Remote Monitoring of Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy and Permanent Pacemakers: A Health Technology Assessment.

Abstract

Background: Under usual care, people with an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy with or without a defibrillator (CRT-D and CRT-P, respectively), or a permanent pacemaker have follow-up in-person clinic visits. Remote monitoring of these devices allows the transfer of the information stored in the device so that it can be accessed by the clinic personnel via a secured website.

Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for remote monitoring of ICDs, CRTs, and permanent pacemakers plus clinic visits compared with clinic visits alone. This is an update of a 2012 health technology assessment. In addition to the eligible randomized controlled trials (RCTs) from the 2012 publication, we included RCTs identified through a systematic literature search on June 1, 2017. We assessed the risk of bias of each study using the Cochrane risk of bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We conducted an economic evaluation to determine the cost-effectiveness of remote monitoring blended with in-clinic follow-up compared to in-clinic follow-up alone in patients with an ICD, a CRT-D, or a pacemaker. We determined the budget impact of blended remote monitoring in patients implanted with ICD, CRT-D, CRT-P, or pacemaker devices from the perspective of the Ontario Ministry of Health and Long-Term Care. To understand patient experiences with remote monitoring, we interviewed 16 patients and family members.

Results: Based on 15 RCTs in patients with implanted ICDs or CRT-Ds, remote monitoring plus clinic visits resulted in fewer patients with inappropriate ICD shocks within 12 to 37 months of follow-up (moderate quality evidence; absolute risk difference -0.04 [95% confidence interval -0.07 to -0.01]), fewer total clinic visits (moderate quality evidence), and a shorter time to detection and treatment of events (moderate quality evidence) compared with clinic visits alone. There was a similar risk of major adverse events (moderate quality evidence).Based on 6 RCTs in patients with pacemakers, remote monitoring plus clinic visits reduced the arrhythmia burden (high quality evidence), the time to detection and treatment of arrhythmias (high quality evidence), and the number of clinic visits (moderate quality evidence]) compared with clinic visits alone. Here again, there was a similar risk of major adverse events (high quality evidence).Results from the economic evaluation showed that among ICD and CRT-D recipients, blended remote monitoring (remote monitoring plus in-clinic follow ups) was more costly (incremental value of $4,354 per person) and more effective, providing higher quality-adjusted life years (incremental value of 0.19), compared to in-clinic follow-up alone. Among pacemaker recipients, blended remote monitoring was less costly (with an incremental saving of $2,370 per person) and more effective (with an incremental value of 0.12 quality-adjusted life years) than with in-clinic follow-up alone. We estimated that publicly funding remote monitoring could result in cost savings of $14 million over the first five years.Participants using remote monitoring reported that these devices provide important medical and safety benefits in managing their heart condition. Remote cardiac monitoring provides patients and their family members with an increased freedom. Their belief that the device will help with earlier detection of technical or clinical problems reduces the amount of stress and distraction their condition causes in their lives.

Conclusions: Remote monitoring of ICDs, CRT-Ds, and pacemakers plus clinic visits resulted in improved outcomes without increasing the risk of major adverse events compared with clinic visits alone. Remote monitoring is a cost-effective option for patients implanted with cardiac electronic devices. Patients reported positive experiences using remote monitoring, and perceived that the device provided important medical and safety benefits.