Implantable Cardioverter-Defibrillators and Cardiovascular Resynchronization Therapy with Left Ventricular Assist Devices: A MOMENTUM 3 Trial Analysis.

Abstract

Background: The benefit of implantable cardioverter-defibrillators (ICD) and cardiovascular resynchronization therapy (CRT-D) in patients supported with a HeartMate 3 left ventricular assist device (LVAD) remains uncertain.

Methods: An analysis of the MOMENTUM 3 randomized clinical trial and the first 1000 patients in the Continued Access Protocol trial. Patients were divided into three groups based on the presence of ICD and/or CRT-D: No device (n=153, 11%), ICD only (n=699, 50.4%), CRT-D (n=535, 38.6%). We assessed the association of ICD or CRT-D with overall mortality, ventricular arrhythmias (VA), rehospitalization rates, quality of life and six-minute walk test distance at 2-years of follow-up.

Results: Patients with ICD or CRT-D had similar survival to those without (HR 1.3, 95% CI 0.8-2.1, p=0.36) with no differences in rehospitalizations, quality-of-life or six-minute walk test distance. VA occurred more frequently in patients with ICD or CRT-D (HR 2.4, 95% CI 1.3-4.3, p=0.006). Compared to ICD alone, patients with CRT-D demonstrated similar survival (HR 1.1, 95% CI 0.9-1.5, p=0.36), however, had increased rates of VA (HR 1.3, 95% CI 1.0-1.7, p=0.03). There were no differences in rate of rehospitalization between those with ICD or CRT-D and those without (p=0.19) or between those with ICD and those with CRT-D (p=0.32). A propensity-matched sensitivity analysis confirmed these findings.

Conclusions: In this post-hoc analysis of the MOMENTUM 3 trial, the presence of ICD or CRT-D at the time of HM3 LVAD implantation was associated with an increased incidence of VA but was not associated with survival, quality of life or functional capacity.

Trial registration: Momentum 3 portfolio, NCT02224755 (Pivotal) and NCT02892955 (CAP).