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Treatment of Lower Extremity Superficial Venous Insufficiency with Endovenous Thermal Ablation

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Treatment of Lower Extremity Superficial Venous Insufficiency with Endovenous Thermal Ablation Multi-society Consensus Quality Improvement Guidelines for the Treatment of Lower- extremity Superficial Venous Insufficiency with Endovenous Thermal Ablation from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Canadian Interventional Radiology Association Neil M. Khilnani, MD, Clement J. Grassi, MD, Sanjoy Kundu, MD, FRCPC, Horacio R. D’Agostino, MD, Arshad Ahmed Khan, MD, J. Kevin McGraw, MD, Donald L. Miller, MD, Steven F. Millward, MD, Robert B. Osnis, MD, Darren Postoak, MD, Cindy Kaiser Saiter, NP, Marc S. Schwartzberg, MD, Timothy L. Swan, MD, Suresh Vedantham, MD, Bret N. Wiechmann, MD, Laura Crocetti, MD, John F. Cardella, MD, and Robert J. Min, MD, for the Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Society of Interventional Radiology Standards of Practice Committees J Vasc Interv Radiol 2010; 21:14–31 Abbreviations: CEAP ϭ clinical status, etiology, anatomy, and pathophysiology [classification], CVD ϭ chronic venous disorder, DVT ϭ deep vein thrombosis, EVTA ϭ endovenous thermal ablation, GSV ϭ great saphenous vein, HL/S ϭ high ligation and stripping, RF ϭ radiofrequency, SSV ϭ small saphenous vein, SF-36 ϭ Short Form–36, SFJ ϭ saphenofemoral junction, SPJ ϭ saphenopopliteal junction, SVI ϭ superficial venous insufficiency, VCSS ϭ venous clinical sever- ity score, VSS ϭ venous severity score PREAMBLE and subsequent major disability. Ve- for incompetence in these veins was to nous hypertension caused by incom- remove them. Endovenous thermal LOWER-extremity chronic venous dis- petent valves in the superficial veins is ablation (EVTA) of the saphenous order (CVD) is a heterogeneous medical by far the most common cause of this veins has been used by physicians condition whose spectrum ranges from condition. The incompetent valves are since the late 1990s as an alternative to visually apparent abnormalities includ- most often found in the great saphe- surgical removal. This document will ing varicose veins and spider telangiec- nous vein (GSV) or small saphenous review the appropriate means by tasias with or without associated symp- vein (SSV) or in their tributaries. Until which the ablative techniques are to be toms to severe edema, skin ulceration, recently, the main treatment strategy used to maximize benefit and mini- From Cornell Vascular (N.M.K.) and the Depart- Medical Center, Bethesda, Maryland; Department of 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033; ment of Radiology (R.J.M.), New York Presbyterian Interventional Radiology (J.K.M.), Riverside Meth- E-mail: [email protected] Hospital–Weill Cornell Medical Center, New York, odist Hospital, Columbus, Ohio; RADIA (R.B.O.), New York; Department of Radiology (C.J.G.), Lahey Everett, Washington; Vascular and Interventional None of the authors have identified a conflict of Clinic Medical Center, Burlington; Department of Radiology (D.P.), University of Florida; Vascular interest. Radiology (J.F.C.), Baystate Health System, Spring- and Interventional Physicians (B.N.W.), Gainesville; This document was prepared by the standards com- field, Massachusetts; The Vein Institute of Toronto Radiology Associates (C.K.S.), Pensacola; Radiology mittee of the Society of Interventional Radiology (S.K.), Toronto; Department of Radiology (S.F.M.), Associates of Central Florida (M.S.S.), Leesburg, (SIR). After completion, the document was pre- University of Western Ontario, London; Depart- Florida; Department of Radiology (T.L.S.), Marsh- sented to the Cardiovascular and Interventional Ra- ment of Radiology (S.F.M.), Peterborough Regional field Clinic, Marshfield, Wisconsin; Department of diological Society of Europe and American College Health Centre, Peterborough, Ontario, Canada; De- Radiology (S.V.), Mallinckrodt Institute of Radiol- of Phlebology, which made recommendations and partment of Radiology (H.R.D.), Louisiana State ogy, Washington University School of Medicine, St. offered their endorsement for this standard of prac- University Health Sciences Center, Shreveport, Louis, Missouri; University Division of Diagnostic tice position statement. Louisiana; Department of Interventional Radiology Imaging/Intervention, Department of Hepatology/ (A.A.K.), Washington Hospital Center; Department Liver Transplantation (L.C.), Cisanello Hospital, of Radiology and Radiologic Sciences (D.L.M.), Uni- Pisa, Italy. Received December 18, 2008; final revi- © SIR, 2010 formed Services University of the Health Sciences; sion received and accepted January 5, 2009. Address Department of Radiology (D.L.M.), National Naval correspondence to N.M.K., c/o Debbie Katsarelis, DOI: 