Abstract
Transcatheter aortic valve (TAV) implantation within a failed bioprosthetic valve is a growing trend for high-risk patients. The non-compliant stent of the previous prosthesis may prevent full expansion of the TAV, which has been shown to distort the leaflet configuration, and has been hypothesized to adversely affect durability. In this study, TAV leaflet fatigue damage under cyclic pressurization in the setting of stent underexpansion by 0 (fully expanded), 1, 2 and 3 mm was simulated using finite element analysis to test this hypothesis. In the 2 and 3 mm underexpanded devices, the TAV leaflets exhibited severe pin-wheeling during valve closure, which increased leaflet stresses dramatically, and resulted in accelerated fatigue damage of the leaflets. The leaflet fatigue damage in the 1 mm underexpanded case was similar to that in the fully expanded case. Clinically a range of 10–15% underexpansion is generally considered acceptable; however, it was observed in this study that ≥2 mm (≥9.1%) underexpansion, will significantly impact device durability. Further study is necessary to determine the impact of various deployment conditions, i.e. non-uniform and non-circular deployments and different implantation heights, on differing TAV devices, but it is clear that the normal TAV leaflet configuration must be preserved in order to preserve durability.
Similar content being viewed by others
References
Abbasi, M., and A. N. Azadani. Leaflet stress and strain distributions following incomplete transcatheter aortic valve expansion. J. Biomech. 48:3663–3671, 2015.
Azadani, A. N., and E. E. Tseng. Transcatheter heart valves for failing bioprostheses: state-of-the-art review of valve-in-valve implantation. Circ. Cardiovasc. Interv. 4:621–628, 2011.
Bruschi, G., L. Botta, P. Fratto, and L. Martinelli. Failed valve-in-valve transcatheter mitral valve implantation. Eur. J. Cardiothorac. Surg. 45:e127, 2014.
Butany, J., V. Nair, S. W. Leong, G. S. Soor, and C. Feindel. Carpentier-Edwards Perimount valves—morphological findings in surgical explants. J. Card. Surg. 22:7–12, 2007.
Chen, H. L., and K. Liu. Clinical outcomes for transcatheter valve-in-valve in treating surgical bioprosthetic dysfunction: a meta-analysis. Int. J. Cardiol. 212:138–141, 2016.
Chevalier, F., J. Leipsic, and P. Genereux. Valve-in-valve implantation with a 23-mm balloon-expandable transcatheter heart valve for the treatment of a 19-mm stentless bioprosthesis severe aortic regurgitation using a strategy of “extreme” underfilling. Catheter. Cardiovasc. Interv. 84:503–508, 2014.
Corden, J., T. David, and J. Fisher. Determination of the curvatures and bending strains in open trileaflet heart valves. Proc. Inst. Mech. Eng. Part H 209:121–128, 1995.
Cribier, A., H. Eltchaninoff, A. Bash, N. Borenstein, C. Tron, F. Bauer, G. Derumeaux, F. Anselme, F. Laborde, and M. B. Leon. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106:3006–3008, 2002.
Dorfmann, A., and R. W. Ogden. A constitutive model for the Mullins effect with permanent set in particle-reinforced rubber. Int. J. Solids Struct. 41:1855–1878, 2004.
Dvir D., H. Eltchaninoff, J. Ye, A. Kan, E. Durand, A. Bizios, A. Cheung, M. Aziz, M. Simonato, C. Tron, Y. Arbel, R. Moss, J. Leipsic, H. Ofek, G. Perlman, M. Barbanti, M. A. Seidman, P. Blanke, R. Yao, R. Boone, S. Lauck, S. Lichtenstein, D. Wood, A. Cribier, and J. G. Webb. First look at long-term durability of transcatheter heart valves: assessment of valve function up to 10-years after implantation. In: Euro PCR 2016, Paris, France, 2016.
