Faculty Collaboration Database

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 Dec 01;200(11):1354-1362

Date

08/01/2019

Pubmed ID

31365298

Pubmed Central ID

PMC6884033

DOI

10.1164/rccm.201902-0383OC

Scopus ID

2-s2.0-85075813055 (requires institutional sign-in at Scopus site)   70 Citations

Abstract

Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema.Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management.Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control).Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV₁ from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV₁ responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment (n = 113) or control (n = 59). Mean FEV₁ showed statistically significant improvements between the treatment and control groups-between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060-0.141) and 0.099 L (95% BCI, 0.048-0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax.Conclusions: In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile.Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

Author List

Criner GJ, Delage A, Voelker K, Hogarth DK, Majid A, Zgoda M, Lazarus DR, Casal R, Benzaquen SB, Holladay RC, Wellikoff A, Calero K, Rumbak MJ, Branca PR, Abu-Hijleh M, Mallea JM, Kalhan R, Sachdeva A, Kinsey CM, Lamb CR, Reed MF, Abouzgheib WB, Kaplan PV, Marrujo GX, Johnstone DW, Gasparri MG, Meade AA, Hergott CA, Reddy C, Mularski RA, Case AH, Makani SS, Shepherd RW, Chen B, Holt GE, Martel S

Authors

Mario G. Gasparri MD Professor in the Surgery department at Medical College of Wisconsin
David Johnstone MD Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Bronchi
Female
Forced Expiratory Volume
Humans
Inhalation
Lung
Male
Prostheses and Implants
Pulmonary Emphysema
Treatment Outcome