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Clinical Trial
. 2023 Aug 29;82(9):771-781.
doi: 10.1016/j.jacc.2023.05.066.

Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device

Aditi Nayak  1 , Shelley A Hall  2 , Nir Uriel  3 , Daniel J Goldstein  4 , Joseph C Cleveland Jr  5 , Jennifer A Cowger  6 , Christopher T Salerno  7 , Yoshifumi Naka  8 , Douglas Horstmanshof  9 , Daniel Crandall  10 , AiJia Wang  10 , Mandeep R Mehra  11
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Free article
Clinical Trial

Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device

Aditi Nayak et al. J Am Coll Cardiol. .
Free article

Abstract

Background: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3, Abbott) left ventricular assist device (LVAD), it is unknown how preimplant factors and postimplant index hospitalization events influence 5-year mortality in those able to be discharged.

Objectives: The goal was to identify risk predictors of mortality through 5 years among HM3 LVAD recipients conditional on discharge from index hospitalization in the MOMENTUM 3 pivotal trial.

Methods: This analysis evaluated 485 of 515 (94%) patients discharged after implantation of the HM3 LVAD. Preimplant (baseline), implant surgery, and index hospitalization characteristics were analyzed individually, and as multivariable predictors for mortality risk through 5 years.

Results: Cumulative 5-year mortality in the cohort (median age: 62 years, 80% male, 65% White, 61% destination therapy due to transplant ineligibility) was 38%. Two preimplant characteristics (elevated blood urea nitrogen and prior coronary artery bypass graft or valve procedure) and 3 postimplant characteristics (hemocompatibility-related adverse events, ventricular arrhythmias, and estimated glomerular filtration rate <60 mL/min/1.73 m2 at discharge) were predictors of 5-year mortality. In 171 of 485 patients (35.3%) without any risk predictors, 5-year mortality was reduced to 22.6% (95% CI: 15.4%-32.7%). Even among those with 1 or more predictors, mortality was <50% at 5 years (45.7% [95% CI: 39.0%-52.8%]).

Conclusions: Long-term survival in successfully discharged HM3 LVAD recipients is largely influenced by clinical events experienced during the index surgical hospitalization in tandem with baseline factors, with mortality of <50% at 5 years. In patients without identified predictors of risk, long-term 5-year mortality is low and rivals that achieved with heart transplantation, even though most were implanted with destination therapy intent. (MOMENTUM 3 IDE Clinical Study Protocol, NCT02224755; MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS, NCT03982979).

Keywords: MOMENTUM 3; advanced heart failure; left ventricular assist device; long-term survival; mechanical circulatory support; predictors of prognosis.

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Conflict of interest statement

Funding Support and Author Disclosures This study was sponsored by Abbott. The sponsor had a role in design of the study, selection of centers, data collection, and analyzing study data. The decisions on manuscript development and submission were within the primary purview of the academic investigators. The manuscript writing, revision, and decision to submit for publication were driven by the trial publications and presentation committee. The sponsor did not control the decision to which journal the manuscript was submitted. The sponsor approved the manuscript prior to submission. The manuscript was written and reviewed by the authors. The sponsor assisted with all data requests under the direction of the first and corresponding author. Dr Hall is a consultant/advisory board member for Abbott, Abiomed, Evaheart, CareDx, and Natera. Dr Uriel is on the advisory board for Livemetric, Revamp, and Leviticus; and has received grant support from Abbott, Abiomed, and Fire1. Dr Goldstein has served as a medical advisory board member for Abbott; and has served as a consultant for Abbott and Abiomed. Dr Cleveland has served as a Clinical Events Committee and Data and Safety Monitoring Board member for Abbott Studies. Dr Cowger has served as a consultant for Abbott, Medtronic, Bioventrix, Endotronix, and Procyrion; and has received grant support and speaker fees from Abbott. Dr Salerno has received personal fees from Abbott and Medtronic. Dr Naka has received personal fees from Abbott. Dr Horstmanshof has served as a consultant for Abbott. Dr Crandall and Ms Wang are employees of Abbott. Dr Mehra has received payment made to institution from Abbott for consulting; has received consulting fees from Mesoblast, Janssen, Moderna, Paragonix, and Baim Institute for Clinical Research; and has served as an advisory board member for Transmedics, NuPulseCV, Leviticus, and FineHeart.

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