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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


Spriestersbach, Hendrik; Prudlo, Antonia; Bartosch, Marco; Sanders, Bart; Radtke, Torben; Baaijens, Frank P T; Hoerstrup, Simon P; Berger, Felix; Schmitt, Boris (2017). 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. Cardiovascular Intervention and Therapeutics, 32(1):36-47.

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.

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute for Regenerative Medicine (IREM)
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:January 2017
Deposited On:03 Feb 2017 09:21
Last Modified:08 Dec 2017 20:48
Publisher:Springer
ISSN:1868-4300
Publisher DOI:https://doi.org/10.1007/s12928-016-0396-y
PubMed ID:27139179

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