Transcatheter aortic valve replacement (TAVR) is a minimally-invasive approach for treating severe aortic stenosis. All clinically-used TAVR valves to date utilize chemically-fixed xenograft as the leaflet material. Inherent limitation of the tissue (e.g., calcific degeneration) motivates the search for alternative leaflet material. Here we introduce a novel polymeric TAVR valve that was designed to address the limitations of tissue-valves. In this study, we experimentally evaluated the hemodynamic performance of the valve and compared its performance to clinically-used valves: a gold standard surgical tissue valve, and a TAVR valve. Our comparative testing protocols included: (i) baseline hydrodynamics (ISO:5840-3), (ii) complementary patient-specific hydrodynamics in a dedicated system, and (iii) thrombogenicity. The patient-specific testing system facilitated comparing TAVR valves performance under more realistic conditions. Baseline hydrodynamics results at CO 4–7 L/min showed superior effective orifice area (EOA) for the polymer valve, most-notably as compared to the reference TAVR valve. Regurgitation fraction was higher in the polymeric valve, but within the ISO minimum requirements. Thrombogenicity trends followed the EOA results with the polymeric valve being the least thrombogenic, and clinical TAVR being the most. Hemodynamic-wise, the results strongly indicate that our polymeric TAVR valve can outperform tissue valves.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
This is the net price. Taxes to be calculated in checkout.
Calcific aortic valve disease
Device thrombogenic emulation
Effective orifice area
Mean arterial pressure
Surgical aortic valve replacement
Transcatheter aortic valve replacement
Alavi, S. H., E. M. Groves, and A. Kheradvar. The effects of transcatheter valve crimping on pericardial leaflets. Ann. Thorac. Surg. 97:1260–1266, 2014.
American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and The Society of Cardiovascular, and The Society for Cardiovascular, Interventions, S. Society of Thoracic, R. O. Bonow, B. A. Carabello, C. Kanu, A. C. de Leon, Jr, D. P. Faxon, M. D. Freed, W. H. Gaasch, B. W. Lytle, R. A. Nishimura, P. T. O’Gara, R. A. O’Rourke, C. M. Otto, P. M. Shah, J. S. Shanewise, S. C. Smith, Jr, A. K. Jacobs, C. D. Adams, J. L. Anderson, E. M. Antman, D. P. Faxon, V. Fuster, J. L. Halperin, L. F. Hiratzka, S. A. Hunt, B. W. Lytle, R. Nishimura, R. L. Page, and B. Riegel. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation 114:e84–e231, 2006.
Arsalan, M., and T. Walther. Durability of prostheses for transcatheter aortic valve implantation. Nat. Rev. Cardiol. 13:360–367, 2016.
Bezuidenhout, D., D. F. Williams, and P. Zilla. Polymeric heart valves for surgical implantation, catheter-based technologies and heart assist devices. Biomaterials 36:6–25, 2015.
Bianchi, M., G. Marom, R. P. Ghosh, H. A. Fernandez, J. R. Taylor, Jr, M. J. Slepian, and D. Bluestein. Effect of balloon-expandable transcatheter aortic valve replacement positioning: a patient-specific numerical model. Artif. Organs 40(12):E292–E302, 2016.
Claiborne, T. E., G. Girdhar, S. Gallocher-Lowe, J. Sheriff, Y. P. Kato, L. Pinchuk, R. T. Schoephoerster, J. Jesty, and D. Bluestein. Thrombogenic potential of Innovia polymer valves versus Carpentier-Edwards Perimount Magna aortic bioprosthetic valves. ASAIO J. 57:26–31, 2011.
Claiborne, T. E., J. Sheriff, M. Kuetting, U. Steinseifer, M. J. Slepian, and D. Bluestein. In vitro evaluation of a novel hemodynamically optimized trileaflet polymeric prosthetic heart valve. J. Biomech. Eng. 135:021021, 2013.
Claiborne, T. E., M. J. Slepian, S. Hossainy, and D. Bluestein. Polymeric trileaflet prosthetic heart valves: evolution and path to clinical reality. Expert Rev. Med. Devices 9:577–594, 2012.
Claiborne, T. E., M. Xenos, J. Sheriff, W.-C. Chiu, J. S. Soares, Y. Alemu, S. Gupta, S. Judex, M. J. Slepian, and D. Bluestein. Towards optimization of a novel trileaflet polymeric prosthetic heart valve via device thrombogenicity emulation. ASAIO J. 59:275–283, 2013.
Dandeniyage, L. S., R. Adhikari, M. Bown, R. Shanks, B. Adhikari, C. D. Easton, T. R. Gengenbach, D. Cookson, and P. A. Gunatillake. Morphology and surface properties of high strength siloxane poly(urethane-urea)s developed for heart valve application. J. Biomed. Mater. Res. B 2018. https://doi.org/10.1002/jbm.b.34101.
Dandeniyage, L. S., P. A. Gunatillake, R. Adhikari, M. Bown, R. Shanks, and B. Adhikari. Development of high strength siloxane poly(urethane-urea) elastomers based on linked macrodiols for heart valve application. J. Biomed. Mater. Res. B 106(5):1712–1720, 2017.
