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 the thresholds access or by open venotomy. The proce- dence-based data with respect to con- as needed to higher or lower values to dure is generally performed on an am- tent, rates, and thresholds. When the ev- meet its specific quality improvement bulatory basis with local anesthetic and idence of literature is weak, conflicting, program situation. typically requires no sedation. The pa- or contradictory, consensus for the pa- The SIR is committed to the basic tients are fully ambulatory following rameter is reached by a minimum of 12 principles of outcomes-focused, evi- treatment and the recovery time is short. Standards of Practice Committee mem- dence-based medicine. Ideally, every These guidelines are intended for use bers with use of a modified Delphi con- Standards of Practice Committee recom- in quality improvement programs that as- sensus method. For the purpose of these mendation would be based on evidence sess EVTA to insure the standard of care documents, consensus is defined as 80% derived from multiple prospective ran- expected of all physicians who perform participant agreement on a value or pa- domized trials of adequate statistical this procedure. The processes to be mon- rameter. power. Unfortunately, there currently itored include (i) patient selection, (ii) per- The draft document is critically re- are only a limited number of small pub- formance of the procedure, and (iii) post- viewed by the Standards of Practice Com- lished randomized trials that evaluate procedural follow-up. Assessment of mittee members in either a telephone con- EVTA in comparison with conventional outcome measures is also desirable, and ference call or face-to-face meeting. The surgery. That is in part because the area these include technical success, complica- revised draft is then sent to the SIR mem- of endovascular venous treatment is in tions, efficacy, and recurrence rates, which bership for further input/criticism during evolution. The majority of the reports in are assigned threshold levels based on the a 30-day comment period. These com- the literature include clinical outcomes currently available data. 16 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

DEFINITIONS Anatomy Superficial veins.—The veins of the lower extremity that are superficial to the fascia surrounding the muscu- lar compartment are considered the superficial veins. These include in- numerable venous tributaries known as collecting veins, as well as the GSV and SSV and their major named tributaries (Fig). Deep veins.—The deep veins are those that are found deep to the muscu- lar fascia. These include the tibial, pero- neal, popliteal, femoral, and iliac veins, as well as the intramuscular sinusoidal and perforating veins. GSV.—An important component of the superficial venous system, the GSV begins on the dorsum of the foot and as- cends along the medial aspect of the leg to ultimately drain into the femoral vein near the groin crease. This vein resides in Figure. Superficial truncal veins of the lower extremity. a space deep to the superficial and super- ficial to the deep fascia. This location is Usually, this is from the foot toward the common causes. Venous obstruction is known as the saphenous space. The word heart and from the skin toward the mus- the most common of these other causes “great” replaces “greater” or “long” by cles. When the valves fail, blood can of CVD and is almost always the result international consensus (1,2; Fig). flow retrogradely, and such flow is de- of prior deep vein thrombosis (DVT). It SSV.—Another important superfi- fined as reflux. Clinically significant re- is initially an obstructive disease but cial vein, the SSV begins on the lat- flux in truncal veins lasts for greater usually progresses to a combination of eral aspect of the foot and ascends up than 0.5–1.0 seconds following release of obstruction and superficial and deep re- the midline of the calf. In as many as compression on the muscular mass be- flux (7). Reflux or outflow vein obstruc- two thirds of cases, it drains into the low the vein itself. tion leads to an increase in pressure in popliteal vein, and in at least one Venous obstruction.—Obstruction of the veins. The veins themselves can di- third of cases more cephalad into the venous segments will impede venous late if unconstrained, and the pressure posterior thigh. The SSV also resides drainage and can lead to venous hyper- causes stretching of receptors in the vein in the saphenous space. The word tension. Thrombosis is the most com- wall that leads to discomfort to the pa- “small” replaces “lesser” or “short” mon cause of acute venous obstruction. tient. The pressure itself can adversely by international consensus (1,2; Fig). Such thrombosis can lead to permanent affect local tissues and metabolic pro- Anterior and posterior accessory GSVs.— occlusion or partial or complete recana- cesses, leading to damage in the vein The anterior and posterior accessory lization with or without valvular incom- wall, the skin, and subcutaneous tissues. GSVs are located in the saphenous petence in that vascular segment. Neovascularization.—“Neovascular- space and travel parallel and anterior or CVD.—CVD is the clinical entity that ization” is a term that describes the pres- posterior to the GSV. The anterior acces- results from chronic venous hyperten- ence of multiple small tortuous connec- sory GSV is much more common (Fig). sion (3). The overwhelming majority of tions between the saphenous stump or Giacomini vein.—This intersaphe- patients with stigmata of venous hyper- the femoral vein and a residual saphe- nous Giacomini vein is a communica- tension have primary (or idiopathic) nous vein or one its patent tributaries tion between the GSV and SSV. It rep- disease of the vein wall with resultant that can occur following surgical liga- resents a form of SSV thigh extension valvular dysfunction in the superficial tion of the saphenofemoral junction that connects the SSV with the posterior veins, which leads to reflux (4). This (SFJ) or less commonly the saphenopo- circumflex vein of the thigh, a posterior subset of CVD is known as SVI. Patho- pliteal junction (SPJ). This is a very com- tributary of the proximal GSV (Fig). physiologically significant reflux in the mon pattern of recurrence following Truncal veins.—This term “truncal GSV or one of its primary tributaries is surgical ligation of the GSV and its trib- veins” refers to the saphenous veins and present in 70%–80% of patients with utary veins near the SFJ and presents as their intrafascial straight primary tribu- CVD. SSV reflux is found in 10%–20% of a tangle of blood vessels in the vicinity taries (Fig). patients and nonsaphenous superficial of the SFJ (8). Disorders reflux is identified in 10%–15% of pa- Clinical status, etiology, anatomy, and tients (5,6). Venous obstruction, deep pathophysiology (CEAP) classification.— Venous reflux.—Veins contain valves vein reflux, muscular pump failure, and “CEAP” is an acronym for a descriptive that direct blood flow in one direction. congenital anomalies are much less classification system that summarizes Volume 21 Number 1 Khilnani et al • 17

jected into a vein to irreversibly occlude of EVTA is defined as patency with or Table 1 without reflux in greater than a 5-cm CEAP Classification it. This is usually done with a syringe and needle, although these medications segment of treated truncal vein beyond Class Description can be injected with a catheter or intra- the junction or initiation of treatment venous cannula. point after EVTA as documented by du- C0 No visible or palpable signs of venous disease Microphlebectomy.—Also known as plex US. Anatomic failure describes sit- C1 Telangiectasias or reticular ambulatory or “stab” phlebectomy, mi- uations when the vein never occludes veins crophlebectomy is a procedure by after ablation or when it is found oc- C2 Varicose veins, distinguished which varicose tributaries are removed cluded on short-term follow-up but re- from reticular veins by a with small hooks through 3–4-mm skin canalizes at some point later. diameter Ն3mm nicks with use of only local anesthetic. Anatomic failure with this definition C3 Edema Duplex ultrasound (US).—Duplex US does not include reflux identified in a C4 Changes in skin and is the most important imaging test to parallel vein such as the anterior acces- subcutaneous tissue investigate patients with CVD. It uses sory GSV after EVTA occlusion of the C4a Eczema, pigmentation (and additionally corona grayscale imaging to visualize the ve- targeted vein. Such reflux was usually phlebectasia) nous anatomy and evaluate patency. present before the EVTA or represents C4b Lipodermatosclerosis or Color and pulse-wave Doppler imag- progression of disease. However, it is atrophie blanche ing is used to investigate direction and recognized anecdotally that disease pro- C5 Healed venous ulcer velocity of blood flow through the gression in a parallel vein can be has- C6 Active venous ulcer veins to identify reflux. Duplex US to tened after successful EVTA if its low- evaluate CVD is much more compli- pressure outflow tributary varicosities cated and time-consuming than to de- are not eliminated. Patency of these tect DVT, as it also involves the anal- veins may induce reflux in the parallel the disease state in a given patient with ysis of segmental competence as well vein that may have been competent and CVD (4,9). The system describes the as patency of all the deep, superficial, previously served as the outflow vein clinical status, etiology, anatomy, and and perforator veins. for the varicosities before EVTA. pathophysiology of the problem. The Tumescent anesthesia.—Tumescent Recanalization.—Recanalization is de- clinical status scale is the most fre- anesthesia refers to the delivery of large fined as the process by which a previ- quently used component, grading pa- volumes of dilute local anesthetic agent ously occluded vein, documented by tients based on physical observations of to cause a large region of anesthesia. duplex US, regains patency. Recanali- disease severity (Table 1). This form of delivery typically causes a zation almost always is the result of an The venous severity score (VSS) is an swelling, leading to the use of the term insufficient thermal dose delivered to additional means of grading the spectrum “tumescent.” Popularized by plastic the vein wall. of disease severity (10). The VSS allows surgeons, this concept has been used in Primary ablation.—Primary ablation more detailed description of the severity the treatment of veins by delivering the denotes anatomic success after initial of attributes of CVD compared with the anesthetic solution perivenously. For treatment. CEAP system. The VSS is the sum of EVTA, the perivenous delivery of this Primary assisted ablation.—Primary scores of the following clinical classifica- solution is optimized by real-time US assisted ablation denotes segmental re- tion systems: Venous Clinical Severity guidance. canalization after initial thermal abla- Score (VCSS), Venous Segmental Disease tion, resulting in anatomic success after Score (VSDS), and Venous Disability Reporting Nomenclature treatment by injection of sclerosant. Score (VDS). The VSS is an important Secondary ablation.—Secondary abla- complement to CEAP in reporting clinical Anatomic success of EVTA.—Ana- tion denotes recanalization after initial success of an intervention. tomic success of EVTA is defined as per- treatment, resulting in anatomic success manent occlusion of the entire treated after treatment by a repeat procedure Treatment Methods vein segment. Duplex US is essential to with the same modality. document the anatomic success of Clinical success.—Clinical success is EVTA.—EVTA refers to the proce- EVTA. In the case of treatment to the defined as an improvement in the clini- dure by which thermal energy is en- SFJ, the segment of vein between the SFJ cal status of a patient as defined by one dovenously delivered to the wall of a and epigastric or other large junctional of the objective assessment instruments, vein with the goal of causing the veins vein usually remains patent. A partially such as the CEAP or VSS classification, to irreversibly occlude and ultimately occluded vein is one with reflux beyond by at least one grade. In practice, most fibrose. It is usually employed to elimi- the junction but with no reflux beyond 5 patients treated with EVTA will also be nate incompetent superficial truncal cm from that point. treated with adjunctive microphlebec- veins responsible for the manifestations Anatomic success.—Anatomic suc- tomy or compression sclerotherapy. It is of SVI. The associated varicose tribu- cess is demonstrated on duplex US fol- generally believed that clinical success tary, reticular veins, and telangiectasias low-up beyond 1 year. A successfully will be dependent on the thoroughness are treated separately with adjunctive treated vein segment will either be oblit- of the adjunctive procedures that are therapies including microphlebectomy erated and difficult to find or will be a performed, as well as the success of the and compression sclerotherapy. thin echogenic structure on duplex US EVTA. Therefore, for the purpose of de- Sclerotherapy.—Sclerotherapy is a and have no flow. fining success, most clinical reviews use procedure by which a medication is in- Anatomic failure.—Anatomic failure anatomic success of EVTA. 18 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

