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.
Abstract

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