利用日常传输进行自动远程监测：TRUST 试验中的传输可靠性和植入式心脏复律除颤器电池寿命。
Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial.
机构信息
Cardiac Pacing and Electrophysiology, Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
Department of Cardiology, New York University Langone Medical Center, New York, NY, USA.
出版信息
Europace. 2018 Apr 1;20(4):622-628. doi: 10.1093/europace/eux059.
AIMS
Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial.
METHODS AND RESULTS
Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to Conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months.
CONCLUSION
Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov; NCT00336284.
目的
植入式心脏复律除颤器（ICD）患者的自动远程家庭监测（HM）可能需要高传输频率。然而，传输可靠性和对电池寿命的影响仍不确定。我们假设 HM 将具有高传输成功率，允许及时进行基于指南的随访，并延长电池寿命。这在前瞻性随机 TRUST 试验中进行了测试。
方法和结果
植入后，ICD 患者被随机分为 2:1 接受 HM（n=908）（每天传输）或常规门诊监测[常规管理（CM），n=431（HM 禁用）]。在两组中，每 3 个月安排 5 次评估，持续 15 个月。通过接收传输与总可能传输次数之比以及由于传输丢失而导致错过的 HM 检查次数来评估 HM 技术性能。在 15 个月时比较 HM 与 CM 的电池寿命，并在植入后 3 年使用连续传输数据再次比较 HM。每位患者的传输成功率为 91%（中位随访 434 天）。总体而言，在潜在的 363450 天中，每天 HM 传输接收了 315795 天（87%）。HM 中只有 55/3759（1.46%）的不成功预约评估归因于传输丢失。HM 与 CM 之间的电击频率和起搏百分比相似。HM 的 15 个月电池寿命长 12%（HM 为 93.2±8.8%，CM 为 83.5±6.0%，P<0.001）。在 HM 患者的扩展随访中，估计 36 个月时的电池寿命为 50.9±9.1%（中位数为 52%）。
结论
自动远程 HM 显示出强大的传输可靠性。无需降低电池寿命即可维持每日传输负荷。HM 可节省电池寿命并跟踪长期设备性能。
临床试验注册
ClinicalTrials.gov；NCT00336284。
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