JOURNAL OF VASCULAR SURGERY Volume 58, Number 1 Harlander-Locke et al 167

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1 Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries Michael Harlander-Locke, BS, Juan Carlos Jimenez, MD, FACS, Peter F. Lawrence, MD, Brian G. Derubertis, MD, David A. Rigberg, MD, and Hugh A. Gelabert, MD, Los Angeles, Calif Objective: To examine outcomes following 1000 consecutive endovenous radiofrequency ablation (RFA) closures of saphenous veins and 500 ambulatory phlebectomy procedures for chronic venous insufficiency. Based on the outcomes in this patient cohort, we aim to determine whether concomitant or staged phlebectomy is preferred and examine the rate and optimal treatment of complications using a dedicated treatment algorithm based on our classification system for level of closure following these procedures. Methods: Between 2004 and 2012, patients with symptomatic superficial venous incompetence who underwent endovenous RFA of incompetent saphenous veins were identified as well as patients with concomitant or staged microphlebectomy. Demographics, risk factors, procedural success rate, concurrent procedures, complications, and symptom relief were recorded. Results: One thousand radiofrequency ablations (95.5% great saphenous vein and accessory great saphenous veins, 4.5% small saphenous vein) were performed in the ambulatory setting (patients [ 735, limbs [ 916); 355 limbs with large (>3 mm) symptomatic incompetent tributaries underwent concomitant phlebectomy. Additionally, 145 limbs required phlebectomy at a later setting for persistent symptoms following saphenous RFA. Indications for treatment included lifestyle-limiting pain (94.8%), swelling (66%), lipodermatosclerosis (5.3%), ulceration (9.4%), and/or bleeding (1.4%). All patients (100%) underwent a follow-up ultrasound 24 to 72 hours following the procedure to assess for successful closure and to rule out deep venous thrombosis. The majority of patients (86.7%) had relief of their symptoms at a mean follow-up of 9 months. No patients developed postoperative deep venous thrombosis; however, saphenous closure extended partially into the common femoral vein wall in 18 patients (1.8%) and flush with the saphenofemoral junction in 47 (4.7%). One patient developed a pulmonary embolus despite a normal postoperative ultrasound. No other patients required hospital admission and no deaths occurred during the follow-up period. Conclusions: The majority of patients with symptomatic chronic venous insufficiency benefit from endovenous RFA of incompetent saphenous veins with comparable results to published surgical outcomes for endovenous closure. The great majority of patients with refluxing tributary veins greater than 3 mm in diameter required phlebectomy in addition to saphenous ablation. These patients may benefit from concomitant phlebectomy along with endovenous saphenous closure. (J Vasc Surg 2013;58: ) Since Friedrich Trendelenburg s description of his operative technique for ligation of the great saphenous vein (GSV) in 1890, open surgical therapy has been the mainstay of treatment for patients with symptomatic chronic venous insufficiency. 1 John Homans advocated the technique of flush ligation at the saphenofemoral junction, and Keller and Mayo pioneered the technique From the Division of Vascular Surgery, Gonda (Goldschmied) Vascular Center, David Geffen School of Medicine at UCLA. Author conflict of interest: Juan Carlos Jimenez is a consultant for Covidien. Presented at the Eighty-third Annual Meeting of the Pacific Coast Surgical Association, Napa Valley, Calif, February 19, Reprint requests: Juan Carlos Jimenez, MD, FACS, 200 Medical Plaza, Ste 526, Los Angeles, CA ( jcjimenez@mednet.ucla.edu). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest /$36.00 Copyright Ó 2013 by the Society for Vascular Surgery. of saphenous vein stripping in the early 1900s. 2-4 Limitations of open saphenous ligation and stripping have included the need for general anesthesia and inpatient hospitalization as well as postoperative deep venous thrombosis (DVT) rates approaching 5%. 5 Endovenous radiofrequency ablation (RFA) of incompetent GSV and small saphenous veins (SSV) employs resistive heating of the vein wall (85 C-120 C) via a percutaneously introduced catheter resulting in luminal occlusion. Advantages of saphenous RFA include its ability to be performed in the ambulatory setting without the need for general anesthesia. We began using endovenous thermal saphenous vein closure at our institution in 2004 and describe our experience with this technique at a large, tertiary care academic medical center following 1000 consecutive ablations. Outcomes following 500 microphlebectomy procedures performed in the ambulatory setting either concomitantly or staged following RFA are also presented. 166

