RESUMEN
Background: Atrial fibrillation (AF) increases thromboembolism and stroke risk; this can be reduced by oral anticoagulation, but only if AF is detected. A portable, point-of-care device, capable of accurately detecting and identifying AF, could reduce workload and diagnostic delay by minimizing need for follow-up 12-lead electrocardiogram (ECGs). Objective: To assess the diagnostic performance of the Plessey imPulse lead I ECG device compared with a 12-lead ECG in detecting AF. Methods: Cross-sectional diagnostic accuracy study. Participants underwent simultaneous 12-lead ECG and imPulse device recordings. The imPulse device reports AF to be "probable," "possible," "unlikely," or "uncontrolled AF unlikely." imPulse and ECG reference results were cross-tabulated; sensitivity, specificity, positive/negative predictive values, and positive/negative likelihood ratios with 95% confidence interval (CI) were estimated based on different imPulse device report categorizations and heart rate subgroups. Results: A total of 217 participants were recruited (mean age 70.2 [standard deviation 12.7]), 56% male, 57% outpatients, 43% inpatients) and 199 were included in analyses. AF was diagnosed on ECG for 41 of 199 (20.6%) participants and reported by imPulse as possible, probable, or uncontrolled AF unlikely present for 49 of 199 (24.6%). Sensitivity and specificity for imPulse detection of possible, probable, or uncontrolled AF unlikely vs unlikely, compared with ECG, were 80.5% (95% CI, 65.1%-91.2%) and 89.9% (84.1%-94.1%), respectively. When probable or uncontrolled AF unlikely were compared vs possible or unlikely AF, sensitivity and specificity were 63.4% (46.9%-77.9%) and 98.1% (94.6%-99.6%), respectively. Conclusion: The imPulse device has moderate sensitivity and good specificity compared with ECG AF detection in a hospital setting.
RESUMEN
Introduction: Telemonitoring technologies enable medical teams to remotely manage outpatients with heart failure (HF) and reduce their risk of HF-related hospitalizations. However, noncompliance threatens the effectiveness of these approaches. This review aims to identify whether patients who are less likely or unable to comply with telemonitoring and their instructions for use are represented by interventional telemonitoring studies, and if their exclusion from studies is resulting in study findings not representative of clinical reality. Methods: A narrative literature review was conducted to identify interventional telemonitoring studies reporting compliance rates for HF patients. A search of PubMed and Medline databases identified eligible studies published between January 2000 and June 2021. Results: Twenty-five (n = 25) eligible studies with an interventional study design were identified. Reported compliance with telemonitoring ranged between 37% and 98.5%; however, 72% of studies reported good or medium compliance. A majority (76%) of studies had exclusion/inclusion criteria favoring the enrollment of patients who may be more likely to comply with telemonitoring and their instructions for use. Forty percent of studies had a sample with a mean or median age of <65 years. Participants were more likely to be male (majority in 92% of studies) and white (majority in 78% of studies that reported ethnicity). Conclusion: Compliance rates reported by current studies are unlikely to be generalizable to the wider HF population, particularly patients who are less likely or unable to comply with telemonitoring. Studies are therefore likely overestimating compliance rates. Future innovation should focus on designing "low compliance" solutions that require minimal engagement from users and future studies should aim to recruit a more generalizable cohort of patients. To achieve a more standardized metric of compliance, studies should report compliance (however defined) achieved by the 25th, 50th, and 75th percentile of all patients enrolled.
