Predictors of Recanalization of the Great Saphenous Vein in Randomized Controlled Trials 1 Year After Endovenous Thermal Ablation.

OBJECTIVE/BACKGROUND: The objective was to identify predictors to develop and validate a prognostic model of recanalization of the great saphenous vein (GSV) in patients treated with endovenous thermal ablation (EVTA). METHODS: The search strategy of Siribumrungwong was updated between August 2011 and August 2014 using MEDLINE, Embase, and the Cochrane register to identify randomized controlled trials (RCTs), in which patients presenting with GSV reflux were treated with radiofrequency or endovenous laser ablation. Leg level data (n = 1226) of 15/23 selected RCTs were pooled. The primary outcome was recanalization of the GSV; the secondary outcome was change in health related quality of life (HRQoL) measured by the Chronic Venous Insufficiency quality of life Questionnaire or Aberdeen Varicose Vein Questionnaire 1 year post-procedure. Candidate predictors were age, sex, body mass index, clinical class, GSV diameter, saphenofemoral junction reflux, type of device, energy, and length of treated vein. RESULTS: At 1 year, 130 GSVs were recanalized (11%). Clinical class (odds ratio [OR] 2.1, 95% confidence interval [CI] 1.4-3.3) and diameter (OR 1.8, 95% CI 1.2-2.7) of the GSV were the strongest predictors of recanalization. Other predictors included in the final model were sex, type of device, and length of treated vein. The performance of the recanalization model was moderate, with an area under the curve above 0.717. GSV diameter, type of device, and amount of energy delivered were the only predictors of the change of HRQoL. None of the candidate predictors were included in the final HRQoL model (R(2) = .027). CONCLUSION: There are several important prognostic factors for GSV recanalization and change of HRQoL after EVTA. However, the performance of each model was unsatisfactory to allow use in clinical practice yet.

Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins.

BACKGROUND: This randomized trial compared four treatments for varicose great saphenous veins (GSVs). METHODS: Five hundred consecutive patients (580 legs) with GSV reflux were randomized to endovenous laser ablation (980 and 1470 nm, bare fibre), radiofrequency ablation, ultrasound-guided foam sclerotherapy or surgical stripping using tumescent local anaesthesia with light sedation. Miniphlebectomies were also performed. The patients were examined with duplex imaging before surgery, and after 3 days, 1 month and 1 year. RESULTS: At 1 year, seven (5.8 per cent), six (4.8 per cent), 20 (16.3 per cent) and four (4.8 per cent) of the GSVs were patent and refluxing in the laser, radiofrequency, foam and stripping groups respectively (P < 0.001). One patient developed a pulmonary embolus after foam sclerotherapy and one a deep vein thrombosis after surgical stripping. No other major complications were recorded. The mean(s.d.) postintervention pain scores (scale 0-10) were 2.58(2.41), 1.21(1.72), 1.60(2.04) and 2.25(2.23) respectively (P < 0.001). The median (range) time to return to normal function was 2 (0-25), 1 (0-30), 1 (0-30) and 4 (0-30) days respectively (P < 0.001). The time off work, corrected for weekends, was 3.6 (0-46), 2.9 (0-14), 2.9 (0-33) and 4.3 (0-42) days respectively (P < 0.001). Disease-specific quality-of-life and Short Form 36 (SF-36(®)) scores had improved in all groups by 1-year follow-up. In the SF-36(®) domains bodily pain and physical functioning, the radiofrequency and foam groups performed better in the short term than the others. CONCLUSION: All treatments were efficacious. The technical failure rate was highest after foam sclerotherapy, but both radiofrequency ablation and foam were associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping.

Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.

OBJECTIVE: This study aims to compare the outcome 2years after treatment of varicose veins by endovenous laser ablation (EVLA) or surgery by assessing recurrence, venous clinical severity score (VCSS) and quality of life. METHODS: A total of 121 patients (137 legs) were randomised to either EVLA or saphenofemoral ligation and stripping of the great saphenous vein (GSV). Follow-up included clinical and duplex ultrasound examinations, VCSS and quality of life questionnaires. RESULTS: A total of 18 (26%) and 25 patients (37%) in the EVLA and surgery group, respectively, developed recurrent varicose veins (not significant (NS) between groups). The source of reflux was not significantly different between the groups. Technical failure occurred in three EVLA and two surgery patients, reflux in the anterior accessory GSV, the groin, thigh and calf perforators was found in six, two, four, and three EVLA patients, and in three, three, nine and six surgery patients. VCSS, Aberdeen Varicose Vein Severity Score and several domains of the Medical Outcomes Study Short Form 36 (SF36) quality of life score improved significantly in both groups. CONCLUSIONS: No significant differences in clinical or ultrasound recurrences were found between EVLA and surgery groups. Our study also shows that similar improvements in clinical severity scores and quality of life were gained in both treatments.