2 Volume 58, Number 1 Harlander-Locke et al 167 METHODS We reviewed the outcomes of 735 patients who underwent 1000 consecutive GSV and SSV endovenous closures with 500 concomitant or staged tributary vein phlebectomy procedures between 2004 and Preoperative risk factors, vein characteristics, postoperative level of occlusion, subsequent treatment, outcomes, and complications were analyzed. Selection of patients for treatment. Patients with symptomatic saphenous and tributary veins were evaluated at the UCLA Gonda (Goldschmied) Vascular Center. Five vascular surgeons performed all the clinical evaluations, and a duplex ultrasound identified the presence of reflux in the great and/or small saphenous veins in the symptomatic lower extremity. All pre- and postoperative ultrasound examinations were performed using the General Electric Logiq E9 (Waukesha, Wisc). The minimum duration of reflux used in this study was 500 milliseconds. Ultrasound was also used to measure the diameter and reflux of symptomatic superficial tributary veins in the standing position in all patients. All ultrasound studies were performed in our accredited vascular laboratory under similar environmental conditions. The largest measured vein diameter was used for the study. The examining vascular surgeon assigned a CEAP classification to each patient, and a value between 2 and 6 was required for endovenous treatment. We used only the highest clinical CEAP class for each limb in the study. All patients underwent a trial of conservative, nonprocedural therapy for a minimum of 3 months, which included the following modalities: graded compression stockings (minimum of 20 to 30 mm Hg), leg elevation, and avoidance of prolonged standing. Patients with saphenous reflux who failed their trial of conservative therapy and presented with persistent lifestyle-limiting symptoms were considered candidates for RFA. Prior to and following saphenous ablation, patients with venous ulcers underwent wound care in a dedicated center with specialized nurses. RFA clinical setting. All procedures were performed in an ambulatory surgery center or an office-based treatment room under local anesthesia and/or monitored anesthesia care based on patient preference, extent of venous disease, and insurance authorization. No patient was treated under general anesthesia. Concomitant or staged microphlebectomy was performed at the discretion of the surgeon and the patient for incompetent, symptomatic tributary veins measuring 3 mm or greater. We used 3 mm as the size threshold for treatment because it is the minimum diameter generally used to define a varicose vein by the American Venous Forum and the Society for Vascular Surgery. 6 The decision to perform concomitant vs staged phlebectomy was based on patient preference and individual insurance coverage. Bleeding or symptomatic phlebitic varicose tributaries were recommended for concomitant removal. Patients on chronic warfarin therapy were treated based on a previously published algorithm. 7 Patients on aspirin therapy were instructed to continue this treatment through the perioperative period. No prophylactic heparin was administered at the time of the procedures. Procedural techniques. All patients were treated based on the manufacturer s instructions for use (VNUS Technologies, San Jose, Calif) for both the ClosurePlus and ClosureFast RFA catheters (both 7F). The ClosurePlus catheter was used early in our experience and was replaced with the newer-generation ClosureFast catheter, which treats a 7-cm segment of saphenous vein to 120 Cat 20-second intervals (segmental thermal ablation). The technique of stab phlebectomy was performed based on standard published techniques. 8,9 Details regarding our GSV RFA technique have been previously described. 10 Patients are placed in the supine position and ultrasound-guided puncture is used to gain percutaneous access to the GSV below or at the level of the knee using a micropuncture needle. A 7F sheath is advanced into the GSV using a flexible guidewire and Seldinger technique. Duplex ultrasound is used to position the tip of the catheter 2 to 3 cm caudal to the saphenofemoral junction prior to treatment. Subcutaneous injection of tumescent anesthesia (normal saline, xylocaine with epinephrine [10%], and sodium bicarbonate [1%]) is administered using a spinal needle to the tissues surrounding the GSV along its entire length prior to ablation. Following vein treatment, patients are placed in a compressive dressing with localized pressure along the treated superficial vein. Endovenous ablation of the SSV is similarly performed, except the patients are placed in the prone position, and ultrasound-guided puncture of the SSV is performed at the distal ankle. A 7F sheath is similarly placed. Duplex ultrasound is used to position the tip of the catheter 2 to 3 cm caudal to the saphenopopliteal junction prior to treatment. Intraoperative tumescence, treatment intensity, and duration are all performed comparably with GSV ablation. Following vein treatment, patients are placed in a similar compressive dressing. Post-RFA imaging and classification system. All patients underwent a postoperative duplex ultrasound 24 to 72 hours following RFA. We developed a classification system for endovenous closure levels (thrombus propagation) at the saphenofemoral junction, which has been previously described (Fig). 9 Patients with normal postoperative closures (levels 1-2) following GSV ablation were instructed to return for a postoperative visit in 6 weeks. Patients with level 3 and 4 closures were managed with repeat duplex and observation and/or low-molecularweight heparin (LMWH) based on individual surgeon discretion. The LMWH was discontinued when the thrombus had retracted to a level 2 or 3 closure. No further anticoagulation was recommended after retraction was confirmed sonographically. Patients with level 5 closures were advised to initiate outpatient LMWH therapy and underwent a repeat duplex at 1-week intervals until the thrombus retracted caudal to the saphenofemoral junction. No patients had a level 6 closure, and no small saphenous closures extended beyond the level of the saphenopopliteal junction.

