Researchers found ‘statistically significant improvements’ in lung function, respiratory symptoms, and quality of life measures at 24 months.
Patients with severe emphysema, a form of chronic obstructive pulmonary disease (COPD), treated with the Spiration valve system experienced a significant improvement in lung function, respiratory symptoms, and quality-of-life scores at 24 months, according to a new study.
The EMPROVE study, published in the Annals of the American Thoracic Society, is the first randomized controlled trial to present a rigorous comparison of bronchoscopic lung volume reduction (BLVR) using endobronchial valve with standard-of-care controls for up to 24 months in severe emphysema patients, according to the researchers.
Researchers measured lung function (using forced expiratory volume in one second; FEV1), respiratory symptoms (using the modified Medical Research Council dyspnea scale), and quality-of-life measures using the St. George’s Respiratory Questionnaire, COPD Assessment Test, and the Short Form Health Survey.
The study results in this longer follow-up time found statistically significant improvements in lung function, dyspnea or shortness of breath, and quality of life in patients treated with the Spiration valve system, according to the published data.
“The results from the EMPROVE trial demonstrate the positive impact the Spiration valve can have on emphysema patients,” says Gerard Criner, MD, chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center, who is lead investigator of the EMPROVE trial, in a release. “[Spiration valve system] treatment offers an important opportunity to improve a patient’s lung function and quality of life. The benefits compared to the control group at 24 months are long-lasting, statistically significant, and clinically meaningful.”
EMPROVE, a prospective, multicenter, randomized controlled trial, included 172 patients from 31 sites in the United States and Canada. Patients with severe heterogeneous emphysema were randomly assigned treatment with the Spiration valve system or to the control group.
Researchers found no difference in adverse events between the Spiration valve system treatment and control groups, and there were no reported cases of migration or erosion in the Spiration valve system treatment group at 24 months.
“This study points to the significant and positive long-term impact [Spiration valve system] treatment can have on the day-to-day functions of emphysema patients,” says John de Csepel, MD, chief medical officer at Olympus Corp, manufacturer of the system, in a release. “Meaningful improvement in breathing can mean fuller lives for patients for activities as simple as the ability to go on daily walks or enjoying time with grandchildren.”
The Spiration valve is an umbrella-shaped device that is placed in the most diseased parts of the lung during a short bronchoscopic procedure. Treatment with endobronchial valves such as the Spiration valve can improve lung function by redirecting air away from hyperinflated portions of the lung to healthier portions.
Potential adverse events that may be associated with the use of the Spiration valve system may include but are not limited to pneumothorax, worsening of COPD symptoms, pneumonia, and dyspnea.
Photo caption: Spiration valve system
Photo credit: Olympus Medical
