Edward’s SAPIEN 3瓣膜系统在接受经房间隔二尖瓣瓣中瓣置换术的外科手术高危患者中的效应评估:一项中国多中心研究Outcomes of transcatheter transseptal mitral valve-in-valve replacement using Edward's SAPIEN 3 in high surgical risk patients-a multicenter study in China
陈翔,王斌,许翌炜,彭小平,乔帆,梁祥文,韩克,姜小飞,马翔,杨文艺,傅国胜,苏茂龙,王焱
摘要(Abstract):
目的 评估使用瓣中瓣(ViV)技术进行经导管二尖瓣置换术(TMVR)在二尖瓣外科生物瓣膜置换术后发生瓣膜退化且外科手术高危患者中的安全性和有效性。方法 本研究为多中心的回顾性队列研究,连续纳入2021年2月至2022年10月于9家医疗中心,应用Edward’s SAPIEN 3瓣膜系统(Edward’s SAPIEN 3 transcatheter heart valve,Edward’s SAPIEN 3 THV)进行ViVTMVR的患者。研究的主要效应终点为二尖瓣学术研究联盟(MVARC)标准定义的技术成功和手术成功率、死亡率,以及根据纽约心脏病协会(NYHA)心功能分级评估的心功能变化情况。临床随访节点包括术后30 d及6个月。结果 经过评估后共20例在外科生物瓣膜置换术后并发瓣膜退化后接受ViV-TMVR的患者被纳入本研究。入选患者的平均年龄为(73.5±5.5)岁,其中女17例(85.0%),14例(70.0%)患者基线NYHA心功能分级为Ⅲ/Ⅳ级。与基线数据相比,患者术后平均跨瓣压差[(6.75±2.27)mmHg比(13.05±5.05)mmHg,P<0.001]和血流峰速[(2.05±0.36)m/s比(2.58±0.42)m/s,P<0.001]均得到显著改善。经过6个月的临床随访,共有2例(10.0%)患者因心力衰竭再入院,其中1例(5.0%)患者发生死亡,但在术后30 d内未发生任何不良心血管事件。此外,在整个随访期内未出现任何与ViV-TMVR相关的不良事件。因此在本研究中,ViV-TMVR术后即刻的技术成功率为100.0%,总手术成功率可达90.0%。此外,随访6个月后NYHA心功能分级与基线相比得到显著改善(P=0.0004)。结论 经房间隔的ViV-TMVR手术具有高度的技术成功率,并可显著改善此类患者的心功能。这一技术对于外科生物瓣膜置换术后出现瓣膜退化的高危患者而言,可成为一种安全、高效的治疗选择。
关键词(KeyWords): 经导管二尖瓣置换术;瓣中瓣;生物瓣退行性变;高危
基金项目(Foundation):
作者(Author): 陈翔,王斌,许翌炜,彭小平,乔帆,梁祥文,韩克,姜小飞,马翔,杨文艺,傅国胜,苏茂龙,王焱
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