Journal Articles

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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AI Filter Improves Positive Predictive Value of Atrial Fibrillation Detection by an Implantable Loop Recorder

Journal Articles: Journal article outlining a study to determine whether incorporation of a 2-part AI filter can improve the positive predictive value (PPV) of implantable loop recorder (ILR)-detected AFib episodes.

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Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation

Journal Articles: Catheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage electrical fields, may limit damage to tissues outside the myocardium. The efficacy and safety of pulsed field ablation as compared with conventional thermal ablation is not known.

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Development of a Care Pathway for Atrial Fibrillation Patients in the Emergency Department

Care Pathways/CDS: Atrial fibrillation (AF) is the most common cardiac arrhythmia and its prevalence is continuously increasing in the United States, leading to a progressive rise in the number of disease-related emergency department (ED) visits and hospitalizations. Although optimal long-term outpatient management for AF is well defined, the guidelines for optimal ED management of acute AF episodes is less clear. Studies have demonstrated that discharging patients with AF from the ED after acute stabilization is both safe and cost effective; however, the majority of these patients in the United States and in our institution are admitted to the hospital. To improve care of these patients, we established a multidisciplinary collaboration to develop an evidence-based systematic approach for the treatment and management of AF in the ED, that led to the creation of the University of California—Cardioversion, Anticoagulation, Rate Control, Expedited Follow-up/Education Atrial Fibrillation Pathway. Our pathway focuses on the acute stabilization of AF, adherence to best practices for anticoagulation, and reduction in unnecessary admissions through discharge from the ED with expedited outpatient follow-up whenever safe. A novel aspect of our pathway is that it is primarily driven by the ED physicians, while other published protocols primarily involve consulting cardiologists to guide management in the ED. Our protocol is very pertinent considering the current trend toward increased AF prevalence in the United States, coupled with a need for widespread implementation of strategies aimed at improving management of these patients while safely reducing hospital admissions and the economic burden of AF.

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Improved Procedural Efficiency of Atrial Fibrillation Ablation Using a Dedicated Ablation Protocol and Lean Management

Journal Articles: In this study the authors hypothesized that “Lean management” within a dedicated ablation protocol could standardize the pulmonary vein isolation (PVI) procedure and improve quality.

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Arrhythmias in Pregnancy

Journal Articles: Increasing maternal mortality and incidence of arrhythmias in pregnancy have been noted over the past 2 decades in the United States. Pregnancy is associated with a greater risk of arrhythmias, and patients with a history of arrhythmias are at significant risk of arrhythmia recurrence during pregnancy. The incidence of atrial fibrillation in pregnancy is rising. This review discusses the management of tachyarrhythmias and bradyarrhythmias in pregnancy, including management of cardiac arrest. Management of fetal arrhythmias are also reviewed. For patients without structural heart disease, bblocker therapy, especially propranolol and metoprolol, and antiarrhythmic drugs, such as flecainide and sotalol, can be safely used to treat tachyarrhythmias. As a last resort, catheter ablation with minimal fluoroscopy can be performed. Device implantation can be safely performed with minimal fluoroscopy and under echocardiographic or ultrasound guidance in patients with clear indications for devices during pregnancy. Because of rising maternal mortality in the United States, which is partly driven by increasing maternal age and comorbidities, a multidisciplinary and/or integrative approach to arrhythmia management from the prepartum to the postpartum period is needed. (J Am Coll Cardiol EP 2022;8:120–135) © 2022 by the American College of Cardiology Foundation.

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An Atrial Fibrillation Transitions of Care Clinic Improves Atrial Fibrillation Quality Metrics

Journal Articles: OBJECTIVES: This study sought to assess whether an atrial fibrillation (AF)–specific clinic is associated with improved adherence to American College of Cardiology (ACC)/American Heart Association (AHA) clinical performance and quality measures for adults with AF or atrial flutter; BACKGROUND: There are significant gaps in care of patients with AF, including underprescription of anticoagulation and treatment of AF risk factors. An AF specialized clinic was developed to reduce admissions for AF but may also be associated with improved quality of care.; METHODS: This retrospective study compared adherence to ACC/AHA measures for patients who presented to the emergency department for AF between those discharged to a typical outpatient appointment and those discharged to a specialized AF transitions clinic run by an advanced practice provider and supervised by a cardiologist. Screening and treatment for common AF risk factors was also assessed; RESULTS: The study enrolled 78 patients into the control group and 160 patients into the intervention group. Patients referred to the specialized clinic were more likely to have stroke risk assessed and documented (99% vs. 26%; p < 0.01); be prescribed appropriate anticoagulation (97% vs. 88%; p ¼ 0.03); and be screened for comorbidities such as tobacco use (100% vs. 14%; p < 0.01), alcohol use (92% vs. 60%; p < 0.01), and obstructive sleep apnea (90% vs. 13%; p < 0.01) and less likely to be prescribed an inappropriate combination of anticoagulant and antiplatelet medications (1% vs. 9%; p < 0.01).; CONCLUSIONS: An AF specialized clinic was associated with improved adherence to ACC/AHA clinical performance and quality measures for adult patients with AF. (J Am Coll Cardiol EP 2020;6:45–52) © 2020 by the American College of Cardiology Foundation.

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Major drivers of healthcare system costs and cost variability for routine atrial fibrillation ablation

Journal Articles: Original research article published in Heart Rhythm 02, outlining a study from the University of Utah that measured the components of direct and indirect costs for routine AF ablation procedures, the variability of those costs, and the main factors driving ablation cost variability.

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EP News – QI and Outcomes—Triaging AF Patients for Optimal Care

Journal Articles: Atrial fibrillation (AF) is a major public health concern that affects millions of people worldwide. AF is associated with increasing health care costs and a higher risk of stroke with increasing comorbidities and age. Despite well-written guidelines for AF care, standardized management is lacking. Therein lies an opportunity to create AF centers of excellence (AF CoEs) with a patient-centered integrated focus and approach that can benefit patients and health care providers (physicians, nurse practitioners, physician assistants, nurses, pharmacists and technologists) alike.

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