Guidelines for Peripheral and Visceral Vascular Embolization Training

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Guidelines for Peripheral and Visceral Vascular Embolization Training Joint Writing Groups of the Standards of Practice Committees for the Society of Interventional Radiology (SIR), Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and Canadian Interventional Radiology Association (CIRA)

Jafar Golzarian, MD, Marc R. Sapoval, MD, PhD, Sanjoy Kundu, MD, David W. Hunter, MD, Elias N. Brountzos, MD, Jean-Francois H. Geschwind, MD, Timothy P. Murphy, MD, James B. Spies, MD, Michael J. Wallace, MD, Thierry de Baere, MD, and John F. Cardella, MD

J Vasc Interv Radiol 2010; 21:436–441

EMBOLOTHERAPY or embolization 1. Vascular malformations: occlusion 3. Trauma: for control of dramatic hem- has rapidly developed in recent years of congenital or acquired aneu- orrhage, for example, related to and now represents an integral part of rysms (cerebral, visceral, extremi- splenic laceration or pelvic fractures. interventional radiology practice. Em- ties), pseudoaneurysms, vascular 4. Uterine artery embolization: devascu- bolotherapy is defined as the percuta- malformations, or other vascular larization of benign uterine leiomyo- neous endovascular application of one abnormalities that have potential mas and adenomyosis for symptom or more of a variety of agents or ma- to cause adverse health effects (1–18). alleviation or to reduce operative terials to accomplish vascular occlu- 2. Nontraumatic hemorrhage: treat- blood loss (3,4,14,54–57). sion. ment of acute or recurrent hem- 5. Oncologic embolization: to relieve Embolotherapy has evolved since its orrhage (eg, hemoptysis, gastro- symptoms, prevent or treat hem- clinical introduction to include a wide intestinal bleeding, postpartum orrhage, reduce operative blood loss, or improve survival and variety of applications that can be and iatrogenic hemorrhage, and quality of life (3,4,14,54–57). Ex- grouped into the following categories: hemorrhagic neoplasms) (18–53). amples include primary and secondary hepatic malignancies, renal cell carcinoma, and primary and secondary bone malignancies. 6. Tissue ablation: ablation of be- From the Division of Interventional Radiology and France; and Department of Radiology (J.F.C.), Geis- nign neoplastic and nonneoplas- Vascular Imaging, Department of Radiology (J.G., inger Health System, Danville, Pennsylvania. Re- tic tissue that produces adverse D.W.H.), University of Minnesota, Minneapolis, ceived December 19, 2009; final revision received health effects to the patient (eg, Minnesota; Department of Cardiovascular Radiol- January 18, 2010; accepted January 19, 2010. Address ogy (M.R.S.), Hôpital Européen Georges Pompidou, correspondence to J.G., c/o Debbie Katsarelis, SIR, hypersplenism, refractory reno- Paris, France; Department of Medical Imaging (S.K.), 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033; vascular hypertension, untreat- Scarborough General Hospital, Richmond Hill, On- E-mail: [email protected] able urine leak, proteinuria in tario, Canada; Second Department of Radiology end-stage kidney disease, renal (E.N.B.), Athens University Medical School, Attikon J.F.H.G. is a paid consultant for Bayer, Gideon, MDS University Hospital, Athens, Greece; Division of Nordion (Kanata, Ontario, Canada), Terumo (Somer- angiomyolipoma, varicocele, pel- Vascular and Interventional Radiology, Russell H. set, New Jersey), Biosphere Medical (Rockland, Mas- vic congestion syndrome, pria- Morgan Department of Radiology and Radiological sachusetts), and BioCompatibles (Surrey, United King- pism, and abdominal pregnancy) dom) and has research funded by Genentech (South Sciences (J.F.H.G.), Johns Hopkins Hospital, Balti- (9,10,14,16,58–68). more, Maryland; Division of Vascular and Interven- San Francisco, California), Boston Scientific (Natick, tional Radiology, Department of Diagnostic Imaging Massachusetts), Biosphere Medical, Philips, Bayer, 7. Flow redistribution: to protect normal (T.P.M.), Rhode Island Hospital, Providence, Rhode Gideon, and Biocompatibles. T.P.M. is an owner of, or tissue (eg, gastroduodenal artery and Island; Department of Radiology (J.B.S.), George- shareholder in, Sentient Bioscience (Providence, right gastric artery embolization in town University Medical Center, Washington, DC; Rhode Island). None of the other authors have identi- fied a conflict of interest. hepatic artery chemoembolization Department of Diagnostic Radiology (M.J.W.), The and radioembolization, or proxi- University of Texas M. D. Anderson Cancer Center, © SIR, 2010 Houston, Texas; Department of Interventional Radi- mal superior gluteal artery coil ology (T.d.B.), Institut Gustave Roussy, Villejuif, DOI: 10.1016/j.jvir.2010.01.006 embolization during particle em-

