Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study

Dommasch M, Steger A, Barthel P, Huster KM, Mueller A, Sinnecker D, Laugwitz KL, Penzel T, Lubinski A, Flevari P, Harden M, Friede T, Kaeaeb S, Merkely B, Sticherling C, Willems R, Huikuri H, Bauer A, Malik M, Zabel M, Schmidt G (2021)

Publication Type: Journal article

Publication year: 2021

Journal

EClinicalMedicine The Lancet

Book Volume: 31

Article Number: 100695

DOI: 10.1016/j.eclinm.2020.100695

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. Funding: European Community's 7th Framework Programme FP7/2007-2013 (602299)

Involved external institutions

Technische Universität München (TUM) DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) Medical University of Łódź / Uniwersytet Medyczny w Łodzi PL Poland (PL) Attikon Hospital / Πανεπιστημιακού Γενικού Νοσοκομείου "Αττικόν" GR Greece (GR) Universitätsklinikum Göttingen DE Germany (DE) Semmelweis University / Semmelweis Egyetem HU Hungary (HU) Universität Basel CH Switzerland (CH) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven BE Belgium (BE) Oulu University Hospital FI Finland (FI) Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK e.V.) DE Germany (DE) Imperial College London / The Imperial College of Science, Technology and Medicine GB United Kingdom (GB)

How to cite

APA:

Dommasch, M., Steger, A., Barthel, P., Huster, K.M., Mueller, A., Sinnecker, D.,... Schmidt, G. (2021). Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study. EClinicalMedicine, 31. https://doi.org/10.1016/j.eclinm.2020.100695

MLA:

Dommasch, Michael, et al. "Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study." EClinicalMedicine 31 (2021).

BibTeX: Download