Rhythmology Unit, Clinique Ambroise Paré, 25-27 boulevard Victor Hugo, Neuilly-Sur-Seine, France.
Cardiology Unit, Centre Hospitalier Universitaire de Limoges, 2 avenue Martin Luther King, Limoges, France.
Europace. 2019 Jan 1;21(1):130-136. doi: 10.1093/europace/euy140.
Remote monitoring (RM) is considered as a standard of care for pacemaker recipients. Remote monitoring systems provide calendar-based intracardiac electrogram recordings (IEGM) only with the current pacemaker settings (passive IEGM). PREMS (Pacemaker Remote Electrogram Monitoring Study), an observational, multicentre trial, prospectively evaluated the clinical value of an active IEGM (aIEGM), including three 10-s sections (passive IEGM, encouraged sensing, and encouraged pacing), compared to other RM data and to its passive IEGM section. Secondary objectives included the added value of the aIEGM to fully assess the sensing and pacing functions of each lead.
Patients were enrolled within 3 months after pacemaker implantation and followed until the first transmitted aIEGM, which was analysed together with all other RM data. In total, 567 patients were enrolled (79 ± 9 years, 62% men, 19% single-chamber, and 81% dual-chamber pacemakers). Of 547 aIEGMs transmitted in 547 patients, 161 [29.4%; 95% confidence interval (95% CI) 25.6-33.3%] indicated at least one anomaly non-detectable with certainty-or at all-on other RM data, including atrial arrhythmia, extrasystoles, undersensing, oversensing, and loss of capture. In 21.7% of cases the detected events deserved a corrective action. The sensing and pacing function of each lead could be fully assessed in 77.3% of aIEGM (95% CI 72.6-82.0%) vs. 15.5% (95% CI 11.4-19.6%) when considering only the passive IEGM section (P < 0.001).
An active IEGM improves the clinical value of remote pacemaker follow-up. Furthermore, compared to a passive IEGM, the aIEGM increases the capability to fully assess remotely the sensing and pacing functions.
远程监测(RM)被认为是起搏器受者的标准护理。远程监测系统仅提供基于日历的心脏内电图记录(IEGM),并带有当前起搏器设置(被动 IEGM)。PREMS(起搏器远程心电图监测研究)是一项观察性、多中心试验,前瞻性评估了主动 IEGM(aIEGM)的临床价值,包括三个 10 秒段(被动 IEGM、鼓励感知和鼓励起搏),与其他 RM 数据及其被动 IEGM 段进行比较。次要目标包括 aIEGM 对全面评估每个导联的感知和起搏功能的附加价值。
患者在起搏器植入后 3 个月内入组,并随访至首次传输 aIEGM,该 aIEGM 与所有其他 RM 数据一起进行分析。共有 567 名患者入组(79±9 岁,62%为男性,19%为单腔起搏器,81%为双腔起搏器)。在 547 名患者中传输了 547 次 aIEGM,其中 161 次[29.4%;95%置信区间(95%CI)25.6-33.3%]表明至少有一个异常不能肯定或根本不能在其他 RM 数据上检测到,包括房性心律失常、早搏、感知不足、感知过度和失夺获。在 21.7%的情况下,检测到的事件需要采取纠正措施。在每个 aIEGM 中,每个导联的感知和起搏功能都可以得到充分评估,为 77.3%(95%CI 72.6-82.0%),而仅考虑被动 IEGM 段时为 15.5%(95%CI 11.4-19.6%)(P<0.001)。
主动 IEGM 提高了远程起搏器随访的临床价值。此外,与被动 IEGM 相比,aIEGM 增加了远程充分评估感知和起搏功能的能力。