Pulmonx’s Zephyr Endobronchial Valve significantly reduces breathlessness and improves physical activity and quality of life in people with severe emphysema, a post-hoc analysis of clinical trial data shows.
The study, “Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels and Quality of Life at One Year,” was published in the Annals of the American Thoracic Society.
The Zephyr Valve is a device that can be used for bronchoscopic lung volume reduction (BLVR), a non-surgical way to block off diseased portions of the lung, allowing healthier parts to take in more air. Functionally, BLVR works the same way as lung volume reduction surgery, but without surgery to remove diseased tissues.
Zephyr Valve is designed for people with emphysema — a severe form of chronic obstructive pulmonary disease (COPD) —who experience shortness of breath and are unable to perform their normal daily activities despite taking medications or oxygen therapy.
BLVR with the Zephyr Valve was evaluated as a treatment for severe emphysema in the LIBERATE clinical trial (NCT01796392). This trial enrolled 190 people, randomized to either the BLVR using the valve (128 participants) plus standard care or standard of care (62 participants) only and followed for one year.
Its main findings were previously reported, demonstrating clinically relevant benefits across multiple domains, including breathlessness and quality of life. (The Zephyr Value was approved by the FDA in 2018 for adults with severe emphysema.)
Researchers now report the results of a post-hoc analysis (an analysis performed after-the-fact) of data from LIBERATE.
Data gathered from questionnaires and assessments undertaken throughout the study period were analyzed. These covered three overarching categories: dyspnea (shortness of breath), physical activity, and quality of life.
Results showed that for all three categories analyzed, scores on multiple assessments significantly improved with Zephyr Valve BLVR compared with standard of care.
In particular, scores on the modified Medical Research Council Dyspnea Scale (mMRC, which measures dyspnea) decreased by an average of 0.5 points with BLVR, and increased by an average of 0.3 points with standard of care only (higher mMRC scores indicate greater shortness of breath).
Additionally, the percentage of people with an mMRC decrease of at least one point was significantly greater with BLVR (48.2% versus 19.0% with standard of care).
Scores on the six minute walk test (6MWT, a common measure of physical fitness for ambulatory people) similarly improved with BLVR (average increase of 12.98 meters, about 43 feet) but declined with standard of care (average decrease of 26.33 meters, about 86 feet). A significantly greater proportion of participants treated with BLVR had a 6MWT increase of at least 25 meters (about 82 feet; 41.8% vs 19.6%).
St. George’s Respiratory Questionnaire (SGRQ) measures quality of life in people with respiratory conditions, with higher scores indicating greater impairment (and poorer life quality). On average, BLVR resulted in a 7.55 point decrease in SGRQ scores, compared to a mean 0.5 point decrease with standard of care only. Significantly more participants treated with BLVR experienced a decrease of at least 4 points (56.2% vs. 30.2%).
Other assessments in these three domains yielded similar results.
Trial participants were also asked to keep daily diaries relating the intensity of their symptoms. People treated with BLVR reported significantly more days where they rated their symptoms as better than before the trial (206 vs. 102 days). Those on standard care only reported significantly more days where their symptoms were worse than before the trial (95 vs. 122 days).
“This post-hoc analysis of data from the LIBERATE multicenter [randomized clinical trial] demonstrated statistically significant and clinically meaningful improvements in multiple patient-reported measures of dyspnea, activity, and psychosocial status favouring the Zephyr valve over [standard of care] at 12-months,” the researchers wrote.
Many with emphysema experience a destructive cycle, wherein breathlessness limits their ability to participate in physical activity, and the lack of physical activity leads to poorer health outcomes. According to the team, these findings suggest that BLVR with the Zephyr Valve can help break this cycle.
“Helping patients breathe easier breaks the downward spiral of symptom-induced inactivity, muscle deconditioning and ensuing weakness, and allows patients to be more active with feelings of well-being, more confidence, and a better quality of life,” Mark Dransfield, MD, a University of Alabama professor, investigator for LIBERATE, and a study co-author, said in a press release.
“Our analysis confirms what we are seeing at the clinical level,” Dransfield added. “My patients report that they are back to socializing and participating in hobbies like golf and gardening that before the valves had become too difficult because of their disease. I have no other treatment options for COPD patients that can give them this kind of improvement in quality of life without major surgery.”
Added Glen French, president and CEO of Pulmonx: “We are very pleased with this comprehensive report showing that Zephyr Valve treatment not only improves lung function and exercise capacity, but also has a positive and profound impact on patients’ quality of life.”
This study was sponsored and funded by Pulmonx.
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