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bolization of the anterior division accredited training pathways to achieve clude the use of microcatheters for of the internal iliac artery for tu- the necessary education to perform subselective catheterization and the mor devascularization) (30,69)or embolization procedures in the body handling and delivery of particulate to facilitate subsequent other treat- is through the Accreditation Council agents and embolization coils. The use ments (eg, right portal vein embo- of Graduate Medical Education–ac- of embolic agents beyond those de- lization to induce left lobe hyper- credited fellowship programs in vas- scribed as “basic” may require addi- trophy before surgical resection) cular and interventional radiology or tional training and proctoring as stip- (70–71). its international equivalent. It is recog- ulated by the manufacturer or by the 8. Endoleak management: including nized that embolization requires a appropriate governing body. Conse- direct sac puncture or collateral skill set only available through such quences of inadequate training or ex- vessel embolization for endoleaks rigorous and comprehensive Ameri- perience can lead to major adverse (72–76). can Board of Medical Specialties–ac- events if the disease or imaging and 9. Regional therapy delivery: vehicle credited medical imaging and inter- embolization techniques are not fully for delivery of drugs or other agents vention training or its international understood by the operator. These ad- that may include oncolytic viruses, equivalent. The 1-year duration of verse events could include nontarget ␤ chemotherapy, -emitting spheres, training is the minimum for attaining embolization that can result in major or other agents used to treat an or- competency in embolization catheter- morbidity depending on the territory gan or specific target lesion. ization techniques and to acquire suf- treated (eg, stroke or blindness for ep- 10. Enterocutaneous tracts and lym- ficient knowledge of the spectrum of istaxis embolization, bowel or bladder phatic abnormalities: embolizing ab- diseases that can be served by embo- infarction for uterine artery emboliza- normal communications between or- lization, including the natural history tion). gans, from cavities or organs to the and risk–benefit analyses associated The clinical relationship between a skin surface, thoracic duct leaks, with provision of the procedures; patient who needs an embolization lymphedema. training on specific aspects of the tech- procedure and an interventional radi- nical procedures; and the performance Embolization has grown dramati- ology physician should be structured characteristics in indications for use so that the physician should see every cally in scope and complexity over the for the numerous embolic materials past three decades, and with this patient for a preprocedural clinical available. This comprehensive train- evaluation and consultation before growth, there is now a need to define ing is critical to ensuring that patients treatment and for a postprocedure standards for those practicing in this receive safe and effective care. longitudinal clinical follow-up after field, including: appropriate training It is expected that, as part of the the procedure. Some of the clinical with monitoring of outcomes; provi- accredited training process in diagnos- skills and responsibilities required for sion of pre-, intra-, and postprocedure tic imaging and vascular and interven- patient care particular to embolization patient care; and performance of the tional radiology, the physician will technical aspects of the procedure. have a thorough understanding of procedures include the following: vascular anatomy including congeni- 1. Knowledge of the natural history PHYSICIAN QUALIFICATIONS tal and developmental variants and of the disease; common collateral pathways, angio- 2. Understanding of the risks of the Embolization is a complex and de- graphic equipment, radiation safety procedure given the patient’s spe- manding endovascular image-guided considerations, and physiologic moni- cific presentation and findings; intervention requiring all of the skills toring equipment. Moreover, it is an- 3. Review of all available diagnostic of the interventional radiologist. Inter- ticipated that, before the performance imaging tests; pretation of diagnostic imaging tests is of any embolization procedure, the 4. Knowledge of the acute tumor ly- integral to performance of emboliza- operator will have received specific sis syndrome; tion