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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

For allocation of primary ICD-therapy, a possible lower limit of inclusion criteria—defining overly advanced heart failure—is less well investigated. Also, a multi-variable approach to stratification beyond ejection fraction (LVEF) appears warranted. We examined whether adding a selection limit of peak VO2 ≤ 14 ml/kg/min to LVEF ≤ 20% improves stratification. Furthermore, we sought to provide current survival data and a size-estimate for prospective trials based on real-life data for this high risk cohort. In our prospective clinical registry 1,926 patients with systolic CHF were recruited consecutively since 1994. Of these patients, 292 met the selection criteria described above. The mean age was 57.6 ± 9.5 years, 83% were male, 37% had ischemic cardiomyopathy and 28% received primary ICD-therapy. All cause mortality was considered as end point. Median follow-up was 45 (18–86) months. ICD was not a significant predictor of outcome either for the entire population, or grouped according to aetiology of CHF. Still, 3-year mortality was 15% (ICD-patients) Vs. 28% (non-ICD-patients); P = 0.05; under combination medical therapy. Inversely, in ICD-patients medical combination therapy conveyed a significant survival benefit ( P < 0.001). Consequently, the number-needed-to-treat was eight under combination therapy and the size estimate amounts to 300 patients for a prospective trial in this cohort. A cut-off of LVEF ≤ 20% and pVO2 ≤ 14 ml/kg/min could identify patients that do not draw a significant survival benefit from adjunct primary ICD-therapy. Our results indicate the need for a specific randomized trial in this cohort. The according mortality data and a size estimate are provided. [ABSTRACT FROM AUTHOR]

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)., Competing Interests: MH and MM reports grant from European Commission. TF reports grant from European Commission and personal fees from Novartis, Bayer, Janssen, Roche, Boehringer Ingelheim, Daiichi Sankyo, Galapagos, Penumbra, Parexel, Vifor, BiosenseWebster, CSL Behring, Fresenius Kabi, and Coherex Medical. BM reports grants from Boston Scientific and Medtronic, and he reports personal fees from Biotronik and Abbott. RW reports grants from European Commission, Medtronic, Biotronik, Abbott, and Boston Scientific. He is funded as a postdoctoral clinical researcher by the Fund for Scientific Research Flanders (FWO Vlaanderen). MZ reports grants from European Commission and Biotronik. All other authors declare no competing interests., (© 2020 The Author(s).)

Background: Implantable cardioverter defibrillator (ICD) was implemented into clinical routine more than 20 years ago. Since then, ICD therapy became standard therapy for primary and secondary prevention of sudden cardiac death in clinical practice., Objectives: Aim of the study was to evaluate the benefit-harm profile of contemporary primary prophylactic ICD therapy., Methods: A total of 1222 consecutive patients of a prospective single-center ICD-registry were analyzed who underwent primary prophylactic ICD implantation between 2000 and 2017. Patients were divided into two groups according to the implantation year: 2010-2017 (group 1, n = 579) and 2000-2009 (group 2, n = 643)., Results: The rate of estimated appropriate ICD therapy after 8 years was 51% in the 2000s and 42% in the 2010s (P < .001). The complication rate changed slightly from 53% to 47% (P = .005). This decline was mainly driven by the reduction of inappropriate ICD shocks (30% vs 14%, P < .001) whereas the rate of ICD shock lead malfunction and device/ lead infection remained unchanged over time. Nonischemic cardiomyopathy was an independent predictor for ICD complications without benefit of ICD therapy (HR 1.37, 95% CI 1.07-1.77)., Conclusion: The ICD therapy rate for ventricular arrhythmias in patients with primary prophylactic ICD implantation is decreasing over the last two decades. Complication rate remains high due to an unchanged rate of ICD shock malfunctions and device infections. Nonischemic cardiomyopathy is an independent predictor for ICD complications without benefit of ICD therapy in primary prophylactic ICD-therapy., (© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)