VNUS Medical Technologies Research Articles

Proteus Syndrome: Report of a Case with Vascular Malformation Successfully Treated with Endovenous Radiofrequency Ablation

We reported a case of a 10 year-old Thai boy diagnosed as Proteus syndrome, presented with progressive enlarging of extremities with asymmetric distorting of the feet and toes. Skin examination showed marked thickening of the soles without characteristic cerebriform appearance, and well-defined purplish plaques with capillary-microcystic lymphatic malformation on the right hip and thigh. MRI/MRA of extremities showed disproportionate overgrowth with combined lymphatic-venous malformation at the right VNUS® Radiofrequency Generator Model RFG2 (VNUS Medical Technologies Inc., San Jose, California, USA and foam sclerotherapy after ablation as an adjunctive treatment for the venous malformation of the right leg with favorable outcomes.

Reflux in the below-knee great saphenous vein can be safely treated with endovenous ablation

Intervention on the great saphenous vein (GSV) has traditionally been limited to the above-knee (AK-GSV) segment for fear of saphenous neuralgia in spite of incompetence demonstrated in the below-knee (BK-GSV) segment. Residual symptoms and need for reintervention are reported to result in nearly half the patients if the refluxing BK-GSV is ignored. Experience with endovenous ablation of the BK-GSV at the time of AK-GSV treatment is sparsely reported in the literature. The aim of this study was to evaluate the safety of endovenous ablation of the refluxing BK-GSV. Data from consecutive patients treated with superficial venous ablation during a 48-month period from January 2010 to December 2013 were retrospectively reviewed. Demographic and procedure-related outcome and complication data were analyzed specifically for patients undergoing BK-GSV interventions. A total of 550 patients were treated with superficial venous ablation during the study period. Of those, 61 (79 limbs) underwent BK-GSV ablation for reflux at this site. There were 36 women and 25 men (mean age, 55years). Median Clinical, Etiologic, Anatomic, and Pathologic (CEAP) score was 3.4; 43 limbs were treated for symptomatic varicose veins (C 1-3) and 36 for advanced venous insufficiency (C 4-6); 14 limbs (18%) were treated for recurrent symptomatic varicose veins or venous insufficiency after prior superficial venous intervention with AK-GSV ablation, sclerotherapy, or stripping. Comorbidities included obesity (54%) with mean body mass index of 30.7 (range, 19 to 52), obstructive sleep apnea (10%), pulmonary hypertension (3%), and congestive heart failure (3%). Ablation was performed in 77 limbs (99%)with the VenaCure EVLT laser vein treatment (AngioDynamics, Queensbury, NY) and in two limbs by radiofrequency ablation with ClosureFAST system (VNUS Medical Technologies, San Jose, Calif). The mean length of GSV ablated was 51.2cm (range, 26-67cm). Endovenous ablation was performed concomitantly on 22 accessory GSVs (28%) and 10 incompetent perforators (13%). Ambulatory stab phlebectomy of branch varicosities was performed simultaneously in 59 limbs (75%). All veins treated were evaluated with ultrasound on postprocedure day 1, and no evidence of endovenous heat-induced thrombosis was detected. Eight patients (10%) went on to have preplanned sclerotherapy treatment for small-branch varicosities. Postoperative paresthesia occurred in three patients (4%) and resolved within 4weeks. Wound infection in three (4%) stab phlebectomy wounds resolved with oral antibiotic therapy. Follow-up surveillance ultrasound was available in 32 of 79 limbs that were >6months from the procedure. Partial late recanalization was noted in four of 32 limbs, but no patient had recurrent symptoms requiring repeated endovenous ablation during this period. Endovenous ablation of the refluxing BK-GSV segment can be performed safely with minimal complications. Consideration should be given to concomitant ablation of the BK-GSV in treatment of patients with varicose veins with reflux extending to the BK segment of the GSV to improve long-term outcomes.

Deep Venous Thrombosis after Saphenous Endovenous Radiofrequency Ablation: Is it Predictable?

