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JACC. Asia · 2024

Extremely Small 20-mm Versus Standard-Size Balloon-Expandable Transcatheter Heart Valves: Propensity-Matched Analysis From the OCEAN-TAVI Registry.

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Okuno Taishi, Izumo Masaki, Takahiko Kai, Kuwata Shingo, Koga Masashi, Akashi Yoshihiro J, Shirai Shinichi, Watanabe Yusuke, Naganuma Toru, Tada Norio, Yamanaka Futoshi, Noguchi Masahiko, Ueno Hiroshi, Ohno Yohei, Nishina Hidetaka, Takagi Kensuke, Asami Masahiko, Mizutani Kazuki, Yashima Fumiaki, Otsuka Toshiaki, Yamamoto Masanori, Hayashida Kentaro

Аннотация

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. (The OCEAN-TAVI registry [Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation]; UMINID:000020423).

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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