Postcardiotomy shock: clinical evaluation of the BVS 5000 Biventricular Support System.

This prospective trial evaluated the safety and efficacy of a new pulsatile, temporary ventricular assist device, the BVS 5000. Patients were 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 first attempt to separate from cardiopulmonary bypass. Fifty-five postcardiotomy patients were enrolled; 31 met all selection criteria and the remainder failed to meet criteria (n = 15) or were not successfully supported (n = 9). The BVS 5000 effectively restored hemodynamics: Mean arterial pressure increased (77.1 +/- 8.0 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 influenced by presupport cardiac arrest events. Survival among patients not experiencing arrest was 47%. Eight patients are long-term survivors and were asymptomatic in New York Heart Association class I or II at 1-year follow-up. The BVS 5000 restored hemodynamics, permitted myocardial recovery, and improved survival in a group of patients who would have otherwise died.