Transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for the unmet clinical need of inoperable patients with severe aortic stenosis (AS). Current clinically used tissue TAVR valves suffer from limited durability that hampers TAVR’s rapid expansion to younger, lower risk patients. Polymeric TAVR valves optimized for hemodynamic performance, hemocompatibility, extended durability, and resistance to calcific degeneration offer a viable solution to this challenge. We present extensive in vitro durability and stability testing of a novel polymeric TAVR valve (PolyNova valve) using 1) accelerated wear testing (AWT, ISO 5840); 2) calcification susceptibility (in the AWT)—compared with clinically used tissue valves; and 3) extended crimping stability (valves crimped to 16 Fr for 8 days). Hydrodynamic testing was performed every 50M cycles. The valves were also evaluated visually for structural integrity and by scanning electron microscopy for evaluation of surface damage in the micro-scale. Calcium and phosphorus deposition was evaluated using micro-computed tomography (μCT) and inductive coupled plasma spectroscopy. The valves passed 400M cycles in the AWT without failure. The effective orifice area kept stable at 1.8 cm2 with a desired gradual decrease in transvalvular pressure gradient and regurgitation (10.4 mm Hg and 6.9%, respectively). Calcium and phosphorus deposition was significantly lower in the polymeric valve: down by a factor of 85 and 16, respectively—as compared to a tissue valve. Following the extended crimping testing, no tears nor surface damage were evident. The results of this study demonstrate the potential of a polymeric TAVR valve to be a viable alternative to tissue-based TAVR valves.
From *Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York
†Department of Biomedical Engineering, University of Arizona, Tucson, Arizona.
Submitted for consideration November 2018; accepted for publication in revised form January 2019.
Disclosure: Dr. Rotman is a consultant for PolyNova Cardiovascular Inc. Drs. Slepian and Bluestein have stock ownership in PolyNova Cardiovascular Inc. Mr. Kovarovic and Bianchi declare that they have no conflicts of interest to report.
This project was supported by National Institute of Biomedical Imaging and Bioengineering Quantum Award Phase II U01EB012487 (Dr. Bluestein), BRP U01EB026414 (Dr. Bluestein), National Heart, Lung, and Blood Institute STTR R41-HL134418 (Dr. Bluestein), and the Center for Biotechnology: A New York State Center for Advanced Technology, New York State Department of Economic Development, and corporate support.
The device discussed in this study is investigational and has not yet been approved by the US Food and Drug Administration for any purpose.
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Correspondence: Dr. Danny Bluestein, Department of Biomedical Engineering, Stony Brook University, StonyBrook, NY 11794–8151. Email: email@example.com.