Remote monitoring combined with fluid monitoring did not significantly influence the time to first heart failure-related hospitalization compared to standard in-office visits (HR 1.23; 95% CI 0.62-2.44; P=0.551).
RCT (n=176)
Randomly allocated
No
Does remote monitoring combined with fluid monitoring reduce HF hospitalizations, ICD shocks, or mortality in patients with implanted ICD or CRT-D devices?
Remote monitoring combined with fluid monitoring did not significantly reduce heart failure hospitalizations, ICD shocks, or mortality compared to standard in-office visits in patients with ICD or CRT-D devices.
Effect estimate: HR 1.23 (95% CI 0.62-2.44)
p-value: p=0.551
AIMS: Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. METHODS AND RESULTS: Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 0.62-2.44 (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). CONCLUSION: In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found.
Lüthje et al. (Sun,) conducted a rct in Heart failure with indication for ICD or CRT-D (n=176). Remote monitoring including OptiVol and predefined management of alerts vs. Standard in-office visits every 3 months was evaluated on Time to first heart failure-related hospitalization (HR 1.23, 95% CI 0.62-2.44, p=0.551). Remote monitoring combined with fluid monitoring did not significantly influence the time to first heart failure-related hospitalization compared to standard in-office visits (HR 1.23; 95% CI 0.62-2.44; P=0.551).