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.