本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2401807

摘要内容如下：

背景

皮下埋藏式心律转复除颤器（ICD）与经静脉ICD相比，导线相关并发症较少；然而，皮下ICD不能提供心动过缓和抗心动过速起搏。包括与皮下ICD无线通信以提供抗心动过速和心动过缓起搏的无导线起搏器的模块化起搏除颤器系统是否安全仍然未知。

方法

我们进行了一项多国、单组研究，纳入了有室性心律失常猝死风险的患者，并在植入模块化起搏器-除颤器系统后随访6个月。安全性终点是无导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毫秒脉宽下高达2.0 V的起搏阈值（性能目标，80%）。

结果

我们招募了293名患者，其中162名在6个月的终点队列中，151名完成了6个月的随访期。患者的平均年龄为60岁，16.7%为女性，平均（±SD）左心室射血分数为33.1±12.6%。无导线起搏器相关主要并发症的患者百分比为97.5%，超过了预先指定的性能目标。在98.8%的通信测试中，无线设备通信是成功的，这超过了预先指定的目标。在151例患者中，147例（97.4%）的起搏阈值为2.0V或更低，超过了预先设定的目标。通过抗心动过速起搏成功终止的心律失常发作的百分比为61.3%，并且没有因通信故障而未发送抗心动过速起搏的发作。162例中死亡8例（4.9%）；没有一例死亡被认为与心律失常或植入手术有关。

结论

与皮下植入式心脏复律除颤器无线通信的无导线起搏器在无导线起搏器相关的主要并发症、无导线起搏器与皮下植入式心脏复律除颤器之间的通信以及6个月时在0.4毫秒脉宽下起搏阈值高达2.0 V的患者百分比方面超过了性能目标。（由Boston Scientific资助；Modular ATP ClinicalTrials.gov NCT04798768。）

英文原文如下：

Abstracts

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. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

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