Technology and Device Management
Journal Articles: Atrial fibrillation (AF) is the most common cardiac arrhythmia diagnosed and treated in the world. The treatment of patients’ symptoms as well as the prevention of stroke and heart failure is dependent on accurate detection and characterization of AF. A variety of electrocardiographic (ECG) monitoring techniques are being used for these purposes. However, these intermittent ECG monitoring techniques have been shown to underdiagnose AF events while having limited ability to characterize AF burden and density. Continuous long-term implantable loop recorder (ILR)–based ECG monitoring has been designed to overcome these limitations. This technology is being increasingly used to diagnose episodes of AF in high-risk patients and to improve characterization of AF episodes in patients with known AF. This review aims to review the potential clinical utility of ILR-based ECG monitoring while highlighting some inherent limitations of the current technology. An understanding of these limitations is important when considering the use of ILR-based ECG monitoring and clinical decision making based on the information being stored within these devices.
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.
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)
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.
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.
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).
Journal Articles: In this issue of Heart Rhythm, we present a new quarterly feature highlighting quality improvement in the delivery of heart rhythm care. These quarterly features will summarize key publications of relevance to the electrophysiology community and provide a forum for recognizing the growing importance of measuring, reporting, and improving the quality of heart rhythm care.