The international newspaper for vascular specialists

Issue 59 INTERNATIONAL September 2013

Alberto Muñoz: Thomas Zeller: Gustavo S Oderich: Latin America Profile Fenestrated grafts Page 14 Page 24 Page 30 Inadequate sealing is top reason for endograft explant

A study looking at endovascular aneurysm repair (EVAR) graft explants has shown that most failures occur between years one and five and are caused by inadequate sealing and endoleaks. In the study, endoleaks were type I in 40% of the patients and type II in 30% of the cases

ric J Turney, Department that occurs 30 days after few years,” he said. of Vascular Surgery, implantation, which implies a The study was a retrospective ECleveland Clinic, successful acute result.” review, and included data presented the data from the on type of graft, time of study at the Vascular Annual During the study period, 100 implantation, indication for Meeting (30 May–1 June patients required an endo- conversion, surgical data 2013, San Francisco, USA). graft explant. The investiga- and outcomes for 30-day He commented: “EVAR is tors looked at the overall mortality, cumulative survival, now the most common method results for this cohort and complications, and failure by for treating abdominal aortic also compared the informa- time of EVAR (less than 12 aneurysms [in the USA], tion with the original data months, between 12 months and increasing numbers of of 41 explants which were and five years, and beyond five patients are being observed published in the Journal of years). in long-term follow-up. In Vascular Surgery in 2009 There were no statistically addition, the treatment of (49[3]:p.589-95). significant difference between patients with indications the patients from 2009 and Eric J Turney outside of instructions for use Turney told delegates that the new cohort. Overall, 91% is common.” there has been a growth in the of the patients were male and The most common indication Turney noted that 71% of the The purpose of the study was number of explants, with a rise the mean age was 75 years; for graft explant was endoleak, explants were performed in an to evaluate the Cleveland Clinic in 2011 and 2012, when 14 coronary disease was the most present in 82% of patients, elective procedure, 10% were experience with late conversion cases explants were performed common comorbidity, present followed by infection (13%), urgent, 19% were emergent. between 1999 and 2012 and on each year. In the first quarter in 65%, followed by chronic acute thrombosis (3%), Amongst the emergent, 9% identify modes of failure and of 2013, 10 cases were per- obstructive pulmonary disease recurrent thrombosis (1%) were cases of rupture. predictors of outcomes. Turney formed in the Cleveland Clinic. and chronic kidney disease. and claudication (1%). The To assess the duration of the explained that “late conversion “It certainly shows the explant Supra-renal fixation was endoleaks were type I in 40% endografts, the investigators is defined as the conversion rate has accelerated in the past present in 37% of cases. of the cases and type II in 30%. Continued on page 2

TEVAR superior to medical Cook Medical therapy alone for type B re-launches Zilver PTX dissections at five years in a phased manner Results from the INSTEAD-XL trial published in Circulation: Cook Medical has begun a phased global re-launch of Cardiovascular Intervention show that thoracic endovascular Zilver PTX, the company’s drug-eluting peripheral stent, in aortic repair of uncomplicated type B dissections in addition line with the company replenishing stock levels to medical therapy is associated with improved five-year aorta- specific survival and delayed disease progression n April this year, Cook Medical system and not stent. Rate of initiated a nationwide/global occurrence of the problem was ata from the study were results of the randomized investigation Ivoluntary recall of Zilver PTX 0.043%, the company clarified. published online on 6 August of stent grafts in aortic dissection trial), based on its investigation into 13 They also highlighted that D2013. led by Christoph A Nienaber, Heart complaints of delivery system tip the problem with the delivery “Thoracic endovascular aortic repair Center Rostock, University of Rostock, separation. Two adverse events, system was solely with the (TEVAR) represents a therapeutic Rostock, Germany, wrote. including one death, occurred Zilver PTX delivery system and concept for type B aortic dissection. A total of 140 patients with stable in cases where a tip separation did not affect any other Zilver Long-term outcomes and morphology type B aortic dissection previously was reported. stent delivery system from after TEVAR for uncomplicated randomised to optimal medical Cook Medical told Vascular Cook. In April, Cook voluntarily dissection are unknown,” the authors treatment and TEVAR (n=72) vs. News that the issue was pulled all products from the of INSTEAD-XL (Endovascular repair optimal medical treatment alone (n=68) restricted to the delivery Continued on page 2 of type B aortic dissection—long-term Continued on page 2

Vascularnews.com VN App @VN_publishing facebook.com/vascularnews 2 Updates September 2013 Inadequate sealing is top reason for endograft explant

Continued from page 1 indication in the majority of transabdominal approach. significance included visceral included the fact that it is a looked at the data for time patients followed by type III Clamp position was supra revascularisation, supra- retrospective single-centre since the implantation to time endoleaks.” He explained that celiac in 54% of the cases, celiac clamp, emergent analysis, that it involved of explantation of the device. the reason for the development followed by suprarenal (33%) nature of the explantation, multiple surgeons with varying The data showed that in 23 of type I endoleaks was mainly and infrarenal (13%). Forty infection and rupture. The preferences and approaches, patients the endograft failed challenging anatomy with neck four per cent of patients had negative predictors of long- and also that 61% of the in the first 12 months, in 55 outside instructions for use in some complication: 29% term survival were chronic explant procedures had been patients it failed between 12 the early failures, and disease were cardiac, 26% were obstructive pulmonary disease, performed in patients who had months and five years, and in progression at intermediate pulmonary and 9% were renal visceral revascularisation, had EVAR in other facilities 22 patients the device failed and late stages. complications. infection, emergent procedure, and, therefore, did not have beyond five years. The explantation procedure He also reported that the rupture, and also preoperative pre-implant imaging available. Turney said that, in terms characteristics were consistent overall 30-day mortality was and postoperative creatinine In his conclusions, Turney of indications for explantation across both cohorts, with 56% 17%; elective mortality was levels. said that many early failures by duration of EVAR, in the performed with retroperitoneal 9.9%. The predictors of 30-day Turney commented that were due to challenging neck first year type I endoleak was approach and 44% with a mortality with statistically the limitations of the study anatomy with inadequate seal the most frequent indication, fixation and infection. He followed by infection. He Many early failures were due to challeng- added that late failures were added, “Between years one often due to device failures and five, type I endoleak ing neck anatomy with inadequate seal or aortic disease progression. continued to be the most “Compared to the initial frequent indication, followed fixation and infection. Late failures experience, morbidity and by type III endoleaks. Beyond were also often due to device failures or mortality remain higher for five year, type I endoleak non-elective explants,” he remained the primary aortic disease progression said.

Cook Medical re- TEVAR superior to medical therapy alone launches Zilver PTX for type B dissections at five years in a phased manner Continued from page 1 as an alternative to open surgery Continued from page 1 were analysed retrospectively for for managing complications of market globally. The investigation aorta-specific, all-cause outcomes, and type B dissection, “even without identified the root cause of the disease progression using landmark any randomised data, may now be problem which was that the raw statistical analysis of years two to five extended to manage stable (initially material used in the delivery after index procedure. Cox regression uncomplicated) type B dissection system was out of specification. was used to compare outcomes because the potential to remodel Vascular News has learned that a between groups; all analyses are based dissected aorta and prevent late correction has been made and a on intention to treat. expansion and malperfusion has been solution implemented. The stent The risk of all-cause mortality confirmed.” itself remains unchanged. (11.1% versus 19.3%; p=0.13), They added that with completed Potential adverse events that aorta-specific mortality (6.9% versus five-year surveillance in all survivors, may occur in cases where inner 19.3%; p=0.04), and progression any discordance of aortic remodelling delivery catheter breakage occurs (27.0% versus 46.1%; p=0.04) after with clinical outcomes after TEVAR include: possible surgery to five years was lower with TEVAR than was refuted. “These initial findings remove the catheter tip; vascular with optimal medical treatment alone, are promising and may prelude a occlusion due to an unretrieved the study shows. paradigm shift in managing type B catheter tip; thrombosis; Landmark analysis suggested a aortic dissection,” they said. amputation; and possible cardiac benefit of TEVAR for all endpoints The authors of the paper made the arrest. between two and five years; for exam- point that, with three conversions to A press release from Cook ple, for all-cause mortality (0% versus Christoph A Nienaber open surgery in both groups within Medical in April stated that the 16.9%; p=0.0003), aorta-specific mor- two years, and two cases of spinal devices that were subsequently tality (0% versus 16.9%; p=0.0005), B aortic dissection, ie. medical injury, TEVAR is not always safe. recalled were distributed to and for progression (4.1% versus management with focus on blood However, they noted, procedural risk medical institutions in the United 28.1%; p=0.004); landmarking at one pressure and surveillance. may be lowered by referral to high- States between 13 December year and one month revealed consist- volume centres, pre-emptive carotid- 2012 and 16 April 2013. ent findings. Both improved survival They said, “Because long-term subclavian bypass and dissection- The device received FDA and less progression of disease at five prognosis of type B dissection is specific endoprosthetic technology. premarket application approval years after elective TEVAR were as- sobering with 20% to 42% mortal- Moreover, they said, elective TEVAR in the USA in November 2012. sociated with stent graft induced false ity at five years and an estimated within 90 days of dissection benefits It received CE mark clearance lumen thrombosis in 90.6% of cases rupture rate of 30% once aortic from ongoing aortic plasticity with in August 2009 and is approved (p<0.0001). expansion reaches 60mm, medi- better remodelling. for sale in 54 countries including The authors commented: “In this cal management may at best delay “Thus, different from early Japan, Australia and Brazil. study of survivors of type B aortic dis- progressive expansion. Conversely, outcomes, INSTEAD-XL suggests section, TEVAR in addition to optimal TEVAR in the subacute (stable) survival benefit from pre-emptive medical treatment is associated with phase of distal aortic dissection TEVAR in patients surviving type improved five-year aorta-specific induces aortic remodelling and B dissection in addition to optimal survival and delayed disease progres- reduces aorta-related mortality >5 medical therapy and surveillance. sion. In stable type B dissection with years as compared with controlled Considering the few cases of suitable anatomy, pre-emptive TEVAR medical management with optional progression after two years of elective should be considered to improve late crossover to TEVAR or open repair TEVAR, surveillance may be tapered outcome.” when complications emerge.” once remodelling was documented. According to Nienaber et al, the Finally, remodelling of dissected aorta long-term results of INSTEAD-XL The investigators also stated seems in concordance with long-term challenge the current consensus on that the concept of thoracic vascular survival,” the investigators treatment of uncomplicated type endovascular repair already adopted concluded.

6 Lower limb September 2013 Re-entry devices improve haemodynamic results in iliac arteries chronic total occlusion

A study has shown that the use ever, improvement in ankle brachial in- of re-entry devices improves dex was statistically significantly higher haemodynamic results in the in patients treated with a re-entry device treatment of chronic total (p=0.004). occlusion in iliac arteries. The The primary patency rate at three years experience also showed a was 75% in the re-entry device group, trend towards better technical and 58% in the non-re-entry device success cohort (p=0.1).

he results from the study on In the subset analysis of IVUS re- the use of re-entry devices with entry device vs. non-IVUS re-entry intravascular ultrasound (IVUS) device, the non-IVUS group had a T larger number of retrograde proxi- on technical success, safety and patency of subintimal angioplasty of chronic total mal dissections (6 vs. 1, p=0.05) and occlusion in iliac arteries were presented more major adverse events (9 vs. 2, by Tareq Massimi, Division of Vascu- p=0.02). lar Surgery, Eastern Virginia Medical School, Norfolk, USA, at the Vascular In the analysis of IVUS-re-entry Annual Meeting (30 May–1 June 2013, device vs. non-IVUS re-entry device and San Francisco, USA). non-re-entry device, the IVUS re-entry “Re-entry devices are adjuncts that can device group showed lower rates of be used during subintimal angioplasty Tareq Massimi retrograde proximal dissection and major to obtain true lumen re-entry. IVUS adverse events. technology can be used with re-entry and 2012 and compared two groups (re- and major adverse events (any retrograde In his conclusions, Massimi noted that devices to facilitate true lumen re-entry,” entry device vs. non-re-entry device) and dissection or iliac rupture). the use of re-entry devices showed sig- he said. “Sufficient data investigating three additional subsets: IVUS re-entry Amongst 1,100 iliac interventions nificant improvement in haemodynamic re-entry device use with or without IVUS device, non-IVUS re-entry device and recorded during the period studied, 214 results and a trend towards better techni- guidance in iliac subintimal angioplasty non-re-entry device. involved iliac chronic total occlusion cal success. He added, “IVUS-guided is still lacking.” The primary endpoints were technical and subintimal angioplasty; of these 72 re-entry device significantly reduced The objective of the study was to in- success (successful true lumen re-entry used re-entry devices and 142 did not. retrograde dissections and overall major vestigate the impact of re-entry devices, with re-establishment of flow), haemo- In the re-entry device group, in half of adverse events, and showed a trend with or without IVUS, on success, safety dynamic change (pre- to post- procedure the patients the treatment was performed towards improved primary patency.” and patency of subintimal angioplasty ankle brachial index) and patency rates; with IVUS. He stated that, in the study, retrograde of iliac artery chronic total occlusions. It the secondary endpoints were retrograde The results showed no difference in dissections requiring proximal treatment reviewed retrospectively iliac subintimal dissection (arterial dissection requiring technical success between the re-entry were an independent negative factor on angioplasty interventions between 2003 proximal stent extension), iliac rupture and non-re-entry device groups. How- primary patency.

lesion. Half of the patients had occluded Balloon with microneedle arteries, and the mean lesion length was 8.9±5.3cm. creates drug-eluting reservoir All patients underwent angioplasty, and three of them also underwent atherectomy. to prevent restenosis Six of the patients had provisional stents placed. Patrice Bergeron, Hôpital Privé Residence du Parc, Marseille, The haemodynamic and clinical results France, presented initial results of a new device used in the showed that ankle brachial index improved treatment of peripheral arterial disease at the Multidisciplinary on discharge, at six months and at 12 European Endovascular Therapy (MEET) Congress (9–11 June months (n=10). The patients treated with 2013, Rome, Italy). The new balloon deploys a microneedle into the the device also had an improvement on adventitia and diffuses anti-inflammatory drug into the artery wall Rutherford scores. Six-month patency rates were comparable to results of drug-eluting ergeron told delegates at the con- The device used dexamethasone, which Patrice Bergeron stents and drug-eluting balloons for longer gress that the physiopathology of is a well known and widely available anti- lesions, Bergeron said. Brestenosis includes injury, inflamma- inflammatory drug. “Inflammation begins after peripheral arterial disease intervention. “Subadventitial injection of dexametha- tion and cell recruitment, resulting in intimal the restenosis cascade, and dexamethasone The objective was to evaluate technical suc- sone seems promising in reducing restenosis hyperplasia, media proliferation and adven- reduces inflammation and remodelling cess, safety and effectiveness outcomes of at six months. The Bullfrog device is safe titial neovascularisation and fibrosis. The proteins, including MCP-1, CRP, TNFα, adventitial dexamethasone delivery by the and reliable, and is showing good results in hypothesis behind this technology is that GM-CSF and MMP-9,” said Bergeron. Bullfrog catheter. The principal investiga- US and European trials,” he noted. stopping inflammation and neovascularisa- He explained that the procedure, using tor is Christopher D Owens, University of The Bullfrog device received the CE tion from adventitia prevents restenosis. Bullfrog, includes percutaneous device California San Francisco, USA. mark in February. It had previously received The Bullfrog drug-delivery catheter placement over the wire and balloon Twenty patients with superficial femoral 510(k) clearance from the FDA. In a press (Mercator MedSystems) is a micro-infusion inflation, followed by subadventitial artery or popliteal lesions were enrolled release distributed by Mercato after the catheter containing a microneedle of injections of dexamethasone plus contrast in the study between February 2011 and granting of the CE mark, Owens com- 130-micron diameter and 0.9mm length. It (1cc) every 3cm. This is then followed by September 2012 at San Francisco VA mented: “The Bullfrog catheter has demon- allows clinicians to pinpoint the delivery of subintimal diffusion and balloon angio- Medical Center. The mean age was 66±10 strated its ability to efficiently deliver potent drugs and biologics deep into the body to plasty and/or stenting. years, 100% were men, 55% were diabetic, therapeutic agents outside the blood vessel, treat the root cause of disease. The balloon The DANCE (Dexamethasone infusion 95% suffered from hypertension and 100% specifically to the adventitia. I believe we deploys a microneedle into the adventitia, to the adventitia to enhance clinical efficacy had hyperlipidaemia. Most of patients (16) are now seeing the promise of adventi- where the drugs are diffused to bathe the after femoropopliteal revascularization) pi- had Rutherford class 2 and 3. In the TASC tial delivery: a biologic effect of the drug entire vessel cylindrically, from the outside lot study is an open-label, non-randomised, II classification, three patients had type A interrupting the inflammatory cascade that to the inside, creating a unique, tissue-based, single-arm, single-centre clinical feasibility lesions, nine had type B, seven had type normally leads to restenosis after a vascular drug-eluting reservoir. evaluation of adventitial dexamethasone C and one patients presented with type D intervention.”

