OBJECTIVES: to compare the result of vein valve disruption with two different valvulotomes during non-reversed saphenous vein bypass. DESIGN: a randomised, blinded clinical study. MATERIALS AND METHODS: twenty patients undergoing femorodistal non-reversed saphenous vein arterial bypass were randomised into two equal groups. Valve leaflet disruption was performed either with a standard size plastic valvulotome or with a metal valvulotome with an exchangeable cutting head. Valvulotomy was done after full exposure of the vein and completion of the proximal anastomosis. The result was evaluated by a surgeon blinded to the valvulotome used, using angioscopy. RESULTS:a total of 219 valve cusps were inspected with angioscopy. There were 83 completely lysed cusps (69%) by plastic and 76 (78%) by metallic valvulotomes (p=0.14). Of all the incompletely lysed cusps 12 (29%) occurred in the most proximal valve pocket treated with valvulotomy. CONCLUSIONS: no significant difference in performance between the investigated valvulotomes was found. Incomplete valvulotomy occurred mainly in the proximal part of the vein and was obviously caused by a size mismatch between the diameter of vein and the valvulotome. Construction of a valvulotome with a variable diameter cutting head is therefore recommended. Copyright 1999 W.B. Saunders Company Ltd.
RCT Entities:
OBJECTIVES: to compare the result of vein valve disruption with two different valvulotomes during non-reversed saphenous vein bypass. DESIGN: a randomised, blinded clinical study. MATERIALS AND METHODS: twenty patients undergoing femorodistal non-reversed saphenous vein arterial bypass were randomised into two equal groups. Valve leaflet disruption was performed either with a standard size plastic valvulotome or with a metal valvulotome with an exchangeable cutting head. Valvulotomy was done after full exposure of the vein and completion of the proximal anastomosis. The result was evaluated by a surgeon blinded to the valvulotome used, using angioscopy. RESULTS: a total of 219 valve cusps were inspected with angioscopy. There were 83 completely lysed cusps (69%) by plastic and 76 (78%) by metallic valvulotomes (p=0.14). Of all the incompletely lysed cusps 12 (29%) occurred in the most proximal valve pocket treated with valvulotomy. CONCLUSIONS: no significant difference in performance between the investigated valvulotomes was found. Incomplete valvulotomy occurred mainly in the proximal part of the vein and was obviously caused by a size mismatch between the diameter of vein and the valvulotome. Construction of a valvulotome with a variable diameter cutting head is therefore recommended. Copyright 1999 W.B. Saunders Company Ltd.