Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure and Atrial Fibrillation: A Pilot Study Using a New Wearable Sensor
Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure and Atrial Fibrillation: A Pilot Study Using a New Wearable Sensor
Heart failure (HF) is a growing global public health concern. Worldwide, the estimated prevalence of HF has increased to >64.3 million cases. Despite improvement in outcomes with medication, HF is a leading cause of hospitalization among individuals >65 years. Approximately 30-40% of HF patients have a history of hospitalization, and 50% are re- admitted with 1 year within their initial diagnosis of HF . In Tunisia, the current statistics (2017) show that the all-cause 1-year mortality rate among acute HF patient was 22.8%, the 1-year rate of hospitalization because of HF was 7.3%, and the 1-year incidence rates of the combined event (all-cause mortality or HF hospitalization) was 18.7%. Available literature highlighted that patient monitoring using wearable biosensors is a promising strategy to improve cardiovascular patients care and have potential to support clinical practice and improve patient outcomes .
The objective of this protocol is to evaluate the feasibility and effectiveness of continuous tele- ECG monitoring in predicting hospital readmission and other clinical relevant outcome in patients with AF discharged from the emergency department (ED) after HF decompensation using a novel device "VIVALINK ECG Patch".
Inclusion Criteria: (1) Patients having an HF decompensation diagnosis, patients with reduced ejection fraction<50%, (2) having a documented AF (3) have a plan for discharging with partnering home health services, (4) agree to use the wearable ECG patch for 30 days (5) with a permanent residential address (6) without significant cognitive impairment and (7) understand English language.
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Exclusion Criteria: (1) patients having implanted pacemaker or any electrical devices; (2) having an allergy to hydrocolloid gel adhesive or skin diseases; (3) unstable vital signs, (4) being on dialysis; (5) having a documented visual, cognitive, or physical impairment that would interfere with the ability to comply with the study procedures, (6) pregnant women (7) having inability to give an informed consent.