Zephyr Valve Led to Sustained Benefits in Homogeneous Emphysema
The Zephyr Endobronchial Valve leads to sustained and significant improvements in lung function, exercise capacity, and quality of life in people with homogeneous emphysema, a severe form of chronic obstructive pulmonary disease (COPD), according to one-year data from the IMPACT clinical study.
“This is very important data because patients with severe COPD/emphysema have few treatment options once medications no longer alleviate symptoms,” Ralf Eberhardt, MD, one of the study’s co-principal investigators and a professor of medicine at the University of Heidelberg’s Thoraxklinik, in Germany, said in a press release.
“Those with homogenous emphysema, where the disease is equally spread throughout the lungs, have had even fewer options,” Eberhardt said, adding that “having a minimally invasive bronchoscopic treatment that can improve breathing and quality of life for these patients is a big advancement in the pulmonary field.”
Arschang Valipour, MD, PhD, another co-principal investigator of the study, said “this is the first study of Zephyr Valves in such patients with assessments out to 12-months.”
“We are excited about these results and can now confidently offer this as a treatment option to patients with … homogeneous emphysema,” added Valipour, who is an associate professor at the Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology in Vienna, Austria.
IMPACT’s data was reported in the study, “Endobronchial Valve (Zephyr) Treatment in Homogeneous Emphysema: One-Year Results from the IMPACT Randomized Clinical Trial,” published in RESPIRATION – International Journal of Thoracic Medicine.
Pulmonx’s Zephyr Valve is a medical device approved in the U.S. for the treatment of severe COPD/emphysema, a progressive and irreversible lung disease characterized by lung tissue destruction. The device is currently covered by several major insurers in the country.
These tiny valves are placed in specific airways through a minimally invasive procedure to block airflow to damaged lung regions, thereby allowing for healthier parts of the lungs to take in more air, reducing hyperinflation and making breathing easier. Of note, hyperinflation occurs when air gets trapped in diseased parts of the lungs, compressing healthier lung tissue, flattening the diaphragm, and impairing breathing.
The IMPACT study (NCT02025205) was the first appropriately controlled trial testing the safety and effectiveness of Zephyr Valves specifically in COPD patients with homogenous emphysema.
The study enrolled 93 patients, ages 40 and older, with little or no collateral ventilation, or ventilation of the lung’s tiny air sacs through pathways that bypass normal airways , which is the population most likely to benefit from Zephyr Valves treatment.
Participants were assigned randomly to undergo either Zephyr Valves placement (43 patients) or receive standard treatment (50 patients). After six months, 41 eligible patients in the standard care group received Zephyr Valves.
IMPACT’s main goal was to assess changes in forced expiratory volume in one second — a measure of lung function — after three months. Secondary goals included assessing changes in target airway volume, hyperinflation, shortness of breath, exercise capacity, quality of life, the COPD Assessment Test (CAT) score, and the BODE score, as well as safety measures.
CAT is a questionnaire designed to measure the impact of COPD on a patient’s life, while the BODE composite score assesses a patient’s condition and predicts prognosis based on their body mass index, lung function, shortness of breath, and exercise capacity.
Previous three-month results showed that Zephyr Valves led to statistically significant and clinically meaningful improvements in patients’ lung function, exercise capacity, and quality of life, compared with standard care.
Nearly all Zephyr Valve-treated patients showed a volume reduction in the target lung lobe, indicating successful airflow blockage to intended damaged lung regions following Zephyr Valve placement.
The trial’s newly published data, up to one-year of follow-up, confirmed previous findings.
At six months, Zephyr Valve treatment significantly improved patients’ lung function, exercise capacity, and quality of life, and significantly reduced hyperinflation and the BODE score (indicating better overall health condition), compared with standard care.
Also, a significantly greater proportion of Zephyr Valve-treated patients achieved clinically meaningful improvements in all these measures, as well as in shortness of breath, compared with those receiving standard of care only, who more often showed worsening in some of these measures.
These clinical benefits were generally maintained at one year in the 34 patients initially assigned to Zephyr Valve and who were evaluated at six- and 12-months following the procedure. Participants who received Zephyr Valve treatment after remaining on standard care for six months were followed only for six months following valve placement.
Zephyr Valve placement was generally well-tolerated, with respiratory serious adverse events being more common in this group of patients only during the first month after the procedure. The rate of such events remained stable between six and 12 months in the Zephyr Valve group.
These findings highlighted that Zephyr Valve placement in people with severe homogeneous emphysema and little to no collateral ventilation “provides clinically meaningful change from [study start] in lung function, quality of life, exercise capacity, [shortness of breath], and the BODE index at 6 months, with benefits maintained out to 12 months,” the researchers wrote.
“The IMPACT study results reinforce our previous assertion that careful selection of patients for Zephyr Valve treatment, with focus on hyperinflation and the absence of collateral ventilation, rather than on the homogeneity or heterogeneity of the disease, is key to clinical success of the procedure,” Valipour said.
Glen French, Pulmonx’s president and CEO, said “the significance of the IMPACT study is that the Zephyr Valve has been shown in a randomized, controlled clinical trial to be effective in treating patients with homogeneous emphysema.
“The Zephyr Valve is the only endobronchial valve approved for the treatment of this large subset of emphysema patients,” French added.