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Clinical Trial
. 2021 Feb;32(2):191-199.
doi: 10.1111/jce.14828. Epub 2020 Dec 14.

Results from the prospective, multicenter AMBULATE-CAP trial: Reduced use of urinary catheters and protamine with hemostasis via the Mid-Bore Venous Vascular Closure System (VASCADE® MVP) following multi-access cardiac ablation procedures

Amin Al-Ahmad  1 , Suneet Mittal  2 , David DeLurgio  3 , G Joseph Gallinghouse  1 , Rodney P Horton  1 , Mark W Preminger  2 , J David Burkhardt  1 , Andrea Natale  1
Affiliations
Clinical Trial

Results from the prospective, multicenter AMBULATE-CAP trial: Reduced use of urinary catheters and protamine with hemostasis via the Mid-Bore Venous Vascular Closure System (VASCADE® MVP) following multi-access cardiac ablation procedures

Amin Al-Ahmad et al. J Cardiovasc Electrophysiol. 2021 Feb.

Abstract

Introduction: Manual compression (MC), historically the most common method to achieve hemostasis after percutaneous vascular procedures, is time consuming, requires prolonged bedrest, and is uncomfortable for patients and clinicians. Recent studies demonstrate the efficacy and safety of vascular closure devices and suggest shorter times to hemostasis and patient ambulation compared with MC. The current study evaluated the feasibility of the VASCADE® venous vascular closure system (VVCS) while allowing for urinary catheter (UC) elimination, and elimination of protamine and/or same calendar day discharge (SCDD).

Methods and results: In this prospective, multicenter trial, patients were enrolled and assigned to the following groups: no UC, no protamine, and/or SCDD (no co-enrollment in no protamine and SCDD). After completing the catheter-based cardiac procedure, access sites were closed using the VVCS. Outcomes included final hemostasis (all sites) without major access site-related complications at 30 days, rates of access site closure-related complications, device success, and study group success. All 168 patients had hemostasis without major access site-related complications through 30 days. In the no UC group, 160 out of 164 (97.6%) patients did not receive a UC. Additionally, 39 out of 41 (95.1%) patients received heparin without protamine reversal and no access site bleeding-related ambulation delays, and 18 out of 18 (100%) patients were discharged on the same day. There were no major access site closure-related complications, few minor complications, and adverse events were generally mild and well managed.

Conclusion: The VVCS was effective for achieving hemostasis following catheter-based procedures; access site closure-related complications and adverse events were well managed.

Keywords: access site; cardiac; hemostasis; manual compression; vascular closure device.

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