Outcomes of Cardiac Resynchronization Therapy by New York Heart Association Class: A Patient‐Level Meta‐Analysis

Author:

Shivakumar Nishkala1ORCID,Friedman Daniel J.23ORCID,Fudim Marat234ORCID,Abraham William T.5ORCID,Cleland John G. F.67ORCID,Curtis Anne B.8ORCID,Gold Michael R.9ORCID,Kutyifa Valentina10ORCID,Linde Cecilia11ORCID,Young James12ORCID,Tang Anthony13ORCID,Olivas‐Martinez Antonio14,Inoue Lurdes Y.T.14,Sanders Gillian D.3151617,Al‐Khatib Sana M.23ORCID

Affiliation:

1. Department of Medicine Duke University School of Medicine Durham NC USA

2. Division of Cardiology, Department of Medicine Duke University School of Medicine Durham NC USA

3. Duke Clinical Research Institute Duke University School of Medicine Durham NC USA

4. Institute of Heart Diseases Wroclaw Medical University Wroclaw Poland

5. Division of Cardiovascular Medicine The Ohio State University Columbus OH USA

6. National Heart and Lung Institute, Royal Brompton & Harefield Hospitals Imperial College London United Kingdom

7. British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Health University of Glasgow Glasgow UK

8. Department of Medicine University at Buffalo Buffalo NY USA

9. Department of Medicine Medical University of South Carolina Charleston SC USA

10. Division of Cardiology, Department of Medicine University of Rochester Medical Center Rochester NY USA

11. Karolinska Institutet and Department of Cardiology Karolinska University Stockholm Sweden

12. Cleveland Clinic Lerner College of Medicine of Case Western Reserve University Cleveland OH USA

13. Department of Medicine Western University Ontario Canada

14. Department of Biostatistics University of Washington Seattle WA USA

15. Duke‐Margolis Center for Health Policy Duke University Durham NC USA

16. Evidence Synthesis Group, Duke Clinical Research Institute Duke University School of Medicine Durham NC USA

17. Department of Population Health Sciences Duke University School of Medicine Durham NC USA

Abstract

Background Data on the benefits of cardiac resynchronization therapy (CRT) in patients with severe heart failure symptoms are limited. We investigated the relative effects of CRT in patients with ambulatory New York Heart Association (NYHA) IV versus III functional class at the time of device implantation. Methods and Results In this meta‐analysis, we pooled patient‐level data from the MIRACLE (Multicenter InSync Randomized Clinical Evaluation), MIRACLE‐ICD (Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation), and COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure) trials. Outcomes evaluated were time to the composite end point of the first heart failure hospitalization or all‐cause mortality, and time to all‐cause mortality alone. The association between CRT and outcomes was evaluated using a Bayesian hierarchical Weibull survival regression model. We assessed if this association differed between NYHA III and IV groups by adding an interaction term between CRT and NYHA class as a random effect. A sensitivity analysis was performed by including data from RAFT (Resynchronization‐Defibrillation for Ambulatory Heart Failure). Our pooled analysis included 2309 patients. Overall, CRT was associated with a longer time to heart failure hospitalization or all‐cause mortality (adjusted hazard ratio [aHR], 0.79 [95% credible interval [CI], 0.64–0.99]; posterior probability or P =0.044), with a similar association with time to all‐cause mortality (aHR, 0.78 [95% CI, 0.59–1.03]; P =0.083). Associations of CRT with outcomes were not significantly different for those in NYHA III and IV classes (ratio of aHR, 0.72 [95% CI, 0.30–1.27]; P =0.23 for heart failure hospitalization/mortality; ratio of aHR, 0.70 [95% CI, 0.35–1.34]; P =0.27 for all‐cause mortality alone). The sensitivity analysis, including RAFT data, did not show a significant relative CRT benefit between NYHA III and IV classes. Conclusions Overall, there was no significant difference in the association of CRT with either outcome for patients in NYHA functional class III compared with functional class IV.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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