Characterizing Real-World Implementation of Consumer Wearables for the Detection of Undiagnosed Atrial Fibrillation in Clinical Practice: Targeted Literature Review

Abstract

Background Atrial fibrillation (AF), the most common cardiac arrhythmia, is often undiagnosed because of lack of awareness and frequent asymptomatic presentation. As AF is associated with increased risk of stroke, early detection is clinically relevant. Several consumer wearable devices (CWDs) have been cleared by the US Food and Drug Administration for irregular heart rhythm detection suggestive of AF. However, recommendations for the use of CWDs for AF detection in clinical practice, especially with regard to pathways for workflows and clinical decisions, remain lacking. Objective We conducted a targeted literature review to identify articles on CWDs characterizing the current state of wearable technology for AF detection, identifying approaches to implementing CWDs into the clinical workflow, and characterizing provider and patient perspectives on CWDs for patients at risk of AF. Methods PubMed, ClinicalTrials.gov, UpToDate Clinical Reference, and DynaMed were searched for articles in English published between January 2016 and July 2023. The searches used predefined Medical Subject Headings (MeSH) terms, keywords, and search strings. Articles of interest were specifically on CWDs; articles on ambulatory monitoring tools, tools available by prescription, or handheld devices were excluded. Search results were reviewed for relevancy and discussed among the authors for inclusion. A qualitative analysis was conducted and themes relevant to our study objectives were identified. Results A total of 31 articles met inclusion criteria: 7 (23%) medical society reports or guidelines, 4 (13%) general reviews, 5 (16%) systematic reviews, 5 (16%) health care provider surveys, 7 (23%) consumer or patient surveys or interviews, and 3 (10%) analytical reports. Despite recognition of CWDs by medical societies, detailed guidelines regarding CWDs for AF detection were limited, as was the availability of clinical tools. A main theme was the lack of pragmatic studies assessing real-world implementation of CWDs for AF detection. Clinicians expressed concerns about data overload; potential for false positives; reimbursement issues; and the need for clinical tools such as care pathways and guidelines, preferably developed or endorsed by professional organizations. Patient-facing challenges included device costs and variability in digital literacy or technology acceptance. Conclusions This targeted literature review highlights the lack of a comprehensive body of literature guiding real-world implementation of CWDs for AF detection and provides insights for informing additional research and developing appropriate tools and resources for incorporating these devices into clinical practice. The results should also provide an impetus for the active involvement of medical societies and other health care stakeholders in developing appropriate tools and resources for guiding the real-world use of CWDs for AF detection. These resources should target clinicians, patients, and health care systems with the goal of facilitating clinician or patient engagement and using an evidence-based approach for establishing guidelines or frameworks for administrative workflows and patient care pathways.