PT  - JOURNAL ARTICLE
AU  - Gaëtan Deslee
AU  - Stephan Blaas
AU  - Wolfang Gesierich
AU  - Felix Herth
AU  - Juergen Hetzel
AU  - Martin Hetzel
AU  - Romain Kessler
AU  - Charles-Hugo Marquette
AU  - Michael Pfeifer
AU  - Franz Stanzel
AU  - Christian Witt
AU  - Dirk-Jan Slebos
TI  - Lung volume reduction coil treatment for patients with emphysema: 6-month multicenter feasibility results
DP  - 2012 Sep 01
TA  - European Respiratory Journal
PG  - 4730
VI  - 40
IP  - Suppl 56
4099  - http://erj.ersjournals.com/content/40/Suppl_56/4730.short
4100  - http://erj.ersjournals.com/content/40/Suppl_56/4730.full
SO  - Eur Respir J2012 Sep 01; 40
AB  - Rationale: The Lung Volume Reduction Coil (LVRC, PneumRx USA) is a bronchoscopic device for the treatment of emphysema. A previous pilot study showed safety and effectiveness in severe upper-lobe heterogeneous emphysema. In this multicenter study (NCT0122098, NCT01328899) we investigated whether LVRC is safe and effective for the treatment of upper- and lower-lobe heterogeneous and homogeneous emphysema.Methods: 71 subjects underwent two separate bronchoscopic treatments using LVR Coils under anesthesia using fluoroscopy (142 procedures). Over 1350 LVR Coils were placed with median 10 Coils (range 5-15) placed per procedure in 48 ± 24 minutes. Safety was evaluated by recording all SAEs and AEs; effectiveness was measured by SGRQ, pulmonary function and exercise testing through 255 days ± 47 days.Results: 71 subjects (42F/29M, 62 ± 8 yrs), FEV1: 29±6 %, RV: 247±50 %, RV/TLC: 66±9 and SGRQ: 63±12 were analyzed. SAEs reported during the Treatment Recovery Period (≤30 days post treatment) for the 142 procedures included exacerbation (8), pneumonia (10), pneumothorax (1), chest pain (3) and hemoptysis (1). SAEs reported post Treatment Recovery Period, up to 295 days included exacerbation (14), pneumonia (8), pneumothorax (1) and chest pain (1); and no hemoptysis. At 255 ±47 days post treatment, study subjects exhibited an absolute ΔFEV1 +14±25%, ΔRV -0.51±0.81L, Δ6MWT +43±72 m and ΔSGRQ -11±13 points (all statistically significant, p≤0.001).Conclusion: LVRC treatment is safe and demonstrated clinically significant improvements in effectiveness in severe upper and lower lobe heterogeneous and homogeneous emphysema.