Complications itation Council for Graduate Medical Table 2 Education–recognized (or approved) Paresthesia and dysesthesia.—Pares- Leg Symptoms Associated with thesia and dysesthesia describe the loss postgraduate training program. Chronic Venous Insufficiency or aberration, respectively, of normal Aching sensory perception. Injury to the saphe- PRETREATMENT Throbbing nous or sural nerves adjacent to the GSV ASSESSMENT Heaviness or SSV, respectively, can lead to these Evaluation of the patient before treat- Fatigue sensory disturbances. Pruritus ment in an outpatient setting provides DVT.—DVT is thrombosis in the Night cramps the physician an opportunity to review veins deep to the muscular fascia. Restlessness the patient’s medical history, perform a Superficial thrombobophlebitis.—Super- Generalized pain or discomfort physical examination, and evaluate the ficial thrombobophlebitis refers to Swelling patient’s venous system with Duplex thrombosis in veins superficial to the US. Only after such an examination can muscular fascia. The veins involved the patient and physician engage in a could include the saphenous veins and conversation regarding treatment op- their named tributaries, as well as sub- Manifestations of CVD such as skin hy- tions. Patients with duplex US–docu- cutaneous collecting veins. perpigmentation, corona phlebectasia, mented truncal incompetence have the Arteriovenous fistula.—An abnormal eczema, lipodermatosclerosis, and ul- option of selecting conservative treat- connection directly between an artery ceration should be noted. It is suggested ment of their symptoms with graduated and a vein is an arteriovenous fistula. that a standardized means of clinically compression stockings, EVTA, surgical Such a connection may be created iatro- assessing the severity of the effects of removal of the vein, or sclerotherapy. genically by a penetrating or thermal the chronic venous hypertension, such A complete medical history of the injury during EVTA. as the CEAP scale, be used to document Toxicity related to tumescent anesthe- presenting venous problem, previous one’s findings. In addition, it is sug- therapy and response, history of throm- sia.—Toxicity can develop from the use gested that a written documentation of bosis, comorbidities, medications, aller- of large doses of lidocaine used for the history and clinical and duplex US gies, and any pertinent family history perivenous anesthesia. examination findings be produced for Skin burn.—Thermal injury to the should be obtained from the patient. each patient, including a discussion of skin can occur from extension of the Chronic venous insufficiency causes the impression and clinical recommen- heat delivered into the vein. symptoms in many patients that can im- dations. Photographs of the visible find- pact their quality of life (QOL). These ings are also helpful to document the symptoms are summarized in Table 2. severity and extent of the disease. PHYSICIAN QUALIFICATIONS All these symptoms are worse with All patients with CVD should un- prolonged standing or sitting, improve Duplex US Evaluation dergo a complete clinical and duplex US with ambulation, and are most notice- evaluation before being considered a able at the end of the day. In longstand- Duplex US is essential in all patients candidate for EVTA. This evaluation ing cases, patients may develop skin with CEAP clinical class C2 or higher and subsequent treatment should be damage in the form of eczema, corona CVD to identify reflux and patency and performed by a physician who is appro- phlebectasia, pigmentation, and lipo- establish the pattern of disease to plan priately trained in the care of patients dermatosclerosis, and eventually may treatment. The technique of duplex US with venous disorders. The body of form skin ulceration. A family history for CVD is different than for the evalu- knowledge required by such a physi- searching for a risk of a hypercoagulable ation of lower-extremity thrombosis. cian includes a thorough understanding state should also be obtained. Labora- The goals, objectives, and technique of of the anatomy, physiology, pathophys- tory evaluation is recommended for pa- this examination have been reviewed in iology, and clinical course pertaining to tients with a history strongly suggestive a consensus statement by the Union In- these conditions. The physician should of a hypercoagulable state. ternationale de Phlebologie and the be experienced in the performance and A complete physical examination of American College of Phlebology, as well interpretation of duplex US of the ve- the patient below the waist should be as in several recent publications (13–15). nous system as well as conservative, performed. This should generally be During this examination it is important medical, and procedural approaches for performed in the standing position and to evaluate the anatomy and the physi- treating venous disorders. The requisite should include all aspects of the lower ology of both the superficial and deep knowledge, clinical, and procedural ex- extremities as well as the lower abdo- venous systems. A thorough knowledge perience required to care for patients men and pelvis in patients in whom iliac of the anatomy of the superficial venous with venous disorders can be acquired vein occlusion is suggested. system and its common variants is nec- in a number of ways. Many physicians Visible vein abnormalities including essary. Accurate use of the newly ac- will acquire the necessary knowledge telangiectasias, venulectasias, and vari- cepted nomenclature to describe these and skills through continuing medical cose veins should be documented. veins is essential for medical reporting education and/or mentored clinical ex- Edema of the extremities should be (1,2,16). periences (11) after their postgraduate identified. Careful attention should be The aim of duplex US is to define all medical training. The knowledge and directed at the skin near the ankle, as the incompetent pathways and their skills can also be obtained through post- this region is most vulnerable to the ef- sources, which involve saphenous and graduate medical training in an Accred- fects of long-term venous hypertension. nonsaphenous veins, perforating veins, Volume 21 Number 1 Khilnani et al • 19 and deep veins. The evaluation should Table 3 also include an assessment of the pa- Medical Indications for EVTA tency of the femoral and popliteal veins. The necessary equipment includes Clinical grayscale US and pulse-wave Doppler Quality of life affecting symptoms of venous insufficiency (see Table 2) imaging using frequencies of 7.5–10 Skin changes associated with chronic venous hypertension Mhz, although higher and lower fre- Corona phlebectasia Lipodermatosclerosis quencies may be used depending on the Atrophie blanche pigmentation in the gaiter region of the lower leg patient’s morphology. Color Doppler Healed or active ulceration imaging is very useful and readily avail- Edema able as a package with most duplex US Superficial thrombobophlebitis units. Anatomic Duplex US should be performed in Significant duplex US–documented reflux the standing position and the examiner Straight vein segment should thoroughly evaluate the GSV, Intra- or epifascial vein segment meeting other anatomic criteria SSV, their named tributaries, and the deep veins for both reflux and obstruc- tion. Venous reflux is diagnosed when there is reversal of flow from the ex- It is generally believed that reflux in treated with surgery, sclerotherapy, or pected physiologicl direction for more truncal veins must be treated before ad- EVTA. than 0.5 seconds following a provoca- dressing any visible abnormalities. Treatment of incompetent superficial tive maneuver to create physiologic However, there is some debate whether truncal veins in the setting of deep vein flow. These include calf or foot com- some forms of minor or segmental trun- reflux is safe. In many cases the reflux in pression by the examiner, dorsiflexion cal reflux may be left untreated, in the deep veins is related to overload of by the patient, or a Valsalva maneuver which case treatment of only the abnor- the deep system by the by the regur- to assess for competency of the SFJ. A mal tributaries can be safely and dura- gitant fraction or related to a siphon standardized report should be created bly undertaken. effect of the incompetent trunks (12). and used to describe the findings for EVTA is a treatment option for elim- In these cases, elimination of super- each examination. The use of diagrams inating reflux in a straight superficial ficial reflux is likely to reverse the significantly enhances the dissemina- venous segment. The indications for ab- deep reflux (17). tion of important clinical findings. lation of incompetent truncal veins are Treatment of incompetent superficial In a few clinical situations, patients identical to those for surgical phlebec- truncal veins in the setting of deep vein may require further imaging to charac- tomy of a given incompetent vein (Ta- obstruction requires a careful assess- terize venous obstruction, reflux, or ve- ble 3). These include reflux in a truncal ment of the adequacy of the patent seg- nous anomaly in the pelvis or lower ex- vein of duration greater than 0.5 sec- ment of the deep venous system. If the tremity such as conventional ascending, onds that is responsible for the patient’s deep system is adequate and the super- computed tomographic (CT), or mag- symptoms, skin findings, or cosmetic ficial venous incompetence is leading to netic resonance venography. Rarely pa- abnormality. Treatment of competent CEAP class C5 or C6 CVD, EVTA of the tients require a conventional catheter, vein segments below an incompetent causative veins is justified. Treatment of CT, or MR arteriogram to evaluate for vein segment, such as the below-knee competent but enlarged superficial ve- the possibility of an arteriovenous mal- GSV when only the above-knee GSV is formation. Following clinical and imag- incompetent, is not substantiated by nous segments has no proven medical ing evaluation, the patient’s clinical state data and should be discouraged to benefit and should not be performed. In should be summarized as to the sever- avoid unnecessary complications. some cases the enlarged vein may ulti- ity, cause, anatomic location and patho- EVTA can be applied to any sufficiently mately become incompetent. In other physiology using the CEAP classifica- straight incompetent truncal or superfi- patients, the enlarged vein may be func- tion system. cial vein that would allow passage of tioning as a reentry or collateral path- the device. way for another source of reflux or deep vein obstruction. Indications for EVTA Treatment of short segments of trun- cal incompetence is justified but may be The use of EVTA to close incompetent Patients seeking treatment of CVD made more challenging by securing suf- perforating veins has been described. At can be divided into those in whom it is ficient access of the vein to allow treat- this point, the indications and contraindi- medically indicated and those in whom ment. Data to evaluate the success of cations for use as well as the success rates it is restorative (ie, cosmetic). The great short segment treatment are not avail- and safety of this approach have only re- majority of patients with CEAP class C2 able. Care should be taken to identify cently begun to be evaluated (18). The use or higher CVD have symptoms, and other segments of incompetence in the of EVTA to directly close surface varicose treatment is medically indicated to im- treated vein or in other veins in the veins is not encouraged. These veins are prove QOL. For a smaller subset of pa- same extremity as complete obliteration usually too tortuous for current genera- tients, derangements in the health of the of such reflux is more likely to result in tion devices to pass through. Also, these skin in the vulnerable medial ankle and durable elimination of the presenting veins are very superficial; EVTA of such calf regions will represent medical indi- problem. This includes searching for re- veins carries a high risk of thermal skin cations for treatment. fluxing remnants of veins previously injury (19). 20 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

