The status of failure and reliability testing of artificial blood pumps.

Artificial blood pumps are today's most promising bridge-to-transplant, bridge-to-recovery, and destination therapy solutions for patients with congestive heart failure. There is a critical need for increased reliability and safety as the next generation of artificial blood pumps approach final development for long-term destination therapy. To date, extensive failure and reliability studies of these devices are considered intellectual property and thus remain unpublished. Presently, the Novacor N100PC, Thoratec VAD, and HeartMate LVAS (IP and XVE) comprise the only four artificial blood pumps commercially available for the treatment of congestive heart failure in the United States. The CardioWest TAH recently received premarket approval from the US Food and Drug Administration. With investigational device exemptions, the AB-180, AbioCor, LionHeart, DeBakey, and Flowmaker are approved for clinical testing. Other blood pumps, such as the American BioMed-Baylor TAH, CorAide, Cleveland Clinic-Nimbus TAH, HeartMate III, Hemadyne, and MagScrew TAH are currently in various stages of mock loop and animal testing, as indicated in published literature. This article extensively reviews in vitro testing, in vivo testing, and the early clinical testing of artificial blood pumps in the United States, as it relates to failure and reliability. This detailed literature review has not been published before and provides a thorough documentation of available data and testing procedures regarding failure and reliability of these various pumps.