Implantable Cardioverter-Defibrillators and Cardiovascular Resynchronization Therapy with Left Ventricular Assist
Gabriel Sayer1, Mustafa M Ahmed2, Mandeep R Mehra3
1Division of Cardiology, Columbia University Irving Medical Center, New York, New York.
Insights
Implantable cardioverter-defibrillators (ICDs) and CRT-Ds did not improve survival or quality of life in HeartMate 3 LVAD patients. However, these devices were associated with a higher incidence of ventricular arrhythmias.
Area of Science:
- Cardiology
- Medical Devices
- Heart Failure Management
Background:
- The efficacy of implantable cardioverter-defibrillators (ICDs) and cardiovascular resynchronization therapy defibrillators (CRT-Ds) in patients with a HeartMate 3 left ventricular assist device (LVAD) is not well-established.
- The MOMENTUM 3 trial provided data on patients with LVADs, but the specific impact of concomitant defibrillator therapy requires further investigation.
Purpose of the Study:
- To evaluate the association of ICDs and CRT-Ds with clinical outcomes in patients receiving a HeartMate 3 LVAD.
- To compare the outcomes between patients with no defibrillator, ICD only, and CRT-D in the context of LVAD support.
Main Methods:
- A post-hoc analysis of the MOMENTUM 3 randomized clinical trial and its Continued Access Protocol (CAP) was performed.
- Patients were stratified into three groups: no device, ICD only, and CRT-D.
- Outcomes including overall mortality, ventricular arrhythmias (VAs), rehospitalization, quality of life, and 6-minute walk test distance were assessed at 2-year follow-up.
Main Results:
- Patients with ICDs or CRT-Ds showed similar survival and rehospitalization rates compared to those without defibrillator support.
- The incidence of ventricular arrhythmias (VAs) was significantly higher in patients with ICDs or CRT-Ds.
- Compared to ICD alone, CRT-D was associated with similar survival but increased VA rates.
Conclusions:
- The implantation of an ICD or CRT-D alongside a HeartMate 3 LVAD did not confer survival benefits or improve quality of life or functional capacity.
- These devices were, however, associated with an increased incidence of ventricular arrhythmias in this patient population.
- The findings suggest a need for careful consideration regarding the routine use of ICDs/CRT-Ds in conjunction with HeartMate 3 LVADs.
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).
