背景:经内镜支气管瓣肺减容术治疗晚期慢性阻塞性肺疾病和肺气肿患者的过度充气已被广泛认可。主要挑战包括上叶植入的技术复杂性和所需的支气管内瓣膜的数量。这些问题可以通过在大叶支气管中放置较大直径的瓣膜来解决。这项研究评估了可行性,效率,猪模型中新型阀门PulmValve(PV-13型)的安全性。
方法:将6个PV-13瓣膜经支气管镜植入6只健康猪的尾叶支气管中。手术时间,瓣膜展开,并记录可移除性。后续检查包括血液检查,胸部CT扫描,和支气管镜检查在30分钟,14天,28天,手术后84天,在最后的随访检查后进行尸检和病理评估。
结果:成功地在体内部署和移除PV-13瓣膜,中位手术时间为6.5分钟。远端肺体积减少在术后30分钟明显,并在第84天持续监测。未检测到任何PV-13阀门的迁移或故障,但3例出现轻度角度偏差。在前7天内在四只猪中观察到咳嗽,并且在所有猪中观察到局部肉芽组织。无气胸病例,弥漫性肺炎,或咯血被检测到。
结论:在这项研究中,我们报告了在较短的手术时间内成功植入和移除新瓣膜PulmValve。引起完全的肺叶不张,没有装置迁移,故障,或严重的并发症。需要进一步的研究来评估长期的,对人类患者的持续影响和潜在益处。
BACKGROUND: Endoscopic lung volume reduction with endobronchial valves has been widely recognized for treating hyperinflation in advanced chronic obstructive pulmonary disease and emphysema patients. The main challenges include the technical complexity of upper lobe implantation and the number of endobronchial valves required. These issues might be addressed by placing larger diameter valves in the lobar bronchus. This study evaluated the feasibility, efficiency, and safety of the new valve PulmValve (model PV-13) in porcine models.
METHODS: Six PV-13 valves were bronchoscopically implanted into the caudal lobe bronchus of six healthy pigs. The procedure time, valve deployment, and removability were recorded. Follow-up examinations included blood tests, chest CT scans, and bronchoscopy at 30 min, 14 days, 28 days, and 84 days post-procedure, with necropsy and pathological evaluations after the final follow-up examination.
RESULTS: The successful in vivo deployment and removal of PV-13 valves was established, with a median procedure time of 6.5 min. The distal lung volume reduction was evident at 30 min post-operation and was persistently monitored on day 84. No migration or malfunction of any PV-13 valves was detected, but a mild angle deviation was found in 3 cases. Coughing was observed in four pigs within the first 7 days and localized granulation tissue was observed in all pigs. No cases of pneumothorax, diffuse pneumonia, or hemoptysis were detected.
CONCLUSIONS: In this study, we report the successful implantation and removal of a new valve PulmValve in a short operation time. Complete lobar atelectasis was induced without device migration, malfunction, or severe complications. Further studies are warranted to evaluate the long-term, sustained effects and potential benefits in human patients.