Pneumothorax is the most common side effect associated with the zephyr valve treatment (criner et al. A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (liberate). Am j respir crit care med. 2018; 198 (9): 1151-1164). Targeted lobar deflation likely causes inflation of the ipsilateral lobe, which can result in a tear of the already compromised parenchymal tissue of the emphysematous ipsilateral lobe, resulting in a pneumothorax (criner et al. A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (liberate). Am j respir crit care med. 2018; 198 (9): 1151-1164). In the liberate study (ide clinical study used to support pma p180002's approval), 26. 6% of the zephyr valve subjects experienced a pneumothorax in the treatment period ([less than or equal to 45 days). These were managed using standard of care procedures as per previously published guidelines (valipour, arschang, et al. Respiration 87. 6 (2014): 513-521). In 17. 4% of the events, the pneumothorax resolved without any additional intervention with subjects under careful observation. In over half the events (56. 5%), the pneumothorax was managed with a chest-tube only. An additional 13% of the events were managed with a chest-tube and the temporary removal of one or more valves, while another 13% of the events were managed with a chest-tube and removal of all the implanted valves. Upon successful resolution of the pneumothorax, removed valves can be replaced. Patients that experienced a pneumothorax experienced clinical benefits of the zephyr valve treatment that were similar to the benefits experienced by patients who did not have a pneumothorax. The zephyr ebv system ifu and pulmonx training program both specifically reference pneumothorax as a known side effect of this procedure and the published guidelines (valipour, arschang, et al. "expert statement: pneumothorax associated with endoscopic valve therapy for emphysema-potential mechanisms, treatment algorithm, and case examples. " respiration 87. 6 (2014): 513-521). The reported event aligns with the experience observed in the liberate clinical study and is an expected side effect to the zephyr valve treatment.
Patient Sequence No: 1, Text Type: N, H10
The patient had a bronchoscopic lung volume reduction (blvr) procedure with four zephyr valves (two 4. 0 ebvs, two 5. 5 ebvs) placed in the left upper lobe (lul) on (b)(6) 2020. Patient was discharged on (b)(6) 2020, and returned to the hospital on feb. 29, 2020 with a large pneumothorax. A chest tube was placed on (b)(6) 2020. On (b)(6) 2020, the patient had a surgery for a bullae rupture/air leak. The air leak resolved, and the patient had complete lul atelectasis. The patient was discharged on (b)(6) 2020 with a chest tube in place. There was no air leak at the time of discharge. The physician is planning to remove the chest tube on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5