terms of advocacy, diagnostic code for critical benefit of combination tiveness of Lithoplasty balloon use in calcified ischaemia,” said Katzen, there are opportunities limb ischaemia and a lot of therapy in these patients followed by drug-coated lesions. The primary who is also the current to get involved with a confusion in terminology has not yet been evalu- balloon vs. drug-coated endpoint of the study president of the new strong unified community which leads to limitations ated. DISRUPT PAD balloon with standard will be acute proce- society. Members contribute of physician, healthcare on determining actual III will study use of the pre-dilatation for the dural success absent the to the scientific study, and industry leaders event rates, outcomes and Shockwave Medical treatment of moderately need for stents and the research, literature and with a focused goal of payment. Early on, we are Lithoplasty system in and severely calcified secondary endpoint will education of critical limb critical limb ischaemia applying resources to try to combination with drug- femoropopliteal arteries. be primary patency at ischaemia and the society education. The society resolve this challenge.” coated balloon therapy The study will enrol up 12 months.

32 Peripheral arterial disease March 2017 UK All Party Parliamentary Group condemns peripheral arterial disease treatment as national “postcode lottery” The All Party Parliamentary Group on Vascular of appropriate clinicians—such NICE guidance should reflect Disease has released its latest report on patient as sonographers to carry out standard practice and should en- access to technologies for the diagnosis and imaging—and lack of education sure that all patients have access treatment of peripheral arterial disease. The report is of the primary care workforce to the most appropriate technol- titled “Saving limbs: Saving lives”. in identifying the symptoms of ogy no matter where they live in peripheral arterial disease. the country. ccess to technology fa- The report reveals a number With an ever-increasing focus This report was produced cilitates earlier and more of barriers to effective diagnosis on accelerating access to in- following an inquiry held by Aaccurate identification and management of periph- novative technology, the group the group, which invited written of people at potential risk of am- eral arterial disease. Sixty-nine wanted to focus on this issue. and oral evidence from a variety putation, heart attack, stroke and per cent of respondents to the Just 25% of respondents to the of stakeholders. The aim of the early death from arterial disease, group’s inquiry do not believe inquiry felt that all patients who inquiry was to identify good the report claims. It also facili- that every patient who requires could benefit from drug-eluting practice and produce a set of tates improvements in the treat- intervention is assessed by technologies have access to it. recommendations which can ment and outcomes of patients an appropriate foot/vascular The issue of drug-eluting tech- be adopted to standardise care who require intervention. Despite multidisciplinary team who can nologies is currently being re- received by patients. The findings this, there is still a wide variation then refer on correctly. Further viewed by the National Institute have been consolidated within a Diabetes UK reveal that 20 within vascular services across challenges revealed by the for Health and Care Excellence final report, which provides guid- diabetes-related amputations are the country, which perpetuates report include problems with (NICE). According to a press ance and recommendations for performed in England every day. the health postcode lottery. recruiting the adequate number release, the group believes that those responsible for the design, Neil Carmichael, chair of the commissioning and delivery of All Party Parliamentary Group Over 11,500 major lower limb amputations vascular services. on Vascular Disease, stated that Over 11,500 major lower “with the diabetes epidemic are carried out every year, the vast majority of limb amputations are carried on the rise and set to continue, out every year, the vast majority rates of amputation and other which are as a direct result of peripheral of which are as a direct result diabetes-related complications arterial disease, diabetes or a combination of of peripheral arterial disease, will also increase, with a spiral- diabetes or a combination of ling cost to the NHS. This trend the two. the two. Statistics released by must be reversed” DANCE data boost for dexamethasone use after revascularisation in femoropopliteal arteries

While drug-eluting devices, be they balloons or stents, use chemotherapeutic agents (usually groups, with 83.6% at 12 months and paclitaxel) to reduce the build-up of scar tissue inside the arteries, a microinfusion device that applies 80% at 13 months in the atherectomy the anti-inflammatory agent, dexamethasone, to the outside of arteries to enhance healing, is seeing group, and 80.2% at 12 months and largescale early positive results. 78.2% at 13 months in the angioplasty group. Primary patency was defined as linical trial data from the the lack of clinically-driven target lesion DANCE (Delivery of dexametha- revascularisation (CD-TLR) or narrow- Csone to the adventitia to enhance ing detected by a duplex ultrasound peak clinical efficacy after femoropopliteal systolic velocity ratio (PSVR) greater revascularization) trial that uses the than 2.4. Freedom from CD-TLR was Bullfrog microinfusion device (Mercator 89.6% at 12 months and 88.7% at 13 MedSystems) were recently presented at months in the atherectomy group and two conferences. was 89.1% at both 12 and 13 months Mahmood Razavi and George Adams, in the angioplasty group. No broad dis- the national co-principal investigators of parities were reported among results by the DANCE trial, respectively presented gender, with 13-month primary patency comprehensive 13-month data from the of 79.3% in men and 77.9% in women, trial during late-breaking sessions at the or by diabetic status, with 13-month International Symposium on Endovascu- primary patency of 79.5% in diabetics lar Therapy (ISET; 4–8 February, Hol- vs. 78.8% in non-diabetics. lywood, Florida) and Leipzig Interven- DANCE is a prospective, multicentre, tional Course (24–27 January, Leipzig, single-arm study that is designed and Germany). Mahmood Razavi Bullfrog microinfusion catheter sponsored by Mercator. The trial is being The Bullfrog microinfusion device conducted in 35 centres. Bullfrog is a was used in the trial to deliver a generic its ability to efficiently deliver drug The 13-month data from DANCE FDA 510(k)-cleared and CE-marked anti-inflammatory steroid, dexametha- in difficult-to-reach anatomy,” said were separated into two groups based on system designed to infuse therapeutic sone, along with radio-opaque contrast Razavi. “Technologies such as drug- method of revascularisation: atherec- and diagnostic agents directly, non- to visualise distribution. The drug was coated balloons or drug-eluting stents tomy was performed in 157 limbs, systemically and safely through blood delivered to the adventitia, the tissues use chemotherapeutic agents to reduce while 124 limbs received angioplasty vessel walls into adventitial tissues. The around femoropopliteal arteries, after the risk of scar tissue build-up inside without atherectomy. For both groups, Bullfrog device is tipped with a balloon- undergoing endovascular intervention to the arteries. Alternatively, we have the primary safety endpoint revealed no sheathed microneedle, and is compatible open the obstructions. The data demon- proposed that the delivery of an anti- postoperative death within 30 days, with with 0.014” guide wires and 5 to 7F strate a high level of durability of the inflammatory agent to the outside of major adverse limb events 13-months introducer sheaths. The closed balloon revascularisation, low occurrence of ma- the artery enhances the healing process after the revascularisation reported as provides a protective covering for a tiny, jor adverse limb events, and no device or and interrupts the cascade leading to 1.6% in the atherectomy group and 0.9% perpendicular-oriented injection needle drug-related adverse events. scar formation and restenosis. Overall, in the angioplasty group. The per-proto- as it is guided safely through the vascu- “We attribute the success seen in the we have found the therapy in DANCE col primary efficacy endpoint of primary lature to target vessels with diameters of DANCE trial to the Bullfrog device and to be intuitive, safe and effective.” patency did not widely vary between two to eight millimetres. A specialised news source in the interventional field

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Available for iPad and iPhone now 34 Peripheral arterial disease March 2017 Treat the patient and not the lesion A session at the Cardiovascular and Interventional He added: “The most important Radiological Society of Europe (CIRSE; 10–14 information is that the patient is September 2016, Barcelona, Spain) saw Mark incapacitated because of their dis- JW Koelemay, vascular surgeon and clinical ease usually due to their inability epidemiologist at the Academic Medical Center, to walk. I am also interested in Amsterdam, The Netherlands, present on the what the patient wants to achieve. patient’s perspective in peripheral arterial disease. A mailman needs to be able to walk in order to complete his atient-reported outcomes are it comes to endpoints such as postal circuit, but another patient measurements of any aspect patency or revascularisation, there might be happy to be able to walk Pof a patient’s health status is a clear discrepancy between to the supermarket. I then work that comes directly from the pa- patency and clinical outcome. We Jim Reekers Mark JW Koelemay with the patient so that we outline tient, without interpretation of the think that if we fix the stenosis, Pictures courtesy: CIRSE their expectations and make the patient’s responses by a physician the patient will get better and choice of treatment together.” or anyone else. Patient-reported that this will be measured by patient is better off with a lifestyle rial disease is a lifestyle disability, outcome measures (PROMs) are the PROMS, but this is not the intervention such as walking exer- but everybody is focused on le- Moving forward questionnaires that are used to case most of the time. There is a cise or giving up smoking, which sions, when we should be focused “I believe that for intermittent clau- assess patient-reported outcomes. discrepancy between radiological has bearing on their cardiovascular on patients.” dicants, we should move towards PROMs aim to capture the subjec- and clinical outcomes. This is not risk, then he or she probably does Commenting on some of the fewer interventions. We should tive, health-related quality of life to say that patency is not impor- not need the quick fix of an inter- challenges that beset data inter- focus more on lifestyle changes. I or functional status experienced by tant at all; a patent vessel is likely vention. However, if the patient, pretation in the field, Koelemay work in The Netherlands and we an individual patient. to improve a patient’s health is a mailman for instance, whose commented: “The difficulty with have highly trained physiothera- Koelemay said: “I am a strong status but there is no one-to-one livelihood depends on being able systematic reviews in this field pists who can provide supervised believer in PROMs; they are relationship between those two to walk long distances, of course is that most studies use different exercise (which is not reimbursed more important than other end- entities. So it is simplistic to think he must be considered for an instruments to measure quality in The Netherlands; a decision points such as patency, restenosis that if you treat the stenosis that intervention.” of life, which obstructs a sensible that is hard to understand). Also, or target lesion revascularisa- you are benefitting the patient.” Reekers echoed Koelemay’s pooling and interpretation of the the costs of supervised exercise tion that are used widely by the Jim Reekers, an interven- views on patency, binary restenosis data. So while there is no correla- are much lower than those of ra- interventional community but are tional radiologist also from the and target lesion revascularisation tion between patency and quality diological or surgical intervention. irrelevant to the patient. However, Academic Medical Center, added: being “pseudoendpoints”. “If you of life, there is also no clear cor- So supervised exercise should be there are essential steps that are “In peripheral arterial disease, you say to a patient ‘your target lesion relation between walking distance the first option, and if this does not still missing in the development have to treat the patient and not revascularisation has improved’ or and quality of life. Indeed, there work, then either an angioplasty and validation of PROMs. This is the lesion—the lesion is always ‘your stenosis has improved’ but is no clear correlation between or bypass can be offered to the where the challenge lies to vali- secondary to the patient. The at the end of the day, the patient walking in a corridor and walking patient, but the majority of patients date and improve the instruments lesion should be treated only if still has walking problems, what on a treadmill. Complicating all of will not need an intervention. I be- that we are using to get a better the patient needs it. The mere fact is the benefit of that intervention? this is the fact that any estimates lieve that this is a lifestyle disease grip on quality of life.” of having a lesion is not reason We need to find real endpoints that of walking distance obtained from and the solution to it needs to be a Continuing, he said: “When enough for intervention. If the matter to patients. Peripheral arte- patients are pretty inaccurate.” change in lifestyle.”

