TY - JOUR
T1 - Initial Results of Intra-Annular Self-Expandable Valves
T2 - Insights From the OCEAN-TAVI Registry
AU - OCEAN-TAVI Investigators
AU - Shirai, Shinichi
AU - Yamamoto, Masanori
AU - Yashima, Fumiaki
AU - Hioki, Hirofumi
AU - Ryuzaki, Toshinobu
AU - Morofuji, Toru
AU - Naganuma, Toru
AU - Yamanaka, Futoshi
AU - Mizutani, Kazuki
AU - Noguchi, Masahiko
AU - Ueno, Hiroshi
AU - Takagi, Kensuke
AU - Ohno, Yohei
AU - Izumo, Masaki
AU - Nishina, Hidetaka
AU - Suzuyama, Hiroto
AU - Yamasaki, Kazumasa
AU - Hachinohe, Daisuke
AU - Fuku, Yasushi
AU - Otsuka, Toshiaki
AU - Asami, Masahiko
AU - Watanabe, Yusuke
AU - Hayashida, Kentaro
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/7
Y1 - 2024/7
N2 - Background: Navitor, an intra-annular self-expanding heart valve (IA-SEV), is the third transcatheter heart valve introduced in Japan (in April 2022) as the next generation of the Portico valve ahead of other Asian countries. Objectives: The purpose of this study was to assess the patient–prosthesis mismatch (PPM) after IA-SEV implantation in Asian patients. Methods: All clinical data were collected from the database of an ongoing prospective Japanese multicenter registry (OCEAN-TAVI [Optimised Catheter Valvular Intervention transcatheter aortic valve implantation]). The primary endpoint was the rate of no PPM; the secondary endpoint included the rate of in-hospital mortality and hemodynamics after IA-SEV implantation. Results: A total of 463 patients (median age 86; 69.7% female) were enrolled in the registry. The percentages of implanted valves sized 23 mm, 25 mm, 27 mm, and 29 mm were 26.1% (n = 121), 41.7% (n = 193), 22.9% (n = 106), and 9.3% (n = 43), respectively. The primary endpoint of no PPM was achieved in 91.7% of the entire cohort and in 87.3%, 94.2%, 91.4%, and 93.0% of each valve size. The rate of in-hospital mortality was 1.9%. Postprocedural mean pressure gradient was 8.3 ± 4.3 mm Hg. The overall rate of pacemaker implantation was 9.7%; the incidence of pacemaker rate tended to be reduced when dividing the first and second half of operator experiences (13.0% vs. 8.0%; P = 0.08). Conclusions: The initial results for the IA-SEV were excellent regarding hemodynamics and reduction of paravalvular leakage regardless of valve size. The IA-SEV is a useful transcatheter heart valve, especially for Asian patients with a high prevalence of small annulus.
AB - Background: Navitor, an intra-annular self-expanding heart valve (IA-SEV), is the third transcatheter heart valve introduced in Japan (in April 2022) as the next generation of the Portico valve ahead of other Asian countries. Objectives: The purpose of this study was to assess the patient–prosthesis mismatch (PPM) after IA-SEV implantation in Asian patients. Methods: All clinical data were collected from the database of an ongoing prospective Japanese multicenter registry (OCEAN-TAVI [Optimised Catheter Valvular Intervention transcatheter aortic valve implantation]). The primary endpoint was the rate of no PPM; the secondary endpoint included the rate of in-hospital mortality and hemodynamics after IA-SEV implantation. Results: A total of 463 patients (median age 86; 69.7% female) were enrolled in the registry. The percentages of implanted valves sized 23 mm, 25 mm, 27 mm, and 29 mm were 26.1% (n = 121), 41.7% (n = 193), 22.9% (n = 106), and 9.3% (n = 43), respectively. The primary endpoint of no PPM was achieved in 91.7% of the entire cohort and in 87.3%, 94.2%, 91.4%, and 93.0% of each valve size. The rate of in-hospital mortality was 1.9%. Postprocedural mean pressure gradient was 8.3 ± 4.3 mm Hg. The overall rate of pacemaker implantation was 9.7%; the incidence of pacemaker rate tended to be reduced when dividing the first and second half of operator experiences (13.0% vs. 8.0%; P = 0.08). Conclusions: The initial results for the IA-SEV were excellent regarding hemodynamics and reduction of paravalvular leakage regardless of valve size. The IA-SEV is a useful transcatheter heart valve, especially for Asian patients with a high prevalence of small annulus.
KW - PPM
KW - TAVR
KW - intra-annular
KW - learning curve
KW - self-expandable valve
UR - http://www.scopus.com/inward/record.url?scp=85196400338&partnerID=8YFLogxK
U2 - 10.1016/j.jacasi.2024.04.010
DO - 10.1016/j.jacasi.2024.04.010
M3 - 学術論文
C2 - 39101119
AN - SCOPUS:85196400338
SN - 2772-3747
VL - 4
SP - 536
EP - 544
JO - JACC: Asia
JF - JACC: Asia
IS - 7
ER -