SESSION TYPE: COPD: Therapeutic Options
PRESENTED ON: Sunday, October 21, 2012 at 10:30 AM - 11:45 AM
PURPOSE: Bronchoscopic lung volume reduction is a rapidly developing area and at present intensively evaluated and discussed. The Lung Volume Reduction Coil (RePneu® LVRC, PneumRx Inc.) can be used in patients with severe heterogeneous and homogeneous emphysema, independent of collateral ventilation, due to its mechanical compression of diseased parenchyma. We report on the safety and efficacy of LVR-coil therapy at 12-months post-treatment, from two feasibility studies with nearly identical protocols (NCT01220908, NCT01328899)
METHODS: The studies were non-randomized, multicenter and single-arm. 85 patients with severe emphysema were treated with LVR-coils under fluoroscopic guidance, 71 of them bilaterally. Upper and lower lobes were treated. Follow-up included SGRQ, lung function tests and 6MWT. Efficacy was reported for bilaterally-treated patients.
RESULTS: In 85 patients (baseline FEV1 29% (±6.4%) predicted), 156 procedures were carried out with, median 10 coils (range 5-15) per procedure. Procedure duration was 48±24 minutes. Serious adverse events possibly related to device or procedure <30 days after treatment were pneumothorax (n=2), pneumonia (n=11), COPD exacerbation (n=10), and hemoptysis (n=2). From 30 days to over 300 days these were: pneumothorax (n=1), dyspnea (n=3), pneumonia (n=10), and COPD exacerbation (n=28). All events resolved with standard care. All efficacy results were reported as change from baseline. At 12 months post-treatment, significant improvements in 6MWT (63.04±13.79 meters), RV (-0.61±0.13 liters), and SGRQ (-12.06±2.43 points) were reported. Overall improvements were sustained relative to the 6-month results.
CONCLUSIONS: LVR-coil treatment is an effective technique for endoscopic lung volume reduction, with an acceptable safety profile and sustained benefit. In this cohort of patients with varying degrees of heterogeneity and homogeneity, upper and lower lobe bilateral treatments demonstrate statistically significant and clinically relevant effectiveness at 360 days.
CLINICAL IMPLICATIONS: LVR-coil treatment appears to offer an effective treatment for a broad range of emphysema patients. Patients may achieve significant and sustained clinical benefits, and importantly, LVRC treatment appears efficacious in heterogeneous as well as homogeneous disease, in upper as well as lower lobes, and independent of collateral ventilation.
DISCLOSURE: The following authors have nothing to disclose: Franz Stanzel, Wolfgang Gesierich, Martin Hetzel, Gaëtan Deslee, Romain Kessler, Christian Witt, Charles Hugo Marquette, Michel Pfeifer, Stefan Blaas, Juergen Hetzel, Felix Herth, Dirk-Jan Slebos
Presenter is discussing information about a product which has received CE clearance in the EU, but is NOT approved for sale in the US.Lung Clinic Hemer, Hemer, Germany