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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.This report was sent on march 31, 2020 under an incorrect report number.This report is a resubmission.
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Patient was a (b)(6) year old gentleman with severe copd and emphysema.He had a remote history of 30 pack-year of tobacco smoking, and had quit more than 10 years ago.On (b)(6) 2020, the medical team initially performed a chartis procedure in the right lower lobe (rll) selected using qct and nuclear perfusion imaging, but learned it had positive collateral ventilation.The team then tested the secondary target, right upper lobe (rul), and it had negative collateral ventilation.Thus, the patient underwent bronchoscopic lung volume reduction procedure in the rul, and three zephyr valves (two 4.0-lp and one 5.5-lp) were placed, all of which were functioning properly.Patient had an immediate post-operative pneumothorax, and a 14 fr.Apical chest tube was placed with slow resolution of the pneumothorax.Later in the day, the patient had a persistent air leak, and an xray revealed there was a persistent, though much smaller, pneumothorax.A second apical chest tube was placed and appeared to resolve the pneumothorax completely with atelectasis of the rul.Re-expansion pulmonary edema was appreciated in the rll despite chest tube setting of only -15 of suction.In the early morning hours of mar.3, 2020, patient had a significant jump in temperature in degrees fahrenheit to 103, then 104.5, and then 105.His fever came down, but not completely, and his chest xray was getting worse.The patient was intubated and broad-spectrum antibiotics were started.On (b)(6) 2020, the medical team performed bedside bronchoscopy in the icu and obtained a bronchoalveolar lavage because the patient continued to have high fevers and worsening respiratory failure.The patient was on and off multiple regimens of antibiotics without much success.The source of his fevers were unknown.His respiratory pathogen profile, (b)(6) swab, and all culture results for bronchoscopy were (b)(6).Patient had two exploratory bronchoscopy procedures on (b)(6) 2020 and again on (b)(6) 2020, which showed questionable pseudomonas with less than 10 polymorphonuclear cells per low power field.The cultures were listed as positive for pseudomonas two days later.The patient had a pan-ct of chest, abdomen, and pelvis with no obvious signs of infection.He did appear to develop acute re-expansion pulmonary edema post-procedure, which likely led to acute respiratory distress syndrome, a type of respiratory failure.The series of events stated occurred prior to the medical team's ability to test for covid-19.The medical team learned that the patient told his wife he fell ill about a week prior with more dyspnea than he had let on.The patient's wife stated the patient did not want the medical team to know because he did not want to postpone the procedure.The wife stated that the patient has felt similarly ill in the past but "just got over it," and did not see a problem with not sharing his low grade subjective fevers.There is a possibility he had a viral infectious process unknown to him or other providers prior to his procedure.The patient had some waxing and waning days in the icu, on and off vasopressors with variability in the fraction of inspired oxygen and positive end-expiratory pressure requirements.He had difficulty with agitation and spontaneous breathing trials, ultimately requiring heavy sedation and analgesia.On (b)(6) 2020, one of his ebvs was removed because the air leak was not resolving, which provided improvement in lung aeration, but he ultimately continued to fail further ventilator liberation spontaneous breathing trials.Several days prior to the patient's death, the patient had worsening shock and fevers requiring vasopressors, oliguria with worsening acute kidney injury, atrial fibrillation with rapid ventricular rate, and anasarca and fluid overloaded.He went on to develop hyperkalemia.The decision about dialysis, possible tracheostomy and peg tube placement, and transfer to a long-term acute care (ltac) hospital were discussed with family.At this time, the patient was stable but not getting better quickly.Given his overall decline and likelihood of overall poor quality of life, the family decided to pursue comfort directed measures, as they felt strongly that the patient would not have wanted a tracheostomy and go to a ltac with prolonged recovering.They stated that he had been suffering for a long time and that he was "ready to go." on (b)(6) 2020, the patient was extubated and he expired quickly thereafter.The patient's wife specifically stated to the medical team that even though he had complications, he would have tried to have the valves placed because his quality of life was unbearable beforehand and that this outcome does not change her mind about permitting the ebv procedure.The medical team believes the patient likely had covid-19 and subsequently succumbed because of covid-19 and sepsis with a prolonged recovery, but cannot prove it because no tests were available to them at the time of his illness.In retrospect, the physician does not believe the procedure to place the ebvs nor the valves themselves were the cause of the death of this patient.The medical team believes it was coincidental that the patient very likely had covid-19 and he would have gotten ill from covid-19 even if he did not get the valves placed and his outcome would have been the same.
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