Dasi, L. P., H. Hatoum, A. Kheradvar, R. Zareian, S. H. Alavi, W. Sun, C. Martin, T. Pham, Q. Wang, P. A. Midha, V. Raghav, and A. P. Yoganathan. On the mechanics of transcatheter aortic valve replacement. Ann. Biomed. Eng. 45:310–331, 2017.
Hatoum, H., J. Dollery, S. M. Lilly, J. Crestanello, and L. P. Dasi. Impact of patient-specific morphologies on sinus flow stasis in transcatheter aortic valve replacement: an in vitro study. J. Thorac. Cardiovasc. Surg. 2018. https://doi.org/10.1016/j.jtcvs.2018.05.086.
Hatoum, H., A. Yousefi, S. Lilly, P. Maureira, J. Crestanello, and L. P. Dasi. An in vitro evaluation of turbulence after transcatheter aortic valve implantation. J. Thorac. Cardiovasc. Surg. 2018. https://doi.org/10.1016/j.jtcvs.2018.05.042.
Jesty, J., and D. Bluestein. Acetylated prothrombin as a substrate in the measurement of the procoagulant activity of platelets: elimination of the feedback activation of platelets by thrombin. Anal. Biochem. 272:64–70, 1999.
Kallis, P., J. F. Sneddon, I. A. Simpson, A. Fung, J. R. Pepper, and E. E. Smith. Clinical and hemodynamic evaluation of the 19-mm Carpentier-Edwards supraannular aortic valve. Ann. Thorac. Surg. 54:1182–1185, 1992.
Kamioka, N., J. Wells, P. Keegan, S. Lerakis, J. Binongo, F. Corrigan, J. Condado, A. Patel, J. Forcillo, L. Ogburn, A. Dong, H. Caughron, A. Simone, B. Leshnower, C. Devireddy, K. Mavromatis, R. Guyton, J. Stewart, V. Thourani, P. C. Block, and V. Babaliaros. Predictors and clinical outcomes of next-day discharge after minimalist transfemoral transcatheter aortic valve replacement. JACC Cardiovasc. Interv. 11:107–115, 2018.
Kheradvar, A., E. M. Groves, L. P. Dasi, S. H. Alavi, R. Tranquillo, K. J. Grande-Allen, C. A. Simmons, B. Griffith, A. Falahatpisheh, C. J. Goergen, M. R. Mofrad, F. Baaijens, S. H. Little, and S. Canic. Emerging trends in heart valve engineering: Part I. Solutions for future. Ann. Biomed. Eng. 43:833–843, 2015.
Khoffi, F., and F. Heim. Mechanical degradation of biological heart valve tissue induced by low diameter crimping: an early assessment. J. Mech. Behav. Biomed. Mater. 44:71–75, 2015.
Luscher, T. F. Cutting edge research on transcatheter aortic valve implantation: moving indications, complications, and current outcomes. Eur. Heart J. 39:633–636, 2018.
Martin, C., and W. Sun. Transcatheter valve underexpansion limits leaflet durability: implications for valve-in-valve procedures. Ann. Biomed. Eng. 45:394–404, 2017.
Marwan, M., N. Mekkhala, M. Goller, J. Rother, D. Bittner, A. Schuhbaeck, M. Hell, G. Muschiol, J. Kolwelter, R. Feyrer, C. Schlundt, S. Achenbach, and M. Arnold. Leaflet thrombosis following transcatheter aortic valve implantation. J. Cardiovasc. Comput. Tomogr. 12:8–13, 2018.
Midha, P. A., V. Raghav, R. Sharma, J. F. Condado, I. U. Okafor, T. Rami, G. Kumar, V. H. Thourani, H. Jilaihawi, V. Babaliaros, R. R. Makkar, and A. P. Yoganathan. The fluid mechanics of transcatheter heart valve leaflet thrombosis in the neosinus. Circulation 136:1598–1609, 2017.
Min, J. K., D. S. Berman, and J. Leipsic. Multimodality Imaging for Transcatheter Aortic Valve Replacement. New York: Springer Science & Business Media, 2013.
Pinchuk, L., and Y. Zhou. Crosslinked polyolefins for biomedical applicatios and method of making same. In: USPTO, edited by USPTO. Miami: Innovia LLC, 2009.
Prawel, D. A., H. Dean, M. Forleo, N. Lewis, J. Gangwish, K. C. Popat, L. P. Dasi, and S. P. James. Hemocompatibility and Hemodynamics of Novel Hyaluronan-Polyethylene Materials for Flexible Heart Valve Leaflets. Cardiovasc. Eng. Technol. 5:70–81, 2014.
Rahmani, B., S. Tzamtzis, R. Sheridan, M. J. Mullen, J. Yap, A. M. Seifalian, and G. Burriesci. In vitro hydrodynamic assessment of a new transcatheter heart valve concept (the TRISKELE). J. Cardiovasc. Transl. Res. 10:104–115, 2017.
