Treatment of chronic obstructive pulmonary disease (COPD) with a minimally invasive investigative procedure called targeted lung denervation (TLD) is feasible, safe, and was found to improve lung function, according to researchers.
Their study, “Long-term safety of bilateral targeted lung denervation in patients with COPD,” was published in the International Journal of Chronic Obstructive Pulmonary Disease.
COPD treatment requires new approaches providing durable health improvements, despite the current availability of options such as bronchodilators or inhaled glucocorticosteroids.
However, the use of alternative options still requires the evaluation of long-term safety before the start of larger clinical trials.
TLD is a new therapy candidate for COPD. It involves passing a special catheter through a bronchoscope into the lungs, which, through a type of electrical energy called radiofrequency, interrupts nerve transmission outside the main bronchi.
By disrupting nerve transmission, TLD aims to dilate the bronchi (bronchodilation) permanently, reduce mucus production, and decrease airway inflammation through a reduction in the release of the neurotransmitter acetylcholine, which is known to influence airway muscle tone, mucus secretion, and inflammation.
A previous pilot study in 22 COPD patients reported that TLD in both lungs in a sequential fashion was feasible, safe, and well-tolerated.
Now, researchers conducted a multicenter study in 15 patients (47% men, mean age 63.2) with moderate to severe COPD to evaluate the safety of treating both lungs with TLD during a single procedure.
The team hypothesized that this approach would be beneficial over staging, primarily due to the reduced exposure to anesthesia and lesser risk of exacerbations caused by bronchoscopy.
The team also evaluated three-year follow-up data in treated patients to have a first look at the potential long-term effects of targeted lung denervation.
Among the parameters analyzed were:
- Absence of sustained worsening of COPD directly attributable to TLD up to one year after treatment;
- Technical feasibility;
- Change in pulmonary function;
- Exercise capacity;
- Health-related quality of life issues.
Results showed that TLD took approximately 89 minutes. No patients showed worsening of their COPD, and there were no reported complications from the TLD procedure. Also, the rate of COPD exacerbations over three years was low.
Tests of lung function and exercise capacity showed that targeted lung denervation without bronchodilators led to similar benefits as long-acting inhaled anticholinergic therapy (a COPD treatment) at 30 days, 180 days, 365 days, two years, and three years post-TLD treatment.
However, no consistent benefits in health-related quality of life were observed.
A total of 12 serious adverse events were reported over three years of follow-up, five of which were respiratory-related. No event was related to TLD.
“TLD delivered to both lungs in a single procedure is feasible and safe with few respiratory-related adverse events through 3 years,“ the researchers wrote, adding that “the overall low rate of severe COPD exacerbations during the follow-up period of up to 3 years appears noteworthy.”
According to the team, future research should focus on optimizing the energy dose, refining the procedure, and identifying patients most likely to benefit from targeted lung denervation.