在右心房附属体顶部实施无心脏起器:初步临床前评估
Yu-Sheng Lin1, Lung-Sheng Wu2, Wan-Chun Ho1
1Department of Cardiology, Chang Gung Memorial Hospital, Chiayi, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan., Chang Gung Memorial Hospital, Chiayi, Taiwan.
Pacing and clinical electrophysiology : PACE
|May 29, 2024
概括
无心脏起器在植入右心脏附属体时显示出对心房节奏的承诺. 然而,一项临床前研究发现,3个月后心肌深度透,需要重新设计设备以安全长期使用.
科学领域:
- 心血管医学 心血管医学
- 生物医学工程 生物医学工程
- 医疗器械开发 医疗器械开发
背景情况:
- 目前的无心脏起器,如Medtronic Micra,主要设计用于右心室植入,限制了心房节奏的选择.
- 在某些心脏病中,心房节奏是至关重要的,在双室节奏系统中也可能是有益的.
研究的目的:
- 评估在右心房附属体 (RAA) 顶部植入无心脏起器的可行性和有效性.
- 在临床前模型中评估无设备的短期 (1周) 和长期 (3个月) 节奏性能.
- 为了确定在RAA中长期植入的潜在安全问题.
主要方法:
- 在四只小型猪 (45.8 ± 10.0 公斤) 的RAA顶部植入了一个无心脏起器 (Micra Transcatheter Pacing System - TPS).
- 监测了节奏参数,包括R波幅度,节奏值,灵敏度和阻抗.
- 设备性能和心肌相互作用在植入后1周和3个月后进行评估.
主要成果:
- 在所有科目中,成功地将Micra TPS植入RAA顶部.
- 最初的节奏参数是令人满意的,在3个月的时间里,灵敏度,值和阻抗保持稳定.
- 3个月后的组织学检查显示,该装置对心肌进行了深度透.
结论:
- 微型TPS的右心房附属体顶部放置是无心房节奏的可行策略.
- 观察到的深心肌透需要修改设备,以确保长期使用的安全性和有效性.
- 在在双室节奏系统中临床应用之前,需要进一步的研究和设备重新设计.
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