evaluated in a single small prospective Table 4 cohort study (22). In this review, 48 pa- Relative Contraindications for EVTA tients with GSV reflux were treated with Pregnancy or nursing* an 810-nm laser with 12W with roughly Obstructed deep venous system inadequate to support venous return after EVTA 60 J/cm. Twenty-four patients were on Liver dysfunction or local anesthetic allergy limiting local anesthetic agent use warfarin and a matched cohort of 24 Severe uncorrectable coagulopathy, intrinsic or iatrogenic patients not on warfarin were selected Severe hypercoagulability syndromes as a control group. The INR of the war- Inability to wear compression stockings secondary to inadequate arterial circulation, hypersensitivity to the compressive materials, or musculoskeletal or neurologic farin treated patients was 2.3–4.1. There limitations to donning the stocking itself were no significant bleeding complica- Inability to adequately ambulate after the procedure tions or excessive bruising in either Sciatic vein reflux group following EVTA. There was a Nerve stimulator tendency toward less effective ablation at one-year follow-up with DUS in the * Secondary to concerns related to anesthetic drug use and related to vein or heated anticoagulated group but given the blood effluent which may pass through the placenta to the fetus. sample size this was not statistically sig- nificant. Of note, the energies in the failed ablations were in the 44–62 J/cm Contraindications for EVTA patients, the use of appropriate general range. Low molecular weight heparins or regional analgesia coupled with sa- are routinely used at prophylactic doses The absolute contraindications for line tumescent infiltration may be a way in Europe immediately following EVTA EVTA have yet to be completely de- to allow safe EVTA. Cold saline solution with little risk of bleeding (23). How- fined. Relative contraindications include has been demonstrated in a small series ever, there are no data that evaluate the several features, some of which relate to as an alternative tumescent agent with safety of EVTA during heparin therapy the clinical condition of the patient and similar efficacy to dilute lidocaine (20). or for its use immediately after EVTA at others to the anatomy (Table 4). Post-EVTA ambulation and the use therapeutic doses. In general, very few truncal veins are of graduated compression hose is im- EVTA in patients with hypercoagu- lable states in theory may lead to an too close to the skin to prevent EVTA. portant following venous treatment to increased incidence of DVT (23). Pa- Even in thin patients, these veins can be minimize the risk of postprocedural pushed away from the skin with tumes- tients with established clotting risks DVT and to decrease superficial throm- cent anesthesia. Some believe EVTA of should be carefully screened for the bobophlebitis in dependent tributary an extrafascial vein such as the superfi- need to perform EVTA. In those who (ie, surface) varicose veins. This com- cial accessory GSV may lead to a higher require therapy for significant QOL- mon belief has not been substantiated incidence of skin pigmentation and skin related symptoms or morbidity from by data. However, at this point, based puckering, and encourage phlebectomy CEAP class 4–6 chronic venous insuffi- over EVTA of this vein. No data exist to on this prevailing notion, those patients ciency, periprocedural anticoagulation evaluate the incidence of these observa- with vascular, cutaneous, neurologic, or may be considered. However, indica- tions, but anecdotally these side effects musculoskeletal conditions that make tions for use, recommendations of drug almost always seem to be transient. ambulation or the use of compression choice and therapy duration, and the Large-diameter veins are safely and stocking difficult should be carefully efficacy of such prophylaxis have not effectively treated with EVTA assuming screened for the need to perform EVTA. been evaluated. sufficient tumescent anesthetic solution Complications after EVTA may be EVTA with RF ablation using the is infiltrated around the vein to collapse potentiated by native and iatrogenic co- first generation devices uses a monoter- it. At this point there are no data to agulopathies. There are few data with minal circuit and a bipolar electrode de- suggest a correlation between diameter regard to these issues other than extrap- sign. As a result, electromagnetic inter- and anatomic success of or complica- olation from literature regarding safety ference with cardiac pacemakers or tions after EVTA. Aneurysmal dilation with other venous procedures (21). implantable defibrillators is very un- of the proximal GSV or SSV at their EVTA performed on patients taking as- likely (24). The original Food and Drug respective junctions is proposed by pirin or nonsteroidal antiinflammatory Administration approval for the device some as a contraindication as it is a pos- medications seems to be safe. No data included the presence of a cardiac pace- sible risk factor for thrombus extension on the safety and efficacy of EVTA in maker or implantable defibrillators as a into the deep venous system. This con- patients being treated with platelet ag- contraindication. The Food and Drug cern has yet to be substantiated by data. gregation inhibitors such as clopidogrel Administration has since removed this Avoidance of treating incompetent sci- are available. Anecdotal reports suggest restriction, although the manufacturer atic veins with EVTA is suggested given that EVTA is safe in patients receiving recommends “appropriate precautions” this vein’s intimate proximity to the sci- this therapy. In patients in whom it is be used. There are no concerns of pace- atic nerve, and the potential for thermal safe to stop such therapy, the drugs maker or defibrillator interference with motor and sensory nerve damage. probably should be discontinued for at the new RF catheter called Closure Fast. The liver metabolizes the anesthetic least 10 days to minimize bleeding com- First generation RF ablation use in agents commonly used with EVTA. Pa- plications as in other venous procedures patients with spinal cord, dorsal col- tients with impaired liver function may (21). The safety of EVTA used on pa- umn, transcutaneous nerve, or vagal be at risk for anesthetic toxicity. In these tients being treated with warfarin was nerve stimulators may lead to a dys- Volume 21 Number 1 Khilnani et al • 21 function in these devices. Consultation quire multiple entry sites. Open venot- other tributary veins is also appropriate with an appropriate physician about the omy requiring a small skin incision may as long as they are straight enough to safety of RF ablation would be neces- also be used to introduce an EVTA de- traverse with the EVTA device and if an sary in patients with such stimulators. vice. Once venous access is achieved, a appropriate amount of tumescent anes- There are no concerns about interfer- guide wire is passed intravenously and thetic is used to protect the skin from a ence with these devices with the use of a vascular introducer sheath (or sheaths) thermal injury. Once the device is ap- Closure Fast. is inserted. propriately placed for ablation, the pa- There are no data to suggest im- tient is placed in Trendelenburg posi- EVTA PROCEDURE proved disease-free durability or clinical tion to facilitate vein emptying and improvement for treatment of normal perivenous tumescent anesthesia is then EVTA begins with a DUS evaluation vein segments below documented in- delivered. Optimal delivery of this fluid by the treating physician to confirm the competent GSV or SSV segments. How- into the saphenous space is accom- location and extent of the venous insuf- ever, the access site or sites for EVTA plished with real-time duplex US guid- ficiency and to direct skin marking of should allow treatment of the entire in- ance. The purposes of the tumescent the vein segment or segments to be competent segment or segments if two fluid are to externally compress and treated. The evaluation and skin mark- or more segments of the same truncal empty the vein to improve thermal ing is an essential part of the EVTA pro- vein are involved. This may include ab- transfer to the vein wall and to separate cedure and it is incumbent on the phy- lation of intervening normal segments. the vein from surrounding structures, as sician performing the procedure to be as Venous access(es) is then followed in well as for its anesthetic effect. accurate as possible to ensure an ade- most cases by positioning the ablation The thermal energy is then delivered quate and durable outcome. The impor- device or devices to be used to the most using protocols inherent to each device; tant components of the pre-EVTA DUS central location of vein to be treated. The data related to success based on the de- include identifying the correct vein or positioning of the device should be care- livered thermal dose for EVTA will be vein segments to be treated (including fully monitored by duplex US to ensure discussed later. Aspirating on the sheath determining the length of vein or veins the device is intravenous, that the device or external compression of the skin over that are incompetent to ensure complete allows access to the entire incompetent the tip of the ablation catheter during treatment), and to mark on the skin their venous segment, and that the working thermal delivery has been performed by course along with other important ana- end is not positioned in the deep venous some in an attempt to further empty the tomical landmarks. These important an- system. Accurate demonstration of the vein and to contain any heated blood atomic landmarks include deep vein device and its positioning in the venous from the deep vein beyond the junction. junctions; hypoplastic, aplastic, aneu- system require meticulous DUS tech- This may have some benefit near the rysmal, or tortuous segments; refluxing nique and should be performed by a junctional end of a large vein but has not perforating veins communicating with skilled operator. The operating physi- been evaluated. The use of cold tumes- the vein to be treated; and large tribu- cian usually performs the DUS during cent anesthetic agent has also been an- taries. Informed consent, including a EVTA. The physician may delegate the ecdotally suggested as helpful in induc- thorough discussion of risk, benefits, performance of the DUS to an appropri- ing vein spasm to assist in vein and alternatives, should be obtained ately trained individual, although the emptying and energy transfer in large from the patient. The patient should responsibility for accurate final position- veins. then be appropriately positioned on a ing rests with the treating physician. Manual compression is applied to table to allow access to all areas that are To treat reflux of the GSV beginning the vein entry site to gain hemostasis to be treated. The region to be treated is at the SFJ, the device is generally posi- after device removal. After the proce- then sterilely prepared and isolated tioned just below the junction of a com- dure, the patient is placed in a gradu- with sterile barriers. The physician per- petent epigastric vein, or other junc- ated compression stocking for 1–2 forming the procedure should wear tional branch to be spared, unless weeks (an additional compressive sterile gloves and a gown, and eye pro- otherwise indicated. Segmental treat- dressing is often used for the first few tection (including laser-specific attenu- ment of the GSV or of GSV remnants days if phlebectomy is performed con- ating glasses for the operator, patient, after previous surgery or ablation may currently). Ambulation is initiated im- and staff in the room when appropri- also be appropriate. mediately and encouraged following ate), and all health care providers in- For SSV ablation, the tip of the device the procedure, although the value of volved should follow universal precau- is positioned just beyond the take-off these practices has not been established tions. A US-guided venous access into point of a competent thigh extension of scientifically. the lowest incompetent segment of the the SSV or gastrocnemius vein, which- The tributary varicose veins improve vein is then performed. In some cases ever is more peripheral. If neither of or less commonly disappear in a reason- several US-guided venous access sites these veins has an SSV connection, ab- able number of patients following EVTA may be needed if the vein to be treated lation generally begins at the cephalad (25,26). However, most patients require is discontinuous because of prior treat- end of the intrafascial SSV before it adjunctive procedures to eliminate the ment or phlebitis; or if the veins have passes below the muscular fascia. If the varicose tributaries. Their eradication is aplastic, hypoplastic, or tortuous vein thigh extension of the SSV is also incom- believed important to complete the hemo- segments; or if vein spasm prevents ad- petent, this segment may be treated dynamic correction and maximize symp- vancement of the ablation device or along with the SSV. tomatic improvement, eliminate incom- sheath. Cases requiring ablation of more Treatment of the anterior accessory petent reservoirs that could facilitate the than one incompetent vein will also re- GSV, superficial saphenous vein, and development of new incompetent path- 22 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR ways, and complete the cosmetic im- deep veins of the calf, the necessity of generally been reported between 85% provement of the treated limb. Also, as a evaluating all patients early for throm- and 100%. The follow-up for these eval- result, their elimination may improve the bus cannot be substantiated. uations varies from 3 months to 4 years. success of EVTA and possibly slow the Follow-up duplex US examinations There are fewer data for the SSV but progression of venous disease in parallel should be periodically performed to the published results are qualitatively venous trunks. Superficial thrombobo- evaluate the anatomic success of EVTA. similar. phlebitis of large incompetent tributar- The natural history of a successfully Most EVTA recanalizations occur in ies occurs following ablation of the un- treated truncal vein includes acute vein the first 6 months, and all occurred in derlying reflux without phlebectomy. It wall thickening without significant in- the first 12 months following EVTA has been proposed that concurrent phle- traluminal thrombus in the first few in every reported series. This has been bectomy of such veins may reduce the weeks after treatment. This is followed interpreted as suggesting recanalization incidence of this minor complication. At over the next few months by progres- may be related to insufficient thermal this point, data to substantiate these sive vein shrinkage and eventual disap- energy delivery to the target vein. With thoughts are not available. pearance on US examination (15,28,29). EVTA, in most cases the first 1–2 cm of Follow-up duplex US will no longer be the treated vein beyond the SFJ or SPJ POSTPROCEDURAL needed when the treated vein is no remains patent. Post-EVTA patency of FOLLOW-UP CARE longer visible. Periodic follow-up du- segments less than 5 cm long beyond plex US may be needed to evaluate the the junction are the most common Immediately following EVTA, pa- etiology of any new tributary varicosi- form of failure. Posttreatment patency tients are instructed to ambulate regu- tites to determine whether they are of more than 5 cm of treated vein seg- larly. Vigorous exercise is generally dis- related to a recurrence of reflux in the ment is much less common (37). Less couraged for the first week after EVTA treated truncal vein or progression of successful closure of the proximal vein to avoid producing increased venous disease in a different venous pathway. segment may be related to an in- pressure near the central, junctional end creased likelihood of insufficient ther- of treated vein segments, although there CLINICAL EVALUATIONS mal transfer to this portion that is gen- are no data to substantiate this recom- OF EVTA erally of larger caliber, more difficult mendation. Long periods of immobility For RF ablation, proof-of-concept to empty, and less likely to develop such as those that occur with long air studies including multiple case series spasm during tumescent anesthetic flights or car rides soon after EVTA and a large sponsor-organized registry administration. As a result, it is less likely should be discouraged to mini- form the bulk of the published experi- likely to develop good device and vein mize venous stasis that could increase ence reporting success and complica- wall apposition in this segment, which the risk of DVT. These practices are not tions with this procedure. The data in- is thought important for optimal vein based on data. cluded in this review were derived from wall energy deposition to achieve suc- There are no convincing data to sup- the published experience with the first cessful laser or RF ablation. port the routine use of anticoagulants generation RF devices (Closure and Clo- There is a correlation between the with EVTA. In Europe the use of a short sure Plus). Recently, a modified version amount of thermal energy delivered course of postprocedural prophylactic- of RF catheter, Closure Fast, has been and the success of laser EVTA. dose low molecular weight heparin is approved for use in the US. The limited With laser, energy deposition has common (23). The complication rate fol- data that were available at the time this been described as that deposited per lowing its use does not seem substan- manuscript was being prepared is also centimeter of vein length (J/cm) or as tially increased, but this has not been included (43)(Table 5). that deposited to the vein wall using a directly investigated. Similarly, there are cylindrical approximation of the inner For laser ablation, multiple proof- 2 no data to clinically evaluate the of these of-concept and case series have been surface area of the vein (J/cm ), which practices in enhancing treatment effi- published reporting success and com- can be considered a fluence equivalent cacy, preventing complications such as plications with this procedure using (54). Durable vein occlusion was dem- deep or superficial vein thrombosis, or lasers with multiple different wave- onstrated in an observational series (51) potentially increasing the rate of post- lengths (Table 6)(23,28–64). as more likely when the energy deliv- procedural bleeding complications. Suggested action thresholds for ana- ered exceeded 80 J/cm, with a median Patients should return for periodic tomic success are presented in Table 7. observation of 30 weeks. Early occlusion clinical and duplex US evaluation to In addition, clinical outcomes investi- was also demonstrated as also more confirm vein closure and exclude com- gation of RF ablation or laser ablation likely in a different nonrandomized plications. If a physician were attempt- include several small randomized con- study (54) that compared two different ing to identify thrombus extension trolled trials comparing each proce- energy levels. In this study, a statisti- across the SPJ or SFJ, duplex US in the dure with conventional vein stripping cally significantly higher occlusion rate first 72 hours after EVTA seems to be (Table 8). by duplex US at 3 months was seen with necessary (27). There is no evidence as mean fluence levels of approximately 30 2 to the best time to evaluate for DVT in SUCCESS RATES J/cm (60 J/cm) compared with fluence the crural, femoral, or popliteal veins. rates of 12 J/cm2 (24 J/cm). High rates Observation Data Regarding However, given the transient and be- of vein occlusion and ultimate duplex Anatomic and Clinical Success nign clinical course of EVTA heat– US disappearance was noted in a se- induced thrombus extension in the deep Anatomic success rates with RF ab- ries in which the thermal dose in each veins at the junctions as well as in the lation and laser EVTA of the GSV have segment of the GSV was tailored to the Volume 21 Number 1 Khilnani et al • 23

