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

ABSTRACT: 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.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.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, ?SGRQ was -12.1±12.9 and -11.1±13.3 points, ?6MWD was +29.7±74.1?m and +51.4±76?m, ?FEV(1) was +0.11±0.20?L and +0.11±0.30?L, and ?RV (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.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.NCT01328899.

SUBMITTER: Deslee G

PROVIDER: S-EPMC4215297 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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

Deslee Gaëtan G Klooster Karin K Hetzel Martin M Stanzel Franz F Kessler Romain R Marquette Charles-Hugo CH Witt Christian C Blaas Stefan S Gesierich Wolfgang W Herth Felix J F FJ Hetzel Juergen J van Rikxoort Eva M EM Slebos Dirk-Jan DJ

Thorax 20140602 11

<h4>Background</h4>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.<h4>Methods</h4>Patients were treated in 11 centres. Safety was evaluated by recording all adverse events, efficacy by the St George's Respiratory Questionnai ...[more]

PMID: 24891327

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Project description:BackgroundLung volume reduction coil (LVR-coil) treatment provides a minimally invasive treatment option for severe emphysema patients which has been studied in multiple clinical trials.ObjectivesThe aim of the study was to assess the effect of LVR-coil treatment on pulmonary function, quality of life, and exercise capacity using individual participant data.MethodPubMed, Web of Science, and EMBASE were searched until May 17, 2021. Prospective single-arm and randomized controlled trials that evaluated the effect of LVR-coil treatment on forced expiratory volume in 1 s (FEV1), residual volume (RV), St. George Respiratory Questionnaire (SGRQ) total score, and/or 6-min walk distance (6MWD) and were registered in an official clinical trial database were eligible for inclusion. Individual patient data were requested, and a linear mixed effects model was used to calculate overall treatment effects.ResultsEight trials were included in the final analysis, representing 680 individual patients. LVR-coil treatment resulted in a significant improvement in FEV1 at 3- (0.09 L [95% confidence interval (95% CI): 0.06-0.12]) and 6-month follow-up (0.07 L [95% CI: 0.03-0.10]), a significant reduction in RV at 3- (-0.45L [95% CI: -0.62 to -0.28]), 6- (-0.33L [95% CI: -0.52 to -0.14]), and 12-month follow-up (-0.36L [95% CI: -0.64 to -0.08]), a significant reduction in SGRQ total score at 3- (-12.3 points [95% CI: -15.8 to -8.8]), 6- (-10.1 points [95% CI: -12.8 to -7.3]), and 12-month follow-up (-9.8 points [95% CI: -15.0 to -4.7]) and a significant increase in 6MWD at 3-month follow-up (38 m [95% CI: 18-58]).ConclusionsLVR-coil treatment in emphysema patients results in sustained improvements in pulmonary function and quality of life and shorter lived improvements in exercise capacity. Since the owner of this LVR-coil has decided to stop the production and newer generations LVR-coils are currently being developed, these results can act as a reference for future studies and clinical guidance.

Dataset Information

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

Publications

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

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