Dvir, D., J. G. Webb, S. Bleiziffer, M. Pasic, R. Waksman, S. Kodali, M. Barbanti, A. Latib, U. Schaefer, J. Rodes-Cabau, H. Treede, N. Piazza, D. Hildick-Smith, D. Himbert, T. Walther, C. Hengstenberg, H. Nissen, R. Bekeredjian, P. Presbitero, E. Ferrari, A. Segev, A. de Weger, S. Windecker, N. E. Moat, M. Napodano, M. Wilbring, A. G. Cerillo, S. Brecker, D. Tchetche, T. Lefevre, F. De Marco, C. Fiorina, A. S. Petronio, R. C. Teles, L. Testa, J. C. Laborde, M. B. Leon, R. Kornowski, and I. Valve-in-Valve International Data Registry. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA 312:162–170, 2014.
Faerber, G., S. Schleger, M. Diab, M. Breuer, H. Figulla, W. Eichinger, and T. Doenst. Valve-in-valve transcatheter aortic valve implantation: the new playground for prothesis-patient mismatch. J. Interv. Cardiol. 27:287–292, 2014.
Gunning, P. S., N. Saikrishnan, A. P. Yoganathan, and L. M. McNamara. Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement. J. R. Soc. Interface 12:20150737, 2015.
Gunning, P. S., T. J. Vaughan, and L. M. McNamara. Simulation of self expanding transcatheter aortic valve in a realistic aortic root: implications of deployment geometry on leaflet deformation. Ann. Biomed. Eng. 42:1989–2001, 2014.
Gurvitch, R., A. Cheung, J. Ye, D. A. Wood, A. B. Willson, S. Toggweiler, R. Binder, and J. G. Webb. Transcatheter valve-in-valve implantation for failed surgical bioprosthetic valves. J. Am. Coll. Cardiol. 58:2196–2209, 2011.
Harbaoui, B., P. Y. Courand, Z. Schmitt, F. Farhat, R. Dauphin, and P. Lantelme. Early Edwards SAPIEN valve degeneration after transcatheter aortic valve replacement. JACC Cardiovasc. Interv. 9:198–199, 2016.
Himbert, D., F. Pontnau, D. Messika-Zeitoun, F. Descoutures, D. Détaint, C. Cueff, M. Sordi, J.-P. Laissy, S. Alkhoder, E. Brochet, B. Iung, J.-P. Depoix, P. Nataf, and A. Vahanian. Feasibility and outcomes of transcatheter aortic valve implantation in high-risk patients with stenotic bicuspid aortic valves. Am. J. Cardiol. 110:877–883, 2012.
John, D., L. Buellesfeld, S. Yuecel, R. Mueller, G. Latsios, H. Beucher, U. Gerckens, and E. Grube. Correlation of device landing zone calcification and acute procedural success in patients undergoing transcatheter aortic valve implantations with the self-expanding CoreValve prosthesis. JACC Cardiovasc. Interv. 3:233–243, 2010.
Kiefer, P., J. Seeburger, M. W. Chu, J. Ender, M. Vollroth, T. Noack, F. W. Mohr, and D. M. Holzhey. Reoperative transapical aortic valve implantation for early structural valve deterioration of a SAPIEN XT valve. Ann. Thorac. Surg. 95:2169–2170, 2013.
Klotz, S., M. Scharfschwerdt, D. Richardt, and H. H. Sievers. Failed valve-in-valve transcatheter aortic valve implantation. JACC Cardiovasc. Interv. 5:591–592, 2012.
Koos, R., A. H. Mahnken, G. Dohmen, K. Brehmer, R. W. Günther, R. Autschbach, N. Marx, and R. Hoffmann. Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation. Int. J. Cardiol. 150:142–145, 2011.
Leber, A. W., M. Kasel, T. Ischinger, U. H. Ebersberger, D. Antoni, M. Schmidt, G. Riess, V. Renz, A. Huber, T. Helmberger, and E. Hoffmann. Aortic valve calcium score as a predictor for outcome after TAVI using the CoreValve revalving system. Int. J. Cardiol. 166:652–657, 2013.
Leon, M. B., C. R. Smith, M. Mack, D. C. Miller, J. W. Moses, L. G. Svensson, E. M. Tuzcu, J. G. Webb, G. P. Fontana, R. R. Makkar, D. L. Brown, P. C. Block, R. A. Guyton, A. D. Pichard, J. E. Bavaria, H. C. Herrmann, P. S. Douglas, J. L. Petersen, J. J. Akin, W. N. Anderson, D. Wang, and S. Pocock. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N. Engl. J. Med. 363:1597–1607, 2010.
