Inpatient

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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Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures – The AMBULATE Trial

Journal Articles: OBJECTIVES This study compared the efficacy and safety of the VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC) for closing multiple access sites after catheter-based electrophysiology procedures. BACKGROUND The The VASCADE MVP VVCS is designed to provide earlier ambulatory hemostasis than MC after catheter-based procedures. METHODS The AMBULATE (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore (VASCADE MVP) VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 – 12 Fr Sheath Sizes) trial was a multicenter, randomized trial of device closure versus MC in patients who underwent ablation. Outcomes included time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes. RESULTS A total of 204 patients at 13 sites were randomized to the device arm (100 patients; 369 access sites) or the MC arm (104 patients; 382 access sites). Baseline characteristics were similar between groups. Mean TTA, TPPT, TTDe, and TTH were substantially lower in the device arm (respective decreases of 54%, 54%, 52%, and 55%; all p < 0.0001). Opioid use was reduced by 58% (p ¼ 0.001). There were no major access site complications. Incidence of minor complications was 1.0% for the device arm and 2.4% for the MC arm (p ¼ 0.45). Patient satisfaction scores with duration of and comfort during bedrest were 63% and 36% higher in device group (both p < 0.0001). Satisfaction with bedrest pain was 25% higher (p ¼ 0.001) for the device overall, and 40% higher (p ¼ 0.002) for patients with a previous ablation. CONCLUSIONS Use of the closure device for multiple access ablation procedures resulted in significant reductions in TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction and no increase in complications. (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes [AMBULATE]; NCT03193021)

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Suspected AF Pathway

Care Pathways/CDS: Clinical Pathway for Suspected AF

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SOP Atrial Fibrillation Therapy

Care Pathways/CDS: SOP for therapy options when treating AFib. Includes flow chart, decision trees, chart for AAD dosage, and risk factors/comorbidities.

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SOP Atrio-esophageal Fistula

Care Pathways/CDS: Care pathway for clinicians to use when suspecting atrio-esophageal fistula in patients.

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Confirmed AF Management Pathway

Care Pathways/CDS: Care pathway for management of confirmed AFib in patients. Includes information about underlying causes, treatment options, reducing stroke risk, and more.

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Guidelines for the Management of Atrial Fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC)

Guidelines/Clinical Documents: Guidelines document outlining best practices for the management of AFib.

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Rationale, considerations, and goals for atrial fibrillation centers of excellence: A Heart Rhythm Society perspective

Guidelines/Clinical Documents: This manuscript builds on the work of a diverse, multiple-stakeholder Think Tank meeting and multidisciplinary Inter-pro Forum educational activity held in January 2019, both led by the Heart Rhythm Society (HRS). When examining the current clinical landscape, the Think Tank concluded that there is a clear need for AF CoEs to improve AF care and its delivery. In this manuscript, HRS hopes to accelerate this evolution by reviewing the rationale for AF CoEs, the available evidence for integrated and multidisciplinary care, and future challenges and opportunities. The document also defines the key priorities to be used as a guide for HRS and its diverse stakeholders to build consensus on defining the core components of an AF CoE.

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