Reddy Vivek Y, Doshi Rahul, Ip James E, Defaye Pascal, Exner Derek V, Canby Robert, Shoda Morio, Bongiorni Maria G, Hindricks Gerhard, Neužil Petr, Callahan Thomas, Badie Nima, Fishler Matthew G, Knops Reinoud E
Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, 1190 5th Ave, New York, NY 10029, USA.
Department of Clinical Cardiac Electrophysiology, HonorHealth Cardiac Arrhythmia Group, Scottsdale, AZ, USA.
Europace. 2025 Jun 3;27(6). doi: 10.1093/europace/euaf074.
A dual-chamber leadless pacemaker (LP) system that employs distinct atrial and ventricular LP devices (ALP, VLP) has been introduced to clinical practice. Proprietary, low-energy, implant-to-implant (i2i) communication at each beat enables the devices to maintain synchronous atrioventricular sensing and pacing. We evaluated device longevities and contributing factors, such as i2i communication.
Patients meeting dual-chamber pacing indications received the dual-chamber LP system as part of a prospective, multi-centre, international clinical trial (Aveir DR i2i Study, NCT05252702). Programming and diagnostics were interrogated from all de novo, non-revised, dual-chamber programmed devices at 12 months post-implant. This analysis included 302 patients (65% male; age 70 ± 13 years; weight 80 ± 19 kg; intrinsic heart rate 55 ± 7 bpm; 58% sinus node dysfunction, 27% atrioventricular block). At 12 months, devices were programmed to dual-chamber pacing (DDD(R) or DDI(R)) at a median 60 bpm rate, median 1.25 V pulse amplitude in ALP and 1.5 V in VLP, median 0.4 ms pulse width, and median i2i signal setting level 5 out of 7. Median ALP and VLP remaining battery longevities at 12 months were 4.3 and 9.1 years, with median total ALP and VLP longevities of 5.3 and 9.9 years. Base rate, pulse amplitude, pacing percentage, event rate, impedance, and i2i setting level all exhibited significant correlations with ALP and VLP longevities (P < 0.001). Programming i2i setting levels below 7 produced the greatest longevity savings.
The first dual-chamber LP demonstrated adequate projected battery longevity after 12 months of use. Patient-specific device programming considerations, unique to leadless devices, may extend longevity.
一种采用不同的心房和心室无导线起搏器（LP）装置（心房无导线起搏器[ALP]、心室无导线起搏器[VLP]）的双腔无导线起搏器系统已引入临床实践。每次心跳时专有的低能量植入物对植入物（i2i）通信使这些装置能够维持同步房室感知和起搏。我们评估了装置寿命及相关因素，如i2i通信。
符合双腔起搏指征的患者接受双腔LP系统，作为一项前瞻性、多中心、国际临床试验（Aveir DR i2i研究，NCT05252702）的一部分。在植入后12个月时，对所有初次植入、未修订的双腔程控装置进行程控和诊断询问。该分析纳入了302例患者（65%为男性；年龄70±13岁；体重80±19 kg；固有心率55±7次/分；58%为窦房结功能障碍，27%为房室传导阻滞）。在12个月时，装置被程控为双腔起搏（DDD[R]或DDI[R]），中位频率为60次/分，ALP的中位脉冲幅度为1.25 V，VLP为1.5 V，中位脉冲宽度为0.4 ms，i2i信号设置水平中位值为7级中的5级。12个月时ALP和VLP剩余电池寿命的中位数分别为4.3年和9.1年，ALP和VLP总寿命的中位数分别为5.3年和9.9年。基础频率、脉冲幅度、起搏百分比、事件发生率、阻抗和i2i设置水平均与ALP和VLP寿命显著相关（P<0.001）。将i2i设置水平程控低于7级可最大程度节省寿命。
首个双腔无导线起搏器在使用12个月后显示出足够的预计电池寿命。无导线装置特有的针对患者的装置程控考虑因素可能会延长寿命。