3 168 Harlander-Locke et al July 2013 Fig. Classification of closure level following radiofrequency ablation (RFA) at the saphenofemoral junction (n ¼ number of procedures). LMWH, Low-molecular-weight heparin. Table I. CEAP classification for symptomatic patients treated with saphenous RFA ablation Variable No. of limbs Clinical severity Varicose veins (C2) 217 Swelling (C3) 346 Hyperpigmentation and/or 230 lipodermatosclerosis (C4) Healed ulcer (C5) 50 Active ulcer (C6) 73 RFA, Radiofrequency ablation. Statistics. All data are presented as mean values. Statistical analysis included two-tailed Fisher exact test for calculation of P values for categorical values (P >.05 was significant). A two-tailed Student t-test was used to calculate P values for all continuous variables. The modified Wald s method was used to calculate 95% confidence intervals for categorical data. Linear regression analysis was used for all noncontinuous variables. Logistic regression was used for all categorical values. All analysis was performed using IBM SPSS 19.0 software (IBM, Armonk, NY). RESULTS Seven hundred thirty-five consecutive patients underwent 1000 GSV and SSV RFA between 2004 and Five hundred stab phlebectomy procedures for symptomatic, incompetent tributaries measuring 3 mm or greater were performed either in staged or concomitant fashion with saphenous ablation. A total of 916 limbs were treated. Five different vascular surgeons performed all the procedures. The mean age of patients treated was years. Five hundred thirty-six patients (73%) were female, and 199 were male (27%). In this cohort, 955 GSV (95.5%) and 45 SSV (4.5%) were treated. The mean preoperative vein diameter was mm. Seven hundred sixty-one saphenous veins (76.1%) underwent segmental thermal ablation with the newer-generation ClosureFast catheter, and 239 (23.9%) underwent RFA with the first-generation ClosurePlus catheter. Indications for endovenous ablation were lifestylelimiting pain (n ¼ 696; 94.8%), swelling (n ¼ 485; 66%), venous ulcer (n ¼ 69; 9.4%), lipodermatosclerosis (n ¼ 39; 5.3%), and bleeding varices (n ¼ 10; 1.4%). Presenting signs based on CEAP classification are listed in Table I. Previous varicose vein procedures (prior to RFA) were performed in 138 patients and included prior saphenous ligation (n ¼ 11; 1.5%), prior accessory saphenous vein stripping (n ¼ 39; 5.3%), and prior phlebectomy (n ¼ 88; 12%). Forty-eight patients (6.5%) were on chronic warfarin therapy at the time of RFA, and 36 (4.9%) were on aspirin therapy. Thirty-eight patients (5.2%) had a prior history of prior DVT. Five hundred seven limbs had incompetent, symptomatic superficial varicose ($3 mm) tributaries identified on duplex ultrasound. The diameters of superficial branch veins treated in our series ranged from 3 to 12 mm. Stab phlebectomy was performed concomitantly with RFA in 355 limbs (355/507; 70%). Additionally, 126 limbs (126/507; 25%) required stab phlebectomy at a later-staged setting for persistent, incompetent symptomatic tributaries (3 mm or greater) identified by duplex prior to RFA. Twenty-six limbs (26/507; 5%) with refluxing varicose tributary veins following RFA did not require phlebectomy because their symptoms had improved with ablation alone. Additionally, 19 limbs developed new superficial varicose tributaries following saphenous ablation and underwent staged stab

