title: First percutaneous implantation of a completely tissue-engineered self-expanding pulmonary heart valve prosthesis using a newly developed delivery system: a feasibility study in sheep.
abstract: In a European consortium, a decellularized tissue-engineered heart valve (dTEHV) based on vessel-derived cells, a fast-degrading scaffold and a self-expanding stent has been developed. The aim of this study was to demonstrate that percutaneous delivery is feasible. To implant this valve prosthesis transcutaneously into pulmonary position, a catheter delivery system was designed and custom made. Three sheep underwent transjugular prototype implantation. Intracardiac echocardiography (ICE), angiography and computed tomography (CT) were applied to assess the position, morphology, function and dimensions of the stented dTEHV. One animal was killed 3 h after implantation and two animals were followed up for 12 weeks. Explanted valves were analyzed macroscopically and microscopically. In all animals, the percutaneous implantation of the stented dTEHV was successful. The prototype delivery system worked at first attempt in all animals. In the first implantation a 22 F system was used: the valve was slightly damaged during crimping. Loading was difficult due to valve-catheter mismatch in volume. In the second and third implantation a 26 F system was used: the valves fitted adequately and stayed intact. Following implantation, these two valves showed moderate regurgitation due to insufficient coaptation. During follow-up, regurgitation increased due to shortened leaflets. At explantation, macroscopic and microscopic analysis confirmed the second and third valve to be intact. Histology revealed autologous recellularization of the decellularized valve after 12 weeks in vivo. It was demonstrated that completely in vitro tissue-engineered heart valves are thin and stable enough to be crimped and implanted transvenously into pulmonary position.
authors.affiliation: Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Spriestersbach
authors.affiliation: Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
authors.forename: Antonia
authors.initials: A
authors.lastname: Prudlo
authors.affiliation: Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
authors.forename: Marco
authors.initials: M
authors.lastname: Bartosch
authors.affiliation: Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.
authors.forename: Bart
authors.initials: B
authors.lastname: Sanders
authors.affiliation: Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
authors.forename: Torben
authors.initials: T
authors.lastname: Radtke
authors.affiliation: Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.
authors.forename: Frank P T
authors.initials: FP
authors.lastname: Baaijens
authors.affiliation: Division of Surgical Research, University and University Hospital Zürich, Zurich, Switzerland.
authors.forename: Simon P
authors.initials: SP
authors.lastname: Hoerstrup
authors.affiliation: Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Berger
authors.affiliation: Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. schmitt@dhzb.de.
authors.forename: Boris
authors.initials: B
authors.lastname: Schmitt
mesh_terms: D000792:Angiography; D000818:Animals; D004195:Disease Models, Animal; D004452:Echocardiography; D004867:Equipment Design; D005240:Feasibility Studies; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D012756:Sheep; D023822:Tissue Engineering; D014057:Tomography, X-Ray Computed
keywords: Animal models; Cardiac catheterization; Feasibility studies; Heart valve prosthesis; Tissue engineering