Percutaneous bypass using femoral vein could be “an important step” in treatment of long superficial artery occlusions In a first-time data release, Dierk Scheinert presented six-month outcomes from the DETOUR trial of 3. With regard to lesions, the mean length percutaneous bypass in long segment femoropopliteal occlusions at the Leipzig Interventional Course was 28.6±15.1cm, and 96.7% were total (LINC; 24–27 January, Leipzig, Germany). occlusions. The primary safety endpoint was he DETOUR (PQ Bypass) percuta- Device (a spring-loaded guidewire support defined as major adverse events (death, neous bypass procedure is designed and delivery system that creates initial target vessel revascularisation, or target Tto achieve the same end result as artery-vein-artery communication). limb amputation) at 30 days. Six month open bypass surgery. Revascularisation is Revascularisation of long, complex results of DETOUR showed that the major via a modular stent graft bypass and uses superficial femoral artery occlusions adverse rate was 3.4% (n=59). There were the femoral vein as a conduit. The technol- has traditionally required open surgical no deaths or amputations, but 3.4% (2/59) ogy is currently unavailable for sale and is bypass for long-term success. Whilst of patients required a target vessel revas- undergoing clinical trials, Scheinert, from endovascular techniques and technolo- cularisation. This figure went up to 10.2% the Division of Interventional Angiology, gies have matured, a durable solution for (6/59) at six months. University-Hospital, Leipzig, Germany, these severe lesions is still lacking, noted The primary efficacy endpoint was the told delegates. Scheinert. “Percutaneous bypass, a novel primary patency (no evidence of clinically Commenting on the results of the study, endovascular approach, may provide the significant stenosis [≥50%] within, imme- Scheinert said: “The clinical performance durability associated with open surgery diately above, or below the treated arterial [of the DETOUR bypass procedure] in se- while reducing morbidity and mortality Dierk Scheinert segment based on duplex ultrasound vere lesions (95% chronic total occlusion associated with more invasive interven- [PSV>2.5]). At six months, the primary and 93% TASC II D, 28.6cm mean lesion tions,” he explained. moderate to heavy calcification; or in-stent patency rate was 84.7%. The investigators length) demonstrates this novel therapy’s The DETOUR study is a prospective, restenosis (>50% stenosis) in order to be also recorded high procedural and techni- potential for complex patients without a multicentre single-arm study designed to included. They also needed to have more cal success rates of >95%. durable endovascular option.” assess the safety and performance of the than one patent tibial artery to the foot and “There was no deep venous throm- The DETOUR percutaneous bypass is technology and technique. It includes one a patent femoral vein ≥10mm in diameter, bosis in the PQ bypass segment and no achieved using a trio of proprietary de- of the largest prospective series evaluating or a duplicate femoral vein. health impact on the venous system at vices including the Torus stent graft (self- the percutaneous treatment of superficial The 60 patients included were mostly six months; ankle brachial index was expanding nitinol wire frame encapsulated femoral artery occlusions >25cm. men, around 65 years of age, and most significantly improved at six months com- in expanded polytetrafluoroethylene), PQ Patients needed to have femoropopliteal smoked. A third of those had had a previ- pared to baseline (p<0.0001); and 94% Snare (an over-the-wire dual-caged scaf- lesions ≥10cm in length that were consid- ous peripheral intervention and a fifth of of patients improved ≥1 Rutherford class fold that captures and extracts guidewires ered chronic total occlusions (100% steno- the group had diabetes. A majority, over at six months as compared to baseline through the tibial vein) and PQ Crossing sis); diffuse stenosis (>50% stenosis) with 95%, were classified as Rutherford class (p<0.0001),” Schienert said. March 2017 Peripheral arterial disease 35 Study demonstrates sustained benefit of endovascular intervention in patients with lower extremity peripheral artery disease Cardiovascular systems presented six-month data from its Rutherford classification LIBERTY 360 degrees post-market study in a presentation at the 29th International Symposium on Endovascular Therapy (ISET; 4-8 RC 2-3 RC 4-5 RC 6 February, Hollywood, USA). The study is evaluating the acute and Freedom from major adverse events (6 mo) 92.6% 81.2% 73.7% long-term clinical and economic outcomes of peripheral vascular Freedom from major amputation interventions in treating patients with symptomatic lower extremity 99.8% 96.8% 87.1% peripheral artery disease. Freedom from target vessel revascularisation 93.0% 83.1% 85.1% Freedom from death hysicians were able to use any specific health-related quality of life 97.1% 95.3% 85.1% US Food and Drug Administra- questionnaire, patients in the LIBERTY Ption (FDA)-approved device, 360° study reported improved quality Table 2: High freedom from major adverse events (MAE) at six months across all including the company’s Diamondback of life across all Rutherford classes, Rutherford classes. Kaplan-Meier method used to estimate event-free rates. MAE 360 peripheral orbital atherectomy sys- including such measures as physical defined as death (≤30 days after the procedure), major amputation of the target tem. Findings continue to demonstrate activity, symptoms and pain. limb, and target vessel revascularisation. that peripheral vascular interventions can be successful in treating patients in all Rutherford classes and suggest that “watchful waiting” for patients in Rutherford class 2-3 and “primary amputation” for patients in Rutherford class 6 may not be necessary. Six-month study outcomes were pre- sented by William Gray of Main Line Health, Wynnewood, USA. Findings suggest that on average peripheral vascular interventions can restore Rutherford 4-5 patients with critical limb ischaemia status (eg. limb pain at rest, cold and/or numbness in feet, open or non-healing wounds on toes or foot) to moderate claudicant status (eg. limb pain during movement) Through six months, these data dem- onstrate on average peripheral artery disease patients (Rutherford 2-6) post- peripheral vascular interventions have maintained good outcomes and positive

Change in Rutherford Classification Following Endovascular Intervention

Baseline 30 Days 6 Months

RC 2-3 2.8 1.3 1.4 RC 4-5 4.5 3.1 2.3 RC 6 6.0 5.5 4.6

Table 1: All Rutherford Classes show improvement in RC from baseline to 30 days. RC4-5 and RC6 show continued improvement from 30 days to six months while RC2-3 maintains improvement at six months. changes in Rutherford classification. Gray said, “Following endovas- cular intervention, we saw a marked improvement across all Rutherford Classes at six months: Rutherford 4-5 and Rutherford 6 patients showed continued improvement from 30 days to six months, while Rutherford 2-3 patients maintained improvement at six months. We also saw a high freedom from major adverse events (MAE) across all classes. This suggests that endovascular intervention is an alternative treatment option in place of watchful waiting or even primary amputation.” According to VascuQoL, a patient- reported, peripheral artery disease- 36 Peripheral arterial disease March 2017 BEST-CLI trial enrolment nears halfway mark As the second year of enrolment draws to a close, the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is well on its way to attaining its target enrolment. In the process, it is serving as a catalyst for an ongoing discussion of how CLI, which affects 8–10 million people worldwide, is optimally managed. This multidisciplinary trial, led yb Alik Farber (Boston Medical Center, Boston, USA), Matthew Menard (Brigham and Women’s Hospital, Boston, USA) and Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), is currently enrolling patients at 135 sites in the USA and Canada. BEST-CLI both encourages and facilitates specialists who treat CLI at a given trial site to work together for the common good of patients, and in so doing, harnesses the talents of all contributing specialties. Key to successful engagement in the effort is the ability of participating investigators to set aside their individual treatment biases and acknowledge the absence of reliable scientific evidence to support their impulses.

