Report on efficacy and safety of endobronchial valve implantation for emphysema in Austria

21

Sep 2018

Chronic obstructive pulmonary disease (COPD) is a progressive, irreversible respiratory disease. Endobronchial valve implantation is an alternative to surgical lung volume reduction in patients with COPD and aims to alleviate disease-related symptoms, to prevent the deterioration of pulmonary function and to improve quality of life.

The authors have not performed a systematic review of the literature, but have instead used the results of the Cochrane Review “Bronchoscopic lung volume reduction procedure for chronic obstructive pulmonary disease” (2017), in order to evaluate the efficacy and safety of endobronchial valve implantation in patients with severe emphysema compared to standard medical care. Five (5) RCTs, of which 703 patients were included, were assessed in this meta-analysis.

All the included RCTs have provided consistent results. In all three efficacy endpoints (pulmonary function measured with FEV1 (Forced expiratory volume in 1 second), physical exercise capacity measured with 6MWT (6-minutes walking test) and quality of life measured with SGRQ (St. George’s Respiratory Questionnaire)) clinically relevant improvements were found above the predefined "minimal important difference" (MID), assuming careful patient selection (exclusion of patients with collateral ventilation). There was no difference in mortality. Serious adverse events (pneumothorax, hospitalization due to exacerbation of COPD, pneumonia) in addition to valve migration and removal occurred significantly more frequently in the intervention group.

Conclusion

The authors have concluded that the intervention is more effective but less safe than standard therapy in selected patients with severe emphysema. Inclusion in the service catalogue is only recommended with restrictions. It should only be performed in highly specialized centres by experienced clinical experts.

See the full report in German (with summary in English) here.

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