A multicentre study has revealed Olympus endobronchial valve therapy has demonstrated clinically meaningful benefits for patients, compared to traditional medical arm control.
The Research to Assess Spiration Valve System Safety and Effectiveness for the Treatment of Severe Emphysema in China (REACH) study showed benefits in patients with severe emphysema selected by high resolution computed tomography.
Australian researcher Professor Alvin Ing, Clinical Professor Faculty of Medicine and Health Sciences at Macquarie University said the study’s findings were considerable.
“It is the first randomised controlled trial involving Spiration valves and it shows clinically significant benefit, not just statistically significant results.”
The Spiration valve is an umbrella-shaped device put into the lungs through a flexible bronchoscope. It was developed to improve patient outcomes and avoid surgery and associated mortality and morbidity from those procedures. This design minimises contact with the bronchial wall, maintains position with zero per cent expectoration, and facilitates removal when needed.
The valve is intended to treat severely diseased lung in patients with emphysema or damaged lung resulting in air leaks by limiting air flow to selected areas.
The study enrolled 101 subjects, 66 randomised to treatment and 35 to the control. Patients involved in the study had to meet strict selection criteria including lung function, degree of hyperinflation and exercise capacity. Their lungs were further assessed using HRCT scans to evaluate emphysema severity and identify a target lobe suitable for treatment with Spiration valves.
Compared to the control group, the treatment group achieved a substantial and clinically meaningful improvement in lung function test as measured by FEV1 at the one, three, and six month visits.
Professor Felix Herth, Chairman and Head of Department of Pulmonology and Critical Care Medicine at Thoraxklinik, Heidelberg University Hospital also endorsed the study.
“The REACH trial confirmed clearly that proper patient selection is the key for a successful endoscopic lung volume procedure with valves. In this RCT, multiple endpoints were reached with a low complication rate,” he said.
This article was supplied by Olympus Australia, a Major Sponsor of APHA.