ost physicians have a bias as to whether “Mendovascular therapy or surgical bypass is appropriate for any given patient with CLI”, says Farber, BEST-CLI national co-principal investigator. “Much of this bias, however, is not based on compelling scientific evidence and the same patient offered endovascular therapy by one specialist may be offered bypass by another one”. Findings of the BEST- CLI trial will help physicians decide which therapy is best for given CLI patients and in many instances, the trial has already shifted the treatment Alik Farber Kenneth Rosenfield Matthew Menard paradigm to one in which both endovascular and surgical therapies are surface each year, it is increasingly the advances in endovascular therapy it is important to remember that there equally considered and discussed with important to accrue the necessary and under the guise that endovascular is significant evidence that open the patient. high-quality evidence to determine treatment is a low-risk “free shot”. surgical revascularisation following a At the heart of this trial is the the best revascularisation strategy While the convenient and minimally failed endovascular attempt has worse ultimate benefit that it will bring to all for these patients. Many practitioners invasive nature of endovascular outcomes than when undertaken as future patients who will suffer from adopt an “endo-first” approach due to therapy is also attractive to patients, first-line therapy. CLI. Beau Hawkins, an interventional cardiologist and lead investigator at the University of Oklahoma Health Sciences Center (Oklahoma City, BASIL trials continue enrolment USA), has frequently commented on the positive patient experiences The original UK NIHR HTA-funded BASIL trial he has encountered, and how they (BASIL-1), the results of which were published accent for him the importance of the in 2010, remains the only randomised controlled trial’s completion and the significant trial to have compared bypass and endovascular contributions to evidence-based intervention for the treatment of severe limb medicine the study will bring. “As ischaemia due to infra-inguinal disease. However, clinicians, we often participate in many interventionalists question the relevance of clinical trials to advance science and the BASIL-1 outcome data to modern practice given determine answers to important clinical the advances in endovascular technologies and questions. The BEST-CLI trial serves techniques. this purpose by aiming to determine The UK NIHR HTA-funded BASIL-2 and BASIL-3 how to optimally treat CLI. I have trials, led by Andrew Bradbury at the Birmingham been struck by two things that I was Clinical Trials Unit (BCTU; University of Birmingham, not expecting through my institution’s Birmingham, UK) are complementary randomised participation. First, the BEST-CLI controlled trials that will provide further level 1 Andrew Bradbury trial has improved the collaboration evidence regarding the surgical and endovascular between specialties caring for CLI management of severe limb ischaemia due secondary to femoropoliteal disease ± infrapopliteal patients at my institution. I have to infrapopliteal and femoropopliteal disease, disease to plain balloon angioplasty ± bail-out bare worked more closely in a more respectively. metal stent, drug-coated balloon ± bare metal stent, congenial fashion with CLI physicians “BASIL-1 indicates that plain balloon angioplasty and drug-eluting stent. from other specialties as a direct result is preferred to surgical bypass for the management “NICE found the results of BASIL-1 more difficult to of this study. Second, patients have of severe limb ischaemia due to femoropopliteal interpret with regard to the treatment of infrapopliteal overwhelmingly wanted to participate disease in those patients who are unlikely to live for disease as only around 25% of the cohort of 452 in this trial, not for their own benefit, at least two years and/or who do not have a suitable patients had an infrapopliteal bypass or intervention. but for the benefit of future patients vein for bypass,” Bradbury told Interventional News. There remains, therefore, very considerable who develop CLI. As an example, one “Since BASIL-1 reported, drug-coated balloons and uncertainty as to whether patients presenting with patient we enrolled in the trial lived in drug-eluting stents have become widely available severe limb ischaemia due to infrapopliteal disease a remote area, four hours away from and this has led interventionalists to argue for a ‘best are best served by endovascular techniques or by the hospital. I never anticipated that he endovascular treatment’ first strategy for (almost) all vein bypass and recommended further randomised would agree to participate due to the severe limb ischaemia patients. However, in the UK, controlled trials in this area,” Bradbury explained. travel demands for follow-up, but when NICE have concluded that there is as yet insufficient NIHR HTA has since funded BASIL-2, which aims to he did, I asked him why. He responded, evidence to justify the use and costs of drug-coated randomise 600 patients with severe limb ischaemia ‘Because I can help other people with balloons or drug-eluting stents and called for a secondary to infrapopliteal disease ± femoropopliteal this problem [CLI] in the future.’ randomised controlled trial to examine the clinical and disease to either a best endovascular treatment first The altruism of our CLI patients is cost-effectiveness of drug-coated balloons, drug- or a vein bypass first revascularisation strategy. humbling and simply highlights the eluting stents and plain balloon angioplasty.” Up to date information on progress with BASIL-2 importance of the BEST-CLI trial.” NIHR HTA subsequently funded BASIL-3, which will and BASIL-3 can be found on the BCTU University of Given that approximately 500–1,000 randomise 861 patients with severe limb ischaemia Birmingham websites. new cases of CLI per million people March 2017 Updates 37 Interventional radiology participation grows at RSNA clinical trials “bootcamp”

MICHAEL SOULEN

COMMENT & ANALYSIS

The Radiological Society of North America (RSNA) held its 12th Clinical Trials Methodology Workshop 7–13 January in San Diego, USA. This programme offers intensive training in clinical trial design and statistics for academic radiology faculty from around the world and is a phenomenal resource to grow the cadre of rigorously trained clinical trialists in interventional radiology, writes Michael Frédéric Deschamps Stephen Hunt Soulen, Philadelphia, USA. pelvic fixation. Vamshi Kotha from workshop ends with a poster reception he workshop offers morning The majority of interventional Calgary, Canada wrote a multicentre of all the students’ projects: didactic sessions, followed by radiology literature still consists of randomised trial of bare metal aortic The Clinical Trials Methodology Tsmall group sessions in which retrospective single institution studies. stenting after hybrid arch repair of Workshop is a phenomenal resource each “student” transforms a concept for Interventional radiology needs to up type 1 dissections. Sailendra Naidu from RSNA to grow the cadre of their own clinical trial into a complete its game to match the standards of our from Mayo Clinic, USA, designed rigorously trained clinical trialists in protocol, ready for submission upon colleagues in oncology and vascular a phase 1/2 study of prostate artery interventional radiology. If we keep return to their home institution. With a disease. For the past few years, I have embolization for high-risk non-surgical training a half-dozen interventional 1:1 faculty to student ratio, the trainees been encouraging colleagues at major candidates. There were multiple radiology faculty each year, we will have ample opportunity to interact with academic interventional radiology interventional oncology projects soon see the payoff with publication of all the faculty, both within, and outside centres in North America and Europe from the USA, including immune prospective controlled trials, improving of their protocol groups. The yield from to send junior faculty to the workshop, checkpoint therapy Nivolumab, with the level of evidence for interventional this programme is rewarding: by three and it really paid off. Six of the 24 transarterial chemoembolization radiology therapies, and increasing the years, half the students have done a students (25%) at the 2017 workshop (TACE) for unresectable hepatocellular impact factor of our journals. trial; half have received grant funding; were interventional radiologists, and carcinoma (Stephen Hunt, University and all have multiple publications. another two were accepted to the of Pennsylvania), TACE for paediatric Michael Soulen is professor of More importantly, the skills acquired programme but were unable to attend. hepatocellular carcinoma (Matthew Radiology at the Hospital of enable trainees to continue to develop Topics were varied. Frédéric Lungren, Stanford University), and the University of Pennsylvania, future trials. In addition, the week- Deschamps from Institut Gustave quality of life in Barcelona Clinic Liver Philadelphia, USA. He is the long immersion provides an intimate Roussy in France developed a phase Cancer (BCLC) C patients treated interventional radiology faculty and environment for networking among I/II trial for a new percutaneous with TACE, sorafenib, or both (Resmi chair-elect for the Clinical Trials young academicians. screw/cementoplasty device for Charalel, Cornell University). The Methodology Workshop. Interventional radiology’s right to compete a healthy competition that in the end of competition and limiting the choices benefits the patient. However, what that patients have, then there should be we should not accept are attempts to a justification based on facts. In cases manipulate the rules of healthy com- like these it is becoming obvious how GREGORY MAKRIS petition so that we are no longer able important it is to have strong national to compete. Interventional radiologists and European professional socie- have all the necessary skills and train- ties and possibly this is the real “take ing required to be independent provid- home” message from this story. COMMENT & ANALYSIS ers of endovascular treatments for the The aforementioned story is an management of varicose veins and any example of what potentially poses the There is a recent story about a UK-based private insurer potentially attempt to keep us out of the contention most serious risk to our profession. It is no longer recognising interventional radiologists as primary for this work is a real threat and should not competition from other specialties practitioners for the treatment of varicose veins that is doing the not be accepted. but our exclusion from being able to rounds. While this story is unconfirmed, it acts as a wake-up call A case in point of such an attempt, in compete on equal grounds for the pro- and a reminder that we have to remain vigilant in order to protect my opinion, is the wide variation in the vision of endovascular services. Once a our professional rights, writes Gregory C Makris, Oxford, UK. status of admitting rights. How can we fair competitive environment has been be expected to compete when we are established, interventional radiologists here are many potential future an even footing. not able to admit our own patients in have nothing to be afraid of since we risks for our specialty. Every- We should accept the fact that like in our own hospital beds? The introduc- have the skills and qualities necessary Tbody has the right to train in any other market, if you have the skills tion of interventional radiology day to provide excellent services for our endovascular techniques in a recog- and you can provide a high quality units in some hospitals has provided a patients and the other specialties we nised training centre and in a regulated and safe service, then you should be partial solution to this, but more needs work with. environment. This means that if you allowed to compete for a place in that to be done in order to ensure a fair have obtained the necessary skills market, whether that is called periph- environment for healthy competition. Gregory C Makris is a vascular and through the required years of training eral arterial work or varicose veins. Despite the fact that I recognise that interventional radiology fellow, Oxford then you should be able to perform cer- The market law of “demand and every organisation has the right to run university hospitals, NHS Foundation tain endovascular tasks independently supply” is usually very efficient at its business the best way they see fit, Trust, and clinical entrepreneur fellow and be given the chance to compete on providing the environment that allows when it comes to damaging the rules at NHS Innovation England, UK. 38 Society news March 2017 Society of Interventional Radiology statement on US President Donald J Trump’s executive order on foreign entry into the United States

Society of Interventional Radiology (SIR) president Charles E Ray Jr issued the following statement in response to President Donald J Trump’s executive order suspending entry into the United States nationals from the countries of Iraq, Iran, Libya, Somalia, Sudan, Syria and Yemen.

