Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial

Area of Science:

• Cardiology
• Biomedical Engineering
• Digital Health

Background:

• An unmet need exists for early detection of heart failure decompensation to enable remote management and reduce hospitalizations.
• Timely intervention is crucial for improving outcomes in patients with heart failure (HF).

Purpose of the Study:

• To compare a management strategy using data from a wearable heart failure monitoring system (HFMS) against usual care for patients following HF hospitalization.
• To evaluate the effectiveness of remote monitoring in preventing HF rehospitalization.

Main Methods:

• A concurrent control study enrolled patients recently discharged after HF hospitalization.
• The intervention arm utilized HFMS data for proactive HF management, while the control arm received usual care.
• The primary endpoint was the time to first HF hospitalization, analyzed using Kaplan-Meier methods over 90 days.

Main Results:

• The study enrolled 522 subjects across 93 sites.
• Patients managed with HFMS data showed a 38% lower rate of HF hospitalization within 90 days compared to the control group (HR: 0.62; P = 0.03).
• This reduction was observed in the intention-to-treat population.

Conclusions:

• Utilizing HFMS data for heart failure management significantly reduces 90-day rehospitalization rates in patients with recent HF hospitalizations.
• The findings support the use of wearable technology for remote monitoring and management of heart failure patients.