Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial

We plan to approach all EBVs candidates that have < 95% lobar fissure completion. Once the patient agrees to participate and sign the consent, all the screening information collected as part of the standard of care will be extracted retrospectively from the medical records including appointment details, 6MWD, and PFTs results. In addition, during the same visit, health-related quality of life will be measured using the Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and dyspnea will be assessed with the self-reported modified Medical Research Council dyspnea scale (mMRC). After completing these questionnaires and indexes, subjects will be randomized by an opaque envelope technique following a block 2-4 pattern to either Group 1 (Combined robotic or VATS-fissure completion and BLVR with EBVs) or Group 2 (Medical management).

Both surgical stapling for fissure completion and EBVs implantation will be performed during the same procedure and under general anesthesia in the operating room. Depending on the duration of the surgical intervention, the endoscopic valve implantation might be deferred and performed within 48 hours, based on the clinical judgment of the PI, surgeon, and anesthesiologist present during the procedure.

Initial Bronchoscopic Evaluation Initial flexible bronchoscopy will be done by the interventional pulmonologist who will perform the endoscopic valve placement as part of the standard of care. The bronchoscope will be passed via the endotracheal tube and the major airways will be examined. A bronchial wash will be performed with samples sent for culture. If there are unexpected findings, such as a lesion suspicious for carcinoma or secretions suggesting infection, then appropriate clinical samples will be obtained, and the subject will be re-evaluated to determine if they are eligible to undergo the study procedure later. If so, the procedure will be rescheduled. If not, the subject will be withdrawn from the study and will be considered as an "Enrollment Failure" and recorded as such for statistical analysis.

First Chartis Pulmonary System Evaluation of CV Following initial bronchoscopy, evaluation of CV using the Chartis system (Pulmonx Inc., Redwood, CA, USA), will be performed also as part of the standard of care of the patients. If there is no evidence of CV between the target lobe and the adjacent one, the patient will be withdrawn from the study and EBVs will be placed. On the other hand, if the ChartisTM evaluation is positive for CV, the bronchoscope will be withdrawn, and the patient will undergo robotic or VATS completion of the inter-lobar fissure adjacent to the previously selected target lobe.

Robotic or VATS Inter-Lobar Fissure Completion Surgery will be performed with a robotic or VATS approach under inhaled anesthetic agents by an experienced thoracic surgeon from BIDMC. A double-lumen endotracheal tube will be inserted allowing one-lung ventilation and the maximal collapse of the operative lung. The subject will be placed in lateral decubitus with the operative side up. Through small incisions, the surgeon will create a camera port through the intercostal space and then the anterior and posterior inferior ports. Electrocautery will be used for dissection and exposure of the anterior aspect of the hilum. Stapling will then be performed on the incomplete fissure adjacent to the target lobe, using the Endo GIATM (CovidienTM, Mansfield, MA).