title: Innovative, replaceable heart valve: concept, in vitro study, and acute in vivo study.
abstract: The purpose of this study was to evaluate the feasibility of our innovative, replaceable heart valves that can be easily detached from the sewing ring at the time of repeat replacement. The prototype devices consist of the base magnet ring assembly and the valve magnet ring assembly that utilize magnetic coupling force for the locking mechanism. Magnetic coupling strength was evaluated in vitro. Prototype bioprosthetic valves were implanted acutely in three sheep to confirm the feasibility of the replaceable mitral valve. The static separation force of prototype size #25 was 12.5 lb, meeting the design goal. In situ attachment and detachment of the valve magnet ring assembly from the base magnet ring assembly were very easily accomplished in all animals. The magnetic coupling did not decouple even under extremely high left ventricular pressures. We have demonstrated the feasibility of this innovative concept of a replaceable mitral valve.
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA. fukamak@ccf.org
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ootaki
authors.forename: Chiyo
authors.initials: C
authors.lastname: Ootaki
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Akiyama
authors.forename: Keiji
authors.initials: K
authors.lastname: Kamohara
authors.forename: Faruk
authors.initials: F
authors.lastname: Cingoz
authors.forename: Ji-Feng
authors.initials: JF
authors.lastname: Chen
authors.forename: David J
authors.initials: DJ
authors.lastname: Horvath
authors.forename: Alex L
authors.initials: AL
authors.lastname: Massiello
authors.forename: Raymond
authors.initials: R
authors.lastname: Dessoffy
mesh_terms: D000818:Animals; D001705:Bioprosthesis; D005240:Feasibility Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D008280:Magnetics; D008422:Materials Testing; D008943:Mitral Valve / Q000601:surgery*; D011474:Prosthesis Design; D012756:Sheep