Combined Registry for the Clinical Use of Mechanical Ventricular Assist Pumps and the Total Artificial Heart in conjunction with heart transplantation: sixth official report--1994.

BACKGROUND

The Combined Registry has existed since 1985 with a design toward the voluntary submission of data from centers undertaking mechanical circulatory assistance.

METHODS

The compiled results of the Combined Registry for the Clinical Use of Mechanical Ventricular Assist Pumps and the Total Artificial Heart was reviewed and subjected to strict statistical evaluation.

RESULTS

More than 2000 implanted devices have been reported through January 1994, and 584 of these have been placed with the intention of bridge to heart transplantation. Nearly 70% of these patients have subsequently undergone heart transplantation, and 69% of those patients have survived to discharge from the hospital. Outcome statistics continue to favor isolated left ventricular support, although only discharge rates are significantly improved over right (p = 0.01) or biventricular assistance (p < 0.001) and the total artificial heart (p < 0.001). Within the group of left ventricular devices no individual mode of support proved advantageous over the others for transplantation or discharge rates. The 30-day mortality for all devices is approximately 36%, which remains much higher than that for orthotopic heart transplants. Isolated left ventricular support, however, had a 30-day mortality of only 9% with similar improvement in 12- and 24-month survival.

CONCLUSIONS

These data show the continued success with these devices for bridging critically ill patients to transplantation. Additionally, it supports the ongoing development of devices implanted for long-term use, which might replace orthotopic transplantation for those patients currently deemed marginal candidates.