TY - JOUR
T1 - Modeling defibrillation benefit for survival among cardiac resynchronization therapy defibrillator recipients
AU - Bilchick, Kenneth C.
AU - Wang, Yongfei
AU - Curtis, Jeptha P.
AU - Cheng, Alan
AU - Dharmarajan, Kumar
AU - Shadman, Ramin
AU - Dardas, Todd F.
AU - Anand, Inder
AU - Lund, Lars H.
AU - Dahlström, Ulf
AU - Sartipy, Ulrik
AU - Maggioni, Aldo
AU - O'Connor, Christopher
AU - Levy, Wayne C.
N1 - Funding Information:
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. The mechanisms associated with a survival benefit from CRT-D include resynchronization pacing and the capability of the ICD to treat sudden cardiac arrest. The SPRM and SHFM may be used to estimate the importance of these mechanisms in individual patients. There is significant variation in clinical practice with respect to the use of CRT-P and CRT-D in CRT candidates. Models to characterize the risk of sudden cardiac arrest in individual patients may eventually be applied to inform device selection. Shared decision making before ICD implantation is now required by the Centers for Medicare and Medicaid Services. Additional information from risk models have the potential to inform shared decision making. The SHFM and SPRM can provide important prognostic information in heart failure patients referred for CRT-D. Considering that the advantage of CRT-D to treat sudden cardiac arrest may be outweighed by device complications and inappropriate shocks in some patients, risk models may be an effective approach to help patients decide whether they would prefer to have a CRT-P or a CRT-D. 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.
Funding Information:
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.
Funding Information:
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.
Publisher Copyright:
© 2019 Elsevier Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/4
Y1 - 2020/4
N2 - 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 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.
AB - 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 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.
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U2 - 10.1016/j.ahj.2019.12.017
DO - 10.1016/j.ahj.2019.12.017
M3 - Article
C2 - 32032927
AN - SCOPUS:85078832835
VL - 222
SP - 93
EP - 104
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -