Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: results of the observational RESPIRE study

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• dc.contributor.author Martí Almor, Julio
• dc.contributor.author Marques, Pedro
• dc.contributor.author Jesel, Laurence
• dc.contributor.author García, Rodrigue
• dc.contributor.author Di Girolamo, Enrico
• dc.contributor.author Locati, Fabio
• dc.contributor.author Defaye, Pascal
• dc.contributor.author Venables, Paul
• dc.contributor.author Dompnier, Antoine
• dc.contributor.author Barceló, Aina
• dc.contributor.author Burr, Haran
• dc.date.accessioned 2020-01-23T07:31:07Z
• dc.date.issued 2019
• dc.description.abstract Background: Patients with atrial fibrillation (AF) often have sleep apnea (SA), but diagnosis of SA with polysomnography is costly. SA monitoring is a pacemaker feature that measures respiratory disturbance index, the sum of abnormal respiratory events divided by sleep duration. Objective: The purpose of this study was to evaluate the incidence and severity of SA and its association with AF in an unselected population fitted with pacemakers. Methods: RESPIRE (REgistry of Sleep APnea monItoring and Atrial Fibrillation in pacemakeR patients) was a multicenter, international, observational, open-label study following adult subjects for 18 months after implantation with an SA monitoring-enabled dual-chamber pacemaker. Severe SA was defined as average respiratory disturbance index ≥20 from implantation to follow-up visit. The first co-primary end point was the difference in significant AF (cumulative AF episodes lasting ≥24 hours over 2 consecutive days) between subjects with severe and those nonsevere SA at 12 months in the full analysis set (N = 553). The second co-primary end point was the rate of major serious adverse events at 18 months in the modified intention-to-treat set (N = 1024). Results: Severe SA was detected in 31.1% (172 of 553). A higher incidence of significant AF was reported in patients with severe SA than in patients with nonsevere SA (25.0% vs 13.9%; difference 11.1%; 95% confidence interval 3.7%-18.4%; P = .002). Significant AF increased with time in both groups, but at a faster rate in the severe SA group. No intergroup difference in the overall rate of major serious adverse events was observed (P = .065). Conclusion: SA screening over 12 months identified severe SA in almost one-third of unselected patients fitted with pacemakers. Severe SA was associated with a higher incidence of significant AF.
• dc.format.mimetype application/pdf
• dc.identifier.citation Marti-Almor J, Marques P, Jesel L, Garcia R, Di Girolamo E, Locati F. et al. Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: results of the observational RESPIRE study. Heart Rhythm. 2019 Sep 4. pii: S1547-5271(19)30822-7. DOI 10.1016/j.hrthm.2019.09.001
• dc.identifier.doi http://dx.doi.org/10.1016/j.hrthm.2019.09.001
• dc.identifier.issn 1547-5271
• dc.identifier.uri http://hdl.handle.net/10230/43390
• dc.language.iso eng
• dc.publisher Elsevier
• dc.rights © Elsevier http://dx.doi.org/10.1016/j.hrthm.2019.09.001
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.subject.keyword Atrial fibrillation
• dc.subject.keyword Dual-chamber pacemaker
• dc.subject.keyword Respiratory disturbance index
• dc.subject.keyword Sleep apnea
• dc.subject.keyword Sleep apnea monitoring
• dc.title Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: results of the observational RESPIRE study
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/acceptedVersion