title: Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Arsenàl.IT, Veneto's Research Centre for eHealth Innovation, Treviso, Italy.
authors.forename: Claudio
authors.identifier: http://orcid.org/0000-0002-9464-4450
authors.initials: C
authors.lastname: Dario
authors.forename: Pietro
authors.identifier: http://orcid.org/0000-0001-7190-4830
authors.initials: P
authors.lastname: Delise
authors.forename: Lorenzo
authors.identifier: http://orcid.org/0000-0002-0272-2635
authors.initials: L
authors.lastname: Gubian
authors.forename: Claudio
authors.identifier: http://orcid.org/0000-0002-6640-955X
authors.initials: C
authors.lastname: Saccavini
authors.forename: Glauco
authors.identifier: http://orcid.org/0000-0003-4470-2197
authors.initials: G
authors.lastname: Brandolino
authors.forename: Silvia
authors.identifier: http://orcid.org/0000-0002-2521-8220
authors.initials: S
authors.lastname: Mancin
keywords: cardiac pacemaker; healthcare economics and organization; implantable cardiac defibrillator; telehealth and telemonitoring