Jump to content

Choose locationSutter Maternity & Surgery Center of Santa Cruz
  • Sign in or Enroll
    • Open I want to choose my medical group or hospital
    • Clear my location
Change Location
Sutter Health
  • Video Visits
  • Find Doctors
  • Find Locations
  • Treatments & Services
  • Locations
  • Sign in or Enroll
    • Video Visits
    • Find Doctors
    • Find Locations
    • Treatments & Services
    • COVID-19 Resources
    • Pay a Bill
    • Symptom Checker
    • Get Care Today
    • Health & Wellness
    • Classes & Events
    • Research & Clinical Trials
    • For Patients
    • About Sutter Health
    • Giving
    • Volunteering
    • Careers
    • News
    • For Medical Professionals
    • Other Business Services
Close Search
  • Home
  • Sutter Maternity & Surgery Center
  • Research
  • Lung Diseases
Content

A multicenter RCT of Zephyr® Endobronchial Valve treatment in heterogeneous emphysema (LIBERATE).

Description

Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group., Am J Respir Crit Care Med. doi: 10.1164/rccm.201803-0590OC. [Epub ahead of print], 2018 May 22

Investigators

Ganesh Krishna, M.D.

Abstract

RATIONALE: This is the first multicenter RCT to evaluate effectiveness and safety of Zephyr® Endobronchial Valve EBV® out to 12-months.OBJECTIVES: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation (CV) in the treated lobe.

METHODS: Subjects were enrolled with a 2:1 randomization (EBV: Standard-of-Care (SoC)) at 24 sites. Primary outcome at 12-months was the ΔEBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of ≥15%. Secondary endpoints included absolute changes in post-BD FEV1, Six-Minute Walk Distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ) scores.

RESULTS: 190 subjects, 128 EBV and 62 SoC were randomized. At 12-months, 47.7% EBV and 16.8% SoC subjects had a ΔFEV1 ≥15% (p<0.001). ΔEBV-SoC at 12-months was statistically and clinically significant: for FEV1 (L), 0.106L (p<0.001); 6MWD, +39.31m (p=0.002); and SGRQ, -7.05 points (p=0.004). Significant ΔEBV-SoC were also observed in hyperinflation (RV, -522ml; p<0.001), mMRC, -0.8 points (p<0.001), and the BODE Index (-1.2 points). Pneumothorax was the most common serious adverse event in the Treatment Period (procedure to 45 days), in 34/128 (26.6%) of EBV subjects. Four deaths occurred in the EBV group during this phase, and one each in the EBV and SoC groups between 46 days and 12-months.

CONCLUSIONS: Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea and quality of life out to at least 12-months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01796392.

Pubmed Abstract

Pubmed AbstractOpens New Window

Associated Topics

  • Disease Management
  • Lung Diseases

Related Publications

Does SLE widen or narrow race/ethnic disparities in the risk of five co-morbid conditions? Evidence from a community-based outpatient care system.

Falasinnu T, Chaichian Y, Li J, Chung S, Waitzfelder BE, Fortmann SP, Palaniappan L, Simard JF.
Lupus. 28(14):1619-1627. doi: 10.1177/0961203319884646. Epub 2019 Oct 29.
2019 Dec 01

Precision lifestyle medicine: a new frontier in the science of behavior change and population health.

Ma J, Rosas LG, Lv N.
Am J Prev Med. pii: S0749-3797(15)00638-8. doi: 10.1016/j.amepre.2015.09.035. [Epub ahead of print]
2015 Dec 01

American Thoracic Society and National Heart, Lung, and Blood Institute Implementation Research Workshop Report.

Bender BG, Krishnan JA, Chambers DA, Cloutier MM, Riekert KA, Rand CS, Schatz M, Thomson CC, Wilson SR, Apter A, Carson SS, George M, Gerald JK, Gerald L, Goss CH, Okelo SO, Mularski RA, Nguyen HQ, Patel MR, Szefler SJ, Weiss CH, Wilson KC, Freemer M.
Ann Am Thorac Soc. 2015 Dec;12(12):S213-21. doi: 10.1513/AnnalsATS.201506-367OT.
2015 Dec 12

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma.

Ma J, Strub P, Lv N, Xiao L, Camargo CA Jr, Buist AS, Lavori PW, Wilson SR, Nadeau KC, Rosas LG.
Eur Respir J. pii: ERJ-00591-2015. doi: 10.1183/13993003.00591-2015. [Epub ahead of print]
2015 Oct 22

Disseminated tuberculosis and lung cancer associated with infliximab treatment of rheumatoid arthritis.

Sankaranarayanan Viji, Krishna G, Gould M, Chitkara R.
Clin Pulmon Med.12(2):115-120.
2005 Mar 01
The Sutter Health Network of Care
Expertise to fit your needs
Primary Care

Check-ups, screenings and sick visits for adults and children.

Specialty Care

Expertise and advanced technologies in all areas of medicine.

Emergency Care

For serious accidents, injuries and conditions that require immediate medical care.

Urgent Care

After-hours, weekend and holiday services.

Walk-In Care

Convenient walk-in care clinics for your non-urgent health needs.

About Sutter

  • About Our Network
  • Annual Report
  • Awards
  • Community Benefit
  • Contact Us
  • News
  • Giving
  • Find Care

  • Birth Centers
  • Care Centers
  • Emergency Rooms
  • Hospitals
  • Imaging
  • Labs
  • Surgery Centers
  • Urgent Care
  • Walk-In Care
  • View All >
  • Featured Services

  • Behavioral Health
  • Cancer Services
  • Family Medicine
  • Home Health and Hospice
  • Orthopedics
  • Pediatrics
  • Pregnancy
  • Primary Care
  • Women's Health
  • View All >
  • Patient Resources

  • Accepted Health Plans
  • Classes and Events
  • Estimate Costs
  • Health and Wellness
  • Medical Records
  • Medicare Advantage
  • My Health Online
  • Pay a Bill
  • Symptom Checker
  • Our Team

  • For Employees
  • Physician Careers
  • Recruiting Events
  • Residencies and Fellowships
  • Sutter Careers
  • Vendors
  • Volunteers
    • ADA Accessibility
    • Contact
    • Privacy
    • Do Not Sell My Personal Information

    • LinkedIn Opens new window
    • YouTube Opens new window
    • Facebook Opens new window
    • Twitter Opens new window
    • Glassdoor Opens new window
    • Instagram Opens new window

    Copyright © 2022 Sutter Health. All rights reserved. Sutter Health is a registered trademark of Sutter Health ®, Reg. U.S. Patent & Trademark office.

    Cookie Policy

    We use cookies to give you the best possible user experience. By continuing to use the site, you agree to the use of cookies. Privacy Policy Cookie Preferences

    Privacy Policy Cookie Preferences