Concurrent prophylactic left atrial appendage exclusion: results from a randomized controlled trial pilot study☆

OBJECTIVE: The left atrial appendage is a significant source of cardioembolic thrombi. Open mitral valve surgery presents an opportune time to exclude this appendage from cardiovascular circulation. However, sparse randomized trial support exists for this concomitant procedure. We therefore designed a randomized controlled trial to assess the short- and long-term outcomes of concomitant left atrial appendage exclusion. This report details early outcomes of the pilot trial. METHODS: Forty-three patients were randomized to either undergo concomitant suture exclusion of their left atrial appendage under direct vision or not during their open mitral valve surgery. Clinical and biochemical postoperative outcomes, including hemodynamic and hemostatic parameters, were analyzed. RESULTS: There were no deaths in either group. The incidence of cerebrovascular events, myocardial infarction, respiratory failure, and acute renal injury were similar between groups; a composite outcome of 10 major postoperative complications occurred in 32% of the left atrial appendage exclusion group versus 38% of the control group (p=0.75). Intensive care (median stay 2 days vs 1 day in the control group, p=0.55) and hospital lengths of stay (median stay 9 days in both groups, p=0.98) were also similar between groups. Specifically, no additional hemodynamic alterations (need for intra-aortic balloon pump in 1 vs 2 patients in the control group, p=0.61) or hemostatic complications (no re-operations for bleeding in either group, need for blood product transfusion in 2 vs 1 patient in the control group, p=1.0) were noted in the left atrial appendage exclusion group. CONCLUSIONS: This pilot trial demonstrates the safety of and feasibility of a larger trial powered to detect clinically relevant short- and long-term outcomes of concomitant left atrial appendage exclusion with open mitral valve surgery.