Extruded poly (glycerol sebacate) and polyglycolic acid vascular graft forms a neoartery
Takuma Fukunishi
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorCecillia Lui
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorChin Siang Ong
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorTyler Dunn
Section of Cardiac Surgery, University of Chicago, Chicago, Illinois, USA
Search for more papers by this authorShanxiu Xu
Section of Cardiac Surgery, University of Chicago, Chicago, Illinois, USA
Search for more papers by this authorCarissa Smoot
The Secant Group, LLC, Telford, Pennsylvania, USA
Search for more papers by this authorJeremy Harris
The Secant Group, LLC, Telford, Pennsylvania, USA
Search for more papers by this authorPeter Gabriele
The Secant Group, LLC, Telford, Pennsylvania, USA
Search for more papers by this authorLakshmi Santhanam
Department of Anesthesiology, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorCorresponding Author
Narutoshi Hibino
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Section of Cardiac Surgery, University of Chicago, Chicago, Illinois, USA
Correspondence
Narutoshi Hibino, Section of Cardiac Surgery, Department of Surgery, The University of Chicago, 5841 S. Maryland Ave, Room E500B | MC5040 Chicago, IL 60637, USA.
Email: [email protected]
Search for more papers by this authorTakuma Fukunishi
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorCecillia Lui
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorChin Siang Ong
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorTyler Dunn
Section of Cardiac Surgery, University of Chicago, Chicago, Illinois, USA
Search for more papers by this authorShanxiu Xu
Section of Cardiac Surgery, University of Chicago, Chicago, Illinois, USA
Search for more papers by this authorCarissa Smoot
The Secant Group, LLC, Telford, Pennsylvania, USA
Search for more papers by this authorJeremy Harris
The Secant Group, LLC, Telford, Pennsylvania, USA
Search for more papers by this authorPeter Gabriele
The Secant Group, LLC, Telford, Pennsylvania, USA
Search for more papers by this authorLakshmi Santhanam
Department of Anesthesiology, Johns Hopkins Hospital, Baltimore, Maryland, USA
Search for more papers by this authorCorresponding Author
Narutoshi Hibino
Division of Cardiac Surgery, Johns Hopkins Hospital, Baltimore, Maryland, USA
Section of Cardiac Surgery, University of Chicago, Chicago, Illinois, USA
Correspondence
Narutoshi Hibino, Section of Cardiac Surgery, Department of Surgery, The University of Chicago, 5841 S. Maryland Ave, Room E500B | MC5040 Chicago, IL 60637, USA.
Email: [email protected]
Search for more papers by this authorTakuma Fukunishi and Cecillia Lui contributed equally to this work.
Abstract
In the ongoing search for the optimal biomaterial for tissue engineered vascular grafts (TEVGs), poly (glycerol sebacate) (PGS) has emerged as a new potential candidate. We have utilized a novel method to create unique, pore-free, extruded PGS grafts with and without a supportive exterior layer of polyglycolic acid (PGA). The 1 mm diameter by 5 mm length TEVGs were implanted in a rat model of infrarenal abdominal aorta interposition grafting. Three months after implantation, TEVGs comprised of extruded PGS with an external PGA braid demonstrated a patency rate of 9/10 (90%) with no signs of dilatation, dehiscence, or rupture. The PGS/PGA graft was remodeled into a neoartery with complete endothelialization of the neoartery lumen and formation of smooth muscle actinin multilayers as demonstrated via immunohistochemistry. Formation and maturation of extracellular matrix material were also observed, with amounts of elastin and collagen comparable to native rat aorta. No significant host inflammatory response was observed. These findings suggest the combination of an extruded PGS tube with an external reinforcing PGA braid is a promising material for small diameter TEVGs.
CONFLICT OF INTEREST
The authors have declared that there is no conflict of interest.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Supporting Information
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term3282-sup-0001-fig_s1.pdf868.2 KB | Supporting Information 1 |
term3282-sup-0002-fig_s2.pdf1.1 MB | Supporting Information 2 |
term3282-sup-0003-fig_s3.pdf910.7 KB | Supporting Information 3 |
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REFERENCES
- Abbott, W. M., Megerman, J., Hasson, J. E., L'Italien, G., Warnock, D. F. (1987). Effect of compliance mismatch on vascular graft patency. Journal of Vascular Surgery, 5(2), 376–382.
