OBJECTIVES: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.25-0.5) were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. RESULTS: Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS: Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R.
OBJECTIVES: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.25-0.5) were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. RESULTS: Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS: Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R.
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Authors: Sung-Han Yoon; Sabine Bleiziffer; Ole De Backer; Victoria Delgado; Takahide Arai; Johannes Ziegelmueller; Marco Barbanti; Rahul Sharma; Gidon Y Perlman; Omar K Khalique; Erik W Holy; Smriti Saraf; Florian Deuschl; Buntaro Fujita; Philipp Ruile; Franz-Josef Neumann; Gregor Pache; Masao Takahashi; Hidehiro Kaneko; Tobias Schmidt; Yohei Ohno; Niklas Schofer; William K F Kong; Edgar Tay; Daisuke Sugiyama; Hiroyuki Kawamori; Yoshio Maeno; Yigal Abramowitz; Tarun Chakravarty; Mamoo Nakamura; Shingo Kuwata; Gerald Yong; Hsien-Li Kao; Michael Lee; Hyo-Soo Kim; Thomas Modine; S Chiu Wong; Francesco Bedgoni; Luca Testa; Emmanuel Teiger; Christian Butter; Stephan M Ensminger; Ulrich Schaefer; Danny Dvir; Philipp Blanke; Jonathon Leipsic; Fabian Nietlispach; Mohamed Abdel-Wahab; Bernard Chevalier; Corrado Tamburino; David Hildick-Smith; Brian K Whisenant; Seung-Jung Park; Antonio Colombo; Azeem Latib; Susheel K Kodali; Jeroen J Bax; Lars Søndergaard; John G Webb; Thierry Lefèvre; Martin B Leon; Raj Makkar Journal: J Am Coll Cardiol Date: 2017-03-18 Impact factor: 24.094
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Authors: Ahmed Elkoumy; John Jose; Christian J Terkelsen; Henrik Nissen; Sengottuvelu Gunasekaran; Mahmoud Abdelshafy; Ashok Seth; Hesham Elzomor; Sreenivas Kumar; Francesco Bedogni; Alfonso Ielasi; Santosh K Dora; Sharad Chandra; Keyur Parikh; Daniel Unic; William Wijns; Andreas Baumbach; Darren Mylotte; Patrick Serruys; Osama Soliman Journal: J Clin Med Date: 2022-01-15 Impact factor: 4.241