荷兰阿姆斯特丹大学Reinoud E. Knops团队研究了模块化通信无引线起搏除颤器系统的相关性能。该项研究成果发表在2024年5月18日出版的《新英格兰医学杂志》上。

皮下植入式心脏复律除颤器（ICD）与经静脉ICD相比，与导线相关的并发症更少；然而，皮下ICD不能提供心动过缓和抗心动过速起搏。模块化起搏-除颤器系统是否安全目前尚不清楚，该系统包括与皮下ICD无线通信的无引线起搏器，以提供抗心动过速和心动过缓起搏。

研究组进行了一项多国、单组研究，招募有室性心律失常猝死风险的患者，并在植入模块化起搏器-除颤器系统后对他们进行了6个月的随访。安全终点是无引线起搏器相关的主要并发症，根据86%的性能目标进行评估。两个主要性能终点是起搏器和植入式心脏复律除颤器之间的成功通信（性能目标，88%）和0.4毫秒脉冲宽度下高达2.0 V的起搏阈值（性能目标：80%）。

研究组招募了293名患者，其中162人在6个月的终点队列中，151人完成了6个月随访期。患者的平均年龄为60岁，女性占16.7%，左心室射血分数的平均值（±SD）为33.1±12.6%。无引线起搏器相关主要并发症的患者比例为97.5%，超过了预先指定的性能目标。在98.8%的通信测试中，无线设备通信成功，超过了预先指定的目标。在151名患者中，147名（97.4%）的起搏阈值为2.0 V或以下，超过了预先指定的目标。通过抗心动过速起搏成功终止心律失常发作的百分比为61.3%，没有因通信故障而未进行抗心动过缓起搏的发作。162例患者中，8例死亡（4.9%）；没有一例死亡被认为与心律失常或植入手术有关。

研究结果表明，与皮下植入式心脏复律除颤器无线通信的无引线起搏器在6个月时无引线起搏器相关的主要并发症、无引线起搏器和皮下植入式心复律除颤器之间的通信以及在0.4毫秒脉冲宽度下起搏阈值高达2.0 V的患者百分比方面均超过了性能目标。

附：英文原文

Title: A Modular Communicative Leadless Pacing–Defibrillator System

Author: Reinoud E. Knops, Michael S. Lloyd, Paul R. Roberts, David J. Wright, Lucas V.A. Boersma, Rahul Doshi, Paul A. Friedman, Petr Neuzil, Carina Blomstrm-Lundqvist, Maria Grazia Bongiorni, Martin C. Burke, Daniel Gras, Steven P. Kutalek, Anish K. Amin, Eugene Y. Fu, Laurence M. Epstein, Jose Maria Tolosana, Thomas D. Callahan, Johan D. Aasbo, Ralph Augostini, Harish Manyam, Devi G. Nair, Blandine Mondésert, Wilber W. Su, Chris Pepper, Marc A. Miller, Jon Grammes, Karim Saleh, Christelle Marquie, Faisal M. Merchant, Yong-Mei Cha, Colin Cunnington, David S. Frankel, Julie West, Elizabeth Matznick, Bryan Swackhamer, Amy J. Brisben, Jonathan Weinstock, Kenneth M. Stein, Vivek Y. Reddy, Lluis Mont

Issue&Volume: 2024-05-18

Abstract:

BACKGROUND

The subcutaneous implantable cardioverter–defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing–defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown.

METHODS

We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker–defibrillator system. The safety end point was freedom from leadless pacemaker–related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%).

RESULTS

We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker–related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure.

CONCLUSIONS

The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months.

DOI: NJ202405180000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2401807