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Updated: Dec 17, 2025

Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
Access site related vascular complications with third generation transcatheter heart valve systems
Hendrik Ruge1,2, Melchior Burri1,2, Magdalena Erlebach1,2
1Department of Cardiovascular Surgery, German Heart Center, TUM, INSURE (Institute for Translational Cardiac Surgery), Munich, Germany.
Insights
Vascular complications after transcatheter aortic valve replacement (TAVR) are linked to sheath-to-femoral-artery ratio and multiple large bore sheath entries. Optimizing these factors can reduce complications and improve patient outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Vascular complications at the femoral access site are a concern in transcatheter aortic valve replacement (TAVR).
- While randomized trials report on complications with current transcatheter heart valve (THV) systems, their clinical presentation and consequences require further study.
Purpose of the Study:
- To investigate the impact of anatomical and procedural factors on vascular complications following TAVR.
- To identify independent risk factors for access-site related vascular complications in TAVR procedures.
Main Methods:
- Retrospective analysis of 878 patients undergoing transfemoral TAVR with specific THV systems (Edwards Sapien3®/Sapien3ultra® or Medtronic Evolut-R®/Evolut-PRO®).
- Inclusion criteria focused on procedures using the PerClose-ProGlide® vascular closure device.
- Logistic regression was used to analyze risk factors, with preoperative and procedural data collected for comparison.
Main Results:
- 17.3% of patients experienced access-site related vascular complications, with 9.9% being major.
- Independent risk factors identified were sheath-to-femoral-artery ratio (SFAR) and more than two vessel entries with large bore sheaths.
- Patients with complications showed increased need for blood transfusion and higher in-hospital mortality.
Conclusions:
- Procedural risk assessment should incorporate SFAR calculation and consideration of large bore sheath exchange.
- Mitigating these procedural factors may decrease vascular trauma and improve clinical outcomes after TAVR.
Objectives:
This study examines the impact of anatomical and procedural factors on Valve Academic Research Consortium-2-defined vascular complications at the femoral access site in transcatheter aortic valve replacement (TAVR) with third generation transcatheter heart valve (THV)-systems.
Background:
Randomized clinical trials reported on vascular complications with current THV-systems. However, clinical presentation and consequences of these events are not well studied.
Methods:
All patients who underwent a transfemoral TAVR using an Edwards Sapien3®/Sapien3ultra® or a Medtronic Evolut-R®/Evolut-PRO® have been identified from our institutional database. Only procedures utilizing the PerClose-ProGlide® vascular closure device were included. Risk factors for vascular complications were analyzed with a logistic regression model. Preoperative and procedural data were collected. The postoperative course of patients with and without vascular complications was compared.
Results:
A total of 878 patients met the inclusion criteria. Of these, 152 patients (17.3%) had an access-site related vascular complication (87 major complications, 9.9%). Sheath-to-femoral-artery-ratio (SFAR) (OR per 0.1 increase = 1.35, p < .001) and more than 2 vessel entries with large bore sheaths (OR = 1.76, p = .029) were independent risk factors for vascular complications. Female gender (OR = 1.44, p = .07) and two vessel entries with large bore sheaths (OR = 1.2, p = .53) increased the risk, although no statistical significance was shown. Age (OR = 1.07, p = .62), body mass index (OR = 1.1 per 5 points, p = .32) and vessel wall calcification at puncture site (OR = 0.93, p = .7) had no influence on vascular complications. Patients with vascular complications had a higher need for blood transfusion (p < .001) and a higher in-hospital mortality (2.6 vs. 0.4%, p = .019).
Conclusions:
Procedural risk assessment should include SFAR calculation and consider the need for large bore sheath exchange. This might reduce the vascular trauma, lower vascular complication rates and improve the clinical outcome after TAVR.
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