• Thorax · Nov 2014

    Randomized Controlled Trial Multicenter Study

    Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial.

    • Gaëtan Deslee, Karin Klooster, Martin Hetzel, Franz Stanzel, Romain Kessler, Charles-Hugo Marquette, Christian Witt, Stefan Blaas, Wolfgang Gesierich, Felix J F Herth, Juergen Hetzel, Eva M van Rikxoort, and Dirk-Jan Slebos.
    • Department of Pulmonary Medicine, University Hospital of Reims, Reims, France.
    • Thorax. 2014 Nov 1;69(11):980-6.

    BackgroundThe lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial in patients with severe emphysema.MethodsPatients were treated in 11 centres. Safety was evaluated by recording all adverse events, efficacy by the St George's Respiratory Questionnaire (SGRQ) as primary endpoint, and pulmonary function testing, modified Medical Research Council dyspnoea score (mMRC) and 6-min walk distance (6MWD) up to 12 months after the final treatment.ResultsSixty patients (60.9 ± 7.5 years, forced expiratory volume in 1 s (FEV(1)) 30.2 ± 6.3% pred) were bronchoscopically treated with coils (55 bilateral, 5 unilateral), with a median of 10 (range 5-15) coils per lobe. Within 30 days post-treatment, seven chronic obstructive pulmonary disease exacerbations (6.1%), six pneumonias (5.2%), four pneumothoraces (3.5%) and one haemoptysis (0.9%) occurred as serious adverse events. At 6 and 12 months, respectively, ΔSGRQ was -12.1±12.9 and -11.1±13.3 points, Δ6MWD was +29.7±74.1 m and +51.4±76 m, ΔFEV(1) was +0.11±0.20 L and +0.11±0.30 L, and ΔRV (residual volume) was -0.65±0.90 L and -0.71±0.81 L (all p<0.01). Post hoc analyses showed significant responses for SGRQ, 6MWD and RV in patients with both heterogeneous and homogeneous emphysema.ConclusionsLVR coil treatment results in significant clinical improvements in patients with severe emphysema, with a good safety profile and sustained results for up to 1 year.Trial Registration NumberNCT01328899.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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