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. 2020 Dec 21:31:100695.
doi: 10.1016/j.eclinm.2020.100695. eCollection 2021 Jan.

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

Michael Dommasch  1 , Alexander Steger  1 , Petra Barthel  1 , Katharina M Huster  1 , Alexander Müller  1 , Daniel Sinnecker  1 , Karl-Ludwig Laugwitz  1   2 , Thomas Penzel  3 , Andrzej Lubinski  4 , Panagiota Flevari  5 , Markus Harden  6 , Tim Friede  6   7 , Stefan Kääb  2   8 , Bela Merkely  9 , Christian Sticherling  10 , Rik Willems  11 , Heikki V Huikuri  12 , Axel Bauer  2   8   13 , Marek Malik  14   15 , Markus Zabel  7   16 , Georg Schmidt  1   2 ; EU-CERT-ICD investigators
Affiliations

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

Michael Dommasch et al. EClinicalMedicine. .

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).

Keywords: Benefit prediction; Nocturnal respiratory rate; Primary prophylactic ICD.

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Conflict of interest statement

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.

Figures

Fig 1
Fig. 1
Study flow chart EU-CERT-ID=EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators. ECGs=electrocardiograms. ICD=implantable cardioverter defibrillator.
Fig 2
Fig. 2
ICD treatment effect as a function of nocturnal respiratory rate Adjusted hazard ratios (ICD group vs control group) for mortality are shown. The solid line shows point estimates, and the broken lines show the 95% CIs. ICD=implantable cardioverter defibrillator.
Fig 3
Fig. 3
Unadjusted cumulative mortality in the ICD and control groups in patients with nocturnal respiratory rate ≥18 brpm and <18brpm. ICD=implantable cardioverter defibrillator.
Fig 4
Fig. 4
Adjusted hazard ratios for the ICD group vs the control group Error bars represent 95% CIs. ICD=implantable cardioverter defibrillator.
See this image and copyright information in PMC

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