A Randomized Study of Remote Follow-Up of Implantable Cardioverter Defibrillators: Safety and Efficacy Report of the ECOST Trial
How safe is remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) compared to conventional ambulatory monitoring (AM)?
Four hundred thirty-three patients (mean age 62 years) who received an ICD were randomly assigned to RM (n = 221) or AM (n = 212). Patients in the RM group were seen in the clinic at 1-3, 15, and 27 months post-implant. Data transmitted by RM were automatically processed on a daily basis, and physicians were notified of notable findings. In the AM group, patients were seen in the clinic at 1-3, 9, 15, 21, and 27 months post-implant. The primary endpoint was major adverse events (MAEs; death and major cardiovascular, procedure-related, or device-related adverse events). The study was designed to test noninferiority of RM compared to AM.
The prevalence of MAE was 40.3% in the RM group and 43.3% in the AM group (p < 0.05 for noninferiority). The proportion of patients experiencing an inappropriate shock was significantly lower in the RM group (5%) than in the AM group (10.4%). There was significantly less battery depletion in the RM group, translating to a 7.9-month increase in longevity.
RM of ICDs is not less safe than AM, and is associated with a lower prevalence of inappropriate ICD shocks and with longer battery life.
A major advantage of RM over AM is that it allows for the early detection and management of factors that predispose to inappropriate shocks, such as oversensing or supraventricular tachycardia. RM also may decrease the prevalence of appropriate shocks by prompting therapy with antiarrhythmic drugs or catheter ablation if there is early detection of ventricular tachycardia.
Keywords: Monitoring, Ambulatory, Tachycardia, Supraventricular, Follow-Up Studies, Cytarabine, Longevity, Equipment Failure, Prevalence, Tachycardia, Ventricular, Electric Power Supplies, Catheter Ablation, Defibrillators, Implantable
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