Clinical Effectiveness of CRT and ICD Therapy in Heart Failure Patients by Racial/Ethnic Classification

Abstract

BACKGROUND Clinical trials have demonstrated benefit for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure with reduced ejection fraction (HFrEF); yet, questions have been raised with regard to the benefit of device therapy for minorities. OBJECTIVES The purpose of this study was to determine the clinical effectiveness of CRT and ICD therapies as a function of race/ethnicity in outpatients with HFrEF (ejection fraction ≤35%). METHODS Data from IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) were analyzed by device status and race/ethnicity among guideline-eligible patients for mortality at 24 months. Multivariate Generalized Estimating Equations analyses were conducted, adjusting for patient and practice characteristics. RESULTS The ICD/cardiac resynchronization defibrillator (CRT-D)–eligible cohort (n = 7,748) included 3,391 (44%) non-Hispanic white, 719 (9%) non-Hispanic black, and 3,638 (47%) other racial/ethnic minorities or race-not-documented patients. The cardiac resynchronization pacemaker (CRT-P)/CRT-D–eligible cohort (n = 1,188) included 596 (50%) non-Hispanic white, 99 (8%) non-Hispanic black, and 493 (41%) other/not-documented patients. There was clinical benefit associated with ICD/CRT-D therapy (adjusted odds ratio: 0.64, 95% confidence interval: 0.52 to 0.79, p = 0.0002 for 24-month mortality), which was of similar proportion in white, black, and other minority/not-documented patients (device–race/ethnicity interaction p = 0.7861). For CRT-P/CRT-D therapy, there were also associated mortality benefits (adjusted odds ratio: 0.55, 95% confidence interval: 0.33 to 0.91, p = 0.0222), and the device–race/ethnicity interaction was not significant (p = 0.5413). CONCLUSIONS The use of guideline-directed CRT and ICD therapy was associated with reduced 24-month mortality without significant interaction by racial/ethnic group. Device therapies should be offered to eligible heart failure patients, without modification based on race/ethnicity.

Persistent sex disparities in implantable cardioverter‐defibrillator therapy

“…More recent studies with adequately powered subgroup analyses, however, have corrected this misconception, showing mortality benefit in men and women alike . Similarly, more recent observational studies have displayed mortality benefit in other vulnerable populations like minorities and the elderly …”

Comparative Efficacy of Cardiac Resynchronization Therapy in Africans Americans Compared With European Americans

“…18 These results were derived from a typical AA HF population (i.e., more often female, younger, with nonischemic cardiomyopathy similar to the findings in MADIT-CRT and the IMPROVE-HF registry). 3,13 These factors did not affect the ethnic comparison results.…”

“…In the IMPROVE-HF registry, race did not appear to be a factor in predicting outcomes. 3 Follow-up in this study was limited to 2 years, and most patients had minimally symptomatic HF. Among randomized trials, only the MADIT-CRT trial included an assessment of race and reported race-based outcomes.…”

“…2 Even large-scale registries, for example Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF), have included relatively small numbers of AAs. 3 Randomized controlled trials of CRT have generally not reported racial characteristics of enrolled patients. When reported, AAs were significantly under-represented.…”

“…The few studies that have assessed the interaction of race and outcomes after defibrillator or CRT implant have been limited by small numbers, relatively short follow-up periods, only a few types of end points reported and, for CRT, have contained mostly minimally symptomatic patients. 3,13 Some results suggest lesser benefit in AAs, questioning the utility of implantable device therapy altogether. In the present study, we sought to determine the incidence of reverse ventricular remodeling and long-term survival free of left ventricular assist device (LVAD) or heart transplant in AA CRT candidates with advanced HF (New York Heart Association [NYHA] class III/IV) compared with an EA control.…”