Realistic Vascular Replicator for TAVR Procedures
- 204 Downloads
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.
KeywordsTAVI Aortic stenosis Aortic valve Mitral valve Prosthetic valve 3D printing
Calcific aortic valve disease
Effective orifice area
Left heart simulator
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.
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.
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)
- 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. https://doi.org/10.1016/j.amjcard.2014.07.019.CrossRefGoogle Scholar
- 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. https://doi.org/10.1016/j.jacc.2006.05.021.CrossRefGoogle Scholar
- 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. https://doi.org/10.1243/09544119JEIM83.CrossRefGoogle Scholar
- 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
- 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. https://doi.org/10.3978/j.issn.2225-319X.2012.11.09.Google Scholar
- 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. https://doi.org/10.1016/j.amjcard.2013.01.332.CrossRefGoogle Scholar
- 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. https://doi.org/10.1161/01.cir.0000441139.02102.80.Google Scholar
- 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. https://doi.org/10.1098/rsif.2015.0737.Google Scholar
- 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. https://doi.org/10.1016/j.jacc.2012.09.001.CrossRefGoogle Scholar
- 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. https://doi.org/10.1016/j.jbiomech.2014.01.024.CrossRefGoogle Scholar
- 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. https://doi.org/10.1161/CIRCULATIONAHA.111.054072.CrossRefGoogle Scholar
- 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. https://doi.org/10.1016/j.jacc.2012.03.075.CrossRefGoogle Scholar
- 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. https://doi.org/10.1016/j.echo.2012.02.013.CrossRefGoogle Scholar
- 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. https://doi.org/10.1161/CIRCRESAHA.116.309306.CrossRefGoogle Scholar
- 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. https://doi.org/10.1111/echo.12358.CrossRefGoogle Scholar
- 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. https://doi.org/10.1093/eurheartj/ehl428.Google Scholar