Oba Yusuke, Kumamaru Hiraku, Hoshide Satoshi, Kohsaka Shun, Shimamura Kazuo, Ohno Yohei, Sato Masafumi, Kobayashi Hisaya, Funayama Hiroshi, Harada Kenji, Kawahito Koji, Kario Kazuomi
Division of Cardiovascular Medicine, Department of Internal Medicine (Y. Oba, S.H., M.S., H. Kobayashi, H.F., K.H., K. Kario), Jichi Medical University School of Medicine, Tochigi, Japan.
Department of Health Data Science, Graduate School of Data Science, Yokohama City University, Japan (H. Kumamaru).
Circ Cardiovasc Interv. 2025 Jul;18(7):e015087. doi: 10.1161/CIRCINTERVENTIONS.124.015087. Epub 2025 May 20.
BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) provides an alternative treatment for high-risk patients with failed surgical bioprosthetic aortic valves. However, limited data exist on ViV-TAVR outcomes in patients with small aortic annuli, particularly among the relatively small-statured Japanese population. METHODS: We analyzed data from the J-TVT (Japan Transcatheter Valve Therapy) registry, which included all TAVR institutions across Japan, with data collected from July 2018, when ViV-TAVR was approved, through December 2022. A small aortic annulus was defined as an aortic annulus area of ≤314 mm², measured using preoperative computed tomography for ViV-TAVR. Prosthesis-patient mismatch (PPM) was defined as an indexed effective orifice area <0.85 cm²/m², assessed using echocardiography within 30 days after ViV-TAVR. The composite end point was evaluated at 30 days and 1 year. RESULTS: Among 47 800 individuals, 1029 underwent ViV-TAVR, resulting in a final sample of 405 patients. The mean indexed effective orifice area was 0.83 cm²/m² in the small annulus group (n=225) and 0.94 cm²/m² in the nonsmall group (n=180), with PPM rates of 59.2% and 44.4%, respectively. Small annuli were independently associated with PPM (odds ratio, 1.9 [95% CI, 1.26-2.87]; =0.002). No differences in 30-day and 1-year outcomes were observed between groups. Among the 225 patients with small annuli, the mean indexed effective orifice area was 0.76 cm/m in the balloon-expandable valve group (n=61) and 0.86 cm/m in the supraannular self-expanding valve group (n=164), with PPM rates of 67.2% and 56.1%, respectively. No differences in outcomes were noted based on the type of valve implanted. CONCLUSIONS: ViV-TAVR for small aortic annuli in Japanese patients was associated with an increased risk of PPM; however, no differences in clinical outcomes were observed according to aortic annulus size or valve type. Due to the small size of our sample, further research is required to validate these findings.
背景：瓣中瓣经导管主动脉瓣置换术（ViV-TAVR）为外科生物人工主动脉瓣功能衰竭的高危患者提供了一种替代治疗方法。然而，关于小主动脉瓣环患者的ViV-TAVR结局的数据有限，尤其是在身材相对矮小的日本人群中。 方法：我们分析了日本经导管瓣膜治疗（J-TVT）注册研究的数据，该研究纳入了日本所有的TAVR机构，数据收集时间为2018年7月（ViV-TAVR获批时间）至2022年12月。小主动脉瓣环定义为使用ViV-TAVR术前计算机断层扫描测量的主动脉瓣环面积≤314 mm²。人工瓣膜-患者不匹配（PPM）定义为经胸超声心动图在ViV-TAVR术后30天内评估的指数化有效瓣口面积<(0.85 cm²/m²)。在30天和1年时评估复合终点。 结果：在47800例个体中，1029例接受了ViV-TAVR，最终样本为405例患者。小瓣环组（(n = 225)）的平均指数化有效瓣口面积为(0.83 cm²/m²)，非小瓣环组（(n = 180)）为(0.94 cm²/m²)，PPM发生率分别为59.2%和44.4%。小瓣环与PPM独立相关（优势比，1.9 [95% CI，1.26 - 2.87]；(P = 0.002)）。两组间在30天和1年结局方面未观察到差异。在225例小瓣环患者中，球囊扩张瓣膜组（(n = 61)）的平均指数化有效瓣口面积为(0.76 cm²/m²)，瓣上自膨式瓣膜组（(n = 164)）为(0.86 cm²/m²)，PPM发生率分别为67.2%和56.1%。根据植入瓣膜类型，结局未见差异。 结论：日本患者小主动脉瓣环的ViV-TAVR与PPM风险增加相关；然而，根据主动脉瓣环大小或瓣膜类型，临床结局未见差异。由于我们的样本量较小，需要进一步研究来验证这些发现。
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