首次在人体临床植入和急性节奏表现的新型子体心脏起器系统的临床植入
Imad Libbus1,2, Venkatakrishna Tholakanahalli3, Henri Roukoz3
1Calyan Technologies, Saint Paul, MN, USA. imad@calyantech.com.
概括
一种新型的外血管起器通过子xiphoidal 方法通过心上传递,在第一次在人体研究中显示可行性. 在设备修改后,在大多数患者中成功实现了心室捕获,没有任何不良事件.
科学领域:
- 心脏病学 心脏病学
- 生物医学工程 生物医学工程
- 医疗器械 医疗器械
背景情况:
- 血管内心脏起器是标准用于心.
- 无心脏起器可以减少与有关的并发症.
- 这项研究探讨了一种新的血管外表心脏节奏技术.
研究的目的:
- 评估新型外血管心脏节拍系统的可行性和初始性能.
- 评估用于传递心表节奏的子体方法.
- 为了确定心室传感和节奏捕捉值.
主要方法:
- 招募了15名接受开放心脏手术的患者.
- 用 subxiphoidal 切口和subternal 道来放置设备.
- 一个心表电极被放置在前右心室上.
主要成果:
- 在所有15名患者中成功植入,没有任何不良事件.
- 最初的步调捕捉问题通过设备设计修改得到解决.
- 90%的后续患者在可接受的值 (3.8 ± 1.6 mA在0.5 ms脉冲宽度) 中实现了心室捕获.
结论:
- 这种新型的外血管起器是可行的心周心室节奏通过一个subxiphoidal方法.
- 这项首次在人身上进行的研究表明了无节奏替代品的潜力.
- 需要进一步的慢性研究来确认安全性和长期性能.
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