he Society of Interventional research in interventional radiology Radiology is a global organi- to be allowed to come to the United “Tsation dedicated to the limit- States to study and share their work, less potential of interventional radiology and for US-based attending physicians to solve the toughest medical problems. from the banned nations who are We represent more than 6,100 interven- traveling overseas—including travel tional radiology professionals worldwide for medical missions, research or and a global medical specialty that im- conferences—be allowed to return to proves lives using innovative, minimally their patients in the United States. invasive, image-guided treatments. “From 4–9 March, the SIR annual and participants in our meeting “Interventional radiology relies scientific meeting in Washington, as they strive to improve health on academic discourse, innovation DC, will bring together more than outcomes worldwide. and continuing medical education 5,000 physicians, researchers, medical “We are also concerned that to deliver quality patient care. As associates and students from more limiting the travel of physicians such, limiting the movement of than 35 countries to discuss the latest from banned countries may also active physicians, researchers and advances in interventional radiology. have detrimental effects on the healthcare professionals puts such The diversity of our attendees, their international healthcare community, Charles E Ray advances in jeopardy by constraining expertise and ideas constitute the particularly in areas that suffer from a Picture courtesy: SIR collaboration, education, research and very backbone of our meeting. This lack of medical infrastructure due to innovation that contribute to optimal ban is discouraging and disruptive ongoing strife. interventional radiology professionals. patient outcomes. to the medical education, sharing “SIR stands committed to We call on our national leaders “Moreover, it is critical for nationals of scientific research and corporate promoting diversity and inclusiveness to eliminate barriers to scientific who are pursuing medical training and innovation that benefits all attendees and welcomes collaboration from all exchange and medical education.” African IR society announced at MEET IO meeting SAFIRE (Society of African Interventional Radiology and Endovascular therapy), a society of over 60 founding members from Egypt, Ethiopia, Ghana, Kenya, Mali, Nigeria, South Africa and Sudan, has recently been established. Its formation was announced at the Middle East Endovascular Therapy and Interventional Oncology symposium (MEET IO; 11–13 January, Cairo, Egypt).

EET IO was the inaugural meeting of interventional radiology in the Middle East, Mattended by over 500 registrants and had distinguished speakers from the USA such as James Benenati (Miami), Michael Dake (Stanford), Alan Matsumoto (Charlottesville) and Riad Salem (Chicago). According to information obtained from the organisers, the meeting was widely covered by media in the Middle East including coverage on television, print and social media. There was a large delegation of speakers from the Middle East including Egypt and Turkey and over 25 speakers from the US and Europe. interventional radiologists, especially in Africa as they The meeting also highlighted the efforts of provide they provide the potential referrals.” the the EBIR (Egyptian Board of Interventional Further, Saad noted that he sees a strong Radiology, which is distinct from the European growth for interventional oncology in Africa and Board of Interventional Radiology certification in interventional oncology and endovascular procedures interventional radiology) The intent of the EBIR is to for the Middle East. Pointing to the challenges that train interventional radiologists and advance the field of face interventional radiology in these regions, he intervention radiology in the Middle East and Africa. added, “Increasing the awareness of the medical The meeting was organised by Wael Saad (University communities and the patients in these regions of what of Michigan, USA, one of the EBIR Trustees and interventional radiology has to offer with regard to the liaison between the EBIR and the Society of its minimally invasive nature and its effectiveness Interventional Radiology [SIR]), Ahmed Kamel in managing an assortment of diseases and medical (University of Alabama in Birmingham [UAB] and conditions is a challenge that needs to be worked on.” Children’s Hospital of Alabama, USA), Wael Darwish Saad explained that the EBIR was established three (National Cancer Institute, Cairo University and years ago and that its process and examination has been associate director of EBIR, Egypt), Bulent Arslan (Rush endorsed through an ongoing partnership with SIR. The University Medical Center, Chicago, USA) and Nael board is a two-year fellowship that is open to post- Saad (Washington University School of Medicine in residency candidates in the Middle East and Africa who St Louis, USA). The EBIR Board of Trustees includes are Arabic speaking, which is a patient care need. “Just Ikram Hamed (former chairman of Radiology, National recently, we have examined the second graduating class. Cancer Institute, Cairo University and director of EBIR). “Biopsies, drainages and interventional oncology The trainees rotate in eight institutions in Egypt. Right Commenting on interventional radiology’s place in procedures are widely performed. Surprisingly, the now, we have trainees from Egypt, Sudan and Iraq. The healthcare in the Middle East and Africa, Wael Saad told challenges are not the expensive angiography suites, but EBIR has faculty from Cairo University, Alexandria Interventional News: “Interventional radiology in the the running costs of consumables (catheters and balloons, University, Mansoura University, Ain Shams University Middle East is becoming integral to the management of for example) and limited awareness in the medical and US universities such as University of Michigan, oncology and is developing in the vascular arena. Overall, community of the role and capabilities of interventional Washington University in St Louis, University of it is developing within the health system in Africa. radiology. The latter is daunting to the small numbers of Washington, UAB and Emory University,” he said. March 2017 Society news 39 The ESR and CIRSE join forces to promote patient care The European Society of Radiology (ESR) and the Cardiovascular (EDiR—an initiative of the ESR dedi- and Interventional Radiological Society of Europe (CIRSE), have cated to continued education and certi- joined forces to address the future of diagnostic and interventional fication for general and sub-specialised radiology with a special focus on improving patient care. radiologists), ESR’s EU and International Affairs, in EuroSafe Imaging, the ESR’s oth societies are non-profit models to make sure that our future col- quality and safety campaign, as well as organisations that aim to pro- leagues embrace clinical responsibilities the European Institute for Biomedical Bmote educational and scientific and feel comfortable to pursue the clini- Imaging Research (EIBIR). I believe exchange and advance patient care, and a cal management of patients. Last but not that the increased commitment of both strengthened collaboration between them least, we should concentrate on establish- societies will greatly benefit patient care will benefit many. Both are dedicated to ing and improving functioning referral and the radiological community,” said supporting teaching, science, research routines in hospitals, which could prove Katrine Riklund, chairperson of the ESR and clinical practice in medical imaging, very valuable for both interventional and Board of Directors, from Umeå, Sweden. with CIRSE focusing on the subspecialty diagnostic radiology,” said Elias Brount- Future plans include increased col- field of cardiovascular and interventional zos, current CIRSE president. laboration with the ESR’s EU and Inter- radiology, and the ESR on the discipline One of the ESR’s successful projects in national Affairs department, as well as of radiology as a whole. the field of education is the establishment joint courses and society booths at major The decision to enhance collaboration of the European Training Curriculum for radiology events to further communi- was taken in a meeting between the lead- Radiology, designed to provide a valu- Elias Brountzos cate that diagnostic and interventional erships of both societies in July 2016. The able template for training radiologists and Picture courtesy: CIRSE radiology belong together. The ESR and first step will be a joint survey on the state enhance the quality of care for patients CIRSE will work together on strategic of the art and current practice of interven- throughout Europe. The ESR has added org), is currently being updated and the issues to promote the subspecialty of in- tional and diagnostic radiology with the further clinical and patient care-related second edition will be released in early terventional radiology, and will meet on a aim to identify synergies and ultimately aspects of interventional radiology to its 2017. The European Curriculum and regular basis to improve communication optimise patient care. The questionnaire is Curriculum for Undergraduate Radiologi- Syllabus for Interventional Radiology and further deepen their ties. planned to be sent out in early 2017. cal Education and will include an update is the blueprint for the European Board Furthermore, CIRSE’s application “This partnership intends to fortify the of CIRSE’s input in its subspecialisation of Interventional Radiology (EBIR), a to become a member of the European position of diagnostic and interventional curriculum. Revised versions of both certificate of competence, providing a CanCer Organisation (ECCO) was radiology and to attract more clinically curricula will be released on the ESR benchmark for European Interventional fully supported by the ESR, which oriented medical students to radiology. website on the occasion of ECR 2017. Radiology practice, which is officially joined ECCO in May 2016. ECCO is We want to support medical students and In 2013, CIRSE established the first endorsed by the ESR. a multidisciplinary federation which radiology residents in their ambitions to edition of the European Curriculum and “CIRSE is at present involved in the upholds the right of all European cancer become full-time interventional radiolo- Syllabus for Interventional Radiology. ESR’s annual congress (ECR), which is patients to the best possible treatment gists or radiologists with a special focus This document, which provides guidance reflected by a broad selection of interven- and care, promoting interaction between and experience in interventional radiol- for radiologists wishing to specialise in tional and vascular radiology sessions, all organisations involved in cancer care ogy. We want to shape future training interventional radiology (www.cirse. in the European Diploma in Radiology at the European level.

RANZCR establishes new US FDA bans powdered gloves Interventional Radiology Committee

The Royal Australian and New Zealand College of Radiologists (RANZCR) recently created a Standing Committee on Interventional Radiology, to promote and facilitate the advancement of interventional radiology in Australia and New Zealand.

ANZCR is a non- increasingly sophisticated profit professional technology, more Rmembership advanced techniques and association and the top an ever-growing body body for advancing of evidence for positive patient care and quality clinical outcomes. This standards in the clinical committee will provide radiology and radiology the College with advice oncology sectors in and guidance relating to Australia and New to help shape the future these areas, as well as Powdered gloves must be replaced by non-powdered Zealand. Representing of the profession and the identifying issues that alternatives, following the ban. over 4,000 medical provision of interventional impact on quality and specialist members, the radiology services. access for patient care.” he US Food and Drug health care providers, patients and role of the College is to Greg Slater, president The Committee is Administration (FDA) other individuals. drive the appropriate, of RANZCR, said comprised of a mix of T has issued a final rule to Given the availability of non- proper and safe use of the formation of this clinical radiologists ban powdered surgical gloves, powdered gloves which can “provide medical imaging and committee “marks the who practice across patient examination gloves and the similar protection, dexterity and radiation oncology beginning of a process general and complex absorbable powder used to lubricate performance” without the risks services for optimum to promote good clinical body interventions, surgical gloves. associated with powder, the health outcomes. care and better support neurointerventions Citing associations with serious FDA states that, “a transition to The new committee interventional radiology and have experience adverse events—including alternatives in the marketplace has been formed at a across the spectrum of in research, quality allergic reactions, lung and airway should not result in any detriment to time when significant activity in this field.” and safety. The group inflammation and post-surgical public health.” policy and advocacy He continued: represents both New bands of fibrous scar tissue that can The FDA has only banned one activity is being seen “Interventional Zealand and Australia, present between internal organs and other medical device in its 110- across both countries, radiology continues with members from a mix tissues, among others—the agency year history. The agency banned providing a unique to rapidly evolve with of metropolitan and rural/ states that powdered gloves “present prosthetic hair fibres for hair opportunity for RANZCR the development of regional settings. unreasonable and substantial risk to transplantation in June 1983.

