Background: A relative high rate of clinical and device-related adverse events (AE) is generally reported in patients with implantable defibrillators for cardiac resynchronization therapy (CRT-D). Aim of this study was to compare a daily remote monitoring (RM) to a standard program of in-office visits.
Methods and results: We retrospectively analyzed RM database and hospital files of 99 CRT-D consecutive patients who were visited in the out-patient clinic every 3-4 months; thirty-three patients were in addition controlled remotely with RM (RM group). Kaplan-Meier curves of clinical or device-related AE-free rates were obtained. During a median follow-up of 7 months, clinical AEs were: ventricular and atrial arrhythmias in 14 and 11 patients, low CRT pacing in nine, heart failure, strokes, or death in 15. Device-related AEs were: insufficient pacing/sensing performances in nine patients, lead dislodgement in five. As comparing the RM group with the remaining patients, Kaplan-Meier curves of clinical AEs diverged to significantly different rates: 23.8% (confidence interval [CI] 0.1%-47.5%) in the RM group and 48.7% (21.6-75.7%) in the remaining patients (P = 0.00002), with a hazard ratio of 0.14 (CI 0.06-0.37). Nondivergent Kaplan-Meier curves were obtained for device-related AE-free rates.
Conclusion: CRT-D patients followed with quarterly in-office visits without a daily RM system had an 86% higher risk of delayed detection of clinical AEs, during a median follow-up of 7 months.
©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.