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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.
Journal article

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.

  • Spriestersbach H Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
  • Prudlo A Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
  • Bartosch M Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
  • Sanders B Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.
  • Radtke T Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
  • Baaijens FP Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.
  • Hoerstrup SP Division of Surgical Research, University and University Hospital Zürich, Zurich, Switzerland.
  • Berger F Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
  • Schmitt B Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. schmitt@dhzb.de.
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  • 2016-05-04
Published in:
  • Cardiovascular intervention and therapeutics. - 2017
Animal models
Cardiac catheterization
Feasibility studies
Heart valve prosthesis
Tissue engineering
Angiography
Animals
Disease Models, Animal
Echocardiography
Equipment Design
Feasibility Studies
Heart Valve Diseases
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Prosthesis Design
Pulmonary Valve
Sheep
Tissue Engineering
Tomography, X-Ray Computed
English 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.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://sonar.ch/global/documents/141867
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