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Dommasch, Michael; Steger, Alexander; Barthel, Petra; Huster, Katharina M.; Mueller, Alexander; Sinnecker, Daniel; Laugwitz, Karl-Ludwig; Penzel, Thomas; Lubinski, Andrzej; Flevari, Panagiota; Harden, Markus; Friede, Tim; Kaeaeb, Stefan; Merkely, Bela; Sticherling, Christian; Willems, Rik; Huikuri, Heikki V.; Bauer, Axel; Malik, Marek; Zabel, Markus and Schmidt, Georg (2021): Nocturnal respiratory rate predicts ICD benefit: A prospective, controlled, multicentre cohort study. In: Eclinicalmedicine, Vol. 31, 100695

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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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