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Annals of Biomedical Engineering

, Volume 47, Issue 1, pp 113–125 | Cite as

Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Applications: In Vitro Hemodynamic Study

  • Oren M. Rotman
  • Brandon Kovarovic
  • Wei-Che Chiu
  • Matteo Bianchi
  • Gil Marom
  • Marvin J. Slepian
  • Danny BluesteinEmail author
Article

Abstract

Transcatheter aortic valve replacement (TAVR) is a minimally-invasive approach for treating severe aortic stenosis. All clinically-used TAVR valves to date utilize chemically-fixed xenograft as the leaflet material. Inherent limitation of the tissue (e.g., calcific degeneration) motivates the search for alternative leaflet material. Here we introduce a novel polymeric TAVR valve that was designed to address the limitations of tissue-valves. In this study, we experimentally evaluated the hemodynamic performance of the valve and compared its performance to clinically-used valves: a gold standard surgical tissue valve, and a TAVR valve. Our comparative testing protocols included: (i) baseline hydrodynamics (ISO:5840-3), (ii) complementary patient-specific hydrodynamics in a dedicated system, and (iii) thrombogenicity. The patient-specific testing system facilitated comparing TAVR valves performance under more realistic conditions. Baseline hydrodynamics results at CO 4–7 L/min showed superior effective orifice area (EOA) for the polymer valve, most-notably as compared to the reference TAVR valve. Regurgitation fraction was higher in the polymeric valve, but within the ISO minimum requirements. Thrombogenicity trends followed the EOA results with the polymeric valve being the least thrombogenic, and clinical TAVR being the most. Hemodynamic-wise, the results strongly indicate that our polymeric TAVR valve can outperform tissue valves.

Keywords

TAVI TAVR Aortic stenosis Heart valve Prosthetic heart valve Valve hydrodynamics Thrombogenicity Medical device 

Abbreviations

AS

Aortic stenosis

CAVD

Calcific aortic valve disease

CO

Cardiac output

DTE

Device thrombogenic emulation

EOA

Effective orifice area

GFP

Gel-filtered platelets

HR

Heart rate

MAP

Mean arterial pressure

PD

Pulse duplicator

PVL

Paravalvular leak

SAVR

Surgical aortic valve replacement

SV

Stroke volume

TAVR

Transcatheter aortic valve replacement

Notes

Acknowledgements

The authors would like to thank Braile Biomédica (Brazil), for providing us with the Inovare valve samples. This project was supported by NIH-NIBIB Quantum Award Phase II-U01EB012487 (DB), NHLBI STTR R41-HL134418 (DB), and the Center for Biotechnology: a New York State Center for Advanced Technology, New York State Department of Economic Development; and corporate support.

Conflict of interest

Author OMR is a consultant for Polynova Cardiovascular Inc. Authors MJS and DB has stock ownership in Polynova Cardiovascular Inc. Authors BK, WCC, MB and GM declare that they have no conflicts of interest.

Supplementary material

10439_2018_2119_MOESM1_ESM.pdf (1.4 mb)
Supplementary material 1 (PDF 1480 kb)
10439_2018_2119_MOESM2_ESM.mp4 (12.6 mb)
Online Video 1 Front (aortic) view of the test valves in the Vivitro PD, at CO of 5 l/min. Supplementary material 2 (MP4 12938 kb)
10439_2018_2119_MOESM3_ESM.mp4 (16.4 mb)
Online Video 2 Endoscopic front (aortic) view of the test valves in the Vivitro PD, at CO of 5 l/min. Supplementary material 3 (MP4 16800 kb)
10439_2018_2119_MOESM4_ESM.mp4 (4.5 mb)
Online Video 3 Angiogram of the 20-mm Polynova polymeric TAVR valve in the patient-specific CAVD model in the Replicator. On the left is the original angiogram. On the right is the subtracted angiogram for better visualization of regurgitation flow. Supplementary material 4 (MP4 4636 kb)
10439_2018_2119_MOESM5_ESM.mp4 (9.1 mb)
Online Video 4 Angiogram of the 19-mm Carpentier-Edwards Perimount Magna Ease SAVR valve in the patient-specific CAVD model in the Replicator. On the left is the original angiogram. On the right is the subtracted angiogram for better visualization of regurgitation flow. Supplementary material 5 (MP4 9299 kb)
10439_2018_2119_MOESM6_ESM.mp4 (5.5 mb)
Online Video 5 Angiogram of the 20-mm Inovare TAVR valve in the patient-specific CAVD model in the Replicator. On the left is the original angiogram. On the right is the subtracted angiogram for better visualization of regurgitation flow. Supplementary material 6 (MP4 5668 kb)

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Copyright information

© Biomedical Engineering Society 2018

Authors and Affiliations

  • Oren M. Rotman
    • 1
  • Brandon Kovarovic
    • 1
  • Wei-Che Chiu
    • 1
  • Matteo Bianchi
    • 1
  • Gil Marom
    • 1
    • 2
  • Marvin J. Slepian
    • 3
  • Danny Bluestein
    • 1
    Email author
  1. 1.Department of Biomedical EngineeringStony Brook UniversityStony BrookUSA
  2. 2.School of Mechanical EngineeringTel Aviv UniversityTel AvivIsrael
  3. 3.Department of Biomedical EngineeringUniversity of ArizonaTucsonUSA

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