procedures. The interventional ra- training, including didactic training as 5. Treatment of the postembolization diologist who performs embolization well as hands-on training with a suffi- syndrome; must be competent in diagnostic im- cient number of procedures in each of 6. Use of relevant medications in- age interpretation with all modalities the areas or vascular territories that cluding pain medications; of diagnostic imaging including com- may be served routinely by emboliza- 7. Hydration; puted tomography (CT), ultrasound tion (ie, vascular malformations, non- 8. Treatment failure and potential sub- (US), magnetic resonance (MR) imag- traumatic hemorrhage, trauma embo- sequent interventions; ing, fluoroscopy, and radiography. lization, benign tumor embolization, 9. Staging embolization; and This is demonstrated by the comple- malignant tumor embolization, tissue 10. Clinical follow-up. tion of an Accreditation Council of ablation, flow redistribution, endoleak Graduate Medical Education–accred- embolization, regional therapy deliv- Angiographic and Interventional ited radiology residency or its equiva- ery, and enterocutaneous and lym- Skills and Knowledge of Embolic lent or an international equivalent. phatic management). In addition, they Materials Training in interventional radiol- must have access to an adequate sup- ogy following completion of a diag- ply of catheters, guide wires, embolic According to the requirements of nostic imaging residency demonstrat- agents, and personnel to perform the American College of Radiology, the ing essential competency in imaging procedures safely. Techniques that operating physician must be capable interpretation is mandatory. The only should be mastered during training in- of accomplishing, with documented 438 • Guidelines for Peripheral/Visceral Vascular Embolization Training April 2010 JVIR and acceptable success and complica- high-flow arteriovenous fistulas re- diation exposure to the patient and the tion rates, each aspect of embolization quire careful sizing of metallic occlu- staff. This training includes not only the procedures, including: sion devices, knowledge of techniques knowledge of radiology physics but also of packing, and knowledge of tech- practical training in radiation protection 1. Percutaneous arterial access; niques to control the delivery of the such as is provided during interven- 2. Manipulation of catheters to selec- devices to prevent paradoxic emboli- tional radiology training (82,83). tively access the target vessel and zation. Techniques of preparation and Physicians, medical physicists, and appropriate use of catheters and injection of liquid and particulate agents radiology technologists have a respon- microcatheters; are very important. For instance, re- sibility to minimize the radiation dose 3. Understanding and handling of mate- cent studies have demonstrated that to patients, staff, and society as a rials used in embolization, including the degree of dilution of embolic par- whole, while maintaining necessary temporary and permanent agents such ticles and the use of the proper tech- image quality. This concept is known as particles, coils, plugs, and occluders; nique for preparation and injection of as “as low as reasonably achievable,” and the particles can significantly affect the or “ALARA” (84). 4. Assessment of the angiographic or technical and clinical success and the In consultation with a medical imaging to determine the therapeu- rate of complications of a procedure physicist, interventional radiology fa- tic endpoint. (77,78). Inappropriate preparation or cilities should adhere to the policies There is a wide variety of embolic injection of liquid embolic agents can and procedures of ALARA. Examina- agents and materials that need to be be a major cause of nontarget emboli- tion protocols should take into ac- mastered by the physician performing zation. Poor preparation technique count patient body habitus and use the embolization procedures. During a and inappropriate dilution can dam- dose reduction devices and techniques single embolization procedure, the in- age embolic materials or create condi- to control radiation dose while main- terventional radiologist frequently uses tions that allow them to clump, which taining image quality. To ensure dose a combination of embolic materials can result in clogging of the catheter or optimization and radiation protection lodging in the incorrect size or loca- of the staff and the patient, the angio- to obtain the optimal occlusion of a tion vessel within the vascular tree, graphic suite should at least be able to vessel and optimal clinical result. resulting in incomplete or nontarget offer