Endobronchial valves for advanced emphysema
In this multicentre randomised trial from USA, the safety and efficacy of unilobar endobronchial valve therapy in patients with heterogeneous emphysema was compared with usual care.
In terms of effectiveness, the co-primary outcomes were percentage change in FEV1 and distance on the 6 min walk test. In terms of safety, the primary outcome was the difference in complication rate, using a composite of six major complications including death, empyema, massive haemoptysis, pneumonia distal to the valves and pneumothorax or air leak of more than 7 days duration.
Patients with endobronchial valves showed modest improvements in FEV1 and 6 min walk test distance, but at the cost of more pneumonia, including episodes requiring hospitalisation, chronic obstructive pulmonary disease exacerbations and haemoptysis. Follow-up was for 12 months with most complications occurring in the 6 months after valve insertion. There were also modest improvements in secondary end points including quality of life, dyspnoea and supplemental oxygen use.
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