Spiration valve system improves lung function in patients with emphysema over 5 years

Criner GJ, et al. Long-term benefits of the Spiration valve system in emphysema patients: 5-year results from the EMPROVE trial. Presented at: American Thoracic Society International Conference; May 19-24, 2023; Washington, D.C.

Criner GJ, et al. Long-term benefits of the Spiration valve system in emphysema patients: 5-year results from the EMPROVE trial. Presented at: American Thoracic Society International Conference; May 19-24, 2023; Washington, D.C.

WASHINGTON — Patients with severe emphysema had improved lung function at 5 years after receiving treatment with a support expiration valve system, according to research presented at the American Thoracic Society International Conference.

"Bronchoscopic lung volume reduction procedures are a durable treatment response compared to optimal medical therapy," Gerard J. Criner, MD, FACP, FACCP, director of the Temple Lung Center and chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, told Healio.

Criner and colleagues evaluated 172 patients with severe emphysema in the EMPROVE trial to see if the Spiration Valve System (Olympus) was safe and effective over 5 years.

As Healio previously reported, the Spiration Valve System showed sustained clinically significant benefit in health-related quality of life at 2 years in patients with severe emphysema.

To assess differences in lung function from baseline over the span of 5 years, researchers utilized the mixed-effects model.

Additionally, researchers calculated the rate of serious adverse events by finding out how many events took place 6 months after the procedure and dividing that by the remaining cumulative follow-up patient-years.

Of the total cohort, 113 patients received Spiration Valve System treatment and 59 patients were a part of the control group.

Following the procedure, patients demonstrated a 0.1098 L increase (P < .001) in lung function, or FEV1; however, this measure was found to fall by 0.044 L per year (P < .001) in both these patients and control patients, according to the abstract.

With the two groups showing a comparable rate of decline, researchers assumed that disease progression was occurring at a "steady rate," signaling that patients who underwent the valve placement procedure instantly got approximately 2.5 years of improvement in FEV1.

When evaluating all serious adverse events, the rate was comparable between both sets of patients, with a rate of 0.6, or 210 events in 5 years, in the treatment group, and 0.48, or 35 events in 2 years, in the control group since researchers only followed control patients for 2 years. Notably, the rate of pneumothorax in the treatment group was 0.21, or 75 events in 5 years, and 0 in the control group, according to the abstract.

In terms of increasing lung function, researchers deemed the treatment "safe and durable" based on the above findings.

"This affirms the prior data with use of lung volume reduction surgery and non-controlled cohort follow-ups post bronchoscopic lung volume reduction that patients have a durable treatment response," Criner told Healio.