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. (PACE 2011; 34:208–216)