Results with the Novacor assist system and evaluation of long-term assistance

Objective: The great number of patients awaiting heart transplant and the s hortage of donors has led to the increasing use of left ventricular assist devices (LVAD) for those patients that cannot wait only on medical therapy. In this study we analyze our experience in order to evaluate the possibili ty of long-term assistance. Methods: We have implanted LVAD Novacor in 36 p atients with a mean age of 50.4 years. They were all critical candidates fo r transplant on high doses of inotrops. We evaluated the clinical and hemod ynamic results and studied statistically the relative risk of complications at different time intervals of support. Results: In all cases we had a sta tistically significant improvement of: cardiac output, wedge pressure, pulm onary vascular resistance and mean pulmonary pressure. Eleven patients died on the device, 23 underwent heart transplant and two are still on the devi ce. Causes of death were mostly related to cerebrovascular events or multio rgan failure. Seven of the 23 patients who underwent heart transplant died with a survival rate after transplant of 69.5% and an overall survival rate of 50%. Complications occurred in 33 patients with: 24 strokes, eight TIAs , four cerebral hemorrhages, three peripheral embolisms, seven cable infect ions, two pocket infections, two sepsis, two major lung infections, one med iastinitis, one right ventricular failure and three multiorgan failure. Tim e-related analysis showed that these complications occurred mostly during t he first 3 months of assistance and this is particularly true for cerebrova scular events. The incidence of infections remained constant during the fol lowup period. With a mean time of assistance of 203.1 days we had only two cases of device malfunction at 662 and 1297 days. Conclusions: LVAD Novacor has provided reliable mechanical performance and good hemodynamic improvem ent. Most complications seem to occur in the first 90 days, therefore long- term assistance could be considered. A reduction of the high rate of thromb oembolic complications remains mandatory to improve the clinical results. ( C) 2000 Elsevier Science B.V. All rights reserved.