Randomized clinical trial comparing a thermosensitive polymer (LeGoo®) versus conventional vessel loops for temporary coronary artery occlusion during off-pump coronary artery bypass surgery

Objective: A bloodless surgical field is mandatory for visualization and optimal construction of coronary anastomoses. Presently used temporary vascular occluders are known to cause endothelial dysfunction/vessel injury. This multicenter randomized study evaluates safety/efficacy of a novel thermosensitive polymer (LeGoo) as an atraumatic temporary vascular occluder.

Methods: Between 8/2008 and 2/2010, 110 patients undergoing off-pump coronary artery bypass surgery were randomized between the use of LeGoo (LG, 56 patients) or vessel loops (VL, 54 patients) for temporary vascular occlusion. A semi-quantitative scale evaluating degree of bloodless surgical field and surgical comfort was used. Time of functional artery occlusion was recorded. Safety was evaluated during the operation and thirty day follow-up through incidence of a composite endpoint: all-cause death, graft occlusion, myocardial infarction, and low cardiac output.

Results: Satisfactory hemostasis was achieved in 86.3% (107 of 124) of LG anastomoses and only 60.0% (72 of 120) of VL anastomoses (P<0.001). Mean coronary anastomosis time was 12.8 minutes in LG and 15.4 minutes in VL (P<0.001). Safety data at one-month were available on 94 patients: 3 of 48 LG patients and 2 out of 46 VL patients experienced a composite adverse event. There was one death in LG group. 1 patient experienced myocardial infarction in LG group, and 1 in VL group.

Conclusion: LeGoo is a safe and effective temporary occlusion device. It offered advantages in surgical comfort and anastomotic visualization over conventional techniques, and resulted in shorter anastomotic times. Adverse events were comparable between groups.