Lung Volume Reduction Coil Treatment in Emphysema.

Conditions

Emphysema

Keywords

Chronic obstructive pulmonary disease, Endoscopic lung volume reduction

Brief summary

* BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema. * METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone. * EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.

Jeanne‐Marie Perotin, Sylvie Leroy, Charles‐Hugo Marquette, Hervé Mal, Hervé Dutau et al. (10 authors)

International Journal of COPD2018-11-0115 citations

10.2147/copd.s176366

Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study).

Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaün M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I, REVOLENS study group.

2018-05-098 citations

10.1186/s12931-018-0796-x

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema

Gaëtan Deslée, Hervé Mal, Hervé Dutau, Arnaud Bourdin, J.M. Vergnon et al. (20 authors)

JAMA2016-01-12205 citations

10.1001/jama.2015.17821

Long‐term follow‐up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema

Jorine E. Hartman, Karin Klooster, Kiki Gortzak, Nick H.T. ten Hacken, Dirk‐Jan Slebos

Respirology2014-11-2385 citations

10.1111/resp.12435

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

Gaëtan Deslée, Karin Klooster, Martin Hetzel, Franz Stanzel, Romain Kessler et al. (13 authors)

Thorax2014-06-02135 citations

10.1136/thoraxjnl-2014-205221

Interventions

PROCEDURELung volume reduction coïl treatment

OTHERRegular medical treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Bilateral emphysema on Chest CT Scanner * Post bronchodilator FEV1 \< 50 % * Total Lung Capacity \> 100 % * Residual Volume \> 220 % * Dyspnea score between 2 and 4 based on the mMRC scale * Stopped cigarette smoking for more than 8 weeks * Pulmonary rehabilitation within the previous twelve months * Consent form signed * Covered by Medical Insurance

Exclusion criteria

* Post bronchodilator FEV1 \< 15% * Post-bronchodilator change in FEV1 \> 20% * Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months * COPD exacerbation requiring hospital stay within 3 months * Pulmonary Hypertension (Pulmonary systolic pressure \>50 mmHg on cardiac echo) * Patient unable to perform a 6-min walking test in room air * Giant bulla of more than 1/3 of the lung field on Chest CT * Strictly homogeneous emphysema on Chest CT * Clinically significant bronchiectasis * Past history of lobectomy, lung volume reduction surgery, lung transplantation * Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…) * Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up * Contra-indication to general anesthesia * Oral anticoagulant treatment (antivitamin K) * Allergy to nitinol * Inclusion in an other study assessing respiratory treatments * Patient protected by the law

Design outcomes

Primary

Measure	Time frame	Description
6-month improvement of the 6-minute walk test	6 months	6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.

Secondary

Measure	Time frame	Description
Dyspnea	6 and 12 months	Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
Pulmonary function assessment	6 and 12 months	Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
Cost-effectiveness	6 and 12 months	Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
Morbidity-mortality	6 and 12 months	Comparison of mortality and severe adverse events using a composite score (death, haemoptysis \> 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage \> 7 days, mechanical ventilation \> 24 hours, lung transplantation).
Quality of life	6 and 12 months	Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)

Other

Measure	Time frame	Description
Exercise testing	6 and 12 months months	Comparison of the 6-min walking test between groups (using the \> 25 meters change from baseline as cut-off for clinically significant change).

Countries

France

Outcome results

None listed