4 Volume 58, Number 1 Harlander-Locke et al 169 Table II. Relief of symptoms by CEAP clinical severity class Clinical severity class Relief of symptoms (mean ¼ 9 months), % No. of limbs Varicose veins (C2) /217 Swelling (C3) /346 Lipodermatosclerosis and/or /230 hyperpigmentation (C4a, b) Healed ulcer (C5) 84 42/50 Active ulcer (C6) 73 53/73 Table III. Level of saphenous vein closure and corresponding mean vein diameter Level of closure No. of procedures Vein diameter 6 SEM Small saphenous vein Unsuccessful closure SEM, Standard error of the mean. Table IV. Multivariate analysis using the multiple linear regression model for predictors and risk factors resulting in level 3, 4, and 5 closures Vein diameter (>8 mm) P ¼.027 Vein diameter (>10 mm) P <.001 History of DVT P ¼.041 Age P ¼.722, NS Chronic anticoagulation P ¼.198, NS Antiplatelet medication taken P ¼.495, NS Previous vein ligation P ¼.312, NS Previous vein stripping P ¼.204, NS Previous stab phlebectomy P ¼.391, NS Concomitant phlebectomy P ¼.483, NS DVT, Deep venous thrombosis; NS, not significant. Table V. Incidence of level 3, 4, or 5 closure of the GSV by GSV diameters Diameter of GSV, mm No. of limbs Incidence of level 3, 4, or 5, % 95% CI, % > CI, Confidence interval; GSV, great saphenous vein. 95% CIs were calculated using the adjusted Wald method. phlebectomy. Thirteen patients underwent bilateral stab phlebectomies. Thus, 95% of limbs (n ¼ 487 patients) with superficial, refluxing tributaries greater than 3 mm who underwent saphenous ablation in our cohort required stab phlebectomy either concomitantly with RFA or in staged fashion. Successful saphenous vein closure was achieved on early postoperative duplex ultrasound in 98.6% of veins treated (986/1000). Closure rates were 98.6% (942/955) for the GSV and 97.8% (44/45) for the SSV, respectively. Mean length of follow up was months. Relief of symptoms by clinical severity CEAP class is listed in Table II. Thirteen patients (1.8%) were found to have late recanalization of the GSV and underwent subsequent RFA. No SSV recanalizations occurred in our series. In the 248 patients who did not undergo stab phlebectomy in this cohort, relief of symptoms was 87% (215/248 patients). There was no significant difference in symptom relief between the group of patients who underwent RFA alone vs the patients who underwent saphenous RFA with either concomitant or staged phlebectomy (P ¼.326) Sixty-nine patients with 79 venous ulcers (CEAP class 6) were treated with RFA in our cohort. Ten patients had bilateral ulcers. In these patients, the mean time with ulceration prior to saphenous vein ablation was months. The ulcer-healing rate was 73%, with a mean healing time of 6 months with a combination of compression therapy and saphenous vein ablation. Subsequent endovenous perforator vein ablation was required in 11% of patients for persistent ulceration. The mean time following saphenous ablation prior to perforator ablation was months. Postablation vein closure levels at the saphenofemoral junction based on our classification system were (by individual procedure): level 1 ¼ 930 (93%), level 2 ¼ 5 (0.5%), level 3 ¼ 24 (2.4%), level 4 ¼ 23 (2.3%), level 5 ¼ 18 (1.8%), and level 6 ¼ 0 (0%). All SSV closures were caudal to the saphenopopliteal junction on the initial postoperative duplex. Levels of closure based on their corresponding vein diameters are listed in Table III. Multivariate analysis was performed on various possible risk factors resulting in level 3, 4, and 5 closures (Tables IV and V). A vein diameter greater than 8 mm and a history of DVT were both statistically significant risk factors for level 3, 4, and 5 closure. All 18 patients with level 5 closures were recommended treatment with outpatient LMWH with repeat duplex at 1-week intervals. Five patients refused treatment with LMWH, and all had duplex evidence of thrombus retraction during follow-up imaging. Patients with level 3 and level 4 closures were treated both conservatively and with LMWH by preference of the individual surgeon. LMWH (1 mg/kg twice daily) was administered until sonographic evidence of thrombus retraction occurred caudal to the saphenofemoral junction. Mean duration of LMWH treatment was days. All patients with level 3, 4, and 5 closures on postoperative duplex demonstrated thrombus retraction into the GSV with or without administration of LMWH. Only one patient required long-term therapeutic anticoagulation (see below).