10.1016/j.jvir.2009.01.034 14 Volume 21 Number 1 Khilnani et al • 15 mize risk of complication for the pa- ments are discussed by the Standards of and proof-of-concept–type publications. tients on whom they are employed. Practice Committee members and appro- In evaluating the existing publications, The membership of the Society of In- priate revisions are made to create the fin- several major limitations are evident: terventional Radiology (SIR) Standards ished Standards document. Before its (i) extreme variation in definitions of of Practice Committee represents ex- publication, the document is endorsed by short-term efficacy and of complica- perts in a broad spectrum of interven- the SIR Executive Council. tions; (ii) reliance on surrogate measures tional procedures from both the private The current guidelines are written to of treatment success instead of scientifi- and academic sectors of medicine. Gen- be used in quality improvement pro- cally rigorous assessment of clinically erally, Standards of Practice Committee grams to assess thermal ablation of meaningful outcomes; and (iii) absence members dedicate the vast majority of lower-extremity superficial venous insuf- of systematic assessment of long-term their professional time to performing in- ficiency (SVI). The most important ele- efficacy. terventional procedures; as such they ments of care are (i) pretreatment evalua- The SIR recognizes the potential pit- represent a valid broad expert constitu- tion and patient selection, (ii) performance falls of developing evidence-based ency of the subject matter under consid- of the procedure, and (iii) postprocedural EVTA standards and of making recom- eration for standards production. follow-up care. The outcome measures or mendations regarding the use of these Technical documents specifying the indicators for these processes are indica- devices. exact consensus and literature review tions, success rates, and complication methodologies as well as the institu- rates. Although practicing physicians tional affiliations and professional cre- should strive to achieve perfect outcomes, INTRODUCTION: EVTA OF dentials of the authors of this document in practice all physicians will fall short of TRUNCAL VEIN are available upon request from SIR, ideal outcomes to a variable extent. There- INCOMPETENCE 3975 Fair Ridge Dr., Suite 400 North, fore, in addition to quality improvement Throughout this document, the pro- Fairfax, VA 22033. case reviews conducted after individual cedure under discussion will be referred procedural failures or complications, out- to as EVTA for incompetent truncal (ie, METHODOLOGY come measure thresholds should be used saphenous) veins. This procedure is to assess treatment safety and efficacy in used to ablate incompetent truncal veins SIR creates its Standards of Practice ongoing quality improvement programs. in patients with SVI. The underlying documents with use of the following For the purpose of these guidelines, a mechanism of this procedure is to de- process. Standards documents of rele- threshold is a specific level of an indicator liver sufficient thermal energy to the vance and timeliness are conceptualized that, when reached or crossed, should wall of an incompetent vein segment to by the Standards of Practice Committee prompt a review of departmental policies produce irreversible occlusion, fibrosis, members. A recognized expert is iden- and procedures to determine causes and and ultimately resorption of the vein. tified to serve as the principal author, to implement changes, if necessary. The currently available devices used to with additional authors assigned de- Thresholds may vary from those listed accomplish this have been evaluated pending on the project’s magnitude. An here; for example, patient referral patterns in-depth literature search is performed and selection factors may dictate a differ- and approved by the Food and Drug with use of electronic medical literature ent threshold value for a particular indi- Administration of the United States and databases. A critical review of peer- cator at a particular institution. The value use radiofrequency (RF) or laser energy reviewed articles is performed with re- of thresholds is the establishment of a (of a variety of different wavelengths) to gard to the study methodology, results, benchmark that can take into account deliver the required thermal dose. The and conclusions. The qualitative weight both operator experience and complexity thermal energy is delivered by a RF of these articles is assembled into an of the case. Therefore, setting universal catheter or a laser fiber inserted into the evidence table, which is used to write thresholds is very difficult and each de- venous system, either by percutaneous the document such that it contains evi- partment is urged to adjust
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