Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation

Abstract

BackgroundPatients 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.ObjectiveThe 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.MethodsA 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.ResultsIn-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.ConclusionsThis 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.

Cost–utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial

“…Cost-utility and cost-effectiveness analyses help to quantify the value of new interventions, informing both medical decision making and public policy [24,25]. Although in the last years, economic assessments of CIEDs have increased [26][27][28][29][30][31][32][33][34], the number of cost-utility analyses used to assess outcomes in terms of utility or quality-adjusted life years (QALYs) is scarce [35], especially in PM devices [36,37], needing more health economic studies to determine the value (the relationship between additional QALYs achieved and additional costs incurred) of systematic remote monitoring in users with pacemakers.…”

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact)

“…Interestingly, observational studies have consistently associated telemetry with a reduction in hospitalisation frequency [ 12 , 23 , 24 ]. Again, this discrepancy is likely due to socioeconomic and geographical bias reflective of real-world trends and applications.…”

Rounding Up the Usual Suspects: Nonsustained Ventricular Tachycardia and Sustained Left Ventricular Dysfunction as Risk Factors for Sudden Death in Isolated AV Block

“…Improved remote device monitoring may be helpful in acquiring this data that will also be needed to define effectiveness of implanted cardiac rhythm devices. 18 Because the cause of death of the patients in this study is not known, appropriate and effective interventions can only be conjectured.…”

“…Far less expensive device interrogation, which could help to establish a cause of death, should be a standard part of the death investigation of any person with a cardiac rhythm device. Improved remote device monitoring may be helpful in acquiring this data that will also be needed to define effectiveness of implanted cardiac rhythm devices . Because the cause of death of the patients in this study is not known, appropriate and effective interventions can only be conjectured.…”