8 Aortic disease September 2013 63% of juxtarenal/pararenal Enrolment in the Ventana aneurysm patients are IDE trial stopped nrolment in the to begin enrolling patients investigational device in the study again and start candidates for off-the-shelf Eexemption study of the limited market introduc- the Ventana Fenestrated tion in Europe by the end of System has been stopped this year.” fenestrated grafts by Endologix. According to McDermott added, “We the company, after the first continue to believe Ventana Results from a study conducted to evaluate the anatomical feasibility of 120 procedures, the safety represents a significant two off-the-shelf fenestrated stent grafts to treat juxtarenal and pararenal results with the device were innovation in the treatment abdominal aortic aneurysms—Endologix Ventana and Cook p-Branch—were good but there have been of juxta and pararenal aortic presented at the Vascular Annual Meeting (30 May–1 June, San Francisco, USA) a high number of renal aneurysms, with the poten- re-interventions. Endologix tial to expand the address- he study was a eurysms considered potential 49% for p-Branch (p<0.05). plans to integrate its next- able EVAR market” retrospective review candidates for the two devices. Overall, 63% of the patients generation covered renal On 1 July, Endologix an- Tof patients treated for Of the total, 222 were juxta- with juxtarenal/pararenal stent in the system and nounced it had completed complex abdominal aortic renal aneurysms and 168 were aneurysms were candidates for conduct additional testing this initial evaluation and aneurysms (juxtarenal, pararenal aneurysms. endovascular repair using one and training to improve has identified training and suprarenal and type IV thoracic of the two devices. future outcomes. design enhancements that aortic aneurysm). Computed Proximal seal (>15mm) In his conclusion, Mendes On 30 April, John McDer- are expected to reduce the tomography angiography was could be achieved in all commented: “P-Branch mott, president and chief re-intervention rate and analysed in 520 consecutive patients using p-Branch and design has greater anatomical executive officer, com- improve clinical outcomes. patients treated with open or in 61% of the patients us- feasibility and achieves mented: “After our first 120 In order to validate these fenestrated endovascular repair ing the Ventana stent graft proximal seal in all patients procedures with Ventana, design enhancements, the for complex abdominal aortic (p<0.0001). The ability to with juxtarenal/pararenal we have seen good overall company will conduct test- aneurysms between 2000 incorporate visceral arteries aneurysms, but is not able to safety results, but a higher ing and meet with regula- and 2012. The anatomical was greater using Ventana incorporate visceral arteries than expected number of tory agencies to determine feasibility of two off-the- (90%) compared to p-Branch in 40% of patients. The renal re-interventions. Be- the requirements and com- shelf fenestrated designs was (61%; p<0.0001) design. Ventana’s design allows the fore we continue enrolling mercialisation timelines. analysed using instructions incorporation of the visceral patients in the IDE clinical Accordingly, the company for use proposed by Less than a third of patients arteries in 90% of patients study and begin the EU lim- does not anticipate that it investigational protocols. met strict instructions for use but fails to provide sufficient ited introduction, we plan to will restart enrolment in the Bernardo Mendes, Division criteria for using Ventana seal in 40%. Nearly 40% of integrate our next genera- Ventana US IDE clinical trial of Vascular and Endovascular (28%) or p-Branch (34%; juxtarenal/pararenal aneurysms tion covered renal stent and or begin the limited market Surgery, Mayo Clinic, Roch- p<0.05) devices. Using do not meet anatomical criteria conduct additional testing introduction of Ventana ester, USA, told delegates that liberal instructions for use for endovascular repair using and training to optimise in Europe before the end of there were 390 patients (75%) criteria, 42% of patients were one the two devices, justifying future outcomes. We hope the year. with juxtarenal/pararenal an- candidates for Ventana and need for additional designs.” “Aortic debranching safe and durable procedure up to five years” Paola De Rango, Vascular and Endovascular Surgery, University of Perugia, Hospital S M Misericordia, Perugia, Italy, presented the five-year outcomes of 104 patients who underwent aortic debranching and thoracic endovascular aortic repair (TEVAR) at the Vascular Annual Meeting (30 May–1 June 2013, San Francisco, USA)

e Rango told delegates that intervals 1.54–59.90; p=0.015), but not for between 2001 and 2012, 104 stroke. Four retrograde dissections, two Dpatients underwent hybrid arch fatal, occurred during the perioperative repair with debranching and TEVAR. period. Two re-interventions for type Paola De Rango The primary endpoints of the study were I endoleaks were undertaken, said De perioperative (30 days) death, stroke Rango, but no late aneurysm-related it was 88.3%. De Rango told delegates In her conclusion, De Rango said and spinal cord ischaemia and five-year mortality was observed. that there were no endoleaks in the that the perioperative mortality risk mortality. zone 0 landing group. (5.8%) which was affected by zone According to the speaker, 20 arches The survival rate was 82.8% at She added that the long-term issues 0 extent, arch manipulation and with dissection were repaired, and 19 three years and 70.9% at five years. that affect aortic arch debranching are retrograde dissection was not ideal. patients underwent debranching in zone De Rango also said that in 95.7% of aorta-related survival, durability and However, she stated that debranching 0. In 59 patients debranching and TEVAR patients there was no increase in efficacy, endoleaks and retrograde and TEVAR was safe and effective procedures were conducted. aneurysm diameter and, in a third of dissection and that any approach to the in the mid term as there was no late At 30 days, according De Rango, the aneurysms treated, there was aortic arch is “not achieved without aorta-related mortality or rupture, low death, stroke and spinal cord ischaemia significant diameter shrinkage. Two risks, whichever the procedure”. endoleak and re-intervention rates and occurred in six, four and three patients, asymptomatic supra-aortic vessel De Rango said that the “incidence of only two asymptomatic supra-aortic respectively. Extension to ascending aorta occlusions were recorded. stroke is acceptable after current arch vessel occlusions. (zone 0 landing) was the only multivariate debranching,” and she commented that She noted that long-term morphology independent predictor for perioperative The three-year freedom from retrograde dissection is a complication surveillance was required to ensure the mortality (odds ratio, 9.6; 95%, confidence endoleaks was 92.5% and at five years that requires a careful arch approach. procedure’s safety and efficacy.

10 Lower limb September 2013 Promising results for long femoropopliteal lesions in VIASTAR with heparin-bonded endoprosthesis One-year results of the VIASTAR trial published online in the Journal of the American College of Cardiology suggest that a heparin-bonded covered stent may be superior to bare metal stents in the treatment of long femoropopliteal artery disease

ata from the randomised trial were published patients it was 53.5% (95%CI, 0.39-0.65) (HR 2.23, ahead of print on 10 July. In the prospective, 95%CI, 1.14-4.34; log rank p=0.009). Dsingle-blind, multicentre study 141 patients with In lesions ≥20cm (TASC D) the 12-month patency symptomatic peripheral arterial disease were assigned to rate was significantly higher in Viabahn patients in the treatment with heparin-bonded, covered stents (Viabahn, intention-to-treat analysis (Viabahn 71.3% versus bare Gore, 72 patients) or bare metal stents (69 patients). metal stent 36.8%; p=0.01) and the treatment per pro- Clinical outcomes and patency rates were assessed at tocol analysis (Viabahn 73.3% versus bare metal stents one, six and 12 months. 33.3%; p=0.004). The authors, led by Johannes Lammer, Vienna Gen- Freedom from target lesion revascularisation was eral Hospital, Austria, wrote as background information 84.6% for Viabahn (95%CI, 0.72-0.91) versus bare for the study: “While endovascular treatment of short metal stents 77% (95%CI, 0.63-0.85; p=0.37). The superficial femoral artery lesions revealed excellent ankle-brachial index in the Viabahn group signifi- results, efficacy in long lesions remains unsatisfac- cantly increased to 0.94±0.23 (versus bare metal stents tory. The hypothesis that endovascular treatment with 0.85±0.23; p<0.05) at 12-months. covered stents has equal risks but higher efficacy than The authors concluded that this randomised trial bare metal stents in long femoropopliteal artery disease in symptomatic peripheral arterial disease patients was tested.” who underwent endovascular treatment for long In VIASTAR, mean lesion length was 19±6.3cm femoropopliteal lesions demonstrated significant in the Viabahn group versus 17.3±6.6cm in the bare clinical and patency benefits for heparin-bonded Johannes Lammer metal stent group. Major complications within 30 days covered stents compared to bare metal stents in were observed in 1.4% of patients. In the intention to lesions ≥20cm and for all lesions in the treatment per nia, Davis Medical Center, Sacramento, USA, stated treat analysis, the 12-month primary patency rate in the protocol analysis. “In the intention-to-treat analysis that the VIASTAR findings confirm that the durability Viabahn group was 70.9% (95%CI, 0.58-0.80), against for all lesions, which however was diluted by 8.5% of femoropopliteal stenting with bare metal stents is 55.1% (95%CI, 0.41-0.67; log rank p=0.11) in the bare major protocol violations, the difference was not inversely related to lesion length, while patency follow- metal stent group. In the treatment per protocol analysis, significant,” they wrote. ing implantation of the covered stent graft appears to be the primary patency rate in patients treated with Viabahn In an editorial published with the study, John R Laird independent of lesion length. was 78.1% (95%CI, 0.65-0.86) and for bare metal stent and Ehrin J Armstrong, from the University of Califor- “There is less certainty about the optimal treatment of short or medium length lesions. Newer bare metal This randomised trial demonstrated significant stents, drug-eluting stents, drug-eluting balloons, and atherectomy devices have all shown promise for these clinical and patency benefits for heparin-bonded shorter lesions,” they wrote. They said that another question is whether drug-eluting stents can provide covered stents compared to bare metal comparable results to an ePTFE-covered stent in these stents in lesions ≥20cm and for all lesions in the longer lesions. “Perhaps covering a stent with an anti- restenotic drug is as effective as an ePTFE barrier,” they treatment per protocol analysis concluded. 3D helical stent data suggest correlation between stented vessel curvature and primary patency ata presented during the Trials trolled trial, conducted at eight German ric curvature that closely mimics the on blood flow mechanics and vascular and Innovations for Peripheral investigational centres, comparing the natural helical geometry of the human disease (Nature 1969), supports a DInterventions Session at EuroP- safety and efficacy of the BioMimics 3D vascular system. This stent is designed threshold value for wall shear stress. CR (21–24 May 2013, Paris, France) stent to a straight nitinol stent (primarily to promote swirling blood flow through have shown that a stent with a unique the Bard LifeStent) in 76 patients with the stented segment, with preclinical The helical geometry of the Bio- three-dimensional helical geometry, peripheral arterial disease undergoing data have shown to significantly reduce Mimics 3D stent, according to the the BioMimics 3D (Veryan Medical), femoropopliteal artery intervention. the formation of neointimal hyperplasia, company, also enhances mechani- has demonstrated safety and promising Data presented by Stephan Duda, potentially conferring a vasoprotective cal performance and biomechani- clinical performance at 12 months in the Gefäβzentrum am Jüdischen Kranken- effect through elevation of wall shear cal compatibility, to reduce stent treatment of patients with peripheral arte- haus, Berlin, Germany, on behalf of the stress. Emerging data from the MIM- fracture, vessel and stent kinking, rial disease undergoing femoro- MIMCS investigators, showed the ICS study were pointing to a correlation deformation and subsequent vessel popliteal artery intervention. 12-month Kaplan Meier estimate between 12-month primary patency and trauma during leg flexion, compared Data from the MIMICS study of freedom from clinically driven stent curvature, measured using bi-planar to straight nitinol stents. appeared to provide the first target lesion revascularisation for X-ray imaging in straight and bent knee clinical substantiation for the subjects receiving the BioMim- positions. Above a threshold curvature “These results indicate that the unique hypothesis that a stent with ics 3D stent was 91.2%, and valve of 0.02mm there was no reported 3D geometry of the BioMimics 3D stent 3D geometric curvature will 12-month primary patency was loss of primary patency. is biomechanically compliant with the be patency protective through 80.4% for BioMimics 3D subjects Swirling flow induced by the vessel which likely reduces the inci- stimulation of swirling flow vs. 72% for the control group. No BioMimics 3D stent and the resulting dence of stent fracture and also chronic and elevation of wall shear stress. stent fractures were reported by the levels of wall shear stress are being vascular injury of the unstented seg- The MIMCS study is independent core lab in either investigated by on-going analysis of ment”, commented Duda. “We now need a prospective, 2:1 treatment group. ultrasound data from the MIMICS additional longer-term data to confirm randomised con- The BioMim- study and computational fluid dynamic these effects”. ics 3D stent modelling. A substantial body of Veryan received CE mark approval Stephan features unique literature, built on the original work of for the BioMimics 3D stent in Duda 3D geomet- Colin Caro (founder of Veryan Medical) November 2012.

12 Updates September 2013 Dehydrated ethanol used in renal artery denervation The first use of a novel, endovascular approach using chemical neurolysis via periadventitial injection of dehydrated ethanol to perform renal artery denervation was reported at EuroPCR 2013. Catheter-based renal denervation is a novel treatment option for patients with resistant arterial hypertension

im A Fischell, professor of three-needle delivery device was Medicine, Michigan State introduced into the renal arteries TUniversity, USA, reporting on of adult swine using fluoroscopic the results of the animal study at the guidance. Ethanol was injected conference (21–24 May, Paris, France), bilaterally with one injection per told delegates that circumferential artery, via the three needles into the adventitial delivery of very low doses adventitial and periadventitial space, of ethanol could be a promising using doses 0.15 ml/artery; n=3, 0.30 alternative to energy-based systems ml/artery; n=3, and 0.60 ml/artery; n=3, to achieve dose-dependent, and with saline injection as a sham control predictable renal denervation. (0.4 ml/artery; n=3), and naive subjects Fischell told Vascular News, “This (n=7) as a true negative control. The is the first definitive publication renal parenchymal norepinephrine Tim Fischell Marc Sapoval demonstrating both the safety and the concentration at two-week follow-up dose-dependent efficacy of ethanol was the primary efficacy endpoint. able, cheaper and more efficacious than very difficult for the interventionalist delivered locally to the adventitia The mean renal norepinephrine even the ‘second generation’ ‘burning’ to be certain that the intervention and periadventitial space to create reduction was 54%, 78% and 88% at energy-based approaches,” Fischell was successful and that it actually predictable, and titratable renal doses of 0.15ml, 0.30ml and 0.60ml, told Vascular News. interrupted the sympathetic flow in the sympathetic denervation (in a porcine respectively (p<0.0001 vs. controls). afferent and/or efferent sympathetic model). Fischell told EuroPCR delegates Further study is warranted nerves. “This type of dose-dependent that histological examination revealed Speaking on the limitations of the study, “On the other hand, clinical success response to escalating (low) doses (of marked, and deep, circumferential Fischell told Vascular News that these is based on the measure of office ethanol), has not been demonstrated renal nerve injury at depths of 2–8mm data were collected from a porcine or ambulatory blood pressure, data with energy-based catheters used from the intimal surface. There was model, and used renal parenchymal that needs careful methods to be for renal denervation, such as no evidence of device-related or norepinephrine drop (vs. control appropriately recorded. In addition, radiofrequency and ultrasound systems. ethanol-induced injury to the intimal animals) as the surrogate endpoint. one major point in the control of the Furthermore, the magnitude of the layers. In some samples, at the higher Although the per cent nerve kill and blood pressure of any patient is their denervation, using very low volumes of doses, there was focal loss of smooth norepinephrine drop seen with ethanol actual drug intake. Compliant patients ethanol, appears equivalent to surgical muscle cells in the outer media. should correlate with blood pressure (those who do take their drugs) and denervation, and superior to limited Angiography at 45 days demonstrated lowering efficacy in patients, this non-compliant ones are not separated (pre-clinical) data presented to date normal appearing renal arteries with no needs to be confirmed in the upcoming by a clear divison; they represent a with energy-based renal denervation. detectable stenoses (n=8). clinical trials. continuum that any physician has The simplicity of delivering a single “The key message about the use of Marc Sapoval, professor of difficulty in evaluating in routine circumferential and deep dose of a three-micro-needle system (Per- clinical radiology and chair of the clinical practice. ethanol over 30 seconds, rather egrine catheter) to inject dehydrated cardiovascular radiology department at This means that being clear about than burning the artery from the ethanol, is that it is very safe, with Hôpital Européen Georges-Pompidou which patient is a “responder” and intima outward may have substantial minimal injury to normal renal arterial in Paris, France, told Vascular News, which one is not, is a very complex advantages. With deep ‘perivascular’ wall structures. It also appears to be “Renal denervation is a very promising task. All interventionalists performing chemical denervation, there is likely very effective, with predictable dose- technique but it is still its infancy. No renal denervation find that clinical more effective sympathetic nerve response to low doses of ethanol, as catheter today gives any information success can be very difficult to foresee. kill, without thermal injury to the measured by renal parenchymal drops on the actual denervation that the Some patients will have excellent blood intima and media. This may reduce or in norepinephrine. In addition, there is intervention produced. In other words, pressure response, despite technically eliminate the risk of intimal thrombus no cumbersome or expensive electronic the currently available devices deliver limited results. In contrast, some embolising into the kidney, and also (radiofrequency or ultrasound) ‘box’ in the best case scenario, indirect patients in whom the procedure was reduce the risk of late renal artery required. We believe this will make information, based on impedance drop, performed with the best technical result stenosis.” this approach to renal denervation, temperature rise or other ablation possible, sometimes do not respond In Fischell et al’s study, a novel, quicker, safer, more efficient, predict- related parameters. Therefore it is ultimately to the intervention.”

to Harris, 195 of the interventions needed re-intervention. Covered stents superior to bare were index procedures. Twenty Harris said that primary of the procedures were in vessels patency for covered stents was metal stents for renal artery stenosis that had already had one interven- 100% at 12 months and 93% at tion, and 11 were in vessels that 24 months and patency in the bare William B Harris, University of Tennessee, Chattanooga, USA, spoke about a required two interventions. metal stent cohort was 83% and retrospective review on the patency of covered stents in comparison to bare Of the interventions included in 74%, respectively. The difference metal stents for the treatment of renal artery stenosis. He told delegates at the the case review, 48 were treated between the two groups was sta- Vascular Annual Meeting (30 May–1 June 203, San Francisco, USA) that covered with angioplasty and covered tistically significant (p<0.045). stents showed better patency rates in primary and secondary interventions stents and 178 with angioplasty He commented: “Covered and bare metal stents. In the stents should be considered in arris said, in the introduc- stents, the use of which can result analysis of cases treated between covered stents group, four (8.3%) renal artery stenting for both tion to his presentation, in restenosis. 2005 and 2011, consisting of 179 of the 41 vessels developed primary index procedures and Hthat endovascular therapy In order to evaluate patients patients and 226 interventions. restenosis which required further secondary interventions due with stents for atherosclerotic who underwent stenting for renal Index cases as well as first and intervention and 41 (23%) of the to their improved performance renal artery stenosis often utilises artery stenosis, Harris and col- second re-interventions were ex- 178 vessels in the bare metal stent over bare metal stenting for balloon-expandable bare metal leagues performed a retrospective amined in the review. According group developed restenosis and ostial renal artery stenosis”.

