Clinical Predictors of 5-year Outcomes Following Heartmate 3 Left Ventricular Assist Device Implant: The Momentum 3 Trial

Document Type

Conference Proceeding

Publication Date

4-1-2023

Publication Title

J Heart Lung Transplant

Abstract

Purpose: The MOMENTUM 3 pivotal trial reported a median survival that exceeds 5-years in patients supported with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD), even in transplant ineligible patients (JAMA 2022;328:1233-1242). Additionally, a HM 3 Risk Score with 6 pre-implant clinical characteristics was developed to predict 2-year outcome in those being considered for HM3 implantation (JACC Heart Fail 2022;online). However, it remains unknown how pre-implant variables in concert with implant related events during the index hospitalization influence 5-year outcomes, especially among those successfully discharged.

Methods: We plan to utilize outcome data from the pivotal MOMENTUM 3 trial, conducted at 69 US centers, among 515 patients from the trial who were randomized to receive the HM3 (median age: 62 years, 20% female, 28% black, 62% destination therapy) in whom a survival of 58.4% was demonstrated at 5-years. The primary goal is to develop and validate clinical predictors for 5-year outcomes including survival, cause specific mortality and serious adverse events in patients successfully implanted with the HM3 pump and able to be discharged from the index hospitalization. In addition to pre-implant clinical characteristics, we shall evaluate surgical events, concomitant procedures, hemocompatibility and non-hemocompatibility related adverse events encountered peri-operatively, end organ function and discharge to a home setting as potential predictors for 5-year survival. Secondarily, we shall ascertain age and sex-based assessment of net survival time prediction at 5-years among this cohort, stratified by intended goal including bridge to transplant, bridge to candidacy or destination therapy.

Endpoints: We expect that the detection of comprehensive clinical predictors (particularly events encountered during implant surgery and index hospitalization) for 5-year outcomes with HM3 LVAD support will guide efforts to enhance processes of medical and surgical care and improve quality of patient outcomes. Importantly, knowledge of patient-specific outcomes will enable clinicians to engage in informed patient centered counseling, estimate individualized long-term outcomes and plan appropriate management strategies in patients implanted with the HM3 LVAD.(NCT02224755 and NCT03982979)

Volume

42

Issue

4

First Page

S88

Last Page

S89

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