| A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. | |
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MedLine Citation:
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PMID: 19923790 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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(R) 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. FEV(1), 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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Authors:
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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; |
Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study Date: 2009-11-17 |
Journal Detail:
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Title: Respiration; international review of thoracic diseases Volume: 79 ISSN: 1423-0356 ISO Abbreviation: Respiration Publication Date: 2010 |
Date Detail:
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Created Date: 2010-01-22 Completed Date: 2010-04-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0137356 Medline TA: Respiration Country: Switzerland |
Other Details:
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Languages: eng Pagination: 222-33 Citation Subset: IM |
Copyright Information:
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Copyright 2009 S. Karger AG, Basel. |
Affiliation:
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University of Pennsylvania Medical Center, Philadelphia, PA 19104-4283, USA. daniel.sterman@uphs.upenn.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Blood Gas Analysis Bronchoscopy Device Removal Exercise Test Female Humans Lung Volume Measurements Male Middle Aged Oxygen / therapeutic use Pilot Projects Pneumonia / epidemiology*, etiology Pneumothorax / etiology* Postoperative Complications / epidemiology* Prospective Studies Prostheses and Implants* / adverse effects Pulmonary Circulation Pulmonary Emphysema / mortality, radiography, surgery* Quality of Life Tomography, X-Ray Computed Treatment Outcome United States / epidemiology |
| Chemical | |
Reg. No./Substance:
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7782-44-7/Oxygen |
| Investigator | |
Investigator/Affiliation:
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Robert McKenna / ; Zab Mohsenifar / ; Carol Geaga / ; Atul Mehta / ; Thomas Gildea / ; Yvonne Meli / ; Michael Machuzak / ; Sudish Murthy / ; Roger Maxfield / ; Mark Ginsburg / ; Fran Brogan / ; Angela Di Mango / ; Bryon Thomashow / ; Chun Yip / ; Joshua Sonett / ; Patricia Jellen / ; Momen Wahidi / ; Thomas D'Amico / ; Linda S Brown / ; John Davies / ; Praveen Mathur / ; Francis Sheski / ; Kathleen Keller / ; Annette Hempfling / ; David Ost / ; Talwar Arunabh / ; Romona Ramdeo / ; Shirley Lilavois / ; Philip Diaz / ; Patrick Ross / ; Mahasti Rittinger / ; Abbas El-Sayed Abbas / ; Bonnie Massey / ; Janice Drake / ; Maria Lucarelli / ; Nitin Bhatt / ; Rachael Compton / ; Shaheen Islam / ; Robert Cerfolio / ; Sara Pereira / ; Jeana Alexander / ; Ayesha Bryant / ; Chad Miller / ; Keith Willie / ; Sandra Calloway / ; Daniel StermanV / ; Ali Musani / ; Barbara Finkel / ; Andrew Haas / ; Colin Gillespie / ; David Lipson / ; Michael Machuzak / ; Michael Sims / ; Steven Leh / ; Jonathon Truwit / ; Yun Michael Shim / ; Peggie Donowitz / ; Ajeet Vinayak / ; Halim Hanna / ; Monojkumar Patel / ; Renee Campbell / ; Douglas Wood / ; Michael Mulligan / ; Jo Ann Broeckel Elrod / ; Linda Harrison / ; Harvey O Coxson / ; Paola V Nasute Fauerbach / ; Claudine Storness-Bliss / ; Sebastian Cogswell / ; Nestor L Muller / ; Yi-Jing Duh / ; Linda Rismondo / ; Bill Sirokman / ; Clint Finger / |
| Comments/Corrections | |
Comment In:
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Respiration. 2010;79(3):191-2
[PMID:
20093849
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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