Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial

Gerard J. Criner; Antoine Delage; Kirk Voelker; D. Kyle Hogarth; Adnan Majid; Michael Zgoda; Donald R. Lazarus; Roberto Casal; Sadia B. Benzaquen; Robert C. Holladay; Adam Wellikoff; Karel Calero; Mark J. Rumbak; Paul R. Branca; Muhanned Abu-Hijleh; Jorge M. Mallea; Ravi Kalhan; Ashutosh Sachdeva; C. Matthew Kinsey; Carla R. Lamb; Michael F. Reed; Wissam B. Abouzgheib; Phillip V. Kaplan; Gregory X. Marrujo; David W. Johnstone; Mario G. Gasparri; Arturo A. Meade; Christopher A. Hergott; Chakravarthy Reddy; Richard A. Mularski; Amy Hajari Case; Samir S. Makani; Ray W. Shepherd; Benson Chen; Gregory E. Holt; Simon Martel

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
, Antoine Delage
, Kirk Voelker
, D. Kyle Hogarth
, Adnan Majid
, Michael Zgoda
, Donald R. Lazarus
, Roberto Casal
, Sadia B. Benzaquen
, Robert C. Holladay
, Adam Wellikoff
, Karel Calero
, Mark J. Rumbak
, Paul R. Branca
, Muhanned Abu-Hijleh
, Jorge M. Mallea
, Ravi Kalhan
, Ashutosh Sachdeva
, C. Matthew Kinsey
, Carla R. Lamb

Michael F. Reed, Wissam B. Abouzgheib, Phillip V. Kaplan, Gregory X. Marrujo, David W. Johnstone, Mario G. Gasparri, Arturo A. Meade, Christopher A. Hergott, Chakravarthy Reddy, Richard A. Mularski, Amy Hajari Case, Samir S. Makani, Ray W. Shepherd, Benson Chen, Gregory E. Holt, Simon Martel

Temple University
Laval University
Memorial Hospital of South Bend
University of Chicago
Harvard University
Carolinas Medical Center
Veterans Health Administration
University of Cincinnati
Louisiana State University in Shreveport
University of South Florida
University of Tennessee
University of Texas at Dallas
Mayo Clinic
Northwestern University
University of Maryland, Baltimore
University of Vermont
Lahey Hospital & Medical Center
Pennsylvania State University
Rowan University
Botsford Hospital
Kaiser Permanente
Medical College of Wisconsin
Sparks Regional Medical Center
University of Calgary
University of Utah
Piedmont Hospital
University of California, San Diego
Virginia Commonwealth University
California Pacific Medical Center
United States Department of Veterans Affairs

Research output: Contribution to journal › Article › peer-review

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 ).

Original language	American English
Journal	American Journal of Respiratory and Critical Care Medicine
Volume	200
Issue number	11
DOIs	https://doi.org/10.1164/rccm.201902-0383OC https://doi.org/10.1164/RCCM.201902-0383OC
State	Published - Dec 1 2019
Externally published	Yes

Keywords

Bronchi
Forced Expiratory Volume
Inhalation
Lung
Prostheses and Implants
Pulmonary Emphysema
Treatment Outcome

Disciplines

Medicine and Health Sciences
Critical Care

Access to Document

10.1164/rccm.201902-0383OCLicense: Unspecified
10.1164/RCCM.201902-0383OCLicense: Unspecified

https://pubmed.ncbi.nlm.nih.gov/31365298/

Cite this

Criner, G. J., Delage, A., Voelker, K., Hogarth, D. K., Majid, A., Zgoda, M., Lazarus, D. R., Casal, R., Benzaquen, S. B., Holladay, R. C., Wellikoff, A., Calero, K., Rumbak, M. J., Branca, P. R., Abu-Hijleh, M., Mallea, J. M., Kalhan, R., Sachdeva, A., Kinsey, C. M., ... Martel, S. (2019). Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial. American Journal of Respiratory and Critical Care Medicine, 200(11). https://doi.org/10.1164/rccm.201902-0383OC, https://doi.org/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. / Criner, Gerard J.; Delage, Antoine; Voelker, Kirk et al.
In: American Journal of Respiratory and Critical Care Medicine, Vol. 200, No. 11, 01.12.2019.