5 170 Harlander-Locke et al July 2013 One patient developed a pulmonary embolus following ablation requiring hospitalization and 6 months of anticoagulation with warfarin. This patient had a 20-mm GSV at the saphenofemoral junction and hypercoagulable risk factors, which included a history of lumpectomy and radiation for breast cancer and hormone replacement therapy. No other patient in our cohort demonstrated cephalad extension of thrombus into the common femoral vein, developed an occlusive DVT, or required long-term anticoagulation or hospitalization. No patient developed a hematoma requiring evacuation. No superficial skin sloughing or skin necrosis occurred. There were no procedure-related deaths in the patient cohort. DISCUSSION Endovenous ablation of the GSV was met with early trepidation due to concerns over high reported rates of DVT following treatment. 11 Subsequent improvements in both techniques and catheter design have resulted in improved outcomes and a decrease in published rates of thrombotic complications. 12 We noted excellent patient outcomes following endovenous saphenous RFA at a large, tertiary care academic medical center with a patient population trending toward more severe, symptomatic CVI. A large number of studies demonstrating similar patient outcomes following saphenous ablation have been composed of patient cohorts consisting primarily of milder CEAP class 2 disease Immediate resolution of saphenofemoral and saphenopopliteal reflux with vein closure, resultant symptomatic improvement, and good ulcer healing rates occurred in the majority of patients who underwent treatment across a wide range of CEAP classes. Our results compare favorably with other published studies reporting outcomes following saphenous RFA. A large study by Merchant et al reported closure rates of 87.1% at 1 week using strictly the first-generation Closure- Plus catheter. 19 Symptomatic improvement was noted in 70% to 80% of patients up to 5 years after the treatment. In contrast to our study, patients in this series presented with milder venous disease with the majority of patients (70%) classified as CEAP 2. Proebstle demonstrated early occlusion rates of 99.6% with segmental thermal ablation using the ClosureFast device in 194 patients. 19 Although limb pain was reported in only 57.5% of patients preoperatively, it decreased to 10.8% at the 3-day follow-up visit. Our findings suggest that concomitant phlebectomy is safe and effective treatment for patients with incompetent, symptomatic tributary veins measuring 3 mm or greater who also need saphenous closure. In our series, the great majority (95%) of patients with refluxing, symptomatic, varicose veins identified prior to RFA by duplex ($3 mm) required stab phlebectomy in addition to saphenous ablation whether in staged or concomitant fashion. The majority of limbs (83%) with incompetent superficial tributaries identified prior to saphenous ablation that did not undergo concomitant phlebectomy required subsequent stab phlebectomy in later, staged fashion due to persistent symptoms. These findings compare favorably with a recent randomized trial by Carradice and colleagues, which demonstrated that concomitant phlebectomy along with saphenous ablation reduced the need for secondary procedures and significantly improved quality of life in these patients. 20 The incidence of clinically relevant post-thrombotic complications in our patient cohort was limited to one patient (0.1%) who sustained a postoperative pulmonary embolus. Although rare, this complication has been previously reported following RFA. 21 Our classification system for categorizing levels of closure at the saphenofemoral junction was developed in an effort to standardize postoperative treatment in patients with thrombus extension into the saphenous vein. There is unequivocal evidence that acute DVT should be treated with therapeutic anticoagulation for 3 to 6 months. 22 In our experience, however, it appears that thrombus extension into the common femoral vein following endovenous thermal ablation (also described as endovenous heat-induced thrombosis or EHIT) does not appear to follow the same natural history as that of DVT. Other authors have also reported this observation. 