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

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.

Trial registration: ClinicalTrials.gov NCT01922726.

Keywords: Atrial fibrillation; Dual-chamber pacemaker; Respiratory disturbance index; Sleep apnea; Sleep apnea monitoring.