OBJECTIVES: The purpose of the present study was to investigate whether transfemoral implantation of the balloon-expandable Edwards SAPIEN 3 device without prior balloon valvuloplasty is feasible. BACKGROUND: Transcatheter aortic valve implantation (TAVI) without predilatation may be advantageous and is feasible with various transcatheter heart valves. METHODS: A total of 163 consecutive patients with severe aortic stenosis undergoing transfemoral TAVI were enrolled at two sites. We assessed whether the crossing of the native aortic valve with the prosthesis without prior pre-dilation was feasible and evaluated for procedural success according to VARC-2 criteria. RESULTS: Direct implantation without pre-dilatation was feasible in 154 patients (94.5%), whereas in nine patients predilatation was required due to difficulties while crossing the native aortic valve. Procedural success was achieved in 85.6%. A large proportion of the procedural failures was mainly driven by increased post-procedural gradients ≥20 mm Hg, which almost exclusively concerned the smaller prostheses sizes (23-mm 10/39 (25.6%) vs. 26-mm 5/72 (6.9%) vs. 29-mm 1/52 (1.9%); P < 0.001). Patients in the pre-ballooning group had higher calcium scores of the aortic valve (5,335 [4,421-7,807] vs. 2,893 [1,879-3,993]), more advanced age, higher transvalvular gradients, and smaller aortic valve area. CONCLUSIONS: The transfemoral implantation of the balloon-expandable SAPIEN 3 prosthesis without pre-dilatation is feasible in the majority of cases. In the presence of severe aortic valve calcification and critical aortic stenosis, however, predilatation may still be necessary. Furthermore, the significance of increased post-procedural gradients requires further verification.
OBJECTIVES: The purpose of the present study was to investigate whether transfemoral implantation of the balloon-expandable Edwards SAPIEN 3 device without prior balloon valvuloplasty is feasible. BACKGROUND: Transcatheter aortic valve implantation (TAVI) without predilatation may be advantageous and is feasible with various transcatheter heart valves. METHODS: A total of 163 consecutive patients with severe aortic stenosis undergoing transfemoral TAVI were enrolled at two sites. We assessed whether the crossing of the native aortic valve with the prosthesis without prior pre-dilation was feasible and evaluated for procedural success according to VARC-2 criteria. RESULTS: Direct implantation without pre-dilatation was feasible in 154 patients (94.5%), whereas in nine patients predilatation was required due to difficulties while crossing the native aortic valve. Procedural success was achieved in 85.6%. A large proportion of the procedural failures was mainly driven by increased post-procedural gradients ≥20 mm Hg, which almost exclusively concerned the smaller prostheses sizes (23-mm 10/39 (25.6%) vs. 26-mm 5/72 (6.9%) vs. 29-mm 1/52 (1.9%); P < 0.001). Patients in the pre-ballooning group had higher calcium scores of the aortic valve (5,335 [4,421-7,807] vs. 2,893 [1,879-3,993]), more advanced age, higher transvalvular gradients, and smaller aortic valve area. CONCLUSIONS: The transfemoral implantation of the balloon-expandable SAPIEN 3 prosthesis without pre-dilatation is feasible in the majority of cases. In the presence of severe aortic valve calcification and critical aortic stenosis, however, predilatation may still be necessary. Furthermore, the significance of increased post-procedural gradients requires further verification.
Authors: Won-Keun Kim; Johannes Blumenstein; Christoph Liebetrau; Andreas Rolf; Luise Gaede; Arnaud Van Linden; Mani Arsalan; Mirko Doss; Jan G P Tijssen; Christian W Hamm; Thomas Walther; Helge Möllmann Journal: Clin Res Cardiol Date: 2017-08-09 Impact factor: 5.460
Authors: Matteo Pagnesi; Luca Baldetti; Paolo Del Sole; Antonio Mangieri; Marco B Ancona; Damiano Regazzoli; Nicola Buzzatti; Francesco Giannini; Antonio Colombo; Azeem Latib Journal: Interv Cardiol Date: 2017-09
Authors: Won-Keun Kim; Matthias Renker; Oliver Doerr; Simon Hofmann; Holger Nef; Yeong-Hoon Choi; Christian W Hamm Journal: Clin Res Cardiol Date: 2021-09-02 Impact factor: 5.460
Authors: Christian Butter; Peter Bramlage; Tanja Rudolph; Claudius Jacobshagen; Jürgen Rothe; Hendrik Treede; Sebastian Kerber; Derk Frank; Lenka Seilerova; Gerhard Schymik Journal: BMC Cardiovasc Disord Date: 2016-11-15 Impact factor: 2.298
Authors: Gerhard Schymik; Tanja Rudolph; Claudius Jacobshagen; Jürgen Rothe; Hendrik Treede; Sebastian Kerber; Derk Frank; Lenka Sykorova; Maki Okamoto; Martin Thoenes; Cornelia Deutsch; Peter Bramlage; Christian Butter Journal: Open Heart Date: 2019-10-03