DOMMASCH, M., A. STEGER, P. BARTHEL, KM HUSTER, A. MULLER, D. SINNECKER, K. L. LAUGWITZ, T. PENZEL, A. LUBINSKI, P. FLEVARI, M. HARDEN, T. FRIEDE, S. KAAB, B. MERKELY, C. STICHERLING, R. WILLEMS, H. V. HUIKURI, A. BAUER, Marek MALÍK, M. ZABEL and G. SCHMIDT. Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study. EClinicalMedicine. AMSTERDAM: ELSEVIER, 2021, vol. 31, JAN 2021, p. 1-6. ISSN 2589-5370. Available from: https://dx.doi.org/10.1016/j.eclinm.2020.100695.
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Basic information
Original name Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study
Authors DOMMASCH, M., A. STEGER, P. BARTHEL, KM HUSTER, A. MULLER, D. SINNECKER, K. L. LAUGWITZ, T. PENZEL, A. LUBINSKI, P. FLEVARI, M. HARDEN, T. FRIEDE, S. KAAB, B. MERKELY, C. STICHERLING, R. WILLEMS, H. V. HUIKURI, A. BAUER, Marek MALÍK (203 Czech Republic, belonging to the institution), M. ZABEL and G. SCHMIDT (guarantor).
Edition EClinicalMedicine, AMSTERDAM, ELSEVIER, 2021, 2589-5370.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30218 General and internal medicine
Country of publisher Netherlands
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 17.033
RIV identification code RIV/00216224:14110/21:00121727
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1016/j.eclinm.2020.100695
UT WoS 000645898300034
Keywords in English Nocturnal respiratory rate; Primary prophylactic ICD; Benefit prediction
Tags 14110211, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 8/6/2021 10:52.
Abstract
Background: Implantable cardioverter defibrillators (ICDs) prevent sudden cardiac death. ICD implantation decisions are currently based on reduced left ventricular ejection fraction (LVEF <= 35%). However, in some patients, the non-arrhythmic death risk predominates thus diminishing ICD-therapy benefits. Based on previous observations, we tested the hypothesis that compared to the others, patients with nocturnal respiratory rate (NRR) >= 18 breaths per minute (brpm) benefit less from prophylactic ICD implantations. Methods: This prospective cohort study was a pre-defined sub-study of EU-CERT-ICD trial conducted at 44 centers in 15 EU countries between May 12, 2014, and September 6, 2018. Patients with ischaemic or non-ischaemic cardiomyopathy were included if meeting primary prophylactic ICD implantation criteria. The primary endpoint was all-cause mortality. NRR was assessed blindly from pre-implantation 24-hour Holters. Multivariable models and propensity stratification evaluated the interaction between NRR and the ICD mortality effect. This study is registered with ClinicalTrials.gov (NCT0206419). Findings: Of the 2,247 EU-CERT-ICD patients, this sub-study included 1,971 with complete records. In 1,363 patients (61.7 (12) years; 244 women) an ICD was implanted; 608 patients (63.2 (12) years; 108 women) were treated conservatively. During a median 2.5-year follow-up, 202 (14.8%) and 95 (15.6%) patients died in the ICD and control groups, respectively. NRR statistically significantly interacted with the ICD mortality effect (p = 0.0070). While the 1,316 patients with NRR<18 brpm showed a marked ICD benefit on mortality (adjusted HR 0.529 (95% CI 0.376-0.746); p = 0.0003), no treatment effect was demonstrated in 655 patients with NRR >= 18 brpm (adjusted HR 0.981 (95% CI 0.669-1.438); p = 0.9202). Interpretation: In the EU-CERT-ICD trial, patients with NRR >= 18 brpm showed limited benefit from primary prophylactic ICD implantation. Those with NRR<18 brpm benefitted substantially. (c) 2020 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
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