Lung function improvement in severe emphysema sustained over 5 years with Zephyr Valves
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Key takeaways:
- Compared with baseline, FEV1 increased 5 years after Zephyr Valve treatment.
- The proportion of patients reporting a respiratory serious adverse event went down after year one.
Patients with severe emphysema had lasting lung function improvement 5 years after bronchoscopic lung volume reduction with Zephyr Valves, according to a poster presented at the European Respiratory Society International Congress.
“The Zephyr Valve has a durable beneficial treatment and acceptable safety profile,” Gerard J. Criner, MD, FACP, FACCP, chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center, told Healio.
In this study, Criner and colleagues analyzed 115 patients with severe emphysema who underwent bronchoscopic lung volume reduction with Zephyr Valves (Pulmonx) in the LIBERATE study to find out how post-bronchodilator FEV1 and the rate of adverse events change over the 5 years following the procedure.
The LIBERATE study measured these outcomes 1 year after the procedure.
As Healio previously reported, a study performed in Europe found that patients with severe emphysema who received the Zephyr Valve had sustained improvements in lung function and quality of life out to at least 24 months.
Researchers had 1-year data for 115 patients, 2-year data for 89 patients, 3-year data for 74 patients, 4-year data for 44 patients and 5-year data for 40 patients.
Compared with baseline, FEV1 was higher in each assessed year following Zephyr Valve treatment (absolute change, 1 year, +0.109 L; 2 years, +0.089 L; 3 years, +0.053 L; 4 years, +0.121 L; 5 years, +0.079 L).
The proportion of FEV1 responders, defined as having 15% FEV1 improvement or more, was highest 1 year after the procedure (49.6%) and gradually decreased as years passed (2 years, 48.3%; 3 years, 35.1%; 4 years, 36.4%; 5 years, 30%).
When evaluating respiratory serious adverse events, year 1 had the largest proportion of patients reporting an event at 58.6% (75/128). In the following 4 years, smaller proportions of patients reported respiratory serious adverse events (year two, 22.7% [25/110]; year three, 31.6% [30/95]; year four, 34.6% [27/78]; year five, 38.5% [20/52]).
COPD exacerbation was the most frequently reported serious adverse event in year two (14.5%), year three (17.9%), year four (23.1%) and year five (13.5%). In year one, this was the second most reported serious adverse event (28.1%) behind pneumothorax (30.5%).
Compared with year one, a lower proportion of patients experienced pneumothorax in the following years (year two, 3.6%; year three, 3.2%; year four, 1.3%; year five, 1.9%).
Researchers further highlighted that four of the nine pneumothorax events reported in years two through five happened after a secondary bronchoscopy procedure.
Other respiratory serious adverse events included pneumonia, which was reported by fewer patients in year two and year four vs. year one, and dyspnea, which was reported by more patients in year one than any other assessed year.
Lastly, a larger proportion of patients experienced respiratory failure in year three (3.2%), year four (5.2%) and year five (11.5%) vs. year one (2.3%).
In terms of mortality, 39 patients died between the first-year follow-up and the fifth-year follow-up, and researchers considered one death related to the valves.
Compared with the medical management arm of the National Emphysema Treatment Trial, patients treated with the Zephyr Valve had a lower death rate at 5 years (0.38 vs. 0.49).
“The findings are in line with other forms of long-term data with lung volume reduction surgery but very encouraging that the safety profile is better,” Criner told Healio.
“This is only for heterogenous emphysema patients with absent collateral ventilation in the treatment lung — that’s only 30% of the emphysema population,” Criner said. “We also need bronchoscopic treatments for patients with homogenous emphysema that are as durable and safe who have collateral ventilation presence.”