additional tube filtration, pulsed Specific knowledge of the following embolization. It is equally important fluoroscopy, last image hold, and fade characteristics of embolic materials is to employ the proper technique of in- in/fade out fluoroscopy. Flat-screen required: the desired duration of oc- jection. Forceful injection is frequently digital panels provide another excel- clusion; the size and shape of the tar- associated with vessel damage, non- lent option, as magnification can be get vessel; the mechanism of occlusion; target embolization, clinical failure, achieved without an increase in dose. the understanding of flow changes and and complications (79). Patient radiation doses should be distribution before, during, and after Knowledge of vascular anatomy, recorded in the medical record for all embolization; and the mechanical and collateral pathways, possible anatomic embolization procedures and should biologic interaction of the embolic ma- variants, and the locations where one be periodically reviewed by a medical terials with the vessel wall and the may encounter small anastomoses that physicist as recommended by the ap- target end organ. are not seen during angiography (also propriate professional organizations Of all the clinical considerations in called “invisible arterial anastomo- (85,86). an embolization procedure, the main ses”) are essential. This requires famil- factors influencing the selection of a iarity with a variety of vascular beds, IMAGING AND specific embolic agent relate to the size as the propensity for downstream tis- of the vessel, the speed of flow in the INTERVENTIONAL sue infarction or distal vascular recon- TECHNOLOGY vessel, the desired level of occlusion in stitution is usually very organ-specific. the vascular tree, and the desired du- Anastomoses between arterial beds Embolization is an image-intensive in- ration of occlusion. For example, when can be the cause of significant compli- tervention. The angiography suite, at a dealing with traumatic bleeding ver- cations if they are not appreciated (80), minimum, should have equipment that, sus hemorrhage caused by a hypervas- if an improper technique of injection is independent of the patient’s weight, can cular tumor, the therapeutic goal, the used, or if an inappropriate type or offer high field of view magnification, the vascular anatomy, the size of vessels size of embolic agent is used. possibility of prolonged fluoroscopy time, involved, and the level of occlusion and high spatial resolution and contrast will all be different and lead to a com- Radiation Safety Training resolution to be able to visualize micro- pletely different selection of embolic catheters, fine 0.010-inch microwires, materials. It is important to note that Complex embolization procedures 2-mm coils, small arteriovenous shunts the level of occlusion, which is primar- require prolonged exposure to radia- and fistulas, and contrast agent reflux. ily determined by the size of the agent, tion to the patient and operator. This Availability of high-quality fluoroscopy can also be affected by the occurrence frequently occurs in regions where and digital subtraction angiograms of “clumping” when using particulate there are radiation-sensitive organs cannot be overemphasized. Mobile agents. such as the lens of the eyes, thyroid, C-arm units do not provide adequate Specific clinical problems can re- breast, or gonads (81). The operator image quality or advanced capabili- quire even more detailed knowledge needs to be cognizant of that risk and ties available in dedicated angiogra- of occlusion devices. For instance, be trained in techniques to reduce ra- phy suites and therefore should not Volume 21 Number 4 Golzarian et al • 439

be used for these interventions. Ad- quality oversight committee regularly Am J Obstet Gynecol 1988; 159:1153– vanced imaging technologies avail- for evaluation. 1160. able in “modern” or state-of-the-art 10. Abbas FM, Currie JL, Mitchell S, Oster- angiography units include roadmap- man F, Rosenshein NB, Horowitz IR. Acknowledgments: Dr. Jafar Golzarian ping, overlay technology, filtration Selective vascular embolization in be- authored the first draft of this document and collimation, semitransparent fil- nign gynecologic conditions. J Reprod and served as topic leader during the sub- Med 1994; 39:492–496. ters, replay, rotational angiography, sequent revisions of the draft. Dr. Sanjoy 11. Komoda K, Hujii Y, Nakajima T, et al. and in some cases, cone-beam CT. Kundu is chair of the SIR Standards of A ruptured thymic branch aneurysm Angiographic CT or rotational sub- Practice Committee. Dr. John F. 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