title: In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE).
abstract: This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.
authors.affiliation: Cardiovascular Engineering Laboratory, UCL Mechanical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK.
authors.forename: Benyamin
authors.identifier: http://orcid.org/0000-0002-8062-6737
authors.initials: B
authors.lastname: Rahmani
authors.affiliation: Cardiovascular Engineering Laboratory, UCL Mechanical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK.
authors.forename: Spyros
authors.initials: S
authors.lastname: Tzamtzis
authors.affiliation: Cardiovascular Engineering Laboratory, UCL Mechanical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK.
authors.forename: Rose
authors.initials: R
authors.lastname: Sheridan
authors.affiliation: Barts Health NHS Trust, University College London Hospital, London, UK.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mullen
authors.affiliation: Barts Health NHS Trust, University College London Hospital, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Yap
authors.affiliation: NanoRegMed Ltd, London, UK.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Seifalian
authors.affiliation: Cardiovascular Engineering Laboratory, UCL Mechanical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK. g.burriesci@ucl.ac.uk.|Ri.MED Foundation, Bioengineering Group, Palermo, Italy. g.burriesci@ucl.ac.uk.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Burriesci
mesh_terms: D000497:Alloys; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D057446:Hydrodynamics; D008422:Materials Testing; D011474:Prosthesis Design; D000069322:Self Expandable Metallic Stents; D013193:Stainless Steel; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*
chemical_list: D000497:Alloys; D013193:Stainless Steel; C013616:nitinol
keywords: Polymeric leaflets; Preclinical assessment; Self-expanding stent; TAVI