Hiromu Hase1, Nobuhiro Yoshijima1, Ryo Yanagisawa1, Makoto Tanaka1, Hikaru Tsuruta1, Hideyuki Shimizu2, Keiichi Fukuda1, Toru Naganuma3, Kazuki Mizutani4, Masahiro Yamawaki5, Norio Tada6, Futoshi Yamanaka7, Shinichi Shirai8, Minoru Tabata9, Hiroshi Ueno10, Kensuke Takagi11, Yusuke Watanabe12, Masanori Yamamoto13,14, Kentaro Hayashida1. 1. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. 2. Department of Cardiovascular Surgery, Keio University School of Medicine, Tokyo, Japan. 3. New Tokyo Hospital, Matsudo, Japan. 4. Department of Cardiology, Osaka City General Hospital, Osaka, Japan. 5. Saiseikai Yokohama-City Eastern Hospital, Tsurumi, Japan. 6. Sendai Kousei Hospital, Sendai, Japan. 7. Shonan Kamakura General Hospital, Kamakura, Japan. 8. Kokura Memorial Hospital, Kokura, Japan. 9. Department of Cardiovascular Surgery, Tokyo Bay Urayasu-Ichikawa Medical Center, Chiba, Japan. 10. Toyama University Hospital, Toyama, Japan. 11. Ogaki Municipal Hospital, Gifu, Japan. 12. Teikyo University School of Medicine, Tokyo, Japan. 13. Toyohashi Heart Center, Toyohashi, Japan. 14. Nagoya Heart Center, Nagoya, Japan.
Abstract
OBJECTIVES: To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. BACKGROUND: Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. METHODS: In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. RESULTS: The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm2 /m2 , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81). CONCLUSIONS: TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups.
OBJECTIVES: To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. BACKGROUND: Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. METHODS: In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. RESULTS: The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm2 /m2 , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81). CONCLUSIONS: TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups.
Authors: Jerome Ferrara; Alexis Theron; Alizee Porto; Pierre Morera; Paul Luporsi; Nicolas Jaussaud; Vlad Gariboldi; Frederic Collart; Thomas Cuisset; Pierre Deharo Journal: J Clin Med Date: 2022-04-01 Impact factor: 4.241
Authors: Pier Pasquale Leone; Fabio Fazzari; Francesco Cannata; Jorge Sanz-Sanchez; Antonio Mangieri; Lorenzo Monti; Ottavia Cozzi; Giulio Giuseppe Stefanini; Renato Bragato; Antonio Colombo; Bernhard Reimers; Damiano Regazzoli Journal: Front Cardiovasc Med Date: 2021-06-04