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 Bluestein

Research output: Contribution to journalArticle

13 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)113-125
Number of pages13
JournalAnnals of Biomedical Engineering
Volume47
Issue number1
DOIs
StatePublished - Jan 15 2019

Keywords

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

ASJC Scopus subject areas

  • Biomedical Engineering

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