A systematic review and meta-analysis of mechanochemical endovenous ablation using Flebogrif for varicose veins: A summary of evidence.

Abstract

OBJECTIVE\nTo review and analyse the currently available literature on Flebogrif and define its role in the global varicose vein treatment devices market.\n\n\nMETHODS\nA systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies were eligible if they included patients treated with Flebogrif for saphenous vein incompetence, were published in English, and had full text available. Methodologic quality of the articles was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. A random-effects model was used to estimate the primary outcome of anatomical success, defined as occlusion rate of the treated vein. The estimate is reported with the 95% confidence interval (CI). Secondary outcomes were clinical success, complication rate, pain during and after the procedure, and time to return to work.\n\n\nRESULTS\nFive articles met the inclusion criteria, reporting 348 procedures in 392 patients. Four studies reported the 3-month anatomical success and three studies reported the 12-month anatomical success. The pooled 3-month anatomical success rate was 95.6% (95% CI, 93.2%-98.0%). The 12-month anatomical success rate was 93.2% (95% CI, 90.3%-96.1%). The only major complication reported within 3 months was deep venous thrombosis, which was seen in 0.3% of the patients. The minor complications thrombophlebitis and hyperpigmentation were seen in 13.3% to 14.5% and in 3.3% to 10.0%, respectively, within 3 months. The methodological quality of the studies included was moderate.\n\n\nCONCLUSION\nMOCA using the Flebogrif device is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, well-designed studies of sufficient sample size and follow-up are required to compare the effectiveness with other endovenous treatment modalities and define the definitive role of the Flebogrif device.