JACC. Cardiovascular interventions · 2026
Impact of Tissue Treatment and Leaflet Design on Fifth-Generation Balloon-Expandable Transcatheter Heart Valve Function.
СтатьяСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Delarive Julien, Khan Jaffar M, MacLeod Brooke, Lai Althea, Kane Alison, Jamieson Colin, Dakroub Ali H, Gill Hacina, Chatfield Andrew G, Loretz Lucca, Quine Edward, Kazerooni Nazanin Afsar, de la Fuente Angela, Muller Olivier, Fournier Stephane, McCabe James M, Webb John G, Wood David A, Meier David, Sellers Stephanie L
Аннотация
BACKGROUND: The SAPIEN 3 Ultra RESILIA (S3UR) transcatheter heart valve incorporates RESILIA-treated tissue and new commissural attachments in smaller valve sizes (20 and 23 mm). However, detailed performance data are lacking.
OBJECTIVES: The aim of this study was to compare the S3UR with the SAPIEN 3 Ultra (S3U) transcatheter heart valve on the bench for transcatheter aortic valve replacement (TAVR), valve-in-valve (VIV), and redo-TAVR.
METHODS: For index TAVR, 23- and 26-mm S3UR and S3U valves were compared at nominal size and during underexpansion. For VIV testing, 23-mm study valves were implanted in 25-mm Epic and 23-mm Mitroflow valves. Redo TAVR involved the implantation of 23-mm study valves in a 26-mm Evolut PRO valve. Hydrodynamic testing assessed mean gradient (MG), geometric orifice area, effective orifice area (EOA), opening index, pinwheeling, and leaflet motion. Histology, light transmission, micrometering, micro-computed tomography, and uniaxial tensile testing compared S3UR and S3U pericardium samples. Leaflet splay area was compared after leaflet modification.
RESULTS: For index TAVR, 26-mm S3U and S3UR valves demonstrated comparable performance. In contrast, the 23-mm S3UR valve showed a lower MG (6.7 mm Hg vs 7.3 mm Hg) and larger EOA, geometric orifice area, and opening index than the 23-mm S3U valve, with MG differences increasing during underexpansion. In VIV, the 23-mm S3UR valve demonstrated systolic leaflet fluttering and hydrodynamics similar to those of S3U. In redo-TAVR, the S3UR showed a slightly lower MG and a marginally larger EOA. By micrometering, S3UR leaflet pericardium was thinner than S3U leaflet pericardium (0.28 ± 0.02 mm vs 0.36 ± 0.03 mm), but S3UR pericardium showed significantly higher tensile strength. S3UR leaflets splayed almost 40% less after modification with a central basal split.
CONCLUSIONS: Commissural changes in smaller S3UR valves and thinner leaflets drive differences in hydrodynamics, leaflet motion, tensile strength, and leaflet splay after leaflet modification. This warrants further study.
OBJECTIVES: The aim of this study was to compare the S3UR with the SAPIEN 3 Ultra (S3U) transcatheter heart valve on the bench for transcatheter aortic valve replacement (TAVR), valve-in-valve (VIV), and redo-TAVR.
METHODS: For index TAVR, 23- and 26-mm S3UR and S3U valves were compared at nominal size and during underexpansion. For VIV testing, 23-mm study valves were implanted in 25-mm Epic and 23-mm Mitroflow valves. Redo TAVR involved the implantation of 23-mm study valves in a 26-mm Evolut PRO valve. Hydrodynamic testing assessed mean gradient (MG), geometric orifice area, effective orifice area (EOA), opening index, pinwheeling, and leaflet motion. Histology, light transmission, micrometering, micro-computed tomography, and uniaxial tensile testing compared S3UR and S3U pericardium samples. Leaflet splay area was compared after leaflet modification.
RESULTS: For index TAVR, 26-mm S3U and S3UR valves demonstrated comparable performance. In contrast, the 23-mm S3UR valve showed a lower MG (6.7 mm Hg vs 7.3 mm Hg) and larger EOA, geometric orifice area, and opening index than the 23-mm S3U valve, with MG differences increasing during underexpansion. In VIV, the 23-mm S3UR valve demonstrated systolic leaflet fluttering and hydrodynamics similar to those of S3U. In redo-TAVR, the S3UR showed a slightly lower MG and a marginally larger EOA. By micrometering, S3UR leaflet pericardium was thinner than S3U leaflet pericardium (0.28 ± 0.02 mm vs 0.36 ± 0.03 mm), but S3UR pericardium showed significantly higher tensile strength. S3UR leaflets splayed almost 40% less after modification with a central basal split.
CONCLUSIONS: Commissural changes in smaller S3UR valves and thinner leaflets drive differences in hydrodynamics, leaflet motion, tensile strength, and leaflet splay after leaflet modification. This warrants further study.