Table 5 Published Observational Series of RF Ablation for Truncal Reflux (28,30–44) Anatomic Duplex US Follow-up Major Study, Year Limbs Vein Success (%) (mo) Complications (%) Goldman et al, 2000 (30) 12 GSV 100 6 0 Goldman et al, 2002 (31) 41 GSV 68 6–24 0 Weiss et al, 2002 (32) 98 GSV 96 6 1 21 GSV 90 24 NR Merchant et al, 2002 (33) 223 GSV 87 — 6 232 GSV 84 12 NR 142 GSV 85 24 NR Wagner et al, 2004 (34) 28 GSV 95 3 3 Pichot et al, 2004 (28) 63 GSV 90 25 NR Hingorani et al, 2004 (35) 66 GSV — — 16 (DVT) Merchant et al, 2005 (36)‡ 1161/61 GSV/SSV — — — 473 — 87 12 NR 263 — 88 24 NR 133 — 84 36 NR 119 — 85 48 NR 117 — 87 60 NR Nicolini et al, 2005 (37) 68 GSV 88 36 0 Merchant et al, 2005 (38) 98 GSV 89 48 NR Mozes et al, 2005 (39) 56 GSV NR NR 8 Puggioni et al, 2005 (40)‡ 53 GSV/SSV 91 1 NR Dunn et al, 2006 (41) 85 GSV 90 6 NR Ravi et al, 2006 (42) 159 GSV 97 36 NR Almeida et al, 2006 (43)‡ 95/11 GSV/SSV 95 16† 0 Proebstle et al, 2008 (44)* 252 GSV 99 6 0 Note.—Clinical evaluations of laser ablation have been performed using laser energy of several wavelengths (810, 940, 980, 1,329, and 1,320 nm) that are produced by several manufacturers. The published experience with this technique is composed of proof- of-concept studies including multiple cases series (Table 6). NR ϭ not reported. * Study used the ClosureFast device. † Mean measurement. ‡ The data for GSV and SSV were reported together in this review.

diameter in that segment (64). The the use a target temperature of 90°C in 2% (62). In another study (65), at ranges of energies used included 50 combination with a faster catheter 2-year follow-up, 41% of occluded J/cm for veins 4.5 mm or smaller and pullback rate (41). This has allowed veins were undetectable and 51% had 120 J/cm for veins larger than 10 mm energy delivery times to be shortened shrunk to a mean diameter of 2.9 mm. in diameter. No increase in complica- by 50% without an increase in compli- Late clinical recurrence is extremely tions was seen with any of the higher- cations. unlikely in an occluded vein that has energy strategies. At this point, a pro- Patients with a high body mass index shrunken to a noncompressible cord spective randomized evaluation of the have been shown to have a higher rate (28,37,64). Based on this and surgical relationship of the amount of laser en- of failure with laser and RF ablation data that demonstrate that the patho- ergy deposition at a fixed wavelength (36,56). The rationale for this observa- logic events that lead to recurrence usu- and its effects on the rate of anatomi- tion is unclear, although it is known that ally take place within 2 years (66), later cally successful vein obliteration and obese patients have higher central ve- clinical recurrences are more likely re- complication rates has not been per- nous pressures and a higher frequency lated to development of incompetence formed. of chronic venous disease. in untreated veins or vein segments (ie, A similar correlation between the Successfully treated veins have been progression of disease in other veins). energy delivered and success has been demonstrated to occlude and shrink To a great extent, late clinical success defined for RF ablation (36). When with time (28,29,64). Successfully after EVTA is predicated by the natural pullback rates were decreased from 3 treated veins eventually shrink and history of the venous insufficiency in a cm/min to 2 cm/min, a clear correla- become difficult to find. The average given patient, the ability of the treat- tion with anatomic success was dem- mean duration for a treated GSV to ing physician to identify and eliminate onstrated. Most of the clinical data col- shrink to a fibrous cord of less than 2.5 all incompetent pathways (often de- lected for RF ablation use a target mm diameter is 6 months (29). In an- scribed as tactical and technical suc- treatment temperature of 85°C and a other study, at 1 year following laser cess), as well as the success of the ad- pullback rate of 3 cm/min. Equivalent ablation of the GSV, the treated seg- junctive procedures used to eradicate results with observational studies at 6 ments were not visualized in 95%, oc- any coexistent incompetent tributary months have been demonstrated with cluded but visible in 2%, and patent in veins after EVTA. 24 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

Table 6 Published Observational Series of Laser Ablation for Truncal Reflux (23,29,40,42,43,45–64) Anatomic Duplex US Follow-up Major Complication Study, Year Limbs Vein Success (%) (mo) Rate (%) Navarro et al, 2001 (45) 40 GSV 100 4.2 0 Min et al, 2001 (46) 90 GSV 97 9 0 Proebstle et al, 2003 (23) 104 GSV 90 12 NR Oh et al, 2003 (47) 15 GSV 100 3 NR Min et al, 2003 (48) 499 GSV 98 17 0 Proebstle et al, 2003 (49) 39 SSV 100 6 NR Perkowski et al, 2004 (50) 154 GSV 97 6–18 NR 37 SSV 96 6–18 NR Sadick et al, 2004 (51) 31 GSV 97 24 0 Timperman 2004 et al, (52) 111 GSV NR 7 NR Proebstle et al, 2004 (53) 106 GSV 90 3 NR Goldman et al, 2004 (54) 24 GSV 100 6 (9‡) NR Proebstle et al, 2005 (55) 223 GSV 92 3 NR Timperman et al, 2005 (56) 100 GSV 91 9 1 Puggioni et al, 2005 (40) 77 GSV/SSV 94 1 NR Kabnick et al, 2006 (57) 60 GSV 92 12 NR Almeida et al, 2006 (43) 483/104 GSV 98 16‡ 0.3† Yang et al, 2006 (29) 71 GSV 94 13 NR Kim et al, 2006 (58) 60 GSV 95 3 NR Kavuturu et al, 2006 (59) 66 GSV? 97 9 NR Meyers et al, 2006 (60) 334 GSV * 36 NR 70 SSV Sadick et al, 2007 (61) 94 GSV 96 48 NR Theivacumar et al, 2007 (62) 81 GSV 98 12 NR Gibson et al, 2007 (63) 210 SSV 100 1.5 NR Ravi et al, 2006 (42) 990 GSV 97 30–42 NR 101 SSV 90 30–42 NR Desmyttere et al, (2007) (64) 511 GSV 97 48 (34 limbs at 4 y) NR Note.—NR ϭ not reported. * Survival determined by Kaplan-Meier analysis. † EVL SFJ thrombus extension. ‡ Mean measurement.