14 Updates September 2013

of Latin America) has promoted the Angiology and Vascular Surgery, the development and education of endolumi- Society of Vascular and Endovascular A unified voice for nal therapy in the region. Endovascular Surgery of Puerto Rico and the surgery is now part of vascular surgery Uruguayan Society of Vascular and training, but a better definition of train- Endovascular Surgery. vascular surgery ing and certification still needs to be During the summit, the appointed del- achieved. egate of each society made a presenta- tion about the state of the art of vascular A new driving force for surgery in their country. The delegates in Latin America integration spoke about the specialty, the number The first international vascular society, of vascular surgeons, the number of founded in 1950, and later named members in their society, existent formal International Society for Cardiovascular training programmes and journals in ALBERTO MUÑOZ Surgery (ISCVS), included a Latin vascular surgery. The performance of American chapter (LA-ISCVS). This each society was analysed conclud- chapter organised 29 congresses— ing that there are very strong and well amongst those three of the ISCVS world organised vascular societies in Latin COMMENT & ANALYSIS meetings—stimulating the development America. However, it was also noted of vascular surgery in the continent. The that, since the dissolution of the ISCVS LA-ISCVS, today called Latin American in 2004, there is poor interaction be- Vascular surgery, as a specialty, has been present in Latin Society for Vascular Surgery and tween the societies which has caused the America since its early days. The first countries to accept Angiology (ALCVA), played a vital role lack of awareness on what is happening vascular surgery and angiology as an independent specialty in promoting the constitution of national in neighboring countries with similar were Brazil in 1958 and Cuba in 1959, thus we can say that societies. Of the 26 Latin American geography, culture, health and economic those countries were amongst the world’s first to recognise the countries, 14 have vascular societies. issues. This reinforced the importance of specialty. Today, vascular surgery is a well-defined specialty in The first was founded in Argentina in having the ALCVA as the new driving most Latin American countries 1952, followed by Brazil (1952), Mexico force dedicated to promote and maintain (1959), Colombia (1965), Uruguay the exchange of knowledge and experi- ignificant contributions, from lum- of general surgery and two years of (1966) and Cuba (1972). Most of the ences and to create bonds of friendship bar sympathectomy (Diez, 1924) vascular surgery. Training in general countries that do not have a vascular and communication between vascular Sand carotid artery reconstruction surgery and cardiovascular surgery is society have a chapter of vascular surgeons in the region. It was also con- (Carrea and Molins, 1951) to Parodi’s necessary in Argentina, Panama, Peru surgery within the country’s surgical cluded that ALCVA will stimulate re- endovascular repair of abdominal aortic and Bolivia. A complete training and society. search and publications and will become aneurysm (1990), have been made by certification in general surgery and With the aim to integrate the specialty the unified voice of the Latin American Latin American surgeons. From its early then two years of vascular surgery are and to understand the work of each societies to interact with the societies of days, vascular surgery in Latin America required in Chile, Colombia, Ecuador independent vascular society in Latin vascular surgery in the world. has been in constant development and and Uruguay. Thanks to the formal America, the first ALCVA summit was The 2nd ALCVA-30 Latin American evolution. Patients with different vascu- education in vascular surgery and held in Santa Cruz de la Sierra, Bolivia, meeting of Vascular Surgery will be held lar pathologies, including trauma, have residency programmes established in in October 2012. The participants were in Cartagena, Colombia, 25–30 March received treatment with different endar- Argentina, Brazil, Colombia, Chile, the Bolivian Society of Cardiothoracic 2014, organised by the Colombian Soci- terectomy, aneurysm repair and bypass Costa Rica, Cuba, Ecuador, Mexico, and Vascular Surgery, the Brazilian ety for Vascular Surgery and Angiology. surgery techniques performed by vascu- Puerto Rico and Uruguay, the number Society of Angiology and Vascular lar surgeons; however, a few general and of physicians dedicated to vascular care Surgery, the Cuban Society of Angiology Alberto Muñoz is president of the Latin cardiac surgeons still undertake some of has increased rapidly during the past two and Vascular Surgery, the Colombian American Society for Vascular Surgery these vascular procedures. The treatment decades. It is also important to mention Association of Angiology and Vascular and Angiology (ALCVA). He is profes- of venous disease and the practice of that each society of vascular surgery in Surgery, the Costa Rican Association sor of Surgery, Universidad Nacional de ultrasonography and endovascular sur- Argentina, Brazil, Ecuador, Colombia, of Peripheral Vascular Surgeons, the Colombia, vascular and endovascular gery are also currently performed by an Mexico and Cuba has a journal dedicated Ecuadorian Society of Angiology and surgeon, Hospital Universitário Funda- important number of vascular surgeons. to the specialty. Vascular Surgery, the Mexican Society cion Santa Fe de Bogotá, and director, Education in vascular surgery varies The development of endovascular sur- of Angiology and Vascular Surgery, Clinica Vascular de Bogotá considerably across Latin American gery in the past 20 years has also created the Peruvian Society of Angiology countries. Brazil, Mexico, Cuba and the need for training. This demand has and Vascular Surgery, the Paraguayan Costa Rica have a four-year training been met by mini-fellowships and proc- Society of Angiology and Vascular programme that includes two years torships. CELA (Endovascular Surgeons Surgery, the Panamanian Society of

News in brief

UK surgeons’ results for reporting has led to the rate of mortality after Endurant shows durable outcomes aneurysm repair and carotid elective infra-renal abdominal aortic aneurysm at three years endarterectomy published repair in the UK falling from 7% in 2008 to 2.4% Three-year data for the Endurant Abdominal The Vascular Society of Great Britain and Ire- in 2013. This is a direct result of the relentless Aortic Aneurysm stent graft system were land has, for the first time, published details of focus by multidisciplinary teams on outcomes presented at the Vascular Annual Meeting. consultant-level outcomes after vascular surgery. over preceding years. The data come from the clinical study that The National Vascular Registry 2013 Report on The audit presents outcomes information for contributed to the device’s approval by the FDA Surgical Outcomes: Consultant-level Statistics consultants working within the UK and gives in December 2010 and show 100% freedom presents information on the results of surgery figures for consultants and NHS trusts/health from aneurysm-related mortality, 0% aneurysm for patients who underwent elective repair of an boards. The data reveal that no surgeon had rupture, 0% stent graft migration and 0% infra-renal abdominal aortic aneurysm and stroke an outcome outside the expected range. Data conversion to open repair for the 107 patients prevention surgery with carotid endarterectomy. were adjusted to take into account the varying followed to three years. This information builds on the UK wide quality risk profiles of differing patients (this is called “It is particularly compelling to review this improvement programmes that vascular sur- “casemix adjustment”). According to the Vascular mid-term data on the Endurant system, which geons have been running since 2005. The soci- Society, this ensures that surgeons who take delivers sustained clinical performance across ety has been reporting unit-level outcomes for on complex, higher risk cases are not unfairly key endpoints at three years,” said William abdominal aortic aneurysm and carotid endarter- criticised for having higher death rates. Jordan Jr, University of Alabama Birmingham, ectomy and has seen significant improvement in The report can be found on www.vsqip.org.uk/ USA. “The robust outcomes seen in the US study surgical performance in the last eight years. This surgeon-level-public-reporting confirm the durability of the Endurant stent graft.”

16 Carotid arteries September 2013 Early onset of neurological symptoms seen in asymptomatic carotid stenosis patients treated with medical therapy Medically managed patients with asymptomatic severe carotid was 80% for patients with 70–89% ste- artery stenosis develop ipsilateral neurological symptoms early, nosis and 45% for patients with 90–99% according to a study presented at the Vascular Annual Meeting stenosis (p=0.003). The use of station (30 May–1 June 2013) in San Francisco, USA. In the study, showed no difference in the incidence of the use of statins and aspirin failed to prevent neurological symptoms (p=0.98). symptoms At five years, 41 patients (33%) died without revascularisation, 44 (34%) n the presentation “Natural history of Conrad noted that a meta-analysis remain alive on medical therapy and 41 asymptomatic severe carotid artery published in Stroke in 2009 stated that (33%) underwent carotid revascularisa- Istenosis”, Mark F Conrad, Division medical intervention alone was best for tion (32 underwent endarterectomy and of Vascular and Endovascular Surgery, prevention of stroke associated with nine carotid artery stenting). The reason Massachusetts General Hospital, Harvard asymptomatic severe carotid stenosis for revascularisation was ipsilateral neu- Medical School, Boston, USA, told and that the rate of stroke with medical rological symptoms in 56% of the cases delegates that stroke is the fourth leading intervention alone has fallen since the and plaque progression in 44%. Multi- cause of death in the USA, and that 6% 1980s. “However, this meta-analysis is variate predictors of death included age, of Americans over 65 years of age have flawed as it included patients with mod- chronic obstructive pulmonary disease, asymptomatic severe carotid artery steno- erate stenosis for whom no intervention diabetes and high risk stenosis. sis. Stenosis over 50% is responsible for is indicated,” he said. 12–20% of anterior circulation infarcts, The objective of the study was to Mark F Conrad In his conclusions, Conrad said that he noted. determine the natural history of medi- ipsilateral neurological symptoms “The superiority of carotid endarter- cally treated patients with asymptomatic severe stenosis (70–89%) and 38 (30%) are frequent and, in this study, oc- ectomy over medical management for severe (>70%) carotid artery stenosis. had very severe stenosis (90–99%). curred mainly within the first year of the prevention of stroke in patients with Asymptomatic severe carotid artery ste- Amongst the reasons for indication of follow-up. He added that surgeons stenosis greater than 70% is supported by nosis patients were identified by duplex medical therapy alone, 34% patients had can identify high risk patients, and level I evidence and practice guidelines (index study 2005–2006) and included if it indicated because they were high risk that the current survival rate is from the Society for Vascular Surgery they were treated with medical therapy. for intervention, 55% received physi- 56%. Diabetes, chronic kidney dis- and other societies. It is clear that the Patients were excluded if they had a cian recommendation and 11% refused ease and chronic obstructive pulmo- addition of statins to medical therapy carotid intervention within six months of intervention. Eight six per cent of patients nary disease predict poor prognosis has improved outcomes when it comes the index duplex. Aspirin and statin use were on statin and 89% were on aspirin. in the asymptomatic population. to stroke, and this has translated in a was recorded for each patient. The study The results showed that, at 60 months decrease in the stroke risk for the general endpoints included ipsilateral neurologi- of follow-up, 31 patients (24.6%) devel- “Although there is a general agreement population over time. It is suggested cal symptoms (stroke, transient ischaemic oped ipsilateral neurological symptoms, that future trials should include a medical that the benefit of endarterectomy in attack and amaurosis fugax referable to and that most of the symptoms (71%) arm, these data show a prohibitively high the asymptomatic trials is secondary to the ipsilateral carotid artery) and death. occurred in the first 12 months. Forty neurological event rate in patients with inadequate medical therapy in the medi- The investigators identified 126 carotid five per cent of the symptoms (14) were >90% stenosis that is not seen in patients cal therapy arm rather than the benefit of arteries in 115 patients (mean age 73.5 strokes. with moderate (50–69%) disease,” he carotid endarterectomy itself.” years). Eighty eight (70%) patients had Freedom from symptoms at 60 months noted. Registry data suggest women benefit as much as men from carotid revascularisation At the Vascular Annual Meeting (30 May–1 June 2013, San Francisco, USA), Jeffrey Jim, Washington School of Medicine, St Louis, USA, presented registry data on the differences in adverse events after carotid revascularisation between men and women with carotid artery stenosis Jeffrey Jim im said that the Society of gender was an influencing factor women had a lower event rate Vascular Surgery Vascular in terms of adverse events. when treated with best medical endarterectomy (6,518) or factors were similar for both JRegistry (SVS-VR) data In cardiovascular disease therapy. Jim said that, in CREST carotid artery stenting (3,801). sexes. were used to determine the treatment, a 2009 (Carotid revascularization There was no difference in age In the stenting group, the “impact” of gender after study, Jim said, showed that endarterectomy versus between the gender groups. adverse event rate was higher patients who underwent carotid stroke incidence in men was stenting trial), there was a The primary endpoint was than the endarterectomy group endarterectomy and carotid 33% higher and prevalence higher rate of adverse events death, stroke, and myocardial but was similar for men and artery stenting for carotid was 41% higher than in females. in women undergoing carotid infarction at 30 days. women alike. Jim said this was stenosis. However, stroke was considered stenting but this was lower for Data from the registry consistent with results from Previous trials have suggested more severe in females than endarterectomy. showed that there were no previous trials. that women have a higher males according to one-month The registry presented by Jim, differences in adverse events in “These data suggest that, risk of perioperative adverse fatality rates (24.7% vs. 19.7%). and described as “representative the group with regards to age contrary to previous reports, events, which could mean According to the results of of real world outcomes”, was and gender. women do not have a higher that intervention may not be ACST (Asymptomatic carotid an observational study and data Jim then spoke about the risk of adverse events after beneficial for them as much as it surgery trial), Jim told delegates, were retrospectively analysed. endarterectomy group as carotid revascularisation”, is for men. there was a higher rate of In the registry, 10,319 patients a whole. He noted that the Jim said. “Women may derive Jim noted that it was perioperative events in women (of which 41% were women) adverse event rate was 4% for similar benefits as men from important to remember that compared to men, even though underwent either carotid both men and women and risk carotid revascularisation.”

18 Abdominal aorta September 2013 35% of men and 60% of women with short infrarenal necks are ineligible for EVAR At the Society for Vascular Surgery (SVS) Vascular Annual eligibility in male and female patients. in the database who had an infrarenal Meeting (30 May–1 June 2013, San Francisco, USA), Tina M In order to “filter” the database for neck diameter of ≤32mm (2,837 Morrison (Center for Devices and Radiological Health, Food and short-neck abdominal aortic aneurysms, patients; 30%). They further retained Drug Administration, Silver Spring, USA), gave a presentation on Morrison said that they used anatomic patients with moderate aortic tapering of the eligibility for endovascular repair of short neck abdominal criteria (sac diameter of ≥40mm; infrarenal:suprarenal diameter of ≤1.1 aortic aneurysms from the CHAP project infrarenal neck length <10mm). She and suprarenal:infrarenal diameter of noted that this left 9,454 (65%) and ≤1.2, which resulted in a final number he told delegates that, of 200,000 the CHAP (Characterization of human 3,395 (36%) patients remaining, of 2,343 patients analysed (25%). people who are diagnosed aortic anatomy project) database, the respectively. Morrison went on to say that the data Sannually with abdominal aortic investigators sought to collect data on Additionally, to further isolate were grouped by gender and short- aneurysms, in the USA, 25% are the anatomy of short infrarenal neck abdominal aortic aneurysms with short neck abdominal aortic aneurysm size women and 75% are men, therefore, in lengths and how this applied to EVAR necks the researchers retained, patients “in 5mm increments for investigating ineligibility.” The anatomic criteria for two endovascular grafts which are approved in the USA (Cook Fenestrated, TriVascular Ovation) were evaluated against the filtered anatomic data. Overall, 2,343 patients were analysed for untreated short-neck infrarenal abdominal aortic aneurysms. Morrison said that 35% of men and 60% of women with short- neck abdominal aortic aneurysms are ineligible for EVAR in the sac diameter treatment range. She added that this was because, using the Cook Fenestrated, the angulation criteria excluded patients and with the Trivascular Ovation it was because of the infrarenal neck length combined with neck angulation. From the CHAP database and the sample population, Morrison noted that one third of abdominal aortic aneurysm patients have a short infrarenal neck. “At least 35% of men and 60% women with short neck abdominal aortic aneurysms are not eligible for EVAR with the current commercially available endografts at the current treatment threshold of 5mm” She added that “Ineligibility increases with larger size abdominal aortic aneurysms.”

