Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation.

BACKGROUND

The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice.

METHODS

This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared.

RESULTS

No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044).

CONCLUSION

Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.