早期一代无畏的跨吸管跨导管中枢替换系统的五年结果
Gilbert H L Tang1, Vivek Rajagopal2, Paul Sorajja3
1Mount Sinai Health System, New York, NY, USA.
概括
透导管 mitra 置换 (TMVR) 显示在高风险的患者与 mitra 吐 (MR) 持久的 5 年的结果. 英特雷皮德系统维持了门功能并改善了患者的状态,这表明TMVR.
科学领域:
- 心血管医学 心血管医学
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 透导管 mitra 置换 (TMVR) 是一种新兴的选择,用于严重的 mitra 吐 (MR) 在不符合手术条件的患者.
- 目前,TMVR的长期耐用性和性能数据有限.
- 无畏的跨吸管 (TA) TMVR系统代表了这个患者群体的早期一代设备.
研究的目的:
- 评估Intrepid TA TMVR系统的5年临床和血液动力学结果.
- 评估TMVR在患有症状严重MR的高风险患者的安全性和有效性.
- 提供TMVR后的门性能和患者功能状态的长期数据.
主要方法:
- 一项多中心,单臂研究 (试点研究NCT02322840) 招募了95名具有症状严重MR的高风险患者.
- 患者接受了早期一代的Intrepid TA TMVR系统.
- 临床事件和心声回声图被判定,随访延长至5年.
主要成果:
- 在5年后,100%的患者有轻度或较小的MR,没有副膜泄漏.
- 中位MV平均梯度保持稳定 (3.6 mmHg),表明持续的血液动力学性能.
- 84.6%的幸存者保持了NYHA I/II类功能状态,尽管死亡率高 (66.7%) 和心力衰竭住院 (55.4%).
结论:
- 在Intrepid TA TMVR系统的5年随访中,证明了MR的持续减少,持久的膜血液动力学,以及幸存者的功能状况的改善.
- 早期一代的Intrepid TA系统的TMVR显示了对选择高风险MR患者的有希望的长期结果.
- 未来的转系统试验 (APOLLO,APOLLO-EU) 将进一步确定TMVR在管理这一具有挑战性的患者群体中的作用.
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