March 2017 Market watch 41

amount of the foam into the malfunctioning vein of a patient through a catheter or a needle. It displaces the blood from the vein to reach and treat the vein wall; Product News the diseased vein should then collapse and blood flow is diverted to healthy veins nearby. “BTG has done a great job preparing the medi- Siemens Healthineers launches Artis arterial vessels visible and helps distinguish ves- cal community with teaching materials and helpful pheno angiography system sels and treatment paths via colour coding. Graphic protocol details,” says Douglas Hill, principal of Siemens Healthineers, overlaying of the selected vessel paths with real-time The Vein Treatment Centre in Calgary, Canada, and the separately managed X-ray images distinguishes the vessels that supply president of the Canadian Society of Phlebology. healthcare business of the tumour for simplified microcatheter navigation, “Polidocanol injectable foam holds great promise to Siemens AG, presented which can reduce radiation and contrast dose. effectively treat varicose vein networks in just one under its new brand visit and is able to treat large diameter great saphen- name for the first time at Merit Medical receives US FDA 510(k) ous veins that may not respond to other extemporane- the Radiological Society clearance for the SwiftNinja steerable ous foam treatments.” of North America microcatheter (RSNA) annual meeting Merit Medical Systems has received 510(k) clearance Spectranetics gets CE mark for (27 November–2 for the SwiftNinja steerable microcatheter, covering Stellarex 0.014” drug-coated balloon December, Chicago, peripheral and coronary applications. USA). With the exception of Japan, Merit has global distri- Artis pheno It also unveiled the bution rights for the SwiftNinja. CREDIT: www.siemens.com/press robot-supported Artis “For the past several months we have been market- Stellarex pheno angiography ing this unique product with great success in Europe,” system that was developed for use in interventional said Fred P Lampropoulos, Merit’s chairman and Spectranetics has announced that its Stellarex 0.014” radiology, minimally invasive surgery, and chief executive officer. “Physician response relating to drug-coated angioplasty balloon has received the CE interventional cardiology at the conference. range, convenience and overall cost, when compared mark. The device is designed to treat small vessels, Artis pheno boasts new 2k recording technology to the use of multiple devices, has validated our initial below-the-knee disease, and challenging critical limb capable of delivering 2D imaging resolution that is expectations.” ischaemia in patients. four times higher in all recording processes than prior The SwiftNinja is scheduled to be launched simul- The combination of the currently available Stel- Siemens Healthineers systems, a press release from the taneously with the Corvocet larex 0.035”and the new 0.014” line available in company states. The system’s StructureScout feature biopsy system, which also Europe expands Spectranetics’ comprehensive can adapt and optimise imaging parameters to suit the recently received 510(k) portfolio of next generation drug-coated balloons to X-rayed area, potentially resulting in less radiation clearance. treat complex disease states across the lower extremi- dose than prior systems from the company. The Artis “We believe these ties. “Now available on a 0.014” balloon platform, pheno also supports the treatment of multimorbid two patented and Stellarex represents a latest generation drug-coated patients and can be fitted with a comprehensive transformative tech- balloon backed by compelling evidence in the femo- range of optional software applications for nologies will provide ropopliteal arteries. It holds strong promise to deliver complex cases. And to aid with infection substantial momentum and safety and efficacy in the notoriously challenging control, the Artis pheno has large, sealed enthusiasm amongst our sales infrapopliteal district,” said Dierk Scheinert of Uni- surfaces with fewer spaces, which are force and customers as we prepare versitätsklinikum in Leipzig, Germany. easy to clean and disinfect. SwiftNinja for 2017,” Lampropoulos said. Spectranetics president and chief executive officer One system for multimorbid Scott Drake states, “Stellarex 0.014” exemplifies patients Canada first country to get DC Bead these important elements and augments our exist- Patients often suffer from multiple health issues that Lumi treatment for liver cancer patients ing product portfolio, which now includes clinically can complicate minimally invasive procedures or BTG International Canada has announced the com- differentiated treatment for both above and below- render them impossible. Older patients, in particular, mercial launch of DC Bead Lumi in Canada. The the-knee disease. The Stellarex 0.014” drug-coated face additional risks due to chronic disease. The Artis launch represents the first market commercialisation balloon is a significant advancement in our effort to pheno angiography system helps facilities respond ac- of DC Bead Lumi in the world, with regulatory clear- eradicate restenosis and amputation.” cordingly. Because it can scan up to 15% faster in the ances and launches planned for additional markets body area than prior Siemens Healthineers systems, the worldwide. Spectranetics files FDA pre-market system’s syngo DynaCT clinical software application DC Bead Lumi is sometimes also known as LC approval application for Stellarex can produce 3D images that use less contrast media, Bead Lumi in other geographies, such as the USA. In November 2016, Spectranetics submitted its thus decreasing the load on the patient’s kidneys. And The company received Health Canada approval for premarket approval application for the Stellarex drug- to accommodate contrast-sensitive patients, Artis pheno DC Bead Lumi in August 2016. coated angioplasty balloon to the US FDA. Stellarex supports CO2 imaging of extremities. The system fol- DC Bead Lumi is the first available radiopaque is designed to restore and maintain blood flow to the lows the tilted patient table and increases CO2 visibility embolic drug-eluting bead that can be loaded with superficial femoral and popliteal arteries in patients within the patient via its new StructureScout feature. doxorubicin for the treatment of hepatocellular carci- with peripheral artery disease. The Artis pheno’s C-arm is five inches wider than noma, the most common type of primary liver cancer “The Stellarex drug-coated balloon has been its predecessor system, the Artis zeego, and has a free or with irinotecan for the treatment of malignant studied extensively in two randomised controlled inner diameter of 37.6 inches, which offers more space colorectal cancer metastasised to the liver. trials as part of the rigorous ILLUMENATE series for handling larger patients and enables use of longer that enrolled more than 1,100 patients,” said Amanda instruments. The system’s multi-tilt table is designed BTG’s Varithena launched in Canada Johnson, vice president of Regulatory and Medical to accommodate patients up to 617 pounds. The end of Following Health Canada regulatory approval, BTG Affairs. “Key opinion leaders have called the results the table can tilt up and down to stabilise patient blood is to launch its polidocanol injectable foam (Var- reported to date ‘remarkable,’ especially in light of pressure or facilitate breathing, for example. And like ithena), a drug/device combination product used Stellarex’s low drug concentration. This pre-market the Artis zeego, the Artis pheno’s robotic construction to treat varicose veins, in Canada. The product is approval application marks a unique and important provides a flexible isocentre, so it can follow all table intended for use in adults with clinically milestone in the future landscape of treating patients positions while representing the patient’s target area significant venous reflux as diagnosed with peripheral artery disease.” from virtually any angle. by duplex ultrasound. President and chief executive officer Scott Drake Easier identification, attribution of arteries Polidocanol injectable foam is said, “We are preparing diligently for our launch into Several applications on the Artis pheno support indicated in Canada for the treatment the US market, which we anticipate in the second half transarterial chemoembolization (TACE) of tumours. of incompetent great saphenous veins, of 2017, and are looking forward to improving patient With syngo DynaCT 360, the Artis pheno can gener- accessory saphenous veins, and visible care with this next-generation device.” ate a large-volume liver or lung image, for example, varicosities of the great saphenous vein Spectranetics launched Stellarex in Europe in Janu- including the tumour’s anatomy and the vessels lead- system, above and below the knee. ary 2015. Stellarex uses EnduraCoat technology, a ing to it. Rapid rotation is vitally important in reduc- Polidocanol injectable foam is a durable, uniform coating designed to prevent drug loss ing movement artifacts, since TACE patients receive uniform, low nitrogen, microfoam during transit and facilitate controlled, efficient drug only local sedation. The syngo Embolization Guid- dispensed from a proprietary canister delivery to the treatment site. ance (pending US FDA approval) application renders device. A physician injects a small Varithena

