The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.
Age 40 to 75 years.
Stable with less than 10mg prednisone (or equivalent) daily.
Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.
Current pneumococcus vaccination.
Clinically significant (greater than 4 tablespoons per day) mucus production.
Myocardial infarction within 6 months of screening.
Decompensated heart failure.
Three or more pneumonia episodes in last year.
Single group
Interlobar fissure completion and pleural adhesiolysis
Procedure/SurgeryA video-assisted thoracic surgery or robotic approach will be used to perform pleural adhesiolysis and the lobar fissure adjacent to the previously targeted lobe during bronchoscopic lung volume reduction will be completed using a surgical stapler.
Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction
The investigators will determine that performing the surgery is feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled.
Incidence of severe adverse events
The investigators will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the procedure. In case the treating physicians consider that the complications seen in patients outweigh the benefits obtained, the surgical technique will be revised and possible changes will be discussed.
Percentage of patients to achieve target lung volume reduction
Describe the percentage of patients that achieve target lung volume reduction of at least 350mL at three months after the procedure.
Percentage of patients with quality of life improvement
Describe the changes in quality of life based on three subjective questionnaires that will be given to patients at baseline and three months after the intervention.
Percentage of patients with significant changes in pulmonary function testing
Describe the changes in PFTs after the intervention.
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