A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial).

BACKGROUND: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. METHODS: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. RESULTS: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. CONCLUSION: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months. REGISTRATION NUMBER: NTR 4821 (www.trialregister.nl).

Safety and Effectiveness of Endovenous Thermal Ablation for Incompetent Saphenous Veins with an Aneurysm Close to the Junction.

OBJECTIVE: The aim was to evaluate the safety and effectiveness of endovenous thermal ablation (EVTA) with or without adding high ligation (HL) for the treatment of incompetent saphenous veins with an aneurysm (>20 mm for the great saphenous vein, >15 mm for the small saphenous vein) close to the junction. METHODS: This was a prospective observational cohort study in a single centre. All patients presenting with saphenous aneurysms close to the junction were included. Those with a venous aneurysm more distally, at >2 cm from the junction, or with associated deep venous aneurysms were excluded. Patients were treated with EVTA alone or combined with HL in cases of an aneurysm with a diameter >30 mm. Phlebectomies were performed during the same treatment session. Patients were followed up one and six weeks, and one year after treatment. Duplex ultrasound (DUS) was performed to evaluate occlusion of the vein and aneurysm as well as possible complications such as endovenous heat induced thrombosis (EHIT) or deep vein thrombosis (DVT). Venous clinical severity scores (VCSS) were registered before and one year after treatment. RESULTS: Thirteen patients (15 limbs) were included between February 2012 and January 2015. Eleven limbs were treated with EVTA alone, the remaining four limbs with EVTA and HL. No severe adverse events occurred (no EHIT, no DVT). After one year none of the aneurysms was still visible on DUS and the truncal obliteration rate was 80% (two partial, one segmental recanalisation). Both treatment strategies showed significant improvement of the VCSS at the one year follow up, from a median score of 6 (interquartile range [IQR] 5-7) to 2 (IQR 1-3) (p = .001). CONCLUSION: EVTA with or without HL appeared to be a safe and effective treatment for patients presenting with incompetent saphenous veins with an aneurysm close to the junction.

Editor's Choice - Five Year Results of Great Saphenous Vein Treatment: A Meta-analysis.

OBJECTIVES: The most frequently used treatment options for great saphenous vein incompetence are high ligation with stripping (HL+S), endovenous thermal ablation (EVTA), mainly consisting of endovenous laser ablation (EVLA) or radiofrequency ablation, and ultrasound guided foam sclerotherapy (UGFS). The objective of this systematic review and meta-analysis was to compare the long-term efficacy of these different treatment modalities. METHODS: A systematic literature search was performed. Randomised controlled trials (RCTs) with follow-up ≥ 5 years were included. Pooled proportions of anatomical success, which was the primary outcome, rate of recurrent reflux at the saphenofemoral junction (SFJ), and mean difference in venous clinical severity score (VCSS) were compared using a z test or Student t test. Quality of life data were assessed and described. RESULTS: Three RCTs and 10 follow-up studies of RCTs were included of which 12 were pooled in the meta-analysis. In total, 611 legs were treated with EVLA, 549 with HL+S, 121 with UGFS, and 114 with HL+EVLA. UGFS had significantly lower pooled anatomical success rates than HL+S, EVLA, and EVLA with high ligation: 34% (95% CI 26-44) versus 83% (95% CI 72-90), 88% (95% CI 82-92), and 88% (95% CI 17-100) respectively; p ≤ .001. The pooled recurrent reflux rate at the SFJ was significantly lower for HL+S than UGFS (12%, 95% CI 7-20, vs. 29%, 95% CI 21-38; p ≤ .001) and EVLA (12%, 95% CI 7-20, vs. 22%, 95% CI 14-32; p = .038). VCSS scores were pooled for EVLA and HL+S, which showed similar improvements. CONCLUSION: EVLA and HL+S show higher success rates than UGFS 5 years after GSV treatment. Recurrent reflux rates at the SFJ were significantly lower in HL+S than UGFS and EVLA. VCSS scores were similar between EVLA and HL+S.