Results of the post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE)

https://doi.org/10.1016/j.healun.2014.01.856Get rights and content

Background

The post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated registry established to collect post–CE Mark Trial clinical data on patients receiving a HeartWare ventricular assist device (HVAD) in the European Union and Australia.

Methods

The ReVOLVE is a multi-center, prospective, single-arm registry performed at seven centers in Europe and two in Australia. Herein we describe a total of 254 commercial HVAD implants according to labeled indications between February 2009 and November 2012. Summary statistics included patients’ demographics, adverse events, length of support and outcomes.

Results

Compared with the clinical trial supporting the CE Mark of the HeartWare system, patient selection differed in that patients were older, and there were higher proportions of females and patients with idiopathic cardiomyopathies in the ReVOLVE cohort. Duration of support ranged from 1 to 1,057 days, with a mean of 363 ± 280 days (median 299.5 days). Transplantation was done in 56 patients (22%), explant for recovery was performed in 3 patients (1%), 43 died while on support (17%), and 152 (60%) remain on the device. Success in patients with the HeartWare system was 87% at 6 months, 85% at 1 year, 79% at 2 years and 73% at 3 years. Adverse event rates were low, comparable or improved when compared to the CE Mark Trial.

Conclusion

Real-world use of the HeartWare system continues to demonstrate excellent clinical outcomes in patients supported with the device.

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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