Baaijens, F.P.T.

Cox, M.A.J.

Driessen - Mol, A.

Oomens, C.W.J.

Simonet, M.

English

Simonet, M Marc

Cox, MAJ Martijn

Oomens, CWJ Cees

Driessen-Mol, A Anita

Baaijens, FPT Frank

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Hemodynamic testing of a 3D electrospun heart valve prosthesis

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 Hemodynamic testing of a 3D electrospun heart valveprosthesisCitation for published version (APA):Simonet, M., Cox, M. A. J., Oomens, C. W. J., Driessen - Mol, A., & Baaijens, F. P. T. (2011). Hemodynamictesting of a 3D electrospun heart valve prosthesis. Poster session presented at Mate Poster Award 2011 : 16thAnnual Poster Contest.Document status and date:Published: 01/01/2011Document Version:Accepted manuscript including changes made at the peer-review stagePlease check the document version of this publication:• A submitted manuscript is the version of the article upon submission and before peer-review. There can beimportant differences between the submitted version and the official published version of record. Peopleinterested in the research are advised to contact the author for the final version of the publication, or visit theDOI to the publisher's website.• The final author version and the galley proof are versions of the publication after peer review.• The final published version features the final layout of the paper including the volume, issue and pagenumbers.Link to publicationGeneral rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright ownersand it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.            • Users may download and print one copy of any publication from the public portal for the purpose of private study or research.            • You may not further distribute the material or use it for any profit-making activity or commercial gain            • You may freely distribute the URL identifying the publication in the public portal.If the publication is distributed under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license above, pleasefollow below link for the End User Agreement:www.tue.nl/taverneTake down policyIf you believe that this document breaches copyright please contact us at:openaccess@tue.nlproviding details and we will investigate your claim.Download date: 15. Jul. 2024/ Department of Bioengineering M. Simonet1,2 , M. A. J. Cox2 , C.W.J. Oomens1,  A. Driessen-Mol1, F.P.T. Baaijens1 1Department of Biomedical Engineering, TU/e Eindhoven 2QTIS/e,  Eindhoven  Hemodynamic testing of a 3D electrospun heart valve prosthesis    Introduction  The feasibility to use electrospun scaffolds as a valvular prosthesis has been tested previously by subjecting a thermoformed valve scaffold to pulmonary conditions in a valve exerciser. Electrospinning also offers possibilities to directly spin a three-dimensional heart valve scaffold. Here, we describe our first findings with a valve scaffold design, in which the valve consists of three separate electrospun leaflets.   Materials and Methods The 3 leaflets were electrospun separately from a 20%(w/w) poly(ɛ-caprolactone) (PCL) solution and combined to a valve (di 27 mm) in a second step (see figure 1). The pores in the valve were sealed with a fibrin gel (thrombin 10 IU/ml + fibrinogen 10 mg/ml) prior to testing for 20 min at pulmonary conditions in a valve exerciser (n=1).        Figure 1 Process to electrospin a 3D valve starting with single leaflets  Results  The fibrin sealed PCL valve shown in figure 2 was tested in a valve exerciser (Hemolab B. V., Eindhoven). Successful hemodynamic characteristics were obtained,  the leakage remained at 6%, whereas total regurgitation was at 10% and the valve showed an effective orifice area of 2.4 cm2 (see table 1).                     a           b  c                            d Figure 2 Images of the used electrospun PCL valves; a) ventricular side,  b) pulmonary side, c) open position in the valve tester, d)  closed position in the valve tester                Figure 3 Pulmonary hemodynamic pressure curves of the electrospun  PCL vs. the TPU reference valve               Table1 Pulmonary performance values from Figure 3 of the electro- spun PCL vs. the TPU reference valve with ISO values needed   for an aortic valve implant  Conclusion  We demonstrated here an electrospun three-dimensional heart valve, capable to function under pulmonary conditions with some key performance factors above the minimum requirements stated in the “standard ISO 5840 for Cardiovascular implants - Cardiac valve prostheses” for the 20 minutes tested. Additional, specifically prolonged, testing is required to evaluate the potential of this valve types.  Acknowledgments We gratefully wish to acknowledge the help of Hemolab and T. Lavrijsen on the valve test experiments.  ISO 5840 TPU film PCL electrospun  Time point [min] N.A. 0 0 20 General configuration         Stroke volume [mL] N.A. 73 71 71 Cardiac output [L/min] 5.0 5.2 5.0 5.0 Conditions         Peak systolic pressure [mmHg]  N.A. 36 36 36 End diastolic pressure [mmHg]  N.A. 8 7 7 Open configuration         Calculated AEO [cm2]  ≥1.7 1.6 2.1 2.3 Max. systolic p. gradient                                [mmHg] N.A. 8 10 8 Closed configuration         Regurgitation [%] ≤20 6 10 10 Leakage [%] N.A. 2 7 6 Closing volume [%] N.A. 4 3 4 The research program of the BioMedical Materials institute is co-funded by the Dutch Ministry of Economic Affairs, Agriculture and Innovation.  The financial contribution of the Nederlandse Hartstichting is gratefully acknowledged.  

