The European experience of Novacor left ventricular assist (LVAS) therapy as a bridge to transplant: a retrospective multi-centre study

Objective: Artificial heart devices have suffered from a negative press bas ed on the early Jarvik experience of the 1980s. This is in stark contrast t o realities of current left ventricular assist (LVAS) therapy. The Novacor N100 PC wearable left ventricular assist system (LVAS) was introduced in Eu rope in late 1993. This system allows implanted recipients to be completely autonomous with the system controlled by a small computer and powered by r echargeable batteries. This report represents the initial European experien ce with the Novacor LVAS. Methods: Since the system was introduced with reg ulatory approval as a commercial product, clinicians were not bound by the constraints of a study protocol and only minimal data were collected. This report presents the results of a retrospective study of 118 consecutive pat ients who had the LVAS implanted as a bridge to transplant, in 19 centres o ver the three year period ending in November 1996. Results: Mortality and m orbidity varied widely between centres. The median implant time was 115 day s (0-585 days) and 33% of patients returned home, supported by the LVAS. Th e overall survival on LVAS was 64%. The major causes of death were infectio n (14%) and MOF (6%). There were no significant device or system failures d espite a cumulative patient experience of 24.8 years outside of a hospital environment. Patient selection and management varied greatly between centre s and this was reflected in disparate outcomes, Conclusions: Optimal select ion and management of LVAS patients has still to be established, While the data available for this report lacked the detail necessary to demonstrate d irect causal relationships between selection and management, it was clear f rom the inter-centre differences that these two factors have a major impact on outcomes. This early experience has directed attention towards improved management regimes. Given the results obtained from the best centres and t he ability to discharge patients to lead near-normal lives in the community , the authors believe that the Novacor LVAS now offers a real therapeutic a lternative for selected end-stage heart failure patients for whom a donor h eart is unavailable or who are unsuitable for transplantation. (C) 1999 Els evier Science B.V. All rights reserved.