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Modeling defibrillation benefit for survival among cardiac resynchronization therapy defibrillator recipients - 17/03/20

Doi : 10.1016/j.ahj.2019.12.017 
Kenneth C. Bilchick, MD a, , Yongfei Wang, MS b, c, Jeptha P. Curtis, MD b, c, Alan Cheng, MD d, Kumar Dharmarajan, MD b, c, Ramin Shadman, MD e, Todd F Dardas, MD, MS m, Inder Anand, MBBS f, Lars H. Lund, MD g, Ulf Dahlström, MD, PhD h, Ulrik Sartipy, MD, PhD i, j, Aldo Maggioni, MD k, Christopher O'Connor, MD l, Wayne C. Levy, MD m
a Department of Medicine, University of Virginia Health System, Charlottesville, VA 
b Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 
c Department of Internal Medicine, Yale University, New Haven, CT 
d Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, MD 
e Southern California Permanente Medical Group, Los Angeles, CA 
f University of Minnesota, Minneapolis, MN 
g Department of Medicine/Cardiology, Karolinska University Hospital, Stockholm, Sweden 
h Department of Cardiology and Department of Medical and Health Sciences, Linkoping University, Linkoping, Sweden 
i Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden 
j Heart and Vascular Theme, Karlolinska University Hospital, Stockholm, Sweden 
k Italian Association of Hospital Cardiologists Research Center, Florence, Italy 
l Innova Healthcare System, Fairfax, VA 
m Department of Medicine, University of Washington, Seattle, WA 

Reprint requests: Kenneth Bilchick, MD, MS, UVA Health System, Cardiovascular Division, P.O. Box 800158, Charlottesville, VA 22908.UVA Health System, Cardiovascular DivisionP.O. Box 800158CharlottesvilleVA22908

Abstract

Background

Patients with heart failure having a low expected probability of arrhythmic death may not benefit from implantable cardioverter defibrillators (ICDs).

Objective

The objective was to validate models to identify cardiac resynchronization therapy (CRT) candidates who may not require CRT devices with ICD functionality.

Methods

Heart failure (HF) patients with CRT-Ds and non-CRT ICDs from the National Cardiovascular Data Registry and others with no device from 3 separate registries and 3 heart failure trials were analyzed using multivariable Cox proportional hazards regression for survival with the Seattle Heart Failure Model (SHFM; estimates overall mortality) and the Seattle Proportional Risk Model (SPRM; estimates proportional risk of arrhythmic death).

Results

Among 60,185 patients (age 68.6 ± 11.3 years, 31.9% female) meeting CRT-D criteria, 38,348 had CRT-Ds, 11,389 had non-CRT ICDs, and 10,448 had no device. CRT-D patients had a prominent adjusted survival benefit (HR 0.52, 95% CI 0.50-0.55, P < .0001 versus no device). CRT-D patients with SHFM-predicted 4-year survival ≥81% (median) and a low SPRM-predicted probability of an arrhythmic mode of death ≤42% (median) had an absolute adjusted risk reduction attributable to ICD functionality of just 0.95%/year with the majority of survival benefit (70%) attributable to CRT pacing. In contrast, CRT-D patients with SHFM-predicted survival <median or SPRM >median had substantially more ICD-attributable benefit (absolute risk reduction of 2.6%/year combined; P < .0001).

Conclusions

The SPRM and SHFM identified a quarter of real-world, primary prevention CRT-D patients with minimal benefit from ICD functionality. Further studies to evaluate CRT pacemakers in these low-risk CRT candidates are indicated.

Le texte complet de cet article est disponible en PDF.

Abbreviations : CPH, CRT-D, CRT-P, HR-CRTP, HR-CRTD, HR-ICD, ICD, LVEF, NYHA, NCDR, RR-CRTP, RR-ICD, ROC, SHFM, SPRM


Plan


 Disclosures: Dr Bilchick has research grant support from Medtronic and Siemens Healthineers. NIH funding for this work is described in the Sources of Funding section below. Dr Curtis has a contract with the American College of Cardiology and NCDR for his role as Senior Medical Officer, receives salary support from the American College of Cardiology and NCDR, receives funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting, and holds equity interest in Medtronic. Dr Dharmarajan is supported by grant K23AG048331 from the National Institute on Aging and the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program. He is also supported by grant P30AG021342 via the Yale Claude D. Pepper Older Americans Independence Center. Dr Dharmarajan also receives salary support under contract with the Centers for Medicare & Medicaid Services and serves as a consultant and scientific advisory board member for Clover Health. Dr Cheng is currently employed by Medtronic but work on this manuscript preceded this employment. Dr Levy has research grants from Novartis, and he serves as a consultant for Abbott, Baim Institute, GE Healthcare, Respircardia, Medtronic, EBR Systems, Cardiac Dimensions, and Impulse Dynamics. The University of Washington CoMotion holds the copyrights for the SHFM and SPRM. Dr Anand is a consultant for Amgen, ARCA, Cyberonics, Novartis and Zensun. Dr Sartipy has nothing to disclose. Dr Maggioni received honoraria for participation in Committees of studies sponsored by Bayer, Novartis, and Fresenius, outside the present work. Dr Lund has research grants from Boston Scientific and speaker's honoraria from St. Jude Medical. Dr Dahlstrom has received speaker's/consulting honoraria from Novartis and research grants from AstraZeneca.
 Funding: This work was supported by NIH grant R21 HL140445 (Bilchick, PI) and a research grant from the American College of Cardiology/National Cardiovascular Data Registry (Bilchick, PI). The funders did not influence the design of this project.
 Acknowledgements: The authors acknowledge the staff of the NCDR Analytic Center at Yale University and the American College of Cardiology for their assistance in facilitating the present analysis.


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