Bovine pericardium leaflet damage during transcatheter aortic valve crimping: a study of the mechanisms

Abstract

Leaflet damage has been documented to occur while deploying a transcatheter aortic valve (TAV) due to mechanical loads during the crimping procedures. In this study, the impact of compressive stress on folded leaflets was measured to investigate the mechanism of traumatic leaflet tissue damage. Numerical simulation of TAV crimping procedure was adapted to calculate stress magnitude and distribution of leaflets. A 20 mm balloon expanding short stent TAV with 0.25 mm thickness leaflets was used in the simulation. Then the calculated stresses were applied on leaflet material (bovine pericardium) samples by loading experiments. Mechanical properties evaluation combined with histological and microscopy observation were used to investigate the tissue damage. The elastic modulus and the tensile strength of the tissue began to decrease significantly at 2 MPa stress and 2.5 MPa stress, respectively. No significant differences were observed at 0–1.5 MPa stress. When the TAV was crimped to 14 Fr and 12 Fr, the 2 MPa greater areas on leaflets increased from 18.17% to 76.96%. 2 MPa compressive stress might be the threshold value for leaflet damage. The TAV crimping size should be paid attention to avoid the compressive stress higher than 2 MPa.

Keywords:

• Transcatheter aortic valve
• bovine pericardium
• damage
• stress
• finite element analyses

Disclosure statement

All authors declare that we have no financial and personal relationships with other people or organizations that can inappropriately influence our work.

Additional information

Funding

This work was supported by the National Key Research and Development Program of China (2016YFC1102202, 2017YFB0702500), Beijing Natural Science Foundation (7194287), Innovation Teams in Priority Areas Accredited by the Ministry of Science and Technology (11421201), Special-Funded Program on National Key Scientific Instruments and Equipment Development (11827803).