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Novel Endobronchial Silicone Valve for Treating Lung Emphysema: A Preclinical Trial and First-In-Human Study
Mingming Deng1, Ziwen Zheng1,2, Run Tong1
1National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
Introduction:
Available endobronchial valves (EBVs) for lung volume reduction in severe emphysema are limited in variety and predominantly feature complex metal-silicone designs (e.g., Zephyr®). This study aimed to introduce a novel, all-silicone endobronchial valve (ESV) designed to simplify manufacturing and potentially improve biocompatibility.
Methods:
A preclinical study implanted ESVs or Zephyr® EBVs (1:1) into unilateral caudal lobes of 8 pigs, assessed using computed tomography, bronchoscopy, and necropsy over 6 weeks. A first-in-human (FIH) trial enrolled 3 severe emphysema patients (male, aged 48-72 years, collateral ventilation-negative). ESVs were placed using a bronchoscope under general anaesthesia. Outcomes included procedural success, safety, target lobar volume reduction, lung function, quality of life, and exercise capacity at baseline and 3 and 6 months.
Results:
Preclinically, all valves (12 ESV, 12 Zephyr®) were successfully implanted and removed. Complete target lobe atelectasis occurred by 6 weeks in all animals, without major adverse events; localised granulation was observed. In the FIH trial, all ESVs were successfully deployed (procedure time: 5-20 min). Target lobar volume reductions occurred at 6 months in 2 of 3 cases (Case 1: 1.5 L, Case 2: 0.4 L). Emphysema volume decreased at 3 and 6 months. Lung function, quality of life, and exercise capacity showed trends toward improvement. One patient experienced an acute exacerbation of chronic obstructive pulmonary disease; no pneumothorax, pneumonia, or haemoptysis occurred.
Conclusion:
Overall, ESV was shown to have an initial feasibility for endobronchial lung volume reduction in humans. Further studies are needed to evaluate the sustained effects.