 Hemodynamic testing of a 3D electrospun heart valveprosthesisCitation for published version (APA):Simonet, M., Cox, M. A. J., Oomens, C. W. J., Driessen - Mol, A., & Baaijens, F. P. T. (2011). Hemodynamictesting of a 3D electrospun heart valve prosthesis. Poster session presented at Mate Poster Award 2011 : 16thAnnual Poster Contest.Document status and date:Published: 01/01/2011Document Version:Accepted manuscript including changes made at the peer-review stagePlease check the document version of this publication:• A submitted manuscript is the version of the article upon submission and before peer-review. There can beimportant differences between the submitted version and the official published version of record. Peopleinterested in the research are advised to contact the author for the final version of the publication, or visit theDOI to the publisher's website.• The final author version and the galley proof are versions of the publication after peer review.• The final published version features the final layout of the paper including the volume, issue and pagenumbers.Link to publicationGeneral rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright ownersand it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.            • Users may download and print one copy of any publication from the public portal for the purpose of private study or research.            • You may not further distribute the material or use it for any profit-making activity or commercial gain            • You may freely distribute the URL identifying the publication in the public portal.If the publication is distributed under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license above, pleasefollow below link for the End User Agreement:www.tue.nl/taverneTake down policyIf you believe that this document breaches copyright please contact us at:openaccess@tue.nlproviding details and we will investigate your claim.Download date: 04. Oct. 2023/ Department of Bioengineering M. Simonet1,2 , M. A. J. Cox2 , C.W.J. Oomens1,  A. Driessen-Mol1, F.P.T. Baaijens1 1Department of Biomedical Engineering, TU/e Eindhoven 2QTIS/e,  Eindhoven  Hemodynamic testing of a 3D electrospun heart valve prosthesis    Introduction  The feasibility to use electrospun scaffolds as a valvular prosthesis has been tested previously by subjecting a thermoformed valve scaffold to pulmonary conditions in a valve exerciser. Electrospinning also offers possibilities to directly spin a three-dimensional heart valve scaffold. Here, we describe our first findings with a valve scaffold design, in which the valve consists of three separate electrospun leaflets.   Materials and Methods The 3 leaflets were electrospun separately from a 20%(w/w) poly(ɛ-caprolactone) (PCL) solution and combined to a valve (di 27 mm) in a second step (see figure 1). The pores in the valve were sealed with a fibrin gel (thrombin 10 IU/ml + fibrinogen 10 mg/ml) prior to testing for 20 min at pulmonary conditions in a valve exerciser (n=1).        Figure 1 Process to electrospin a 3D valve starting with single leaflets  Results  The fibrin sealed PCL valve shown in figure 2 was tested in a valve exerciser (Hemolab B. V., Eindhoven). Successful hemodynamic characteristics were obtained,  the leakage remained at 6%, whereas total regurgitation was at 10% and the valve showed an effective orifice area of 2.4 cm2 (see table 1).                     a           b  c                            d Figure 2 Images of the used electrospun PCL valves; a) ventricular side,  b) pulmonary side, c) open position in the valve tester, d)  closed position in the valve tester                Figure 3 Pulmonary hemodynamic pressure curves of the electrospun  PCL vs. the TPU reference valve               Table1 Pulmonary performance values from Figure 3 of the electro- spun PCL vs. the TPU reference valve with ISO values needed   for an aortic valve implant  Conclusion  We demonstrated here an electrospun three-dimensional heart valve, capable to function under pulmonary conditions with some key performance factors above the minimum requirements stated in the “standard ISO 5840 for Cardiovascular implants - Cardiac valve prostheses” for the 20 minutes tested. Additional, specifically prolonged, testing is required to evaluate the potential of this valve types.  Acknowledgments We gratefully wish to acknowledge the help of Hemolab and T. Lavrijsen on the valve test experiments.  ISO 5840 TPU film PCL electrospun  Time point [min] N.A. 0 0 20 General configuration         Stroke volume [mL] N.A. 73 71 71 Cardiac output [L/min] 5.0 5.2 5.0 5.0 Conditions         Peak systolic pressure [mmHg]  N.A. 36 36 36 End diastolic pressure [mmHg]  N.A. 8 7 7 Open configuration         Calculated AEO [cm2]  ≥1.7 1.6 2.1 2.3 Max. systolic p. gradient                                [mmHg] N.A. 8 10 8 Closed configuration         Regurgitation [%] ≤20 6 10 10 Leakage [%] N.A. 2 7 6 Closing volume [%] N.A. 4 3 4 The research program of the BioMedical Materials institute is co-funded by the Dutch Ministry of Economic Affairs, Agriculture and Innovation.  The financial contribution of the Nederlandse Hartstichting is gratefully acknowledged.  

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Hemodynamic testing of a 3D electrospun heart valve prosthesis

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