Skip to main content
SpringerLink
Log in

A mechanistic investigation of the EDWARDS INTUITY Elite valve’s hemodynamic performance

  • Original Article
  • Published:
General Thoracic and Cardiovascular Surgery Aims and scope Submit manuscript

Abstract

Objective

Rapid deployment surgical aortic valve replacement has emerged as an alternative to the contemporary sutured valve technique. A difference in transvalvular pressure has been observed clinically between RD-SAVR and contemporary SAVR. A mechanistic inquiry into the impact of the rapid deployment valve inflow frame design on the left ventricular outflow tract and valve hemodynamics is needed.

Methods

A 23 mm EDWARDS INTUITY Elite rapid deployment valve and a control contemporary, sutured valve, a 23 mm Magna Ease valve, were implanted in an explanted human heart by an experienced cardiac surgeon. Per convention, the rapid deployment valve was implanted with three non-pledgeted, simple guiding sutures, while fifteen pledgeted, mattress sutures were used to implant the contemporary surgical valve. In vitro flow models were created from micro-computed tomography scans of the implanted valves and surrounding cardiac anatomy. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated pulsatile flow loop system.

Results

The rapid deployment and control valves were found to have mean transvalvular pressure gradients of 7.92 ± 0.37 and 10.13 ± 0.48 mmHg, respectively. The inflow frame of the rapid deployment valve formed a larger, more circular, left ventricular outflow tract compared to the control valve. Furthermore, it was found that the presence of the control valve’s sub-annular pledgets compromised its velocity distribution and consequently its pressure gradient.

Conclusions

The rapid deployment valve’s intra-annular inflow frame provides for a larger, left ventricular outflow tract, thus reducing the transvalvular pressure gradient and improving overall hemodynamic performance.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics—2017 update: a report from the american heart association. Circulation. 2017;135:e146–603.

    Article  Google Scholar 

  2. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary. J Am Coll Cardiol. 2014;63:2438–88.

    Article  Google Scholar 

  3. Di Eusanio M, Phan K. Sutureless aortic valve replacement. Ann Cardiothorac Surg. 2015;4:123–30.

    PubMed  PubMed Central  Google Scholar 

  4. Liakopoulos OJ, Gerfer S, Weider S, et al. Direct comparison of the Edwards Intuity Elite and Sorin Perceval S rapid deployment aortic valves. Ann Thorac Surg. 2018;105:108–14.

    Article  Google Scholar 

  5. Sohn SH, Jang M, Hwang HY, et al. Rapid deployment or sutureless versus conventional bioprosthetic aortic valve replacement: a meta-analysis. J Thorac Cardiovasc Surg. 2018;155(2402–2412):e5.

    Google Scholar 

  6. Phan K, Tsai Y-C, Niranjan N, et al. Sutureless aortic valve replacement: a systematic review and meta-analysis. Ann Cardiothorac Surg. 2015;4:100–11.

    PubMed  PubMed Central  Google Scholar 

  7. Young C, Laufer G, Kocher A, et al. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018;155:575–85.

    Article  Google Scholar 

  8. Rahmanian PB. Invited commentary. Ann Thorac Surg. 2018;106(6):1749–50. https://doi.org/10.1016/j.athoracsur.2018.08.004.

    Article  PubMed  Google Scholar 

  9. Ferrari E, Roduit C, Salamin P, et al. Rapid-deployment aortic valve replacement versus standard bioprosthesis implantation. J Card Surg. 2017;32:322–7.

    Article  Google Scholar 

  10. Jahren SE, Heinisch PP, Wirz J, et al. Hemodynamic performance of Edwards Intuity valve in a compliant aortic root model. In: 2015 37th annual international conference of the IEEE Engineering in Medicine and Biology Society, vol. 2015, IEEE; 2015. p. 3315–18.

  11. Capelli C, Corsini C, Biscarini D, et al. Pledget-armed sutures affect the haemodynamic performance of biologic aortic valve substitutes: a preliminary experimental and computational study. Cardiovasc Eng Technol. 2017;8:17–29.

    Article  Google Scholar 

  12. Bloodworth CH, Pierce EL, Easley TF, et al. Ex vivo methods for informing computational models of the mitral valve. Ann Biomed Eng. 2017;45:496–507.

    Article  Google Scholar 

  13. Midha PA, Raghav V, Okafor I, et al. The effect of valve-in-valve implantation height on sinus flow. Ann Biomed Eng. 2017;45:405–12.

