二尖瓣基线瓣口面积与经导管二尖瓣缘对缘修复术的手术及临床结局的关联：来自OCEAN - 二尖瓣注册研究的见解
Association of Baseline Mitral Valve Area With Procedural and Clinical Outcomes of Mitral Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry.
作者信息
Mushiake Kazunori, Kubo Shunsuke, Ono Sachiyo, Maruo Takeshi, Nishiura Naoki, Osakada Kohei, Kadota Kazushige, Yamamoto Masanori, Saji Mike, Asami Masahiko, Enta Yusuke, Nakashima Masaki, Shirai Shinichi, Izumo Masaki, Mizuno Shingo, Watanabe Yusuke, Amaki Makoto, Kodama Kazuhisa, Yamaguchi Junichi, Izumi Yuki, Naganuma Toru, Bota Hiroki, Ohno Yohei, Yamawaki Masahiro, Ueno Hiroshi, Mizutani Kazuki, Otsuka Toshiaki, Hayashida Kentaro
机构信息
Department of Cardiology, Kurashiki Central Hospital, Japan (K. Mushiake, S.K., S.O., T.M., N.N., K.O., K. Kadota).
Department of Cardiology, Toyohashi Heart Center, Japan (M. Yamamoto).
出版信息
Circ Cardiovasc Interv. 2024 Dec;17(12):e014420. doi: 10.1161/CIRCINTERVENTIONS.124.014420. Epub 2024 Dec 17.
BACKGROUND
A small mitral valve area (MVA) is one of the challenging anatomies for transcatheter edge-to-edge repair (TEER) for mitral regurgitation, but the relationship between baseline MVA and clinical outcomes remains unknown. This study aimed to evaluate the association of baseline MVA with procedural and clinical outcomes in patients undergoing TEER with MitraClip from the OCEAN-Mitral registry (Optimized Catheter Valvular Intervention-Mitral).
METHODS
A total of 1768 patients undergoing TEER were divided into 3 groups according to baseline MVA: group 1: <4.0 cm, n=358; group 2: 4.0-5.0 cm, n=493; and group 3: ≥5.0 cm, n=917. The primary end point was a composite of all-cause death and heart failure hospitalization within 2 years of TEER and compared between the 3 groups.
RESULTS
Patients with smaller MVA had significantly fewer clips implanted and higher postprocedural transmitral mean pressure gradient. There was no significant difference in the acute procedural success rate and postprocedural mitral regurgitation severity between the 3 groups. The incidence of the primary end point was similar in group 1 compared with groups 2 and 3 (35.2% versus 34.5% versus 34.0%; =0.96) and was also similar in patients with MVA <3.5 cm and those with MVA 3.5 to 4.0 cm. The adjusted risk of MVA <4.0 cm relative to MVA of 4.0 to 5.0 cm and MVA ≥5 cm for the primary end point remained insignificant (hazard ratio, 1.06 [95% CI, 0.79-1.41]; =0.68; hazard ratio, 0.99 [95% CI, 0.75-1.31]; =0.96, respectively). At 1 year, no significant difference in the proportion of residual mitral regurgitation 3+/4+ was observed between the 3 groups (7.2% versus 4.4% versus 6.5%; =0.49).
CONCLUSIONS
In patients undergoing TEER, a small MVA <4.0 cm may limit the number of clips implanted and increase the transmitral pressure gradient after TEER, but baseline MVA was not associated with mitral regurgitation reduction and clinical outcomes.
REGISTRATION
URL: https://center6.umin.ac.jp/cgiope n-bin/ctr/ctr_view.cgi?recptno=R000027188; Unique identifier: UMIN000023653.
背景
二尖瓣面积（MVA）较小是经导管缘对缘修复术（TEER）治疗二尖瓣反流具有挑战性的解剖结构之一，但基线MVA与临床结局之间的关系尚不清楚。本研究旨在评估来自OCEAN - 二尖瓣注册研究（优化导管瓣膜干预 - 二尖瓣）中接受MitraClip TEER治疗患者的基线MVA与手术及临床结局之间的关联。
方法
总共1768例接受TEER治疗的患者根据基线MVA分为3组：第1组：<4.0 cm²，n = 358；第2组：4.0 - 5.0 cm²，n = 493；第3组：≥5.0 cm²，n = 917。主要终点是TEER术后2年内全因死亡和心力衰竭住院的复合终点，并在3组之间进行比较。
结果
MVA较小的患者植入的夹子明显较少，术后经二尖瓣平均压力梯度较高。3组之间急性手术成功率和术后二尖瓣反流严重程度无显著差异。第1组的主要终点发生率与第2组和第3组相似（35.2%对34.5%对34.0%；P = 0.96），MVA <3.5 cm的患者和MVA为3.5至4.0 cm的患者之间也相似。相对于MVA为4.0至5.0 cm和MVA≥5 cm，MVA <4.0 cm的主要终点调整风险仍然不显著（风险比，1.06 [95% CI，0.79 - 1.41]；P = 0.68；风险比，0.99 [95% CI，0.75 - 1.31]；P = 0.96，分别）。1年时，3组之间残余二尖瓣反流3+/4+比例无显著差异（7.2%对4.4%对6.5%；P = 0.49）。
结论
在接受TEER治疗的患者中，MVA <4.0 cm较小可能会限制植入夹子的数量，并增加TEER术后的经二尖瓣压力梯度，但基线MVA与二尖瓣反流减少和临床结局无关。
注册信息
网址：https://center6.umin.ac.jp/cgiope n-bin/ctr/ctr_view.cgi?recptno=R000027188；唯一标识符：UMIN000023653。
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