Tina M Morrison

20 Abdominal aorta September 2013 Improved pre-discharge surveillance and closer follow-up needed to improve 30-day outcomes after EVAR Athird of the deaths and complications after endovascular aneurysm repair (EVAR) occur after discharge, and improving pre-discharge surveillance and post-discharge follow-up may help to identify high-risk patients and further improve 30-day outcomes after EVAR. A study presented at the Vascular Annual Meeting (29 May–1 June 2013, San Francisco, USA) also concluded that post-discharge interventions are needed for complications with high rates of occurrence after the procedure

utcome improvement in the (p<0.0001). Patients with peripheral field of aortic surgery, spe- arterial disease also had higher rates of “Ocifically endovascular repair complications after EVAR (7.1% vs. of abdominal aortic aneurysms (EVAR), 4.3%, p=0.001). This also correlated has received much attention. The focus, with a higher wound infection rate however, has been on in-patient out- in these patients (3.2% vs. 1.7%, comes,” Prateek K Gupta, Department p=0.01),” he said. of Surgery, University of Wisconsin, A previous cardiac surgery also Madison, USA, told delegates. “With predisposed patients towards a higher EVAR, the index hospital stay after overall post-discharge complication aortic surgery has decreased significantly, rate (5.3% vs. 4.2%, p=0.007). Gupta leaving a need for better understanding commented: “This was also driven of post-discharge outcomes, which is primarily by post-discharge wound necessary to improve quality and reduce infection (2.2% vs. 1.7%, p=0.04) and readmission rates with implementation of post-discharge cardiac complication targeted outpatient interventions.” rates (0.3% vs. 0.1%, p=0.047). Post-discharge wound infections were The objective of this study was also more common in smokers and to examine post-discharge 30- diabetics.” day outcomes after elective He added, “Usually, patients EVAR. Patients who underwent undergoing EVAR are followed up an elective EVAR for abdominal at two weeks for wound evaluation, aortic aneurysm (n=11,229) were or at one month with a CT scan. identified from the American In the present study, the median College of Surgeons 2005–2010 occurrence for most of the post- National Surgical Quality discharge complications was within Improvement Program database. the first 10 days after intervention. The The primary outcome of interest interquartile range was 11–22 days was post-discharge mortality, for the diagnosis of a wound infection while the secondary outcome was after EVAR. These data suggest that post-discharge overall morbidity. earlier follow-up of high-risk patients Prateek K Gupta may help identify and possibly prevent Gupta explained that the some of these complications and investigators—from University of who died post discharge experienced population. In contrast to patients who subsequently decrease readmissions. Wisconsin and Creighton University, an in-hospital complication. Compared survived after EVAR, patients who A standardised protocol for triage and Omaha, USA—looked at outcome with patients who did not develop a died post-discharge were more likely surveillance of high-risk patients post- and timing of in-hospital and post- post-discharge complication, those to have been admitted from a nursing EVAR is needed.” discharge complications after EVAR. who experienced a post-discharge facility/acute care (13.9% vs. 1.8%, Gupta noted that the limitations The results of the analysis showed complication had a more than six-fold p<0.0001). of the study include “the fact that that the 30-day death rate was 1%, likelihood of reoperation (3.1% vs. The mean age of patients who despite controlling for more than and 30.8% of the cases of death 20.4%, p<0.0001) and death (0.2% vs. died post discharge was higher, and 50 preoperative variables in the occurred after discharge. The median 3%, p<0.0001) within 30 days of the the anaesthesia time was also longer multivariate analysis, we may have time to death was nine days. Overall intervention. for these patients. The 30-day post- missed some confounders such as morbidity at 30 days was 10.7%, Subsequently, Gupta added, discharge death rate amongst patients socioeconomic status and hospital- with 40.1% occurring after discharge. the investigators performed a who had post-discharge renal failure level and region-level variation. Acute renal failure with dialysis, and multivariable analysis for post- was 27%, for those who had post- Although the data were prospectively cardiac arrest or myocardial infarction, discharge mortality and found that discharge myocardial infarction was collected, they were retrospectively occurred in 1% of the patients, preoperative congestive heart failure 19% and for those with post-discharge analysed and being an observational with 13.1% and 17.2% of the cases, (odds ratio 4.7), admission from pneumonia was 14%. study, causality could not be respectively, occurring after discharge. skilled nursing facility (2.2) and A multivariable analysis for determined. The timing of re-operation The investigation also showed that advanced age (1.09) were significantly post-discharge morbidity showed was not specified and data on re- the 30-day rate of wound infections associated with post-discharge that female gender, history of admission were also not available from was 2.1%, urinary tract infection was death. The highest odds ratio was peripheral arterial revascularisation or these datasets.” 1.6%, pneumonia was 1.2%, venous seen for post-discharge renal failure amputation, previous cardiac surgery, In his conclusions, Gupta stated thromboembolism was 0.6% and requiring dialysis (72.5), cardiac bleeding disorder, diabetes, smoking that a third of the deaths and stroke was 0.4%. arrest/myocardial infarction (46.6) within the previous year, advanced age complications after EVAR occur after More than 90% of patients (456/500) and pneumonia (26.5). “There was no and increased operative time were all discharge. “Improve pre-discharge who developed a post-discharge significant association for preoperative significantly associated with post- surveillance and closer post-discharge complication did not experience an comorbidities as well as postoperative discharge morbidity. follow-up to identify high-risk inpatient complication. However, in-hospital complications and post- Women had a post-discharge overall patients may further improve 30-day the occurrence of a complication in discharge mortality,” he said. complication rate of 6.1% in contrast outcomes after EVAR. Post-discharge the inpatient setting increased the The 30-day post-discharge death to 4.1% in men (p<0.0001). “This was interventions are needed and should likelihood of occurrence of a post- rate amongst patients admitted mostly driven by the higher post- focus on complications with high discharge complication (4.3% to 6.5%, from nursing facility/acute care was discharge wound infection rate, which rates of occurrence after the index p=0.005). Only 20% of patients (7/36) 2.5%—the rate was 1% for the overall was 2.8% in women and 1.6% in men hospitalisation,” he said.

22 Thoracic aorta September 2013 STABLE trial shows favourable aortic remodelling

Joseph Lombardi

At the Vascular Annual Meeting, Joseph V Lombardi (Cooper University Hospital, Camden, USA), presented a report from the STABLE trial. He presented clinical and anatomical outcomes through two years of follow-up and concluded that aortic remodelling and mortality after endovascular treatment of complicated type B aortic dissection using a composite device design was favourable

ombardi said that the STABLE ing thoracic aorta and the more distal (Clinical study to assess safety abdominal aorta, with a concomitant Land effectiveness of the Zenith decrease in false lumen diameter”. Dissection Endovascular System in At two years, the majority of patients patients with aortic dissection) trial was exhibited a stable or shrinking transaortic a prospective, multicentre study which diameter in the thoracic (73.3%) and evaluates the safety and effectiveness of abdominal aorta (65.9%). Transaortic Zenith Dissection Endovascular System growth (>5mm) was observed in 22 (Cook Medical), comprising a proximal patients in the descending thoracic aorta stent graft and distal bare metal stent, and in 26 patients in the abdominal aorta for the treatment of complicated type B within two years. Lombardi commented aortic dissection. that the majority of the patients with The study enrolled 86 patients (mean transaortic growth had acute dissections age 59 years; 73% male) who were (18/22 with growth in the thoracic aorta treated within 90 days of symptom onset and 22/26 with growth in the abdominal (64% of the patients were treated for aorta). These observations are consistent acute dissection ie., within 14 days of with other published literature on onset of symptoms). Inclusion criteria for the endovascular treatment of aortic complicated type B aortic dissection were dissection. branch vessel obstruction or compro- He concluded that endovascular repair mise, impending rupture as evidenced of complicated type B aortic dissection by periaortic effusion or haematoma, using the composite device “demonstrat- resistant hypertension, persistent pain or ed favourable remodelling”. However, symptoms, or aortic growth ≥5mm within he said that patients treated in an acute three months (or transaortic diameter setting may be prone to aortic growth and ≥40mm). According to Lombardi, the 30- require close observation. day mortality rate was 4.7% (4/86) and The Zenith Dissection Endovascular patient survival was 88% at one year and System is comprised of the Zenith TX2 85% at two years. TAA Endovascular Graft and the Zenith Lombardi said that from baseline Dissection Endovascular Stent. Lombardi to two years the true lumen diameter also noted that follow-up will continue up “increased significantly in the descend- to five years. The true lumen diameter increased significantly in the descending thoracic aorta and the more distal abdominal aorta, with a concomitant decrease in false lumen diameter

24 Interview September 2013 Profile Thomas Zeller

Thomas Zeller, head, Department of Angiology at Universitäts—Herzzentrum Freiburg, Bad Krozingen, Germany, says that interventional angiology “almost did not exist” when he performed his first non-coronary intervention in 1996. In this interview, Zeller talks about his career, mentors, first insights from the DEFINITIVE AR trial, renal angioplasty and other of his research topics

When did you decide you wanted a was one of the first who tried to manage such lesions be enrolled. There was no proof of the haemodynamic career in medicine? Why cardiology non-surgically. I had the opportunity to visit him in 1997 relevance of the renal artery stenosis; more than 50% and angiology? in Berlin for one week and was very impressed with of lesions enrolled were not significant. Finally, almost The decision to study medicine was made a couple his kindness and willingness to teach me (a “nobody” 40% of the patients were lost for follow-up after two of months before I became a medical student at the in the cathlab at that time) and give me the opportunity years when the primary endpoint was analysed. The Albert-Ludwigs-University of Freiburg. My initial plan of having some hands-on experience. As a result of only conclusion that can be drawn from ASTRAL is that was to become a veterinary doctor but I soon realised this experience I built up a workshop programme in one should not treat patients with an uncertain indication it would be difficult to communicate with animals. my institution teaching more than 100 physicians which are basically the ones without a clear proof of the My primary intention was to pursue an education in every year. Moreover, we established a network of haemodynamic relevance of the lesion. Internal Medicine, with global knowledge and skills experienced European endovascular centres to conduct RADAR was the first and, to date, only trial in this specialty. However, in 1987 I met a colleague interventional trials. which was designed in a way that only patients with who enjoyed the same hobby as I did—playing tennis. haemodynamically relevant lesions could be enrolled. This colleague convinced me that cardiology would What have been your proudest Unfortunately, study enrolment slowed done to almost be more attractive. After over two years working in a moments? zero after the publication of ASTRAL and the sponsor general Internal Medicine department in a small regional My proudest moment Certainly was my first publication finally stopped his support after the enrolment of about hospital, in 1991 I moved to the Benedikt-Kreutz in a peer-reviewed journal in 2001, followed by the one third of the intended study population. Basically, Rehabilitation Center for Heart and Circulation Diseases first publication inCirculation in 2003. An important an analysis of the primary endpoint of the study, the Bad Krozingen—now part of the University Heart and challenging step in my career was the nomination difference in GFR-rate after one year between Center Freiburg-Bad Krozingen to start my training as associate professor at the University of Freiburg in the endovascular and medical group as a cardiologist, and starting my invasive career in 2009. Becoming a member of the scientific committee accurately confirmed the assumption the end of 1992. However, in 1993 I participated in of TCT and of the guideline commission of the ESC made for the power calculation. an exchange programme with the University Hospital were other milestones. However, due to the small number Basel, Switzerland, where I stayed for six months in of patients, this difference was not the angiology department. During this time, I realised How has interventional angiology significant in favour of the stent that cardiovascular diseases have almost the same evolved since you began your career? cohort. etiology and that the diagnostic and therapeutic tools Interventional angiology almost did not exist at the and techniques are very similar. After returning back time I performed my first intervention in 1996. At What are your to Bad Krozingen in 1994 I stepwise built up a section least in Germany, at that time, almost all interventions expectations in vascular medicine, first establishing non-invasive were performed by radiologists. Interventional tools with regards to diagnostic pathways and, in 1996, starting with the had not yet been developed as in cardiology, eg. renal the results of first peripheral endovascular intervention. Nowadays, interventions had been performed through 9F guiding the CORAL trial the section is established as an angiology department catheters over 0.035 inch guidewires with hand comparing medical comprising of 26 physicians and performing almost crimped stiff Palmaz stents. The interventional toolbox 2,700 peripheral interventional procedures per year. The consisted of balloon catheters, some early stent devices reason for moving from cardiology to angiology was and the excimer laser. Dedicated below-the-knee a lack of qualified angiologists and an oversupply of devices were not available. cardiologists in Germany. What have been your most Who has inspired you in your career memorable clinical cases? and what advice of theirs do you My first non-coronary intervention, which was a remember today? renal procedure; and my first carotid intervention, The first person who was important in my career was my which was done under the proctorship of Prof Klaus chief physician in the department of Internal Medicine Matthias, who is the inventor of this intervention; and in the small regional hospital in Schopfheim, Dr Fabian- the life-saving implantation of an endoprosthesis in a Krause. He was trained in almost all fields of internal patient with a ruptured type B dissection of the thoracic medicine and he trained me in echocardiography, right aorta four hours before I had to give a lecture about heart catheterisation and pacemaker implantation. the endovascular treatment of aortic dissection and The next one was Dr Achim Büttner, at that time one aneurysm. of the most experienced interventional cardiologists in Germany and the head of the interventional cardiology You criticised a supposed “selection department in my clinic, who convinced me to become bias” in the ASTRAL (Angioplasty an interventional cardiologist. and stent for renal artery lesions) Prof Kurt Jäger from Basel was the first one who trial and the effect its results had on raised my interest for angiology and trained me in the RADAR trial enrolment. Do you duplex ultrasound techniques. still hold the same opinion about During my career as an interventional angiologist I ASTRAL? was most influenced by three people: Prof Blum, Prof I still believe that ASTRAL was a very biased trial. Felix Mahler and Prof Giancarlo Biamino. Prof Blum Firstly, the power calculation was based on a sample and Prof Mahler were pioneers in endovascular renal size of 1,000 patients but the study was terminated artery revascularisation, the topic of my postdoctoral already after enrolling 806 patients. Secondly, study lecture qualification thesis. Prof Biamino is probably the inclusion criteria did exclude from enrolment patients interventional angiologist who changed the paradigms which might have had the most benefit from of endovascular therapy in Europe. By introducing laser- revascularisation—only patients with an uncertain assisted angioplasty of long femoropopliteal lesions, he indication for revascularisation were allowed to September 2013 Interview 25

Fact File

Current position Head, Department of Angiology at Universitäts - Herzzentrum Freiburg, Bad Krozingen, Germany

Professional career 1980–1985 Studies in human medicine at Albert-Ludwigs-University, Freiburg i Br, Germany therapy vs. medical therapy and balloon vs. drug-eluting balloon alone. 1988 Conferral of doctorate Dr med stenting for renal artery stenting? What insights from this trial could you (medical doctor) at Albert-Ludwigs- Unfortunately, this trial enrolled in the majority share with us at this point? When will University, Freiburg moderate lesions, there was no need to prove the results be presented? 2006 Postdoctoral lecture qualification, significance of a lesion, inclusion criterion was at least The results of this pilot trial will be available in the Albert-Ludwigs-University Freiburg 60% renal artery stenosis by angiography (no QA, first quarter of 2014. What we have learnt so far is 2009 Associate professor nomination at eyeballing only). Thus, I do not expect any difference in that we should not be too aggressive with atherectomy Albert-Ludwigs-University Freiburg outcomes between both study cohorts. if a drug-eluting balloon will be used afterwards; even small perforations or cuts through the adventitia Qualifications What is your experience with renal can result in pseudoaneurysm formation. Regarding 1994 Admission medical specialist denervation and how are you making restenosis rates, we did not perform an interim Internal Medicine sure you select the right patients for analysis after six months; we are waiting for the 1995 Subarea term Cardiology this procedure? final angiographic outcome results after one year. 1996 Subarea term Angiology With renal denervation we are still at the very beginning, My expectation is that we will find a trend to a lower 2006 Admission “hypertension specialist” still understanding this therapy. So far, it seems that all minimal lumen diameter for the combination therapy by the German Hypertension approved devices result in a modest reduction in office cohort, if we eliminate those patients who received a League (DHL) based blood pressure. However, therapy is still limited stent graft for sealing a pseudoaneurysm. to patients with resistant hypertension, other Appointments indications are still investigational. In In your opinion, what is the best way 1987–1989 Medical assistant of the my clinical experience, the responder to treat in-stent restenosis? Department of Internal Medicine at rate is about 60%, and 10% to 20% In-stent restenosis can be successfully treated with Klinikum Lahr respond so well that medication drug-eluting balloon balloons. If it is an in-stent 1989–1991 Medical assistant of Department can be reduced. I am not yet sure reocclusion, the lesion should undergo debulking prior of Internal Medicine at Municipal which technology will make the to drug-eluting balloon, eg. Rotarex thrombectomy, Hospital Schopfheim race: radiofrequency, ultrasound, laser or directional atherectomy. 1991–1993 Medical assistant at Herz-Zentrum radiation or local drug delivery. Bad Krozingen (Prof Dr H We will need hard endpoint What other topics are you researching Roskamm) trials with meaningful at the moment? 1993–1994 Medical assistant at Kantonsspital endpoints such as survival, We are doing cost-effectiveness analyses of drug- Basle, Department Angiology and stroke, hospitalisation etc. eluting balloons and drug-eluting stents in different Department Intensive Care applications. In general, our current focus is still the 1994 Herz-Zentrum Bad Krozingen, You are a co-principal evaluation of different drug-based approaches to reduce in interventional cardiology, and investigator in the restenosis in peripheral interventions (above and below constitution of Interventional DEFINITIVE AR (anti- the knee). Another hot topic is identifying expanded Angiology Department restenosis) study indications for renal denervation. 2002 Senior physician at Herz-Zentrum comparing atherectomy Bad Krozingen, head of the plus drug-eluting What is the most interesting paper you Department of Angiology have come across recently? 2003 Head physician, head of It is probably the paper about the prognostic value of Department Clinical and elevated troponin in peripheral arterial disease patients Interventional Angiology at Herz- regarding cardiovascular events (Linnemann et al. Zentrum Bad Krozingen, now JACC 2013). Another landmark trial published this year Universitäts-Herzzentrum Freiburg, was the randomised controlled trial comparing primary Bad Krozingen stenting with percutaneous transluminal angioplasty and stenting on indication in the popliteal artery Honours and awards (Rastan et al. Circulation 2013). 2001 Young Investigator Award, International College of Angiology What skills does the interventionalist 2013 Honorary Membership at the of the 21st century need to develop? Austrian Society of Angiology He must be familiar with different access techniques including retrograde access; he needs advanced Scientific activity knowledge about the unique features of dedicated „„Member Guideline Commission, European guidewires; and he needs to know which device in the Society of Cardiology big toolbox will most likely result in a durable clinical „„Member of Scientific Committee, Transcath- benefit for the patient. In the future, reimbursement eter Cardiovascular Therapeutics (TCT), will be based on the cost-effectiveness of a particular EuroPCR, Leipzig Interventional Course technology. Thus, he needs to be up to date with (LINC), Resistant Hypertension Course (RHC), current research results. president-elect of the Annual Meeting of the German Society of Vascular Medicine 2015 Outside of medicine, what are your „„Editorial board member, VASA, Eurointer- interests? vention, Vascular Medicine, Catheterization In the rare case of time outside medicine, I like Cardiovascular Interventions, Journal of Endo- playing tennis and driving fast cars. Together with the vascular Therapy, Gefäßmedizin.net family, I enjoy hiking and travelling around the world. 26 Updates September 2013