Endovenous radiofrequency ablation (RFA) is a safe and effective treatment for varicose veins caused by saphenous reflux. Deep venous thrombosis (DVT) is a known complication of this procedure. The purpose of this study is to describe the frequency of DVT after RFA and the associated predisposing factors. A retrospective analysis was performed using prospectively collected data from December 2008 to December 2011; a total of 277 consecutive office-based RFA procedures were performed at a single institution using the VNUS ClosureFast catheter (VNUS Medical Technologies, San Jose, CA). Duplex ultrasonography scans were completed 2 weeks postprocedure in all patients. Risk factors assessed for the development of DVT included: great versus small saphenous vein (SSV) treated, right versus left side treated, number of radiofrequency cycles used, hypercoagulable state, history of DVT, tobacco use, medications (i.e., oral contraceptives, aspirin, warfarin, and clopidogrel), and vein diameter at the junction of the superficial and deep systems. Seventy-two percent of the patients were women, 56% were treated on the right side, and 86% were performed on the great saphenous vein (GSV). The mean age was 54 ± 14 years (range: 23-88 years). Three percent of patients had a preprocedure diagnosis of hypercoagulable state, and 8% had a history of previous DVT. On postprocedural ultrasound, thrombus protrusion into the deep system without occlusion (endovenous heat-induced thrombosis) was present in 11 patients (4%). DVT, as defined by thrombus protrusion with complete occlusion of the femoral or popliteal vein, was identified in 2 patients (0.7%). Previous DVT was the only factor associated with postprocedural DVT (P = 0.018). Although not statistically significant, there was a trend toward a higher risk of DVT in SSV-treated patients. Factors associated with endovascular heat-induced thrombosis alone were male sex (P = 0.02), SSV treatment (P = 0.05), aspirin use (P = 0.008), and factor V Leiden deficiency (P = 0.01). The use of RFA to treat patients with symptoms caused by saphenous reflux involves a small but definite risk of DVT. This study shows that the risk of post-RFA DVT is greater in patients with previous DVT, with a trend toward an increased risk in patients having treatment of the SSV. Periprocedural anticoagulation may be considered in this subset to reduce the risk of DVT after RFA. Thrombus protrusion without DVT was found to be more likely in patients with hypercoagulability, male sex, SSV treatment, and aspirin use. Additional prospective studies are required to analyze these and other factors that may predict thrombotic events after endovenous RFA.

Complications of endovenous ablation in randomized controlled trials.

Endovenous ablation (EVA) of the great saphenous vein (GSV), with radiofrequency (RFA) or laser ablation (EVLA), has largely replaced the standard ligation and stripping (L&S). Several randomized controlled trials (RCTs) have reported data on efficacy of the ablation with little focus on complications. We analyzed the current literature for short-term complications of EVA as compared with L&S. We searched MEDLINE, the Cochrane Central Trials Registry, and individual journals from January 2008 through January 8, 2013 for RCTs comparing RFA and/or EVLA and/or L&S to treat GSV incompetence. We excluded studies using foam sclerotherapy, re-do GSV surgery, or the addition of a high GSV ligation to an EVA procedure. We meta-analysized short-term (<1 year) complications using the Peto odds ratio to elucidate differences between RFA (using the VNUS ClosureFAST catheter; VNUS Medical Technologies, Inc, San Jose, Calif), EVLA, and L&S. Seventeen RCTs met inclusion criteria. There were 317 patients who underwent RFA with ClosureFAST, 1057 patients who had EVLA, and 975 who had L&S. Seventy percent were female with a mean age of 47.5 years. The majority had CEAP clinical class 2 or 3. There was an overall complication rate of 39.6% in the 2624 limbs analyzed over all procedures. There was no evidence of a difference in the rates of venous thromboembolism. There was a significantly higher rate of wound infection for L&S (2.3%; 95% confidence interval [CI], 1.3%-3.1%) vs EVLA (0.5%; 95% CI, 0.3%-1.3%; P=.006), but not between L&S and RFA (1.5%; 95% CI, 0.4%-3.0%; P= .094). The paresthesia rate was significantly lower with EVLA (3.8%; 95% CI, 2.4%-4.5%) as compared with RFA (5.2%; 95% CI, 3.1%-7.9%; P< .001) and L&S (7.4%; 95% CI, 5.3%-8.3%; P< .001). The rate of thrombophlebitis was significantly lower for L&S (3.0%; 95% CI, 2.9%-4.0%) as compared with RFA (5.5%; 95% CI, 3.0%-7.8%; P= .003) and EVLA (5.6%; 95% CI, 4.2%-7.0%; P= .003). There was no difference in the rate of thermal skin burns between RFA and EVLA. Endovenous ablation and ligation and stripping of the GSV are not without complications, although usually minor. L&S has a higher wound infection rate and a lower thrombophlebitis rate as compared with EVA. EVLA has a significantly lower rate of paresthesia as compared with RFAand L&S. Thermal skin burns occur with equal frequency in RFA and EVLA.

