Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study
American Journal of Respiratory and Critical Care Medicine, Vol. 194, No. 9, Nov 01, 2016
Patients with homogeneous emphysema also benefit from therapy with endobronchial valves
This new clinical study demonstrates the benefits of Pulmonx Zephyr Endobronchial Valves in patients with homogeneous emphysema.
The positive results of the IMPACT STUDY, published in the American Journal of Respiratory and Critical Care Medicine online (Sept. 2016), demonstrate that patients with homogeneous emphysema benefit from treatment with the Zephyr Endobronchial Valve (EBV®) from Pulmonx. Patients pre-selected with the Chartis® System and treated with EBV, experienced significant improvements in lung function, exercise capacity and quality of life following therapy.
The IMPACT STUDY is the first prospective, randomized, multi-centre study examining the effectiveness of the Zephyr EBV specifically in patients with homogeneous emphysema. The study enrolled and randomized 93 patients with severe homogeneous emphysema to compare the safety and effectiveness of Zephyr EBV treatment versus medical management. The Chartis System was used to select patients with little or no collateral ventilation, and thus most likely to benefit from treatment whilst advanced imaging technology was used to select a target lobe for treatment.
The three-month results from the IMPACT STUDY showed that patients with homogeneous emphysema and little or no collateral ventilation in the target lobe (assessed using the Chartis System) treated with the Zephyr Endobronchial Valve experienced a 17 percent improvement in FEV1 compared to the control group. EBV-treated patients also experienced improved exercise tolerance, with a 40-meter increase over the control group in the Six Minute Walk Test (6MWD), and improved quality of life, with a 10-point improvement in the St. Georges Respiratory Questionnaire (SGRQ) score over the control group. The results also showed that 97 percent of EBV subjects experienced target lobe volume reduction, indicating effective occlusion of the target lobe following Zephyr EBV placement. These data indicate that EBV therapy can benefit substantially more patients than previously believed.
Click here to see detailed information about the IMPACT STUDY.