DRG 238 technical costs (US$31,672) what surprisingly, our findings revealed New cost models to surpassed DRG 238 technical revenue that the vendor with the largest market (US$27,657), resulting in a negative share (54%) was not the lowest cost technical margin of -US$4,015 per case, device. In addition, the two vendors offset margin losses consistent with the annual net operat- with the lowest priced grafts, derived ing margin finding. Furthermore, when the smallest market shares respectively DRG 238 overall costs and length of stay (12% and 9%). Historically, device cost associated with EVAR were benchmarked to other academic has not been routinely factored into case medical centres, using UHC 2012 data, planning paradigms, highlighting the we determined that our institution was paucity of surgeon awareness of vendor are needed already in the lowest quartile nationally, price differential. Interestingly, our study suggesting that we were not merely a additionally projected that when cost high-cost EVAR provider, thus driving was factored into case planning for the our negative margin. Rather, there was estimated 40% of all locally performed something intrinsic to the current EVAR EVARs in which all major commer- DAVID H STONE delivery paradigm such as implant costs, cially available devices could be used which better accounted for the negative interchangeably with equipoise, vendor operating margin. market share could be shifted to lower Second, this study demonstrated that cost devices, with an anticipated savings COMMENT & ANALYSIS stent graft implants indeed accounted of US$200,000 annually. for the majority of the procedure’s While this study had several intrinsic technical costs (52%). Among the non- limitations, including that costs, After looking at the costs associated with endovascular graft implant drivers for technical cost, revenues and margins for EVAR are aneurysm repair (EVAR) procedures at his institution, David depicted as a percentage of technical likely to fluctuate among institutions, H Stone writes that Medicare remunerated EVAR is potentially costs, operating room (17%) was the the compelling procedure associated unsustainable for hospitals which provide comprehensive EVAR largest. Additional procedure associated margin findings are likely to be prevalent care in the USA costs included supplies (8%), beds (7%), across many institutions throughout the radiology (2%), lab and pharmacy (2%), United States for Medicare remunerated he rapidly changing economic costs and operating margins associated and other (12%). Interestingly, when EVAR. Based on these significant healthcare landscape has ushered with Medicare remunerated EVAR at a compared to non-implant costs, stent findings, Medicare remunerated EVAR Tin a new era of care delivery with tertiary care academic medical centre in grafts still accounted for more than is potentially unsustainable for hospitals a growing emphasis placed on cost re- contemporary practice. We believe these three-fold more in technical cost than which provide comprehensive EVAR duction, quality, and overall value. While findings will have a growing relevance to operating rooms costs. Furthermore, care. Furthermore, fostering surgeon endovascular aneurysm repair (EVAR) all vascular specialists alike who provide there was an apparent inequity between awareness of vendor price differentials has changed how we treat aneurysm EVAR care in a myriad of practice envi- the stent graft cost, when depicted as may serve to both inform case planning disease in contemporary practice, it ronments. a percentage of technical cost, versus and better negotiate competitive device remains associated with significant pro- After creating a relatively uniform a percentage of technical revenue. pricing, thus offsetting the primary driver cedure associated costs, which may have EVAR cohort for cost analysis over More specifically, the requisite grafts for EVAR technical costs. This study implications surrounding its financial a one-year period, there were several were found to account for 52% of the emphasises the need for novel models sustainability for hospitals and healthcare interesting findings worthy of high- procedure’s technical costs, though of more cost neutral EVAR delivery, systems alike. In this setting, we recently lighting. First, this study demonstrated assumed 60% of the DRG payment, thus offsetting procedure associated presented our findings at the Society of that the annual net operating margin highlighting their prominent footprint margin losses and supporting long-term Vascular Surgery Annual Meeting in San for Medicare DRG 238 remunerated regarding contemporary EVAR’s sustainable healthcare systems. Francisco, USA, regarding the financial EVAR within the Section of Vascular technical financial margin. implications of EVAR in the cost con- Surgery was substantially negative at our Thirdly, this study determined that David H Stone, vascular surgeon, is tainment era. The purpose of the study institution, approaching -US$500,000. graft implant cost and local EVAR with the Dartmouth-Hitchcock Medical was to examine the procedure associated More specifically, we determined that market share did not correlate. Some- Center, Lebanon, USA New surgical table provides up to 20% reduction in C-arm radiation exposure A comparative study performed to verify the new imagiQ2 study was conducted using an abdomen body from more than 250 conventional low-dose table top from Stille has shown that the new device phantom with human bone surrounded chest posteroanterior X-ray procedures. produces 20% lower radiation exposure than the previous by acrylic plastic and a GE OEC 9900 The study proved that the new imagiQ2 model, imagiQ. The analysis was conducted at the Shoreline C-arm unit. The phantom was placed table can help reduce harmful radiation Surgical Associates Clinic, Middletown, USA, a clinic managed by in the centre of the fluoroscopy field exposure and can be an important vascular surgeon Joseph Coatti on both surgical tables. The image contributor of keeping dose exposure intensifier was placed 15 inches from according to the ALARA principle,” n recent years, there has been will have a beneficial effect on patient the table tops. A standard fluoroscopy Coatti said. increasing concern regarding the dose. Globally established guidelines exposure was made and data recorded. Industry standard surgical imaging Iradiation risks to both the patient and regulations by institutions as the The C-arm unit recorded 0.10mGy tables report to have table top and operator for fluoroscopy based International Atomic Energy Agency radiation exposure on the imagiQ attenuation levels of 0.7–1.5mm Al, interventional procedures. Mean stipulate the fundamental principles and 0.08mGy on the imagiQ2. Image a variable which should be measured fluoroscopy time in EVAR procedures of radiation safety which is to keep pictures were equal in resolution. The according to the medical device have been reported in published occupational radiation exposures comparative study showed that the directives of the European Committee studies to be in the range of 13–39.4 “as low as reasonable achievable imagiQ2 table required 20% lower for Electrotechnical Standarization minutes, and procedures requiring large (ALARA)” and that equipment should exposure than the imagiQ table at (CENELEC). The imagiQ2 with its fluoroscopy times are associated with a be operated at the lowest fluoroscopic constant standard fluoroscopy set-up. 0.4 mm Al, is developed with a patent significant radiation hazard. dose rate that yields adequate images. As compared to already published pending carbon fibre technology Significant reduction in patient The aim of the study was to assess dose rates in EVAR procedures, a that has proven its extremely low radiation dose can be achieved by how the new imagiQ2 surgical table 20% reduction in radiation can be attenuation. changing radiological procedures, with a low-dose table top may help equivalent to more than 5.0mGy of The imagiQ2 table was introduced in radiological equipment or both. Any to reduce radiation exposure relative reduced mean effective dose. “To put 2012 and includes a new carbon fibre reduction of the attenuation between to the industry standard table top of into perspective, this reduction equals table top (patent pending) and free float the patient and the image receptor the first generation imagiQ table. The the radiation exposure affecting the (also pending patent). Stay in touch with Vascular News

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Ia endoleaks, cases of sac growth, or the outflow of potential endoleaks, and Chimney EVAR ruptures. In a cursory literature review, I the length of the seal zone. How much could find only one case of rupture after seal is necessary for standard EVAR? fenestrated EVAR in 10 reported series Despite the FDA approving some grafts demands strategy with a combined 931 patients. for use in shorter necks based on their 12 month performance, almost all long-term These data highlight the Achilles’ data has shown that 15mm of seal is for dealing with heel of chimney EVAR. That is, the needed for durability. For example, data parallel configuration can interfere from EUROSTAR on over 4,000 EVARs compromised seal with the conformability of the en- using grafts with transrenal fixation dografts to the aortic wall, leading showed that, despite early success, the to gutters and potential continued late endoleak rate at 48 months was pressurisation of the sac. There- 9–11% when the length of seal was DAVID MINION fore, the seal achieved with parallel 15mm or less. Further, data on over endografts cannot be equated to the 10,000 EVAR cases in the M2S database “true” seal attained with standard revealed a late sac growth incidence of EVAR. Rather, it should be concep- 43% in patients with short necks. In more COMMENT & ANALYSIS tualised as “gutter” seal. recent years, the rate was an alarming 62%, a grim indication that we have However, before we condemn parallel become much too cavalier with respect to David Minion says that parallel endografts are not a fail-proof endografts, 1.6% is a low rupture rate and acceptable seal lengths. solution for every patient that is not a candidate for standard still leaves chimney EVAR with an over- Parallel endografts represent a mini- EVAR and should be carried out only by centres experienced in all aneurysm-related mortality less than mally invasive option that can increase treating juxtarenal anatomy that of open repair in a cohort considered seal length while preserving branch too high risk to undergo that procedure. vessels—all of which are inherently n recent years, few techniques have cases and 15.4% for patients with rupture. In addition, most of the chimney EVAR good and justify their use in appropri- generated greater interest and con- By comparison, the American College patients were not anatomically suitable ate circumstances. There are now fairly Itroversy in the field of endovascular of Surgeons National Surgical Quality for fenestrated EVAR, which may invali- robust published data showing that chim- aneurysm repair (EVAR) than parallel Improvement Program reported a 30-day date direct comparisons between the two ney EVAR is comparable to alternative endografts. The technique refers to the mortality of 5.1% for elective repair of techniques. As case in point, the average strategies, even though the technique has placement of two or more endografts aortic aneurysms involving renal or vis- infrarenal neck length approached 10mm been utilised for the most part in severely alongside each other to preserve flow to ceral vessels and 25% in cases of rupture in the Cook FDA trial. disadvantaged anatomy. covered branch vessels. It is commonly for the year of 2011, which represents the Further, of the three reported postopera- However, parallel endografts are by referred to as the “snorkel” or “chimney” most recent available data. Further, the tive chimney EVAR ruptures, one was no means a fail-proof solution for every procedure (ch-EVAR). 30-day mortality for fenestrated endovas- likely from a type Ib. Another appears to patient that is not a candidate for standard Although still considered “experimen- cular aneurysm repair in Globalstar was have occurred in a patient with approxi- EVAR. Despite some enthusiasts recom- tal” by many, there is now fairly extensive 4.1%, with all cases being elective. mately 12mm of “gutter” seal in a 34mm mending this approach with only 15mm published data on outcomes using vari- In terms of branch vessel preservation, diameter suprarenal aorta and no addition- of “gutter” seal or less, the evolving ations of this configuration. In terms of the overall incidence of target vessel al “true” seal in the infrarenal aorta. The data show that this threshold can lead to reno-visceral chimneys, series have been loss was 1.6% in the combined series for third appears to have occurred in a patient compromised durability. Many centres are published from such centres of excellence chimney EVAR, matching that of fenes- with approximately 10mm of “gutter” now using techniques such as “sandwich” as Orebro University, Malmö University, trated EVAR as reported in Globalstar. seal in a 35mm diameter suprarenal aorta grafts to achieve a minimum of 5cm of University of California San Francisco, The rate was 2.5% in the FDA trial for with an additional 5mm of “true” seal in “gutter” seal in ultra-challenging anato- University of Florida, Henri Mondor the Cook Zenith Fenestrated device. a 29mm diameter infrarenal aorta. Even my. Other techniques are being developed University, Münster and Zurich Univer- However, the combined rate of if the renal arteries had been covered in to eliminate the gutters altogether. At sities, Stanford University, University persistent type Ia endoleak for chimney these cases, it is not clear that enough any rate, parallel endografts should only Medical Center Utrecht, and Manchester EVAR was a concerning 7.6%, with sac “true” seal would have been achieved for be performed in centres experienced in Royal Infirmary. Combined, these series growth identified in approximately 11% a durable result. In other words, although treating juxtarenal anatomy, with a well represent 378 reno-visceral chimneys in of the patients, and postoperative rupture chimneys can be life saving in the appro- thought out strategy for dealing with 185 patients, including 13 with ruptured reported in three cases (1.6%). By com- priate situation, they cannot defy the basic the compromised seal inherent to the aneurysms, with median follow-up for the parison, Globalstar reported immediate principles of seal. configuration. most part in the range of 12 months. type Ia endoleaks in 4.6% of cases (plus In EVAR, seal is actually a complex Using this combined cohort, it appears an additional 1.7% type III rate), but has process determined by multiple factors, David Minion is professor that the 30-day mortality for chimney yet to report any long-term follow-up. In including the “health” of the sealing of Surgery, University of Kentucky EVAR is approximately 2.3% in elective the Cook FDA trial, there were no type vessel, the sealing ability of the endograft, Medical Center, Lexington, USA

Secondary endpoints include technical success, clinical suc- Early experience shows no restenosis cess, complication rate, amputation rate, and cost-effective- ness. Alongside De Vries, J A Vos, interventional radiologist, with new drug-eluting balloon St Antonius Hospital, is the trial’s principal investigator. Cardionovum initiated the market launch of Legflow arly results with the new Legflow paclitaxel-eluting comprise both clinical and angiographic parameters. in the beginning of 2013. According to the company, the peripheral balloon show promising clinical results in It has been shown that restenosis rates for long-segment device provides a unique hydrophobic and stable paclitaxel Ethe treatment of femoropopliteal artery lesions. “The obstructions of the superficial femoral artery are substantial balloon surface coating. It added that the Legflow pacli- preliminary six-month patient results show no restenosis (up to 60% at one year). Paclitaxel-eluting balloons have taxel coating is designed to protect both the physician and effect,” said Jean Paul de Vries, St Antonius Hospital, Nieu- been found to reduce restenosis significantly due to reduction the patient against toxic paclitaxel particles falling or being wegin, The Netherlands. De Vries is a principal investiga- of neo-intimal hyperplasia. According to Cardionovum, the wiped off the balloon surface during catheter manipula- tor in the study, which is being carried out in six hospitals Legflow balloon provides an equally distributed paclitaxel in tion. During catheter tracking to the lesion site, there is in association with the Dutch Endovascular Alliance. The tissue concentration, achieving optimal drug in tissue avail- no noticeable drug wash off effect, and Legflow provides first six-month data on 55 patients will be presented at the ability by a 90sec short-term balloon inflation time. a targeted drug delivery to the lesion site. No noticeable VEITHsymposium (19–23 November, New York, USA). In the RAPID trial, a total of 176 patients will be dosage of paclitaxel is distributed into the systemic blood The RAPID trial is a Dutch multicentre randomised randomised to confirm the hypothesis that the use of the stream and no noticeable microemboli are generated. trial comparing standard percutaneous transluminal an- Legflow drug-eluting balloon significantly reduces the Legflow sizes range from 2–12mm, at balloon lengths gioplasty (combined with superficial femoral artery stent- restenosis rate in intermediate and long-segment superficial 20–200mm. Most specifications are available in rapid ing) to Legflow paclitaxel-releasing balloon (Cardiono- femoral artery lesions. Patients with symptomatic (Ruther- exchange and over the wire catheter design, compatible vum) angioplasty combined with stenting for intermediate ford class 2–6) >5cm obstructions are being enrolled. with 0.014” and 0.035” guidewire dimensions. Another (5–15cm) and long-segment (>15cm) obstructions of the The primary endpoint will be absence or significant reduc- 0.018” guidewire compatible Legflow device is expected superficial femoral artery. Two years of follow-up will tion of binary restenosis of the superficial femoral artery. to be launched by end of the year.