23 We continue to advocate the use of routine postoperative duplex ultrasound because it provides information regarding the success and extent of vein closure, provides reassurance to patients, and confirms continued patency of the common femoral vein. However, its role in predicting future thrombotic complications following RFA has not been demonstrated. The indications for treatment with LMWH in patients with level 3 to 5 closures also remain unclear. In our series, with use of either close observation or LMWH, there was no case of thrombus extension into the femoral vein in patients who demonstrated postoperative level 3 to 5 closures. Of note, the patient who developed a pulmonary embolus had a normal postoperative duplex examination. Because our experience demonstrates an increased risk of more proximal vein closure in patients with GSV diameters greater than 8 mm and a prior history of DVT, a high index of suspicion for proximal thrombus extension should be maintained in these patients. We recommend the use of therapeutic LMWH in all patients with level 5 closures. In patients with level 3 and 4 closures with vein diameters smaller than 8 mm, no history of prior DVT or hypercoagulable risk factors, we advocate repeat ultrasonography at 1 week with LMWH therapy reserved for patients demonstrating proximal thrombus extension. For patients with larger vein diameters (>15 mm), high ligation and stripping may be the preferred method of treatment. Routine cessation of hormone replacement therapy preoperatively should also be considered for all patients. Patients with level 1 and 2 closures on their initial postoperative scan require no further imaging or treatment unless new symptoms develop. Limitations of this study include the lack of a formal quality-of-life assessment tool for uniform measurement of patient symptoms post-rfa (ie, SF-36, VCSS, Aberdeen Varicose Vein Questionnaire, EQ-5D, etc). Symptomatic

6 Volume 58, Number 1 Harlander-Locke et al 171 improvement was assessed and documented by the operating board-certified vascular surgeons during outpatient follow-up. There is potential bias when using informal data collection methods, and our conclusions are reported with these limitations present. The postoperative ultrasound examinations were performed and reviewed independently. Another limitation is the lack of long-term duplex follow-up data in asymptomatic patients. Following the initial duplex scan 24 to 72 hours following RFA in our protocol, patients did not obtain routine late follow-up ultrasonography unless they returned with recurrent or residual symptoms. Our rationale behind this protocol is that asymptomatic patients are not suitable candidates for endovenous therapy or phlebectomy and would not qualify for treatment on the basis of radiographic evidence of saphenous vein reflux alone. Differences in size variability and reflux duration of the saphenous veins among patients in the standing and supine position have been well documented. 24,25 Although ultrasound examinations of vein diameter were performed in the standing position for all patients under similar conditions, certain variables such as the time of day the study was performed, temperature, and individual differences in venous distensibility and amount of tumescence used were not completely standardized for all patients in this study and could introduce potential errors in determining true size. Although we observed an increased risk of EHIT with larger-diameter saphenous veins (>8 mm) using a relatively uniform measurement protocol, this conclusion should be viewed with the realization that these limitations and potential sources of error may be present. Our data demonstrate that RFA of the great and small saphenous vein in patients with symptomatic, lifestylelimiting reflux can be performed in the ambulatory setting with excellent closure rates, symptomatic improvement across all CEAP classes, good ulcer healing rates, and a low rate of thrombotic complications. Patients with incompetent, symptomatic tributary veins measuring 3 mm or greater and axial reflux may benefit from endovenous ablation with concomitant phlebectomy. Patients with GSV vein diameters greater than 8 mm and a history of prior DVT are at higher risk for proximal extension of EHIT. Although the natural history of EHIT appears more benign than that of DVT, severe thromboembolic complications may occur, albeit rare. 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7 172 Harlander-Locke et al July Marsh P, Price BA, Holdstock J, Harrison C, Whiteley MS. Deep vein thrombosis (DVT) after venous thermoablation techniques: rates of endovenous heat-induced thrombosis (EHIT) and classical DVT after radiofrequency and endovenous laser ablation in a single centre. Eur J Endovasc Surg 2010;40: Jeanneret C, Jager KA, Zaugg CE, Hoffmann U. Venous reflux and venous distensibility in varicose and healthy veins. Eur J Vasc Endovasc Surg 2007;34: Jeanneret C, Labs KH, Aschwanden M, Bollinger A, Hoffmann U, Jager K. Physiological reflux and venous diameter change in the proximal lower limb veins during a standardized Valsalva manoeuvre. Eur J Endovasc Surg 1999;17: Submitted Aug 31, 2012; accepted Dec 15, 2012.