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.
Introduction The VenaSeal™ Closure System is a non-thermal, non-tumescent venous closure device that employs a cyanoacrylate adhesive to occlude incompetent veins for superficial truncal reflux. The aim was to examine patient, Duplex-defined venous characteristics and treatment-related factors that may predict variances in remnant stump length at the sapheno-femoral and sapheno-popliteal junctions in the peri-procedural period. Methods A total of 73 patients (87 legs; 85 great saphenous veins; 11 small saphenous veins) of median age 63 years (range 26–86 years) underwent VenaSeal™ Closure System ablation. 44/85 (52%) great saphenous veins were treated with a modified instructions-for-use technique of using double-dose injection of glue (0.3 cc) at initial deposition for great saphenous veins diameters >6 mm. Median great saphenous veins and small saphenous veins lengths ablated were 48.0 cm (range 13–69 cm) and 32.0 cm (range 19–40 cm), respectively. A total of 62/87 (71.3%) legs had CEAP classification 4–6. A completion Duplex scan was performed immediately and 1 week post-procedure to measure remnant stump lengths at the sapheno-femoral and sapheno-popliteal junctions. Multivariate regression modelling was used to look for predictors of remnant stump length. Results Mean sapheno-femoral and sapheno-popliteal junctions stump lengths immediately post procedure were 33.0 mm (range 0–58 mm) and 27 mm (range 5–33 mm), –17.0 mm and –23.0 mm less than the expected 50-mm baseline length, respectively. At 1 week post-procedure, mean sapheno-femoral and sapheno-popliteal junctions stump lengths were 25.0 mm and 25.0 mm, respectively, the former found to be shorter compared to immediately post-procedure (25 mm vs 33 mm; p < 0.05). Multivariate analysis found larger upper thigh great saphenous veins diameter at sapheno-femoral junction to be predictive of shorter remnant stump lengths immediately post-procedure (<30 mm stump distance). Larger sapheno-femoral junction diameters and pre-existing ischemic heart disease for the sapheno-femoral junction and larger small saphenous veins diameters and age for the sapheno-popliteal junction were predictive of interval shortening of the measured remnant lengths found at the completion of the procedure and 1 week later. Initial double-dosing application of glue was not found to be predictive of shorter stump lengths. Conclusion In patients undergoing VenaSeal™ Closure System ablation for superficial truncal reflux, larger upper thigh great saphenous veins diameters predicted shorter remnant sapheno-femoral junction stump lengths immediately post-procedure. Comparing stump lengths at one week to immediately after procedure, larger sapheno-femoral junctions and ischemic heart disease predicted shorter stump lengths at the sapheno-femoral junction, while larger small saphenous vein diameters predicted shorter stump lengths at the sapheno-popliteal junction.
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