Closed loop stimulation reduces the incidence of atrial high-rate episodes compared with conventional rate-adaptive pacing in patients with sinus node dysfunctions.
Journal
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
ISSN
1532-2092
Date Issued
2024-07-02
Author(s)
Pisanò, Ennio C L
Calvi, Valeria
Viscusi, Miguel
Rapacciuolo, Antonio
Lazzari, Ludovico
Bontempi, Luca
Pelargonio, Gemma
Arena, Giuseppe
Caccavo, Vincenzo
Wang, Chun-Chieh
Merkely, Béla
et al.
Abstract
Aims Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. Methods Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual- and results chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72–0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71–0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. Conclusion Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing. © The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.
Subjects
Accelerometer pacemaker sensor
Atrial fibrillation
Atrial high-rate episodes
Closed loop stimulation
Rate-adaptive pacing
Stroke
SDGs
Type
journal article