Adverse Events During the First Year on Continuous flow LVAD Support: The Rabin Medical Center Experience

Background: Since the approval of the HeartMate II by the FDA in 2008, the use of LVADs has steadily climbed. Concomitantly, the first year free of major adverse events defined as: thrombotic event, device malfunction, bleeding, infection and death has improved from 20% to 30%. Data on the first year freedom of major events in Israel has not been described yet.

Methods: The first year major events of the 59 consecutive LVAD implanted patients at RMC f 07/2008 until 03/2015 were evaluated. An analysis of the relationship between the first year event and: DM, HTN, CRF, COPD, etiology for HF, indication for LVAD implantation, gender, and age at transplantation was performed.

Results: During the first year post LVAD implantation, 36 (61%) patient had a major adverse event. Fourteen (24%) patients had an infection, 12 (20%) had a thrombotic event and 6 (10%) patients had bleeding events. None of the patients had pump failure and 10 (17%) patients had died. In the univariate analysis (table 1) we found that men (n= 49, P= 0.03) and CRF (n=24, P=0.006) were predictive values for a first year major adverse event. In the multivariate analysis we found that only CRF (n=24, p = 0.001) remained a strong predictive value for a first year major event.

Conclusions: During the first year post continuous flow LVAD implantation at the RMC 39% of the 59 patients were free of major events: better than the 30% reported in contemporary literature.

CRF is the strongest predictive factor for the occurrence of an adverse event during the first year after continuous flow LVAD implantation.