An Analysis of Post-Implant Severe Right Heart Failure in Real-World Use of the HeartWare (TM) HVAD (TM) System in Destination Therapy
Tedford RJ, Potapov E, Cowger JA, Hayward C, Rich JD, Kusmierczyk M, Jacoski MV, Lavine K, and Moazami N. An Analysis of Post-Implant Severe Right Heart Failure in Real-World Use of the HeartWare (TM) HVAD (TM) System in Destination Therapy. J Heart Lung Transplant 2021; 40(4):S435-S435.
J Heart Lung Transplant
Purpose: Patients with the HeartWare HVAD require careful medical management in order to maintain an INR within therapeutic range (2-3) and prevent thrombotic events. We compared the incidence of epistaxis in patients with the HVAD and HeartMate 3 using propensity score matching (PSM).
Methods: Ninety-eight patients implanted with a left ventricular assist device (LVAD) from 2015-2020 were included in this study. Patients were matched on the basis of baseline characteristics, including age, gender, body mass index (BMI), indication, etiology, concomitant procedures, and the right ventricular assist device (RVAD) usage.
Results: To our knowledge, this is the first study to perform a PSM comparison of epistaxis events in patients with the HVAD and HeartMate 3. After matching, there were no significant differences in any of the baseline characteristics between groups ( P >0.05 for all). Patients with the HVAD were more likely to suffer from epistaxis than HeartMate 3 patients (43% vs 18%, P = 0.027), an absolute risk increase of 25% (95% CI 5.7-44.3%) and a number needed to harm of 4 patients (95% CI 2.3-17.6). In both the univariate and multivariate analyses, HVAD usage was significantly associated with epistaxis ( P <0.05). Independent predictors of epistaxis were found to be HVAD usage (OR 3.39, 95% CI 1.13-11.15, P = 0.034) and out of range INR at discharge (OR 7.16, 95% CI 2.46-23.09, P <0.001). Out of range INR was also associated with a significantly longer length of stay ( P = 0.01). Between patients with the HVAD and those with the HeartMate 3, there were no significant differences in length of stay, survival, and whether INR at discharge was in therapeutic range ( P >0.05 for all).
Conclusion: Patients with the HVAD may be at a greater risk for developing epistaxis than those with the HeartMate 3. However, other outcomes such as length of stay and survival are comparable. Prospective, multi-center studies should be done to accurately assess the impact of device type on clinical outcomes following LVAD implantation.