Respiration; international review of thoracic diseases · 2025
First-In-Human Trial of the Implantable Artificial Bronchus: A Novel Bronchoscopically Delivered Treatment Option for Patients with Severe Emphysema.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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de Oliveira Hugo Goulart, Slebos Dirk-Jan, Herth Felix
Аннотация
INTRODUCTION: IAB-1 is the first-in-human study of the implantable artificial bronchus (IAB) in patients with severe emphysema. The IAB is a bronchoscopically delivered, self-expanding, tapered stent made of polyether ether ketone. By restoring the original airway and preventing expiratory collapse, it allows release of hyperinflated air. It is indifferent to collateral ventilation and disease distribution.
METHODS: In a primary bronchoscopy, 1 or 2 IABs are implanted in the most diseased lobe. A secondary bronchoscopy at 30 days allows implantation of 1 or 2 additional IABs in another lobe. The primary endpoint, evaluated at 90 days, was safety, defined as any of 10 prespecified respiratory serious adverse device events (SADEs). Secondary endpoints included other related adverse events and multiple efficacy measures.
RESULTS: Twenty patients were implanted with 53 IABs: 5 subjects formed the early termination set (ETS) because of SADEs; 15, the full analysis set (FAS), continued to the 90-day endpoint. All 5 ETS patients and 2 FAS patients experienced 4 of the 10 primary respiratory SADEs: pneumonia, airway injury, COPD exacerbation, and pneumothorax. The majority of patients improved clinically with statistically significant outcomes in all effectiveness variables (residual volume, six-minute walk distance, modified Medical Research Council, COPD Assessment Test, Saint George Respiratory Questionnaire, and EuroQual 5-Dimensional) with the exception of forced expiratory volume in 1 s.
CONCLUSION: IAB-1 demonstrated feasibility and a risk profile that improved during the trial by identifying and addressing the need for improved patient selection, implant site selection, implant technique, and delivery system improvements. The IAB may be desirable for emphysema patients who are ineligible for other interventional treatments and wish to avoid surgery.
METHODS: In a primary bronchoscopy, 1 or 2 IABs are implanted in the most diseased lobe. A secondary bronchoscopy at 30 days allows implantation of 1 or 2 additional IABs in another lobe. The primary endpoint, evaluated at 90 days, was safety, defined as any of 10 prespecified respiratory serious adverse device events (SADEs). Secondary endpoints included other related adverse events and multiple efficacy measures.
RESULTS: Twenty patients were implanted with 53 IABs: 5 subjects formed the early termination set (ETS) because of SADEs; 15, the full analysis set (FAS), continued to the 90-day endpoint. All 5 ETS patients and 2 FAS patients experienced 4 of the 10 primary respiratory SADEs: pneumonia, airway injury, COPD exacerbation, and pneumothorax. The majority of patients improved clinically with statistically significant outcomes in all effectiveness variables (residual volume, six-minute walk distance, modified Medical Research Council, COPD Assessment Test, Saint George Respiratory Questionnaire, and EuroQual 5-Dimensional) with the exception of forced expiratory volume in 1 s.
CONCLUSION: IAB-1 demonstrated feasibility and a risk profile that improved during the trial by identifying and addressing the need for improved patient selection, implant site selection, implant technique, and delivery system improvements. The IAB may be desirable for emphysema patients who are ineligible for other interventional treatments and wish to avoid surgery.