Skip to main content
SpringerLink
Log in

Redo Transcatheter Aortic Valve Implantation with the ALLEGRA Transcatheter Heart Valve: Insights from Bench Testing

  • Original Article
  • Published:
Cardiovascular Engineering and Technology Aims and scope Submit manuscript

Abstract

Purpose

Failure of transcatheter heart valves (THV) may potentially be treated with repeat transcatheter aortic valve implantation (redo TAVI). We assessed hydrodynamic performance, stability and pinwheeling utilizing the ALLEGRA (New Valve Technology, Hechingen, Germany) THV, a CE approved and marketed THV in Europe, inside different THVs.

Methods

Redo TAVI was simulated with the 27 mm ALLEGRA THV at three implantation depths (−4 mm, 0 mm and +4 mm) in seven different ‘failed’ THVs: 26 mm Evolut Pro, 25 mm Lotus, 25 mm JenaValve, 25 mm Portico, 23 mm Sapien 3, 27 mm ALLEGRA and M ACURATE neo. Hydrodynamic evaluation was performed according to International Standards Organization 5840-3:2021.

Results

The ALLEGRA THV was stable with acceptable performance (gradient <20 mmHg, effective orifice area >2 cm2, and regurgitant fraction <20%) in all ‘failed’ THVs except the Evolut Pro at −4 mm implantation depth. In this configuration, the outflow of the ALLEGRA frame was constrained by the Evolut Pro THV and the ALLEGRA leaflets were unable to fully close. Pinwheeling was severe for the ALLEGRA in Evolut Pro. The neo-skirt was higher with taller frame THVs.

Conclusion

The ALLEGRA THV had favorable hydrodynamic performance, stability and pinwheeling in all redo TAVI samples except the Evolut Pro at low implantation depth with compromised function. The choice of initial THV may have late implications on new THV choice and function.

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

Figure 1
Figure 2
Figure 3
Figure 4
Figure 5

Similar content being viewed by others

References

  1. Cardiovascular implants - cardiac valve prosthesis. Part 3: Heart valve substitutes implanted by trans catheter techniques. In: organization Is, editor. Geneva, Switzerland: International standard organization; 2013.

  2. Cuevas, O., R. Moreno, V. Pascual-Tejerina, S. Toggweiler, M. Brinkert, J. Baz, et al. The Allegra transcatheter heart valve: European multicentre experience with a novel self-expanding transcatheter aortic valve. EuroIntervention. 15:71–73, 2019. https://doi.org/10.4244/EIJ-D-18-00861.

    Article  Google Scholar 

  3. DeBacker, O., U. Landes, A. Fuchs, S.-H. Yoon, O. N. Mathiassen, A. Sedaghat, et al. Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography. JACC Cardiovascular Interventions. 13:2528–2538, 2020. https://doi.org/10.1016/j.jcin.2020.06.016.

    Article  Google Scholar 

  4. Hellhammer, K., K. Piayda, S. Afzal, L. Kleinebrecht, M. Makosch, I. Hennig, et al. The latest evolution of the medtronic corevalve system in the era of transcatheter aortic valve replacement: matched comparison of the Evolut PRO and Evolut R. JACC Cardiovasc Interv. 11(22):2314–2322, 2018.

    Article  Google Scholar 

  5. Landes, U., J. G. Webb, O. De Backer, L. Sondergaard, M. Abdel-Wahab, L. Crusius, et al. Repeat transcatheter aortic valve replacement for transcatheter prosthesis dysfunction. J Am Coll Cardiol. 75(16):1882–1893, 2020. https://doi.org/10.1016/j.jacc.2020.02.051.

    Article  Google Scholar 

  6. Mack, M. J., M. B. Leon, V. H. Thourani, R. Makkar, S. K. Kodali, M. Russo, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 380(18):1695–1705, 2019. https://doi.org/10.1056/NEJMoa1814052.

