Results of the post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE)
Section snippets
Study design
ReVOLVE was an investigator-initiated registry of commercial implants performed between February 2009 and November 2012. Patients receiving the HeartWare system for labeled indications only are included in this report. Data were collected at nine centers in Europe7 and Australia.2 We report here the data on patients’ demographics, the most common adverse events, length of support and outcomes. ReVOLVE was not sponsored by HeartWare, Inc., although the company did provide support and assisted in
Results
A total of 314 commercial implants were collected in the ReVOLVE study at these nine centers. Off-label cases (BiVAD use or right VAD use, age <18 years) accounted for 27 of the cases, and another 33 implants were performed using a thoracotomy approach. This report excludes those off-label patients and thoracotomy implants (addressed in separate studies). Baseline patient data for the 254 on-label cases are presented in Table 1. Mean age of patients was 52.5 ± 12.0 years, and females accounted
Discussion
Data from the ReVOLVE study demonstrate continued high-level safety and performance of the HeartWare system as an LVAD. The small size and pericardial placement permit a less invasive implant procedure and theoretically less post-operative morbidity.
Compared with the HeartWare system CE Mark Trial,7 commercial patients (patients who are not in REVOLVE Registry) were older (52.5 vs 48.5 years) with 64% more females (23% vs 14%) in the commercial group as compared with the CE Mark Trial group.
Limitations
The ReVOLVE study data were collected retrospectively, and therefore comparisons to clinical trials and other post-market trials should be interpreted with caution due to inherent differences in reporting and trial design. Variability may also exist in patient selection and management at the different ReVOLVE participating centers. Finally, as with other registries, the data were not monitored, and therefore reporting inconsistencies and/or data collection biases cannot be excluded.
In
Disclosure statement
M.S. has received research support and consulting fees from HeartWare, Inc. D.Z. receives research support from HeartWare, Inc.
The other authors have no conflicts of interest to disclose.
We thank Marc T. Swartz and Mary V. Jacoski, both of HeartWare, Inc., for analysis and editorial support in preparation of this manuscript. This study was supported in part by HeartWare, Inc.
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