March 2017 Market watch 43

in a range of diameters from 5–11mm and lengths of 15, 19, 29, 39, 59, and 79mm to cover a wide variety of treat- Product News ment needs. Medtronic receives CE mark for lower-profile HawkOne directional OsteoCool RF ablation system gets closer to becoming available to European physicians,” Micro atherectomy system expanded indication for palliative Medical Solutions chief executive officer Gregory Sullivan Medtronic has been granted CE mark approval for the treatment of metastatic bone tumours added. “We are delighted to share this exciting news with HawkOne directional atherectomy system in a lower profile Medtronic has announced that the US FDA has cleared an interventionists, who are seeking much-needed innovation in size for treating patients with peripheral artery disease. The expanded indication for the OsteoCool radiofrequency (RF) this underserved area.” new HawkOne 6F provides an effective and easy-to-use ablation system. Originally cleared for use in the spine, the Greg Mathison, director of Regulatory and Clinical treatment option for patients with peripheral artery disease FDA now allows the marketing of the OsteoCool system for Affairs at MMS, confirms the importance of CE mark but both above and below the knee with a single device. The palliative treatment of metastases in all bony anatomy—such anticipates even more exciting news to follow: “This ap- HawkOne system is designed to remove plaque from the as ribs, sacrum, extremities, and hip—in patients who have proval is an important step forward in our regulatory path. vessel wall and restore blood flow. failed or are not candidates for standard therapy. The system We look forward to providing data from a US clinical trial of “Directional atherectomy is an established treatment mo- uses targeted radiofrequency energy to ablate malignant the MicroStent in 2017.” dality for patients with complex peripheral artery disease to metastatic bone tumours. restore patency, maximise luminal gain and preserve future “Patients with metastatic bone cancer may be treated with US FDA approves first balloon treatment options,” says Thomas Zeller, head, Department conventional therapies such as opioids, chemotherapy or expandable stent graft to treat iliac of Angiology, Universitäts-Herzzentrum Freiburg, Bad Kro- radiation therapy for pain palliation,” said Sandeep Bagla, an arteries zingen, Germany. “The new smaller HawkOne 6F size is an interventional radiologist with the Vascular Institute of Vir- advanced option to treat patients with multi-level peripheral ginia in Woodbridge, USA. “With the expanded indication artery disease, addressing lesions of various length, morphol- for the OsteoCool system, I now have the option to ablate ogy, and location, particularly those below the knee.” these patients’ painful bone tumours when conventional The HawkOne system is also designed to enable physi- therapies are considered ineffective, too slow-acting or cause cians to treat severe calcified lesions more efficiently with no unacceptable side effects.” increase in cut depth. The system can treat calcified lesions Metastatic bone disease has been reported to occur in up to two times more effectively than the TurboHawk 60–80% of cancer patients, most frequently among patients device, according to a company release. The HawkOne with primary malignancies of the breast, prostate, liver, and system has a preloaded flush tool, which improves cleaning lung. More than 80% of bone metastases are found in the Gore Viabahn VBX time by up to 55% when compared to the TurboHawk high axial skeleton, which includes the skull, spine, and ribs. efficiency cutter. The 6F size is designed to simplify device Medtronic acquired the OsteoCool technology and as- Gore has announced that the Gore Viabahn VBX balloon selection and provide easy set-up with no capital equipment. sociated intellectual property from Baylis Medical on 16 expandable endoprosthesis has received US FDA approval December 2015 and partnered with the company to further for treatment of de novo or restenotic lesions found in iliac ConvertX nephroureteral stent system innovate the system. arteries, including lesions at the aortic bifurcation. receives FDA clearance The OsteoCool system is the only cooled radiofrequency This marks the availability of the only balloon expandable BrightWater Medical has announced that the US FDA has ablation technology that offers simultaneous, dual-probe ca- stent graft with an indication for the iliac artery. cleared the company’s ConvertX nephroureteral stent system pabilities providing for procedural flexibility and predictable, “The VBX stent graft demonstrated notable immedi- for treatment of ureteral obstructions. Patients with obstruc- customised treatment, a press ate and nine-month safety and efficacy in treating patients tions preventing urine in the kidneys from draining to the release from Medtronic states. with iliac occlusive disease which can be attributed to bladder face potential pain, infection, and long-term damage, The system is temperature the exceptional device design,” said Jean Bismuth. He necessitating immediate treatment. In severe cases referred controlled and uses internally continued: “Overall, there were multiple clinical benefits to the interventional radiologist, the ConvertX is the only de- water-cooled probes to prevent observed, including no median change in the device length vice that enables the interventional radiologist to eliminate a overheating of surrounding upon deployment and a 100% technical success rate with second invasive interventional procedure to treat the patient. tissue during the procedure, no occurrences of stent dislodgement or significant residual In the two traditional procedures, the interventional radi- it adds. stenosis. The study device performed well in disadvantaged ologist first implants a nephrostomy catheter to externally The device also has a lesions, including occlusions, which speaks to its trackability, drain urine and in the second procedure exchanges the CE mark for the ablation of radial strength, conformability, and stent retention.” nephrostomy catheter for an internal ureteral stent to cir- benign bone tumours such as FLEX clinical study cumvent the blockage. The ConvertX system, in contrast, is osteoid osteoma and pallia- Of the patients in the Gore VBX FLEX investigational implanted only once and converts from a catheter to a stent tive treatment of metastatic device exemption clinical study (n=134), 32% pre- in a brief office procedure without the need for radiation or malignant lesions involving sented with TASC II type C or D lesions, 18% required sedation, in less than one minute. The ConvertX stent then bone, including the vertebral contralateral access to the lesion, and 42% involved remains implanted in the patient like a standard internal body. This indication is not kissing stents at the aortic bifurcation. Clinical data from ureteral stent. Osteocool available in the USA. study conducted for US FDA approval reflected that the “Ureteral blockages due to kidney stones, tumours or design components of the VBX stent graft were resilient scarring from previous surgeries must be treated quickly so Micro Medical Solutions receives CE both during stenting procedures and over time: urine can be voided,” explained ConvertX system developer mark for MicroStent „„100% success rate in device delivery and coverage of Bob Smouse, founder and CEO of BrightWater Medical, Micro Medical Solutions (MMS) has received CE mark target lesions in all patients and professor of Radiology and Surgery, University of approval for MicroStent, allowing the company to market „„100% success rate in reducing the target lesion to less Illinois College of Medicine. “The ConvertX System saves this technology in Europe. MicroStent is a vascular stent than or equal to 30% of the original stenosis the patient the risk and discomfort of an additional second specifically designed to reduce below-the-knee amputa- „„Zero change in median length of the device upon interventional procedure and may reduce healthcare costs, tions for critical limb ischaemia resulting from peripheral deployment; and free up the hospital’s angiosuite for other procedures and artery disease. „„96.9% primary patency at nine-months, including a save the interventional radiologist procedural time that can “The MicroStent is the centrepiece of an integrated 95.3% primary patency rate in those patients with TASC be devoted to care of other patients.” delivery platform that will help fill an unmet need in the II C or D type lesions. “The ConvertX system is the kind of technology interventional community. Amputation prevention in this Further, there were no reported incidences of device advancement that we require to meet the dual goals of critical limb ischaemia patient population is an ongoing dislodgement, failures in stent integrity, or device-related improving patient care and reducing the financial burden fight, and we welcome new tools that have such promise to serious adverse events through the primary endpoint follow to the healthcare system,” explained James F Benenati, make a difference,” said Jihad Mustapha, a board-certified up, meaning no additional costs incurred for either endo- clinical associate professor of Radiology at the University interventional cardiologist specialising in minimally inva- vascular or surgical stent removal. The VBX stent graft of South Florida College of Medicine. “Interventional sive, non-surgical therapy for heart and peripheral vascular does not require predilation, which reduces the number of radiology enables patients with severe ureteral blockages disease. A global thought leader for amputation prevention in balloons required, and the longer lengths available reduce to be quickly treated, and technologies like the ConvertX the treatment of patients with critical limb ischaemia, Musta- the need to use multiple stents for extensive lesions, both of platform provide the interventional radiologist with simpler, pha has been instrumental in guiding clinical and regulatory which also contribute to procedural cost savings. more cost-effective solutions.” Benenati is also medical di- pathways for MMS. The VBX stent graft was developed utilising the small rector of the Peripheral Vascular Laboratory, Miami Cardiac “This major milestone for MMS brings our Micro Vascu- diameter, ePTFE stent graft technology from the Gore and Vascular Institute, and past president of the Society of lar Integrated Platform, which includes MicroStent, one step Viabahn Endoprosthesis. The VBX stent graft is available Interventional Radiology.

March 2017 Market watch 45

Product News

Medtronic announces Health current generation of AFX products, Canada licence for In.Pact which was also outlined in a recent Admiral drug-coated balloon letter to physicians provided by the Medtronic Canada, a subsidiary of company. Medtronic, has announced it has John McDermott, chief executive obtained Health Canada licence for officer of Endologix, says, “We are the In.Pact Admiral drug-coated pleased that AFX and AFX2 are once balloon. In.Pact Admiral is a primary again available to physicians and endovascular device used in patients patients in Europe. with peripheral artery disease in the upper leg, specifically, in the Bentley receives CE mark for superficial femoral and popliteal new BeGraft aortic stent graft arteries. In November 2016, Bentley launched Medtronic says that what its BeGraft aortic stent graft system: distinguishes the In.Pact Admiral from a balloon expandable, large diameter other alternatives for peripheral artery covered stent with sizes ranging from disease is the coating formulation, 12mm to 24mm available in lengths of composed of a proven antiproliferative 19mm to 59mm in Europe. drug (paclitaxel) and an excipient A Bentley press release says that (urea). Once inflated, the coating the whole diameter range is covered comes into contact with water in the by three different stent designs in bloodstream, which hydrates the urea, order to guarantee low foreshortening facilitating the release of solid-phase combined with high radial force of the paclitaxel to the vessel wall to help stent, and the “excellent flexibility” prevent restenosis. of the BeGraft aortic contributes to A Medtronic press release notes that optimised lesion care. In.Pact Admiral has been studied in The BeGraft aortic is indicated more than 20 individual clinical trials, for the implantation in native and/or “demonstrating durable safety and recurring coarcation of the aorta in clinical benefits”. Recently, three- adolescent or adult patients as well year data from the IN.PACT SFA as for restoring and improving the clinical trial demonstrated the highest patency of the iliac arteries. rate of primary patency and lowest As all products from the BeGraft rate of clinically driven target lesion range, the BeGraft aortic is also made revascularisation in a pivotal study of of cobalt chromium and is mounted on interventional treatments for peripheral a semi-compliant balloon which allows artery disease. a slight variation in diameter. The stent “Patients experiencing graft allows high post dilation when incapacitating intermittent claudication using a large-diameter high-pressure or rest pain need a safe and durable balloon. For example, the diameter of treatment option,” said Andrew Benko, 12mm can be post-dilated up to 20mm Centre Hospitalier Universitaire de and the 24mm up to 30mm. Sherbrooke, Sherbrooke, Canada. “I am very pleased that a balloon “In my practice, In.Pact Admiral expandable large diameter stent graft will be the device of choice for is now easily available with which such patients with femoropopliteal I can treat coarctations secure and lesions giving the opportunity for accurately,” said Piotr Kasprzak, outstanding clinical results with head of Vascular Surgery, University very low reintervention rates. This Hospital Regensburg, Germany, after technology has been one of the most implanting the first BeGraft aortic at significant advancements I have seen the beginning of November. in the endovascular management of “With BeGraft aortic we now have peripheral artery disease.” a valuable and safe alternative for treating aortic and iliac lesions,” Peter CE mark reinstated for Goverde, ZNA Endologix AFX and AFX2 Stuivenberg systems Hospital, The CE mark for Endologix’ AFX and Antwerp, AFX2 endovascular abdominal Belgium, aortic aneurysm systems has explained been reinstated, effective after the immediately. implantation The CE mark of the first large was temporarily diameter BeGraft. suspended due to The BeGraft reports of type III aortic is now endoleaks with a commercially available prior generation of in all countries accepting the AFX system. the CE mark, while The CE mark was Bentley says that regulatory reinstated based upon approvals for many other low rates of reported ype countries around the globe are “on III endoleaks with the BeGraft their way”.

