TY - JOUR
T1 - Closed loop stimulation reduces the incidence of atrial high-rate episodes compared with conventional rate-adaptive pacing in patients with sinus node dysfunctions
AU - Pisano, E. C. L.
AU - Calvi, V.
AU - Viscusi, Maria Rosa
AU - Rapacciuolo, A.
AU - Lazzari, L.
AU - Bontempi, L.
AU - Pelargonio, Gemma
AU - Arena, G.
AU - Caccavo, V.
AU - Wang, C. -C.
AU - Merkely, B.
AU - Lin, L. -Y.
AU - Il-Young, O.
AU - Bertaglia, E.
AU - Saporito, D.
AU - Menichelli, Maurizio
AU - Nicosia, A.
AU - Carretta, D. M.
AU - Coppolino, A.
AU - Ching, C. K.
AU - del Castillo, A. M.
AU - Su, X.
AU - Maestro, M. D.
AU - Giacopelli, D.
AU - Gargaro, A.
AU - Botto, G. L.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - Accelerometer pacemaker sensor
KW - Atrial fibrillation
KW - Stroke
KW - Closed loop stimulation
KW - Rate-adaptive pacing
KW - Atrial high-rate episodes
KW - Accelerometer pacemaker sensor
KW - Atrial fibrillation
KW - Stroke
KW - Closed loop stimulation
KW - Rate-adaptive pacing
KW - Atrial high-rate episodes
UR - http://hdl.handle.net/10807/306247
U2 - 10.1093/europace/euae175
DO - 10.1093/europace/euae175
M3 - Article
SN - 1099-5129
VL - 26
SP - N/A-N/A
JO - Europace
JF - Europace
ER -