and another compared 810 nm and 980 rates has been performed. Several retro- Table 7 Anatomic Success at 1 Year* nm in a randomized prospective study spective analyses of observational data (55,57). Both studies demonstrated have demonstrated qualitatively similar Reported Action equivalent occlusion rates for the differ- occlusion and complication rates Treatment Range Threshold ent wavelengths when used at similar (42,43,67). Anecdotally, bruising and Type (%) (%) rates of energy deposition. No differ- discomfort have been thought to be less RF ablation ences in the complication rates were with continuous-mode laser deposition GSV 68–100 80 seen in patients treated with different than with pulsed-mode deposition. This SSV None 80 wavelengths, but differences in the side too has not been substantiated by pub- Laser ablation effects of bruising and postprocedural lished data. GSV 92–100 85 discomfort were described. No random- Several studies have documented SSV 92 85 ized analysis evaluating outcomes and significant and durable improvements Other veins† None 90 complications using differences in rate in validated assessments of QOL follow- * Defined as duplex US disappearance of energy delivery (Watts), linear energy ing EVTA. Two studies demonstrated of the entire treated vein segment. deposition or fluence, controlling for significant improvements in the Aber- † Remnant after surgery or accessory other variables, has been performed. deen Varicose Veins Questionnaire GSV. EVTA success has been demon- (AVVQ), Short Form–36 (SF-36), and strated in retrospective data review to VCSS as long as 6 months following be independent of vein diameter in laser ablation (which were at least as many studies. However, a prospective good or better than the improvements Two comparisons of wavelength of confirmation of this conclusion has not seen following high ligation and strip- delivered laser energy have been per- been performed. ping (HL/S) (68,69). VCSS scores were formed. One study compared 940 nm No prospective comparison of RF ab- shown to decrease significantly in those and 1,320 nm in a retrospective analysis lation and laser anatomic or clinical patients treated with either laser or RF Volume 21 Number 1 Khilnani et al • 25

Table 8 Comparison of EVTA and Surgery for GSV Reflux (64,68,69,72–78) Study, Year Type Limbs Method Follow-up Results for RF Ablation Versus Surgery Rautio et al, 2002 (73) RCT 15 RF 50 d 1. VAS pain score and med use less at 14 d 13 HL/S 2. Less sick leave 3. RAND-36 pain score lower at 1 week but equal later 4. Duplex US closure rate, 100% 5. VSS and complications no different Lurie et al, 2003 (64)* RCT 44 RF 4 months 1. Time to normal activity,1dvs4d 36 HL/S 2. Return to work,5dvs12d 3. CIVIQ2 better for RF at 1 week and 4 months 4. VCSS better for RF at 1 and 3 weeks, equal at 4 months 5. Duplex US closure rate, 91% 6. Equal complications Lurie et al, 2005 (74)* RCT 44 RF 2 y 1. Equal rates of new vessels (2% vs. 11%) 36 HL/S 2. Equal recurrent varicose veins (14% vs. 21%) 3. CEAP improvement equal 4. VCSS better with RF at 72 h and 1 weeks, equal at 4 months and 2 y 5. QOL better with RF at 72 h, 1 weeks, and 1 and 2 y, equal at 3 weeks and 4 months 6. Duplex US: no reflux segments of GSV in 88% vs 92% Perala et al, 2005 (75)* RCT 44 RF 2 y 1. Equal VCSS, VDS, VSDS score 36 HL/S improvements 2. Equal recurrent varicose veins and neovascularity de Medeiros et al, 2005 Contralateral legs 20 HL/S 8 weeks 1. More swelling/bruising with surgery (72) 20† HL/laser 2. At 60 d, equivalent outcomes by QOL evaluation, APG 3. 70% favored laser, 10% felt treatments were equivalent Stotter et al, 2005 (76) RCT 20 RF 1 y 1. Duplex US: 90/100/90 20 HL/S 2. VAS pain less for RF ablation 20 HL/cryo 3. CIVIQ activity impairment better with RF to 1y 4. RTW/RTA better for RF Mekako et al, 2006 (68) Case comparison 62 HL/S 12 weeks 1. SF-36 better for laser at 1 and 6 weeks, equal 70 Laser at 12 weeks 2. AVVQ better for laser at 1, 6, and 12 weeks 3. VCSS improvements at 1 ,6, and 12 weeks Vulsteke et al, 2006 (77) RCT 84 HL/S NR 1. QOL, medication use, and sick days better 80 Laser for EVLT Hinchliffe et al, 2006 (78) RCT — HL/S — — RF Rasmussen et al, 2007 (69) RCT 68 Laser 6 months 1. Equivalent technical success, VAS, VSS, 67 HL/S AVVQ, SF-36, duplex US Note.—APG ϭ air plethysmography; AVVQ ϭ Aberdeen Varicose Veins Questionnaire; HL ϭ high ligation; HL/S ϭ high ligation and stripping; NR ϭ not reported; QOL ϭ quality of life; RCT ϭ randomized controlled trial. * Same patients.

ablation and powered phlebectomy patent tributary branches found at the with significant improvements in ve- (67). Another study (57) demonstrated SFJ. nous clinical severity scores and air significant improvements in the VCSS 4 Evaluation of the effectiveness of plethysmography findings. The correc- months after treatment with laser alone. EVTA in CEAP class 4–6 patients was tion in venous filling index on air pleth- Another study (70) demonstrated signif- performed in a retrospective review of ysmography has been correlated with icant Aberdeen Varicose Veins Score patients 6 weeks after they were treated long-term symptomatic relief in surgical improvement at 1 year following laser with RF ablation and laser (67). An 85% series (71). Marston et al (67) docu- ablation, regardless of the number of rate of vein occlusion was noted overall, mented improvement in air plethys- 26 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR mography following EVTA at 6 weeks comes with shorter recovery periods for dition, patient satisfaction, analgesia and de Medeiros and Luccas (72)at8 EVTA. use, and number of days before return weeks following ablation. Ulcer healing Several small comparison studies to work were significantly better for the has been induced after EVLT. One re- have evaluated the outcomes of laser laser-treated group. port documented an 84% success with ablation and surgery. In the first to be A randomized trial of 68 limbs ulcer healing with a combination of ei- published (72), 20 patients with bilateral treated with HL/S and 62 with laser ther RF ablation or laser and microphle- GSV reflux were treated with conven- was performed with both groups being bectomy with 77% of these healing less tional HL/S on one leg and HL and treated with only tumescent anesthesia than 2 weeks after the procedure (42). laser in the other and then followed for (69). The preliminary report of this on- 3 months. The patients were not in- going study evaluated the patients up to 6 months after their procedure using a Randomized Clinical Comparisons formed which leg received which ther- apy, the choice of which technique was variety of validated instruments includ- of EVTA and Surgery used was randomized, and all patients ing a visual analog scale of pain, VCSS, As with any new treatment method- were treated with spinal or epidural an- AVVSS and SF-36. Initial technical suc- ology, its acceptance as a standard of esthesia. No tumescent anesthetic was cesses were equivalent. In this trial the practice goes thought an evolution from used. Early pain was similar for both early bruising and pain favored laser proof-of-concept studies to clinical com- procedures, although bruising and but by 3 months both procedures dem- parisons to other existing standards of swelling was worse with surgery. All onstrated significant improvements in practice. Randomized and controlled patients thought the aesthetic improve- all indices compared with pretreatment data to compare the short-term and in- ment was much better in both limbs but baselines; however, no differences were termediate outcomes in patients with 70% thought the laser-treated limb ben- seen between HL/S and laser. One in- venous disease from truncal reflux efited more, 20% the surgical limb, and fection requiring antibiotics occurred in treated with EVTA or HL/S are avail- 10% thought they were equal. Air pleth- the surgical group. One patient in the able at this time (Table 8). ysmography improvements were laser group developed proximal exten- Several small comparisons of EVTA equivalent in both groups. sion of thrombus into the femoral vein using RF ablation and HL/S for the A nonrandomized consecutive treat- that spontaneously resolved without GSV have been performed (65,73,74,78). ment comparison of conventional HL/S treatment. In the EVOLVEeS sponsor-supported with general anesthesia and laser abla- As previously mentioned, given that tion of the GSV using tumescent anes- the case series have demonstrated a prospective randomized trial (65), thesia has been performed (68). This very high rate of treated vein disappear- postoperative pain was less severe, ab- study’s goal was to compare the sever- ance following EVTA, it is likely that sence from work and return to normal ity of venous disease and QOL changes clinical recurrence will infrequently be activities was shorter, and physical at 1 and 12 weeks following laser treat- related to failure of the EVTA. Recur- function was restored faster after RF ment using the SF-36, Aberdeen Vari- rence in these cases will likely result ablation at 4-month follow-up. At cose Veins Questionnaire, and VCSS in- from progression of the venous disease 2-year follow-up, recurrent varicose struments. The authors demonstrated in other vein segments. However, ran- veins were found in 21% of patients that, with the SF-36 at 1 and 6 weeks, the domized and controlled data to com- treated with HL/S and 14% of patients laser treatment recipients did not have pare late clinical recurrence in patients treated with RF ablation, but this dif- the decrease in QOL seen in the surgical treated with EVTA or HL/S to substan- ference did not reach significance be- group at the same time. By 12 weeks, tiate this assertion are not available at cause of the small treatment popula- both groups had similar improvements this time. tions (74). However, the likelihood of in QOL and in an objective assessment recurrence was 4.5 times higher in of the severity of their venous disease. COMPLICATIONS limbs with open GSV segments com- With the Aberdeen Varicose Veins pared with those with successfully Questionnaire, at 1 week, EVLT was Adverse events following EVTA oc- closed truncal veins, but this also did similar in the decrease in QOL com- cur, but almost all are minor. Ecchymo- not achieve significance. In addition, pared with surgery. However, at 6 and sis over the treated segment frequently at 2 years after treatment, the patients 12 weeks, QOL with laser treatment was occurs and normally can last for 14 treated with RF ablation had main- significantly better than that with sur- days. Approximately 1 week after tained better QOL scores compared gery. The VCSS improvement was sig- EVTA, the treated vein may develop a with the HL/S group (74). nificant compared with the pretreat- feeling of tightness similar to that after a Another small prospective random- ment assessment and similar for both strained muscle. This transient discom- ized trial by Rautio et al (73) demon- groups of patients. fort, likely related to inflammation in strated less pain and more rapid recov- A randomized comparison of 118 the treated vein segment, is self-limited ery following GSV RF ablation limbs treated with laser and microphle- and may be ameliorated with the use of compared with HL/S. Finally, clinical bectomy and 124 with conventional nonsteroidal antiinflammatory drugs outcome and patient satisfaction were HL/S and microphlebectomy compared and graduated compression stockings. also better in the short term, but by 6 the QOL of the postprocedural period of Both of these side effects are more com- months these differences were no longer both procedures (77). The study demon- monly described after EVTA using ex- significant. The conclusions of these strated significantly less postoperative isting laser protocols than for RF abla- small randomized studies of surgery morbidity for the laser procedure using tion, although direct objective blinded and RF ablation suggest equivalent out- the CIVIQ instrument of Launois. In ad- comparison has not been performed. Volume 21 Number 1 Khilnani et al • 27

