Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Dec 1;200(11):1354-1362.
doi: 10.1164/rccm.201902-0383OC.

Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial

Gerard J Criner  1 , Antoine Delage  2 , Kirk Voelker  3 , D Kyle Hogarth  4 , Adnan Majid  5 , Michael Zgoda  6 , Donald R Lazarus  7 , Roberto Casal  7 , Sadia B Benzaquen  8 , Robert C Holladay  9 , Adam Wellikoff  9 , Karel Calero  10 , Mark J Rumbak  10 , Paul R Branca  11 , Muhanned Abu-Hijleh  12 , Jorge M Mallea  13 , Ravi Kalhan  14 , Ashutosh Sachdeva  15 , C Matthew Kinsey  16 , Carla R Lamb  17 , Michael F Reed  18 , Wissam B Abouzgheib  19 , Phillip V Kaplan  20 , Gregory X Marrujo  21 , David W Johnstone  22 , Mario G Gasparri  22 , Arturo A Meade  23 , Christopher A Hergott  24 , Chakravarthy Reddy  25 , Richard A Mularski  26 , Amy Hajari Case  27 , Samir S Makani  28 , Ray W Shepherd  29 , Benson Chen  30 , Gregory E Holt  31 , Simon Martel  2
Affiliations
Randomized Controlled Trial

Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial

Gerard J Criner et al. Am J Respir Crit Care Med. .

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).

Keywords: FEV; chronic obstructive pulmonary disease; quality of life.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Key components of the Spiration Valve.
Figure 2.
Figure 2.
Study subject disposition flow chart.
Figure 3.
Figure 3.
Change in FEV1 at 6 and 12 months; data are shown as mean and 95% Bayesian credible interval (BCI). PP = posterior probability; SVS = Spiration Valve System.
See this image and copyright information in PMC

Comment in

References

    1. Wheaton AG, Cunningham TJ, Ford ES, Croft JB Centers for Disease Control and Prevention (CDC) Employment and activity limitations among adults with chronic obstructive pulmonary disease: United States, 2013. MMWR Morb Mortal Wkly Rep. 2015;64:289–295. - PMC - PubMed
    1. U.S. Department of Health and Human Services, National Institutes of Health and National Heart, Lung, and Blood Institute. COPD national action plan. Washington, D.C.: U.S. Department of Health and Human Services; 2017 [accessed 2018 Jul 6]. Available from: https://www.nhlbi.nih.gov/sites/default/files/media/docs/COPD National A....
    1. van Agteren JE, Hnin K, Grosser D, Carson KV, Smith BJ. Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017;2:CD012158. - PMC - PubMed
    1. Kaplan RM, Ries AL. Health-related quality of life in emphysema. Proc Am Thorac Soc. 2008;5:561–566. - PMC - PubMed
    1. Vogelmeier CF, Criner GJ, Martínez FJ, Anzueto A, Barnes PJ, Bourbeau J, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report: GOLD executive summary. Arch Bronconeumol. 2017;53:128–149. - PubMed

Publication types

Associated data