PURPOSE: The Lung Volume Reduction Coil (LVRC) is an experimental device for the treatment of emphysema. In this study we investigated the safety and efficacy of LVRC treatment in patients with severe heterogeneous emphysema.
METHODS: Study design: prospective, uncontrolled cohort study in COPD patients Gold stage 3/4 with heterogeneous emphysema (digitally quantified on CT). Patients were bronchoscopically treated with LVRCs (PneumRx, USA) in either one or two lungs (in two sequential procedures) under fluoroscopic guidance. Safety was evaluated by recording of all (S)AEs. At baseline and at 3 months after each procedure mMRC, SGRQ, pulmonary function testing and 6MWT were assessed.
RESULTS: 27 LVRC procedures in 16 pts (12F/4M, 56.6±7.6yrs, baseline FEV1 28%pred ±7.6%) were performed. 5 pts were treated in one, and 11 pts were treated in both lungs. Median 10 (5-12) coils in 37 (21-60) minutes were placed per lung. (S)AEs rated as possibly related to either the device or the procedure <30 days after treatment: pneumothorax (n=1), pneumonia (n=1), COPD exacerbation (n=7), transient chest discomfort (n=9), <5mL hemoptysis (n=15). From 30 days until a mean follow-up of 180 days (±71 days) these were: pneumonia (n=1), COPD exacerbation (n=8). All these (S)AEs resolved. In 4 pts the coils caused a partial atelectasis of the treated lobe. Treatment of one lung resulted in: ΔFEV1 +9.2% ± 4.9%, ΔFVC +8.7% ±5.0%, ΔRV -7.5% ±2.6%, Δ6MWT +28.8% ±9.5%, ΔmMRC -0.8 points ±0.4, and ΔSGRQ -13.1 points ±4.0 (all p<0.01). Compared to baseline, the second LVRC treatment resulted in a ΔFEV1 of +19.9% ± 7.1%, ΔFVC +13.0% ±3.8%, ΔRV -11.2% ±2.8%, Δ6MWT +35.0% ±15.4%, ΔmMRC -1.0 points ±0.4, and ΔSGRQ -14.5 points ±4.0 (all p<0.01).
CONCLUSION: LVRC treatment in this patient population with severe heterogeneous emphysema resulted in significant improvements in pulmonary function, exercise capacity and quality of life, with an acceptable safety profile.
CLINICAL IMPLICATIONS: With these promising data, larger and controlled trials evaluating the impact of LVRC treatment for patients with emphysema are warranted.
DISCLOSURE: Dirk-Jan Slebos, Other Conflict of interest: The study was sponsored by PneumRx Inc, Mountain View, CA. The authors serve as advisors to the company and were reimbursed for study related travel expenses. None of the authors has a financial interest in the company. All authors had complete access to the data, reviewed and approved the manuscript. PneumRx was not involved in the draft of the manuscript, except the right to review the manuscript in its’ final form regarding publication of proprietary information. No information was deleted.; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. The Lung Volume Reduction Coils (PneumRx, Inc., Mountain View, CA) are made from Nitinol wire that has been pre-formed to a shape that results in parenchymal compression after deployment. The coils are implanted bronchoscopically using a proprietary delivery system under fluoroscopic guidance.