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In Vitro Durability and Stability Testing of a Novel Polymeric Transcatheter Aortic Valve.

ABSTRACT: 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 (?CT) and inductive coupled plasma spectroscopy. The valves passed 400M cycles in the AWT without failure. The effective orifice area kept stable at 1.8?cm 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.

SUBMITTER: Rotman OM

PROVIDER: S-EPMC7136031 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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In Vitro Durability and Stability Testing of a Novel Polymeric Transcatheter Aortic Valve.

Rotman Oren M OM Kovarovic Brandon B Bianchi Matteo M Slepian Marvin J MJ Bluestein Danny D

ASAIO journal (American Society for Artificial Internal Organs : 1992) 20200201 2

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 pre ...[more]

PMID: 30845067

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Project description:BACKGROUND:This study aimed at assessment of post-transcatheter aortic valve (TAV) replacement hemodynamics and turbulence when a same-size SAPIEN 3 (Edwards Lifesciences Corp, Irvine, Calif) and Medtronic Evolut (Minneapolis, Minn) were implanted in a rigid aortic root with physiological dimensions and in a representative root with calcific leaflets obtained from patient computed tomography scans. METHODS:TAV hemodynamics were studied by placing a SAPIEN 3 26-mm and an Evolut 26-mm in rigid aortic roots and representative root with calcific leaflets under physiological conditions. Hemodynamics were assessed using high-fidelity particle image velocimetry and high-speed imaging. Transvalvular pressure gradients (PGs), pinwheeling indices, and Reynolds shear stress (RSS) were calculated. RESULTS:(1) PGs obtained with the Evolut and the SAPIEN 3 were comparable among the different models (10.5 ± 0.15 mm Hg vs 7.76 ± 0.083 mm Hg in the rigid model along with 13.9 ± 0.19 mm Hg vs 5.0 ± 0.09 mm Hg in representative root with calcific leaflets obtained from patient computed tomography scans respectively); (2) more pinwheeling was found in the SAPIEN 3 than the Evolut (0.231 ± 0.057 vs 0.201 ± 0.05 in the representative root with calcific leaflets and 0.366 ± 0.067 vs 0.122 ± 0.045 in the rigid model); (3) higher rates of RSS were found in the Evolut (161.27 ± 3.45 vs 122.84 ± 1.76 Pa in representative root with calcific leaflets and 337.22 ± 7.05 vs 157.91 ± 1.80 Pa in rigid models). More lateral fluctuations were found in representative root with calcific leaflets. CONCLUSIONS:(1) Comparable PGs were found among the TAVs in different models; (2) pinwheeling indices were found to be different between both TAVs; (3) turbulence patterns among both TAVs translated according to RSS were different. Rigid aortic models yield more conservative estimates of turbulence; (4) both TAVs exhibit peak maximal RSS that exceeds platelet activation 100 Pa threshold limit.

Dataset Information

In Vitro Durability and Stability Testing of a Novel Polymeric Transcatheter Aortic Valve.

Publications

In Vitro Durability and Stability Testing of a Novel Polymeric Transcatheter Aortic Valve.

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