A new study has shown that a minimally invasive procedure involving one-way valves can improve lung function in patients with severe emphysema in a multi-center clinical trial.
The study titled, “A Multicenter RCT of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM),” was published in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.
Lung volume reduction surgery (LVRS) is a current option to treat patients with severe emphysema. This surgery can improve a patient’s lung function, dyspnea, exercise tolerance, and long-term survival; however, it also is highly invasive and associated with high morbidity rates.
Pulmonx Corporation’s Zephyr endobronchial valves may present a new alternative that eliminates the associated negative factors. The endobronchial valves are inserted through a bronchoscope into lung airways of emphysema patients and demonstrate the advantages as LVRS. They function by diverting air flow from the diseased areas of the lung to the healthier areas. This allows healthy areas of the lung to expand and function better.
Single-center randomized controlled trials of endobronchial valves have been shown to be efficacious in treatment of severe heterogeneous emphysema. Therefore, researchers in Europe conducted a multicenter study (NCT02022683) to determine the efficacy and safety of endobronchial valves. This study recruited 97 patients with heterogeneous emphysema and treated them with either the endobronchial valves plus standard of care (SoC) or just standard of care.
Results showed that 55.4% of patients who received endobronchial valves demonstrated FEV1 improvement by ≥ 12% compared with 6.5% of SoC patients. At six months, 56.3% of patients who received endobronchial valves had a ≥ 12% improvement compared with 3.2% in the SoC group. The mean change in FEV1 at six months was 20.7 ±29.6% for patients who received endobronchial valves and -8.6 ±13.0% for SoC patients. Pneumothorax, or a collapsed lung, occurred in 29.2% of the EBV patients, which mad it the most common adverse event.
“EBVs have been shown to work in single center trials, but these studies tend to be performed at centers, and by physicians, with considerable experience, so the results may not be generalizable to other centers,” said lead study author Dr. Samuel V. Kemp, MD, a respiratory physician and expert in interventional bronchoscopy at Royal Brompton Hospital, in the U.K. in a press release. “What is interesting about this multicenter trial is that the results are at least as good as the single center studies, even though some of the investigators were new to the technique.”
Furthermore, the study’s authors conclude: “Benefits are in line with those seen with LVRS, and the consistent trial results, potential reduction in post-procedure morbidity, and reversibility of the procedure position Zephyr endobronchial valve treatment as a viable treatment option in those who remain symptomatic on maximal medical therapy.”
Although endobronchial valves are approved for use in Europe, they have not yet received approval in the U.S. A clinical trial (NCT01796392) is underway to support an application to the Food and Drug Administration.