Temple Lung Center Director Reports Continued Positive Results for Study Examining Minimally Invasive Treatment of Severe Emphysema
Twelve months in, EMPROVE shows patients with the Spiration® Valve System have statistical and clinically meaningful improvements in lung function, target lobe volume reduction, shortness of breath and quality-of-life parameters
Dr. Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University, announced the 12-month results of the EMPROVE multicenter, randomized and controlled study for the Spiration® Valve System (SVS), a minimally invasive treatment for severe emphysema, at the European Respiratory Society International Congress (ERS) in Paris, France, on Sept. 18.
The EMPROVE trial enrolled 172 patients across 31 centers in the U.S. and Canada and evaluated the safety and effectiveness of the Spiration® Valve System compared to optimal medical care in patients with severe emphysema in a 2-to-1 randomization. Patients eligible for the EMPROVE trial were those with severe airflow obstruction, dyspnea (shortness of breath) and hyperinflation, which occurs when air becomes trapped in the lungs and makes breathing difficult.
Dr. Criner, the EMPROVE study’s lead enroller, presented initial positive results based on a six-month primary endpoint earlier in the year at the American Thoracic Society Annual Conference in San Diego. The subsequent presentation at ERS, one of the largest respiratory meetings of the year, reported on the longer-term 12-month results of the study.
“The EMPROVE study shows that treatment of severe emphysema with the Spiration® Valve System resulted in statistical and clinically meaningful improvements in FEV1, target lobe volume reduction, dyspnea and quality-of-life parameters, with a good safety profile. Most importantly, the results presented at ERS show the benefits of valve treatment continue to be durable through 12 months,” Dr. Criner said.
Spiration® Valve System treatment, designed to isolate and reduce volume in the targeted emphysematous lobe, resulted in a mean reduction of 974 milliliters (52.8 percent reduction). As a result of the targeted lobe volume reduction, 37.2 percent of the SVS-treated group had a greater than 15 percent improvement in FEV1 at one year compared to 5.1 percent in the control group, a statistically significant and clinically meaningful improvement in lung function.
Additionally, patients treated with the Spiration® Valve showed a statistically significant 33 percent relative improvement in shortness of breath (measured by the mMRC score) in the SVS-treated group compared to the control group.
“The reduction of dyspnea reflected by the reduction in the mMRC score is a clinical improvement of the highest priority in patients with emphysema and severe hyperinflation,” Dr. Criner said.
The Spiration® Valve is an umbrella-shaped, one-way valve that is placed in the lungs through a flexible bronchoscope that provides surgeons and pulmonologists with a novel method for limiting distal airflow to the damaged or diseased lung. The system is CE Mark-approved in Europe for the treatment of air leaks and severe, heterogeneous emphysema with evidence of low collateral ventilation such as complete fissures. It is not approved for use in emphysema patients in the U.S. but is subject to ongoing clinical investigation in which approval for use in emphysema will be sought.
The most common procedure-related serious adverse event was pneumothorax (lasting more than seven days) in 12.4 percent of the SVS-treated patients, a complication that is a consequence of effective bronchoscopic lung volume reduction that has previously been demonstrated in patients undergoing endobronchial valve insertion for severe emphysema.
“The EMPROVE study demonstrates that HRCT assessment alone is an effective method for appropriate patient and the target lobe selection, resulting in a favorable risk-benefit profile with the Spiration® Valve System. Data from randomized controlled trials such as the EMPROVE study help further physician understanding of new treatment options for this underserved emphysema population,” Dr. Criner said.
The EMPROVE study was sponsored by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration® Valve System.
Editor’s Note: Neither Dr. Criner nor any member of his immediate family has financial interest in Olympus Respiratory America or Olympus Corporation.