Abstract
BackgroundLung volume reduction surgery is effective at improving lung function, quality of life, and mortality in carefully selected individuals with advanced emphysema. Recently, less invasive bronchoscopic approaches have been designed to utilize these principles while avoiding the associated perioperative risks. The Endobronchial Valve for Emphysema PalliatioN Trial (VENT) posits that occlusion of a single pulmonary lobe through bronchoscopically placed Zephyr® endobronchial valves will effect significant improvements in lung function and exercise tolerance with an acceptable risk profile in advanced emphysema.MethodsThe trial design posted on Clinical trials.gov, on August 10, 2005 proposed an enrollment of 270 subjects. Inclusion criteria included: diagnosis of emphysema with forced expiratory volume in one second (FEV1) < 45% of predicted, hyperinflation (total lung capacity measured by body plethysmography > 100%; residual volume > 150% predicted), and heterogeneous emphysema defined using a quantitative chest computed tomography algorithm. Following standardized pulmonary rehabilitation, patients were randomized 2:1 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 180 days. Secondary end-points included mean percent change in St. George's Respiratory Questionnaire score and the mean absolute changes in the maximal work load measured by cycle ergometry, dyspnea (mMRC) score, and total oxygen use per day. Per patient response rates in clinically significant improvement/maintenance of FEV1 and six minute walk distance and technical success rates of valve placement were recorded. Apriori response predictors based on quantitative CT and lung physiology were defined.ConclusionIf endobronchial valves improve FEV1 and health status with an acceptable safety profile in advanced emphysema, they would offer a novel intervention for this progressive and debilitating disease.Trial RegistrationClinicalTrials.gov: NCT00129584
Highlights
Lung volume reduction surgery is effective at improving lung function, quality of life, and mortality in carefully selected individuals with advanced emphysema
In this paper we describe the design of the Endobronchial Valve for Emphysema Palliation Trial (VENT)
The primary objective of this study is to evaluate patients with heterogeneous emphysema treated with optimal medical management including pulmonary rehabilitation with or without implantation of the Emphasys (Emphasys Medical, Inc., Redwood City, CA) Endobronchial Valve (EBV)
Summary
Overview VENT is a two-arm, randomized, controlled, multi-center trial designed to study the safety and efficacy of the EBV implantation procedure, and the ability of the EBV to produce sustained improvement of symptoms in emphysema. A pulmonary rehabilitation program was required for both control and treatment patients in the NETT study, and its inclusion in VENT allows more accurate comparisons between the results of both trials. Treatment group The study group received the EBV implantation procedure within three weeks of randomization, and continued optimal medical management and exercise similar to the control group. The samples size required to detect a 15% improvement in the treatment arm in FEV1 and a 17% improvement in 6 MWT distance at an alpha of 0.05 and a power of 0.90 is a minimum of 270 subjects with a 2:1 randomization to EBV procedure Both of these values are above the threshold for minimal clinically important differences for these tests[17,18,19]. Post hoc analysis will use these datapoints to define the speed of treatment success if present
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