Cardiovascular Engineering and Technology

, Volume 9, Issue 3, pp 339–350 | Cite as

Realistic Vascular Replicator for TAVR Procedures

  • Oren M. Rotman
  • Brandon Kovarovic
  • Chander Sadasivan
  • Luis Gruberg
  • Baruch B. Lieber
  • Danny BluesteinEmail author


Transcatheter aortic valve replacement (TAVR) is an over-the-wire procedure for treatment of severe aortic stenosis (AS). TAVR valves are conventionally tested using simplified left heart simulators (LHS). While those provide baseline performance reliably, their aortic root geometries are far from the anatomical in situ configuration, often overestimating the valves’ performance. We report on a novel benchtop patient-specific arterial replicator designed for testing TAVR and training interventional cardiologists in the procedure. The Replicator is an accurate model of the human upper body vasculature for training physicians in percutaneous interventions. It comprises of fully-automated Windkessel mechanism to recreate physiological flow conditions. Calcified aortic valve models were fabricated and incorporated into the Replicator, then tested for performing TAVR procedure by an experienced cardiologist using the Inovare valve. EOA, pressures, and angiograms were monitored pre- and post-TAVR. A St. Jude mechanical valve was tested as a reference that is less affected by the AS anatomy. Results in the Replicator of both valves were compared to the performance in a commercial ISO-compliant LHS. The AS anatomy in the Replicator resulted in a significant decrease of the TAVR valve performance relative to the simplified LHS, with EOA and transvalvular pressures comparable to clinical data. Minor change was seen in the mechanical valve performance. The Replicator showed to be an effective platform for TAVR testing. Unlike a simplified geometric anatomy LHS, it conservatively provides clinically-relevant outcomes and complement it. The Replicator can be most valuable for testing new valves under challenging patient anatomies, physicians training, and procedural planning.


TAVI Aortic stenosis Aortic valve Mitral valve Prosthetic valve 3D printing 



Aortic stenosis


Aortic regurgitation


Calcific aortic valve disease


Cardiac output


Effective orifice area


Left heart simulator


Pulse duplicator


Paravalvular leak


Transcatheter aortic valve replacement



The authors would like to acknowledge Braile Biomédica from Brazil, for providing us with the 24 mm Inovare TAVR valve.


This project was supported by NIH-NIBIB Quantum Award Phase II-1U01EB012487 (DB) and NHLBI STTR R41-HL134418 (DB).

Conflict of interest

Author OR was a consultant for Vascular Simulations LLC. Author BK is partly employed by Vascular Simulations LLC. Author CS has stock ownership in Vascular Simulations LLC. Author BL has stock ownership in Vascular Simulations LLC. Author LG declares that he has no conflicts of interest. Author DB declares that he has no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was waived by the Stony Brook University Institutional Review Board as this study was retrospective and the CT scans for this study were received anonymized. This article does not contain any studies with animals performed by any of the authors.

Supplementary material

Online Video1 Guidance of the delivery system via femoral access in the Replicator. Supplementary material 1 (MP4 20537 kb)

Online Video2 Deployment of the 24 mm Inovare valve in the Replicator. Supplementary material 2 (MP4 17906 kb)

Online Video3 Inovare valve in the Replicator post-procedural. Supplementary material 3 (MP4 13954 kb)

Online Video4 Angiogram of the severe calcified aortic valve model (S-CAVD-50) pre-TAVR. Left – original angiogram; Right – subtracted angiogram. Supplementary material 4 (MP4 2245 kb)

Online Video 5 Angiogram of the severe calcified aortic valve model (S-CAVD-50) post-TAVR. Left – original angiogram; Right – subtracted angiogram. Supplementary material 5 (MP4 2244 kb)

Online Video 6 Video of the Inovare TAVR valve; Left – in the Vivitro PD; Right – in the Replicator. Supplementary material 6 (MP4 6138 kb)


