Key result
Prophylactic ICD implantation reduced mortality in patients with a nocturnal respiratory rate <18 brpm, but provided no benefit in those with a rate ≥18 brpm.
Why the study?
In some patients meeting ICD criteria based on LVEF <=35%, non-arrhythmic death risk predominates, diminishing ICD benefit; the authors tested whether patients with nocturnal respiratory rate >=18 brpm benefit less from prophylactic ICDs.
Does ICD implantation reduce all-cause mortality in patients with ischaemic or non-ischaemic cardiomyopathy meeting primary prophylactic criteria, and is this benefit modified by nocturnal respiratory rate?
Cohort (n=1,971)
Blinded assessment
Yes
Does ICD implantation reduce all-cause mortality in patients with ischaemic or non-ischaemic cardiomyopathy meeting primary prophylactic criteria, and is this benefit modified by nocturnal respiratory rate?
Answers are grounded in this paper and cite their sources.
A nocturnal respiratory rate of ≥18 breaths per minute identifies a subgroup of patients with cardiomyopathy who may not derive a mortality benefit from primary prophylactic ICD implantation.
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.
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Dommasch et al. (2020) conducted a cohort in Ischaemic or non-ischaemic cardiomyopathy (n=1,971). Prophylactic ICD implantation vs. Conservative treatment was evaluated on All-cause mortality (p=0.0070 for interaction). Prophylactic ICD implantation reduced mortality in patients with a nocturnal respiratory rate <18 brpm, but provided no benefit in those with a rate ≥18 brpm.
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