Airway Scaffolds for Emphysema-related Hyperinflation: Six-Month Results from the BREATHE Trial

Rationale: 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. Objectives: To assess the feasibility, safety, and initial outcomes of airway scaffolds in treating emphysema-related hyperinflation. Methods: 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. Measurements and Main Results: 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 ± 8 yr; mean residual volume percent predicted, 255 ± 47%) 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. Conclusions: 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.