Gerard Criner, MD: Spiration Valve System Shows Sustained Improvement in Emphysema

Gerard Criner, MD

Credit: Temple Health

Gerard Criner, MD, a professor of medicine and chair of the Department of Thoracic Surgery and Medicine at Temple University Health System Lung Center, presented findings on interventional treatments for COPD. Among a handful of Temple-led posters and discussions on the outcomes of bronchoscopic lung volume reduction, he shared data on the first long-term outcomes for endobronchial valves in emphysema patients.¹

Criner and colleagues concluded that the 5-year results from the EMPROVE trial demonstrated that Spiration Valve System (SVS) treatment was safe and durable, effectively improving lung function in patients with emphysema

HCPLive: What motivated you to conduct the study on the long-term efficacy and safety of the Spiration Valve System (SVS) in patients with severe emphysema?

Criner: There are limited data on the durability of outcomes from randomized control trials with bronchoscopic lung volume reduction. With lung volume reduction surgery in the National Emphysema Treatment Trial (NETT), we follow patients for at least 5 years or more.

There’s prolonged follow up so we know the durability of the treatment effect. But most of the valve studies looked at people at 3, 6, or 12 months, and this is the only study that had a control population of 2 years.

It helps to determine for patients and providers, if you undergo a procedure like this, how long you should expect a positive improvement in your lung function.

Could you provide a brief overview of the EMPROVE Trial, including the methodology used and the number of participants involved?

This is a prospective randomized control multicenter trial in which 172 patients were randomized 2-to-1 to be treated with SVS versus controlled medical therapy. Patients were followed up for 1 year and the primary outcome was improvement in lung function. Secondary endpoints were improved quality of life and reduction in breathlessness.

The results of your study showed that FEV1 values in the SVS treatment group improved by 0.1098 liters after valve placement, while both treatment and control groups saw a decrease in FEV1 over time. Can you discuss the significance of these findings?

Like other organs, the lung ages over time. So patients who received SVS saw a statistically and clinically meaningful improvement in lung function, but over time the decline was the same as it was in the control population, which goes along with aging and the progression of the disease.

This was similar to what is found with the normal rate of progressions with patients who undergoes LVRS compared with those who don’t. You don’t keep that lung function forever, you’re better at any point compared with a control population but the lung function declines slightly.

Based on the results, the treatment group gained approximately 2.5 years of FEV1 improvement immediately following SVS treatment, which was maintained, compared with the control group. Could you elaborate on the potential clinical impact of this outcome?

It’s a durable treatment effect with an acceptable safety profile.

Moving forward, what are the next steps or future research in this area to further enhance the understanding of long term benefits of SVS treatment in patients with severe emphysema?

Different analyses that are going to be conducted will look at which patients benefit the most – patients with the most emphysema in the target lobe or greater differences of emphysematous destruction in the target versus the same side not-targeted lobe to determine if the people with a more substantial reduction in size of the emphysematous lobe – whether that translates to a survival benefit or not.

References:

1. Criner GJ, Reed M, Abu-Hijleh M, Majid A, EMPROVE Trial Investigator Group. Long-Term Benefits of the Spiration® Valve System in Emphysema Patients: 5-Year Results from the EMPROVE Trial. In: "CUTTING" EDGE: CLINICAL STUDIES IN INTERVENTIONAL PULMONARY AND PLEURAL DISEASE. Session C21. [. Presented at the American Thoracic Society Annual Meeting; May 23, 2023; Washington DC.