Reflux in the Below-knee Great Saphenous Vein Can Be Safely Treated with Endovenous Ablation.

Intervention on the great saphenous vein (GSV) has traditionally been limited to the above-knee (AK-GSV) segment for fear of saphenous neuralgia, in spite of incompetence demonstrated in the below-knee (BK-GSV) segment. Ignoring the refluxing BK-GSV is reported to result in residual symptoms and need for re-intervention in nearly half the patients. Experience with endovenous ablation of the BK-GSV at the time of AK-GSV treatment is sparsely reported in the literature. The aim of this study is to evaluate the safety of endovenous ablation of the refluxing BK-GSV. Data from consecutive patients treated with superficial venous ablation over a 30-month period from January 2010 until August 2012 were retrospectively reviewed. Demographic and procedure-related outcome and complication data were analyzed specifically for patients undergoing BK-GSV interventions. A total 387 patients were treated with superficial venous ablation during the study period. Of those, 38 (47 limbs) underwent BK- GSV ablation for reflux at this site. There were 22 females and 16 males (mean age, 51 years). Median CEAP score was 3; 27 limbs were treated for symptomatic varicose veins (C 1-3) and 20 for advanced venous insufficiency (C 4-6). Five (10.6%) limbs were treated following prior failed intervention with AK-GSV ablation, sclerotherapy, or stripping. Comorbidities included obesity (41.7%) with mean body mass index of 31.4 (range, 19 to 52), obstructive sleep apnea (13.2%), pulmonary hypertension (2.6%), and congestive heart failure (2.6%). Ablation was performed in 45 limbs (97%), utilizing the VenaCure EVLT laser vein treatment (AngioDynamics, Queensbury, NY) and two limbs using RFA (radiofrequency ablation) with ClosureFAST system (VNUS Medical Technologies, San Jose, CA) . Mean GSV length ablated was 51.6 cm (range, 26 to 65 cm). Endovenous ablation was performed concomitantly on 18 accessory GSVs (38.3%) and 4 incompetent perforators (8.5%). Ambulatory stab phlebectomy of branch varicosities was performed simultaneously in 37 (79%) limbs. All veins treated were evaluated with ultrasound on post procedure day 1, and no evidence of endovenous heat induced thrombosis (EHIT) was detected. Seven patients (14.9%) went on to have preplanned sclerotherapy treatment for small branch varicosities. Postoperative hyperesthesia occurred in one patient (2.1%) and resolved within 2 weeks. No patient required repeat endovenous ablation during this period. Wound infection in two (4.3%) stab phlebectomy wounds resolved with oral antibiotic therapy. Endovenous ablation of the refluxing BK-GSV segment can be performed safely with minimal complications. Consideration should be given to concomitant ablation of the BK-GSV when treating patients with varicose veins with reflux extending below the knee to improve long-term outcomes.

Case of the disappearing heat-induced thrombus causing pulmonary embolism during ultrasound evaluation

We report a case of a 58-year-old male patient who underwent successful endovenous radiofrequency ablation of the left great saphenous vein for CEAP class 4a venous disease. On the third postoperative day, he had a duplex ultrasound scan for evaluation which showed successful occlusion of the great saphenous vein (GSV) with class 2 endovenous heat-induced thrombus (EHIT) that disappeared during the evaluation and caused a pulmonary embolism. To our knowledge, no case of pulmonary embolism has been reported to occur during postoperative follow-up duplex scanning. Relevant literature is reviewed and a possible mechanism for thrombus dislodgement is entertained.

Clinical Experience of VNUSⓇClosure fast in Treatment of Varicose Vein: Comparison with Traditional Radiofrequency Ablation

