Dual-Chamber Leadless Pacing: Atrioventricular Synchrony in Preclinical Models of Normal or Blocked Atrioventricular Conduction.

Overview

abstract

BACKGROUND: Dual-chamber leadless pacemakers (LP) require robust communication between distinct right atrial (RA) and right ventricular (RV) LPs to achieve atrioventricular (AV) synchrony. OBJECTIVE: This preclinical study evaluated a novel, continuous implant-to-implant (i2i™) communication methodology for maintaining AV-synchronous, dual-chamber DDD(R) pacing by the 2 LPs. METHODS: RA and RV LPs were implanted and paired in 7 ovine subjects, 4 of 7 with induced complete heart block. AV synchrony (% AV intervals <300 ms) and i2i communication success (% successful i2i transmissions between LPs) were evaluated acutely and chronically. During acute testing, 12-lead ECG and LP diagnostic data were collected from 5-minute recordings, in 4 postures and 2 rhythms (AP-VP and AS-VP or AP-VS and AS-VS) per subject. Chronic i2i performance was evaluated through 23 weeks post-implant (final i2i evaluation period: week 16-23). RESULTS: Acute AV synchrony and i2i communication success across multiple postures and rhythms were 100.0% [100.0-100.0] (median [interquartile range]) and 99.9% [99.9-99.9], respectively. AV synchrony and i2i success rates did not differ across postures (P=0.59, P=0.11) or rhythms (P=1.00, P=0.82). During the final i2i evaluation period, the overall i2i success was 98.9% [98.1-99.0]. CONCLUSION: Successful AV-synchronous, dual-chamber DDD(R) leadless pacing using a novel, continuous, wireless communication modality was demonstrated across variations in posture and rhythm in a preclinical model.