Subclinical Paroxysmal Atrial Fibrillation in Outpatients with Heart Failure Detected by a Novel Non-invasive Wireless Remote Monitoring Platform

Abstract

Atrial fibrillation (AF) is a frequent and important comorbidity in patients with heart failure (HF). However, the frequency of subclinical paroxysmal AF (PAF) in HF patients has not been well-characterized. We have developed a novel wireless remote monitoring platform (BodyGuardian®) which provides continuous 24/7 real-time cardiac telemetry including automated rhythm classification supported by a dedicated 24/7 monitoring center with technician over-read. Herein we report our initial experience with deployment of the BodyGuardian® platform in HF subjects for detection of PAF. Subclinical PAF is frequent in outpatients with chronic stable HF. We performed continuous cardiac rhythm monitoring using the BodyGuardian® platform over an interval of 2-4 weeks in ambulatory subjects (n=24) with stable chronic NYHA class I-IV HF receiving standard therapy. The platform includes an external removable sensor-patch on the front-end which acquires EKG signals wirelessly transmitted via cell-phone technology to Cloud servers for storage, summary and analysis and down-loaded on the back-end for technician over-read with reporting to the electronic medical record for review by providers. Automated rhythm classification, alerts and summaries provide clinical decision-support. Proprietary technology enables assessment of EKG and HR reliability with appropriate filtering for reported data. The system also enables two-way communication between providers and patients (subjects) with programmable thresholds for automated alerts as well as subject-activated alerts by button-push. AF < 30 seconds duration was not considered for analysis. Subjects (4 women, 20 men) were 32-84 years old (mean 63.4 years) with LVEF 15-72% (mean 32.6%); 18 subjects were NYHA class I-II and 6 class III-IV. The sensor-patch was well tolerated; compliance with sensor-patch was high. Mean monitoring interval was 23.2 ± 18.0 days. EKG signal reliability was 93.1% before filtering. 11 subjects had no history of AF. During the study period 19 separate subjects had remotely detected AF including 4 individuals with no prior history of AF. Hence, 4 of 11 (36%) HF subjects with no AF history developed at least one episode of PAF during the study period. Subclinical PAF is frequently detected in outpatients with chronic, stable HF monitored continuously by an external wireless remote monitoring platform over an interval of 2-4 weeks. Remote telemetry may potentially increase detection rates and quantification of PAF burden in HF patients and support outpatient management of AF where hospital monitoring might otherwise be required. These findings are important as they may enable modification of management strategies.