在左侧结构性心脏干预中使用SAFARI 2TM作为工作马线
Ibrahim H Inanc1, Deniz Mutlu2, Kostas Marmagkiolis3
1Kırıkkale Yuksek Ihtisas Hospital, Department of Cardiology, Kırıkkale, Turkey.
概括
在MitraClip和左心房尾闭塞 (LAAO) 程序中,SAFARI 2TM导线是安全有效的. 这项研究在1730名患者中没有发现与导线相关的并发症,支持其在这些干预中使用.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 穿皮治疗技术正在进步,增加了使用MitraClip的左心房尾闭塞 (LAAO) 和透导管 mitra门修复 (TMVR) 的使用.
- 通常用于跨导管大动脉植入 (TAVI) 的SAFARI 2TM导线,也被我们的团队用于MitraClip和LAAO手术.
研究的目的:
- 在MitraClip和LAAO程序中评估SAFARI 2TM导线的安全性和有效性.
- 在这些干预性心脏病应用中分享SAFARI 2TM导线的临床数据.
主要方法:
- 一项回顾性,单臂,多中心研究包括1730名患者 (948名MitraClip,782名LAAO) 在2016年7月至2022年8月期间.
- 在所有程序中,仅使用SAFARI 2TM导线.
主要成果:
- 在LAAO患者中没有观察到与导线相关的并发症,中风,严重出血,心脏手术,肺炎或血管解剖/破裂.
- 在MitraClip患者中,没有发生中风,严重出血,死亡率,心脏手术,肺炎,导线并发症,心周溢血,血管解剖/破裂或栓栓塞.
- 在LAAO小组中,在没有吸管的情况下发现了两个与设备相关的心周溢出.
结论:
- 凭借其预先成形的结构,SAFARI 2TM导线似乎是MitraClip和LAAO程序中的设备交付的可靠和安全选择.
- 建议通过更大的随机或前性试验进行进一步验证,以确认这些发现.
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