A multicenter pilot study of a bronchial valve for the treatment of severe emphysema

D. H. Sterman; A. C. Mehta; D. E. Wood; P. N. Mathur; R. J. McKenna; D. E. Ost; J. D. Truwit; P. Diaz; M. M. Wahidi; R. Cerfolio; R. Maxfield; A. I. Musani; T. Gildea; F. Sheski; M. MacHuzak; A. R. Haas; H. X. Gonzalez; S. C. Springmeyer

doi:10.1159/000259318

A multicenter pilot study of a bronchial valve for the treatment of severe emphysema

D. H. Sterman, A. C. Mehta, D. E. Wood, P. N. Mathur, R. J. McKenna, D. E. Ost, J. D. Truwit, P. Diaz, M. M. Wahidi, R. Cerfolio, R. Maxfield, A. I. Musani, T. Gildea, F. Sheski, M. MacHuzak, A. R. Haas, H. X. Gonzalez, S. C. Springmeyer

Research output: Contribution to journal › Article › peer-review

130 Scopus citations

Abstract

Background: Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients. Objective: To study the safety and effectiveness of the IBV® Valve for the treatment of severe emphysema. Methods: A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. Results: Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (-8.2 ± 16.2, mean ± SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean -294 ± 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV₁, exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma. Conclusion: Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.

Original language	English (US)
Pages (from-to)	222-233
Number of pages	12
Journal	Respiration
Volume	79
Issue number	3
DOIs	https://doi.org/10.1159/000259318
State	Published - Jan 2010
Externally published	Yes

Keywords

Bronchial valve
Bronchoscopic treatment of emphysema
Chronic obstructive pulmonary disease
Emphysema
Endobronchial lung volume reduction
Valve placement

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

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10.1159/000259318

Cite this

Sterman, D. H., Mehta, A. C., Wood, D. E., Mathur, P. N., McKenna, R. J., Ost, D. E., Truwit, J. D., Diaz, P., Wahidi, M. M., Cerfolio, R., Maxfield, R., Musani, A. I., Gildea, T., Sheski, F., MacHuzak, M., Haas, A. R., Gonzalez, H. X., & Springmeyer, S. C. (2010). A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. Respiration, 79(3), 222-233. https://doi.org/10.1159/000259318

Sterman, DH, Mehta, AC, Wood, DE, Mathur, PN, McKenna, RJ, Ost, DE, Truwit, JD, Diaz, P, Wahidi, MM, Cerfolio, R, Maxfield, R, Musani, AI, Gildea, T, Sheski, F, MacHuzak, M, Haas, AR, Gonzalez, HX & Springmeyer, SC 2010, 'A multicenter pilot study of a bronchial valve for the treatment of severe emphysema', Respiration, vol. 79, no. 3, pp. 222-233. https://doi.org/10.1159/000259318

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title = "A multicenter pilot study of a bronchial valve for the treatment of severe emphysema",

abstract = "Background: Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients. Objective: To study the safety and effectiveness of the IBV{\textregistered} Valve for the treatment of severe emphysema. Methods: A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. Results: Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (-8.2 ± 16.2, mean ± SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean -294 ± 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV1, exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma. Conclusion: Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.",

keywords = "Bronchial valve, Bronchoscopic treatment of emphysema, Chronic obstructive pulmonary disease, Emphysema, Endobronchial lung volume reduction, Valve placement",

author = "Sterman, {D. H.} and Mehta, {A. C.} and Wood, {D. E.} and Mathur, {P. N.} and McKenna, {R. J.} and Ost, {D. E.} and Truwit, {J. D.} and P. Diaz and Wahidi, {M. M.} and R. Cerfolio and R. Maxfield and Musani, {A. I.} and T. Gildea and F. Sheski and M. MacHuzak and Haas, {A. R.} and Gonzalez, {H. X.} and Springmeyer, {S. C.}",

year = "2010",

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doi = "10.1159/000259318",

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pages = "222--233",

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T1 - A multicenter pilot study of a bronchial valve for the treatment of severe emphysema

AU - Sterman, D. H.

AU - Mehta, A. C.

AU - Wood, D. E.

AU - Mathur, P. N.

AU - McKenna, R. J.

AU - Ost, D. E.

AU - Truwit, J. D.

AU - Diaz, P.

AU - Wahidi, M. M.

AU - Cerfolio, R.

AU - Maxfield, R.

AU - Musani, A. I.

AU - Gildea, T.

AU - Sheski, F.

AU - MacHuzak, M.

AU - Haas, A. R.

AU - Gonzalez, H. X.

AU - Springmeyer, S. C.

PY - 2010/1

Y1 - 2010/1

N2 - Background: Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients. Objective: To study the safety and effectiveness of the IBV® Valve for the treatment of severe emphysema. Methods: A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. Results: Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (-8.2 ± 16.2, mean ± SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean -294 ± 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV1, exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma. Conclusion: Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.

AB - Background: Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients. Objective: To study the safety and effectiveness of the IBV® Valve for the treatment of severe emphysema. Methods: A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. Results: Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (-8.2 ± 16.2, mean ± SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean -294 ± 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV1, exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma. Conclusion: Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.

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KW - Bronchoscopic treatment of emphysema

KW - Chronic obstructive pulmonary disease

KW - Emphysema

KW - Endobronchial lung volume reduction

KW - Valve placement

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A multicenter pilot study of a bronchial valve for the treatment of severe emphysema

Abstract

Keywords

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