Dario Claudio, Delise Pietro, Gubian Lorenzo, Saccavini Claudio, Brandolino Glauco, Mancin Silvia
Arsenàl.IT, Veneto's Research Centre for eHealth Innovation, Treviso, Italy.
Interact J Med Res. 2016 Jan 13;5(1):e4. doi: 10.2196/ijmr.4270.
Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach.
The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency.
A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months.
In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per patient per year were detected within a mean (SD) time of 1.18 (2.08) days. Mean time spent by physicians to treat a patient was lower in the I-group compared to the U-group (-4.1 minutes PM; -13.7 minutes ICD). Organizational analysis showed that remote monitoring implementation was rather haphazard and fragmented. From a health care system perspective, the economic analysis showed statistically significant gains (P<.001) for the I-group using PM.
This study contributes to build solid evidence regarding the usefulness of RM in detecting and managing clinical and technical events with limited use of manpower and other health care resources. To fully gain the benefits of RM of PM/ICD, it is vital that organizational processes be streamlined and standardized within an overarching strategy.
植入起搏器（PM）和植入式心脏除颤器（ICD）等植入设备的患者应每3 - 12个月进行一次随访，传统上这需要患者到诊所就诊。创新设备允许数据传输以及从患者家中向医生发送技术或医疗警报（远程监测）。多项研究已表明其在及时检测和管理临床及技术事件方面的有效性，并支持采用该技术。遗憾的是，在日常实践中，远程监测的实施方式缺乏协调性且相当零散，需要一种更具战略性的方法。
本研究的目的是在“真实世界”背景下分析与门诊随访相比，远程监测对PM和ICD的影响。评估重点在于地方卫生当局如何开展这项服务、对心脏病科和卫生系统的影响以及促进或阻碍其有效性和效率的组织特征。
进行了一项多中心、多供应商、对照、观察性前瞻性研究，以分析远程监测实施的影响。共有2101名患者纳入研究：1871名患者通过PM/ICD远程监测进行随访（I组），230名患者通过门诊就诊进行随访（U组）。随访期为12个月。
与U组相比，I组的门诊设备随访和心脏科就诊次数显著更低：PM，I组 = 0.43，U组 = 1.07，P <.001；ICD，I组 = 0.98，U组 = 2.14，P <.001。PM，I组 = 0.37，U组 = 0.85，P <.001；ICD，I组 = 1.58，U组 = 1.69，P = 0.01。仅PM患者中，I组因任何原因的住院率显著更低（I组 = 0.37，U组 = 0.50，P = 0.005）。PM和ICD患者在急诊科的就诊情况无显著差异。在I组中，每位患者每年检测到0.30（PM）和0.37（ICD）次实际临床事件，平均（标准差）时间为1.18（2.08）天。与U组相比，I组医生治疗每位患者花费的平均时间更低（PM减少4.1分钟；ICD减少13.7分钟）。组织分析表明，远程监测的实施相当随意且零散。从医疗保健系统的角度来看，经济分析显示I组使用PM有统计学上的显著收益（P <.001）。
本研究有助于为远程监测在以有限的人力和其他医疗资源检测和管理临床及技术事件方面的有用性建立确凿证据。为了充分获得PM/ICD远程监测的益处，在总体战略内简化和标准化组织流程至关重要。
