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Randomized Controlled Trial
. 2014 Nov;69(11):980-6.
doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.

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

Gaëtan Deslee  1 , Karin Klooster  2 , Martin Hetzel  3 , Franz Stanzel  4 , Romain Kessler  5 , Charles-Hugo Marquette  6 , Christian Witt  7 , Stefan Blaas  8 , Wolfgang Gesierich  9 , Felix J F Herth  10 , Juergen Hetzel  11 , Eva M van Rikxoort  12 , Dirk-Jan Slebos  2
Affiliations
Randomized Controlled Trial

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

Gaëtan Deslee et al. Thorax. 2014 Nov.

Abstract

Background: The 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.

Methods: Patients 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.

Results: Sixty 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.

Conclusions: LVR 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 number: NCT01328899.

Keywords: Bronchoscopy; Emphysema.

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Figures

Figure 1
Figure 1
Fully deployed nitinol RePneu lung volume reduction coil.
Figure 2
Figure 2
Study flow chart.
See this image and copyright information in PMC

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References

    1. Shah PL, Herth FJ. Current status of bronchoscopic lung volume reduction with endobronchial valves. Thorax 2014;69:280–6.. - PubMed
    1. Gasparini S, Zuccatosta L, Bonifazi M, et al. Bronchoscopic treatment of emphysema: state of the art. Respiration 2012;84:250–63. - PubMed
    1. Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003;348:2059–73. - PubMed
    1. Criner GJ, Cordova F, Sternberg AL, et al. The NETT: part I. Lessons learned about emphysema. Am J Respir Crit Care Med 2011;184:763–70. - PubMed
    1. Meyers BF, Patterson GA. Chronic obstructive pulmonary disease. 10: Bullectomy, lung volume reduction surgery, and transplantation for patients with chronic obstructive pulmonary disease. Thorax 2003;58:634–8. - PMC - PubMed

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