Document Detail


A multicenter pilot study of a bronchial valve for the treatment of severe emphysema.
MedLine Citation:
PMID:  19923790     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Clinical Trial; Journal Article; Multicenter Study     Date:  2009-11-17
Journal Detail:
Title:  Respiration; international review of thoracic diseases     Volume:  79     ISSN:  1423-0356     ISO Abbreviation:  Respiration     Publication Date:  2010  
Date Detail:
Created Date:  2010-01-22     Completed Date:  2010-04-16     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  0137356     Medline TA:  Respiration     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  222-33     Citation Subset:  IM    
Copyright Information:
Copyright 2009 S. Karger AG, Basel.
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MeSH Terms
Descriptor/Qualifier:
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:
S88TT14065/Oxygen
Investigator
Investigator/Affiliation:
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:
Respiration. 2010;79(3):191-2   [PMID:  20093849 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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