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Femoral Arterial Calcification and Plug- vs. Suture-Based Closure Device Strategies Post-Transcatheter Aortic Valve
Sean Fitzgerald1, Oliver Dumpies1, Masafumi Shibata1
1Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Insights
Vascular calcification at the access site increases complications after transfemoral transcatheter aortic valve implantation. However, calcification severity does not alter the effectiveness of plug-based versus suture-based closure techniques.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Vascular calcification at the access site can impact closure device success in transfemoral transcatheter aortic valve implantation (TAVI).
- Assessing the influence of calcification location and severity on outcomes is crucial for TAVI procedures.
Purpose of the Study:
- To analyze the effects of vascular access-site calcification on vascular and bleeding outcomes following TAVI.
- To investigate whether calcification influences the success of different vascular closure techniques.
Main Methods:
- Subgroup analysis of the CHOICE-CLOSURE trial involving 516 patients undergoing TAVI.
- Patients were categorized based on the presence and severity of anterior calcification at the access site.
- Comparison of vascular and bleeding complications between plug-based (MANTA) and suture-based (ProGlide) closure strategies.
Main Results:
- Increased access-site-related vascular complications were observed in patients with anterior wall calcification and severe calcification (MASH severe).
- No significant interaction was found between calcification presence/severity and the choice of closure technique regarding complications.
Conclusions:
- The total number of vascular complications is higher with anterior and severe calcification.
- The efficacy of suture-based versus plug-based closure strategies is not significantly modified by the presence of anterior or severe calcification.
Background:
The location and severity of vascular calcification may influence closure device success in transfemoral transcatheter aortic valve implantation. The aim of this study was to analyze effects of vascular access-site calcification on vascular and bleeding outcomes post-transcatheter aortic valve implantation.
Methods:
The Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE) trial assigned 516 patients to access site closure using a pure plug-based technique (MANTA, Teleflex) or a primary suture-based technique (ProGlide, Abbott Vascular). The principal finding of the overall study was that access-site or access-related complications were more common after the plug-based strategy compared to percutaneous closure with a suture-based strategy. In this predefined subgroup analysis, the overall cohort was split into patients with and without anterior calcification at the access site and divided by degree of calcification severity using the classification system developed in the MANTA vs. suture-based vascular closure after transcatHeter aortic valve replacement (MASH) trial. Differences in bleeding and vascular complications were compared. The primary endpoint consisted of access-site- or access-related major and minor vascular complications.
Results:
There were more access-site-related major and minor vascular complications for patients with anterior wall vascular calcification and MASH severe calcification. No significant interaction with choice of closure technique in terms of access-site-related major and minor vascular complications was observed (odds ratio 1.70, 95% CI 0.77-3.78, p = 0.19 for the primary endpoint in plug- vs. suture-based strategy in patients with anterior calcification, odds ratio 1.78, 95% CI 0.56-5.65, p = 0.33 for primary endpoint in plug- vs. suture-based strategy with MASH severe calcification, pint = 0.97 for anterior calcification, pint = 0.95 for MASH severe calcification).
Conclusions:
The total number of vascular complications was found to be greater in the presence of anterior and MASH severe calcification. Overall, the presence of anterior or severe calcification does not significantly modify the efficacy of the suture-based strategy compared to the plug-based strategy.
