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Nocturnal respiratory rate predicts ICD benefit : a prospective, controlled, multicentre cohort study |
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| Author: | Dommasch, Michael1; Steger, Alexander1; Barthel, Petra1; |
| Organizations: |
1Klinikum rechts der Isar, Medizinische Klinik und Poliklinik I, Technical University of Munich, Munich, Germany 2German Center for Cardiovascular Research partner site Munich Heart Alliance, Munich, Germany 3Interdisciplinary Sleep Medicine Center, Charité Universitätsmedizin Berlin, Germany
4Department of Cardiology, Medical University of Lodz Hospital, Lodz, Poland
5Second Department of Cardiology, Attikon University Hospital, Athens, Greece 6Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany 7Department of Cardiology and Pneumology, Heart Center University Medical Center Göttingen, Göttingen, Germany 8Medizinische Klinik und Poliklinik I, Munich University Clinic, Munich, Germany 9Department of Cardiology, Semmelweis University Heart Center, Budapest, Hungary 10University Hospital, University of Basel, Basel, Switzerland 11University Hospitals of Leuven, Leuven, Belgium 12Medical Research Center, Oulu University Hospital and University of Oulu, Oulu, Finland 13University Hospital for Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria 14Heart and Lung Institute, Imperial College London, London, United Kingdom 15Department of Internal Medicine and Cardiology, Medical Faculty, Masaryk University, Brno, Czech Republic 16DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany |
| Format: | article |
| Version: | published version |
| Access: | open |
| Online Access: | PDF Full Text (PDF, 0.8 MB) |
| Persistent link: | http://urn.fi/urn:nbn:fi-fe2021061436782 |
| Language: | English |
| Published: |
Elsevier,
2021
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| Publish Date: | 2021-06-14 |
| Description: |
AbstractBackground: 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) see all
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| Series: |
EClinicalMedicine |
| ISSN: | 2589-5370 |
| ISSN-E: | 2589-5370 |
| ISSN-L: | 2589-5370 |
| Volume: | 31 |
| Article number: | 100695 |
| DOI: | 10.1016/j.eclinm.2020.100695 |
| OADOI: | https://oadoi.org/10.1016/j.eclinm.2020.100695 |
| Type of Publication: |
A1 Journal article – refereed |
| Field of Science: |
3121 General medicine, internal medicine and other clinical medicine |
| Subjects: | |
| Funding: |
The study was supported by the European Community's Seventh Framework Programme [HEALTH-F2-2009-602299] for 5 years (starting Oct 1, 2013). The sponsor had no input to the design or conduct of the study, to the evaluation of the results, to the writing of the report, and to the decision to submit the paper for publication. |
| Copyright information: |
© 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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https://creativecommons.org/licenses/by-nc-nd/4.0/ |