A randomized study of endobronchial valves for advanced emphysema.
Details
Serval ID
serval:BIB_7BD663C99E0A
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A randomized study of endobronchial valves for advanced emphysema.
Journal
New England Journal of Medicine
Working group(s)
VENT Study Research Group
Contributor(s)
Sciurba F., Landreneau R., Crespo M., Lane L., Slivka W., Fuhrman C., Ferson P., Witt C., End A., Schneider F., Klepetko W., Stanzel F., Weber N., Haeussinger K., Gasparini S., De Luca S., Golden E., Smith M., Williams G., Ernst A., Feller-Kopman D., Garland R., Ashiku S., DeCamp M., Ferguson G., Thompson TM., McKenna R.<Suffix>Jr</Suffix> , Geaga C., Kusuanco D., Pison Ch., Wuyam B., Ferretti G., Vivodtzev I., Righini C., Lebargy F., Deslee G., Dury S., Witt C., Schmidt B., Gonzalez-Bermejo J., Trosini-Desert V., Similowski T., Beigelman C., Becquemin MH., Simoff M., Almario R., Mal H., Marceau A., Fournier M., Brugière O., Dauriat G., Marquette C., Leroy S., Perez T., Bautin N., Massard G., Kessler R., Charloux A., Jeung MY., Jory A., Muir JF., Viacroze C., Benhamou D., Cuvelier A., Molano L., Degano B., Hermant C., Pontier S., Rami J., Chabbert V., Vergnon JM., Veyret C., Costes F., De Matos L., Febvre M., Chouaid C., Lebeau B., Pinet C., Dutau H., Thomas P., Badier M., Gaubert J., Xaubet A., Torres A., Agustí C., Barberà J., Agustí A., Togores B., Renom F., Sauleda J., Ramos R., Nathan S., Ahmad S., Collazo L., Battle E., Hecker E., Volmerig J., Jahn T., Ficker J., Wagner M., Fink T., Egan J., Coyle J., Edell E., Midthun D., Utz J., Andrist B., Meiras K., Strange C., Silvestri G., Williams-Cummings E., Freilich E., Amin D., Masson J., Orlando D., Morgan L., Bowler R., Wheeler C., Mitchell K., Maxfield R., Ginsburg M., Jellen P., Brogan F., Valipour A., Kohansal R., Burghuber C., Elton D., Sy A., McFarland E., Haase N., Stout M., Tillis W., Whitten P., Crabb J., Hartwig K., Scott A., Levine B., Ross J., Baratz D., Fu L., Cordasco E., Adamo J., Botte J., Voelker K., Horiuchi T., Hurwitz K., Ferreira G., Morgan K., Jantz M., Deem A., Fox A., Campbell S., Vincent T., Shen W., Hazelrigg S., Boley T., Boomer WM., Goulet J., Mullins C., Cicena J., O'Neill P., Criner G., Travaline J., Chatila W., Jones G., Herth F., Eberhardt R., Leeds W., Fair G., Ludlow L., Nicklin S., Davis C., Kovitz K., Ditta S., Chan A., Allen R., Albertson T., Morrissey B., Juarez M., Germonpre P., Janssens A., De Backer W., Noppen M., De Mey J., Meysman M., McLennan G., Ferguson J., Ross A., Sprenger K., Keating J., Zgoda M., Berger R., McClung J., Cortes R., Krasna M., Britt J., Gamliel Z., Moskowitz I., Gay S., Konkle J., Goodnight-White S., Soubra S., Smithwick P., Velamuri K., Cooper C., Badduke B., Hsiao E., Wise R., Celli B., Ciccone A., Keenan R., Gilman D., Goldin J., Brown M., McNitte-Gray M., da Costa I., Ho J., Kaplan R., Ganiats T., Groessl E., Harvey J., Mulligan B.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
2010
Volume
363
Number
13
Pages
1233-1244
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't Publication Status: ppublish
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.)
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.)
Keywords
Adult, Aged, Antibiotic Prophylaxis, Bronchodilator Agents/therapeutic use, Bronchoscopy, Exercise Tolerance, Forced Expiratory Volume, Humans, Middle Aged, Pneumonectomy/methods, Proportional Hazards Models, Prostheses and Implants, Pulmonary Disease, Chronic Obstructive/complications, Pulmonary Emphysema/complications, Pulmonary Emphysema/drug therapy, Respiratory Physiological Phenomena
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Web of science
Create date
07/05/2012 15:03
Last modification date
20/08/2019 15:37
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