新型尺寸可调肺 美国早期可行性研究:一年的结果
Mark E Galantowicz1, Corey A Stiver2, Oliver M Barry3
1Department of Cardiothoracic Surgery, Nationwide Children's Hospital, The Ohio State University, Columbus, Ohio.
The Journal of thoracic and cardiovascular surgery
|August 2, 2025
概括
新的Autus大小调节 (ASAV) 显示了儿科肺置换的可行性和安全性. 这项早期可行性研究在一年内没有发现与设备相关的不良事件.
科学领域:
- 心血管外科心血管外科
- 儿童心脏病学 儿童心脏病学
- 生物医学工程 生物医学工程
背景情况:
- 肺置换对于患有先天性心脏病的儿科患者至关重要.
- 目前的假体门在适应生长方面存在局限性,需要重新操作.
- 奥图斯尺寸调节式门 (ASAV) 是一种新的,全合成的,可扩展的门,专为儿科使用而设计.
研究的目的:
- 评估ASAV在需要肺置换的儿科患者的初始可行性和安全性.
- 通过一年的随访来评估ASAV的初步有效性.
主要方法:
- 一个前性的,单臂的,多中心的调查设备豁免早期可行性研究.
- 11名儿科患者 (年龄为1.5-16岁) 接受了ASAV植入.
- 术前和术后的心声回声被用于评估;报告了一年的结果.
主要成果:
- 在所有11名受试者中,在植入器上成功调整了ASAV的大小.
- 在研究队列中没有观察到死亡率或与设备相关的不良事件.
- 一年后,90.9%的受试者没有肺吐,平均RV-PA压力梯度为16±6mmHg.
结论:
- 一年的结果表明,ASAV的完整的门功能和出色的安全概况.
- 新的ASAV显示了作为儿科肺置换的可行选择的潜力.
- 目前,ASAV正在一个关键的调查设备豁免研究中进行评估.
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