Background: Radiofrequency endovenous ablation of incompetent saphenous vein has gaining popularity over the conventional ligation and stripping as a minimally invasive technique. The latest version of radiofrequency endovenous catheter, VNUS ⓡ Closure fast VNUS medical Technologies, San Jose, CA, adopted a segmental ablation system, instead of continous pullback, is designed to reduce treatment time in comparison with the previous model-VNUS ⓡ Closure plus VNUS medical Technologies, San Jose, CA. The purpose of this study is to compare the difference between two endovenous radiofrequency ablation systems in terms of treatment efficacy and complication rates. We analyze the initial efficacy and complication rates of VNUS ⓡ Closure fast with VNUS ⓡ Closure plus. Material and Method: Between June 2006 and August 2009, VNUS ⓡ Closure plus was performed to treat varicose vein on 59 limbs in 41 patients and VNUS ⓡ Closure fast was performed on 76 limbs in 67 patients. We retrospectively compared in both group with sex, mean treatment time, mean treatment diameter, conjugated treatment, and complications after the procedure. Result: All patient were symptomatic and diagnosed as varicose vein and underwent level 2 clinical classification with color duplex scan. The mean treatment time for the great saphenous vein was significantly less with VNUS ⓡ Closure fast (17.0±6.5 min) than VNUS ⓡ Closure plus (62.7±29.8 min). There was no significant difference in 1 yr closure rate between groups (p=0.32). Minor complications such as skin burn, thrombophlebitis, ecchymosis, hematoma, cellulitis, tenderness, and there were not different between the groups. Conclusion: Both VNUS ⓡ Closure fast and VNUS ⓡ Closure plus are effective methods of endovenous saphenous ablation. VNUS ⓡ Closure fast is superior to the previous model with less treatment time preserving compatible efficacy and complications. The efficacy of VNUS ⓡ Closure fast for long term closure rate remains to be established.

Randomized Clinical Trial of VNUS® ClosureFAST™ Radiofrequency Ablation versus Laser for Varicose Veins

Conclusion: Radiofrequency ablation (RFA) using VNUS ClosureFAST (VNUS Medical Technologies, San Jose, Calif) is associated with less postprocedural pain than endovenous laser ablation (EVLA). Clinical and quality of life improvements for the two procedures are similar at 6 weeks. Summary: Endovenous ablative procedures have largely replaced standard saphenous stripping for treatment of saphenous reflux in patients with primary varicose veins. At the time of publication of this article, only one small randomized trial has compared VNUS ClosureFAST and EVLA (Almeida JI et al, J Vasc Interv Radiol 2009;20:752-9). This current study compares the most utilized technique for EVLA in Great Britain (980-nm wavelength and bare fiber) vs the most popular RFA system in Great Britain (VNUS ClosureFAST). Consecutive patients with primary great saphenous vein reflux were randomized to EVLA or RFA at a single center. The primary outcome measure was postprocedural pain at 3 days. Secondary outcome measures were quality of life at 6 weeks, as determined by the Aberdeen Varicose Vein Questionnaire (AVVQ) and Short Form 12 (SF-12), and clinical improvement using the Venous Clinical Severity Score (VCSS). Analysis was on an intention-to-treat basis. There were 64 patients randomized to EVLA and 67 to RFA. At 3 days, mean (SD) pain scores were 26.4 (22.1) mm for RFA and 36.8 (22.5) mm for EVLA (P = .010). Over 10 days, mean (SD) pain scores were 22.0 (19.8) mm for RFA vs 34.3 (21.1) mm for EVLA respectively (P = .001). Mean number of analgesic tablets used over 3 days and over 10 days was lower for RFA (P = .003) than EVLA (P = .001). There were no differences in AVVQ, SF-12, and VCSS scores at 6 weeks between the two groups (P = .887, P = .076, P = .449, respectively). Comment: The study demonstrated that VNUS ClosureFAST results in significantly less pain than 980-nm EVLA for ablation of the great saphenous veins in treatment of patients with varicose veins. The study supports previous publications that demonstrate less postprocedural pain after RFA but failed to show differences in outcomes after 1 month (Morrisson N, Semin Vasc Surg 2005;18:15-8 and Almeida J, et al, J Vasc Interv Radiol 2009;20:752-9). However, EVLA is continuing to be refined. There are newer fibers with longer wave lengths and jacketed laser fibers that appear to be associated with lower postintervention pain scores (Almeida J, et al. Vasc Endovasc Surg 2009;43:467-72). Data comparing these new devices with VNUS closure system will also eventually be required.

