Mariama Akodad1,2, Maximilian Kütting3, Stephanie Sellers1,2,4,5, Alina Kirsten3, Philipp Marx3, Isabel Kim1,2, Anson Cheung1,2, Jonathon Leipsic1,2, Lars Søndergaard6, Stefan Toggweiler7, David A Wood1,2, John G Webb1,2, Janarthanan Sathananthan8,9,10,11. 1. Centre for Heart Valve Innovation, St Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. 2. Centre for Cardiovascular Innovation, Vancouver, Canada. 3. New Valve Technology, Hechingen, Germany. 4. Cardiovascular Translational Laboratory, St. Paul's Hospital, Vancouver, BC, Canada. 5. Centre for Heart Lung Innovation, Vancouver, Canada. 6. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 7. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland. 8. Centre for Heart Valve Innovation, St Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. jsathananthan@providencehealth.bc.ca. 9. Centre for Cardiovascular Innovation, Vancouver, Canada. jsathananthan@providencehealth.bc.ca. 10. Cardiovascular Translational Laboratory, St. Paul's Hospital, Vancouver, BC, Canada. jsathananthan@providencehealth.bc.ca. 11. Centre for Heart Lung Innovation, Vancouver, Canada. jsathananthan@providencehealth.bc.ca.
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.
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.
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Authors: Michael J Mack; Martin B Leon; Vinod H Thourani; Raj Makkar; Susheel K Kodali; Mark Russo; Samir R Kapadia; S Chris Malaisrie; David J Cohen; Philippe Pibarot; Jonathon Leipsic; Rebecca T Hahn; Philipp Blanke; Mathew R Williams; James M McCabe; David L Brown; Vasilis Babaliaros; Scott Goldman; Wilson Y Szeto; Philippe Genereux; Ashish Pershad; Stuart J Pocock; Maria C Alu; John G Webb; Craig R Smith Journal: N Engl J Med Date: 2019-03-16 Impact factor: 91.245
Authors: Janarthanan Sathananthan; Rob Fraser; Maximilian Kütting; Mark Hensey; Uri Landes; Abdullah Alkhodair; Alexander Sedaghat; Philipp Blanke; Stefan Toggweiler; Jonathon Leipsic; Lars Søndergaard; David Wood; John G Webb Journal: EuroIntervention Date: 2020-02-07 Impact factor: 6.534
Authors: Janarthanan Sathananthan; Rob Fraser; Uri Landes; Courtney Rich; Stephanie L Sellers; Jonathon Leipsic; Philipp Blanke; Georg Lutter; Derk Frank; Thomas Puehler; David A Wood; Lars Søndergaard; John G Webb Journal: EuroIntervention Date: 2021-01-26 Impact factor: 6.534