Association between implanted cardioverter-defibrillators and mortality for patients with left ventricular ejection fraction 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, 526440 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%.