Surgical Management Of Varicose Veins: Meta-analysis

Open surgery remains the gold standard by which endovascular treatment of superficial chronic venous insufficiency is measured. This meta-analysis of randomized controlled trials reviews the current evidence base, comparing open and endovascular treatment of varicose veins. Systematic review of studies reporting duplex scan follow-up after open surgical, laser (endovenous laser therapy [EVLT]), or radiofrequency (VNUS Closure device, VNUS Medical Technologies, San Jose, CA) treatment of refluxing great saphenous veins was completed. Primary outcome measures were occlusion and complication rates and time taken to resume work. No significant difference in recurrence rates at 3 months between open surgery and EVLT (RR 2.19, 95% CI 0.99-4.85, p = .05) or VNUS device (RR 7.57; 95% CI 0.42-136.02) were found. Return to work is significantly faster following VNUS (by 8.24 days; 95% CI 10.50-5.97) or EVLT (by 5.02 days; 95% CI 6.52-3.52). Endovascular treatment of varicose veins is safe and effective and offers the significant advantage of rapid recovery.

A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein

Great saphenous vein (GSV) incompetence is the most common cause of superficial venous insufficiency. Radiofrequency catheter ablation (RFA) is superior to conventional ligation and stripping, and endovenous laser treatment (EVL) has emerged as an effective alternative to RFA. This randomized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results. Between June 2006 and May 2008, patients with symptomatic primary venous insufficiency due to GSV incompetence were randomized to RFA or EVL. Patients with bilateral disease were randomized for treatment of the first leg and received the alternative method on the other. Pretreatment examination included a leg assessment using the Venous Clinical Severity Score (VCSS) and CEAP classification. Patients completed the Chronic Venous Insufficiency Questionnaire 2 (CIVIQ2). RFA was performed with the ClosurePlus system (VNUS Medical Technologies, Sunnyvale, Calif). EVL was performed with the EVLT system (AngioDynamics Inc, Queensbury, NY). Early (1-week and 1-month) postoperative results of pain, bruising, erythema, and hematoma were recorded. Duplex ultrasound (DU) imaging was used at 1 week and 1 year to evaluate vein status. VCSS scores and CEAP clinical class were recorded at each postoperative visit, and quality of life (QOL) using CIVIQ2 was assessed at 1 month and 1 year. The study enrolled 118 patients (141 limbs): 46 (39%) were randomized to RFA and 48 (40%) to EVL, and 24 (20%) had bilateral GSV incompetence. At 1 week, one patient in the RFA group had an open GSV and was deemed a failure. More bruising occurred in the EVL group (P = .01) at 1 week, but at 1 month, there was no difference in bruising between groups. At 1 year, DU imaging showed evidence of recanalization with reflux in 11 RFA and 2 EVL patients (P = .002). The mean VCSS score change from baseline to 1 week postprocedure was higher for RFA than EVL (P = .002), but there was no difference between groups at 1 month (P = .07) and 1 year (P = .9). Overall QOL mean score improved over time for all patients (P < .001). CEAP clinical class scores of >or=3 were recorded in 21 RFA (44%) and 24 EVL patients (44%) pretreatment, but at 1-year, 9 RFA (19%) and 12 EVL patients (24%) had scores of >or=3 (P < .001). This represented a significant improvement in all patients compared with baseline. Both methods of endovenous ablation effectively reduce symptoms of superficial venous insufficiency. EVL is associated with greater bruising and discomfort in the perioperative period but may provide a more secure closure over the long-term than RFA.

Analysis of the postoperative hemodynamic changes in varicose vein surgery using air plethysmography

This study used air plethysmographic parameters to evaluate the changes in venous hemodynamics after the surgical treatment of primary varicose veins. We retrospectively analyzed 1756 limbs of 1620 patients who had undergone surgery for great saphenous vein (GSV) reflux from January 1996 to June 2009 at Samsung Medical Center. Venous hemodynamic changes were evaluated by performing air plethysmography preoperatively and 1 month postoperatively and assessing the venous volume (VV), the venous filling index (VFI), the residual volume fraction (RVF), and the ejection fraction (EF). Preoperatively, median (interquartile range) values were VV, 121.6 (94.7-160.6) mL; VFI, 4.8 (2.9-7.6) mL/s; RVF, 40.6% (29.7%-50.0%); and EF, 53.5% (44.3%-64.1%). Postoperatively, the median (interquartile range) values were VV, 90.6 (69.1-116.8) mL; VFI, 1.4 (0.9-1.9) mL/s; RVF, 28.4% (17.5%-38.7%); and EF, 65.2% (54.5%-77.2%). VV, VFI, and RVF were reduced 25.2%, 71.5%, and 29.9%, respectively; EF was increased 20.3%. The results were significant for all four variables (P < .001). We compared the degree of hemodynamic changes according to the treatment modalities: the high ligation and stripping group , 1578 cases; the GSV valvuloplasty group, 124 cases; and the VNUS group (VNUS Medical Technologies Inc, San Jose, CA), 54 cases. The reduction of the VV, VFI, and RVF was greater in the GSV stripping group and in the VNUS group than in the valvuloplasty group (P < .001), yet no difference was noted in the EF increase among the surgical modalities (P = .157). Our results show that the venous hemodynamic parameters of primary varicose veins were improved after surgical treatment.

