Temple University Hospital Performs Nation’s First Post-FDA Approval Endobronchial Treatment Using the Spiration® Valve System to Treat Severe Emphysema
Temple University Hospital has become the first U.S. hospital to treat a patient with the Spiration® Valve System, a minimally invasive treatment for severe emphysema, following U.S. Food and Drug Administration (FDA) approval. It is the second time in the past year that TUH became the first hospital in the U.S. to perform a newly FDA-approved minimally invasive treatment for patients with severe emphysema.
Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and his Lung Center team completed the procedure on March 26.
The Spiration Valve is an umbrella-shaped, one-way valve that is placed in the lungs through a flexible bronchoscope during a short procedure and provides surgeons and pulmonologists with a novel method for limiting distal airflow to the damaged or diseased lung.
Spiration valves are indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
“Performing the first procedure post-FDA approval is a critical moment in our continual efforts to expand the treatment options available to Temple Lung Center patients,” said Dr. Criner. “We are pleased to be able to offer this minimally invasive endobronchial treatment to patients with severe emphysema and severe hyperinflation.”
Last September, Dr. Criner announced 12-month results of the EMPROVE multicenter, randomized and controlled study for the Spiration Valve System (SVS)i at the European Respiratory Society International Congress (ERS) in Paris, France. Thanks to those positive results, which indicated statistically significant and clinically meaningful improvements in lung function, target lobe volume reduction, shortness of breath and quality-of-life parameters, the FDA granted the Spiration Valve System approval in December 2018 under its breakthrough medical devices designation along with priority review status.
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.
The Temple Lung Center was the EMPROVE study’s lead enroller. Dr. Criner presented initial positive results based on a six-month primary endpoint earlier in 2018 at the American Thoracic Society Annual Conference in San Diego.ii The subsequent presentation on Sept. 18 at ERS, one of the largest respiratory meetings of the year, reported on the longer-term 12-month results of the study.
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 target lobe volume reduction, the SVS-treated group had a 100 milliliter (12 percent) improvement in FEV1 at six months compared to the control group, an effect that was durable through 12 months. These changes represented statistically significant and clinically meaningful improvement in lung function. FEV1, an abbreviation for forced expiratory volume, is a measure of the amount of air a person can forcefully exhale from their lungs in one second and is an important part of a pulmonary function test.
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 improvement in dyspnea (shortness of breath) reflected by the reduction in the mMRC score is a crucial development for patients with severe emphysema and severe hyperinflation, as it is their most common symptom,” Dr. Criner said.
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 and has previously been demonstrated in patients undergoing endobronchial valve insertion for severe emphysema. COPD exacerbations, pneumonia and death were also observed, but these events were not statistically different between the study groups.
“The approval and availability of new treatments like the Spiration Valve mark key steps in treating this long-term, progressive disease,” added Dr. Criner.
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: Dr. Gerard Criner has received consulting money from Olympus Corporation.
i Criner GJ, Delage A, Voelker KG, for the EMPROVE Trial Investigator Group. Late Breaking Abstract - Endobronchial Valves for Severe Emphysema – 12-month Results of the EMPROVE Trial. European Respiratory Journal, Sep 2018, 52 (suppl 62) OA4928; DOI: 10.1183/13993003.congress-2018.OA4928.
ii Criner GJ, Delage A, Voelker KG, for the EMPROVE Trial Investigator Group. The EMPROVE Trial - a Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration® Valve System for Single Lobe Treatment of Severe Emphysema. American Thoracic Society International Conference Abstracts. 2018:A7753-A7753. doi:10.1164/ajrccm-conference.2018.197.1_ MeetingAbstracts.A7753.