Cardiac resynchronization therapy pacemaker or cardiac resynchronization therapy defibrillator: what determines the choice?—findings from the ESC CRT Survey II

Normand, Camilla; Linde, Cecilia; Bogale, Nigussie; Blomström‐Lundqvist, Carina; Auricchio, Angelo; Stellbrink, Christoph; Witte, Klaus K.; Mullens, Wilfried; Sticherling, Christian; Marinskis, Germanas; Sciaraffia, Elena; Papiashvili, Giorgi; Iovev, Svetoslav; Dickstein, Kenneth

doi:10.1093/europace/euz002

Cited by 20 publications

(17 citation statements)

References 21 publications

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“… 36 The distribution of baseline characteristics between CRT-P and CRT-D patients in our study was similar with the distribution in previous CRT studies as the ESC CRT Survey II. 37 …”

Section: Discussionmentioning

confidence: 99%

Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project

Hadwiger

Dagres

Haug

et al. 2022

European Heart Journal

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Aims Cardiac resynchronization therapy (CRT) is an established treatment for heart failure. There is contradictory evidence whether defibrillator capability improves prognosis in patients receiving CRT. We compared the survival of patients undergoing de novo implantation of a CRT with defibrillator (CRT-D) option and CRT with pacemaker (CRT-P) in a large health claims database. Methods and results Using health claims data of a major German statutory health insurance, we analysed patients with de novo CRT implantation from 2014 to 2019 without indication for defibrillator implantation for secondary prevention of sudden cardiac death. We performed age-adjusted Cox proportional hazard regression and entropy balancing to calculate weights to control for baseline imbalances. The analysis comprised 847 CRT-P and 2722 CRT-D patients. Overall, 714 deaths were recorded during a median follow-up of 2.35 years. A higher cumulative incidence of all-cause death was observed in the initial unadjusted Kaplan–Meier time-to-event analysis [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38–1.92]. After adjustment for age, HR was 1.13 (95% CI: 0.95–1.35) and after entropy balancing 0.99 (95% CI: 0.81–1.20). No survival differences were found in different age groups. The results were robust in sensitivity analyses. Conclusion In a large health claims database of CRT implantations performed in a contemporary setting, CRT-P treatment was not associated with inferior survival compared with CRT-D. Age differences accounted for the greatest part of the survival difference that was observed in the initial unadjusted analysis. Key question Is the defibrillator capability needed in cardiac resynchronization therapy (CRT)? Aim: Compare survival of patients receiving de novo CRT with and without defibrillator option between 2014 and 2019. Health claims data, same inclusion and exclusion criteria as in RESET-CRT randomized trial. Key finding CRT-P patients 6.7 years older than CRT-D patients. Comparable aetiology of heart failure. Median follow-up 2.35 years: 203 (24%) deaths in CRT-P and 511 (19%) deaths in CRT-D patients. Age differences accounted for the greatest part of the survival difference. Take-home message No survival differences between CRT-D and CRT-P after adjustment for age and entropy balancing. Results corroborate the hypothesis of the RESET-CRT randomized clinical trial.

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“… 36 The distribution of baseline characteristics between CRT-P and CRT-D patients in our study was similar with the distribution in previous CRT studies as the ESC CRT Survey II. 37 …”

Section: Discussionmentioning

confidence: 99%

Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project

Hadwiger

Dagres

Haug

et al. 2022

European Heart Journal

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“…Despite very similar clinical characteristics, practice in neighbouring countries in Europe is remarkably different. Fewer than 20% of implants in Germany are CRT-P devices whereas the proportion in many parts of Europe is significantly higher 8. Local, regional and peer-group practice contribute to behaviour, but another issue is likely to be the better reimbursement of CRT-D in many countries despite largely similar implant procedures.…”

Section: What Other Factors Might Influence These Decisions?mentioning

confidence: 99%

Cardiac resynchronisation therapy with or without a defibrillator: individualising device prescription

Straw

Mullens

Witte

2022

Heart

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“…1) Health-care expenditures: CRT-D is technologically considerably more complex than CRT-P with a roughly three times higher price. CRT-D is not even closely implanted in all patients that meet the current guidelines criteria 5 . A proof of absence of CRT-D superiority over CRT-P in a strictly defined patient population with a DCM could theoretically enable implantation of devices with a clear mortality benefit (CRT-P) in an approximately three times larger patient population in countries where health care expenditures are set according to a strict cost-benefit analysis 7 .…”

Section: Trial Ethicsmentioning

confidence: 99%

“…In the recent DANISH trial, implantation of a cardiac defibrillator (ICD) in patients who had HF that was not caused by ischemic heart disease did not provide an overall survival benefit 4 . Since no randomized controlled trial (RCT) has been designed to compare the effects on clinical outcomes of cardiac resynchronization therapy pacemaker (CRT-P) and cardiac resynchronization therapy with a defibrillator (CRT-D) in patients with DCM, the scientific community now wavers over the justification of an ICD implantation in this patient group 5 . The question of whether there is a benefit of CRT-D over CRT-P and at what cost is very important.…”

Section: Introductionmentioning

confidence: 99%

Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in patients with dilated cardiomyopathy and heart failure without late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) high-risk markers - CRT-REALITY study - Study design and rationale

Táborský

Škála

Aiglová

et al. 2022

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub

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Background. Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF <35%. Thanks to advances in heart failure pharmacotherapy, a decrease in mortality could render a benefit of ICD insufficient to justify its implantation in some patients. Methods. Study design: multicenter, prospective, randomized, controlled trial evaluating the benefit of implantation of Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in non-ischemic patients with reduced left ventricle ejection fraction (LVEF) and optimal pharmacotherapy without significant mid-wall myocardial fibrosis detected by cardiac magnetic resonance (CMR). The primary end-point: Re-hospitalization for heart failure, ventricular tachycardia, major adverse cardiac events (MACE). The secondary end-points: Sudden cardiac death, cardiovascular death, resuscitated cardiac arrest or sustained ventricular tachycardia, device-related complications, and change in quality of life. Course of the study: After a pharmacotherapy is optimized and significant mid-wall myocardial fibrosis excluded, patients will be randomized 1:1 to CRT-P or CRT-D implantation. Discussion. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. Trial registration. ClinicalTrials.gov, NCT04139460

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Cardiac resynchronization therapy pacemaker or cardiac resynchronization therapy defibrillator: what determines the choice?—findings from the ESC CRT Survey II

Cited by 20 publications

References 21 publications

Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project

Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project

Cardiac resynchronisation therapy with or without a defibrillator: individualising device prescription

Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in patients with dilated cardiomyopathy and heart failure without late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) high-risk markers - CRT-REALITY study - Study design and rationale

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