Gerard Criner, MD, FACP, FACCP, 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, presented the first long-term five year follow-up data of the LIBERATE study for the Zephyr® Endobronchial Valve® (Zephyr® EBV®), a minimally invasive treatment for severe emphysema, at the European Respiratory Society (ERS) Congress in Vienna, Austria, on Sept. 9.
Dr. Criner helped design and was a principal investigator on the original LIBERATE study, which enrolled 190 patients in a multicenter, randomized, controlled trial to evaluate the effectiveness and safety of Zephyr® EBV® in select patients. That study showed Zephyr® EBV® provided clinically meaningful benefits, including reduced shortness of breath and improved respiratory function, out to at least 12 months. It also demonstrated Zephyr® EBV® has an acceptable safety profile in patients with little or no collateral ventilation -- opening in the walls between the lung lobes -- in the target lobe.
Dr. Criner published these initial positive results in the American Journal of Respiratory and Critical Care Medicine in March 2018, which led to the Zephyr® EBV® receiving FDA approval. In August 2018, Temple became the first U.S. hospital to perform bronchoscopic lung volume reduction (BLVR) using the Zephyr® EBV®. Since then, BLVR with Zephyr® EBV® has become an established guideline-based treatment for patients with severe emphysema.
The subsequent presentation this month at ERS, one of the largest respiratory meetings of the year, reported on the longer-term five-year durability results of the LIBERATE study.
“The benefits of BLVR in improving lung function, exercise tolerance, and quality of life have been established through several randomized clinical trials but prospective long-term data were lacking,” Dr. Criner said. “The results presented at ERS show the benefits of Zephyr® EBV® continue to be durable through five years with an acceptable safety profile.”
The Zephyr®-treated patients in the LIBERATE Study were evaluated annually to assess lung function (FEV1) and adverse events.
Thirty percent of the Zephyr®-treated group had a greater than 15 percent improvement in FEV1 at year five, a clinically meaningful improvement in lung function.
“Even in the absence of a control group beyond year one, the FEV1 improvement over baseline through year five would be considered an advantage over maximal medical treatment alone given the known decline in lung function over time,” Dr. Criner said.
The results of the five-year follow-up also showed that the safety profile continued to be acceptable.
The Zephyr® EBV® provides a minimally invasive treatment option for patients with emphysema and suffering from hyperinflation, which happens when air becomes trapped in the lungs and makes breathing difficult. The Zephyr® EBV® is implanted using a bronchoscope and flexible delivery catheter and then functions as a one-way valve causing the damaged lung lobe to deflate, while preventing further lobar inflation.
In addition to leading the LIBERATE trial, the Temple Lung Center became the first U.S. site to train U.S. physicians on the care and management of emphysema patients who may receive the Zephyr® EBV®.
LIBERATE was funded by Pulmonx Corporation, Redwood City, California.
Editor’s Note: Dr. Criner reports research and educational grants from Pulmonx, as well as having received consultant fees.