  1. 1.
    Alkhouli, M., and P. P. Sengupta. 3-dimensional-printed models for TAVR planning: why guess when you can see? JACC Cardiovasc. Imaging. 10(7):732–734, 2017. Scholar
  2. 2.
    Amat-Santos, I. J., A. Dahou, J. Webb, D. Dvir, J. G. Dumesnil, R. Allende, et al. Comparison of hemodynamic performance of the balloon-expandable SAPIEN 3 versus SAPIEN XT transcatheter valve. Am. J. Cardiol. 114(7):1075–1082, 2014. Scholar
  3. 3.
    American College of C, American Heart Association Task Force on Practice G, Society of Cardiovascular A, R. O. Bonow, B. A. Carabello, K. Chatterjee, et al. 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. J. Am. Coll. Cardiol. 48(3):e1–e148, 2006. Scholar
  4. 4.
    Armillotta, A., P. Bonhoeffer, G. Dubini, S. Ferragina, F. Migliavacca, G. Sala, et al. Use of rapid prototyping models in the planning of percutaneous pulmonary valved stent implantation. Proc. Inst. Mech. Eng. Part H 221(4):407–416, 2007. Scholar
  5. 5.
    Arthur, A., D. Hoit, A. Coon, J. E. D. Almandoz, L. Elijovich, S. Cekirge, et al. Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study. J. Neurointerv. Surg. 17:13310, 2017.Google Scholar
  6. 6.
    Bianchi, M., G. Marom, R. P. Ghosh, H. A. Fernandez, J. R. Taylor, M. J. Slepian, et al. Effect of balloon-expandable transcatheter aortic valve replacement positioning: a patient-specific numerical model. Artif. Organs. 2016. Scholar
  7. 7.
    Bloodworth, C. H., E. L. Pierce, T. F. Easley, A. Drach, A. H. Khalighi, M. Toma, et al. Ex vivo methods for informing computational models of the mitral valve. Ann. Biomed. Eng. 45(2):496–507, 2017.CrossRefGoogle Scholar
  8. 8.
    Cao, C., S. C. Ang, P. Indraratna, C. Manganas, P. Bannon, D. Black, et al. Systematic review and meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis. Ann. Cardiothorac. Surg. 2(1):10–23, 2013. Scholar
  9. 9.
    De Paulis, R., C. Schmitz, R. Scaffa, P. Nardi, L. Chiariello, and H. Reul. In vitro evaluation of aortic valve prosthesis in a novel valved conduit with pseudosinuses of Valsalva. J. Thorac. Cardiovasc. Surg. 130(4):1016–1021, 2005.CrossRefGoogle Scholar
  10. 10.
    Douglas, P. S., M. B. Leon, M. J. Mack, L. G. Svensson, J. G. Webb, R. T. Hahn, et al. Longitudinal hemodynamics of transcatheter and surgical aortic valves in the PARTNER Trial. JAMA Cardiol. 2(11):1197–1206, 2017. Scholar
  11. 11.
    Falahatpisheh, A., D. Morisawa, T. T. Toosky, and A. Kheradvar. A calcified polymeric valve for valve-in-valve applications. J. Biomech. 50:77–82, 2017. Scholar
  12. 12.
    Gaia, D. F., J. R. Breda, C. B. Duarte Ferreira, J. A. Marcondes de Souza, M. T. Macedo, M. V. Gimenes, et al. New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up. EuroIntervention 11(6):682–689, 2015. Scholar
  13. 13.
    Gallet, R., A. Seemann, M. Yamamoto, D. Hayat, G. Mouillet, J. L. Monin, et al. Effect of transcatheter (via femoral artery) aortic valve implantation on the platelet count and its consequences. Am. J. Cardiol. 111(11):1619–1624, 2013. Scholar
  14. 14.
    Go, A. S., D. Mozaffarian, V. L. Roger, E. J. Benjamin, J. D. Berry, M. J. Blaha, et al. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation. 129(3):e28–e292, 2014. Scholar
  15. 15.
    Groves, E. M., A. Falahatpisheh, J. L. Su, and A. Kheradvar. The effects of positioning of transcatheter aortic valves on fluid dynamics of the aortic root. ASAIO J. 60(5):545–552, 2014. Scholar
  16. 16.
