1. Nocturnal respiratory rate predicts ICD benefit:a prospective, controlled, multicentre cohort study
- Author
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Dommasch, M. (Michael), Steger, A. (Alexander), Barthel, P. (Petra), Huster, K. M. (Katharina M.), Müller, A. (Alexander), Sinnecker, D. (Daniel), Laugwitz, K.-L. (Karl-Ludwig), Penzel, T. (Thomas), Lubinski, A. (Andrzej), Flevari, P. (Panagiota), Harden, M. (Markus), Friede, T. (Tim), Kääb, S. (Stefan), Merkely, B. (Bela), Sticherling, C. (Christian), Willems, R. (Rik), Huikuri, H. V. (Heikki V.), Bauer, A. (Axel), Malik, M. (Marek), Zabel, M. (Markus), Schmidt, G. (Georg), and T. E. (The EU-CERT-ICD investigators)
- Subjects
Benefit prediction ,Nocturnal respiratory rate ,Primary prophylactic ICD - 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
- Published
- 2021