30 Updates September 2013

reducing tie is removed, followed by frequently, balloon displacement of the Fenestrated endografts: deployment and retrieval of the top cap main stent graft. and balloon dilatation of the proxi- mal neck using a compliable balloon. Branch perforation or How to avoid Each alignment stent is sequentially dissection deployed; flared and selective angiog- Branch vessel perforation and/or dis- raphy is performed with hand injection. section can be prevented by meticulous complications and get The repair is extended distally using technique, visualisation of the tip of the a universal bifurcated component and guidewire and avoiding manipulations. out of trouble a contralateral limb. The procedure is The guidewire should not be positioned in completed by balloon dilatation of the small terminal branches, which are prone attachment sites and final angiography to perforate or dissect. It should be stabi- to demonstrate patency of the visceral lised during exchanges, avoiding forward GUSTAVO S arteries, main body, iliac limbs and or retrograde movement. If perforation iliac arteries. occurs, it should be immediately recog- ODERICH nised and treated by coil embolisation. Difficult target vessel cath- eterisation Endoleaks COMMENT & ANALYSIS Although most target vessels are Endoleaks from attachment sites such as accessed without difficulty, several type I and III endoleaks are infrequent manoeuvres can be used to facilitate (<1% to 3%) with proper selection of a Inadequate proximal neck limits the use of standard catheterisation. The 7F Ansel sheath healthy landing zone. In the event of a endovascular approaches in up to 40% of patients because of may be positioned in the fenestration type Ia endoleak, the proximal neck may short length, angulation or involvement of the visceral arteries. with support of a 0.018-inch guidewire be re-dilated, but all the alignment stents Fenestrated and branched stent grafts have been increasingly allowing a 5F “buddy” catheter (eg. Van need to be protected by separate balloons. utilised to treat complex aneurysms with high rates of technical Schie 3) to be used to locate the renal success, low morbidity and mortality. This article summarises the artery. In cases of down-going, tortuous Stent kinks or narrowing basic concepts of device design, techniques of implantation and or diseased renal arteries, the catheter Kinks can be anticipated from review some of the “bail-out” manoeuvres that may be required during and guidewire may bounce up into of CT angiography and completion an- endovascular repair using the fenestrated stent grafts the top cap, providing enough support giography. If a kink is evident by com- to advance the catheter into the renal pletion angiography, a self-expandable Anatomical considerations the fenestrations and placement of side artery. Advancement of the sheath may stent should be deployed distal to the The Zenith Fenestrated stent graft (Cook stents, while the left femoral access is be facilitated by using an undersized balloon expandable stent. Kinks remain Medical) has been approved for treatment used for introduction of the fenestrated balloon instead of the dilator. a cause of re-intervention or branch of patients with short-neck or juxtarenal device. Multi-sheath access via the vessel loss if not recognised. abdominal aortic aneurysms who do not right femoral artery is obtained using a Avoiding damage to side meet the proposed anatomical criteria for 20F Check-Flo sheath (Cook Medical), stents during exchanges Summary use of infrarenal stent grafts and have which is accessed with two short 7F The dilator of the bifurcated device often Endovascular repair of complex aneu- an infrarenal neck length >4mm and sheaths for placement of pre-selective encroaches the contralateral renal stent. rysms involving the visceral arteries <15mm. The device consists of a proxi- catheters. Aortography is avoided In these cases it is useful to leave a 10mm has become a reality. Fenestrated stent mal fenestrated component, a bifurcated during the implantation of the device. balloon ready to be inflated in the renal grafts have been increasingly utilised universal component and a contralateral Instead, hand injections of 3ml of con- stent to protect from any damage. to treat pararenal and thoracoabdominal iliac limb extension. The fenestrated stent trast in 7ml of saline are sufficient to aneurysms. The technique is safe, ef- graft is custom-made with up to three demonstrate the anatomy for side stent Misalignment of fective and can be performed with high fenestrations. Device planning starts with placement. Once the target vessels are fenestrations technical success and low risk of com- selection of a 2cm proximal landing zone catheterised, the fenestrated component Neck angulation, tortuosity and errors plications by experienced physicians. based on “healthy” aorta, which should is oriented extra-corporeally, intro- of design can lead to misalignment Over 6,500 patients have been treated be parallel wall with outer-to-outer diam- duced via the left femoral approach, between fenestration and target vessel. by Zenith fenestrated endografts. eter of >18mm and <32mm, no calcium and deployed with perfect apposition The fenestrations may be pulled Single-centre reports and a US prospec- or thrombus. between the fenestrations and the target slightly more posterior because of tive trial have shown high technical catheters. Each selective catheter is the diameter-reducing tie, which success, exceptionally low rates of type Technique sequentially removed from the target runs posteriorly. Rotation of each I and III endoleak and excellent branch. Bilateral femoral access is established. artery and used to regain access into fenestration to an anterior position The patient is systematically heparin- the fenestrated component, fenestra- often allows successful catheterisation. Gustavo S Oderich is professor of Sur- ised with a target activated clotting tion and target vessel. After access Other manoeuvres are rarely needed gery, director of Endovascular Therapy, time >300 seconds. The right femoral into the renal arteries is established but include use of curved catheters (eg. Division of Vascular and Endovascular access is used for catheterisation of with hydrophilic sheaths, the diameter- VS1 or SOS); microcatheters and, less Therapy, Mayo Clinic, Rochester, USA Obesity not a contraindication for percutaneous TEVAR There are currently limited data regarding undergoing percutaneous TEVAR with the preclose quired additional operations. the preclose technique, but obesity technique were reviewed. The patients in the percutaneous Univariate analysis revealed, according to Zakko, does not seem to be a contraindication, TEVAR cohort were stratified by body mass index. that higher age, increased sheath size, large aortic according to a study presented at the stent diameter, the use of two or more Perclose Vascular Annual Meeting 2013 in San Of 536 TEVAR procedures, 359 were percutane- devices, the need for iliac stents and higher femoral Francisco, USA ous interventions. The percutaneous TEVAR artery calcium score were indicators of an patient group, according to Zakko, had increased risk of failure, but not obesity. review of the safety of percutaneous thoracic a mean age of 62.9±15.7 years and a Zakko concluded: “Obesity does not endovascular aneurysm repair (TEVAR) was mean body mass index of 27.5±5.4. appear to be a contraindication for presented to delegates at the Vascular Annual The mean number of Perclose deploy- the preclose technique”. He also A ments was 2.1±0.4. Meeting (30 May–1 June 2013, San Francisco, recommended that, for patients that USA). It was said in the presentation that there may require adjunctive stenting or who were currently limited data regarding the preclose The preclose success rate, defined as have smaller access vessel diameters technique, but that obesity does not seem to be a ability to achieve haemostasis and maintain with a greater degree of calcification, contraindication. limb perfusion without the need for surgical this particular technique should be used Jason Zakko, a medical student in the Department of vessel repair, was 92.6% (non-obese 92.2%; selectively. Surgery, University of Florida, Gainesville, USA, told obese 93.8%; p=0.57). Two obese patients delegates that all data from 2005 to 2011 of patients and one non-obese patient re- Jason Zakko

32 Updates September 2013 Staged carotid artery stenting shows superior late outcomes in open heart surgery patients

In carotid artery stenosis patients undergoing open heart surgery, staged carotid artery stenting demonstrated to have the best outcomes compared to staged and combined carotid endarterectomy and open heart surgery. The results of the retrospective comparison conducted at the Cleveland Clinic appear online in the Journal of the American College of Cardiology

he investigators set out to compare 2009. The study population consisted competing risks were used. both being better than staged endarterec- risk-adjusted outcomes of three primarily of patients who were found to Using propensity analysis, staged tomy-open heart surgery. However, the Tapproaches to carotid revasculari- have severe carotid artery disease as part carotid artery stenting-open heart surgery outcomes are significantly in favour of sation in the open heart surgery popula- of their evaluation prior to open heart and combined endarterectomy-open staged carotid artery stenting-open heart tion. They write: “Without randomised surgery. heart surgery had similar early hazard surgery after the first year. clinical trials, the best approach to phase composite outcomes while staged “Our study shows that carotid stenting managing coexisting severe carotid and Of the procedures, 45 were staged endarterectomy-open heart surgery followed by open heart surgery should coronary disease remains uncertain. endarterectomy-open heart surgery, incurred the highest risk driven by inter- be the first line strategy for treating Staged carotid endarterectomy followed 195 were combined endarterec- stage myocardial infarction. Subsequent- patients with severe carotid and coro- by open heart surgery or combined en- tomy-open heart surgery and 110 ly, staged carotid stenting-open heart nary disease, if the three- to four-week darterectomy and open heart surgery are were staged carotid artery stenting- surgery experienced significantly fewer wait between procedures is clinically commonly used. A recent alternative is open heart surgery. late hazard phase events in comparison acceptable,” said Shishehbor. “There has carotid artery stenting.” to both staged endarterectomy-open heart never been a randomised clinical trial The researchers, led by Mehdi H The primary composite endpoint of surgery (adjusted hazard ratio [HR]: to determine the best approach for these Shishehbor, director of Endovascular the study was all-cause mortality, stroke, 0.33; 95% confidence interval [CI]: 0.15 patients, but the evidence in this study Services in the Sydell and Arnold Miller and myocardial infarction. Staged to 0.77; p=0.01) and combined endarter- may be enough to change practice.” He Family Heart and Vascular Institute at carotid stenting-open heart surgery ectomy-open heart surgery (adjusted HR: added, “As a result of this work, we are Cleveland Clinic, examined the short- patients had higher prevalence of prior 0.35; 95% CI: 0.18 to 0.70; p=0.003). making changes to the way we approach and long-term outcomes of 350 patients stroke (p=0.03) and underwent more Staged carotid artery stenting-open patients with severe carotid and coro- who underwent a carotid revascu- complex open heart surgery. Therefore, heart surgery and combined endarterec- nary artery disease at Cleveland Clinic. larisation procedure within 90 days of a propensity score adjusted multiphase tomy-open heart surgery are associated We are collaborating across disciplines planned open heart surgery at Cleveland hazard function models with modulated with similar risk of death, stroke or myo- to identify the lowest risk treatment op- Clinic between January 1997 and August renewal to account for staging, and cardial infarction in the short term, with tion for each patient.” New stent yields promising results for stenosis in the iliac arteries

SABRINA BEN AHMED EUGENIO ROSSET

COMMENT & ANALYSIS

n increasing number of patients are affected when they occur, incur a negative prognosis on patient ischaemic rest pain and 3.6% had major tissue loss. We by iliac artery atherosclerotic disease every clinical outcome. used 44 stents to treat 35 limbs and 40 lesions. The loca- Ayear, and this can be explained by an aging A new balloon expandable stent, recently developed tion of the lesions was the common iliac artery in 77.5% population and the growing incidence of diabetes. A by CID and named Isthmus Logic, has been specially of the cases. We had no procedural complications and stenosis or an occlusion of the iliac artery may cause designed to provide several advantages in the treatment all the patients had technical and clinical procedural suc- intermittent claudication or critical limb ischaemia. In of the iliac arteries. The stent strut thickness is extremely cess. Nine-month follow-up was available for 24 patients the past few years, endovascular therapy has become reduced with a positive impact on the device profile and 12-month follow-up for 16 patients. The results also the gold standard for the treatment of these lesions, (6F compatible with the entire range of sizes) allowing showed that all patients benefited from clinical improve- and several randomised studies have demonstrated a minimal puncture size and limited compression time. ment, and there were no cases of restenosis. that stenting is more effective than percutaneous In spite of the strut thickness reduction, the stent design In our experience, we have found that new Isthmus transluminal angioplasty alone for the treatment of these guarantees an optimal scaffolding and radial strength Logic stent was easy to use. The placement of this device conditions. without compromising flexibility and conformability. is simplified by the good visibility of the platinum mark- When looking at the different types of devices The second generation coating, iCarbofilm, is a thin layer ers at both stent ends, even in difficult procedures. Our indicated for the treatment of iliac disease, balloon ex- of pure carbon deposited on the stent’s surface, which mid-term results show that the new Isthmus Logic stent pandable stents are used because their high radial force has demonstrated faster stent endothelialisation aimed to is safe with a very good clinical improvement. These first and precision; on the other hand, self-expandable stents reduce thrombogenicity and restenosis. results are promising; the ongoing international Logic are used because of higher flexibility, which potentially In Clermont-Ferrand, we have tested the new Isthmus Registry will provide further evidence on device efficacy minimises the risk of stent fracture/crush in the presence Logic stent in iliac arteries lesions. Twenty eight patients, and safety. of extensive forces (ie. compression, torsion). There- 23 men and five women were enrolled in the study, and fore, the ideal stent for the treatment of the iliac arteries the data were prospectively collected. The mean age Sabrina Ben Ahmed and Eugenio Rosset are with the has not been found yet. In addition, although clinical of the patients was of 65.5 years, 60.7% had severe Department of Vascular Surgery, University Hospital, results are generally good, restenosis and thrombosis, claudication, 25% had moderate claudication, 10.7% had Clermont-Ferrand, France September 2013 Societies 33 Julie Ann Freischlag elected president of the Society for Vascular Surgery

​Julie Ann Freischlag was elected 2013–2014 president of the Society for Vascular Surgery (SVS) during the 67th Vascular Annual Meeting (30 May–1 June 2013, San Francisco, USA

or the past 10 years Freischlag the American College of Surgeons as a has served as the surgeon-in-chief regent for the past seven years and serves Fin the Department of Surgery at as the chair of the Board of Regents since Johns Hopkins Medical Institutions; chair October 2012. She is also a member of of the Department of Surgery at Johns the Eastern Vascular Society, the Southern Hopkins University School of Medicine Association for Vascular Surgery, and is and a William Stewart Halsted Professor; a past president of the Association of VA a surgeon at Maryland VA Hospital; and a Surgeons, the Baltimore Academy of Sur- trustee for the Robert Garrett Foundation gery, and the Society of Surgical Chairs. at the Johns Hopkins Children Center. Freischlag earned her medical degree As an accomplished author, Freischlag from Rush University in Chicago. She is the editor of JAMA Surgery (formerly completed both her general surgery the Archives of Surgery). She serves on the residency and vascular fellowship at editorial boards of the Annals of Vascular University California Los Angeles. Surgery, the Journal of the American Col- Julie Ann Freischlag Peter Lawrence lege of Surgeons, and the Journal of the Peter Lawrence becomes American Medical Association. SVS president-elect was on the faculty at the University of Medical School and completed his Freischlag is a national and interna- ​Also at the Vascular Annual Meeting, Utah in Salt Lake City from 1978–1998, surgical residency and vascular surgery tional expert on thoracic outlet syndrome, Peter Lawrence, Wiley Barker chief of where he served as chief of surgery at the fellowship at Columbia-Presbyterian writing extensively about its diagnosis, vascular surgery in the David Geffen Veterans Administration Hospital, chair Medical Center in New York City. He treatment, and patient outcomes. She is School of Medicine at the University of the division of vascular surgery, and has written over 200 clinical and basic the national principal investigator for the California Los Angeles (UCLA), was president of the medical staff. He moved research papers, 70 book chapters, VA OVER trial (Open vs. endovascular elected the 2013–2014 president-elect to California in 1998 to become associate and five textbooks. He is an editor of repair of abdominal aortic aneurysms), a of the SVS. He also is the director of the dean of clinical affairs, vice president for the Journal of Vascular Surgery and prospective trial which has randomised UCLA Gonda (Goldschmied) Vascular specialty services, and professor of surgery has been on the editorial boards more than 800 patients from 34 medical Center and the Bergman Chair in at the University of California, Irvine. of the Vascular and Endovascular centres across the USA. Vascular Research. Lawrence earned his medical Surgery, Perspectives in Vascular Freischlag has also been involved with Prior to his current positions, Lawrence degree with honours from Harvard Surgery, and Contemporary Surgery. September 2013

Offer less invasive treatments before surgery for varicose veins, says UK NICE Surgery should only be offered to treat varicose veins if other less invasive should be offered. If endother- quite clearly that interventional treatments are unsuitable for patients, according to a guidance issued by the mal treatment is not suitable, treatment for some patients who UK National Institute for Health and Care Excellence (NICE) on 24 July then ultrasound-guided foam are suffering from symptomatic scleropathy should be offered. If varicose veins is a better alter- or the first time, NICE these treatments are not suitable, native to surgery, and is both recommends endovenous then surgery should be consid- clinically and cost effective. It Fablation therapy as first ered. Compression hosiery such will help standardise care for all line treatment instead of the as tights and stockings should those with this condition.” more invasive surgical proce- only be offered if none of the Mark Whiteley, consultant dures currently being used for interventional treatments are surgeon and clinic director, varicose veins. “This recog- suitable. In addition, interven- The Whiteley Clinic, and nition signals a new era for tional treatments for varicose visiting professor, University the management of patients veins should not be carried out of Surrey, UK, commented: with varicose veins, who will during pregnancy. “The new NICE guidelines benefit from a walk-in, walk-out Mark Baker, director of the recommending endothermal procedure requiring only local Centre for Clinical Practice at ablation are very welcome and anaesthetic and allowing them NICE, said: “This guidance hopefully should see the end to return to normal activities the sets out the options for patients of stripping with the associ- next day,” NICE stated in the Alun Davies Mark Whiteley and their physicians to treat ated unnecessary scars, pain document. the individual symptoms of and bruising and recurrence Varicose veins affect up to treatment of varicose veins in or recurrent varicose veins; each patient so that no matter due to neovascularisation. three in 10 adults in the UK and the UK, as there is no definitive lower limb skin changes such as where they live, they have However as these techniques their impact on quality of life is system for determining which pigmentation or eczema, hard access to the therapy that’s become more widespread and comparable with that of conges- people would benefit most from painful veins (superficial vein right for them.” clinicians more experienced, tive heart failure and chronic interventional treatment. There thrombosis), or leg ulcers below Alun Davies, professor of I would expect to see pro- lung disease. Additionally, the is also currently no established the knee. Duplex ultrasound Vascular Surgery and honorary gression of the guidelines to burden to the National Health framework within the NHS for should be used to confirm the consultant surgeon, Imperial recommend local anaesthesia Service (NHS) of managing the the diagnosis and management diagnosis of varicose veins and College and Imperial College and other forms of endovenous impact of untreated varicose of the condition. plan the course of treatment. NHS Trust, Charing Cross and ablation, both thermal (such as veins such as leg ulcers is esti- In the new guideline, NICE For confirmed cases of vari- St Mary’s Hospitals, London, steam vein sclerosis) as well as mated at £1billion annually. says that people should be cose veins, NICE recommends UK, and chair of the group non-thermal endovenous abla- Currently, according to NICE, referred to a vascular service if that endothermal ablation (radi- which developed the guideline tion such as glue and mechan- there is wide regional variation they have symptomatic primary ofrequency or laser treatment), added: “This guideline shows ochemical ablation (MOCA).”

