JACC:常规临床实践中可重新定位且可完全取回主动脉瓣的应用

2019-01-08 xiangting MedSci原创

RESPOND研究的1年结局证实了Lotus瓣膜用于常规临床实践的安全性和有效性。

研究人员试图在一个大型国际、多中心前瞻性登记中评估Lotus瓣膜(Boston科技,马尔伯勒,美国马萨诸塞州)的1年临床结局,该登记纳入基于心脏团队共识适合进行经导管主动脉瓣置换术(TAVR)的患者。

TAVR是治疗严重主动脉瓣狭窄的一种安全有效的方法;然而,在不受限制的当代临床实践中,使用可重新定位且可完全取回Lotus瓣膜进行TAVR的数据很少。

RESPOND研究(可重新定位的Lotus瓣膜系统-真实临床结局的上市后评估)招募了1,014名患者;996名患者植入Lotus瓣膜(平均年龄80.8岁,女性50.8%,平均STS评分6.0±6.9%)。主要终点是意向治疗人群30天和1年的全因死亡率。扩展队列包括50名使用包括改良递送系统具有深度防护装置Lotus瓣膜治疗的患者。分别判定死亡率和卒中。由一个独立的中心实验室评估超声心动图数据。

99.9%的Lotus瓣膜治疗患者完成了1年临床随访。1年时,全因死亡率为11.7%,4.1%的患者出现了致残性卒中。永久起搏器植入率为32%(37%为起搏器初次植入患者)。62.6%的患者有可用于中心实验室评估的1年超声心动图数据。94.5%的患者无瓣周渗漏或微量,5.1%为轻度,0.4%为中度。扩展队列的数据证实30天的临床结局良好,永久起搏器植入率为18%(20%为起搏器初次植入患者)。

RESPOND研究的1年结局证实了Lotus瓣膜用于常规临床实践的安全性和有效性。(可重新定位的Lotus瓣膜系统-真实临床结局的上市后评估[RESPOND]; NCT02031302)

原始出处:

Nicolas M. Van Mieghem. Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice The RESPOND Study and RESPOND Extension Cohort. JACC:Cardiovascular Interventions. 14 January 2019.

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    2019-06-02 hbwxf
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    2019-01-08 明月清辉

    谢谢分享,学习了

    0