Technology and Device Management
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)
Read MoreJournal 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.
Read MoreJournal 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.
Read MoreJournal 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).
Read MoreJournal 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.
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