Abstract
BackgroundThere is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. Endobronchial Coils (coils) are nitinol devices implanted bronchoscopically under fluoroscopic guidance to re-tension the lung. We report the medium term effectiveness and safety of coils in a study of patients with emphysema.MethodsForty five subjects with severe airflow obstruction and hyperinflation received bilateral sequential treatment with coils (30 day interval between treatments) as part of a randomised controlled trial with a primary endpoint 90 days after the final treatment (Clinicaltrials.gov NCT01334307). Further assessments were made at 180 and 360 days and in this study the primary outcome was the effect of coil treatment on the St. George’s Respiratory Questionnaire (SGRQ) 360 days following treatment.ResultsAt 360 days following treatment, there was an improvement in the SGRQ score of -6.1±14.0 points (p = 0.01) compared to baseline. Improvements in secondary outcomes were seen with increases in forced expiratory volume in the first second of 8.9 ±22.2% (p = 0.002) and 6-minute walking distance of 34.1±52.4m (p = 0.003). The safety profile was acceptable out to 360 days post-treatment.ConclusionsStatistically and clinically meaningful benefits in quality of life, exercise capacity and pulmonary function in patients treated with coils are sustained twelve months after treatment.Trial registration informationClinicaltrials.gov NCT01334307.
Highlights
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally [1] and has high morbidity and resource utilisation, with a prevalence above 5% in both Europe [2] and the United States.[3]
And clinically meaningful benefits in quality of life, exercise capacity and pulmonary function in patients treated with coils are sustained twelve months after treatment
There were eight serious adverse events (SAE) in eight patients related to respiratory tract infections or COPD exacerbations in the 30 days following the 84 treatments (9.5% of procedures), including one pneumonia which resolved with outpatient treatment with oral antibiotics (Table 4)
Summary
There is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. We report the medium term effectiveness and safety of coils in a study of patients with emphysema
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