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Results with the Novacor assist system and evaluation of long-term assistance
I Di Bella1, F Pagani, C Banfi
1Department of Cardiac Surgery, Policlinico San Matteo, IRCCS, Piazzale Golgi 2, 27100, Pavia, Italy.
Insights
Left ventricular assist devices (LVAD) offer reliable mechanical performance and hemodynamic improvement for heart transplant candidates. While complications are common early on, long-term assistance is feasible with reduced thromboembolic events.
Area of Science:
- Cardiology
- Mechanical Circulatory Support
- Transplantation
Background:
- Increasing heart transplant waiting lists and donor shortages necessitate advanced support options.
- Left Ventricular Assist Devices (LVADs) are crucial for patients awaiting heart transplantation.
- Medical therapy alone is insufficient for critically ill patients nearing transplant eligibility.
Purpose of the Study:
- To evaluate the long-term viability of LVAD assistance.
- To analyze clinical and hemodynamic outcomes of LVAD implantation.
- To assess the risk of complications associated with LVAD support over time.
Main Methods:
- Implantation of the Novacor LVAD in 36 critically ill patients awaiting heart transplant.
- Evaluation of clinical and hemodynamic parameters.
- Statistical analysis of complication risks at different support intervals.
Main Results:
- Significant improvements observed in cardiac output, wedge pressure, and pulmonary pressures.
- High complication rate (33/36 patients), predominantly cerebrovascular events and infections within the first 90 days.
- Overall survival rate of 50%, with 23 patients successfully transplanted.
Conclusions:
- The Novacor LVAD demonstrates reliable mechanical function and hemodynamic benefits.
- Early complications, particularly thromboembolic events, necessitate mitigation strategies for improved outcomes.
- Long-term LVAD support is a viable option, contingent on managing early-onset complications.
Objective:
The great number of patients awaiting heart transplant and the shortage 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 possibility of long-term assistance.
Methods:
We have implanted LVAD Novacor in 36 patients with a mean age of 50.4 years. They were all critical candidates for transplant on high doses of inotrops. We evaluated the clinical and hemodynamic results and studied statistically the relative risk of complications at different time intervals of support.
Results:
In all cases we had a statistically significant improvement of: cardiac output, wedge pressure, pulmonary vascular resistance and mean pulmonary pressure. Eleven patients died on the device, 23 underwent heart transplant and two are still on the device. Causes of death were mostly related to cerebrovascular events or multiorgan 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 infections, two pocket infections, two sepsis, two major lung infections, one mediastinitis, one right ventricular failure and three multiorgan failure. Time-related analysis showed that these complications occurred mostly during the first 3 months of assistance and this is particularly true for cerebrovascular events. The incidence of infections remained constant during the follow-up 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 improvement. Most complications seem to occur in the first 90 days, therefore long-term assistance could be considered. A reduction of the high rate of thromboembolic complications remains mandatory to improve the clinical results.