RT Journal Article
SR Electronic
T1 Safety and feasibility of targeted lung denervation in patients with moderate to severe COPD
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3720
VO 44
IS Suppl 58
A1 Dirk-Jan Slebos
A1 Karin Klooster
A1 Coenraad Koegelenberg
A1 Johan Theron
A1 Dorothy Steyn
A1 Martin Mayse
A1 Chris Bolliger
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P3720.abstract
AB Background: Acetylcholine derived from parasympathetic nerves is a well-validated target to treat patients with COPD. Targeted lung denervation (TLD) is a novel bronchoscopic therapy that ablates parasympathetic pulmonary nerves along the main bronchi.Aim: Evaluate safety and feasibility of TLD in COPD patients.Methods: A first-in-human, prospective, multicenter, study in COPD patients (FEV1/FVC<0.70; FEV1 30-60% predicted) was performed (NCT01483534). Patients underwent TLD using a catheter based lung denervation system (Holaira, Inc., USA) delivered during two rigid bronchoscopies 30 days apart, in an outpatient setting. Follow-up bronchoscopy to assess airways was performed 90 days post 2nd treatment. Feasibility was defined as ability to deliver treatment to the airway and safety determined by registration of all adverse events (AE) out to 365 days after TLD.Results: Twelve patients (FEV1 33.8±9.4 % predicted, age 62.9±11.4 yrs) were treated at a 20W energy dose and 10 (FEV1 34.5±6.3 % predicted, age 64.4±8.9 yrs) at 15W. The procedure time was 49±15 mins per lung. TLD was 100% technically successful. No serious AEs directly related to TLD and no unexpected AEs occurred. Sixteen serious AEs were observed; 8 COPD exacerbations, 2 respiratory infections, 1 flu, 1 myocardial infarction, 1 chest pain, 1 drug reaction, 1 episode of gastroparesis, and 1 stomach cancer. Ten of these were in the 15W group with 7 in one single patient. Follow-up bronchoscopy showed asymptomatic local airway wall effects post TLD in 5 patients in the 20W group, but not in the 15W group.Conclusion: TLD is technically feasible with an acceptable rate of AEs and no unexpected AEs in COPD patients.