Affiliation:
1. Department of Vascular Surgery, Singapore General Hospital, Singapore
2. Department of General Surgery, Changi General Hospital, Singapore
3. Clinical Trials & Research Unit, Changi General Hospital, Singapore
Abstract
Objectives The aim of this prospective single-centre study is to assess the effectiveness and patient experience of the VenaSeal™ Closure System, a novel non-thermal, non-tumescent catheter technique, which uses cyanoacrylate glue to occlude the refluxing truncal superficial veins to treat varicose veins and chronic venous insufficiency, in a multi-ethnic Asian population from Singapore. Methods Seventy-seven patients (93 legs; 103 procedures) underwent VenaSeal™ Closure System ablation. Forty-nine (63.6%) for great saphenous vein incompetence, 16 (20.8%) bilateral great saphenous vein, 2 (2.6%) small saphenous vein and 10 (13.0%) combined unilateral great saphenous vein and small saphenous vein/anterior thigh vein reflux. In addition, 65/93 legs (69.9%) had C4–C6 disease. Patients were reviewed at 2 weeks, 3, 6 and 12 months post-procedure. Results There was 100% technical success. 28/77 (36.4%) underwent concomitant phlebectomies. All procedures were well tolerated with a mean post-operative pain score of 3.0 (range: 0–5). After three months, median patient satisfaction was 9.0 (interquartile range: 7.0–10.0). At two-week follow-up, the great saphenous vein was completely occluded in 88/88 (100%) veins and small saphenous vein completely closed in 11/11 (100%) veins. At three-month follow-up, the great saphenous vein was occluded in 51/53 (96.2%) veins and small saphenous vein completely closed in 5/5 (100%) veins. At six-month follow-up, the great saphenous vein was completely occluded in 42/45 (93.3%) veins and small saphenous vein completely closed in 5/7 (71.4%) veins. At one year, great saphenous vein and small saphenous vein occlusion rates were 54/59 (91.5%) and 5/8 (62.5%), respectively. There was one deep vein thrombosis. Transient superficial phlebitis was reported in 10/93 (10.8%) legs, which were all self-limiting. There were 9/103 (8.7%) anatomical recurrences, but no patients required re-intervention as they were asymptomatic. Conclusions Cyanoacrylate glue is a safe and efficacious modality to ablate refluxing saphenous veins in Asian patients in the short term. There is a high satisfaction rate and peri-procedural pain is low. Early results are promising but further evaluation and longer term follow-up are required.
Subject
Cardiology and Cardiovascular Medicine,General Medicine
Cited by
26 articles.
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