POSTCARDIOTOMY SHOCK - CLINICAL-EVALUATION OF THE BVS-5000 BIVENTRICULAR SUPPORT SYSTEM

This prospective trial evaluated the safety and efficacy of a new puls atile, temporary ventricular assist device, the BVS 5000. Patients wer e eligible for treatment if they were hemodynamically unstable despite maximal pharmacologic and intraaortic balloon pump therapy, were free of concomitant complications, and were less than 6 hours from the fir st attempt to separate from cardiopulmonary bypass. Fifty-five postcar diotomy patients were enrolled; 31 met all selection criteria and the remainder failed to meet criteria (n = 15) or were not successfully su pported (n = 9). The BVS 5000 effectively restored hemodynamics: Mean arterial pressure increased (77.1 +/- 0.8 mm Hg on-support versus 50.1 +/- 15.3 mm Hg presupport; p = 0.0001). Cardiac index increased (2.3 +/- 0.3 L . min-1 . m-2 on-support versus 1.6 +/- 0.6 L . min-1 . m-2 presupport; p = 0.0013). Left ventricular filling pressure decreased ( 11.9 +/- 4.5 mm Hg on-support versus 23.8 +/- 8.7 mm Hg presupport; p = 0.0030). The most frequent complication was bleeding in 42 patients (76%). Of the patients meeting all criteria, 17 (55%) were weaned from support and 9 (29%) were discharged. Survival was significantly influ enced by presupport cardiac arrest events. Survival among patients not experiencing arrest was 47%. Eight patients are long-term survivors a nd were asymptomatic in New York Heart Association class I or II at 1- year follow-up. The BVS 5000 restored hemodynamics, permitted myocardi al recovery, and improved survival in a group of patients who would ha ve otherwise died.