SESSION TITLE: COPD
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Wednesday, October 30, 2013 at 02:45 PM - 03:45 PM
PURPOSE: The Lung Volume Reduction Coil (LVRC, PneumRx Inc.) is a bronchoscopic implant for the treatment of severe emphysema, proven to be effective in the treatment of severe COPD. To evaluate longer term efficacy and perform subgroup analyses on efficacy in homogeneous disease, four European studies with nearly identical protocols were analyzed out to one year post-treatment.
METHODS: 119 patients (mean age: 61 years, mean FEV1: 29%, mean RV: 245% pred., mean 6MWT 313m) were treated by bilateral LVRC performed in two separate procedures in two contralateral lobes, with follow-up at 6 months and one year. A post-hoc blinded CT analysis was performed on a subset of data I) by a digital lobar CT emphysema score assessing the percentage destruction below -950HU with a <25% difference between ipsilateral lobes defining homogeneous emphysema, and II) by a visual pattern approach grading from 0 (no damage) to 4 (bullous disease) with a difference of ≤1 point defining homogeneous emphysema.
RESULTS: 2311 LVRCs were placed in 238 procedures (mean 9.7±1.6 per lobe). Serious adverse events (SAE) in the 30 days following treatment included 13 COPD exacerbations (5.5%), 1 hemoptysis (0.5%), 11 pneumonia (4.6%), 9 pneumothorax (3.8%), no deaths or acute respiratory failure. All SAEs resolved with standard care. Effects of LVRC treatment at 6 and 12 months showed significant and sustained mean efficacy: ΔFEV1: +14.9%±22 and +13.2%±27; ΔRV: -0.59L ±0.76 and -0.52L ±0.77; Δ6MWD: +44m±67 and +51m±62; and ΔSGRQ: -11.2pts±12 and -10pts±12 (p<0.0001 for all values). Post-hoc analysis at 6 months was performed on 63 patients to compare homogeneous and heterogeneous response. Digital CT analyses identified 25 homogenous and 38 heterogeneous cases; the visual approach identified 34 homogeneous and 29 heterogeneous. Both RV, 6MWT and SGRQ responses were similar between the two groups, regardless of the calculation method. Only the FEV1 response differed significantly in favor of the heterogeneous group.
CONCLUSIONS: LVRC treatment results in significant and clinically relevant improvements in exercise capacity, lung function, and quality of life for patients with homogeneous and heterogeneous emphysema. Patient relevant improvements from LVRC treatment are sustained at one year.
CLINICAL IMPLICATIONS: The Bronchoscopic Lung Volume Reduction Coil Treatment is a feasible, safe and effective treatment modality for patients with severe heterogeneous and homogeneous emphysema
DISCLOSURE: Dirk-Jan Slebos: Consultant fee, speaker bureau, advisory committee, etc.: DJS has been on advisory board meetings of PneumRx and received travel support from PneumRx for presentation of scientific data. The following authors have nothing to disclose: Stephen Bicknell, Wolfgang Gesierich, Felix Herth, Juergen Hetzel, Martin Hetzel, Romain Kessler, Charles-Hugo Marquette, Michel Pfeifer, Pallav Shah, Franz Stanzel, Christian Witt, Gaetan Deslee
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