Pain Following 980-nm Endovenous Laser Ablation and Segmental Radiofrequency Ablation for Varicose Veins: A Prospective Observational Study

The aim of this study was to evaluate postoperative pain following endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) and identify risk factors for increased pain. Patients undergoing either segmental RFA (VNUS Closure Fast, VNUS Medical Technologies, San Jose, California) or EVLA (980 nm) for varicose veins completed a preoperative disease-specific quality-of-life questionnaire (Aberdeen Varicose Vein Questionnaire [AVVQ]) and a diary card recording postoperative pain, return to normal activities, and return to work. Median 3- and 10-day pain scores were calculated. In all, 81 patients returned diary cards (RFA = 45, EVLA = 36). Patients receiving RFA reported less postoperative pain than those receiving EVLA at 3 days (14.5 vs 25.8 mm, P = .053, Mann-Whitney U test) and 10 days (13 vs 23.3 mm, P = .014, Mann-Whitney U test) and returned to work earlier than those receiving EVLA (median 5 vs 9 days, P = .022). Patients treated with segmental RFA had less postoperative pain and returned to work quicker than those treated with EVLA.

Endovascular radiofrequency ablation: A novel treatment of venous insufficiency in Klippel-Trenaunay patients

Klippel-Trenaunay Syndrome (KTS) is an uncommon congenital disorder of uncertain etiology that comprises the clinical triad of varicose veins, port wine stain, and bony or soft-tissue hypertrophy. The literature suggests that the deep venous system is often under-developed. We propose that duplex venous ultrasound can effectively demonstrate patent deep venous systems in KTS patients with mild to moderate disease, and that endovascular radiofrequency ablation can be utilized in a safe and appropriate therapeutic manner. A single center retrospective review of three patients with KTS treated with endovascular radiofrequency ablation of the KT veins and/or great saphenous veins was conducted. Preoperatively, patients underwent both venography and were studied with color flow duplex ultrasound system iU22 with a 7-5 MHz linear array probe (Philips Medical Systems, NA, Bothell, Wash). The anomalous KT veins, great saphenous and saphenous tributaries, and associated incompetent perforators were ablated with radiofrequency catheters (VNUS Medical Technologies, Inc, San Jose, Calif). All the radiofrequency ablations were complimented by ultrasound guided sclerotherapy of the varicose tributaries and when evident, incompetent perforator veins. The diagnostic series of duplex ultrasounds performed on our KTS patients has demonstrated contiguous deep venous systems in the effected extremity and effectively recognized the associated anomalous superficial venous systems. Our treatment resulted in successful occlusion of the incompetent veins in all three patients. The three patients, females aged 39, 19, and 16, presented with port wine stains and many years of leg-swelling and varicose veins that were recalcitrant to conservative treatment measures, including compression stockings and pulsed-dye laser therapy. Venography initially revealed poorly developed deep venous systems. However, venous ultrasound demonstrated patent and competent deep venous systems in all of the affected limbs. Radiofrequency ablations were performed to manage the sequella of venous insufficiency. At short-term follow-up, all patients demonstrated markedly decreased leg pain, edema, and varicose vein bulging. Three KTS patients were successfully treated with radiofrequency ablation of the incompetent great saphenous and/or anomalous superficial veins. Although the deep veins were poorly visualized on venography, they were clearly demonstrated with duplex ultrasound and functioned adequately once the incompetent superficial veins were ablated.