Martin, C., and W. Sun. Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: a fatigue simulation study. J. Biomech. 48:3026–3034, 2015.
Martin, C., and W. Sun. Modeling of long-term fatigue damage of soft tissue with stress softening and permanent set effects. Biomech. Model. Mechanobiol. 12:645–655, 2013.
Martin, C., and W. Sun. Simulation of long-term fatigue damage in bioprosthetic heart valves: effects of leaflet and stent elastic properties. Biomech. Model. Mechanobiol. 13:759–770, 2014.
Milburn, K., V. Bapat, and M. Thomas. Valve-in-valve implantations: is this the new standard for degenerated bioprostheses? Review of the literature. Clin. Res. Cardiol. 103:1–13, 2014.
Muñoz-García, A. J., J. H. Alonso-Briales, M. F. Jiménez-Navarro, J. Caballero-Borrego, A. J. Domínguez-Franco, I. Rodríguez-Bailón, M. Such-Martínez, J. M. Hernández-García, and E. de Teresa-Galván. Mechanisms, treatment and course of paravalvular aortic regurgitation after percutaneous implantation of the CoreValve aortic prosthesis. Int. J. Cardiol. 149:389–392, 2011.
Perlman, G. Y., P. Blanke, D. Dvir, G. Pache, T. Modine, M. Barbanti, E. W. Holy, H. Treede, P. Ruile, F.-J. Neumann, C. Gandolfo, F. Saia, C. Tamburino, G. Mak, C. Thompson, D. Wood, J. Leipsic, and J. G. Webb. Bicuspid aortic valve stenosis: favorable early outcomes with a next-generation transcatheter heart valve in a multicenter study. JACC Cardiovasc. Interv. 9:817–824, 2016.
Schoen, F. J., J. Fernandez, L. Gonzalez-Lavin, and A. Cernaianu. Causes of failure and pathologic findings in surgically removed Ionescu-Shiley standard bovine pericardial heart valve bioprostheses: emphasis on progressive structural deterioration. Circulation 76:618–627, 1987.
Schoen, F. J., and R. J. Levy. Tissue heart valves: current challenges and future research perspectives. J. Biomed. Mater. Res. 47:439–465, 1999.
Schultz, C. J., A. Weustink, N. Piazza, A. Otten, N. Mollet, G. Krestin, R. J. van Geuns, P. de Feyter, P. W. J. Serruys, and P. de Jaegere. Geometry and degree of apposition of the CoreValve ReValving system with multislice computed tomography after implantation in patients with aortic stenosis. J. Am. Coll. Cardiol. 54:911–918, 2009.
Shalabi, A., D. Spiegelstein, L. Sternik, M. S. Feinberg, A. Kogan, S. Levin, B. Orlov, E. Nachum, A. Lipey, and E. Raanani. Sutureless versus stented valve in aortic valve replacement in patients with small annulus. Ann. Thorac. Surg. 102:118–122, 2016.
Simo, J. C. On a fully three-dimensional finite-strain viscoelastic damage model: Formulation and computational aspects. Comput. Methods Appl. Mech. Eng. 60:153–173, 1987.
Simonato, M., J. Webb, R. Kornowski, A. Vahanian, C. Frerker, H. Nissen, S. Bleiziffer, A. Duncan, J. Rodes-Cabau, G. F. Attizzani, E. Horlick, A. Latib, R. Bekeredjian, M. Barbanti, T. Lefevre, A. Cerillo, J. M. Hernandez, G. Bruschi, K. Spargias, A. Iadanza, S. Brecker, J. H. Palma, A. Finkelstein, M. Abdel-Wahab, P. Lemos, A. S. Petronio, D. Champagnac, J. M. Sinning, S. Salizzoni, M. Napodano, C. Fiorina, A. Marzocchi, M. Leon, and D. Dvir. Transcatheter replacement of failed bioprosthetic valves: large multicenter assessment of the effect of implantation depth on hemodynamics after aortic valve-in-valve. Circ. Cardiovasc. Interv. 9:e003651, 2016.