    Article  Google Scholar 

  14. International Organization for Standardization (ISO 5840-3). Cardiovascular implants—cardiac valve prostheses—Part 3: heart valve substitutes implanted by transcatheter techniques. Switzerland, Geneva; 2013.

  15. Gunning PS, Saikrishnan N, McNamara LM, et al. An in vitro evaluation of the impact of eccentric deployment on transcatheter aortic valve hemodynamics. Ann Biomed Eng. 2014;42:1195–206.

    Article  Google Scholar 

  16. Gibson PH, Becher H, Choy JB. Classification of left ventricular size: diameter or volume with contrast echocardiography? Open Hear. 2014;1:e000147.

    Article  Google Scholar 

  17. Borger MA, Moustafine V, Conradi L, et al. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg. 2015;99:17–24.

    Article  Google Scholar 

  18. Bobiarski J, Newcomb AE, Elhenawy AM, et al. One-year hemodynamic comparison of perimount magna with st jude epic aortic bioprostheses. Arch Med Sci. 2013;3:445–51.

    Article  Google Scholar 

  19. Barnhart GR, Accola KD, Grossi EA, et al. TRANSFORM (Multicenter experience with rapid deployment Edwards INTUITY valve system for aortic valve replacement) US clinical trial: performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017;153(241–251):e2.

    Google Scholar 

  20. Kocher AA, Laufer G, Haverich A, et al. One-year outcomes of the surgical treatment of aortic stenosis with a next generation surgical aortic valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system. J Thorac Cardiovasc Surg. 2013;145:110–6.

    Article  Google Scholar 

  21. Andreas M, Wallner S, Habertheuer A, et al. Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor. Interact Cardiovasc Thorac Surg. 2016;22:799–805.

    Article  Google Scholar 

  22. Wahlers TCW, Andreas M, Rahmanian P, et al. Outcomes of a rapid deployment aortic valve versus its conventional counterpart: a propensity-matched analysis. Innovations. 2018;13(3):177–83. https://doi.org/10.1097/imi.0000000000000509.

    Article  PubMed  Google Scholar 

  23. Dayan V, Vignolo G, Soca G, et al. Predictors and outcomes of prosthesis-patient mismatch after aortic valve replacement. JACC Cardiovasc Imaging. 2016;9:924–33.

    Article  Google Scholar 

  24. Mannacio V, Mannacio L, Mango E, et al. Severe prosthesis-patient mismatch after aortic valve replacement for aortic stenosis: analysis of risk factors for early and long-term mortality. J Cardiol. 2017;69:333–9.

    Article  Google Scholar 

  25. Theron A, Gariboldi V, Grisoli D, et al. Rapid deployment of aortic bioprosthesis in elderly patients with small aortic annulus. Ann Thorac Surg. 2016;101:1434–41.

    Article  Google Scholar 

  26. Botzenhardt F, Eichinger WB, Guenzinger R, et al. Hemodynamic performance and incidence of patient-prosthesis mismatch of the complete supraannular perimount magna bioprosthesis in the aortic position. Thorac Cardiovasc Surg. 2005;53:226–30.

    Article  CAS  Google Scholar 

  27. Rahmanian PB, Kaya S, Eghbalzadeh K, et al. Rapid deployment aortic valve replacement: excellent results and increased effective orifice areas. Ann Thorac Surg. 2018;105:24–30.

    Article  Google Scholar 

  28. Laufer G, Haverich A, Andreas M, et al. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardio-Thorac Surg. 2017;52:281–7.

    Article  Google Scholar 

Download references

Funding

This study was funded by a research grant from Edwards Lifesciences.

Author information

Authors and Affiliations

  1. Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA, USA

    Vahid Sadri, Charles H. Bloodworth IV & Ajit P. Yoganathan

  2. George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USA

    Immanuel David Madukauwa-David & Prem A. Midha

  3. Department of Aerospace Engineering, Auburn University, Auburn, AL, USA

    Vrishank Raghav

Authors
  1. Vahid Sadri
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Charles H. Bloodworth IV
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Immanuel David Madukauwa-David
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Prem A. Midha
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Vrishank Raghav
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ajit P. Yoganathan
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ajit P. Yoganathan.

Ethics declarations

Conflict of interest

Georgia Tech Research Corporation received a grant from Edwards Lifesciences to carry out this research.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sadri, V., Bloodworth, C.H., Madukauwa-David, I.D. et al. A mechanistic investigation of the EDWARDS INTUITY Elite valve’s hemodynamic performance. Gen Thorac Cardiovasc Surg 68, 9–17 (2020). https://doi.org/10.1007/s11748-019-01154-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11748-019-01154-y

Keywords

Search

Navigation