Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.
Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.
If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.
A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.
These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.
Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent
Emphysema (homogeneous or heterogeneous) on a recent CT scan (< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.
Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
Smoking quit for 3 months
Asthma considered as main diagnosis
Recurrent exacerbations: (>3 over the last year or 2 requiring hospitalization)
Myocardial infarction or stroke in the 6 months prior to inclusion
Symptoms of heart failure in the 6 months prior to inclusion
Parallel
Endoscopic lung volume reduction in 2 stages
Procedure/SurgeryAfter the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the experimental group, patients will be treated according to Limoges' treatment algorithm (2 stages)
Endoscopic lung volume reduction in 1 stage
Procedure/SurgeryAfter the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the control group, the entire lobe will be treated during one procedure
Pneumothorax rate
Proportion of patients suffering from at least one pneumothorax rate between the beginning and the first 45 days following the end of lung volume reduction with ZEPHYR® valves
Forced expiratory volume in one second (FEV1) measurement
Functional parameters at rest (plethysmography) - assessment of FEV1 in liter
Force Vital Expiratory (FVE) measurement
Functional parameters at rest (plethysmography) - assessment of FVE in Liter
Functional Residual Capacity (FRC) measurement
Functional parameters at rest (plethysmography) - assessment of FRC in Liter
Inspiratory Capacity (IC) measurement
Functional parameters at rest (plethysmography) - assessment of IC in Liter
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