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DOI: 10.1055/s-0039-1679021
Long-Term Support of Patients Receiving a Left Ventricular Assist System for Advanced Heart Failure
Publication History
Publication Date:
28 January 2019 (online)
Background: The HeartWare centrifugal flow ventricular assist device system (HVAD) is approved for treatment of advanced heart failure. The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is a multicenter registry that collected post-CE Mark clinical data on patients implanted with the HVAD System as a BTT in the European Union and Australia.
The last follow-up of patients from the ReVOLVE post-CE Mark registry reported continued excellent survival of 68, 63, and 59% at 3, 4, and 5 years, respectively.
This extended-term follow-up analysis of ReVOLVE aims to demonstrate the longest formal analysis of reliability and durability of the HeartWare ventricular assist device system.
Methods: The ReVOLVE study is an investigator-initiated, prospective review of the HVAD in commercial use following initial CE Mark approval in 2009.
A total of 248 patients implanted with the HVAD Pump as a left ventricular assist device at 9 centers in Europe and Australia between February of 2009 and November 2012 were included, with follow-up previously reported through January 2015. This extended follow-up will report on those patients through June 2018.
Results: Thirty percent of patients were still alive on support with a mean follow-up of 1,464 days at the time of the last follow-up report. Extended follow-up on those patients will be reported.
Conclusions: The paucity of donor hearts leads to longer support times for patients on LVAD support awaiting transplantation. This report will demonstrate extended survival and adverse event burden on an HVAD System.