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使用一种新型传导遥测通信方法对无导线起搏器进行远程监测。

Remote monitoring of leadless pacemakers using a novel conductive telemetry communication method.

作者信息

Sundaram Sri, Chellappa Nitika, Chaniary Kunal, Lo Monica, Nair Devi, Banker Rajesh

机构信息

South Denver Cardiology Associates, 1000 SouthPark Drive, Littleton, CO, 80111, USA.

Abbott Laboratories, 15900 Valley View Ct, Sylmar, CA, 91342, USA.

出版信息

J Interv Card Electrophysiol. 2025 Jul 22. doi: 10.1007/s10840-025-02095-8.

Abstract

BACKGROUND

Remote care has become part of the standard of care for cardiac rhythm device management. The Aveir™ single-chamber (AR and VR) and dual-chamber (DR) leadless pacemaker (LP) systems (Abbott, Abbott Park, IL) utilize a novel conductive telemetry communication schema for device interrogation and programming. A patient transmitter is designed as an at-home remote monitoring solution that interrogates the Aveir leadless pacemaker system via conductive telemetry and transmits the patient data.

OBJECTIVE

To characterize the performance of a remote care system that interrogates implanted Aveir LP systems via conductive telemetry.

METHODS

Patients implanted with an Aveir DR, VR, or AR system were enrolled in a data collection study upon hospital IRB approval of the study. The study protocol included (1) in-clinic interrogation of the LP system using the patient transmitter in a controlled setting, in two modes of use (hand-held and wired modes); and (2) optional at-home interrogation using the patient transmitter.

RESULTS

Thirty-one (25 males/6 females) subjects in three centers completed in-clinic interrogation of their Aveir system using the patient transmitter in both modes of use. Eighteen subjects completed at-home interrogation. Transmitter performance was comparable between modes of use, and between in-clinic and at-home interrogation. In all subjects 31/31 (100%), end-to-end remote care system use was successful.

CONCLUSION

The initial, real-world experience of utilizing an end-to-end remote care system with Aveir LP patients demonstrated feasibility of this technology to offer an at-home remote monitoring solution for leadless pacemaker patients via conductive telemetry (Funded by Abbott Laboratories; Clinical Trials.gov ID:NCT06542133).

摘要

背景

远程护理已成为心脏节律设备管理护理标准的一部分。Aveir™单腔(AR和VR)及双腔(DR)无导线起搏器(LP)系统(雅培公司,伊利诺伊州雅培公园)采用了一种新型的传导遥测通信模式进行设备问询和编程。患者发送器被设计为一种家庭远程监测解决方案,通过传导遥测问询Aveir无导线起搏器系统并传输患者数据。

目的

描述通过传导遥测问询植入的Aveir LP系统的远程护理系统的性能。

方法

植入Aveir DR、VR或AR系统的患者在医院机构审查委员会批准该研究后被纳入数据收集研究。研究方案包括:(1)在受控环境中使用患者发送器对LP系统进行门诊问询,采用两种使用模式(手持和有线模式);(2)使用患者发送器进行可选的家庭问询。

结果

三个中心的31名(25名男性/6名女性)受试者使用患者发送器在两种使用模式下完成了对其Aveir系统的门诊问询。18名受试者完成了家庭问询。发送器在不同使用模式之间以及门诊和家庭问询之间的性能相当。在所有31名受试者(100%)中,端到端远程护理系统的使用均成功。

结论

对Aveir LP患者使用端到端远程护理系统的初步真实世界经验表明,该技术通过传导遥测为无导线起搏器患者提供家庭远程监测解决方案是可行的(由雅培实验室资助;临床试验.gov标识符:NCT06542133)。

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