Two-Year Outcome after Implantation of a Full Magnetically Levitated Left Ventricular Assist Device: Results from the ELEVATE Registry

Abstract

Background: The ELEVATE Registry was designed to study long-term outcomes with the Heartmate 3 (HM3), a fully magnetically levitated centrifugal ventricular assist device, in a real-world population following CE-mark approval. Methods: A total of 540 patients implanted in Europe and the Middle East were followed in ELEVATE. Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. Full data sets were available of 463 patients receiving the HM3 as primary implant (Primary Implant Cohort). In addition, the Registry Full Cohort included also pump upgrades from another device (19 patients, Pump Exchange Cohort) and patients experiencing an outcome before having the possibility to sign the Informed Consent for which only outcome data were collected (Anonymized Cohort). The two-year outcomes for the Primary Implant and Full Cohort are presented. Findings: Mean age was 55·6 ± 11·7 years (89% male, 48% ischemic cardiomyopathy). Seventy percent of patients were in INTERMACS Profile 1-3 (Profile 1: 9%, 2:22%, 3:39%) and 12·7% were on temporary mechanical circulatory support. Primary Implant Cohort survival was 83% and Full cohort survival 74·5% after two years. In the Primary Implant Cohort, strokes were observed in 9·7%, gastrointestinal bleedings in 9·7%, pump thrombosis in 1·5% and outflow graft twists in 3·5%. HM3 implantation resulted in a sustained improvement of functional capacity (mean 6MWD increase of 180 meters) and QOL (mean score increase of 31 points). Interpretation: ELEVATE demonstrates good long-term survival rates and sustained improvement of functional capacity in a real-world population with the HM3 ventricular assist device. Adverse event rates including pump thrombosis remain low up to two years. Trial Registration: ClinicalTrials.gov Identifier: NCT02497950 Funding Statement: The ELEVATE Registry was funded by Abbott. Declaration of Interests: Daniel Zimpfer: research grant and advisor, Abbott; Finn Gustafsson: consultant, Abbott; Evgenij Potapov: institutional travel grant, consultant and proctor for Abbott; Yuriy Pya: nothing to declare; Jan Schmitto: consultant and research grant, Abbott; Michael Berchtold-Herz: travel grants, Abbott; Michiel Morshuis: nothing to declare; Steven Shaw: consultant, Abbott; Diyar Saeed: consultant, Abbott; Jacob Lavee: nothing to declare; Gerald Heatley: Abbott employee; Carlo Gazzola: Abbott employee; Jens Garbade: consultant, Abbott. Ethical Approval Statement: The registry was conducted in accordance with the Declaration of Helsinki and its protocol and informed consent form were approved by each institution’s Ethics Committee.