New COPD Treatment Option: Lung DenervationOct. 14, 2021 - Todd Ackerman
Houston Methodist doctors have begun testing a new bronchoscopic procedure to treat chronic obstructive pulmonary disease (COPD), the condition that causes airflow blockage and breathing-related problems.
This new procedure, known as targeted lung denervation, brings hope of an additional treatment possibility for patients suffering from frequent COPD flare-ups, or exacerbations. It uses radio wave energy to disrupt nerve cell transmission, relaxing the airways and diminishing mucus production.
"This would be a big advance for a patient population, those suffering from chronic bronchitis, for whom there's been no new therapy in at least a decade," says Dr. Lisa Kopas, a pulmonologist who is leading the Houston Methodist arm of the international trial testing the procedure's efficacy. "Lung denervation should better treat their condition and improve their quality of life."
Houston Methodist is among 33 sites, 20 in the U.S., aiming to enroll roughly 480 patients over the next 18 months in a randomized trial testing the procedure. Trial participants, who must have moderate to severe COPD, receive either lung denervation or sham therapy.
Positive trial results should lead to FDA approval
The trial, known as AIRFLOW-3, was paused last year because of the COVID-19 pandemic but resumed in June 2021.
If trial results are positive, FDA approval is expected to follow soon. Previous studies have shown targeted lung denervation is safe, well-tolerated and long-lasting, and a phase 2 trial showed the therapy lowered the risk of hospitalization due to exacerbations. The FDA designated the system that delivers the therapy a Breakthrough Device in 2020.
COPD, a progressive disease that gets worse over time, affects more than 15 million Americans, according to the CDC. Usually smoking-related, it is the third leading cause of death by disease in the U.S.
It includes chronic bronchitis and emphysema.
Decreasing patients' amount of mucus is important because that's thought to be the primary cause of COPD exacerbations. Symptoms become markedly worse during exacerbations, which lead to a decline in lung function and exercise capacity.
Lung denervation expected to become routine
Dr. Kopas performed the procedure last month, the first in Texas, as part of the AIRFLOW-3 trial. She's currently screening five more possible candidates.
Dr. Kopas says she expects Houston Methodist will perform about 10 procedures for the trial, then do them fairly routinely once the procedure is approved.
The Houston Methodist patient who received the lung denervation suffered from a daily cough, shortness of breath and frequent exacerbations. He'd been on steroids two or three times in the past year.
The lung denervation system, manufactured by Nuvaira, includes a specialized catheter that delivers radiofrequency energy to the nerves located on the outside of the major airways and a cooling solution that prevents mucosal damage.
Lung denervation works much like ablation to treat cardiac arrhythmia. The high dose of radio frequency ablation in the airways on the left and right sides of the lung reduces the clinical consequences of neural hyperactivity.
Decrease in exacerbations isn't immediate
The procedure lasts about an hour and patients are usually discharged from the hospital the same day.
Lung denervation can result in an in increase in exacerbations in the 12 weeks immediately following the procedure. But in subsequent months, patients who have received the therapy in trials typically experience less frequent exacerbations.
More than 170 procedures have been performed under the AIRFLOW-3 trial so far.
"This is a promising treatment option for COPD patients whose exacerbations are not well controlled with medications," says Dr. Kopas. "It's a needed advance for patients whose quality of life is currently low."