Singhal, P., A. Luk, and J. Butany. Bioprosthetic heart valves: impact of implantation on biomaterials. ISRN Biomater. 2013:1–14, 2013.
Smuts, A. N., D. C. Blaine, C. Scheffer, H. Weich, A. F. Doubell, and K. H. Dellimore. Application of finite element analysis to the design of tissue leaflets for a percutaneous aortic valve. J. Mech. Behav. Biomed. Mater. 4:85–98, 2011.
Sun W. Biomechanical simulations of heart valve biomaterials. In: Department of Bioengineering. Pittsburgh: University of Pittsburgh, 2003, p. 240.
Sun, W., A. Abad, and M. S. Sacks. Simulated bioprosthetic heart valve deformation under quasi-static loading. J. Biomech. Eng. 127:905–914, 2005.
Sun, W., E. L. Chaikof, and M. E. Levenston. Numerical approximation of tangent moduli for finite element implementations of nonlinear hyperelastic material models. J. Biomech. Eng. 130:061003, 2008.
Sun, W., K. Li, and E. Sirois. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J. Biomech. 43:3085–3090, 2010.
Trowbridge, E. A., and C. E. Crofts. Pericardial heterograft valves: an assessment of leaflet stresses and their implications for heart valve design. J. Biomech. Eng. 9:345–355, 1987.
Vesely, I. The influence of design on bioprosthetic valve durability. J. Long-Term Eff. Med. Implant. 11:13, 2001.
Watanabe, Y., B. Chevalier, K. Hayashida, T. Leong, E. Bouvier, T. Arai, A. Farge, T. Hovasse, P. Garot, B. Cormier, M.-C. Morice, and T. Lefèvre. Comparison of multislice computed tomography findings between bicuspid and tricuspid aortic valves before and after transcatheter aortic valve implantation. Catheter. Cardiovasc. Interv. 86:323–330, 2015.
Webb, J. G., and D. Dvir. Transcatheter aortic valve replacement for bioprosthetic aortic valve failure: the valve-in-valve procedure. Circulation 127:2542–2550, 2013.
Webb, J. G., D. A. Wood, J. Ye, R. Gurvitch, J.-B. Masson, J. Rodés-Cabau, M. Osten, E. Horlick, O. Wendler, E. Dumont, R. G. Carere, N. Wijesinghe, F. Nietlispach, M. Johnson, C. R. Thompson, R. Moss, J. Leipsic, B. Munt, S. V. Lichtenstein, and A. Cheung. Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves. Circulation 121:1848–1857, 2010.
Willson, A., J. Webb, T. LaBounty, S. Achenbach, R. Moss, M. Wheeler, C. Thompson, J. Min, R. Gurvitch, B. Norgard, S. Toggweiler, R. K. Binder, C. Hague, M. Freeman, S. H. Poulter, R. Poulter, D. Wood, and L. Jonathon. Three-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis. J. Am. Coll. Cardiol. 59:E325, 2012.
Willson, A. B., J. G. Webb, R. Gurvitch, D. A. Wood, S. Toggweiler, R. Binder, M. Freeman, M. Madden, C. Hague, and J. Leipsic. Structural integrity of balloon-expandable stents after transcatheter aortic valve replacement: assessment by multidetector computed tomography. JACC Cardiovasc. Interv. 5:525–532, 2012.
Zegdi, R., V. Ciobotaru, M. Noghin, G. Sleilaty, A. Lafont, C. Latrémouille, A. Deloche, and J.-N. Fabiani. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent?: Results from a human anatomic study in adults. J. Am. Coll. Cardiol. 51:579–584, 2008.
Acknowledgments
Research for this project was funded in part by NIH HL104080 and HL108240 grants and a NIH F31 HL112632 predoctoral fellowship.
Conflict of Interest
None.
Author information
Authors and Affiliations
Corresponding author
Additional information
Associate Editor Jane Grande-Allen oversaw the review of this article.
Rights and permissions
About this article
Cite this article
Martin, C., Sun, W. Transcatheter Valve Underexpansion Limits Leaflet Durability: Implications for Valve-in-Valve Procedures. Ann Biomed Eng 45, 394–404 (2017). https://doi.org/10.1007/s10439-016-1738-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10439-016-1738-8