    Gunning, P. S., N. Saikrishnan, L. M. McNamara, and A. P. Yoganathan. An in vivo evaluation of the impact of eccentric deployment on transcatheter aortic valve hemodynamics. Ann. Biomed. Eng. 42(6):1195–1206, 2014. Scholar
  17. 17.
    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 2015. Scholar
  18. 18.
    Kalejs, M., and L. K. von Segesser. Rapid prototyping of compliant human aortic roots for assessment of valved stents. Interact. Cardiovasc. Thorac Surg. 8(2):182–186, 2009. Scholar
  19. 19.
    Kappetein, A. P., S. J. Head, P. Genereux, N. Piazza, N. M. van Mieghem, E. H. Blackstone, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J. Am. Coll. Cardiol. 60(15):1438–1454, 2012. Scholar
  20. 20.
    Kuetting, M., A. Sedaghat, M. Utzenrath, J. M. Sinning, C. Schmitz, J. Roggenkamp, et al. In vitro assessment of the influence of aortic annulus ovality on the hydrodynamic performance of self-expanding transcatheter heart valve prostheses. J. Biomech. 47(5):957–965, 2014. Scholar
  21. 21.
    Kurtz, C. E., and C. M. Otto. Aortic stenosis: clinical aspects of diagnosis and management, with 10 illustrative case reports from a 25-year experience. Medicine. 89(6):349–379, 2010. Scholar
  22. 22.
    Maragiannis, D., M. S. Jackson, S. R. Igo, S. M. Chang, W. A. Zoghbi, and S. H. Little. Functional 3D printed patient-specific modeling of severe aortic stenosis. J. Am. Coll. Cardiol. 64(10):1066–1068, 2014. Scholar
  23. 23.
    Maragiannis, D., M. S. Jackson, S. R. Igo, R. C. Schutt, P. Connell, J. Grande-Allen, et al. Replicating patient-specific severe aortic valve stenosis with functional 3D modeling. Circ. Cardiovasc. Imaging. 8(10):e003626, 2015. Scholar
  24. 24.
    Meschini, V., M. De Tullio, G. Querzoli, and R. Verzicco. Flow structure in healthy and pathological left ventricles with natural and prosthetic mitral valves. J. Fluid Mech. 834:271–307, 2018.MathSciNetCrossRefGoogle Scholar
  25. 25.
    Midha, P. A., V. Raghav, J. F. Condado, I. U. Okafor, S. Lerakis, V. H. Thourani, et al. Valve type, size, and deployment location affect hemodynamics in an in vivo valve-in-valve model. JACC Cardiovasc. Interv. 9(15):1618–1628, 2016.CrossRefGoogle Scholar
  26. 26.
    Midha, P. A., V. Raghav, I. Okafor, and A. P. Yoganathan. The effect of valve-in-valve implantation height on sinus flow. Ann. Biomed. Eng. 45(2):405–412, 2017.CrossRefGoogle Scholar
  27. 27.
    Nardi, A., B. Even-Chen, and I. Avrahami. Experimental and numerical study of the flow dynamics in treatment approaches for aortic arch aneurysms. InTech: Aortic Aneurysm, 2017.CrossRefGoogle Scholar
  28. 28.
    Otto, C. M. Calcific aortic stenosis–time to look more closely at the valve. N Engl J Med. 359(13):1395–1398, 2008. Scholar
  29. 29.
    Otto, C. M., J. Kuusisto, D. D. Reichenbach, A. M. Gown, and K. D. O’Brien. Characterization of the early lesion of ‘degenerative’ valvular aortic stenosis. Histological and immunohistochemical studies. Circulation. 90(2):844–853, 1994.CrossRefGoogle Scholar
  30. 30.
    Rahmani, B., S. Tzamtzis, R. Sheridan, M. J. Mullen, J. Yap, A. M. Seifalian, et al. In vitro hydrodynamic assessment of a new transcatheter heart valve concept (the TRISKELE). J. Cardiovasc. Transl. Res. 10(2):104–115, 2017. Scholar
  31. 31.
    Reynolds, M. R., E. A. Magnuson, K. Wang, Y. Lei, K. Vilain, J. Walczak, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation. 125(9):1102–1109, 2012. Scholar
  32. 32.
