Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Applications: In Vitro Hemodynamic Study
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.
KeywordsTAVI TAVR Aortic stenosis Heart valve Prosthetic heart valve Valve hydrodynamics Thrombogenicity Medical device
Calcific aortic valve disease
Device thrombogenic emulation
Effective orifice area
Mean arterial pressure
Surgical aortic valve replacement
Transcatheter aortic valve replacement
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.
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