Insanity of left ventricular assist therapy: doing the same thing and expecting different results.

Abstract

The success or failure of left ventricular assist device (LVAD) therapy can be measured in several ways. The landmark clinical trials, REMATCH1 and INTrEPID,2defined success in terms of mortality and morbidity, compared with standard medical therapy. Indeed, these are the primary benchmarks used by the US Food and Drug Agency when evaluating a device for market approval. On a grander scale, success may be measured in terms of the popularity or use of the therapy. In this respect, LVAD therapy could be deemed as an abject failure. Thirty years ago, the Office of Technology Assessment projected the annual need to be on the order of 100,000 in the United States and 200,000 worldwide3; yet the current rate of LVAD implantation has yet to achieve 5% of this target.</p