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Using an Artificial Heart as a Bridge to Transplant

A potential option for critically ill adults awaiting donor hearts

For patients with end-stage heart failure, cardiac transplantation improves quality of life and longevity. Unfortunately, not enough donor hearts are available for the estimated 30,000 to 70,000 Americans who could benefit from them. Mechanical circulatory-support devices (left-ventricular and biventricular assist devices) are approved as "bridges to transplant" and as destination therapy for people who are not transplant candidates. However, such devices can be associated with adverse neurologic events, infection, bleeding, and poor outcomes, and are contraindicated in many patients.

In a manufacturer-funded, prospective study of patients with end-stage biventricular heart failure, researchers tested the investigational CardioWest Total Artificial Heart (TAH), which "completely replaces the patient's native ventricles and all four cardiac valves orthotopically." The 130-person cohort comprised an 81-patient protocol group who were awaiting transplantation, were at high risk for imminent death, and were unsuitable for LVAD therapy (most because of severe right-heart failure); 35 controls who received medical therapy alone; and 14 patients who did not meet the protocol-inclusion criteria but received the TAH on a compassionate-use basis.

The protocol group fared better than the control group in the rate of survival to transplantation (79% vs. 46%) and in post-transplantation survival rates at 1 year (86% vs. 69%) and 5 years (64% vs. 34%). (According to the U.S. Organ Procurement and Transplantation Network, survival rates after heart transplantation are 85% at 1 year and 70% at 5 years.) Among all 95 TAH recipients, the most common adverse events were bleeding (62%) and infection (77%).

Comment: Compared with medical therapy alone, implantation of this total artificial heart yielded better survival rates to and after cardiac transplantation in appropriate candidates with end-stage biventricular heart failure. The TAH also yielded better outcomes than have been documented in previous studies of left-ventricular assist devices. Pending FDA approval, the CardioWest TAH is another option for critically ill adults awaiting donor hearts, although costs must be considered when applying such new technologies to patient care.

— William T. Abraham, MD

Published in Journal Watch Cardiology October 15, 2004

Citation(s):

Copeland JG et al. for the CardioWest Total Artificial Heart Investigators. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004 Aug 26; 351:859-67.

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