Rahul N. Doshi MD, FHRS , James E. Ip MD, FHRS , Pascal Defaye MD , Derek V. Exner MD, PhD, FHRS , Vivek Y. Reddy MD , Gerhard Hindricks MD , Robert Canby MD, FHRS , Morio Shoda MD , Maria G. Bongiorni MD , Petr Neužil MD, PhD , Thomas Callahan MD, FHRS , Nima Badie PhD , David Ligon MS , Reinoud E. Knops MD, PhD
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引用次数: 0
Abstract
Background
Aveir DR (Abbott, Abbott Park, IL) is a dual-chamber leadless pacemaker (LP) system with distinct atrial and ventricular LPs (ALP, VLP) that communicate wirelessly to deliver atrioventricular synchronous pacing. Success rates of these implant-to-implant (i2i) transmissions have not been systematically evaluated.
Objective
This study aims to evaluate chronic i2i success rates in a clinical setting.
Methods
Patients meeting standard dual-chamber pacing indications were enrolled and implanted with dual-chamber LP systems as part of a prospective international clinical trial (Aveir DR i2i Study). The percent of successful i2i transmissions from ALP-to-VLP (A-to-V) and VLP-to-ALP (V-to-A) were interrogated from LPs in de novo patients using the device programmer at implant, discharge, and at 1, 3, and 6 months postimplant (1M, 3M, 6M).
Results
A total of 399 patients completed device implant and i2i diagnostic interrogation (62% male; age 69 years; 65% sinus node dysfunction, 32% atrioventricular [AV] block). Median A-to-V and V-to-A i2i success rates exceeded 90% of beats at all time-points from implant to 6M. The minority of patients with A-to-V or V-to-A i2i success in <70% of beats at implant (A-to-V: 19% of patients, V-to-A: 31% of patients) showed roughly 40% improvement by 1M, with this minority dropping to roughly 5% of patients by 6M. Improvement in i2i communication success may be attributed to reprogramming of i2i setting levels, natural changes in dominant posture, and device stabilization.
Conclusion
Wireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in >90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time postimplant for specific subgroups.
Clinical Trial Registration
Aveir DR i2i Study, ClinicalTrials.gov ID NCT05252702.
期刊介绍:
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.