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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European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/ Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus statement on catheter and surgical ablation of atrial fibrillation
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2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update: A Report of the American College of Cardiology Foundation Task Force
Journal Articles: The last expert consensus document on cardiac catheterization laboratory standards was published in 2001 (1). Since then, many changes have occurred as the setting has evolved from being primarily diagnostic based into a therapeutic environment. Technology has changed both the imaging and reporting systems. The lower risk of invasive procedures has seen the expansion of cardiac catheterization laboratories to sites without onsite cardiovascular surgery backup and even to community hospitals where primary percutaneous coronary intervention (PCI) is now being performed. This has increased the importance of quality assurance (QA) and quality improvement (QI) initiatives. At the same time, the laboratory has become a multipurpose suite with both diagnostic procedures to investigate pulmonary hypertension and coronary flow and with therapeutic procedures that now include intervention into the cerebral and peripheral vascular systems as well as in structural heart disease. These new procedures have impacted both the adult and pediatric catheterization laboratories. The approaches now available allow for the treatment of even very complex heart disease and have led to the development of hybrid cardiac catheterization laboratories where a team of physicians (including invasive cardiologists, cardiovascular surgeons, noninvasive cardiologists, and anesthesiologists) is required.