Redo Transcatheter Aortic Valve Implantation with the ALLEGRA Transcatheter Heart Valve: Insights from Bench Testing
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Cardiovascular Engineering and Technology |
| Vol/bind | 13 |
| Udgave nummer | 6 |
| Sider (fra-til) | 930-938 |
| ISSN | 1869-408X |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
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.
Publisher Copyright:
© 2022, The Author(s) under exclusive licence to Biomedical Engineering Society.
ID: 314280078