Related Experiment Video
Updated: Aug 17, 2025
Fully Endoscopic Mitral Valve Repair with Percutaneous Cannulation of Groin Vessels
Published on: May 26, 2023
Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter
Beytullah Cakal1, Sinem Cakal2, Oguz Karaca1
1Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey.
Insights
Adding the Angio-Seal device as a bailout strategy after dual Perclose ProGlide use for transfemoral transcatheter aortic valve implantation showed similar major complication rates. This approach may be a safe and feasible option for patients with incomplete hemostasis.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Vascular Surgery
Background:
- Vascular closure device failure is a key factor in major vascular complications during transcatheter aortic valve implantation (TAVI).
- Incomplete hemostasis after TAVI procedures necessitates effective management strategies.
Purpose of the Study:
- To evaluate the safety and efficacy of using the Angio-Seal device as a bailout strategy for incomplete hemostasis after dual Perclose ProGlide device use in transfemoral TAVI.
- To compare outcomes between patients treated with dual Perclose ProGlide alone versus a combination of dual Perclose ProGlide and Angio-Seal.
Main Methods:
- Retrospective analysis of 185 patients undergoing transfemoral TAVI.
- Patients were divided into two groups: dual Perclose ProGlide (n=139) and dual Perclose ProGlide + Angio-Seal (n=46).
- Outcomes were assessed based on Valve Academic Research Consortium-2 criteria.
Main Results:
- No significant differences in major vascular complications (9.4% vs 4.3%), minor vascular complications (9.4% vs 14.7%), major bleeding (11.5% vs 4.3%), or minor bleeding (6.5% vs 10.9%) between the groups.
- The dual Perclose ProGlide + Angio-Seal group showed a higher rate of hematoma (2.9% vs 10.9%).
Conclusions:
- Adjunctive Angio-Seal deployment appears feasible and safe for managing incomplete hemostasis after dual Perclose ProGlide use in transfemoral TAVI.
- This bailout strategy can be considered an optimal procedural option.
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.
