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A Randomized Study of Endobronchial Valves for Advanced Emphysema

Open access
Sciurba, Frank C., Ernst, Armin, Herth, Felix J.F., Strange, Charlie, Criner, Gerard J., Marquette, Charles H., Kovitz, Kevin L., Chiacchierini, Richard P., Goldin, Jonathan, McLennan, Geoffrey·2010·New England Journal of Medicine
DOI 10.1056/nejmoa0900928
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Abstract

BACKGROUND: Endobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients with pulmonary hyperinflation related to advanced emphysema. METHODS: We compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis. We assessed safety on the basis of the rate of a composite of six major complications. RESULTS: Of 321 enrolled patients, 220 were randomly assigned to receive endobronchial valves (EBV group) and 101 to receive standard medical care (control group). At 6 months, there was an increase of 4.3% in the FEV1 in the EBV group (an increase of 1.0 percentage point in the percent of the predicted value), as compared with a decrease of 2.5% in the control group (a decrease of 0.9 percentage point in the percent of the predicted value). Thus, there was a mean between-group difference of 6.8% in the FEV1 (P=0.005). Roughly similar between-group differences were observed for the 6-minute walk test. At 12 months, the rate of the complications composite was 10.3% in the EBV group versus 4.6% in the control group (P=0.17). At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, P=0.03) and hemoptysis (6.1% vs. 0%, P=0.01). The rate of pneumonia in the target lobe in the EBV group was 4.2% at 12 months. Greater radiographic evidence of emphysema heterogeneity and fissure completeness was associated with an enhanced response to treatment. CONCLUSIONS: Endobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation. (Funded by Pulmonx; ClinicalTrials.gov number, NCT00129584.)

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Metadata

Authors
Sciurba, F. C., Ernst, A., Herth, F. J. F., Strange, C., Criner, G. J., Marquette, C. H., Kovitz, K. L., Chiacchierini, R. P., Goldin, J., & McLennan, G.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2010-09-23
Volume
363
Issue
13
Pages
1233-1244
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa0900928
OpenAlex
W2078446222
Cited by
832
References
31
FWCI
40.09
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: A Randomized Study of Endobronchial Valves for Advanced Emphysema. https://app.cochat.ai/papers/10.1056/nejmoa0900928
The paper
Sciurba, F. C., Ernst, A., Herth, F. J. F., Strange, C., Criner, G. J., Marquette, C. H., Kovitz, K. L., Chiacchierini, R. P., Goldin, J., & McLennan, G. (2010). A Randomized Study of Endobronchial Valves for Advanced Emphysema. New England Journal of Medicine. https://doi.org/10.1056/nejmoa0900928

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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