Research output: Contribution to journal › Article › peer-review

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 2019, 'Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial', American Journal of Respiratory and Critical Care Medicine, vol. 200, no. 11. https://doi.org/10.1164/rccm.201902-0383OC, https://doi.org/10.1164/RCCM.201902-0383OC

Criner GJ, Delage A, Voelker K, Hogarth DK, Majid A, Zgoda M et al. Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial. American Journal of Respiratory and Critical Care Medicine. 2019 Dec 1;200(11). doi: 10.1164/rccm.201902-0383OC, 10.1164/RCCM.201902-0383OC

@article{b5192477bdb0462c8be27cc0577918ad,

title = "Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial",

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 = "Bronchi, Forced Expiratory Volume, Inhalation, Lung, Prostheses and Implants, Pulmonary Emphysema, Treatment Outcome",

author = "Criner, \{Gerard J.\} and Antoine Delage and Kirk Voelker and Hogarth, \{D. Kyle\} and Adnan Majid and Michael Zgoda and Lazarus, \{Donald R.\} and Roberto Casal and Benzaquen, \{Sadia B.\} and Holladay, \{Robert C.\} and Adam Wellikoff and Karel Calero and Rumbak, \{Mark J.\} and Branca, \{Paul R.\} and Muhanned Abu-Hijleh and Mallea, \{Jorge M.\} and Ravi Kalhan and Ashutosh Sachdeva and Kinsey, \{C. Matthew\} and Lamb, \{Carla R.\} and Reed, \{Michael F.\} and Abouzgheib, \{Wissam B.\} and Kaplan, \{Phillip V.\} and Marrujo, \{Gregory X.\} and Johnstone, \{David W.\} and Gasparri, \{Mario G.\} and Meade, \{Arturo A.\} and Hergott, \{Christopher A.\} and Chakravarthy Reddy and Mularski, \{Richard A.\} and Case, \{Amy Hajari\} and Makani, \{Samir S.\} and Shepherd, \{Ray W.\} and Benson Chen and Holt, \{Gregory E.\} and Simon Martel",

note = "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. 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 1;200(11):1354-1362. doi: 10.1164/rccm.201902-0383OC. PMID: 31365298; PMCID: PMC6884033.",

year = "2019",

month = dec,

day = "1",

doi = "10.1164/rccm.201902-0383OC",

language = "American English",

volume = "200",

journal = "American Journal of Respiratory and Critical Care Medicine",

issn = "1535-4970",

publisher = "American Thoracic Society",

number = "11",

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TY - JOUR

T1 - Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial

AU - Criner, Gerard J.

AU - Delage, Antoine

AU - Voelker, Kirk

AU - Hogarth, D. Kyle

AU - Majid, Adnan

AU - Zgoda, Michael

AU - Lazarus, Donald R.

AU - Casal, Roberto

AU - Benzaquen, Sadia B.

AU - Holladay, Robert C.

AU - Wellikoff, Adam

AU - Calero, Karel

AU - Rumbak, Mark J.

AU - Branca, Paul R.

AU - Abu-Hijleh, Muhanned

AU - Mallea, Jorge M.

AU - Kalhan, Ravi

AU - Sachdeva, Ashutosh

AU - Kinsey, C. Matthew

AU - Lamb, Carla R.

AU - Reed, Michael F.

AU - Abouzgheib, Wissam B.

AU - Kaplan, Phillip V.

AU - Marrujo, Gregory X.

AU - Johnstone, David W.

AU - Gasparri, Mario G.

AU - Meade, Arturo A.

AU - Hergott, Christopher A.

AU - Reddy, Chakravarthy

AU - Mularski, Richard A.

AU - Case, Amy Hajari

AU - Makani, Samir S.

AU - Shepherd, Ray W.

AU - Chen, Benson

AU - Holt, Gregory E.

AU - Martel, Simon

N1 - 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. 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 1;200(11):1354-1362. doi: 10.1164/rccm.201902-0383OC. PMID: 31365298; PMCID: PMC6884033.

PY - 2019/12/1

Y1 - 2019/12/1

N2 - 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 ).

AB - 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 ).

KW - Bronchi

KW - Forced Expiratory Volume

KW - Inhalation

KW - Lung

KW - Prostheses and Implants

KW - Pulmonary Emphysema

KW - Treatment Outcome

UR - https://www.atsjournals.org/doi/pdf/10.1164/rccm.201902-0383OC

U2 - 10.1164/rccm.201902-0383OC

DO - 10.1164/rccm.201902-0383OC

M3 - Article

SN - 1535-4970

VL - 200

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

IS - 11

ER -

Improving lung function in severe heterogenous Emphysema with the Spiration Valve System (EMPROVE) a multicenter, open-label randomized controlled clinical trial

Abstract

Keywords

Disciplines

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