    Article  Google Scholar 

  7. 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 vitro valve-in-valve model. JACC. 9:1618–1628, 2016. https://doi.org/10.1016/j.jcin.2016.05.030.

    Article  Google Scholar 

  8. Perlman, G. Y., A. Cheung, E. Dumont, D. Stub, D. Dvir, M. Del Trigo, et al. Transcatheter aortic valve replacement with the Portico valve: one-year results of the early Canadian experience. EuroIntervention. 12(13):1653–1659, 2017.

    Article  Google Scholar 

  9. Pighi, M., M. Lunardi, and F. L. Ribichini. NVT ALLEGRA transcatheter heart valve for valve-in-valve procedures in failing surgical aortic bioprostheses: let us wait and see. EuroIntervention. 15(9):e739–e741, 2019. https://doi.org/10.4244/EIJV15I9A137.

    Article  Google Scholar 

  10. Popma, J. J., G. M. Deeb, S. J. Yakubov, M. Mumtaz, H. Gada, D. O’Hair, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 380(18):1706–1715, 2019. https://doi.org/10.1056/NEJMoa1816885.

    Article  Google Scholar 

  11. Sathananthan, J., R. Fraser, M. Kütting, M. Hensey, U. Landes, A. Alkhodair, et al. Impact of implant depth on hydrodynamic function of the ALLEGRA bioprosthesis in valve-in-valve interventions. EuroIntervention. 15:e1335–e1342, 2020. https://doi.org/10.4244/EIJ-D-19-00782.

    Article  Google Scholar 

  12. Sathananthan, J., R. Fraser, U. Landes, C. Rich, S. L. Sellers, J. Leipsic, et al. Repeat transcatheter aortic valve replacement and implications for transcatheter heart valve performance: insights from bench testing. EuroIntervention. 2021. https://doi.org/10.4244/EIJ-D-20-00697.

    Article  Google Scholar 

  13. Sathananthan, J., S. L. Sellers, R. Fraser, D. Dvir, M. Hensey, D. J. Murdoch, et al. Impact of implant depth on hydrodynamic function with the ACURATE neo transcatheter heart valve following valve-in-valve transcatheter aortic valve replacement in Mitroflow bioprosthetic valves: an ex vivo bench study. EuroIntervention. 15(1):78–87, 2019.

    Article  Google Scholar 

  14. Seigerman, M. E., A. Nathan, and S. Anwaruddin. the lotus valve system: an in-depth review of the technology. Curr Cardiol Rep. 21:157, 2019. https://doi.org/10.1007/s11886-019-1234-5.

    Article  Google Scholar 

  15. Treede, H., A. Rastan, M. Ferrari, S. Ensminger, H.-R. Figulla, and F.-W. Mohr. JenaValve. EuroIntervention. 8:88–93, 2012. https://doi.org/10.4244/EIJV8SQA16.

    Article  Google Scholar 

  16. Webb, J., G. Gerosa, T. Lefèvre, J. Leipsic, M. Spence, M. Thomas, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 64(21):2235–2243, 2014. https://doi.org/10.1016/j.jacc.2014.09.026.

    Article  Google Scholar 

  17. Wenaweser, P., S. Stortecky, T. Schütz, F. Praz, S. Gloekler, S. Windecker, et al. Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve. EuroIntervention. 12(71–77):1, 2016. https://doi.org/10.4244/EIJV12I1A13.

    Article  Google Scholar 

Download references

Funding

This study has no relevant funding

Author information

Authors and Affiliations

  1. Centre for Heart Valve Innovation, St Paul’s Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada

    Mariama Akodad, Stephanie Sellers, Isabel Kim, Anson Cheung, Jonathon Leipsic, David A. Wood, John G. Webb & Janarthanan Sathananthan

  2. Centre for Cardiovascular Innovation, Vancouver, Canada

    Mariama Akodad, Stephanie Sellers, Isabel Kim, Anson Cheung, Jonathon Leipsic, David A. Wood, John G. Webb & Janarthanan Sathananthan

