The DOI matches its Crossref record; 36 of the 36 references it cites were found in a registry or an index.
Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study
Abstract
Abstract Rationale Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema. Objectives To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system. Methods Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George’s Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction. Measurements and Main Results Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV1 from baseline was 13.7 ± 28.2% in the EBV group and −3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, −8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. −17.34 ± 52.8 m). Target lobe volume reduction at 3 months was −1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves. Conclusions EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.
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Cites
A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema
(2003) · New England Journal of Medicine · doi:10.1056/nejmoa030287 · Cited by 2,071
Outcomes for COPD pharmacological trials: from lung function to biomarkers
Cazzola, M., MacNee, W., Martinez, F. J., Rabe, K. F., Franciosi, L. G., Barnes, P. J., Brusasco, V., Burge, P. S., Calverley, P. M. A., Celli, B. R., et al. (2008) · European Respiratory Journal · doi:10.1183/09031936.00099306 · Cited by 858
A Randomized Study of Endobronchial Valves for Advanced Emphysema
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) · New England Journal of Medicine · doi:10.1056/nejmoa0900928 · Cited by 832
Self-citationMinimal Clinically Important Differences in COPD Lung Function
Donohue, J. F. (2005) · COPD: Journal of Chronic Obstructive Pulmonary Disease · doi:10.1081/copd-200053377 · Cited by 529
Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation
Klooster, K., ten Hacken, N. H. T., Hartman, J. E., Kerstjens, H. A. M., van Rikxoort, E. M., & Slebos, D.-J. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1507807 · Cited by 487
Self-citationSciurba, F. C., Rogers, R. M., Keenan, R. J., Slivka, W. A., Gorcsan, J., Ferson, P. F., Holbert, J. M., Brown, M. L., & Landreneau, R. J. (1996) · New England Journal of Medicine · doi:10.1056/nejm199604253341704 · Cited by 462
Davey, C., Zoumot, Z., Jordan, S., McNulty, W. H., Carr, D. H., Hind, M. D., Hansell, D. M., Rubens, M. B., Banya, W., Polkey, M. I., et al. (2015) · The Lancet · doi:10.1016/s0140-6736(15)60001-0 · Cited by 362
Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort
Herth, F. J. F., Noppen, M., Valipour, A., Leroy, S., Vergnon, J.-M., Ficker, J. H., Egan, J. J., Gasparini, S., Agusti, C., Holmes-Higgin, D., et al. (2012) · European Respiratory Journal · doi:10.1183/09031936.00161611 · Cited by 337
Self-citationRadiological and clinical outcomes of using Chartis™ to plan endobronchial valve treatment
Herth, F. J. F., Eberhardt, R., Gompelmann, D., Ficker, J. H., Wagner, M., Ek, L., Schmidt, B., & Slebos, D.-J. (2013) · European Respiratory Journal · doi:10.1183/09031936.00015312 · Cited by 274
Self-citationSciurba, F. C., Criner, G. J., Strange, C., Shah, P. L., Michaud, G., Connolly, T. A., Deslée, G., Tillis, W. P., Delage, A., Marquette, C.-H., et al. (2016) · JAMA · doi:10.1001/jama.2016.6261 · Cited by 242
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Criner, G. J., Sue, R., Wright, S., Dransfield, M., Rivas-Perez, H., Wiese, T., Sciurba, F. C., Shah, P. L., Wahidi, M. M., de Oliveira, H. G., et al. (2018) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201803-0590oc · Cited by 428
Self-citationCriner, G. J., Delage, A., Voelker, K., Hogarth, D. K., Majid, A., Zgoda, M., Lazarus, D. R., Casal, R., Benzaquen, S. B., Holladay, R. C., et al. (2019) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201902-0383oc · Cited by 182
“In addition, the EMPROVE study, and other recent multicenter, randomized controlled trials, did not blind either subjects or assessors (16, 25, 34).”
Background
Metadata
- Authors
- Valipour, A., Slebos, D.-J., Herth, F., Darwiche, K., Wagner, M., Ficker, J. H., Petermann, C., Hubner, R.-H., Stanzel, F., & Eberhardt, R.
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2016-11-01
- Volume
- 194
- Issue
- 9
- Pages
- 1073-1082
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- OpenAlex
- W2507196609
- Cited by
- 365
- References
- 36
- FWCI
- 33.63
- Type
- journal article
- Language
- en
- Open access
- closed
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- Valipour, A., Slebos, D.-J., Herth, F., Darwiche, K., Wagner, M., Ficker, J. H., Petermann, C., Hubner, R.-H., Stanzel, F., & Eberhardt, R. (2016). Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. American Journal of Respiratory and Critical Care Medicine. https://doi.org/10.1164/rccm.201607-1383oc
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