ing vein, and the sural nerve adjacent to manent paresthesias with adequate Table 9 amounts of tumescent anesthesia. It is Complications of EVTA* the SSV in the mid- and lower calf. Both of these nerves have only sensory com- also suggested by these data that spar- Reported Suggested ponents. The most common manifesta- ing the treatment of the distal 5–10 cm Range Threshold tion of a nerve injury is a paresthesia or may accomplish clinical benefit and po- Complication (%) (%) dysesthesia, most of which are transient. tentially avoid saphenous nerve injury DVT The nerve injuries can occur with sheath risk in patients with reflux to the medial RF ablation and catheter introduction, during the malleolus. GSV 0–16 5 delivery of tumescent anesthesia, or by Skin burns following EVTA have SSV NR 5 thermal injury related to heating of the been reported following RF and laser Laser ablation perivenous tissues. ablation. Skin burns are fortunately rel- GSV 0–8 2 Tumescent anesthesia has been dem- atively rare and seem be avoidable with SSV 0–6 5 onstrated to reduce perivenous temper- adequate tumescent anesthesia. The Paresthesia atures with laser (79) and with RF abla- rates of skin burn in one series (38) us- (temporary and permanent) tion (41,80). The delivery of the ing RF ablation were 1.7% before and RF ablation perivenous fluid is believed to be re- 0.5% after the initiation of the use of GSV 0–15 10 sponsible for the low rate of cutaneous tumescent technique during RF ablation SSV NR 10 and neurologic thermal injuries seen in EVTA. The early experience had rates as Laser ablation the series of patients treated with it. An high as 4% (33) that decreased to almost GSV 0–12 10 extremely high rate of nerve injuries and zero as the use of tumescent anesthesia SSV 0–10 10 skin burns were reported in the article became a standard of practice. Skin burn by Chang and Chua (20). This clearly DVT following EVTA is unusual. RF ablation was related to the use of extraordinarily DVT can occur as an extension of GSV 0–7 1 high rates of energy delivery and direct thrombus from the treated truncal vein SSV NR 1 Laser ablation treatment of varicose tributaries without across the junctional connection into the GSV 0–12 1 the use of tumescent anesthetic treat- deep vein or in the calf or femoral pop- SSV 0 1 ment. Neurologic injuries are seen after liteal veins. The reported rates of junc- truncal vein removal and are related to tional thrombosis following GSV EVTA Note.—NR ϭ not reported separately. injury to nerves adjacent to the treated varies widely. This variability may re- * Complications other than those vein (81). Paresthesias caused by EVTA late to the time of the follow-up exami- considered minor by SIR classification. are mostly temporary. Excluding outli- nation and the methods used. Most se- ers, the rates of permanent paresthesias ries using early duplex US (Յ72 h after typically reported for laser EVTA of EVTA) document a proximal extension above-knee GSV are 0%–15%. Only a for the GSV of approximately 1% (Ta- Superficial phlebitis is another uncom- small number of series look at the SSV. bles 5 and 6). Those performing the du- mon side effect after EVTA, being re- The reported rates of temporary pares- plex US later identify a lower rate. It is ported after approximately 5% of proce- thesia following SSV EVTA are approx- possible the rates are different for differ- dures (48). There are no published imately 0%–10%. ent operators or that the proximal exten- reports of superficial phlebitis after The higher rates typically reported sion of thrombus is self limited without EVTA progressing to DVT, and it has for RF ablation may be related to the fact a clinical event. Pooling data from sev- been managed in most series with non- that tumescent anesthesia was not com- eral sources suggests the incidences are steroidal antiinflammatory medication, monly used with this procedure when approximately 0.3% after laser ablation graduated compression hose, and am- some of the data were collected. The and 0.4% after RF ablation (83). This bulation. Anecdotally, superficial phle- 1-week paresthesia rate following RF type of DVT is almost universally bitis seems to be more common in larg- ablation was shown to decrease from asymptomatic. The significance of this er-diameter dependent varicose veins or 15% to 9% after the introduction of tu- type of thrombus extension into the in varicose veins that have their inflow mescent anesthesia (36). Patients treated femoral vein seems to be different that and outflow ablated by EVTA. Concur- with laser EVTA performed without tu- that with native GSV thrombosis with rent phlebectomy of these veins at the mescent anesthetic infiltrations exhib- extension or compared with typical time of EVTA has been recommended ited a high rate of such injuries (20). femoral vein thrombosis (84). to decrease the risk of this side effect, There is evidence suggesting a The incidence of junctional extension but at this point there are no data to higher rate of nerve injuries reported of thrombus after SSV ablation has been substantiate this claim. when treating below-knee GSV with to described to be low (Յ6%) (42,63). In More significant AEs reported fol- the above-knee segment (32,33,82) and one study (63), the rate of popliteal ex- lowing EVTA include neurologic inju- the SSV (36). Treatment of below-knee tension of SSV thrombus at 2–4 days ries, skin burns, and DVT (Table 9). The GSV or the lower part of the SSV may be after EVTA was thought to be related to overall rate of these complications has necessary in many patients to treat to the anatomy of the SPJ. The incidences been shown to be higher in low-volume eliminate symptoms or skin disease were zero when no SPJ existed and 3% centers compared with high-volume caused by reflux to the ankle. A retro- when a thigh extension existed, but 11% centers (36). The nerves at highest risk spective review (82) demonstrated that when no junctional vein could be iden- include the saphenous nerve, adjacent below-knee laser ablation can be per- tified. to the GSV below the midcalf perforat- formed with an 8% rate of mild but per- The incidence of DVT in other pe- 28 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

ripheral deep veins after EVTA has not minimize the risk of these arteriovenous ture of the veins of the lower limbs: an been well evaluated, as the results of fistulas include careful advancement of international interdisciplinary consen- routine scanning of the entire extremity the intravascular devices, atraumatic de- sus statement. J Vasc Surg 2002; are rarely described. However, the inci- livery of the tumescent anesthetic fluid, 36:416–422. dence of symptomatic DVT of the calf, the use of copious amounts of tumes- 2. Caggiati A, Bergan JJ, Gloviczki P, popliteal, and femoral veins is very low. cent fluid, and avoidance of treating the Eklof B, Allegra C, Partsch H, for the International Interdisciplinary Consen- Neovascularity at the SFJ after subfascial portion of the SSV where sus Committee on Venous Anatomical EVTA, as a form of recurrence of vari- popliteal artery branches exist. Terminology. Nomenclature of the cose veins, seems to be rare at 1–3-year veins of the lower limb: extensions, re- follow-up (28,48,70). Neovasculariza- CONCLUSIONS finements, and clinical application. J tion was seen in only two of the 1,222 Vasc Surg 2005; 41:719–724. limbs followed for up to 5 years in an EVTA is one of several potential 3. Nicolaides AN, Hussein MK, Szendro G, industry-sponsored registry of patients treatment options for patients with SVI. Christopoulos D, Vasdekis S, Clarke H. treated with RF ablation (36). Longer It can safely, effectively, and durably The relation of venous ulceration with follow-up may be necessary to feel con- eliminate reflux in truncal veins using ambulatory venous pressure measure- fident with this observation; however, only local anesthesia. Successful out- ments. J Vasc Surg 1993; 17:414–419. 4. Kistner RL, Eklof B, Masuda EM. neovascularization following HL/S comes require a thorough understand- ing of the disease process and the anat- Diagnosis of chronic venous disease of neovascularization is common and of- the lower extremities: the CEAP classifi- ten an early event (8,85). A study was omy of the superficial venous system. A thorough examination with Duplex US cation. Mayo Clinic Proc 1996; 71:338– performed with the principal endpoint 345. comparing the number of vessels seen is essential to make the correct diagno- 5. Labropoulos N, Delis K, Nicolaides before and 1 year after laser ablation sis. Treatment planning, technical de- AN, Leon M, Ramaswami G, Volteas (70). At 1 year there was a 98% success tails, and postprocedural care unique to N. The role of the distribution and rate in vein occlusion, with 97% of the this procedure are important to under- anatomic extent of reflux in the devel- occluded veins becoming invisible by stand. opment of signs and symptoms in this point. Neovascularity was found chronic venous insufficiency. J Vasc Acknowledgments:Neil M. Khilnani, MD, Surg 1996; 23:504–510. in only one patient. In all the others, authored the first draft of this document and 6. Labropoulos N. Clinical correlation there was either flush occlusion to served as topic leader during the subsequent to various patterns of reflux. J Vasc the SFJ (40%) or one or more compe- revisions of the draft. Clement J. Grassi, MD, Surg 1997; 31:242–248. tent tributaries in continuity with the is chair of the SIR Standards of Practice Com- 7. Meissner M, Caps MT, Zierler B, et al. SFJ (59%) (70). mittee. John F. Cardella, MD, is Councilor of Determinants of chronic venous dis- Anecdotal reports of laser fiber frac- the SIR Standards Division. All other authors ease after acute deep vein thrombosis. ture or retained venous access sheaths are listed alphabetically. Other members of Vasc Surg 1998; 28:826–833. the Standards of Practice Committee and SIR 8. Jones L, Braithwaite BD, Selwyn D, have been made to the device manufac- who participated in the development of this turers, and a case report exists describ- Cooke S, Earnshaw JJ. Neovasculari- clinical practice guideline are as follows: San- zation is the principle cause for varicose ing a retained vascular sheath after laser joy Kundu, MD, John “Fritz” Angle, MD, ablation (86). Respecting the fragile vein recurrence: results of a randomized Ganesh Annamalai, MD, Stephen Balter, trial of stripping the long saphenous glass laser fibers and being gentle with PhD, Daniel B. Brown, MD, Danny Chan, vein. Eur J Vasc Endovasc Surg 1996; its handling should help minimize laser MD, Timothy W.I. Clark, MD, MSc, Bairbre 12:442–445. fiber fractures. The possibility of a laser L. Connolly, MD, Brian D. Davison, MD, 9. Labropoulos N. CEAP in clinical fiber fracture should be considered with Peter Drescher, MD, Debra Ann Gervais, practice. J Vasc Surg 1997; 31:224–225. the removal of the device in each case. MD, S. Nahum Goldberg, MD, Manraj K.S. 10. Rutherford RB, Padberg FT Jr, Comerota Care to deliver thermal energy only be- Heran, MD, Maxim Itkin, MD, Sanjeeva P. AJ, et al. Venous severity scoring: an Kalva, MD, Patrick C. Malloy, MD, Tim Mc- adjunct to venous outcome assessment. J yond the introducer sheath and away Sorley, BS, RN, CRN, Philip M. Meyers, MD, from any other parallel placed sheath is Vasc Surg 2000; 31:1307–1312. Charles A. Owens, MD, Dheeraj K. Rajan, 11. Nguyen T, Bergan J, Min R, Morrison N, essential to avoid severing segments of MD, Anne C. Roberts, MD, Steven C. Rose, these catheters. No specific manage- Zimmet S. Curriculum of the Ameri- MD, Tarun Sabharwal, MD, Nasir H. Sid- can College of Phlebology. Phlebology ment recommendations of retained in- diqu, MD, LeAnn Stokes, MD, Patricia E. 2006; 21(suppl 2):1–20. travenous laser fiber or sheath frag- Thorpe, MD, Richard Towbin, MD, 12. Kurz X, Kahn SR, Abenhein L, et al. ments can be made based on the data. Aradhana Venkatesan, MD, Louis K. Wag- Chronic venous disorders of the A case report of an arteriovenous fis- ner, PhD, Michael J. Wallace, MD, Joan leg: epidemiology, outcomes, diagno- tula between a small popliteal artery Wojak, MD, Darryl A. Zuckerman, MD, Cur- sis and management. Summary of an branch and the SSV exists (87). Anec- tis W. Bakal, MD, Curtis A. Lewis, MD, evidence-based report of the VEINES MBA, JD, Kenneth S. Rholl, MD, David task force (Venous Insufficiency Epide- dotal references have been made of ad- Sacks, MD, Thierry de Baere, MD, Fabricio ditional arteriovenous fistulas between miologic and Economic Studies). Int Fanelli, MD, Alexis Kelekis, MD, and Man- Angiol 1999; 18:83–102. the proximal GSV and the contiguous uel Maynar, MD superficial external pudendal artery. Al- 13. Coleridge-Smith P, Labropoulos N, References Partsch H, Myer K, Nicolaides A, though thought to be related to a heat- 1. Caggiati A, Bergan JJ, Gloviczki P, Cavezzi A. Duplex ultrasound inves- induced injury caused by the thermal Jantet G, Wendell-Smith CP, Partsch H, tigation of the veins in chronic venous device, an arteriovenous fistula could be for the International Interdisciplinary disease of the lower limbs–UIP con- caused by a needle injury during tumes- Consensus Committee on Venous An- sensus document. Part 1: basic prin- cent anesthetic administration. Ways to atomical Terminology. Nomencla- ciples. Phlebology 2006; 21:158–167. Volume 21 Number 1 Khilnani et al • 29