  3. New Valve Technology, Hechingen, Germany

    Maximilian Kütting, Alina Kirsten & Philipp Marx

  4. Cardiovascular Translational Laboratory, St. Paul’s Hospital, Vancouver, BC, Canada

    Stephanie Sellers & Janarthanan Sathananthan

  5. Centre for Heart Lung Innovation, Vancouver, Canada

    Stephanie Sellers & Janarthanan Sathananthan

  6. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

    Lars Søndergaard

  7. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland

    Stefan Toggweiler

Authors
  1. Mariama Akodad
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Maximilian Kütting
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Stephanie Sellers
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alina Kirsten
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Philipp Marx
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Isabel Kim
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Anson Cheung
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Jonathon Leipsic
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Lars Søndergaard
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Stefan Toggweiler
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. David A. Wood
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. John G. Webb
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Janarthanan Sathananthan
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

MA: Conceptualization, Formal analysis, Methodology, Visualization, Writing—original draft, Writing—review & editing; MK: Conceptualization, Formal analysis, Methodology, Visualization, Validation, Writing—review & editing; SS: Conceptualization, Data curation, Formal analysis, Methodology, Validation, Visualization, Writing—review & editing; AK: Conceptualization, Data curation, Formal analysis, Methodology, Visualization, Writing—review & editing; PM: Conceptualization, Data curation, Formal analysis, Methodology, Visualization, Writing—review & editing; IK: Methodology, Visualization, Writing—review & editing; JL Writing—review & editing ; LS Writing—review & editing; ST Writing—review & editing ; DA Visualization, Writing—review & editing ; JG W Visualization, Writing—review & editing ; JS Conceptualization, Formal analysis, Methodology, Supervision, Visualization, Validation, Writing—original draft, Writing—review & editing

Corresponding author

Correspondence to Janarthanan Sathananthan.

Ethics declarations

Data availability

Yes

Code availability

Not applicable

Conflict of interest

Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore and Federation Française de Cardiologie. Dr Kütting, A. Kirsten and Philipp Marx are employees of NVT. Dr. Sellers is supported by fellowships from the Canadian Institutes of Health Research and the Michael Smith Foundation for Health Research. Dr Leipsic is consultant to Edwards Lifesciences and provide CT core lab services for Edwards Lifesciences, Medtronic, Neovasc, Guided Delivery Systems, and Abbott, for which no direct compensation is received. Dr. Toggweiler is a proctor and consultant for Biosensors / New Valve Technology, Medtronic and Boston Scientific, a proctor for Abbott, a consultant for Shockwave, Teleflex, Medira, at Heart Medical, Veosource, has received institutional research grants from Boston Scientific and Fumedica and holds equity in Hi-D Imaging. Dr Wood is a consultant to, and has received research funding from, Edwards Lifesciences and Abbott. Dr. Webb is a consultant to, and has received research funding from, Edwards Lifesciences, Abbott, and Medtronic. Lars Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr Sathananthan is a consultant to Edwards Lifesciences, Boston Scientific and Medtronic. He has received research funding from Medtronic and Edwards Lifesciences. The other authors do not have any relevant disclosures.

Ethical Approval

Not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Additional information

Associate Editor Jamshid Karimov oversaw the review of this article.

Publisher's Note

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

Supplementary Information

Below is the link to the electronic supplementary material.

Video 1 High-speed video showing the 27 mm ALLEGRA in “failed” 26 mm Evolut Pro THV at −4 mm. Constrained ALLEGRA THV frame by the Evolut Pro THV and ALLEGRA leaflets unable to close. Supplementary file1 (MOV 3709 kb).

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Akodad, M., Kütting, M., Sellers, S. et al. Redo Transcatheter Aortic Valve Implantation with the ALLEGRA Transcatheter Heart Valve: Insights from Bench Testing. Cardiovasc Eng Tech 13, 930–938 (2022). https://doi.org/10.1007/s13239-022-00627-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13239-022-00627-1

Keywords

Search

Navigation