TY - JOUR
TI - A randomised trial of lung sealant versus medical therapy for advanced emphysema
AU - Come, C.E.
AU - Kramer, M.R.
AU - Dransfield, M.T.
AU - Abu-Hijleh, M.
AU - Berkowitz, D.
AU - Bezzi, M.
AU - Bhatt, S.P.
AU - Boyd, M.B.
AU - Cases, E.
AU - Chen, A.C.
AU - Cooper, C.B.
AU - Flandes, J.
AU - Gildea, T.
AU - Gotfried, M.
AU - Hogarth, D.K.
AU - Kolandaivelu, K.
AU - Leeds, W.
AU - Liesching, T.
AU - Marchetti, N.
AU - Marquette, C.
AU - Mularski, R.A.
AU - Pinto-Plata, V.M.
AU - Pritchett, M.A.
AU - Rafeq, S.
AU - Rubio, E.R.
AU - Slebos, D.-J.
AU - Stratakos, G.
AU - Sy, A.
AU - Tsai, L.W.
AU - Wahidi, M.
AU - Walsh, J.
AU - Wells, J.M.
AU - Whitten, P.E.
AU - Yusen, R.
AU - Zulueta, J.J.
AU - Criner, G.J.
AU - Washko, G.R.
JO - The European respiratory journal
PY - 2015
VL - 46
TODO - 3
SP - 651-662
PB - European Respiratory Society
SN - null
TODO - 10.1183/09031936.00205614
TODO - acute kidney failure;  adult;  adverse outcome;  aged;  Article;  clinical effectiveness;  controlled study;  depression;  device safety;  disease exacerbation;  dyspnea;  female;  fever;  forced expiratory volume;  forced vital capacity;  heart infarction;  human;  ileus;  inguinal hernia;  lung emphysema;  lung sealant;  major clinical study;  male;  minimally invasive procedure;  multicenter study;  pneumonia;  pneumothorax;  priority journal;  quality of life;  randomized controlled trial;  respiratory failure;  respiratory therapeutic device;  sepsis;  tachycardia;  therapy effect;  thorax pain;  treatment duration;  treatment outcome;  treatment planning;  urinary tract infection;  comparative study;  follow up;  lung function test;  lung resection;  middle aged;  mortality;  procedures;  Pulmonary Emphysema;  quality of life;  risk assessment;  severity of illness index;  survival rate;  time factor;  x-ray computed tomography, fibrin glue, Aged;  Female;  Fibrin Tissue Adhesive;  Follow-Up Studies;  Humans;  Male;  Middle Aged;  Pneumonectomy;  Pulmonary Emphysema;  Quality of Life;  Respiratory Function Tests;  Risk Assessment;  Severity of Illness Index;  Survival Rate;  Time Factors;  Tomography, X-Ray Computed;  Treatment Outcome
TODO - Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting. Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis. 57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events. Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility. Copyright © ERS 2015.
ER -