14. Bergan J, Min R, Zimmet S, Zygmunt J. Statement of the American Venous Fo- nous thrombus into the femoral vein: a Duplex ultrasound imaging of lower rum and the Society of Interventional potential complication of new endo- extremity veins in chronic venous dis- Radiology. J Vasc Interv Radiol 2007; venous ablation techniques. J Vasc ease, exclusive of deep venous throm- 18:1073–1080. Surg 2005; 41:130–135. bosis: guideline for performance and 28. Pichot O, Kabnick LS, Creton D, Mer- 40. Puggioni A, Kalra M, Carmo M, Mozes interpretation of studies; ACP Guide- chant RF, Schuller-Petroviae S, Chandler G, Gloviczki P. Endovenous laser line, April 2006. San Leandro, CA: JG. Duplex ultrasound scan findings therapy and radiofrequency ablation of American College of Phlebology, 2006. two years after great saphenous vein ra- the great saphenous vein: analysis of 15. Min RJ, Khilnani NM, Golia P. Duplex diofrequency endovenous obliteration. J early efficacy and complications. J Vasc ultrasound evaluation of lower extrem- Vasc Sug 2004; 39:189–195. Surg 2005; 42:488–493. ity venous insufficiency. J Vasc Interv 29. Yang CH, Chou HS, Lo YF. Incom- 41. Dunn CW, Kabnick LS, Merchant RF, Radiol 2003; 14:1233–1241. petent great saphenous veins treated Owens R, Weiss RA. Endovascular 16. Cavezzi A, Labropoulos N, Partsch H, with endovenous 1,320-nm laser: results radiofrequency obliteration using 90°C et al. Duplex ultrasound investiga- for 71 legs and morphologic evolvement for treatment of great saphenous vein. tion of the veins in chronic venous dis- study. Dermatol Surg 2006; 32: Ann Vasc Surg 2006; 20:625–629. ease of the lower limbs—UIP consen- 1453–1457. 42. Ravi R, Rodriguez-Lopez JA, Trayler sus document. Part 2: anatomy. Eur J 30. Goldman MP. Closure of the greater EA, Barrett DA, Ramaiah V, Diethrich Vasc Endovasc Surg 2006; 31:288–299. saphenous veins with endoluminal ra- EB. Endovenous ablation of incompe- 17. Ahmad I, Ahmad W, Dingui M. diofrequency thermal heating of the vein tent saphenous veins: a large single- Prevention or reversal of deep venous wall in combination with ambulatory center experience. J Endovasc Ther insufficiency by aggressive treatment phlebectomy: preliminary 6-month fol- 2006; 13:244–248. of superficial venous disease. Am J low-up. Dermatol Surg 2000; 26:452–456. 43. Almeida JI, Raines JK. Radiofrequency Surg 2006; 191:33–38. 31. Goldman MP, Amiry S. Closure of the ablation and laser ablation in the treat- 18. Peden E, Lumsden A. Radiofrequency greater saphenous veins with endolumi- ment of varicose veins. Ann Vasc Surg ablation of incompetent perforator veins. nal radiofrequency thermal heating of 2006: 20:547–552. Perspect Vasc Surg Endovasc Ther 2007; the vein wall in combination with ambu- 44. Proebstle TM, Vago B, Alm J, Gockeritz 19:73–77. latory phlebectomy: 50 patients with O, Lebard C, Pichot O, for the 19. Chang C, Chua J. Endovenous laser more than 6-month follow-up. Dermatol Closure Fast Clinical Study. Treatment photocoagulation (EVLP) for varicose Surg 2002; 28:29–31. of the incompetent great saphenous veins. Lasers Surg Med 2002; 31:257–262. 32. Weiss RA, Weiss MA. Controlled radio- vein by endovenous radiofrequency 20. Chong PFS, Kumar R, Kushwaha R, frequency endovenous occlusion using a powered segmental thermal ablation: Sweeney A, Chaloner EJ. Technical unique radiofrequency catheter under first clinical experience. J Vasc Surg tip: cold saline infiltration instead of duplex guidance to eliminate saphenous 2008; 47:151–156. local anaesthic in endovenous laser varicose vein reflux: a 2 year follow-up. 45. Navarro L, Min RJ, Bone C. Endove- treatment. Phlebology 2006; 21:88–89. Dermatol Surg 2002; 28:38–42. nous laser: a new minimally invasive 21. Malloy PC, Grassi CJ, Kundu S, et al. 33. Merchant RF, dePalma RG, Kabnick method of treatment of varicose Consensus guidelines for periproce- LS. Endovascular obliteration of sa- veins-preliminary observations using dural management of coagulation sta- phenous reflux: a multicenter study. J an 810nm diode laser. Dermatol Surg tus and hemostasis risk in percutane- Vasc Surg 2002; 35:1180–1186. 2001; 27:117–122. ous image-guided interventions. J Vasc 34. Wagner WH, Levin PM, Cossman DV, 46. Min RJ, Zimmet SE, Isaacs MN, Forr- Interv Radiol 2009; 20:S240–S249. Lauterbach SR, Cohen JL, Farber A. estal MD. Endovenous treatment of 22. Theivacumar NS, Gough MJ. Influence Early experience with radiofrequency the incompetent greater saphenous of warfarin on the success of en- ablation of the greater saphenous vein. vein. J Vasc Interv Radiol 2001; 12: dovenous laser ablation (EVLA) of the Ann Vasc Surg 2004; 18:42–47. 1167–1171. great saphenous vein (GSV). Eur J Vasc 35. Hingorani AP, Ascher E, Markevich N, 47. Oh CK, Jung DS, Jang HS, Kwon KS. Endovasc Surg 2009; 38:506–510. et al. Deep vein thrombosis after ra- Endovenous laser surgery of incompe- 23. Proebstle TM, Gul D, Lehr HA, et al. diofrequency ablation of the grater sa- tent grater saphenous vein with a Infrequent early recanalization of phenous vein: a word of caution. J Vasc 980-nm diode laser. Dermatol Surg greater saphenous vein after en- Surg 2004; 40:500–504. 2003; 29:1135–1140. dovenous laser treatment. J Vasc Surg 36. Merchant RF, Pichot O, for the 48. Min RJ, Khilnani NM, Zimmett SE. 2003; 38:511–516. Closure Study Group. Long-term out- Endovenous laser treatment of saphe- 24. Yu SS, Tope WD, Grekin RC. Cardiac comes of endovenous radiofrequency nous vein reflux: long-term results. J devices and electromagnetic interference obliteration of saphenous reflux as a Vasc Interv Radiol 2003; 14:991–996. revisited: new radiofrequency technolo- treatment of superficial venous insuffi- 49. Proebstle TM, Gul D, Kargl A, Knop J. gies and implications for dermatologic ciency. J Vasc Surg 2005; 42:502–509. Endovenous laser treatment of the surgery. Dermatol Surg 2005; 31: 37. Nicolini P, the Closure Group. Treat- lesser saphenous vein with a 940-nm 932–940. ment of primary varicose veins by en- diode laser: early results. Dermatol 25. Monahan DL. Can phlebectomy be dovenous obliteration by the Closure Surg 2003; 29:357–361. deferred in the treatment of varicose system: results of a prospective multi- 50. Perkowski P, Ravi R, Gowda RCN, veins? J Vasc Surg 2005; 42:1145–1149. centre study. Eur J Vasc Endovasc Surg et al. Endovenous laser ablation of the 26. Welch HJ. Endovenous ablation of 2005; 29:433–439. saphenous vein for treatment of venous the great saphenous vein may avert 38. Merchant RF, Pichot O, Meyers KA. insufficiency and varicose veins: early re- phlebectomy for branch varicose veins. Four-year follow-up on endovascular sults from a large single-center experi- J Vasc Surg 2006; 44:601–605. radiofrequency obliteration of great sa- ence. J Endovasc Ther 2004; 11:132–138. 27. Kundu S, Lurie F, Millward SF, et al. phenous reflux. Dermatol Surg 2005; 51. Sadick NS, Waser S. Combined endo- Recommended reporting standards for 31:129–134. vascular laser with ambulatory phle- percutaneous ablation for the treat- 39. Mozes G, Kalra M, Carmo M, Swenson bectomy for the treatment of superfi- ment of venous insufficiency: Joint L, Gloviczki P. extension of saphe- cial venous incompetence: a 2-year 30 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

