Is the Spiration Valve System an Effective Treatment for Severe Heterogeneous Emphysema?
The Spiration Valve System (SVS) can safely and significantly improve multiple efficacy outcomes—including forced expiratory volume in one second (FEV1)—among individuals with severe heterogeneous emphysema, according to results of the EMPROVE trial.
The SVS involves a one-way valve that blocks inspired airflow to distal portions of the disease-affected lung, and the researchers sought to compare this system’s safety and efficacy with that of optimal medical management among patients with severe emphysema.
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To conduct their trial, the researchers randomly assigned patients from 41 clinical sites who were aged 40 years or older and had severe, heterogeneous emphysema to receive either SVS with medical management (n=113) or medical management alone (n=59). The randomization took place between October 2013 and May 2017.
The researchers measured the difference in mean FEV1 from baseline to 6 months and found a statistically significant improvement among the SVS group compared with the non-SVS group. While the treatment group improved by 0.099 L on average from baseline to month 6, the control group changed by −0.002 L. The statistically significant difference in improvement continued through month 12, with the between-group difference being 0.099 L.
The researchers also evaluated for the difference in FEV1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. With the exception of the 6-minute-walk distance, the SVS group had statistically significant improvements in all secondary endpoints at month 6 compared with the non-SVS group.
The primary safety outcome was the incidence of composite thoracic serious adverse events. Assessing for this, the researchers found that the incidence through 6 months was greater among the SVS group than among the non-SVS group (31.0% vs 11.9%). According to the study authors, this is primarily due to a 12.4% incidence of serious pneumothorax.
“The SVS offers clinically relevant benefits for severely ill patients with emphysema and, although there are risks with the therapy, they are primarily manageable and tend to diminish over time,” the authors concluded. “The results of the EMPROVE trial and other randomized trials of valve therapy have led to the inclusion of endobronchial valve therapy as an important component of the clinical therapy recommendations for the underserved patient population with severe emphysema.”
—Colleen Murphy
Reference:
Criner GJ, Delage A, Voelker K, et al; EMPROVE Study Group. Improving lung function in severe heterogenous emphysema with the Spiration Valve System (EMPROVE). A multicenter, open-label randomized controlled clinical trial. Am J Respir Crit Care Med. 2019;200(11):1354-1362. https://doi.org/10.1164/rccm.201902-0383OC.