superficial thrombophlebitis; most Symptom burden reduced in varicose veins were related to treatment and resolved without sequelae. patients with polidocanol endovenous microfoam “VANISH-2 is an important study ata from the VANISH-2 study, in symptoms at week eight, the study significant improvements in the Venous because it is the first time improvement published online in Phlebol- primary endpoint as measured by the Clinical Severity Score (VCSS) and in symptoms has been shown using a Dogy, indicate that polidocanol VVSymQ score, compared with patients Venous Insufficiency Epidemiological and patient-reported outcome measure in a endovenous microfoam (PEM) provides who received placebo (p<0.0001). Economic Study-Quality of Life (VEINES- randomised controlled clinical trial in a clinically meaningful benefit in treating The study’s co-secondary endpoint, QOL) score compared to placebo. patients with varicose veins,” said Todd. symptoms and appearance in patients with improvement of appearance as measured Elimination of saphenofemoral junction “The publication of the full results for varicose veins caused by saphenofemo- by both a patient-reported outcome reflux and/or complete occlusion of the VANISH-2 demonstrates that PEM, if ral junction reflux. In the study, patients (PA-V[3]) and by a blinded independent target vein(s) at week eight, a tertiary approved, could offer a new treatment with symptomatic and visible varicose panel review of photographs (IPR-V[3]), endpoint, was achieved by 85% of patients option for patients with symptomatic veins caused by saphenofemoral junc- was also met. Patients treated with in the pooled PEM group (p=0.0002, varicose veins.” tion incompetence were treated with the PEM achieved a statistically significant compared with the control group PEM PEM is a patent-protected experimental investigational drug. improvement in appearance in both the 0.125%). This endpoint was achieved in drug/device combination product PA-V(3) and IPR-V(3) scores compared 83% and 86% of patients receiving PEM that produces engineered polidocanol VANISH-2, the first of two US pivotal with patients who received placebo 0.5% and PEM 1.0%, respectively. endovenous microfoam and was phase III trials of PEM (Varisolve, (p<0.0001 for both). There were no serious or unexpected manufactured in accordance with GMP BTG), was published online on 17 At week eight, eight out of 10 patients adverse events associated with the use standards for the clinical trial. PEM July. The first author, Kenneth Todd, in the pooled PEM group (composed of PEM. No pulmonary emboli were is delivered from a canister through Southeast Vein and Laser Center, of PEM 0.5% and PEM 1%) reported detected and no clinically important a syringe into the incompetent vein USA, was a principal investigator for clinically meaningful improvements in neurologic or visual adverse events under ultrasound guidance. PEM first VANISH-2. The study achieved all pri- symptoms compared to 20% in the placebo were reported. Of the 230 PEM-treated displaces blood and then the polidocanol mary, secondary and tertiary efficacy group. Additionally, treatment with PEM patients (including open-label patients), chemically ablates the inner lining of the endpoints in patients with vein diam- was superior to placebo in improving 60% had an adverse event compared vein wall, causing the vein to close. A eters ranging from 3.1 to 19.4mm. symptoms when either a duration or with 39% of placebo; 95% were mild or compression bandage and stocking are intensity scale was used to measure moderate. The most common adverse worn continuously for the first 48 hours, Patients treated with PEM demonstrated patients’ symptoms. The improvement in events in patients treated with PEM and the compression stocking only is worn a statistically significant improvement symptoms was supported by statistically were retained coagulum, leg pain and day and night for an additional 12 days.

September 2013 37 Indwelling retrievable inferior vena cava filters associated with higher complications than permanent filters Indwelling retrievable inferior vena cava permanent devices. In the indwelling filter group, there filters are associated with significantly were six cases (1.6%) of perforation, one migration higher complication rates than permanent (0.3%) and one fracture (0.3%). There was no occur- filters, according to a retrospective review rence of these types of complications in the permanent conducted in the USA. The authors of the group. The indwelling retrievable filter group also had study recommend that retrievable filters more cases of other types of complications. should only be used when retrieval is When the symptomatic complications were cat- “highly likely” egorised as thrombotic, device-related and systemic, indwelling retrievable filter patients had significantly e anecdotally had the experience, and higher (p=0.006) complication rates in all three catego- many of you might have had, of a vari- ries. “Indwelling retrievable filters are associated with “Wety of complications related to retriev- almost 10% incidence of symptomatic complications, able filters, especially with the stripes of the filters that significantly higher than permanent filters,” Desai said. we put through the vena cava, and sometimes stripe When asymptomatic device perforations and fractures rupture,” Tina R Desai, NorthShore University Health are considered, the incidence of complications with System, Skokie, USA, told delegates at the Vascular indwelling retrievable filters is greater than 15%. She Annual Meeting (30 May–1 June 2013, San Francisco, also commented that both device-related and thrombotic USA). “These anecdotal experiences led us to pursue complications are significant concerns with indwelling the current study in which we wanted to understand retrievable filters. the differences and complications between retrievable Desai told delegates that the limitations of the study and permanent filters. In addition, the long-term safety Tina R Desai —retrospective review and lack of follow-up imag- of retrievable filters compared to permanent filters is ing studies—likely result in an underestimation of the largely unknown.” common indication. number of asymptomatic complications. “We cannot In the retrospective review of electronic medical Desai told delegates that most of the retrievable filters draw meaningful conclusions related to the effects of records, 1,234 inferior vena cava filters placed between used were Celect from Cook Medical (240) followed by anticoagulation on thrombotic complications,” she said. January 2005 and December 2010 were identified (449 G2X from Bard (84), Gunther-Tulip from Cook (54), The investigator concluded that “retrievable filters retrievable and 785 permanent). Sixty seven patients Recovery from Bard (39) and OptEase from Cordis should only be used in conditions where retrieval is with retrievable filters removed electively were ex- (28). Venatech from Braun (686) was the most used highly likely; in all other patients, permanent filters cluded, yielding 382 patients in whom retrievable filters permanent filter followed by TrapEase from Cordis (65) should be utilised when inferior vena cava filters are were left in place. and Greenfield from Boston Scientific (26). indicated.” She stated that organised programmes to Patients in the retrievable filter group were younger The indwelling retrievable filter group presented with track and follow patients who receive retrievable filters (average age 63.6 years) than patients in the permanent significantly higher complications (8.9%) compared are necessary to optimise retrieval dates, and that a filter group (75.1). Both groups had acute deep vein to the permanent group (2.9%, p=0.0001). Throm- further study is needed to determine the significance of thrombosis as the most common diagnosis for filter botic complications occurred in 4.2% of patients with asymptomatic device fracture and device penetration placement and inability to anticoagulation was the most indwelling retrievable filters and 1.8% of patients with through the inferior vena cava.

efficacy and safety endpoints between patients entering Less bleeding with oral apixaban for the study with a deep vein thrombosis or a pulmonary embolism. Major bleeding occurred in 0.6% of pa- acute venous thromboembolism tients who received apixaban and in 1.8% of those who received conventional therapy (relative risk, 0.31; 95% The use of apixaban was shown to be non-inferior to enoxaparin and warfarin for CI, 0.17 to 0.55; p<0.001 for superiority). The compos- the treatment of acute venous thromboembolism, according to results of the phase ite outcome of major bleeding and clinically relevant III AMPLIFY study published in the New England Journal of Medicine. In the study, non-major bleeding occurred in 4.3% of the patients in apixaban (Eliquis, Bristol-Myers Squibb) was associated with significantly less the apixaban group, as compared with 9.7% of those in bleeding. The results were also presented as a late-breaking trial at the Congress the conventional-therapy group (relative risk, 0.44; 95% of the International Society on Thrombosis and Haemostasis (29 June–4 July 2013, CI, 0.36 to 0.55; p<0.001). Rates of other adverse events Amsterdam, The Netherlands) were similar in the two groups. The authors concluded that “a fixed-dose regimen of pixaban, an oral factor Xa inhibitor admin- composite endpoint of recurrent symptomatic venous apixaban alone was non-inferior to conventional therapy istered in fixed doses, may simplify the thromboembolism or venous thromboembolism-related for the treatment of acute venous thromboembolism and “Atreatment of venous thromboembolism,” death. The primary efficacy outcome occurred in 59 of was associated with significantly less bleeding.” wrote the authors, led by Giancarlo Agnelli, Harry R 2,609 patients (2.3%) in the apixaban group, as compared “The study results showed that apixaban, as a single Buller and Jeffrey I Weitz. with 71 of 2,635 (2.7%) in the conventional-therapy group agent, has comparable efficacy with significantly fewer In this randomised, double-blind study, the investiga- (relative risk, 0.84; 95% confidence interval [CI], 0.60 major bleeding events with respect to the standard of tors compared apixaban (at a dose of 10mg twice daily to 1.18; difference in risk [apixaban minus conventional care. These results complement the previously published for seven days, followed by 5mg twice daily for six therapy], −0.4 percentage points; 95% CI, −1.3 to 0.4). results for the AMPLIFY-EXT study,” said Giancarlo months) with conventional therapy (subcutaneous enoxa- Agnelli, professor of internal medicine, University of parin, followed by warfarin) in 5,395 patients with acute Apixaban was non-inferior to conventional Perugia, Italy, and director of the Department of Internal venous thromboembolism. The primary efficacy outcome therapy (p<0.001) for predefined upper limits of and Cardiovascular Medicine and Stroke Unit, University was recurrent symptomatic venous thromboembolism or the 95% confidence intervals for both relative Hospital, Perugia, Italy. He is also the lead investigator of death related to venous thromboembolism. The principal risk (<1.80) and difference in risk (<3.5 percent- the study. “Together these studies represent exciting data safety outcomes were major bleeding alone and major age points). in the field of venous thromboembolism treatment and bleeding plus clinically relevant non-major bleeding. indicate that apixaban may offer an important potential In this trial, apixaban as a single-agent achieved the Apixaban also met the primary safety endpoint of alternative in both acute and extended anticoagulation primary efficacy endpoint of non-inferiority to current superiority for major bleeding, with a 69% relative risk therapy for venous thromboembolism patients.” standard of care (initial parenteral enoxaparin treatment reduction compared to current standard of care. AM- The AMPLIFY study is funded by Pfizer and Bristol- overlapped with warfarin therapy) in the reduction of the PLIFY demonstrated comparable results for the primary Myers Squibb. 38 September 2013 Thermocoagulation of the great saphenous vein with EVRF is safe and shows high occlusion rate at six months

Thermocoagulation with a new endovenous radiofrequency The ecchymosis score was 0.02 at one system is a safe and efficient technique in the treatment of week (maximum score 0.13). The pain reflux of the great saphenous vein, according to a pilot study score was measured using a VAS scale conducted in Belgium (0–10). This was 2.5 at day two, 2.0 at day five, 1.6 at day seven and 0.6 at day hermocoagulation with EVRF thesia. Preoperative mean diameter was 10. One patient had paraesthesia of the (F Care Systems) is a treatment 6.5mm. For the procedure, the patient saphenous nerve, and there was a mean Twhere energy is delivered in was placed in an anti-trendelenburg of 1.1 days of periphlebitis. The patient the vein causing a destruction of the position for the puncturing of the great satisfaction score was 8.9 out of 10. endothelial cells and collapsing the vein. saphenous vein at its lowest point of The quality of life questionnaire was “Previous studies have demonstrated that incompetence. A guidewire and a 6F filled in three times by the patients. The this is efficient for treating small veins sheath were introduced and the CR45i mean score was 35.2 preoperatively, 38.5 like telangiectasia. In this study, we catheter was placed 1.5–2cm from the at seven days and 27 at one month. would like to assess the efficacy in treat- saphenofemoral junction. The patient ing the great saphenous vein insufficien- was then placed in the trendelenburg po- At one month all veins were occlud- cy,” wrote Sarah Thomis, Department of sition. Tumescent anaesthesia (approxi- ed with 34. At six months, 92.5% Vascular Surgery, UZ Leuven, Belgium, mately 10cc/cm) was delivered around of the great saphenous veins were the study investigator. the vein with ultrasound (according to occluded with four veins showing Sarah Thomis Forty patients with a unilateral in- the diameter of the vein, 25W or 20W a diameter reduction of more than competence of the great saphenous vein was delivered). The catheter was then 30%), 23 veins with a diameter were only partially occluded, but not were included in this prospective study pulled back gradually. “Concomitant reduction of more than 50% and 10 refluxing. We expect that after another between November 2011 and March phlebectomies were performed in almost veins with only a fibrotic cord. six months these two veins will be oc- 2012. The mean age was 50 years, 28 pa- all cases, but were not performed around cluded.” tients were females, the mean body the great saphenous vein tract in the Thomis stated that the occlusion rate The investigator said the complication mass index was 25.2 and 22 of thigh,” Thomis noted. was 92.5%, “which is com- rates were very low with one paraesthe- the patients had a standing The mean energy delivered parable with other sia and 1.1 days of periphlebitis. There profession. The CEAP was 7365.8J. The average endovenous treat- were no cases of deep vein throm- classification showed a treated vein length was ments on the bosis or thrombophlebitis. predominance for C2 (34) 37.2cm. market.” There was a very varicose veins. After the treatment, a She add- low ecchymosis The study endpoints compression stocking class ed, “Of score and a low pain were occlusion rate at one 2 was applied. No pain the veins score. and six months assessed with medication was prescribed, which did Thomis concluded ultrasound, pain score, ecchy- but if necessary ibuprofen or not occlude, that EVRF is a safe and mosis score, satisfaction score paracetamol could be taken. one was still efficient treatment for and quality of life score. Low molecular weight heparin open and with reflux. treating great saphenous The 40 patients were treated was only given in a prophylactic This probably was a techni- vein incompetence with a low under local, spinal or general anaes- dose when a risk factor such as cal failure. The other two veins pain score, no ecchymosis, high previous deep vein thrombosis or quality of life and an occlusion CR45i catheter obesity was present. EVRF rate of 92.5% at six months.

ultrasound. The group receiving The ultrasound patch weighs Ultrasound patch heals venous 15 minutes of 20kHz ultrasound just 100g—the equivalent of showed the greatest improvement, a king sized candy bar—and ulcers in human trial with all five patients experiencing is connected to two lithium complete healing by the fourth ion batteries which are fully n a small clinical study, ultrasound treatment during their (kHz), which is at least an order treatment. rechargeable. Lewin says the researchers administered weekly check-up (in addition to of magnitude lower, we might see The team’s clinical findings design gives patients the option Ia new method for treating standard compression therapy), more profound changes; that is were corroborated by their in of using the transducer in a home chronic wounds using a novel showed a net reduction in wound exactly what happened.” vitro studies in which mouse environment, while still wearing ultrasound applicator that can size after just four weeks (Figure In order to determine the opti- fibroblasts—cells that play an their compression socks. It also be worn like a band-aid. The ap- 1). In contrast, patients who did mal ultrasound frequency as well active role in wound healing— prevents the need for a doctor’s plicator delivers low-frequency, not receive ultrasound treat- as treatment duration, the research- experienced on average a 32% visit, which can be a difficult task low-intensity ultrasound directly ment had an average increase in ers treated patients with either 15 increase in cell metabolism and for patients with chronic wounds. to wounds, and was found to wound size during the same time minutes of 20kHz ultrasound, 45 a 40% increase in cell prolifera- Studies with larger numbers significantly accelerate healing period (Figure 2). minutes of 20kHz ultrasound, 15 tion compared with control cells of patients are needed to confirm in five patients with venous “There have been studies minutes of 100kHz ultrasound, or 24 hours after receiving 20kHz that the technology is both effec- ulcers. The technology was de- on the therapeutic benefits of 15 minutes of a sham (placebo) ultrasound for 15 minutes. tive and safe to use. veloped by researchers at Drexel ultrasound for wound heal- University, Philadelphia, USA, ing, but most of the previous with funding from the National research was performed at much Institute of Biomedical Imaging higher frequencies, around 1-3 and Bioengineering, part of the megahertz (MHz),” said Peter A National Institutes of Health. Lewin, Richard B Beard Profes- In an article to be published in sor of Biomedical Engineer- the Journal of the Acoustical So- ing at Drexel, and the primary ciety of America, the researchers investigator on this project. “We report that patients who received had an idea that if we went down low-frequency, low-intensity to the range of 20 to 100 kilohertz

