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

• Published in: Ontario health technology assessment series 2018, Vol.18 (7), p.1-199
• Format: Article
• Language: English
• Subjects: Ambulatory Care; Arrhythmias, Cardiac - economics; Arrhythmias, Cardiac - therapy; Cardiac Resynchronization Therapy; Cost-Benefit Analysis; Defibrillators, Implantable - economics; Health Care Costs; Humans; Monitoring, Ambulatory - economics; Pacemaker, Artificial - economics; Patient Preference; Remote Sensing Technology - economics; Technology Assessment, Biomedical
• ISSN: 1915-7398

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. 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. 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 cli