Device Management

Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation – BASEL Wearable Study

Journal Articles: BACKGROUND Multiple smart devices capable to detect atrial fibrillation (AF) are presently available. Sensitivity and specificity for the detection of AF may differ between available smart devices, and this has not yet been adequately investigated. OBJECTIVES The aim was to assess the accuracy of 5 smart devices in identifying AF compared with a physician interpreted 12-lead electrocardiogram as the reference standard in a real-world cohort of patients. METHODS We consecutively enrolled patients presenting to a cardiology service at a tertiary referral center in a prospective, diagnostic study. RESULTS We prospectively analyzed 201 patients (31% women, median age 66.7 years). AF was present in 62 (31%) patients. Sensitivity and specificity for the detection of AF were comparable between devices: 85% and 75% for the Apple Watch 6, 85% and 75% for the Samsung Galaxy Watch 3, 58% and 75% for the Withings Scanwatch, 66% and 79% for the Fitbit Sense, and 79% and 69% for the AliveCor KardiaMobile, respectively. The rate of inconclusive tracings (the algorithm was unable to determine the heart rhythm) was 18%, 17%, 24%, 21%, and 26% for the Apple Watch 6, Samsung Galaxy Watch 3, Withings Scan Watch, Fitbit Sense, and AliveCor KardiaMobile (P < 0.01 for pairwise comparison), respectively. By manual review of inconclusive tracings, the rhythm could be determined in 955 (99%) of 969 single-lead electrocardiograms. Regarding patient acceptance, the Apple Watch was ranked first (39% of participants). CONCLUSIONS In this clinical validation of 5 direct-to-consumer smart devices, we found differences in the amount of inconclusive tracings diminishing sensitivity and specificity of the smart devices. In a clinical setting, manual review of tracings is required in about one-fourth of cases.

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2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic

Guidelines/Clinical Documents: Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

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EP News – QI and Outcomes – MAY 2019 CIED Infection (CatanzaroNasir)

Journal Articles: This is the second in a series of Heart Rhythm quarterly features, highlighting science relevant to quality improvement. The focus of this feature is the prevention of cardiac implantable electronic device infection.

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EP News – QI and Outcomes – JULY 2022 Remote Monitoring Pediatric (ClarkTanel)

Journal Articles: Remote monitoring of pediatric cardiac implantable electronic devices (CIEDs) has become an important tool in outpatient management. Recent guidelines (Shah et al, JACC Clin Electrophysiol 2021;7:1437, PMID 34794667) from the Pediatric and Congenital Electrophysiology Society (PACES) have recommended remote monitoring of CIEDs every 3–12 months for pacemakers and every 3–6 months for implantable cardioverter-defibrillators, with an increase in frequency when the device is approaching elective replacement indicators. Compared with their adult counterparts, pediatric and adult patients with congenital heart disease have a higher frequency of epicardial devices that carry an elevated risk of lead fracture, which may lead to adverse outcomes, especially in pacemaker-dependent patients (Post et al, Neth Heart J 2011;19:331, PMID 21567217). CIED remote transmission remains a vital modality to ensure safe monitoring and assessment of temporal CIED trends, especially battery longevity and lead functionality. Furthermore, advances in remote monitoring foster a sense of disease-specific knowledge, improved self-management, and shared decision making (Walker et al, Int J Med Inform 2019;124:78, PMID 30784430).

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