Rodriguez-Gabella, T., P. Voisine, R. Puri, P. Pibarot, and J. Rodes-Cabau. Aortic bioprosthetic valve durability: incidence, mechanisms, predictors, and management of surgical and transcatheter valve degeneration. J. Am. Coll. Cardiol. 70:1013–1028, 2017.
Rosenhek, R., T. Binder, G. Maurer, and H. Baumgartner. Normal values for Doppler echocardiographic assessment of heart valve prostheses. J. Am. Soc. Echocardiogr. 16:1116–1127, 2003.
Rotman, O. M., B. Kovarovic, C. Sadasivan, L. Gruberg, B. B. Lieber, and D. Bluestein. Realistic vascular replicator for TAVR procedures. Cardiovasc. Eng. Technol. 2018. https://doi.org/10.1007/s13239-018-0356-z.
Scherman, J., D. Bezuidenhout, C. Ofoegbu, D. F. Williams, and P. Zilla. Tavi for low to middle income countries. Eur. Heart J. 38:1182–1184, 2017.
Sheriff, J., D. Bluestein, G. Girdhar, and J. Jesty. High-shear stress sensitizes platelets to subsequent low-shear conditions. Ann. Biomed. Eng. 38:1442–1450, 2010.
Sheriff, J., T. E. Claiborne, P. L. Tran, R. Kothadia, S. George, Y. P. Kato, L. Pinchuk, M. J. Slepian, and D. Bluestein. Physical characterization and platelet interactions under shear flows of a novel thermoset polyisobutylene-based co-polymer. ACS Appl. Mater. Interfaces 7:22058–22066, 2015.
Thourani, V. H., S. Kodali, R. R. Makkar, H. C. Herrmann, M. Williams, V. Babaliaros, R. Smalling, S. Lim, S. C. Malaisrie, and S. Kapadia. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 387:2218–2225, 2016.
Vahanian, A., H. Baumgartner, J. Bax, E. Butchart, R. Dion, G. Filippatos, F. Flachskampf, R. Hall, B. Iung, J. Kasprzak, P. Nataf, P. Tornos, L. Torracca, A. Wenink, and Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology and E. S. C. C. F. P. Guidelines. Guidelines on the management of valvular heart disease: the Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur. Heart J. 28:230–268, 2007.
Wang, M., A. P. Furnary, H. F. Li, and G. L. Grunkemeier. Bioprosthetic aortic valve durability: a meta-regression of published studies. Ann. Thorac. Surg. 104:1080–1087, 2017.
Yin, W., Y. Alemu, K. Affeld, J. Jesty, and D. Bluestein. Flow-induced platelet activation in bileaflet and monoleaflet mechanical heart valves. Ann. Biomed. Eng. 32:1058–1066, 2004.
Yousefi, A., D. L. Bark, and L. P. Dasi. Effect of arched leaflets and stent profile on the hemodynamics of tri-leaflet flexible polymeric heart valves. Ann. Biomed. Eng. 45(2):464–475, 2016.
The authors would like to thank Braile Biomédica (Brazil), for providing us with the Inovare valve samples. This project was supported by NIH-NIBIB Quantum Award Phase II-U01EB012487 (DB), NHLBI STTR R41-HL134418 (DB), and the Center for Biotechnology: a New York State Center for Advanced Technology, New York State Department of Economic Development; and corporate support.
Conflict of interest
Author OMR is a consultant for Polynova Cardiovascular Inc. Authors MJS and DB has stock ownership in Polynova Cardiovascular Inc. Authors BK, WCC, MB and GM declare that they have no conflicts of interest.
Associate Editor Arash Kheradvar oversaw the review of this article.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Front (aortic) view of the test valves in the Vivitro PD, at CO of 5 l/min. Supplementary material 2 (MP4 12938 kb)
Endoscopic front (aortic) view of the test valves in the Vivitro PD, at CO of 5 l/min. Supplementary material 3 (MP4 16800 kb)
Angiogram of the 20-mm Polynova polymeric TAVR valve in the patient-specific CAVD model in the Replicator. On the left is the original angiogram. On the right is the subtracted angiogram for better visualization of regurgitation flow. Supplementary material 4 (MP4 4636 kb)
Angiogram of the 19-mm Carpentier-Edwards Perimount Magna Ease SAVR valve in the patient-specific CAVD model in the Replicator. On the left is the original angiogram. On the right is the subtracted angiogram for better visualization of regurgitation flow. Supplementary material 5 (MP4 9299 kb)
Angiogram of the 20-mm Inovare TAVR valve in the patient-specific CAVD model in the Replicator. On the left is the original angiogram. On the right is the subtracted angiogram for better visualization of regurgitation flow. Supplementary material 6 (MP4 5668 kb)
About this article
Cite this article
Rotman, O.M., Kovarovic, B., Chiu, W. et al. Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Applications: In Vitro Hemodynamic Study. Ann Biomed Eng 47, 113–125 (2019). https://doi.org/10.1007/s10439-018-02119-7
- Aortic stenosis
- Heart valve
- Prosthetic heart valve
- Valve hydrodynamics
- Medical device