{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T16:52:50Z","timestamp":1781542370139,"version":"3.54.5"},"reference-count":16,"publisher":"S. Karger AG","issue":"6","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Respiration"],"abstract":"<jats:p>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\u00ae). 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\u00ae 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\u201372 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\u00ae) 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\u201320 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.<\/jats:p>","DOI":"10.1159\/000549779","type":"journal-article","created":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T17:12:56Z","timestamp":1764609176000},"page":"654-661","source":"Crossref","is-referenced-by-count":0,"title":["Novel Endobronchial Silicone Valve for Treating Lung Emphysema: A Preclinical Trial and First-In-Human Study"],"prefix":"10.1159","volume":"105","author":[{"given":"Mingming","family":"Deng","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1711-6328","authenticated-orcid":false,"given":"Ziwen","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Run","family":"Tong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8933-387X","authenticated-orcid":false,"given":"Ke","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gang","family":"Hou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2025,12,1]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61728-0"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61729-2"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1111\/crj.12033"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-019-57354-2"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201803-0590OC"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1080\/17476348.2024.2388293"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1378\/chest.11-2886"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1111\/resp.13295"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1159\/000538269"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2024.1293940"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00015312"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00056008"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1097\/RLI.0b013e318262292e"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.3348\/kjr.2018.0724"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507807"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0900928"}],"container-title":["Respiration"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/000549779","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T16:01:02Z","timestamp":1781539262000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000549779"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,1]]},"references-count":16,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2026,6,15]]},"published-print":{"date-parts":[[2026,6,17]]}},"URL":"https:\/\/doi.org\/10.1159\/000549779","archive":["Portico"],"relation":{},"ISSN":["0025-7931","1423-0356"],"issn-type":[{"value":"0025-7931","type":"print"},{"value":"1423-0356","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,1]]}}}