心力衰竭和减小喷射率的患者的巴罗反射激活疗法:长期结果
Michael R Zile1, JoAnn Lindenfeld2, Fred A Weaver3
1Medical University of South Carolina, Charleston, South Carolina and the Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.
European journal of heart failure
|April 12, 2024
概括
在心脏衰竭与减少喷射率 (HFrEF) 的患者中,心血管死亡率或心力衰竭事件没有显著降低. 然而,BAT证明了对生活质量和功能状况的持久改善.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 心脏衰竭管理的管理
背景情况:
- Carotid baroreflex激活疗法 (BAT) 在心力衰竭中调节自主功能,减少喷射分数 (HFrEF).
- 之前的研究表明,BAT可以恢复巴罗反射灵敏度并改善心脏自主平衡.
研究的目的:
- 评估BAT在降低HFrEF患者心血管死亡率和心力衰竭发病率方面的有效性.
- 用BAT评估症状改善的长期安全性和可持续性.
主要方法:
- BeAT-HF试验是一项前性,多中心,随机,受控的研究.
- 323名HFrEF患者被随机分配到BAT加最佳医疗管理或单独最佳医疗管理.
- 主要终点:心血管死亡率和心力衰竭发病率;次要终点包括生活质量,运动能力和功能状态.
主要成果:
- 主要终点在BAT和对照组之间没有显著差异 (率比为0.94,p=0.82).
- 最佳技术与生活质量的持久和可持续的改善有关,走廊距离6分钟,NYHA类 (所有名义p<0.001).
- 安全性概况是有利的,与设备和程序相关的重大不良事件的自由率为97%.
结论:
- BeAT-HF试验的主要终点是中性的,这表明死亡率或主要发病率没有显著降低.
- BAT治疗是安全的,并为HFrEF患者的功能状态,运动能力和生活质量提供可持续的改善.
- 虽然在统计学上不显著,但趋势有利于复合胜率和免于死亡,LVAD或移植的BAT.
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