40 Market watch September 2013

over-the-wire peripheral balloon that is compatible with both 0.014-inch and Product News 0.018-inch guidewires and 4F or 5F introducer sheaths. It is available in Medtronic ery profile, tip capture for length of 50 and 70mm. shaft lengths of 90cm, receives FDA easy and accurate deploy- The distal diameter of 130cm and 180cm and approval for ment and compatibility the ipsilateral side varies catheter lengths ranging aorto-uni-iliac with contralateral iliac from 12 to 22mm and from 20mm to 120mm Endurant II limbs and aortic exten- from 12 to 24mm for the for balloon diameters Medtronic has expanded sions for ultimate patient contralateral leg. 2–7mm, with a 150mm its portfolio of products applicability. Jotec has launched an catheter also available for endovascular aortic The Sentrant Intro- additional main body of on balloon diameters repair in the United States ducer Sheath is specially 130mm length with either 2–3.5mm. with two new medical designed for use with the 50mm or 70mm trunk The new device devices: the company has Endurant II AAA and length. This short main complements the exist- recently received approval Valiant Captivia Stent body was achieved by Pacific Plus ing Pacific Xtreme PTA from the FDA for the En- Graft Systems and is also length reduction of the catheter, which is avail- durant II Aorto-Uni-Iliac compatible with competi- ipsilateral leg. It allows able in lengths ranging (AUI) Stent Graft System tive systems. The Sentrant physicians to flexibly aneurysm exclusion. The new peripheral balloon from 150mm to 300mm and the FDA’s 510(k) Introducer Sheath is extend both leg sides with 28mm Heli-FX Guide catheter is underway in for a variety of balloon clearance for the Sentrant inserted at the access site appropriate extensions in is a line extension of the the United States and diameters. Introducer Sheath. in the patient’s femoral order to treat the aneu- original 22mm Heli-FX internationally. The Endurant II AUI artery and advanced rysm in the best possible Guide and facilitates the Indicated for the treat- Ovation stent Stent Graft System is the upwards into the iliac way. According to the precise positioning and ment of narrowed arteries graft is approved only FDA-approved AUI arteries to facilitate the Jotec, all new versions of implantation of the helical in a variety of locations in Canada device in the United States implant procedure and E-vita abdominal XT are EndoAnchors in aortic within the vasculature, TriVascular announced on indicated for the primary enable smooth passage already CE marked and necks up to 32mm in including the renal, iliac, 6 August 2013 approval endovascular treatment of the stent graft delivery available. diameter. iliofemoral, femoral, pop- from Health Canada of of infrarenal abdominal system en route to the “The longer reach liteal and infrapopliteal the Ovation Abdominal aortic or aorto-iliac aneu- treatment site in the aorta. Heli-FX line 28mm guide gives physi- arteries, the Pacific Plus Stent Graft System. The rysms in patients whose The Sentrant Introducer extension cians a greater ability PTA catheter epitomises ultra-low profile system, anatomy does not allow Sheath can accommodate receives FDA to implant anchors and versatility. It features a with novel O-ring sealing for the use of a bifurcated a wide range of anato- clearance improve the long term hydrophilic coating for technology, expands the device. mies, with diameters of Aptus Endosystems an- durability of EVAR. This improved crossability, patient population suitable Whereas use of the 12–26F and shaft lengths nounced on 28 May that it will be a useful addition and enables fast defla- for endovascular aortic re- bifurcated device requires of 28cm. Other distin- has received 510(k) clear- to the Heli-FX system tion, which may shorten pair (EVAR) by address- access to both iliac guishing features of the ance from the FDA for its especially when treating procedure time. ing a wider range of dis- arteries, the AUI device accessory device include 28mm Tip Reach Heli-FX difficult aortic anatomy,” “Vascular specialists eased anatomy, according requires access to only optimal seal for superior Guide. A line extension said William P Jordan, have been eagerly await- to the company. Delivered one iliac artery. In pub- haemostasis, reinforced of the original Heli-FX chief, Section of Vascular ing the Pacific Plus PTA through a 14F (4.7mm) lished studies of endo- coil for kink resistance, System, the new product Surgery at the Univer- catheter,” said Juan Pablo outer diameter catheter, vascular abdominal aortic hydrophilic coating and enhances treatment of sity of Alabama Hospital, Zambrano, director of the Ovation device is the aneurysm repair, current flexibility for easy track- wide neck abdominal Birmingham, USA. cardiovascular medicine lowest profile commer- global usage of AUI stent ing through tortuous and aortic aneurysms. at Jackson South Commu- cially available system for graft configurations aver- calcified iliacs and a dila- The Heli-FX system New Pacific nity Hospital in Miami, EVAR. In a 161-patient, ages 5% (range 0–26%) tor locking mechanism for can be used during pri- Plus peripheral USA. “The device’s ease global clinical study, the for intact aneurysm and secure positioning. mary EVAR procedures angioplasty of deliverability and vari- Ovation system demon- 39% (range 0–91%) for The Sentrant Introducer to enhance an endograft’s balloon gets FDA ous shaft lengths provide Continued on page 43 ruptured aneurysms. Sheath received the CE inherent fixation and clearance and the us with a flexible solution “The new Endurant mark in April 2013. sealing mechanisms. CE mark for both straightforward II Aorto-Uni-Iliac Stent According to Aptus, Medtronic announced and complex cases.” Graft extends the proven E-vita abdominal doing so can potentially on 4 June 2013 that the Spanning a broad size performance of the Endur- XT new stent graft improve the long-term Pacific Plus percutane- matrix, the Pacific Plus ant System to patients version available durability of the aneurysm ous transluminal an- PTA catheter is an with difficult access,” said Jotec has recently re- repair. The system can gioplasty (PTA) catheter Michel Makaroun, chief ceived the CE mark for its also repair endovascular has received both FDA of vascular surgery at the updated stent graft system grafts that have developed clearance and the CE University of Pittsburgh E-vita abdominal XT. Ac- endoleaks, migrated away mark. The launch of the Medical Center and co-di- cording to the company, from the implant site, or rector of the UPMC Heart the modified system offers are at risk of developing and Vascular Institute, latest catheter technology these complications. In USA. “By maintaining the with excellent properties such cases, augmented deliverability, conform- and has already clini- fixation and/or sealing ability and deployment cally proven superiority is required to regain or accuracy of the bifurcated compared to the previous maintain effective Endurant device, the AUI system. configuration offers E-vita abdominal XT aneurysm patients with features a modular stent challenging outflow anato- graft design consisting of mies a better option for a four different modules: successful endovascular main body, contralat- aortic repair.” eral leg, iliac and aortic As with the bifurcated extension. The main body Endurant II Stent Graft, is available in diameters distinguishing features of from 24 to 34mm with the Endurant II AUI Stent different covered length of Graft include a low deliv- 150 and 170mm and trunk E-vita abdominal XT

Continued from page 40 September 2013 Market watch 43

The Aorflex delivery China, recently performed tion across the aortic arch system has been commer- the initial implants of safely and less invasively. cially available in Europe a branched stent graft Product News since April 2012 and has system (Microport). Cordis announces received positive feedback The use of the system additional sizes from clinicians. Aorflex marks, according to a of Sleek over-the- Continued from page 40 safely expand the pool of nounced on 21 June that offers a range of clinical press release, the world’s wire platform strated excellent safety patients to whom we can the Aorflex delivery benefits over the original first-in-human multicentre On 24 June 2013, Cordis and effectiveness results. offer EVAR,” commented system has been approved delivery system aimed clinical trial of the Cas- announced the European Prior to Health Canada Randolph P Guzman, head for commercial use in the at improving the overall tor branched stent graft, CE marking and FDA approval, the Ovation and professor of Surgery, USA by the FDA. The ease of use of the Aorfix which is expected to be approval of additional Abdominal Stent Graft Section of Vascular Sur- Aorflex delivery system is stent graft, including carried out at 11 centres in sizes of its Sleek over- System was used to treat gery, University of Mani- the company’s next gen- smoother introduction of China. the-wire (OTW) platform, 20 patients in Canada toba, Canada. His team eration delivery system the delivery system into Jing Zaiping, the a 0.014 inch ultra-low under Health Canada’s recently performed the for its Aorfix stent graft, blood vessels through the study’s primary investi- profile percutaneous Special Access Program. first post-approval cases which was approved by use of a hydrophilic coat- gator, according to the transluminal angioplasty The Ovation system re- in Canada at St Boniface the FDA in February 2013 ing, greater deployment release, has successfully (PTA) dilatation catheter. ceived premarket approval Hospital in Winnipeg. (along with the previous control with exceptional used the Castor branched The Cordis Sleek OTW from the US Food and “Our experience to date is generation delivery de- one-to-one torque, X-ray aortic stent graft system PTA Dilatation Catheter Drug Administration in encouraging and we look vice) for the endovascular marker to give positional in ten cases as of the end is a highly deliverable October 2012. TriVascular forward to broader use repair of abdominal aortic feedback to physicians, of June. balloon catheter has been actively market- now that Health Canada aneurysms. and reduced deployment Castor is designed for designed to treat patients ing the Ovation system in has approved the Ovation Aorfix is the only forces. the entirely endovascu- undergoing peripheral Europe since late 2010. system,” said Guzman. device licensed in the lar treatment of thoracic angioplasty procedures Since initiating a first-in- TriVascular has signed USA to treat abdominal MicroPort reports dissection encroaching on below the knee. The Sleek man clinical study with an exclusive distribution aortic aneurysms with first-in-human the left subclavian artery OTW catheter was first the Ovation Abdominal agreement with Inter V neck angulations up to implant of or the original tear located launched around the world Stent Graft System in late Medical, a Montreal- 90 degrees. According branched stent within 15mm distal to the in 2011. Cordis will start 2009, TriVascular has based Canadian medical to Lombard, this is a key graft for thoracic left subclavian artery. Ac- commercialising these treated over 2,000 patients products distributor, to advantage over other dissection cording to the company, new sizes immediately in worldwide. commercialise the Ova- currently available stent Vascular specialists at Castor has an easy-for-use various countries. “I believe the Ovation tion Abdominal Stent grafts. The company the 2nd Military Medi- unibody design, includ- According to Cordis, Abdominal Stent graft Graft in Canada. intends to launch Aorfix cal University-Shanghai ing a main body and a left the Sleek OTW catheter system is an important with Aorflex in the USA Hospital, the 2nd Affili- subclavian branch graft. has a unique balance of addition to our clinical FDA approves in H2 2013; a coordinated ated Hospital of Harbin The invention of Cas- excellent pushability with toolkit. The combination next generation launch event will take Medical University, tor branched stent-graft a small crossing profile of a novel sealing technol- Aorflex delivery place at the VEITHsym- Jiangsu Province People’s system makes it possible that helps physicians ogy with a low profile de- system posium in New York in Hospital and Peking Uni- to treat a large number restore blood flow to livery system allows us to Lombard Medical an- November 2013. versity People’s Hospital, of patients with dissec- Continued on page 44 44 Market watch September 2013

launch of its Ebony .035 PTA Balloon Catheter New Generation. Accord- Product News ing to Natec, the device, which is CE marked and 510(k) cleared, is a highly Continued from page 43 es in Europe were ex- exhausted all other access deliverable 0.035- the lower limbs. As pected to be performed in options, such as arterio- inch percutaneous translu- part of the product July 2013. The surgeons venous fistulas and grafts. minal angioplasty catheter line extension, Cordis performing these initial designed for now offers additional cases will establish the FDA clearance for a wide range of lengths of 20mm and first HeRO Graft training Arrow GPSCath peripheral angio- 280mm for most of its centre in Europe, which balloon dilatation plasty proce- current diameters. The will support the com- catheters in dures. new 280mm length will pany’s controlled market higher RBP and enable physicians to treat introduction of the prod- 80cm lengths diffuse disease with fewer uct during the second half Teleflex has announced inflations. The Sleek of 2013, followed by a that its subsidiary OTW catheter continues broader European launch Hotspur Technologies, to be the only peripheral in 2014. The company which Teleflex acquired balloon offering an estimates the European in June 2012, received ultra-low profile 1.25mm market opportunity for the FDA 510(k) clearance Sleek diameter option. The HeRO graft to be approxi- to market the company’s addition of these sizes mately US$30 million. Arrow GPSCath balloon now means that the Cordis “We have received dilatation catheters Sleek OTW platform positive feedback on the in higher rated burst offers physicians the HeRO graft from Europe- pressure (RBP) and 80cm broadest 0.014 over-the- an physicians at medical lengths. These novel wire catheter portfolio on meetings in Europe and products enable multiple the market. the United States,” noted vascular procedures “The Sleek OTW Steven G Anderson, chair- to be performed with catheter has enabled me to man, president and CEO one dual-function The device, Natec said, the Lynx catheter comes and endoleak detection. treat patients with severe of CryoLife. “We believe catheter, potentially includes improvements in various options: either According to the chronic limb ischaemia it will be well received in reducing procedure time such as new ProGlide as plain dilation catheter, company, for the first using the angiosome Europe because it is clini- and expense for both hydrophilic coating on as stent delivery system, time it is now possible concept. Now, more cally proven to reduce patients and medical shaft and balloon for or as drug-coated delivery to use ultrasound to than ever, with the new infection rates by 69% professionals. minimal friction and platform. generate high quality 3D expanded sizes, we will as compared to tunneled The Arrow GPSCath optimal trackability In a press release, images of the stented be able to effectively treat dialysis catheters, which catheter is the first and crossability, and Arthesys said that the Lynx abdominal aorta suitable extremely distal lower is a benefit for patients dual-functional balloon provides a frictional balloon catheter is designed for diagnosis and review. leg peripheral vascular and government pay- dilatation catheter that force decrease of 85%. for below-the-knee applica- “Curefab CS 3.0 disease using fewer ers. Following the initial combines angioplasty In addition, the device tion, to cross the most dif- combines the objectivity inflations,” said William European cases, we will and the proprietary features optimum ficult lesions. The company and easy interpretation Wu, Heart and Vascular gradually train physicians VisioValve Injection deflation time—a gain of added that, on top of this, of CT angiography Clinic of San Antonio, and roll out the product to System. This innovative 16% versus competition, the catheter hypotube has with the quick and USA. “I look forward to additional centres in order combination enables according to the been designed with unique safe application continue working with to ensure positive clini- physicians to perform company. pushability and comes with of sonography, Cordis as they bring more cal outcomes ahead of a high-pressure angioplasty Natec said the device an extremely high kink revolutionising EVAR products to market that broader launch in 2014. and inject physician- is a unique six-fold resistance. “Hydrophilic aftercare,” said Sebastian will help provide safe We will also evaluate our specified fluids, such balloon, with extremely coating comes in various Wittmeier, managing and optimal outcomes for early HeRO graft experi- as contrast, all while low profile and excellent options, allowing optimal director of Curefab. patients.” ence in Europe, which maintaining the guidewire re-wrapping. trackability to reach and “We are providing we expect will further position. cross stenosis even more a real alternative to CryoLife receives demonstrate the clinical Arthesys renews effectively. Lynx RX is the CT angiography, and the CE mark for utility of the product.” Natec launches CE mark for its reference catheter to cross furthermore giving HeRo graft The HeRO graft new generation peripheral Lynx the tightest lesions,” the patients with high CryoLife announced on received its initial FDA of the Ebony .035 RX PTA catheter company said. creatinine levels the 10 June 2013 achieve- 510(k) clearance in 2008 PTA catheter Arthesys has announced The Lynx balloon is chance for a regular ment of a CE mark for and initial CE mark Natec Medical has the renewal of the CE available in diameters follow-up.” the HeRO (Hemodialysis approval in 2011. It is announced the global mark of its Lynx RX PTA 2–7mm, and lengths Curefab CS has a wide Reliable Outflow) Graft indicated for catheter peripheral balloon catheter. 8–200mm. range of applications for system produced at the dependent end-stage re- According to the company, Arthesys noted that vascular imaging. Beside company’s new manufac- nal disease patients all these variables allow its focus on EVAR fol- turing facility in Atlanta, on long-term for special catheter low-up, its core uses are USA. The HeRO Graft is haemodialy- customisation and unique plaque analysis, carotid a proprietary graft-based sis who designs for each of artery stenosis graduation solution for end-stage re- have Arthesys unique OEM and imaging of peripheral nal disease haemodialysis clients. arteries and catheter ac- patients with limited ac- cess pathways. cess options and central Curefab Curefab CS is venous stenosis. introduces new CE certified and a The first EVAR follow-up demonstration of the HeRO graft solution upcoming product line clinical GPS Catheter Curefab has announced will be on display at cas- that version 3.0 of its the Annual Meeting of computed sonography the European Society for line provides a Vascular Surgery (18–21 comprehensive solution September) in Budapest, for EVAR follow-up Hungary.

46 Companies September 2013

EkoSonic Endovascular manufacturing know- System (EkoSonic), a dif- how; Vascular News ferentiated interventional „„Potential revenue team Industry News product using a locore- benefits from a shared gional approach in the customer base with treatment of severe blood BTG’s Interventional Editor-in-chief: Biosensors will A Biosensors press BTG announces clots. EkoSonic is cleared Medicine and Specialty Roger Greenhalgh market drug- release reported that acquisition of for use in the USA and EU. Pharmaceuticals field eluting balloons the agreement involves EKOS According to BTG, forces; Publisher: manufactured by three of of Biosensors- BTG announced in May the rationale for the „„Enhancement of the Stephen Greenhalgh Eurocor branded paclitaxel-eluting that it has entered into an acquisition of EKOS and planned Varisolve (PEM) Head of Publishing: Biosensors has entered balloons: BioStream, agreement to buy EKOS the EkoSonic product was: vein clinic field force Marcio Brito into a licensing agreement BioPath 014, and BioPath Corporation (EKOS), a „„Complementary by accessing in-hospital with Eurocor for its drug- 035. All three devices “fast growing and profitable transaction in line with interventional physicians Editor: eluting balloon technology are drug-eluting balloon interventional vascular BTG’s strategy of grow- and vascular surgeons Marcio Brito and related intellectual dilatation catheters business” on a debt-free ing its interventional who carry out varicose [email protected] property rights in relation designed for percutaneous cash-free basis for an medicine business; vein procedures through to the treatment of both transluminal angioplasty. initial cash consideration „„Significant addressable EKOS’s existing sales Assistant editor: coronary and peripheral BioStream has been of approximately US$180 market opportunity in a force; Frances Carson arterial disease. As a first developed for use in million (£120 million) and growing treatment area; „„Attractive financial im- step in this process, Bio- coronary arteries, while up to US$40 million (£27 „„Differentiated technolo- pact with an estimated Editorial contribution: Urmila Doraswami sensors will market and the other two devices have million) in future milestone gy protected by granted ROI in line with BTG’s sell, under its own brand, been optimised for the payments. patents through 2022 target for this type of Design: drug-eluting balloons treatment of patients with EKOS owns, manufac- with additional filings acquisition of 15% to David Reekie manufactured by Eurocor. peripheral arterial disease. tures and distributes the to 2030 and extensive 20% in year five. Layout: Matt Hadfield

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