Interventions for valvular disease and heart failure

A bench study of balloon-expandable valves for the treatment of self-expanding valve failure

EuroIntervention 2023;19:93-102. DOI: 10.4244/EIJ-D-22-00769

Mariama Akodad
Mariama Akodad1,2,3,4, MD, PhD; David Meier1,2,3, MD; Stephanie Sellers1,2,3, PhD; Ole De Backer5, MD; Darren Mylotte6, MD; Uri Landes7, MD; Chris Frawley8, BEng; Lisa Lynch8, MSc; Gilbert H.L. Tang9, MD, MSc, MBA; Lars Sondergaard5, MD, DMSc; David A. Wood1,2,3, MD; John G. Webb1,2,3, MD; Janarthanan Sathananthan1,2,3, MBChB, MPH
1. Centre for Heart Valve Innovation, St Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada; 2. Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, BC, Canada; 3. Cardiovascular Translational Laboratory, Centre for Heart Lung Innovation & Providence Research, Vancouver, BC, Canada; 4. Institut Cardiovasculaire Paris Sud, Hôpital privé Jacques-Cartier, Ramsay Santé, Massy, France; 5. Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 6. Department of Cardiology, National University of Ireland, Galway, (NUIG), Galway, Ireland; 7. Edith Wolfson Medical Center, Holon, Israel and Tel-Aviv University, Tel-Aviv, Israel; 8. Boston Scientific Corporation, Marlborough, MA, USA; 9. Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, NY, USA

Background: Coronary obstruction and access are concerns in patients undergoing redo transcatheter aortic valve implantation (TAVI).

Aims: We sought to assess the neoskirt height, leaflet overhang, leaflet deflection,and transcatheter heart valve (THV) expansion and performance, at 2 different implant depths, of the SAPIEN 3 Ultra (S3U) within the ACURATE neo2 (ACn2) THV.

Methods: An in vitro study was performed with a 23 mm S3U deployed within a small (S) ACn2 and a 26 mm S3U deployed within a medium (M) and a large (L) ACn2. The S3U outflow was positioned at the top of the ACn2 crown (low implant) and at the base of the commissural post of the ACn2 (high implant). Testing was performed under physiological conditions as per ISO-5840-3 standard.

Results: The neoskirt height was shorter when the S3U outflow was positioned at a low implantation depth (S: 9.6 mm, M: 12.2 mm, L: 13.8 mm vs S: 15.2 mm, M: 15.1 mm, L: 17.8 mm ACn2 for high implants). Hydrodynamic performance was acceptable for all configurations. Leaflet overhang was <50% for all configurations except the low implant of the 26 mm S3U in the L ACn2 (77.6%). There was a gap from the side of the neoskirt to the outer border of the THV frame which was >2 mm for all configurations. The S3U was underexpanded for all configurations, and the achieved area was 77.9%-92.9% of the expected nominal area.

Conclusions: Redo TAVI with an S3U within an ACn2 has favourable hydrodynamics and moderate leaflet overhang. Importantly, the design of the ACn2 results in a neoskirt that is not deflected all the way to the outer dimensions of the THV, hence creating a space that facilitates coronary flow and access.

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