March 2017 Market watch 47

Product News

Cook Medical Australia and cardiogenic effusions. opens new Asia Pacific “Our research found that the Pleurx Commercialisation and catheter provided palliation of congestive Development Centre heart failure patients’ pleural effusions and freedom from re-intervention equal to that of talc pleurodesis using thoracoscopy while resulting in a shorter mean length of hospital stay,” states Richard K Freeman, regional chief medical officer, St Vincent Indianapo- lis. “Lower rates of operative morbidity and readmission related to the pleural effusion were also seen in the Pleurx catheter treat- ment group.” Opening of the new centre Final patient enrolled for Cook Medical Australia has officially iliofemoral venous stent opened a new Commercialisation and study Development Centre in Brisbane, designed to assist businesses, entrepreneurs and researchers from across Asia Pacific to bring innovative medical products and health related technologies to market. Cook Medical Australia is committing $4 million to establishing the Asia Pacific Commercialisation and Development Centre (ACDC), located in the Cook Medical Aus- tralia precinct at Brisbane Technology Park, Eight Mile Plains. The establishment of ACDC represents Cook Medical Australia’s long-term commit- ment to fostering R&D in Australia, while simultaneously creating opportunities for local advanced manufacturing jobs. Zilver Vena Successful ACDC research partners will have access to a full range of ACDC resourc- Cook Medical has completed enrolment es to support product commercialisation, in the first clinical study of an iliofemoral including a world-class fabrication labora- venous stent conducted in the USA under tory with 3D printing capabilities, electrical an FDA-approved investigational device and mechanical systems for testing products, exemption. The VIVO clinical study is a business facilities, as well as workshop and prospective, non-randomised, multicentre demonstration spaces. study intended to evaluate the safety and A local team will coordinate the day-to- effectiveness of the Zilver Vena venous stent day operation of ACDC, while advisors, in the treatment of symptomatic iliofemoral sourced from Cook Medical’s highly experi- venous outflow obstruction. enced management ranks, will provide prac- A total of 243 patients with acute or tical advice and expertise at relevant points chronic symptomatic iliofemoral venous out- along the pathway to commercialisation. flow obstruction were enrolled in the VIVO clinical study, which has a one-year primary PleurX catheter system endpoint. The study is being conducted in receives US FDA 510(k) 29 active sites throughout the USA as well clearance for specific non- as one in Taiwan. A press release reports that malignant recurrent pleural Cook Medical recently completed a similar effusions first-of-its-kind study in the European Union BD (Becton, Dickinson and Company) an- on the safety and performance of the Zilver nounced its PleurX catheter system received Vena stent. Gerard O’Sullivan (Galway US FDA 510(k) clearance for the use in University Hospitals, Galway, Ireland) specific non-malignant recurrent pleural will present data from the VIVO-EU study effusions aetiologies, including congestive on Friday at the 2016 VEITHsymposium heart failure, during the 53rd Annual Society (15–19 November, New York, USA). of Thoracic Surgeons (STS) Meeting, taking Anthony Comerota (Jobst Vascular In- place 21–25 January, Houston, USA. stitute, Toledo, USA), one of the study’s When a pleural effusion occurs, the Pleu- principal investigators, comments: “I rX catheter system provides patients with the view the completion of enrolment for this option to drain pleural fluid in the comfort of trial as an important milestone in devel- their homes, which can help avoid the need opment of options for managing patients for multiple hospital visits for thoracentesis with proximal venous obstruction. I am procedures. The PleurX catheter system was excited to see the full enrolment of the initially approved in 1997 for managing ma- first FDA-approved venous stent trial.” lignant and recurrent pleural effusions. With “This has the opportunity to help the indication, the system is commercially many patients,” agreed Lawrence available for patients suffering from certain “Rusty” Hofmann (Stanford University non-malignant recurrent pleural effusion ae- Hospital, Stanford, USA), co-principal tiologies, including congestive heart failure investigator. 48 Companies March 2017

Industry News

Terumo completes thrombectomy systems, BioPince acquisition of vascular full-core biopsy instrument, TLAB closure business and other transjugular liver biopsy instrument, assets of Abbott and St Jude Atrieve vascular snare, Skater drainage Terumo has announced that it has systems and T-Lok bone marrow biopsy completed its acquisition of certain needles. assets owned by Abbott and St Jude A press release from Merit on 6 Medical on 20 January 2017. February states that it has acquired Terumo has acquired the Angio- certain products from Argon Medical Seal and FemoSeal vascular closure Devices and Catheter Connections. “The product lines and Kalila Medical, a combined revenues of the two acquired company developing next-generation product lines were approximately US$46 access technologies, the first being the million in 2016. The transactions were Vado steerable sheath, used in cardiac financed with a combination of cash and electrophysiology procedures. The existing credit facilities, which totalled acquisitions enhance company offerings US$48 million,” the release added. in the interventional access device business. Abbott completes St Jude The acquired assets become part Medical acquisition of Terumo Interventional Systems, Abbott announced on 4 January 2017 a division of Terumo Corporation. that it has completed the acquisition of St By building on Terumo’s existing Jude Medical. infrastructure and competencies, the “Abbott has a strong track record acquisition will enable Terumo to of successfully integrating dozens maximise the value of the acquired of businesses on a global scale and businesses and contribute to supporting accelerating growth,” said Miles D safe and efficient interventional White, chairman and chief executive procedures. officer, Abbott. “The addition of St Jude Medical strengthens our global Terumo sets sight on Bolton medical device leadership while offering to accelerate growth of innovative products to address more areas vascular graft business of care, in more physicians’ offices and Terumo Corporation has announced that hospitals around the world.” it has entered into a definitive agreement Pursuant to the terms of the Merger under which it has agreed to acquire Agreement, upon completion of the Bolton Medical from its parent company. acquisition, St Jude Medical became a Bolton Medical is a leading innovator wholly-owned subsidiary of Abbott. in thoracic and abdominal stent graft systems. Teleflex to acquire Vascular “The acquisition will enhance Solutions in US$1 billion deal Terumo’s existing product portfolio Teleflex is to acquire Vascular Solutions in the global stent graft market and in a transaction valued at approximately our vascular graft business will be US$1 billion. Under the terms of the further strengthened in the USA, in agreement, Teleflex will acquire all of what is the largest stent graft market the issued and outstanding shares of today,” said Shinjiro Sato, president of Vascular Solutions common stock for Cardiac and Vascular company, Terumo US$56 per share, in cash. Corporation. The Boards of Directors of both The transaction is expected to close Teleflex and Vascular Solutions in a few months and it will be funded have unanimously approved the through cash on hand and debt. The transaction. This transaction is subject closing is subject to antitrust clearance to the approval of Vascular Solutions’ and other customary closing conditions. shareholders and the satisfaction of The impact of the acquisition on customary closing conditions and is Terumo’s financial is currently being expected to close during the first half of scrutinised. 2017. Founded in 1997, Vascular Argon sells critical care Solutions is an innovative medical platform to Merit device company that focuses on Argon has announced that it has developing clinical solutions for completed the sale of its Critical Care minimally invasive coronary and Unit including a manufacturing facility peripheral vascular procedures. The in Yishun, Singapore and related company’s product line consists of commercial operations in Europe and more than 90 proprietary products and Japan, to Merit. services that are sold to interventional The sale of the Critical Care Unit cardiologists, interventional radiologists, allows Argon to focus solely on its electrophysiologists and vein specialists interventional business worldwide, a through its direct US sales force and press release from the company says. international independent distributor The Argon interventional product network. portfolio consists of the Option Elite According to a company release, the retrievable inferior vena cava filter, combination is expected to accelerate CleanerXT and Cleaner15 rotational The growth of Teleflex’s vascular and March 2017 Companies 49

