Long-Term Data Support Valve Value for Emphysema

VIENNA — Bronchoscopic lung volume reduction (BLVR) was associated with sustained improvements in adults with severe emphysema over a 5-year period, based on data from 190 individuals. The LIBERATE study, a randomized clinical trial, showed the benefits of BLVR for adults with severe emphysema, wrote Gerard J. Criner, MD, and colleagues, in a poster presented at the European Respiratory Society (ERS) 2024 International Congress.
The current study presented at the meeting was conducted to assess the 5-year durability of the Zephyr valve for BLVR, said Criner, chair and professor of thoracic surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
In the original LIBERATE study, published in the American Journal of Respiratory and Critical Care Medicine in 2018, Criner and colleagues showed that compared with standard of care, the Zephyr endobronchial valve was associated with clinically meaningful improvements in lung function, exercise tolerance, dyspnea, and quality of life for at least 12 months, with an acceptable safety profile.
In the current study, the researchers reviewed 5-year data from 52 of the 190 adults with severe emphysema who were originally randomized to treatment with the Zephyr valve or standard of care.
At 1 year, nearly half of the 115 patients who received Zephyr valves (49.6%) showed an improvement in forced expiratory volume per second (FEV1) of 15% or more. At 5 years, 30% of the 40 patients for whom data were available showed this level of improvement.
The average percent change in FEV1 from baseline was 17.07 at 1 year and 13.45 at 5 years; the absolute change in FEV1 was 109 mL at 1 year and 79 mL at 5 years.
The continued improvement over baseline with the valve would be considered an advantage over the maximum medical standard care, given the known decline in lung function over time in patients with severe emphysema, the researchers wrote in their poster.
No new types of respiratory serious adverse events (SAEs) and no increase in the frequency of SAEs were noted between the end of year 1 and year 5. The most common SAEs in the years after year 1 were chronic obstructive pulmonary disease (COPD) exacerbations, pneumonia, respiratory failure, and pneumothorax. A total of 39 patients died during the period between years 1 and 5, including 10 in the Zephyr valve group, and one of these deaths was deemed related to the valves, the researchers noted.
Takeaways and Next Steps
The findings align with other long-term data on lung volume reduction surgery, but the persistently positive safety profile is very encouraging, Criner told Medscape Medical News.
The takeaway for clinical practice is that the Zephyr valve shows durability in both beneficial treatment and an acceptable safety profile after 5 years, he said.
A main limitation of the study is the relatively small percentage of patients for whom it is indicated, and this represents an area for additional research, Criner noted. Currently, the treatment is only for patients with heterogenous emphysema who lack collateral ventilation in the treatment lung, which only represents 30% of patients with emphysema, and more research is needed in other populations, he said. “We also need bronchoscopic treatments for patients with homogenous emphysema that are as durable and safe who have collateral ventilation presence,” he told Medscape Medical News.
The findings were also limited by the lack of a control group beyond the first year, the researchers noted in their poster. However, the death rate in the Zephyr valve group in the LIBERATE study was 0.38 at 5 years, which compares favorably with the rate of 0.49 in the medical management group of a similar study conducted by the National Emphysema Treatment trial, the researchers wrote in their poster. The resulting improvements and acceptable safety profile out to at least 5 years support treatment with the Zephyr valve, they concluded.
Data Show Long-Term Value of Valve
“Bronchoscopic lung volume reduction is a valuable treatment for many patients with symptomatic COPD/emphysema with hyperinflation, but there has been a paucity of long-term prospective data on the safety and efficacy,” said Emily DuComb, DO, clinical assistant professor of medicine in the interventional pulmonology department of the University of Michigan, Ann Arbor, Michigan, in an interview.
The new study provides important information that can be used to inform shared decision-making among healthcare providers and patients, said DuComb, who was not involved in the study.
“For patients who are deemed to be candidates, this treatment can offer substantial symptomatic benefit — reduced breathlessness, improved activity tolerance and quality of life, and may also reduce exacerbations and potentially have survival benefit,” DuComb said.
Barriers to the routine use of the Zephyr valve include patients’ anatomical or pathophysiologic factors that keep them from being candidates, and also lack of awareness of the treatment on the part of patients and potential referring healthcare providers, she noted.
“Additional research is needed to determine what therapies may be offered to increase patient candidacy,” DuComb told Medscape Medical News. Exclusion of patients because of incomplete fissural integrity is an ongoing area of research, she noted. Other targets for further study include continuing to amass long-term data on the efficacy of the valves based not only on objective values but also on clinical quality of life metrics, she said. More research will help determine how best to mitigate potential valve-related complications and/or the need for secondary procedures, she added.
Criner and Temple University disclosed research funding and educational grants from Pulmonx, manufacturer of the Zephyr valve, and Criner has received grants from other companies, including GSK, Boehringer Ingelheim, Novartis, AstraZeneca, Respironics, MedImmune, Pearl, PneumRx, Broncus, Spiration, Olympus, Fisher & Paykel Healthcare, Chiesi, Gilead Sciences, Pfizer, Corvus, Eli Lilly and Company, Regeneron Pharmaceuticals, Genentech, and Roche. Criner has also served as a consultant for companies such as Almirall, AstraZeneca, Nuvaira, GSK, CSA Medical, PneumRX, BTG, Mereo BioPharma, Broncus, Pulmonx, GSK, EOLO, and Aerwave. DuComb had no financial conflicts to disclose.
 
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