TY - JOUR
T1 - Extremely Small 20-mm Versus Standard-Size Balloon-Expandable Transcatheter Heart Valves
T2 - Propensity-Matched Analysis From the OCEAN-TAVI Registry
AU - Okuno, Taishi
AU - Izumo, Masaki
AU - Takahiko, Kai
AU - Kuwata, Shingo
AU - Koga, Masashi
AU - Akashi, Yoshihiro J.
AU - Shirai, Shinichi
AU - Watanabe, Yusuke
AU - Naganuma, Toru
AU - Tada, Norio
AU - Yamanaka, Futoshi
AU - Noguchi, Masahiko
AU - Ueno, Hiroshi
AU - Ohno, Yohei
AU - Nishina, Hidetaka
AU - Takagi, Kensuke
AU - Asami, Masahiko
AU - Mizutani, Kazuki
AU - Yashima, Fumiaki
AU - Otsuka, Toshiaki
AU - Yamamoto, Masanori
AU - Hayashida, Kentaro
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/2
Y1 - 2025/2
N2 - Background: The 20-mm balloon-expandable transcatheter heart valve (THV) represents the smallest available option for transcatheter aortic valve replacement (TAVR). Its current underutilization stems from concerns regarding prosthesis-patient mismatch, durability, and potential adverse outcomes. Objectives: The purpose of this study was to compare the long-term outcomes between the 20-mm balloon-expandable THVs and standard-size balloon-expandable THVs. Methods: Patients who underwent transfemoral TAVR with SAPIEN THVs were sourced from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention) registry, an ongoing, multicenter cohort study that has enrolled over 7,000 TAVR patients in Japan. A 1:3 propensity-matched analysis, based on 24 baseline clinical and echocardiographic variables, was used to contrast the 20-mm with >20-mm balloon-expandable THVs. Results: Of 5,086 eligible patients, 284 (5.6%) received the 20-mm balloon-expandable THV. After propensity-matching, the 20-mm THV group (n = 276) and the >20-mm THV group (n = 828) demonstrated balanced baseline characteristics, with an absolute standardized difference <0.10. The average follow-up duration for patients who were alive was 955 ± 512 days, and the average time to death was 584 ± 543 days. The 20-mm group showed a higher frequency of prosthesis-patient mismatch (PPM) (moderate PPM: 29.2% vs 10.8%; severe PPM: 4.9% vs 1.5%; P < 0.001). Over a 5-year period, all-cause mortality and heart failure rehospitalization rates were comparable between the 2 groups (all-cause mortality: 34.2% vs 38.0%; HR: 1.01; 95% CI: 0.74-1.37; P = 0.970; heart failure rehospitalization: 15.2% vs 16.3%; HR: 0.81; 95% CI: 0.50-1.29; P = 0.371). Conclusions: This registry-based study suggests that the initially observed inferior forward hemodynamics associated with the 20-mm THV do not translate into heightened long-term mortality or heart failure rehospitalization risks.
AB - Background: The 20-mm balloon-expandable transcatheter heart valve (THV) represents the smallest available option for transcatheter aortic valve replacement (TAVR). Its current underutilization stems from concerns regarding prosthesis-patient mismatch, durability, and potential adverse outcomes. Objectives: The purpose of this study was to compare the long-term outcomes between the 20-mm balloon-expandable THVs and standard-size balloon-expandable THVs. Methods: Patients who underwent transfemoral TAVR with SAPIEN THVs were sourced from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention) registry, an ongoing, multicenter cohort study that has enrolled over 7,000 TAVR patients in Japan. A 1:3 propensity-matched analysis, based on 24 baseline clinical and echocardiographic variables, was used to contrast the 20-mm with >20-mm balloon-expandable THVs. Results: Of 5,086 eligible patients, 284 (5.6%) received the 20-mm balloon-expandable THV. After propensity-matching, the 20-mm THV group (n = 276) and the >20-mm THV group (n = 828) demonstrated balanced baseline characteristics, with an absolute standardized difference <0.10. The average follow-up duration for patients who were alive was 955 ± 512 days, and the average time to death was 584 ± 543 days. The 20-mm group showed a higher frequency of prosthesis-patient mismatch (PPM) (moderate PPM: 29.2% vs 10.8%; severe PPM: 4.9% vs 1.5%; P < 0.001). Over a 5-year period, all-cause mortality and heart failure rehospitalization rates were comparable between the 2 groups (all-cause mortality: 34.2% vs 38.0%; HR: 1.01; 95% CI: 0.74-1.37; P = 0.970; heart failure rehospitalization: 15.2% vs 16.3%; HR: 0.81; 95% CI: 0.50-1.29; P = 0.371). Conclusions: This registry-based study suggests that the initially observed inferior forward hemodynamics associated with the 20-mm THV do not translate into heightened long-term mortality or heart failure rehospitalization risks.
KW - aortic valve stenosis
KW - paravalvular regurgitation
KW - prosthesis-patient mismatch
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85210544391&partnerID=8YFLogxK
U2 - 10.1016/j.jacasi.2024.09.005
DO - 10.1016/j.jacasi.2024.09.005
M3 - 学術論文
C2 - 39967214
AN - SCOPUS:85210544391
SN - 2772-3747
VL - 5
SP - 245
EP - 254
JO - JACC: Asia
JF - JACC: Asia
IS - 2
ER -