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. 2021;13(3):6-13.
doi: 10.17691/stm2021.13.3.01. Epub 2021 Jun 28.

Mechanism of Vascular Injury in Transcatheter Aortic Valve Replacement

E A Ovcharenko  1 , K U Klyshnikov  2 , A A Shilov  3 , N A Kochergin  4 , M A Rezvova  5 , N V Belikov  6 , V I Ganyukov  7
Affiliations

Mechanism of Vascular Injury in Transcatheter Aortic Valve Replacement

E A Ovcharenko et al. Sovrem Tekhnologii Med. 2021.

Abstract

The aim of the study was to determine the potential mechanism of vascular complications due to "catheter-vascular wall" interaction in transcatheter aortic valve replacement using experimental and numerical analysis.

Materials and methods: A series of full-scale bench tests and numerical simulations were carried out using the CoreValve commercial transfemoral delivery system for aortic valve bioprosthesis (Medtronic Inc., USA). Full-scale tests were carried out using a phantom of the vascular system (a polymeric silicone model of Transcatheter Aortic Valve; Trandomed 3D Inc., China) with simulation of all stages of delivery system movement along the vascular bed. They involved introduction into the common femoral artery, movement along the abdominal and thoracic parts of the aorta, the aortic arch, and positioning the system to the implantation site. The force arising from the passage of the delivery system was assessed using sensors of a Z50 universal testing machine (Zwick/Roell, Germany). Numerical simulation of transcatheter valve replacement procedure was carried out in a similar way with allowance for the patient-specific anatomy of the recipient's aorta using the finite element method in the Abaqus/CAE environment (Dassault Systèmes, France).

Results: It was found that in the process of the delivery system passing through the vascular system, there occurred force fluctuations associated with catheter bending and its interaction with the aortic wall in the region of its arch. For example, in the initial straight portions, the pushing force was 3.8-7.9 N; the force increased to the maximum (11.1 and 14.4 N with and without the prosthesis) with bending of the distal portion of the catheter. A similar increase was observed when performing numerical simulation with high-quality graphic visualization of stress on the "spots" of contact between the catheter and the vascular wall with an increase in stress to 0.8 MPa.

Conclusion: Numerical and full-scale bench tests prove the significant effect of the properties of delivery system catheter for transcatheter aortic valve replacement on the interaction with the aortic walls.

Keywords: aortic valve; finite element method; the delivery system of TAVR bioprosthesis; transcatheter valve replacement.

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Conflict of interest statement

Conflicts of interest. There are no conflicts of interest related to this study.

Figures

Figure 1
Figure 1. Full-scale test of the AccuTrak transcatheter system (Medtronic Inc.) when simulating the implantation procedure:
(a) general setup of the experiment and installation of the system under study in the experimental facility; (b) top view of the vascular system phantom with the initial stage of delivery system advancement; (c) enlarged views of the delivery system in two versions (with and without a packed bioprosthesis)
Figure 2
Figure 2. Numerical simulation of transcatheter delivery system advancement:
(a) identifying patient-specific anatomy of the aortic root based on clinical data; (b) the stage of crimping the transcatheter prosthesis using an auxiliary surface; (c) stages of delivery system advancement along the guidewire inside the aorta with visualization of contact “spots”; (d) commercial model of the AccuTrak delivery system (Medtronic Inc.)
Figure 3
Figure 3. Quantitative results of a full-scale test of the AccuTrak transcatheter system (Medtronic Inc.) during simulation of implantation procedure using a polymer phantom on a Z50 universal testing machine (Zwick/Roell) for two cases — with and without a crimped prosthesis:
(a) “pushing force–catheter advancement” relationship in the forward direction; (b) “pushing force–catheter bending angle” dependence in the forward direction (k — visualization of delivery system stiffness coefficient); (c) quantitative data of “force–displacement” testing during transcatheter delivery system extraction
Figure 4
Figure 4. Qualitative visualization of features of transcatheter system under study:
(a) intraoperative aortography during the TAVR procedure; (b) enlarged photo during a full-scale test on a phantom of the circulatory system; (c) visualization of the intermediate stage of introducing the delivery system into the aortic root in patient-specific TAVR modeling. The arrows indicate zones of bending taking place in the distal part of the delivery system
Figure 5
Figure 5. Quantitative results of numerical simulation of a patient-specific procedure for transcatheter aortic valve replacement:
(a) evaluation of the pushing force obtained as a result of simulation in comparison with the results of the full-scale test with a phantom of the circulatory system (two cases); (b) maximum von Mises stress in the delivery system and the aortic wall when moving the catheter along the vascular bed
Figure 6
Figure 6. Quantitative relationship between the stiffness of the distal region of the AccuTrak delivery system (Medtronic Inc.), stress-strain state of the aorta, and the pushing force of the catheter in numerical simulation
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