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Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety—ANTARCTICA study
Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety – ANTARCTICA study
Very high-power short-duration ablation for pulmonary vein isolation utilizing a very-close protocol—the FAST AND FURIOUS PVI study
Very high-power short-duration ablation for pulmonary vein isolation utilizing a very-close protocol—the FAST AND FURIOUS PVI study
ED AF Center Decision Pathway Sheet
Care Pathways/CDS: Quick guide for AF decision pathway in the emergency department.
Cryoballoon Ablation as Initial Treatment for Atrial Fibrillation
Journal Articles: Atrial fibrillation (AF), the most common sustained arrhythmia observed in clinical practice, is a chronic and progressive disorder characterized by exacerbations and remissions. Guidelines recommend antiarrhythmic drugs as the initial therapy for the maintenance of sinus rhythm; however, antiarrhythmic drugs have modest efficacy to maintain sinus rhythm and can be associated with significant adverse effects. An initial treatment strategy of cryoballoon catheter ablation in patients with treatment-naïve AF has been shown to significantly improve arrhythmia outcomes (freedom from any, or symptomatic atrial tachyarrhythmia), produce clinically meaningful improvements in patient-reported outcomes (symptoms and quality of life), and significantly reduce subsequent health care resource use (hospitalization), and it does not increase the risk of serious or any adverse events compared with initial antiarrhythmic drug therapy. These findings are relevant to inform patients, providers, and health care systems regarding the initial choice of rhythm-control therapy in patients with treatment-naïve AF. (J Am Coll Cardiol 2021;78:914–930) © 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Center for Atrial Fibrillation
Succinct presentation for clinicians and administrators describing the mission and strategy of a Center for Atrial Fibrillation.
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.
AF Center Anticoagulation Pathway
Care Pathways/CDS: Care pathway for anticoagulation and decision support tool for an AF center.
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)