TABLE 1

Overview of results of the four randomised controlled trials performed to date using the Chartis measurement

STELVIO [3]IMPACT [4]TRANSFORM [1]LIBERATE [2]
Patients nEBV: 34; SoC: 34EBV: 43; SoC: 50EBV: 65; SoC: 32EBV: 128; SoC: 62
Emphysema distributionHeterogeneous and homogeneousHomogeneousHeterogeneousHeterogeneous
Procedure
 Procedure time min18 (6–51)NRNR29 (4–123)
 Valves used n4 (2–7)44 (2–8)4 (2–8)
 Hospital stay days1 (1–13)6 (3–40)4 (1–49)NR
Efficacy
 Target lobe volume reduction# mL−1366−1195−1090−1142
 Between group difference6 months follow-up3 months follow-up6 months follow-up12 months follow-up
  Change in lung function
   FEV1+17.8%§+17%§+29%§+18%§
   RV mL−831−480§−700§−522§
  Change in exercise capacity
   6MWD m+74§+40§+79§+39§
  Change in patient-centred outcomes
   SGRQ total score−14.7−9.7§−6.5§−7.1§
   mMRC change−0.61−0.57§−0.6§−0.8§
   Physical activity steps per day+1340 (+57%)NRNRNR
Responder rates
 FEV172%40%66%56%
 RV71%44%68%62%
 6MWD79%57%66%42%
 SGRQ87%50%65%56%
Safety+
 Pneumothorax18%26%29%34%
 Valve retainment79%93%97%94%
 Re-bronchoscopy35%19%28%27%
 Deaths3%0%2%4%

Data are presented as median (range) or mean change, unless otherwise stated. FEV1: forced expiratory volume in 1 s; RV: residual volume; 6MWD: 6-min walk distance; SGRQ: St George's Respiratory Questionnaire; mMRC: modified Medical Research Council scale; EBV: endobronchial valve; SoC: standard of care; NR: not reported. #: change in the EBV group only; : percentage of patients who reached the earlier established minimal important difference: FEV1 ≥12% (STELVIO ≥10%), RV ≥430 mL (LIBERATE ≥310 mL), 6MWD ≥25 m, SGRQ ≥4 points; +: EBV group only; §: intention to treat analyses.