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Association between implanted cardioverter-defibrillators and mortality for patients with left ventricular ejection
Jason H Wasfy1, Aditya Achanta2, Michael K Hidrue3
1Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA JWASFY@mgh.harvard.edu.
Insights
Implanted cardioverter-defibrillators (ICD) showed no mortality benefit for patients with left ventricular ejection fraction (LVEF) near 35%. Further trials are needed to confirm efficacy for primary prevention in this LVEF range.
Area of Science:
- Cardiology
- Medical Devices
- Public Health
Background:
- Consensus guidelines recommend implanted cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death in patients with cardiomyopathy and left ventricular ejection fraction (LVEF) ≤35%.
- Evidence supporting ICD efficacy in patients with LVEF near 35% is limited due to underpowered past trials.
- Future large-scale trials for this specific population are unlikely.
Purpose of the Study:
- To evaluate the association between ICD implantation and mortality in patients with LVEF between 30% and 35%.
- To assess the efficacy of ICDs for primary prevention in the narrow LVEF range near the guideline threshold.
- To conduct a secondary analysis for patients with LVEF between 36% and 40%.
Main Methods:
- Retrospective analysis of echocardiography data from Massachusetts General Hospital (2001-2020).
- Identification of patients with LVEF 30-35% without prior ICD implantation.
- Propensity score matching and time-dependent Cox proportional hazards models were used to assess ICD association with mortality.
Main Results:
- The analytical cohort included 6109 patients after applying inclusion/exclusion criteria.
- Propensity score matching revealed no statistically significant association between ICD implantation and mortality (HR 0.93, 95% CI 0.75-1.15).
- Patients receiving ICDs were more likely to be male, white, and have a history of ventricular tachycardia or myocardial infarction.
Conclusions:
- ICD therapy was not associated with reduced mortality in patients with LVEF near the 35% threshold.
- The study findings are consistent with existing trial data but cannot definitively prove lack of efficacy.
- A well-powered clinical trial is necessary to definitively determine the efficacy of primary prevention ICDs in patients with LVEF between 30% and 35%.
Background:
Consensus guidelines support the use of implanted cardioverter-defibrillators (ICD) for primary prevention of sudden cardiac death in patients with either non-ischaemic or ischaemic cardiomyopathy with left ventricular ejection fraction (LVEF) ≤35%. However, evidence from trials for efficacy specifically for patients with LVEF near 35% is weak. Past trials are underpowered for this population and future trials are unlikely to be performed.
Methods:
Patients with lowest LVEF between 30% and 35% without an ICD prior to the lowest-LVEF echo (defined as 'time zero') were identified by querying echocardiography data from 28 November 2001 to 9 July 2020 at the Massachusetts General Hospital linked to ICD treatment status. To assess the association between ICD and mortality, propensity score matching followed by Cox proportional hazards models considering treatment status as a time-dependent covariate was used. A secondary analysis was performed for LVEF 36%-40%.
Results:
Initially, 526 440 echocardiograms representing 266 601 unique patients were identified. After inclusion and exclusion criteria were applied, 6109 patients remained for the analytical cohort. In bivariate unadjusted comparisons, patients who received ICDs were substantially more often male (79.8% vs 65.4%, p<0.0001), more often white (87.5% vs 83.7%, p<0.046) and more often had a history of ventricular tachycardia (74.5% vs 19.1%, p<0.0001) and myocardial infarction (56.1% vs 38.2%, p<0.0001). In the propensity matched sample, after accounting for time-dependence, there was no association between ICD and mortality (HR 0.93, 95% CI 0.75 to 1.15, p=0.482).
Conclusions:
ICD therapy was not associated with reduced mortality near the conventional LVEF threshold of 35%. Although this treatment design cannot definitively demonstrate lack of efficacy, our results are concordant with available prior trial data. A definitive, well-powered trial is needed to answer the important clinical question of primary prevention ICD efficacy between LVEF 30% and 35%.
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