Evidence map›Paper›PMID 34350884›Full record

Trial reportRespiration; international review of thoracic diseases

Endobronchial Valve (Zephyr) Treatment in Homogeneous Emphysema: One-Year Results from the IMPACT Randomized Clinical Trial.

Ralf Eberhardt, Dirk-Jan Slebos, Felix J F Herth, Kaid Darwiche, Manfred Wagner, Joachim H Ficker, Christoph Petermann, Ralf-Harto Hübner, Franz Stanzel, Narinder S Shargill and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respiration; international review of thoracic diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Lung volume reduction: surgeryBreathe (Sheffield, England) · 2024
    Review
  8. Interventional pulmonology for chronic inflammatory airway diseases.Chinese medical journal pulmonary and critical care medicine · 2024
    Review
  9. Surgical and bronchoscopic pulmonary function-improving procedures in lung emphysema.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  10. Review
  11. Review
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 4 countries.

Ralf EberhardtDepartment of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg (TLRCH, German Center for Lung Research (DZL), Heidelberg, Germany.
Dirk-Jan SlebosDepartment of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Felix J F HerthDepartment of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg (TLRCH, German Center for Lung Research (DZL), Heidelberg, Germany.
Kaid DarwicheDepartment of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Clinic Essen, Essen, Germany.
Manfred WagnerDepartment of Respiratory Medicine, Allergology and Sleep Medicine, Paracelsus Medical University, General Hospital Nuremberg, Nuremberg, Germany.
Joachim H FickerDepartment of Respiratory Medicine, Allergology and Sleep Medicine, Paracelsus Medical University, General Hospital Nuremberg, Nuremberg, Germany.
Christoph PetermannLungenabteilung, Thoraxzentrum Hamburg, Asklepios Klinik, Hamburg, Germany.
Ralf-Harto HübnerCharité Campus Virchow-Klinikum (CVK), Berlin, Germany.
Franz StanzelLungenklinik Hemer, Hemer, Germany.
Narinder S ShargillPulmonx Corporation, Redwood City, California, USA.
Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Otto-Wagner-Spital, Wien, Austria.
IMPACT Study Team
Heidelberg University · DENuremberg Hospital · DEAsklepios · DECharité - Universitätsmedizin Berlin · DELungenklinik Hemer · DEOtto Wagner Hospital · ATPulmonx (United States) · USRuhrlandklinik · DEUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleThe long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr endobronchial valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established.

methodsNinety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr valves or standard of care (SoC) (1:1). Zephyr valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr valve treatment.

resultsThe mean group difference (Zephyr valve - SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George's Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr valve and SoC groups from 31 days to 6 months, and stable in the Zephyr valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr valve group out to 12 months.

conclusionsBronchoscopic lung volume reduction with Zephyr valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months.

Indexed as

EmphysemaPulmonary EmphysemaBronchoscopyForced Expiratory VolumeHumansPneumonectomyQuality of LifeTreatment OutcomeBronchoscopic lung volume reductionEmphysemaLung functionQuality of lifeResidual volume

Identifiers

PMID34350884
PMCPMC8743904
OpenAlexW3184990103

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.