- Anderson, J. S., Price, T. M., Hanson, S. R., Harker, L. A. (1987). In vitro endothelialization of small-caliber vascular grafts. Surgery, 101(5), 577–586.
- Ballyk, P. D., Walsh, C., Butany, J., & Ojha, M. (1997). Compliance mismatch may promote graft–artery intimal hyperplasia by altering suture-line stresses. Journal of Biomechanics, 31(3), 229–237.
- Cooper, M. L., Hansbrough, J. F., Spielvogel, R. L., Cohen, R., Bartel, R. L., & Naughton, G. (1991). In vivo optimization of a living dermal substitute employing cultured human fibroblasts on a biodegradable polyglycolic acid or polyglactin mesh. Biomaterials, 12(2), 243–248.
- Crapo, P. M., Gao, J., & Wang, Y. (2008). Seamless tubular poly(glycerol sebacate) scaffolds: High-yield fabrication and potential applications. Journal of Biomedical Materials Research Part A, 86A(2), 354–363.
- Crapo, P. M., & Wang, Y. (2010). Physiologic compliance in engineered small-diameter arterial constructs based on an elastomeric substrate. Biomaterials, 31(7), 1626–1635.
- Dardik, H., Dardik, I., & Laufman, H. (1971). Clinical use of polyglycolic acid polymer as a new absorbable synthetic suture. The American Journal of Surgery, 121(6), 656–660.
- de Mel, A., Bolvin, C., Edirisinghe, M., Hamilton, G., & Seifalian, A. M. (2008). Development of cardiovascular bypass grafts: Endothelialization and applications of nanotechnology. Expert Review of Cardiovascular Therapy, 6(9), 1259–1277.
- Feinberg, A. W. (2012). Engineered tissue grafts: Opportunities and challenges in regenerative medicine. Wiley Interdisciplinary Reviews: Systems Biology and Medicine, 4(2), 207–220.
- Fukunishi, T., Best, C. A., Siang-Ong, C., Groehl, T., Reinhardt, J., Yi, T., Miyachi, H., Zhang, H., Shinoka, T., Breuer, C. K., Johnson, J., & Hibino, N. (2018). Role of bone marrow mononuclear cell seeding for nanofiber vascular grafts. Tissue Engineering Part A. 24(1–2), 135–144.
- Fukunishi, T., Best, C. A., Sugiura, T., Shoji, T., Yi, T., Udelsman, B., Ohst, D., Ong, C. S., Zhang, H., Shinoka, T., Breuer, C. K., Johnson, J., & Hibino, N. (1932). Tissue-engineered small diameter arterial vascular grafts from cell-free nanofiber PCL/chitosan scaffolds in a sheep model. PLoS one, 11(7), e0158555.
- Gao, J., Crapo Pm Fau - Wang, Y., & Wang, Y. (2006). Macroporous elastomeric scaffolds with extensive micropores for soft tissue engineering (pp. 1076–3279). Tissue engineering.
- Kemppainen, J. M., & Hollister, S. J. (2010). Tailoring the mechanical properties of 3D-designed poly(glycerol sebacate) scaffolds for cartilage applications. Journal of Biomedical Materials Research Part A, 94A(1), 9–18.
- Kinley, C. E., & Marble, A. E. (1980). Compliance: A continuing problem with vascular grafts. The Journal of Cardiovascular Surgery, 21(2), 163–170.
- Lee, K.-W., Johnson, N. R., Gao, J., & Wang, Y. (2013). Human progenitor cell recruitment via SDF-1α coacervate-laden PGS vascular grafts. Biomaterials, 34(38), 9877–9885.
- Lee, K.-W., Stolz, D. B., & Wang, Y. (2011). Substantial expression of mature elastin in arterialconstructs. Proceedings of the National Academy of Sciences, 108(7), 2705–2710.
- Lu, S., Gabriele, D. P., Harris, J. J., Winner, S. A., & Metzger, A. (2021). Flexible hollow lumen composite (U.S. Patent No. 11,065,099). U.S. Patent and Trademark Office.