Evaluation of endovenous radiofrequency ablation and laser therapy with endoluminal optical coherence tomography in an ex vivo model

This study evaluated the ability of endovascular optical coherence tomography (eOCT) to detect qualitative tissue alteration and quantitative changes of vein wall thickness and vein lumen diameter comparing endovenous radiofrequency ablation (RFA) and endovenous laser therapy (ELT) in an established ex vivo model. Endoluminal eOCT was performed by means of a new prototype rotating system (System M1, LightLab Imaging Inc, Boston, Mass) with automatic pullback of 1 mm/s. In the course of an eOCT examination of a 50-mm vein segment, 264 electronic cross section images with a spatial resolution of 15 to 20 mum are acquired. The eOCT scans were performed before and after treatment of each of 13 treated vein segments and of six control vein segments. Thirteen subcutaneous cow foot veins were reperfused in situ, and the defined 50-mm vein segments in the study were treated with RFA (n = 2) and ELT (n = 11). RFA followed the clinical VNUS-Closure protocol (VNUS Medical Technologies, San Jose, Calif) using a 6F 60-mm Closure-Plus catheter. ELT was performed using light of lambda = 980 nm with a laser power of 3 (n = 2), 5 (n = 2), and 7 W (n = 4) with a paced pullback protocol with laser irradiation for 1.5 seconds every 3 mm, resulting in linear endovenous energy densities (LEED) of 15, 25, and 35 J/cm. Using 11 W (n = 3) with a continuous pullback protocol at 3 mm/s resulted in a LEED of 36.5 J/cm. Ten histologic cross sections of each treated and control vein segment were correlated with the corresponding eOCT cross sections to evaluate qualitative representation of vein wall layers and tissue alterations such as ablation and vein wall perforation. In addition, 26 eOCT cross sections of every treated vein segment before and after treatment and every control vein segment were analyzed to calculate quantitative changes in media thickness and vein lumen diameter. In all specimens, qualitative analysis with eOCT demonstrated a clear match with histologic cross sections. A symmetrical, complete, circular disintegration of intima and media structures, without any transmural tissue defects, was shown after RFA. Pronounced semicircular tissue ablations (3 to 14 per 50 mm) and complete vessel wall perforations (0 to 16 per 50 mm) were detected after ELT. The quantitative analysis demonstrated a significant (P < .0001) increase in intima-media thickness after RFA (37.8% to 66.7%) and ELT (11.1% to 45.7%). A significant (P < .0001) reduction of vessel lumen diameter (36.3% to 42.2%) was found after RFA. Owing to the limited number of treated vein segments and inhomogeneous baseline vein lumen diameters, no linear correlation between laser energy level and effects on tissue such as ablation/perforation, media thickening, or vein lumen diameter could be identified. In our ex vivo cow foot model, eOCT is able to reproduce normal vein wall structures and endovenous acute thermal alterations, such as tissue ablation and vessel wall perforations. Endovenous eOCT images can also be analyzed quantitatively to measure media thickness or vein lumen diameter. Endovascular OCT could become a valuable alternative tool for morphologic investigation of tissue alterations after endovenous thermal procedures.

Treatment of Primary Varicose Veins by Endovenous Obliteration with the VNUS Closure System: Results of a Prospective Multicentre Study

BackgroundRadio frequency obliteration of the saphenous veins has been introduced as a less invasive alternative to traditional surgery for varicose veins. ObjectiveTo report the efficacy of obliteration and clinical outcomes following endovenous obliteration of the saphenous vein with limited follow-up to 3 years Materials and methodsRadiofrequency obliteration (Closure® system, VNUS Medical Technologies, San Jose, CA) was performed in 330 limbs of 294 patients in a prospective worldwide multicentre study with 31 participating sites. Follow-up duplex ultrasound and clinical examinations were performed at annual intervals. The main outcome measures were the completeness of occlusion of the treated vein segment, presence of reflux and presence of signs and symptoms of venous disease. ResultsBefore treatment 3.9% of limbs were categorised as CEAP clinical class zero or one. This improved to 82.9% at 1 year, 83.1% at 2 years and 86.8% at 3 years following treatment. Varicose vein free rates were 1 year: 90.1%, 2 years: 87.2%, 3 years: 88.2%. Duplex ultrasound demonstrated a reflux-free rate of about 88% over 3 years. Total occlusion (TO) of veins was 1 year: 81%, 2 years: 80.4% and 3 years: 75%. Partial occlusion (PO, <5cm open segment) was 1 year: 6.3%, 2 years: 7.4% and 3 years: 17.6%. Incomplete occlusion (IO, >5cm open segment) was 1 year: 12.7%, 2 years: 12.2% and 3 years: 7.4%. Partial occlusion did not result in any differences in the symptom severity score, the number of symptom free limbs, or the varicose vein absence rates at any follow-up time point when compared to the total occlusion group. The varicose vein absence rates were significantly lower in the IO group comparing to the TO and PO groups. ConclusionsRadiofrequency saphenous vein obliteration improves the symptoms of varicose veins. The reflux-free rates in the treated veins remain constant over a 3 year follow-up period. There is no difference in clinical outcomes between the TO and the PO limbs, suggesting clinical effectiveness of the PO category. Greater than a 5cm open segment in treated veins poses a risk of recurrence.

