使用第二代无线电频率的气球表面温度控制的除热气球:体内可行性研究
Yasutoshi Shinoda1, Hiro Yamasaki1, Nobuyuki Murakoshi1
1Department of Cardiology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.
概括
一个新的第二代射频热气球 (RHB) 系统精确监测气球表面温度 (BST). 使用该系统在60°C的消去会产生用于心房治疗的持久病变,从而提高安全性和疗效.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 电子生理学 电子生理学
背景情况:
- 第一代射频热气球 (RHB) 的有效性和安全性受到限制,原因是能量输出基于中心温度,而不是气球表面温度.
- 开发了第二代RHB,用于监测气球表面温度 (BST) 以进行受控切除.
研究的目的:
- 评估第二代RHB中的新型BST监控系统的准确性.
- 在动物模型中确定最佳的BST以实现有效和安全的切除.
主要方法:
- 协议1:通过将热囊连接到上腔静脉 (SVC) 副心脏,评估BST监测的准确性.
- 协议2:在急性和慢性动物模型中,在各种温度 (51-60°C) 上评估BST控制的消去的疗效和安全性.
- 评估了电生理学和病理学发现,病变持久性和不良事件.
主要成果:
- BST监测显示,与心表温度 (r = 0.98) 有显著的正相关性.
- 在≥57°C的切除过程中,可以实现目标静脉的完全电隔离 (100%).
- 在慢性模型中,在60°C的温度下实现了持久性病变,而在57°C的温度下则导致44%的重新连接. 在60°C的病变显著增加,不增加不良事件.
结论:
- 第二代RHB的BST监控系统是准确的.
- 使用第二代RHB在60°C的BST控制的切除似乎是安全创建持久病变的最佳方法.
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