Background—Heart failure (HF) patients with implantable defibrillators (ICD) or ICD for resynchronization therapy (CRT-D) often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that internet-based remote interrogation systems could reduce emergency healthcare utilizations.

Methods and Results—This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary endpoint was the rate of emergency department or urgent in-office visits for HF, arrhythmias or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; Incidence density: 0.59 versus 0.93events/year; p=0.005). A 21% difference was observed in the rates of total healthcare utilizations for HF, arrhythmias or ICD-related events (4.40 versus 5.74events/year; p<0.001). The time from an ICD alert condition to review of the data was reduced from 24.8days in the standard arm to 1.4days in the remote arm (p<0.001). The patients’ clinical status, as measured by the Clinical Composite Score, was similar in the two groups, while a more favorable change in quality of life (Minnesota Living with HF Questionnaire) was observed from the baseline to the 16^th month in the remote arm (p=0.026).

Conclusions—Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare utilization in patients with ICD/CRT-D. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients.

Clinical Trial Registration Information—ClinicalTrials.gov; Identifier:  NCT00873899.