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 ((b)(6)).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 ((b)(6)).Am j respir crit care med.2018; 198 (9): 1151-1164).In the (b)(6) study ((b)(6) 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 (b)(6) clinical study and is an expected side effect to the zephyr valve treatment.
|
On (b)(6) 2019, patient underwent bronchoscopic lung volume reduction procedure with placement of four zephyr 5.5 endobronchial valves in the right upper lobe (rul) and right middle lobe (rml).Patient displayed signs of pneumothorax within one hour post procedure and a chest tube was placed.One day after the procedure, the patient was improving, and the physician reported minimal air leak, fissures elevating, and rul and rml were partially atelectatic on film.On (b)(6) 2019, patient remained in hospital due to failed clip test.As of (b)(6) 2019, the patient's chest tube was removed on (b)(6) 2019, and it cannot be confirmed if the pneumothorax has completely healed.
|