First in vivo Experiment with PulmValve Endobronchial Valve: Feasibility, Efficiency, and Safety

Introduction: 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. Endoscopic lung volume reduction with endobronchial valves has been widely recognized as a treatment for advanced emphysema and chronic obstructive pulmonary disease. The main challenges include the technical complexity of implanting valves in the upper lobes and the number of valves required. These issues may be addressed by using larger diameter endobronchial valves in the lobar bronchi. The newly developed PulmValve System offers five variants of valves designed to accommodate airways with diameters ranging from 7.0 to 15.0 mm. The system is specifically designed for lobar bronchial implantation, with valve diameters within the range of 10.5-16.5 mm. Our study reports the successful implantation and subsequent removal post-placement of the PulmValve (PV-13) within a short operative time in healthy porcine models. During an 84-day follow-up period, significant atelectasis was induced in the distal lung without evidence of device migration, malfunction, or severe complications.