Knops Reinoud E, Ip James E, Doshi Rahul, Exner Derek V, Defaye Pascal, Canby Robert, Bongiorni Maria Grazia, Shoda Morio, Hindricks Gerhard, Neužil Petr, Rashtian Mayer, Breeman Karel T N, Nevo Jordan R, Ganz Leonard, Hubbard Chris, Bulusu Anu, Reddy Vivek Y
Amsterdam UMC, the Netherlands (R.E.K., K.T.N.B.).
Weill Cornell Medicine/New York Presbyterian Hospital, NY (J.E.I.).
Circ Arrhythm Electrophysiol. 2025 Apr;18(4):e013619. doi: 10.1161/CIRCEP.124.013619. Epub 2025 Mar 27.
A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals.
Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (≤3.0 V at 0.4 ms) and sensing amplitude (P-wave ≥1.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%.
Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5-91.8; <0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7-95.8; <0.001).
Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05252702.
双腔无导线起搏器可为大多数有起搏器植入指征的患者提供心动过缓治疗，且无导线或脉冲发生器相关并发症。我们试图通过确定12个月无并发症和性能成功率是否超过预先设定的性能目标，来确认先前报告的3个月安全性和性能结果在12个月内是否持续。
如果患者有双腔起搏的标准指征，则纳入前瞻性单组Aveir DR i2i研究。纳入的患者植入Aveir DR双腔无导线起搏器系统，该系统由2个相互通信的无导线起搏器组成（1个位于右心房，1个位于右心室）。主要安全结局评估365天内无严重器械或手术相关事件的情况是否超过预定性能目标的76.5%。主要性能结局确定12个月随访时心房捕获阈值（0.4毫秒时≤3.0伏）和感知幅度（P波≥1.0毫伏）的综合指标是否超过预定性能目标的80.0%。
各研究点尝试对300名受试者进行植入，其中63.3%的受试者主要起搏指征为窦房结功能障碍，33.3%为房室传导阻滞。达到了主要安全终点，12个月时Kaplan-Meier无并发症发生率为88.6%（95%可信区间，84.5-91.8；P<0.001）。92.8%的患者达到了主要性能终点（95%可信区间，89.7-95.8；P<0.001）。
1年后主要安全和性能终点均达到，表明与先前报告的双腔无导线起搏器3个月结局一致。
