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植入式心脏复律除颤器家庭监测预测定期就诊需求的可靠性,以及患者观点。日本 HOME-ICD 研究。

Reliability of implantable cardioverter defibrillator home monitoring in forecasting the need for regular office visits, and patient perspective. Japanese HOME-ICD study.

机构信息

Department of Cardiology, Fujita Health University School of Medicine.

出版信息

Circ J. 2013;77(11):2704-11. doi: 10.1253/circj.cj-13-0387. Epub 2013 Jul 30.

DOI:10.1253/circj.cj-13-0387
PMID:23903000
Abstract

BACKGROUND

Remote monitoring (RM) technology has emerged as a potentially efficient method to manage patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). This study evaluated the reliability of daily RM in forecasting the need for regular in-hospital follow-ups (RFUs).

METHODS AND RESULTS

Two hundred and fifteen patients implanted with Biotronik Lumax devices (142 ICDs, 73 CRT-Ds) were enrolled. RFU was performed at 3, 6, 9, and 12 months after implantation. Immediately before an RFU, the physician forecasted the need for RFU based on RM data (pre-RFU assessment). A completed RFU session was classified as necessary if an action was undertaken potentially influencing patient safety, device therapy, or medication therapy (post-RFU assessment). Overall, 663 pairs of pre- and post-RFU assessments were compared. The number of pre-RFU assessments failing to predict the need for RFU was 38 (5.7%), fulfilling the study hypothesis of 5.0±4.0% (P<0.002; 95% confidence interval: 4.1-7.8%). Judged by an independent committee, the rate of false pre-RFU forecasts with high clinical relevance was 2 (0.3%). RM correctly forecasted non-necessity of 498 scheduled RFUs (75.1%). Patient acceptance of RM was evaluated using a targeted questionnaire. Of 182 interviewed patients, 172 (94.5%) felt security and comfort.

CONCLUSIONS

RM-based forecasts appear sufficiently accurate to safely individualize RFU. Most patients have a positive attitude towards RM.

摘要

背景

远程监测 (RM) 技术已成为管理植入式心脏复律除颤器 (ICD) 或心脏再同步治疗除颤器 (CRT-D) 患者的一种潜在有效方法。本研究评估了日常 RM 预测常规住院随访 (RFU) 需求的可靠性。

方法和结果

共纳入 215 名植入百多力 Lumax 设备的患者(142 例 ICD,73 例 CRT-D)。植入后 3、6、9 和 12 个月进行 RFU。在进行 RFU 之前,医生根据 RM 数据(预 RFU 评估)预测 RFU 的需求。如果采取了可能影响患者安全、设备治疗或药物治疗的行动,则完成的 RFU 会话被归类为必要(后 RFU 评估)。总共比较了 663 对预 RFU 和后 RFU 评估。有 38 次预 RFU 评估未能预测 RFU 的需求(5.7%),满足研究假设的 5.0±4.0%(P<0.002;95%置信区间:4.1-7.8%)。由独立委员会判断,具有高临床相关性的虚假预 RFU 预测率为 2 例(0.3%)。RM 正确预测了 498 次计划 RFU 的非必要性(75.1%)。使用针对性问卷评估患者对 RM 的接受程度。在接受采访的 182 名患者中,有 172 名(94.5%)感到安全和舒适。

结论

基于 RM 的预测似乎足够准确,可以安全地个体化 RFU。大多数患者对 RM 持积极态度。

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