American Thoracic Society International Conference

American Thoracic Society International Conference

Source:

Slebos DJ, et al. Hot Takes from Clinical Trials in Lung Disease. Presented at: American Thoracic Society International Conference; May 14-19, 2021 (virtual meeting).

Disclosures: The study was funded by Pneumonx. Slebos reports he has financial ties with Aeris, Asthmatx, Boston Scientific, Broncus, CSA Medical, FreeFlow Medical, Nuvaira, Olympus, PneumRx/BTG, Portaero and Pulmonx.
June 14, 2021
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Improvements in lung function, quality of life sustained long-term with endobronchial valve

Source:

Slebos DJ, et al. Hot Takes from Clinical Trials in Lung Disease. Presented at: American Thoracic Society International Conference; May 14-19, 2021 (virtual meeting).

Disclosures: The study was funded by Pneumonx. Slebos reports he has financial ties with Aeris, Asthmatx, Boston Scientific, Broncus, CSA Medical, FreeFlow Medical, Nuvaira, Olympus, PneumRx/BTG, Portaero and Pulmonx.
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Patients with severe emphysema who received an endobronchial valve had sustained improvements in lung function and quality of life out to at least 24 months, according to long-term data from the TRANSFORM study.

Additionally, improvements in exercise capacity were sustained out to at least 18 months.

Lungs
Source: Shutterstock.

“Bronchoscopic lung volume reduction with Zephyr valves provide durable reduction in hyperinflation and meaningful improvements in lung function and quality of life based on multiple patient-reported measures. There was a statistical clinical improvement in outcomes from baseline through 24 months despite the progressive nature of emphysema,” Dirk-Jan Slebos, MD, PhD, professor of interventional pulmonology at the University of Groningen, the Netherlands, said during a presentation at the American Thoracic Society International Conference.

Slebos presented new follow-up data out to 24 months from the TRANSFORM study. TRANSFORM was the first multicenter, randomized controlled trial to evaluate the effectiveness and safety of Zephyr valves (Pulmonx) in patients with heterogeneous emphysema prospectively identified for absence of collateral ventilation in the target lobe, he said. Six-month data were previously reported in 2017 in the American Journal of Respiratory and Critical Care Medicine.

The study was performed in 17 centers in Europe and enrolled 97 patients (mean age, 64.3 years) with heterogeneous emphysema. Patients were randomly assigned to receive an Zephyr endobronchial valve (n = 65) or standard care (n = 32).

At 24 months’ follow-up, Slebos reported a persistent decrease in hyperinflation with the Zephyr valve vs. standard care (P = .004 vs. baseline). Results also demonstrated persistent improvement in FEV1 with a gradual decline over time (P = .052) and a consistent improvement in 6-minute walk distance (P = .36).

At 24 months, positive changes with the Zephyr valve vs. standard of care on the St. George’s Respiratory Questionnaire score (P < .001 vs. baseline), dyspnea score (P = .032) and survival measured by BODE index (P = .013) persisted, according to the results.

Researchers observed no unexpected adverse events between 6 and 12 months. Between 12 and 24 months, among patients treated with endobronchial valves, 13% had COPD exacerbations, 3.7% had pneumonia, 1.9% had pneumothorax, 3.7% had respiratory failure and 1.9% had end-stage COPD, according to the results.

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