肺静脉隔离或老年患有持续心房的老年患者的节奏和切除 (ABLATE与PACE) - 理由,方法和设计
Andreas A Boehmer1, Bernhard M Kaess1, Christian Ruckes2
1St Josefs-Hospital, Wiesbaden, Germany.
The Canadian journal of cardiology
|July 27, 2024
概括
在老年患有持续性心房的患者中,心脏起器植入与心房节除提供了比肺静脉隔离更好的症状控制. 这种方法旨在改善生活质量,而不会增加不良事件.
科学领域:
- 心脏病学 心脏病学
- 电子生理学 电子生理学
- 老年医学 老年医学
背景情况:
- 年龄是心房动 (AF) 的重要危险因素,导致经常住院治疗.
- 肺静脉隔离 (PVI) 经常被考虑用于老年患者的节律控制,但其有效性在持续性AF中有限.
- 带有心房结节 (AVN) 切除的心脏起器植入为这种人口群体的症状管理和生活质量改善提供了潜在的替代方案.
研究的目的:
- 测试这样的假设,心脏起器植入与AVN切除提供优越的症状控制与PVI相比,在老年患者有症状的持续性AF.
- 评估这种优越的症状控制是否可以在不增加不良事件风险的情况下实现.
主要方法:
- 一个前性的,开放的,随机的,多中心优越性试验 (ABLATE Versus PACE) 涉及196名老年患者 (≥75岁) 具有症状持久性AF和正常射出分数.
- 患者被随机分配到冷热气球PVI (ABLATE) 或双腔心脏起器植入与AVN切除 (PACE).
- 随访时间至少为12个月,评估综合初级疗效终点和各种二级终点,包括死亡率,中风和生活质量.
主要成果:
- 这项研究旨在确定主要的疗效结局,即因心房律乱或心力衰竭而重新住院的复合物,电动心脏转换或CRT升级.
- 二次结果包括全因死亡率,中风,生活质量评估和与程序相关的并发症.
- 样本大小计算为提供80%的功率来检测主要终点的显著差异.
结论:
- 该ABLATE Versus PACE试验将提供关键证据,以比较心脏起器植入与AVN切除与PVI的相对有效性和安全性,以管理老年人症状持久性AF.
- 结果将指导治疗决策,以改善这种脆弱患者群体的症状控制和生活质量.
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