    Reynolds, M. R., E. A. Magnuson, K. Wang, V. H. Thourani, M. Williams, A. Zajarias, et al. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results From the PARTNER (Placement of AoRTic TraNscathetER Valve) trial (Cohort A). J. Am. Coll. Cardiol. 60(6):548–558, 2012. Scholar
  33. 33.
    Rosenhek, R., T. Binder, G. Maurer, and H. Baumgartner. Normal values for Doppler echocardiographic assessment of heart valve prostheses. J. Am. Soc. Echocardiogr. 16(11):1116–1127, 2003. Scholar
  34. 34.
    Salaun, E., A. S. Zenses, M. Evin, F. Collart, G. Habib, P. Pibarot, et al. Effect of oversizing and elliptical shape of aortic annulus on transcatheter valve hemodynamics: an in vitro study. Int. J. Cardiol. 208:28–35, 2016. Scholar
  35. 35.
    Shames, S., A. Koczo, R. Hahn, Z. Jin, M. H. Picard, and L. D. Gillam. Flow characteristics of the SAPIEN aortic valve: the importance of recognizing in-stent flow acceleration for the echocardiographic assessment of valve function. J. Am. Soc. Echocardiogr. 25(6):603–609, 2012. Scholar
  36. 36.
    Siefert, A. W., J. P. M. Rabbah, K. J. Koomalsingh, S. A. Touchton, N. Saikrishnan, J. R. McGarvey, et al. In vitro mitral valve simulator mimics systolic valvular function of chronic ischemic mitral regurgitation ovine model. Ann. Thorac. Surg. 95(3):825–830, 2013.CrossRefGoogle Scholar
  37. 37.
    Simard, L., N. Cote, F. Dagenais, P. Mathieu, C. Couture, S. Trahan, et al. Sex-related discordance between aortic valve calcification and hemodynamic severity of aortic stenosis: is valvular fibrosis the explanation? Circ. Res. 120(4):681–691, 2017. Scholar
  38. 38.
    Spethmann, S., H. Dreger, G. Baldenhofer, E. Pflug, W. Sanad, V. Stangl, et al. Long-term Doppler hemodynamics and effective orifice areas of Edwards SAPIEN and medtronic CoreValve prostheses after TAVI. Echocardiography. 31(3):302–310, 2014. Scholar
  39. 39.
    Thourani, V. H., S. Kodali, R. R. Makkar, H. C. Herrmann, M. Williams, V. Babaliaros, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. The Lancet. 387(10034):2218–2225, 2016.CrossRefGoogle Scholar
  40. 40.
    Vahanian, A., H. Baumgartner, J. Bax, E. Butchart, R. Dion, G. Filippatos, et al. 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(2):230–268, 2007. Scholar
  41. 41.
    Wagner, M., S. Schafer, C. Strother, and C. Mistretta. 4D interventional device reconstruction from biplane fluoroscopy. Med. Phys. 43(3):1324–1334, 2016.CrossRefGoogle Scholar
  42. 42.
    Weiler, M., C. H. Yap, K. Balachandran, M. Padala, and A. P. Yoganathan. Regional analysis of dynamic deformation characteristics of native aortic valve leaflets. J. Biomech. 44(8):1459–1465, 2011.CrossRefGoogle Scholar
  43. 43.
    Wu, W., D. Pott, B. Mazza, T. Sironi, E. Dordoni, C. Chiastra, et al. Fluid-structure interaction model of a percutaneous aortic valve: comparison with an in vivo test and feasibility study in a patient-specific case. Ann. Biomed. Eng. 2015. Scholar

Copyright information

© Biomedical Engineering Society 2018

Authors and Affiliations

  • Oren M. Rotman
    • 1
  • Brandon Kovarovic
    • 1
  • Chander Sadasivan
    • 2
    • 3
  • Luis Gruberg
    • 4
  • Baruch B. Lieber
    • 1
    • 2
    • 3
  • Danny Bluestein
    • 1
    Email author
  1. 1.Department of Biomedical EngineeringStony Brook UniversityStony BrookUSA
  2. 2.Department of Neurological SurgeryStony Brook UniversityStony BrookUSA
  3. 3.Vascular Simulations LLCStony BrookUSA
  4. 4.Southside HospitalBay ShoreUSA

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