- Lyman, D. J., Fazzio, F. J., Voorhees, H., Robinson, G., & Albo, D. (1978). Compliance as a factor effecting the patency of a copolyurethane vascular graft. Journal of Biomedical Materials Research, 12(3), 337–345.
- Matsuda, T. (2004). Recent progress of vascular graft engineering in Japan. Artificial Organs, 28(1), 64–71.
- Middleton, J. C., & Tipton, A. J. (2000). Synthetic biodegradable polymers as orthopedic devices. Biomaterials, 21(23), 2335–2346.
- Motlagh, D., Yang, J., Liu, K. Y., Webb, A. R., & Ameer, G. A. (2006). Hemocompatibility evaluation of poly(glycerol-sebacate) in vitro for vascular tissue engineering. Biomaterials, 27(24), 4315–4324.
- Mukherjee, D. P., Smith, D. F., Rogers, S. H., Emmanual, J. E., Jadin, K. D., & Hayes, B. K. (2009). Effect of 3D-microstructure of bioabsorbable PGA:TMC scaffolds on the growth of chondrogenic cells. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 88B(1), 92–102.
- Newman, J., Patel, N., & Caldorera-Moore, M. (2016). Engineered stem cell-based scaffolds and patches for heart disorders. In A. Singh & A. K. Gaharwar (Eds.), Microscale Technologies for Cell Engineering (pp. 93–112). Springer International Publishing.
10.1007/978-3-319-20726-1_5 Google Scholar
- Nicholson, C. B., Harris, J. J., & Gabriele, P. D. (2016). Water-mediated preparations of polymeric materials (U.S. Patent No. 9,359,472). U.S. Patent and Trademark Office.
- Pashneh-Tala, S., MacNeil, S., & Claeyssens, F. (2015). The tissue-engineered vascular graft—past, present, and future. Tissue Engineering Part B: Reviews, 22(1), 68–100.
- Qu, X.-H., Wu, Q., & Chen, G.-Q. (2006). In vitro study on hemocompatibility and cytocompatibility of poly(3-hydroxybutyrate-co-3-hydroxyhexanoate). Journal of Biomaterials Science, Polymer Edition, 17(10), 1107–1121.
- Sun, Z.-J., Chen, C., Sun, M.-Z., Ai, C.-H., Lu, X.-L., Zheng, Y.-F., Yang, B.-F., & Dong, D.-L. (2009). The application of poly (glycerol–sebacate) as biodegradable drug carrier. Biomaterials, 30(28), 5209–5214.
- Wang, Y., Ameer, G. A., Spheppard, B. J., & Langer, R. (2002). A tough biodegradable elastomer (pp. 1087–0156).
- Wang, Z., Cui, Y., Wang, J., Yang, X., Wu, Y., Wang, K., Gao, X., Li, D., Li, Y., Zheng, X.-L., Zhu, Y., Kong, D., & Zhao, Q. (2014). The effect of thick fibers and large pores of electrospun poly(ε-caprolactone) vascular grafts on macrophage polarization and arterial regeneration. Biomaterials, 35(22), 5700–5710.
- Wroblesky, K., Smoot, C., Gabriele, P.D., Harris, J. J., Nicholson, C. B., & Lu, S. (2018). Composite containing poly (glycerol sebacate) filler (U.S. Patent No. 10,525,140). U.S. Patent and Trademark Office.
- Wu, W., Allen, R. A., & Wang, Y. (2012). Fast degrading elastomer enables rapid remodeling of a cell-free synthetic graft into a neo-artery. Nature Medicine, 18(7), 1148–1153.
- Yates, S. G., D’Sa, A. A. B., Berger, K., Fernandez, L. G., Wood, S. J., Rittenhouse, E. A., Davis, C. C., Mansfield, P. B., & Sauvage, L. R. (1978). The preclotting of porous arterial prostheses. Annals of Surgery, 188, 611–622.
- Yi-Cheun, Y., Highley, B. C., Ouyang, L., & Burdick, J. A. (2016). 3D printing of photocurable poly(glycerol sebacate) elastomers. Biofabrication, 8(4), 045004.
- Zhang, Z., Wang, Z., Liu, S., & Kodama, M. (2004). Pore size, tissue ingrowth, and endothelialization of small-diameter microporous polyurethane vascular prostheses. Biomaterials, 25(1), 177–187.