perspective. J Cosmet Laser Ther 2004; ries of 500 patients. J Vasc Surg 2007; nous vein in the management of pri- 24:149–153. 46:1242–1247. mary varicose veins: 3-year outcome of 52. Timperman PE, Sichlau M, Ryu RK. 65. Lurie F, Creton D, Eklof B, et al. a randomized study. Ann Vasc Surg Greater energy delivery improves treat- Prospective randomized study of en- 2005; 19:669–672. ment success of endovenous laser treat- dovenous radiofrequency obliteration 76. Stotter L, Schaaf I, Bockelbrink A. ment of incompetent saphenous veins. J (closure procedure) versus ligation and comparative outcomes of radiofrequency Vasc Interv Radiol 2004; 10:1061–1063. stripping in a selected patient popula- endoluminal ablation, invagination strip- 53. Proebstle TM, Krummenauer F, Gul D, tion (EVOLVeS Study). J Vasc Surg ping, and cryostripping in the treatment of et al. Nonocclusion and early reopen- 2003; 38:207–214. great saphenous vein insufficiency. Phle- ing of the great saphenous vein after 66. Dwerryhouse S, Davies B, Harradine bology 2006; 21:60–64. endovenous laser treatment is fluence K, Earnshaw JJ. Stripping the long sa- 77. Vuylsteke M, Van den Bussche D, Au- dependent. Dermatol Surg 2004; 30: phenous vein reduced the rate of reop- denaert EA, Lissens P. Endovenous 174–178. eration for recurrent varicose veins: obliteration for the treatment of pri- 54. Goldman MP, Mauricio M, Rao J. five-year results of a randomized trial. mary varicose veins. Phlebology 2006; Intravascular 1320-nm laser closure of J Vasc Surg 1999; 24:589–592. 21:80–87. the great saphenous vein:a6to12- 67. Marston WA, Owens LV, Davies S, 78. Hinchliffe RJ, Ubhi J, Beech A, et al. A month follow-up study. Dermatol Surg Mendes RR, Farber MA, Keagy BA. prospective randomized controlled 2004; 30:1380–1385. Endovenous saphenous ablation cor- trial of VNUS closure versus surgery 55. Proebstle TM, Moehler T, Gul D, Herde- rects the hemodynamic abnormality in for the treatment of recurrent long sa- mann S. Endovenous treatment of the patients with CEAP clinical class 3–6 phenous veins. Eur J Vasc Endovasc great saphenous vein using a 1,320 nm CVI due to superficial reflux. Vasc En- Surg 2006; 31:212–218. Nd:YAG laser causes fewer side effects dovasc Surg 2006; 40:125–130. 79. Zimmet SE, Min RJ. Temperature than using a 940 nm diode laser. Derma- 68. Mekako AI, Hatfield J, Bryce J, et al. changes in perivenous tissue during en- tol Surg 2005; 31:1678–1683. A nonrandomized controlled trial of dovenous laser treatment in a swine 56. Timperman PE. Prospective evalua- endovenous laser therapy and surgery model. J Vasc Interv Radiol 2003; 14:911– tion of higher energy great saphenous in the treatment of varicose veins. Ann 915. vein endovenous laser treatment. J Vasc Surg 2006; 20:451–457. 80. Zikorus AW, Mirizzi MS. Evaluation of Vasc Interv Radiol 2005; 16:791–794. 69. Rasmussen LH, Bjoern L, Lawaetz M, setpoint temperature and pullback speed 57. Kabnick LS. Outcome of different en- et al. Randomized trial comparing on vein adventitial temperature during en- dovenous laser wavelengths for great endovenous laser ablation of the great dovenous radiofrequency energy delivery saphenous vein ablation. J Vasc Surg saphenous vein with high ligation and in an in-vitro model. Vasc Endovascular 2006; 43:88–93. stripping in patients with varicose Surg 2004; 38:167–174. 58. Kim HS, Paxton BE. Endovenous la- veins: short term results. J Vasc Surg 81. Morrison C, Dalsing MC. Signs and ser ablation of the great saphenous 2007; 46:308–315. symptoms of saphenous nerve injury vein with a 980-nm diode laser in con- 70. Theivacumar NS, Dellagrammaticas D, after greater saphenous vein strip- tinuous mode: early treatment failures Beale RJ, Mavor AI, Gough MJ. Fate ping: prevalence, severity and rele- and successful repeat treatments. J and clinical significance of saphe- Vasc Interv Radiol 2006; 17:1449–1455. nofemoral junction tributaries following vance for modern practice. J Vasc 59. Kavuturu S, Girishkumar H, Ehrlich F. endovenous laser ablation of great sa- Surg 2003; 38:886–890. Endovenous laser ablation of saphe- phenous vein. Br J Surg 2007; 94:722–725. 82. Timperman PE. Endovenous laser nous veins is an effective treatment 71. Owens LV, Farber MA, Young ML, et al. treatment of incompetent below-knee modality for lower extremity varicose The value of air plethysmography in great saphenous vein. J Vasc Interv Radiol veins. Am Surg 2006; 72:672–675. predicting clinical outcome after surgical 2007; 18:1495–1499. 60. Myers K, Fris R, Jolley D. Treatment treatment of chronic venous insuffi- 83. Merchant RF, Kistner RL, Kabnick LS. of varicose veins by endovenous laser ciency. J Vasc Surg 2000; 32:961–968. Re: “Is there an increased risk for DVT therapy: assessment of results by ultra- 72. de Medeiros, Luccas GC. Comparison of after the Closure procedure? J Vasc Surg sound surveillance. Med J Austral endovenous treatment with an 810 nm la- 2003; 38:628. 2006; 185:199–202. ser versus conventional stripping of the 84. Kabnick LS, Ombrellino M, Agis H, et 61. Sadick NS, Wasser S. Combined endo- great saphenous vein in patients with pri- al. Endovenous heat induced throm- vascular laser plus ambulatory phlebec- mary varicose veins. Derm Surg 2005; 31: bus (EHIT) at the superficial-deep venous tomy for the treatment of superficial ve- 1685–1694. junction: a new post-treatment clinical en- nous incompetence: a 4-year perspective. 73. Rautio T, Ohinmaa A, Perala J, et al. tity, classification and patient treatment J Cosmet Laser Ther 2007; 9:9–13. Endovenous obliteration versus con- strategies [abstract]. Presented at the 62. Theivacumar NS, Beale RJ, Mavor AI, ventional stripping operation in the American Venous Forum 18th Annual Gough MJ. Initial experience in en- treatment of primary varicose veins: a Meeting; February 23, 2006; Miami, FL. dovenous laser ablation (EVLA) of var- randomized controlled trial with com- 85. van Rij AM, Jones GT, Hill GB, Jiang icose veins due to small saphenous parison of the costs. J Vasc Surg 2002; P. Neovascularization and recur- vein reflux. Eur J Vasc Endovasc Surg 35:958–965. rent varicose veins: more histologic 2007; 33:614–618. 74. Lurie F, Creton D, Eklof B, et al. and ultrasound evidence. J Vasc Surg 63. Gibson KD, Ferris BL, Polissar N, Prospective randomized study of en- 2004; 40:296–302. Neradilek B, Pepper D. Endovenous dovenous radiofrequency obliteration 86. Ravi R, Bhutani A, Diethrich EB. “No laser treatment of the short saphenous (Closure) versus ligation and stripping sheath left behind.” J Endovasc Ther 2007; vein: efficacy and complications. J Vasc (EVOLVeS): two-year follow-up. Eur J 14:265–267. Surg 2007; 45:795–801. Vasc Endovasc Surg 2005; 29:67–73. 87. Timperman PE. Arteriovenous fistula 64. Desmyttere J, Grard C, Wassmer B, 75. Perala J, Ratio T, Biancari F, et al. after endovenous laser treatment of the Mordon S. Endovenous 980-nm laser Radiofrequency endovenous oblitera- short saphenous vein. J Vasc Interv Ra- treatment of saphenous veins in a se- tion versus stripping of the long saphe- diol 2004; 15:625–627. Volume 21 Number 1 Khilnani et al • 31

SIR DISCLAIMER The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles that generally should assist in producing high quality medical care. These guidelines are voluntary and are not rules. A physician may deviate from these guidelines, as necessitated by the individual patient and available resources. These practice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care that are reasonably directed towards the same result. Other sources of information may be used in conjunction with these principles to produce a process leading to high quality medical care. The ultimate judgment regarding the conduct of any specific procedure or course of management must be made by the physician, who should consider all circumstances relevant to the individual clinical situation. Adherence to the SIR Quality Improvement Program will not assure a successful outcome in every situation. It is prudent to document the rationale for any deviation from the suggested practice guidelines in the department policies and procedure manual or in the patient’s medical record.

CME TEST QUESTIONS Examination available at http://directory.sirweb.org/jvircme The CME questions in this issue are derived from Khilnani et al, Multi-Society Consensus Quality Improvement Guidelines for the Treatment of Lower Extremity Superficial Venous Insufficiency With Endovenous Thermal Ablation. 1. Which of the following terms best describes a superficial vein running from the lateral aspect of the foot and draining into the popliteal vein? a. Great saphenous vein b. Giacomini vein c. Posterior accessory great saphenous vein d. Small saphenous vein

2. A patient you are seeing in the vein clinic for consideration of treatment of superficial venous insufficiency is noted to have brownish darkening of the skin and clusters of small (Ͻ1 mm width) intradermal venules at the medial ankle. What CEAP (Clinical severity, Etiology, Anatomy, Pathophysiology) clinical grade would you record for this patient? a. Grade 3 b. Grade 4a c. Grade 4b d. Grade 5

3. Which of the following treatment strategies for symptomatic superficial venous insufficiency does this quality improvement guideline discourage? a. Treatment of competent vein segments below an incompetent vein segment b. Treatment of incompetent superficial truncal veins in the setting of deep vein reflux c. Treatment of an incompetent truncal vein with reflux of greater than 0.5 sec duration d. Treatment of a great saphenous vein measuring 1.0 cm in diameter

4. What is the suggested action threshold for skin burn following endovascular thermal ablation for lower extremity venous insufficiency? a. 0.5% b. 1% c. 2% d. 5%