Product News interventional businesses through increased revenue Systems EMEA, said he was delighted to be bringing associated with entry into the coronary and peripheral the Starsystem to Europe and anticipated strong interest vascular market, as well as increased cross-portfolio from clinicians. He comments: “Seeking partnerships selling opportunities to both Teleflex and Vascular of this kind in addition to investing in our own research Solutions customer bases. and development means we continue to lead the field in transradial access solutions for interventional cardiology Guerbet expands distribution and peripheral intervention. By making the world’s best partnership in Canada with Methapharm equipment available to our customers we help them to perform at their best, ultimately helping achieve the best BioMimics 3D stent outcomes for patients.” The press release states that weighing 1kg, the First-in-human trial of Golden Retriever Starboard is extremely lightweight, compact and very to take place at Karolinska easy to handle for cath lab staff. It also states that the Amnis Therapeutics has received approval to perform a first- unique, one-piece, “foldaway” design of the device takes in-human clinical trial with its neuro thrombectomy device, up minimal storage space. the Golden Retriever. The approval was received from the Guerbet has announced that as of 1 February 2017, Karolinska Institute (Stockholm, Sweden). Methapharm will promote and distribute all Guerbet Medtronic to distribute QT Vascular’s Tommy Andersson, Karolinska University Hospital, products in Canada. Chocolate balloon worldwide Stockholm, Sweden, will be the trial’s principal investigator. “As a result of our excellent experience with QT Vascular has signed a definitive agreement with The trial will include 60 patients suffering from acute Methapharm over the past four years, we have Medtronic, for the worldwide distribution of its ischaemic stroke, with a large intracerebral vessel occlusion. expanded the range of Guerbet products in their care for Chocolate percutaneous transluminal angioplasty The company will start recruiting patients shortly and promotion and distribution,” says Massimo Carrara, vice (PTA) catheter for a period of five years and expects the trial to conclude during Q1 2018. The physicians president North America, Guerbet. automatically renewable for two additional one- will use the Golden Retriever to extract the blood clot and Guerbet is committed to partnering with local year periods. The parties continue to negotiate restore blood flow in the brain. The device’s small size and associates to support Canadian patients and practitioners other aspects of their commercial relationship. extreme flexibility enable easy access and fast extraction of and to fostering local production in Canada at its Chocolate’s nitinol-constraining structure any clot, regardless of the clot’s size or consistency. Guerbet fill and finish plant in Montreal. is designed to provide atraumatic dilatation The trial will be the basis for submission of CE mark Guerbet solutions distributed by Methapharm will in the treatment of blocked arteries. The approval in order to market the device in CE countries. The now span the full range of the company’s products Chocolate Bar1 post-market registry of 490 company is in the process of adding more clinical centres to registered in Canada. This includes contrast media patients showed that use of the device results be included in the trial, including centres in Barcelona, Spain products (including Lipiodol, Patent Blue V, OptiRay, in low rates of dissections and bailout stenting. and in Israel. Conray and Telebrix); injectors and consumables. Chocolate PTA may be used as a stand-alone Aviv Lotan, CEO of Amnis Therapeutics, says, “We With these developments, Guerbet continues treatment or adjunctive treatment for stenosis in are happy to start the clinical phase of testing the Golden to extend its footprint in North America. Guerbet vessels above and below the knee. It is approved Retriever, which is the last phase, prior to receiving a CE previously solidified its position as a global leader with for use in the USA, Europe, Australia, Turkey, mark. We believe that the Golden Retriever’s attributes the acquisition of US-based Mallinckrodt’s Contrast Singapore and Hong Kong. (small diameter, deployment mechanism, ease of access Media and Delivery Systems (CMDS) business in 2015. Current sales of the device in the USA are and use), suggest significant advantages over existing conducted through the direct sales force of the products for neurothrombectomy.” Terumo to distribute Starsystem for company’s wholly-owned subsidiary, Trireme radial access procedures in Europe Medical, and a distribution partner. Outside the Codman Neuro announces acquisition USA, sales are conducted via country-specific of Pulsar Vascular distribution partners. Under the new distribution Codman Neuro has announced the acquisition of Pulsar agreement with Medtronic, transition of the Vascular, a privately-held company with breakthrough Chocolate PTA business will occur on a country- platform technology for the neurovascular treatment of by-country basis over the coming months complex aneurysms. DePuy Synthes Products, an affiliate starting with the USA. of Codman Neuro, is the acquiring entity. According to a company release, QT A Codman Neuro press release states that “this Vascular plans to focus on its drug- Chocolate acquisition marks the latest expansion of its neurovascular coated Chocolate programme. The portfolio and will complement a comprehensive portfolio company hopes to have full investigational device of products for haemorrhagic and ischaemic stroke.” exemption approval from the US Food and Drug Financial terms of the transaction were not disclosed. Starboard Administration. The PulseRider device received CE mark certification in Europe in 2013 and is currently sold in nine countries. Terumo Europe has entered into a distribution agreement Veryan Medical receives £13.5m further Codman Neuro was previously the exclusive distributor of with New Zealand company Adept Medical to make funding Pulsar Vascular’s technology in Europe, the Middle East the Starsystem available to clinicians working across Veryan Medical has received a further £13.5m of and Africa. Western Europe. A press release reports that the support funding in the form of both equity and debt from its for transradial angiography and revascularisation (STAR) existing investors, including Touchstone Innovations, Enrolment complete in ARISE II trial of system is a combination of the Starboard and Startable. Invesco Perpetual and Seroba Life Sciences. The debt EmboTrap device It adds that Starboard is a forearm and hand support that element of the round has been provided by Silicon Enrolment is now complete in the ARISE II clinical trial is designed to make performing transradial procedures Valley Bank in the form of a €5m capital term loan. which is assessing the safety and effectiveness of the quicker and easier. This new funding follows several significant EmboTrap II revascularisation device (Neuravi), an ad- According to the press release, the Starboard is milestones for the company’s BioMimics 3D in vanced stent retriever platform for the treatment of acute ergonomically designed with fully articulating arms 2016, including: the completion of enrolment into ischaemic stroke. and friction joints and aims to provide excellent patient the MIMICS-2 IDE study in the USA, Germany Data from ARISE II (Analysis of revascularization in comfort and ease of use for clinicians. Starsupport and Japan; the publication of the results from the ischemic stroke with EmboTrap) will be submitted as part connects to the Starboard, facilitating left arm Mimics Randomised Controlled Trial in Circulation: of an application to US Food and Drug Administration procedures. Additionally, the Startable provides a stable Cardiovascular Interventions; and the first 50 subjects (FDA) for market clearance of the device in the USA. work surface and support for catheters, wires and other enrolled into the MIMICS-3D Registry. The ARISE II study enrolled 228 patients in 19 enrolling equipment as well as additional X-ray scatter reduction. Nooman Haque, director of Life Sciences and sites across the USA and Europe. Sam Zaidat, St Vincent The Starboard vertical shield reduces X-ray scatter at Healthcare, said: “This smart technology (BioMimics Mercy Hospital, Toledo, USA, is the study’s principal neck height by 80%. 3D) could be transformative for patients suffering from investigator. Tommy Andersson, Karolinska Institute, Peter Coenen, president of Terumo Interventional arterial disease.” Stockholm, Sweden, is the European principal investigator. 50 Events March 2017

Calendar of events

1–5 March 25–28 April 26 May 8–11 June ECR 2017 Charing Cross Symposium New Developments and Controversies WCIO 2017 European Congress of Radiology Olympia Grand in the Multidisciplinary Management World Conference on Interventional Vienna, Austria London, UK of the Diabetic Foot Oncology W myESR.org T +44 (0)20 7736 8788 Divani Caravel Hotel Boston, USA E [email protected] Athens, Greece W www.wcioevents.org 4–9 March W www.conferre.gr/congress/mdf2017 SIR 2017 16–18 May 23–24 June Society of Interventional Radiology ESOC: European Stroke 31 May–2 June ESIR Course Critical Limb Ischemia 42nd Annual Scientific Meeting Organisation Conference New CardioVascular Horizons Rome, Italy Washington, DC, USA Prague, Czech Republic New Orleans, USA E [email protected] W www.sirmeeting.org W www.esoc2017.com The Roosevelt New Orleans W www.cirse.org W www.ncvh.org 9–12 March 16–19 May 29 June–1 July TGRD EuroPCR 31 May–3 June 18th Annual Meeting of the European Turkish Society Of Interventional Paris, France GEST Europe 2017 Venous Forum Radiology Annual Meeting W www.europcr.com Global Embolization Symposium and Porto, Portugal Antalya, Turkey Technologies Alfandega Porto Congress Centre T 90 312 442 36 53 17–18 May Florence Italy W www.europeanvenousforum.org E [email protected] BSIR IOUK Annual Meeting E [email protected] W www.girisimselradyoloji2017.org British Society of Interventional 24–28 July Radiology Interventional Oncology 1–2 June SNIS 15–18 March UK iMEET Society of NeuroInterventional PAIRS 2017 Glasgow, UK Nice, France Surgery 14th Annual Meeting Pan Arab Interventional Radiology E [email protected] W www.meetcongress.com Colorado Springs, USA Society W www.bsir.org W www.snisonline.org Dubai 2-6 June W www.pairs2017.com 18–19 May ASCO Annual Meeting 3–6 August Seldinger Society’s Annual Meeting American Society of Clinical SIDI 2017 24–25 March Stockholm, Sweden Oncology Sociedad Iberoamericana de ICCA Stroke 2017 E [email protected] Chicago, USA Intervencionismo annual meeting Acute Stroke Interventions and W www.seldingermotet.se E [email protected] Cartagena de Indias, Colombia Carotid Stenting E [email protected] T 0057 (4) 262 69 78 Moscow, Russia 18–20 May E [email protected] E [email protected] Wires Asia Radiology 2017 3–6 June W www.sidicartagena2017.org W www.cme4u.org Singapore 54th ERA–EDTA Congress T 0065 66357911 European Renal Association– 11–14 September 24–25 March E [email protected] European Dialysis and Transplant VIVA 1st Erasmus MC Conference on Acute W www.radiologyasia.com Association Vascular Interventional Advances Stroke Treatment Madrid, Spain Las Vegas, USA Rotterdam, The Netherlands 25–28 May W www.era-edta.org W www.vivaphysicians.org E [email protected] sIRcro 2017 W www.era-edta2017.org W www.erasmusmc-acute-stroke-conference.nl XIth Meeting of Interventional 16–20 September Radiologists of Croatia 8–9 June CIRSE 23–26 April Solaris, Šibenik DFIR Cardiovascular and Interventional ECIO 2017 T 385(0)1 2431413 Danish Society of Interventional Radi- Radiological Society of Europe The Eighth European Conference on E [email protected] ology Copenhagen, Denmark Interventional Oncology W www.sircro.org Nyborg, Denmark W www.cirse.org Bilbao, Spain E [email protected] E [email protected] W www.dfir.dk

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