The BVS 5000 biventricular assist device. The worldwide registry experience.

The BVS 5000 is an extracorporeal pulsatile assist device for temporary univentricular or biventricular support. A registry of BVS 5000 usage has enrolled 420 patients between June 1987 and February 1994. Data were voluntarily contributed from more than 60 centers in 15 countries. The device has been implanted for post-cardiotomy shock (n = 211), cardiomyopathy (n = 94), acute myocardial infarction (AMI) shock (n = 44), failed transplant (n = 45), and other indications (n = 26). Device support was biventricular in 65% of patients, left in 29%, and right in 5%. Mean length of support was 5.2 days. Of the patients, 78% were men and 81% were 60 years of age or younger. In the post-cardiotomy group, 116 (55%) were weaned or bridged, and 27% were discharged. Seventy percent of cardiomyopathy patients went on to transplant, of which 39 (58%) were discharged. Of the patients with AMI shock, 52% underwent transplant, and 16 (70%) of these were discharged. The use of ventricular support in the setting of post-cardiotomy is explored and compared with the standard practice of supporting patients with inotropes and intra-aortic balloon pumps (IABP). Analysis of the poor outcomes and high cost of standard practice suggests that ventricular assist may positively affect outcomes in this population. This multi-institutional experience supports the use of the BVS 5000 for short-term ventricular assistance and suggests the need for additional study of ventricular support in the post-cardiotomy setting.