Implantable Cardioverter-Defibrillators and Cardiovascular Resynchronization Therapy with Left Ventricular Assist DevicesA MOMENTUM 3 Trial Analysis

Abstract

Background

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

Methods

An analysis was done of the Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) randomized clinical trial and the first 1000 patients in the Continued Access Protocol (CAP) trial. Patients were divided into 3 groups based on the presence of an ICD and/or CRT-D: No device (n = 153, 11%), ICD only (n = 699, 50.4%), and CRT-D (n = 535, 38.6%). We assessed the association of ICDs or CRT-Ds with overall mortality, ventricular arrhythmias (VAs), rehospitalization rates, quality of life, and the 6-minute walk test distance at 2 years’ follow-up.

Results

Patients with an ICD or CRT-D had similar survival to those without (hazard ratio [HR], 1.3; 95% CI 0.8–2.1, P = .36) with no differences in rehospitalizations, quality of life or 6-minute walk test distance. VA occurred more frequently in patients with an ICD or CRT-D (HR, 2.4; 95% CI 1.3-4.3, P = .006). Compared with an ICD alone, patients with a CRT-D demonstrated similar survival (HR, 1.1; 95% CI 0.9–1.5, P = .36). However, they had increased rates of VA (HR, 1.3; 95% CI 1.0–1.7, P = .03). There were no differences in rate of rehospitalization between those with an ICD or CRT-D and those without (P = .19) or between those with an ICD and those with a CRT-D (P = .32). A propensity-matched sensitivity analysis confirmed these findings.

Conclusions

In this post-hoc analysis of the MOMENTUM 3 trial, the presence of an 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)