Technical considerations in the development of clinical systems for temporary and permanent cardiac support

Summary

Fundamental distinctions exist between systems designed for temporary (<15 days) and long-term (>2 years) ventricular support. These are illustrated with a description of two ABIOMED systems: an extracorporeal system (“the BVS”) designed for short-term in-hospital use and an implantable system (“the VAS”) designed for longterm ambulatory use. In the last decade, temporary support to either or both ventricles has moved from the research laboratory to the clinical arena. During this same period, devices designed for permanent assist or total replacement have entered an intensive reliability testing phase with some limited clinical trials. Temporary systems are indicated for postcardiotomy ventricular dysfunction, post-MI cardiogenic shock, and as a bridge to cardiac transplantation. Indications for permanent support are essentially identical to those for cardiac transplantation, namely: end-stage cardiomyopathies of ischemic, viral, or unknown etiology. The BVS system, currently undergoing clinical trials, was developed for in-hospital temporary use following technical considerations designed to expand clinical applicability of cardiac support beyond research and teaching hospitals. The VAS system, currently undergoing reliability tests, was developed following technical criteria designed to minimize the risks of thromboembolism, infection, and other potential complications in permanently implanted ambulatory recipients.