{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T10:56:41Z","timestamp":1788865001787,"version":"build-2803163510"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T00:00:00Z","timestamp":1773187200000},"content-version":"vor","delay-in-days":253,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Apreo Health"},{"name":"Apreo Health"}],"content-domain":{"domain":["www.atsjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Despite advancements in emphysema treatment, high morbidity and mortality rates highlight the need for innovative therapies. A novel self-expanding nitinol airway scaffold was designed to alleviate lung hyperinflation by connecting emphysematous parenchyma with central bronchi, releasing trapped air.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the feasibility, safety, and initial outcomes of airway scaffolds in treating emphysema-related hyperinflation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a pooled analysis of two first-in-human studies (NCT05949645, NCT05854550) involving patients with heterogeneous or homogeneous emphysema treated bronchoscopically with up to three permanent airway scaffolds per lung.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The primary outcome was safety, measured by procedure- and\/or device-related serious adverse events over 6 months. Secondary outcomes were technical feasibility, pulmonary function, quality of life, symptoms, exercise capacity at 3 and 6 months, and airway patency assessment by high-resolution computed tomography. Sixty severe emphysema patients (33 female, 27 male; mean age, 66\u2009\u00b1\u20098 yr; mean residual volume percent predicted, 255\u2009\u00b1\u200947%) were included. Ninety-eight procedures were performed, and 328 airway scaffolds were successfully placed. A proportion of 21.7% of patients experienced at least one related serious adverse event within 6 months, including pneumonia (10.0%) and chronic obstructive pulmonary disease exacerbation (5.0%), but no pneumothoraxes occurred. Residual volume improved (decreased) from baseline by a mean [95% confidence interval] of 866 [626, 1,106] ml at 3 months and 753 [512, 994] ml at 6 months. Clinically meaningful improvements were further observed in spirometry, quality of life, symptoms, and exercise capacity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study provides the first clinical evidence of the feasibility, safety, and initial outcomes after treatment with airway scaffolds in patients with emphysema-related hyperinflation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1164\/rccm.202502-0378oc","type":"journal-article","created":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T16:48:25Z","timestamp":1749833305000},"page":"1175-1184","update-policy":"https:\/\/doi.org\/10.1164\/crossmarkpolicies","source":"Crossref","is-referenced-by-count":11,"title":["Airway Scaffolds for Emphysema-related Hyperinflation: Six-Month Results from the BREATHE Trial"],"prefix":"10.1093","volume":"211","author":[{"given":"Anand","family":"Tana","sequence":"first","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London, London, United Kingdom"},{"name":"Royal Brompton Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6574-1721","authenticated-orcid":false,"given":"Arschang","family":"Valipour","sequence":"additional","affiliation":[{"name":"Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna Health Care Group, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6391-020X","authenticated-orcid":false,"given":"Alvin","family":"Ing","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8998-2949","authenticated-orcid":false,"given":"Daniel P.","family":"Steinfort","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Sleep Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia"},{"name":"Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9167-5462","authenticated-orcid":false,"given":"Christopher M.","family":"Orton","sequence":"additional","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London, London, United Kingdom"},{"name":"Royal Brompton Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3198-8202","authenticated-orcid":false,"given":"Karin","family":"Klooster","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2847-3550","authenticated-orcid":false,"given":"Theresa","family":"Klemm","sequence":"additional","affiliation":[{"name":"Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna Health Care Group, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4957-3961","authenticated-orcid":false,"given":"Jonathan P.","family":"Williamson","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4478-0494","authenticated-orcid":false,"given":"Jemma J.","family":"Christie","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Sleep Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1292-8346","authenticated-orcid":false,"given":"Justin L.","family":"Garner","sequence":"additional","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London, London, United Kingdom"},{"name":"Royal Brompton Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8550-0722","authenticated-orcid":false,"given":"T. David","family":"Koster","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Welz","sequence":"additional","affiliation":[{"name":"Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna Health Care Group, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2043-1276","authenticated-orcid":false,"given":"Marlies","family":"van Dijk","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin L.","family":"Mayse","sequence":"additional","affiliation":[{"name":"Apreo Health, Menlo Park, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9052-4638","authenticated-orcid":false,"given":"Pallav L.","family":"Shah","sequence":"additional","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London, London, United Kingdom"},{"name":"Royal Brompton Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9555-3422","authenticated-orcid":false,"given":"Dirk-Jan","family":"Slebos","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 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