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阜外医院吴永健等点评PARTNER 3试验:中国所有主动脉瓣狭窄患者都能不开胸换瓣的时代到来了吗?

2019-08-01 卢芳 中国循环杂志

ACC2019上,PARTNER 3试验一炮重击,有力支持经导管主动脉瓣置换术(TAVR)向外科主动脉瓣置换术(SAVR)低危患者过渡。

ACC2019上,PARTNER 3试验一炮重击,有力支持经导管主动脉瓣置换术(TAVR)向外科主动脉瓣置换术(SAVR)低危患者过渡。

这对不开胸换瓣治疗的发展和中国主动脉瓣狭窄患者的治疗有何影响?

阜外医院吴永健、王媛在本刊发表述评指出,PARTNER 系列研究为中国开展 TAVR 相关临床研究提供了很好借鉴参考;对于中国外科中低危患者的不开胸换瓣治疗,由于严重钙化和高二叶瓣发生率,挑战重重,需要审慎,但未来可期。

PARTNER 3对中国患者的参考有限制

中国的不开胸换瓣治疗历经近10年的发展,已积累了较为丰富且具有中国患者针对性的治疗经验,但发展速度较国际缓慢。

中国已有的相关研究证实,对于外科高危患者,不开胸换瓣获益比肩外科,安全有效。PARTNER 3试验的优异结果也为进一步开展低危患者研究注入一剂强心针。

现阶段,中国采用 Sapien 3 瓣膜的临床研究仅受限于外科高危患者,PARTNER 3 试验结果预示调整国内研究计划至低危患者的可能。

但中国患者瓣叶瓣环钙化重、二叶式主动脉瓣占比高、入路血管并发症较重的特征及 PARTNER 3 试验的局限性,一定程度限制了其结论对中国患者的可参考性。

PARTNER 3 试验排除了二叶式主动脉瓣患者、髂股动脉入路禁忌患者及心功能较差(左心室射血分数 <30%)患者,上述局限性也为中国开展相关补充研究提供了启发。

据介绍,中国医学科学院阜外医院已开展针对外科中危二叶瓣患者的随机对照研究。

TAVR 治疗未来的热点

PARTNER 3 试验(球囊扩张式瓣膜)携手同期公布的 EVOLUTE Low-risk 研究(自膨胀式瓣膜),开辟了不开胸换瓣迈入治疗外科低危人群的时代。

吴永健等认为,下一个临床研究热点很可能为中低危患者的头对头比较(球囊扩张式瓣膜 vs 自膨胀式瓣膜)和瓣膜耐久性问题探究。

一则低危患者中低龄患者更为常见,预期寿命更长,对植入瓣膜的使用时长要求更高。另外,虽然介入置入瓣膜与外科生物瓣膜结构相似,但介入置入瓣膜具有原瓣叶存续、体外蜷缩状态等特征,因此介入置入瓣膜的耐久性引人关注。

瓣膜衰退相关的亚临床血栓问题,对于外科低危患者而言为信息灰色地带,PARTNER 3 试验的研究者全面考虑到 CT 评估介入置入瓣叶动度等情况,期待后续研究结果的公布弥补该热点问题的空白。

总之,对于 TAVR 瓣膜衰败的预防性及治疗性探索从未止步,抗钙化及祛除抗原性瓣膜的研发、抗栓治疗方案的修正与优化、维生素 K 拮抗剂治疗亚临床血栓、“瓣中瓣”或“瓣中瓣中瓣”治疗人工生物瓣衰败等,均旨在为适应证扩宽至低危患者保驾护航。

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    2019-08-29 amyloid
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    2019-08-03 zhaojie88
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