Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial.

ABSTRACT

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 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 (n = 100; 369 access sites) or the MC arm (n = 104; 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 = 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 = 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 = 0.001) for the device overall, and 40% higher (p = 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).