Laboratorio di Elettrofisiologia, Clinica San Michele, Via Montella, 16, Maddaloni (CE) 81024, Italy
Policlinico Universitario, Padua, Italy.
Europace. 2015 Aug;17(8):1267-75. doi: 10.1093/europace/euu318. Epub 2015 Apr 4.
Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking.
The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm.
Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice.
URL: http://clinicaltrials.gov/ Identifier: NCT01723865.
基于互联网的远程询问系统已被证明可以减少植入式心脏复律除颤器（ICD）患者的急诊科和门诊就诊次数，从而提高医疗保健提供者的效率。尽管如此，旨在证明远程监测对患者预后影响的研究仍缺乏。
EFFECT 研究是一项多中心临床试验，旨在测量和比较通过常规门诊就诊（标准组）或通过远程监测（远程组）对 25 个意大利中心的临床实践中的 ICD 患者进行随访的结果。2011 年至 2013 年期间，共纳入 987 例连续患者，并至少随访 12 个月。主要终点是死亡率和心血管住院率。499 例患者采用了远程监测。标准组和远程组患者的基线临床特征无显著差异，除了远程组中更频繁地使用带心脏再同步治疗（CRT-D）的 ICD（48%比 36%，P<0.001）。标准组患者的 1 年主要联合终点发生率为 0.27 例/年，远程组为 0.15 例/年（发生率比，0.55；95%CI，0.41-0.73；P<0.001）。标准组和远程组 CRT-D 患者的终点发生率分别为 0.27 和 0.08 例/年（P<0.001），ICD 患者分别为 0.28 和 0.21 例/年（P=0.094）。标准组每年门诊就诊次数为 1.9 次，远程组为 1.7 次。
与通过门诊就诊进行的标准随访相比，在临床实践中，远程监测与 ICD 患者的死亡率和心血管住院率降低相关。
网址：http://clinicaltrials.gov/ 标识符：NCT01723865。
