Original Investigation
Clinical Effectiveness of CRT and ICD Therapy in Heart Failure Patients by Racial/Ethnic Classification: Insights From the IMPROVE HF Registry

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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.

Key Words

cardiac resynchronization therapy
clinical effectiveness
heart failure
mortality
race/ethnicity

Abbreviations and Acronyms

CI
confidence interval
CRT
cardiac resynchronization therapy
CRT-D
cardiac resynchronization defibrillator
CRT-P
cardiac resynchronization pacemaker
GEE
generalized estimating equations
HF
heart failure
HFrEF
heart failure with reduced ejection fraction
ICD
implantable cardioverter-defibrillator
LVEF
left ventricular ejection fraction
OR
odds ratio

Cited by (0)

The IMPROVE HF registry and this study are supported by Medtronic, Inc. Outcome Sciences performed data abstraction and checks, stored site-specific and aggregate data, and provided benchmarked quality-of-care reports to participating sites with funding from Medtronic. This paper was submitted to Medtronic prior to submission for publication, and all authors have read and agreed to the written content. Dr. Ziaeian’s brother is a clinical specialist for Biotronik. Dr. Zhang is an employee of Medtronic, Inc. Dr. Curtis has received research honoraria from Medtronic, Inc. and St. Jude Medical; and has served on the advisory board of Sanofi-Aventis, St. Jude Medical, Biosense Webster, Janssen Pharmaceuticals, Bristol-Myers-Squibb, Pfizer, Inc., and Daiichi Sankyo. Dr. Mehra has served as a consultant to Thoratec, Medtronic, Inc., Johnson & Johnson, St. Jude Medical, Boston Scientific, and Abbott Vascular; has received grants/research support from the National Institutes of Health/National Heart, Lung, and Blood Institute and American Board of Internal Medicine; and serves as editor-in-chief of the Journal of Heart and Lung Transplantation. Dr. Gheorghiade has served as a consultant to Abbott Laboratories, Astellas, AstraZeneca, Bayer Schering Pharma AG, CorThera, Inc., Cytokinetics, Inc., DebioPharm SA, Errekappa Terapeutici, GlaxoSmithKline, Johnson & Johnson, Medtronic, Inc., Merck, Novartis Pharma AG, Otsuka Pharmaceuticals, Pericor Therapeutics, Protein Design Laboratories, Sanofi-Aventis, Sigma Tau, Solvay Pharmaceuticals, and Takeda. Dr. Heywood has received research grants from Biosite, Medtronic, Inc., and St. Jude Medical; has served on the Speaker’s Bureau of or received honoraria from GlaxoSmithKline, Medtronic, AstraZeneca, Novartis, Actelion, St. Jude Medical, Otsuka, Biotronik, and Boston Scientific; and has served as a consultant to or on the advisory board of Emerge, Medtronic, Inc., Biotronik, and Actelion. Dr. O’Connor has served as a consultant to Forest, Medtronic, Inc., Amgen, Medpace, Impulse Dynamics, Actelion, Cytokinetics, Roche, and Trevena. Dr. Reynolds has received research grants from Medtronic and Biotronik; has served on the Speakers' Bureau of Medtronic and Sorin; and has served as a consultant to Medtronic. Dr. Walsh has served on the scientific advisory board for United HealthCare; and has served as a consultant to Eli Lilly, United HealthCare, and Novartis. Dr. Fonarow has received research support from the National Institutes of Health and AHRQ; and has served as a consultant to Medtronic, Novartis, Johnson & Johnson, Takeda, The Medicines Company, and Gambro. Drs. Albert and Yancy have reported that they have no relationships relevant to the contents of this paper to disclose.

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