von Felten Elia, Breitenstein Alexander, Müller Andreas, Wiederkehr Caroline, Brix Theresa, Jeger Raban, Hofer Daniel
Department of Cardiology, Triemli Hospital Zürich, Zürich, Switzerland.
Department of Cardiology, University Heart Center, University Hospital Zürich, Zürich, Switzerland.
Heart Rhythm O2. 2025 May 16;6(8):1062-1069. doi: 10.1016/j.hroo.2025.05.011. eCollection 2025 Aug.
Leadless pacemakers (LPs) can reduce long-term complications compared with conventional devices. However, previous studies have primarily focused on single chamber right ventricular LPs.
This study aimed to evaluate the implantation, safety, and device performance characteristics in a first real-world European use of an active fixation atrial LP for either dual chamber or single chamber pacing.
For this prospective, single-center, single-operator analysis, we included consecutive patients undergoing implantation of an active fixation atrial LP either as a standalone therapy or as part of a dual chamber LP system.
Of the 45 included patients, 22 (48.9%) underwent de novo dual chamber, 9 (20%) an upgrade from ventricular single chamber to dual chamber, and 14 (31.1%) an atrial single chamber LP implantation. All implantations were successful and without the need for device repositioning. The median procedure time was 35 minutes (interquartile range 30-40), and complications occurred in 2 patients (4.4%) who developed pericardial effusions. Sensing, impedance, and stimulation thresholds of the atrial and ventricular device remained stable or improved over a median follow-up of 21 days. Median implant-to-implant throughput was 88% for atrial-to-ventricular and 87% for ventricular-to-atrial. The estimated median battery life of the atrial device was significantly higher in single chamber vs dual chamber settings (11.9 years vs 5.8 years, .001).
Our first real-world European experience demonstrates that leadless atrial pacemaker implantation can be performed efficiently and safely, with satisfactory device measurements during the early follow-up period.
与传统起搏器相比，无导线起搏器（LPs）可减少长期并发症。然而，先前的研究主要集中在单腔右心室无导线起搏器。
本研究旨在评估在欧洲首次实际应用主动固定心房无导线起搏器进行双腔或单腔起搏时的植入情况、安全性和设备性能特征。
对于这项前瞻性、单中心、单术者分析，我们纳入了连续接受主动固定心房无导线起搏器植入的患者，这些患者要么接受单独治疗，要么作为双腔无导线起搏器系统的一部分。
在纳入的45例患者中，22例（48.9%）接受了全新的双腔植入，9例（20%）从心室单腔升级为双腔，14例（31.1%）接受了心房单腔无导线起搏器植入。所有植入均成功，无需重新定位设备。中位手术时间为35分钟（四分位间距30 - 40），2例患者（4.4%）出现心包积液并发症。在中位随访21天期间，心房和心室设备的感知、阻抗和刺激阈值保持稳定或有所改善。心房到心室的中位植入到植入通过率为88%，心室到心房为87%。单腔设置下心房设备的估计中位电池寿命显著高于双腔设置（11.9年对5.8年，P <.001）。
我们在欧洲的首次实际经验表明，无导线心房起搏器植入可以高效、安全地进行，在早期随访期间设备测量结果令人满意。
