Treatment of advanced emphysema with emphysematous lung sealant (AeriSeal)
Background: This report summarizes initial tests of an emphysematous lung synthetic polymer sealant (ELS) designed to reduce lung volume in patients with advanced emphysema.Objectives: The primary study objective was to define a therapeutic strategy to optimize treatment safety and effectiveness. Me...
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| Main Authors: | , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
[June 2011]
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| In: |
Respiration
Year: 2011, Volume: 82, Issue: 1, Pages: 36-45 |
| ISSN: | 1423-0356 |
| DOI: | 10.1159/000322649 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1159/000322649 Verlag, lizenzpflichtig, Volltext: https://www.karger.com/Article/FullText/322649 
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| Author Notes: | F.J.F. Herth, D. Gompelmann, F. Stanzel, R. Bonnet, J. Behr, B. Schmidt, H. Magnussen, A. Ernst, R. Eberhardt |
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| 245 | 1 | 0 | |a Treatment of advanced emphysema with emphysematous lung sealant (AeriSeal) |c F.J.F. Herth, D. Gompelmann, F. Stanzel, R. Bonnet, J. Behr, B. Schmidt, H. Magnussen, A. Ernst, R. Eberhardt |
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| 520 | |a Background: This report summarizes initial tests of an emphysematous lung synthetic polymer sealant (ELS) designed to reduce lung volume in patients with advanced emphysema.Objectives: The primary study objective was to define a therapeutic strategy to optimize treatment safety and effectiveness. Methods: ELS therapy was administered bronchoscopically to 25 patients with heterogeneous emphysema in an open-label, noncontrolled study at 6 centers in Germany. Treatment was performed initially at 2-4 subsegments. After 12 weeks, patients were eligible for repeat therapy to a total of 6 sites. Safety and efficacy were assessed after 6 months. Responses were evaluated in terms of changes from baseline in lung physiology, functional capacity, and health-related quality of life. Follow-up is available for 21 of 25 patients. Results: Treatment was well tolerated. There were no treatment-related deaths (i.e. within 90 days of treatment), and an acceptable short- and long-term safety profile. Physiological and clinical benefits were observed at 24 weeks. Efficacy responses were better among Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III patients [n = 14; change in residual volume/total lung capacity (ΔRV/TLC) = -7.4 ± 10.3%; Δ forced expiratory volume in 1 s (ΔFEV<sub>1</sub>) = +15.9 ± 22.6%; change in forced vital capacity (ΔFVC) = +24.1 ± 22.7%; change in carbon monoxide lung diffusion capacity (ΔDL<i>CO)</i> = +19.3 ± 34.8%; change in 6-min walk test (Δ6MWD) = +28.7 ± 59.6 m; change in Medical Research Council Dyspnea (ΔMRCD) score = -1.0 ± 1.04 units; change in St. George’s Respiratory Questionnaire (ΔSGRQ) score = -9.9 ± 15.3 units] than for GOLD stage IV patients (n = 7; ΔRV/TLC = -0.5 ± 6.4%; ΔFEV<sub>1</sub> = +2.3 ± 12.3%; ΔFVC = +2.6 ± 21.1%; ΔDL<i>CO</i> = -2.8 ± 17.2%; Δ6MWD = +28.3 ± 58.4 m; ΔMRCD = 0.3 ± 0.81 units; ΔSGRQ = -6.7 ± 7.0 units). <i>Conclusions:</i> ELS therapy shows promise for treating patients with advanced heterogeneous emphysema. Additional studies to assess responses in a larger cohort with a longer follow-up are warranted. | ||
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