The Unresolved Problem of Recurrent Saphenofemoral Reflux

Contemporary surgical treatment of lower-extremity varicosities and chronic venous insufficiency continues to be marred by the development of recurrent reflux, most commonly in the area of the ligated saphenofemoral junction (SFJ). Careful physical examination alone, while notably accurate in assessing lowerextremity arterial occlusive disease, has very poor sensitivity and specificity for detecting the presence, and particularly the source, of recurrent venous reflux. As a consequence, a rather surprising incidence of recurrent saphenofemoral reflux has been progressively unmasked over the past 30 years, beginning with hand-held Doppler assessments in the 1970s and culminating in widespread use of color-coded duplex imaging in the last decade of the 20th century. Systematic duplex scanning shows persistent or new connections allowing reflux of femoral vein blood into remnants of the superficial system within one or two years after SFJ ligation and greater saphenous vein (GSV) stripping, even in patients operated on in centers with a special focus on venous disease (Fig. 1). The prevalence of recurrent reflux appears to increase with additional years of followup, with 60% of the limbs of patients surviving 30 or more years after ligation and stripping showing demonstrable reflux at, or nearby, the site of the former junction. Approximately 40% of these limbs develop clinically distressing new varicosities (Fig. 2) and recurrent venous insufficiency symptoms sufficient to warrant further treatment. Despite repeated admonitions to ligate the GSV flush with the surface of the femoral vein and to transect all medial and lateral tributaries entering the saphenous vein in the area of the junction, the commonest findings at reexploration are a patent, intact SFJ and overlooked junctional tributaries. Duplex scanning also often shows new connecting veins that have presumably arisen in response to an angiogenic stimulus inherent to the surgical procedure. These are more commonly found in cases where redissection of the fossa ovalis confirms that the first procedure was anatomically correct and did interrupt all of the junctional tributaries. Typically, this neovascularity takes the form of multiple, small, convoluted, epifascial channels converging on the site of the former SFJ. In a perplexing number of instances they exist as a single conduit, juxtaposed to the site of an anatomically correct ligation, and conveying clinically Dr Chandler and Dr Bergan are paid consultants to VNUS Medical Technologies, Inc.

Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized controlled trial with comparison of the costs

Objective: The aim of this randomized study was to compare a new method of endovenous saphenous vein obliteration (Closure System, VNUS Medical Technologies, Inc, Sunnyvale, Calif) with the conventional stripping operation in terms of short-term recovery and costs. Methods: Twenty-eight selected patients for operative treatment of primary greater saphenous vein tributary varicose veins were randomly assigned to endovenous obliteration (n = 15) or stripping operation (n = 13). Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day. The length of sick leave was determined. The RAND-36 health survey was used to assess the patient health-related quality of life. The patient conditions were controlled 7 to 8 weeks after surgery, and patients underwent examination with duplex ultrasonography. The comparison of costs included both direct medical costs and costs resulting from lost of productivity of the patients. Costs that were similar in the study groups were not considered in the analysis. Results: All operations were successful, and the complication rates were similar in the two groups. Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group (at rest: 0.7, standard deviation [SD] 0.5, versus 1.7, SD 1.3, P =.017; on standing: 1.3, SD 0.7, versus 2.6, SD 1.9, P =.026; on walking: 1.8, SD 0.8, versus 3.0, SD 1.8, P =.036; with t test). The sick leaves were significantly shorter in the endovenous obliteration group (6.5 days, SD 3.3 days, versus 15.6 days, SD 6.0 days; 95% CI, 5.4 to 12.9; P <.001, with t test). Physical function was also restored faster in the endovenous obliteration group. The estimated annual investment costs of the closure operation were US $3360. The other direct medical costs of the Closure operation were about $850, and those of the conventional treatment were $360. With inclusion of the value of the lost working days, the Closure treatment was cost-saving for society, and when 40% of the patients are retired (or 60% of the productivity loss was included), the Closure procedure became cost-saving at a level of 43 operations per year. Conclusion: Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for society, especially among employed patients. Because the procedure is also associated with shorter convalescence, this new method may potentially replace conventional varicose vein surgery. (J Vasc Surg 2002;35:958-65.)