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Published on: June 12, 2021
Implantable Cardioverter Defibrillators in Patients With Continuous Flow Left Ventricular Assist Devices: Utilization
Paulino A Alvarez1,2, Brett W Sperry1,3, Antonio L Pérez1
11 Department of Cardiovascular Medicine Cleveland Clinic Foundation Cleveland OH.
Insights
Implantable cardioverter defibrillators (ICDs) do not appear to improve survival in patients with left ventricular assist devices (LVADs). The study found no mortality benefit, despite significant ICD-related complications and procedures in LVAD patients.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Outcomes
Background:
- The impact of implantable cardioverter defibrillators (ICDs) on outcomes in patients with continuous flow left ventricular assist devices (LVADs) lacks randomized clinical trial data.
- This study addresses the clinical utility of ICDs in the LVAD population.
Purpose of the Study:
- To evaluate the association between pre-existing implantable cardioverter defibrillators (ICDs) and outcomes in patients with continuous flow left ventricular assist devices (LVADs).
- To assess the mortality benefit and morbidity associated with ICDs in LVAD recipients.
Main Methods:
- Retrospective single-center study of 486 patients undergoing continuous flow LVAD implantation (October 2004 - March 2017).
- Patients were analyzed based on the presence or absence of an ICD at the time of LVAD insertion.
- Multivariable analysis and time-varying covariate analysis were used to assess mortality risk.
Main Results:
- Of 486 patients, 387 (79.6%) had a pre-LVAD ICD. Patients with ICDs were older and had fewer pre-LVAD interventions.
- 81 patients (21.4% of those with ICDs) required 93 procedures post-LVAD (generator exchanges, lead revisions, system removals).
- The presence of a pre-LVAD ICD was not significantly associated with mortality (HR 1.19, P=0.492), nor was an ICD analyzed as a time-varying covariate (HR 1.05, P=0.907).
Conclusions:
- There is no apparent mortality benefit of having an implantable cardioverter defibrillator (ICD) in contemporary patients with continuous flow left ventricular assist devices (LVADs).
- The potential morbidity from ICD-related procedures and complications may outweigh any survival advantage in this patient population.
Abstract:
Background The effect of implantable cardioverter defibrillators ( ICD ) in patients with continuous flow left ventricular assist devices ( LVAD s) on outcomes has not been evaluated in a randomized clinical trial. Methods and Results This is a retrospective single-center study that included patients who underwent continuous flow LVAD implantation at the Cleveland Clinic between October 2004 and March 2017. Patients were evaluated according to the presence or absence of ICD at the time of LVAD insertion. Among 486 patients in the study cohort, 387 (79.6%) had an ICD before LVAD insertion. Patients with ICD before LVAD were older and had lower use of pre- LVAD inotropes, extracorporeal membrane oxygenation, and mechanical ventilation. There were 81 patients (21.4% of patients with ICD ) who required 93 procedures after LVAD : 74 generator exchanges, 12 lead revisions, and 7 complete system removals because of infection. Of the 99 patients without ICD , 52 (53%) underwent ICD implantation: 29 for primary prevention and 23 for secondary prevention. Patients were followed for a median of 401 (interquartile range 150-966) days. The presence of a pre- LVAD ICD was not associated with mortality in a multivariable model (hazard ratio 1.19, 95% CI 0.73-1.93, P=0.492), nor was the presence of an ICD at any point when analyzed as a time-varying covariate (hazard ratio 1.05, 95% CI 0.50-2.20, P=0.907). Conclusions There is no apparent mortality benefit associated with an ICD in a contemporary cohort of patients with continuous flow LVAD s to balance considerable morbidity involving ICD -related procedures and complications.
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