Lung transplantation can effectively cure COPD, but trades it for a ticking clock of organ rejection. With hundreds of thousands of potential patient-customers affected, device makers have long sought a less invasive method of improving the efficiency of airflow in people with severe emphysema.
Endobronchial valves EBV are one-way valves inserted via bronchoscopy, which divert inspired air to healthy lung away from non-functioning dead spaces.
Such valves have been prototyped, tweaked and tested over the past decade, but their uncertain benefits and sometimes concerning rates of complications kept EBVs in the development stages. In an EBV device finally gained FDA approval: called Zephyr, it has been shown to significantly improve lung function, exercise capacity and quality of life for patients living with emphysema.
One reason why previous device-based solutions failed was likely the presence of so-called collateral ventilation, which allowed air to slip back into patients' dead spaces, defeating any benefit from the devices.
The Zephyr manufacturer touts its proprietary system using a catheter deployed during endoscopy to confirm low collateral ventilation, increasing the chances of EBV utility.
The company plans to begin marketing Zephyr in the U. Effect of lung-volume-reduction surgery in patients with severe emphysema. Lung function 4 years after lung volume reduction surgery for emphysema. Patient selection for lung volume reduction surgery: An objective model based on prior clinical decisions and quantitative CT analysis. Functional and morphological heterogeneity of emphysema and its implication for selection of patients for lung volume reduction surgery.
Eur Respir J. Preoperative severity of emphysema predictive of improvement after lung volume reduction surgery: use of CT morphometry.
Mechanism of short-term improvement in lung function after emphysema resection. No-cut thoracoscopic lung plication: a new technique for lung volume reduction surgery. J Am Coll Surg. Hoppin FG Jr. Theoretical basis for improvement following reduction pneumoplasty in emphysema. Application of the fold plication method for unilateral lung volume reduction in pulmonary emphysema. Ann Thorac Surg. Effectiveness of the fold plication method in lung volume reduction surgery.
Intern Med. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. Epub May Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy. Epub Jul Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Epub Jan A randomized study of endobronchial valves for advanced emphysema.
BMC Pulm Med. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Methods: The trial design posted on Clinical trials.
Following standardized pulmonary rehabilitation, patients were randomized to receive unilateral lobar placement of endobronchial valves plus optimal medical management or optimal medical management alone. The co-primary endpoint was the mean percent change in FEV1 and six minute walk distance at days. Secondary end-points included mean percent change in St.
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