Arrythmia Unit, Cardiology Department, Hospital Universitario de Burgos, Av. Islas Baleares 3, Burgos, Spain.
Hospital Universitario y Politécnico La Fe, Av de Fernando Abril Martorell 106, Valencia, Spain.
Eur Heart J. 2019 Jun 14;40(23):1837-1846. doi: 10.1093/eurheartj/ehz067.
This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months.
The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001).
The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.
本试验旨在评估基于远程监测（RM）的心脏植入式电子设备（CIED）监测的常见简化方案的安全性和有效性，该方案适用于至少 24 个月的起搏器（PM）和植入式心脏除颤器（ICD）患者。
RM-ALONE 是一项多中心前瞻性试验，将 445 例患者随机分为两组，均行 RM 监测：仅家庭监测（HMo）组基于 RM + 每 6 个月进行远程询问（RI），HM + IO 组在此基础上每 6 个月增加 RM 下的诊室评估。共纳入 445 例患者，其中 294 例为 PM 患者，151 例为 ICD 患者。在 HMo 组中，20%的患者发生≥1 例主要不良心脏事件（MACE），而 HM + IO 组为 19.5%（非劣效性检验 P=0.006）。HMo 组中 PM/ICD 患者发生≥1 例 MACE 的比例为 15.2%/29.3%，HM + IO 组为 16.1%/26.3%（风险比 0.95/1.15，95%置信区间 0.53-1.70/0.62-2.10）。共进行了 789 次诊室评估（HMo 组 136 次，HM + IO 组 653 次；P<0.001）。HMo 组的诊室评估次数减少了 79.2%，但两组的非计划就诊次数无显著差异：HMo 组 122 次（54.5%），HM + IO 组 101 次（45.3%）；P=0.15。HMo 组医生/护士每次就诊/随访的时间显著减少：4/5 分钟（0-30）/（1-30）与 HM + IO 组的 10/10 分钟（0-40）/（1-40）（P<0.0001）。
RM-ALONE 方案适用于 ICD 和 PM 监测，包括每 6 个月进行一次 RM + RI，已被证明在减少就诊次数和工作人员工作量方面是安全且有效的。
