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Endobronchial valves for severe emphysema

Jorine E. Hartman, Lowie E.G.W. Vanfleteren, Eva M. van Rikxoort, Karin Klooster, Dirk-Jan Slebos
European Respiratory Review 2019 28: 180121; DOI: 10.1183/16000617.0121-2018
Jorine E. Hartman
1Dept of Pulmonary diseases, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
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  • For correspondence: j.hartman@umcg.nl
Lowie E.G.W. Vanfleteren
3COPD Centre, Sahlgrenska University Hospital and Institute of Medicine, Gothenburg University, Gothenburg, Sweden
4Dept of Development and Education, CIRO+, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands
5Dept of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
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  • ORCID record for Lowie E.G.W. Vanfleteren
Eva M. van Rikxoort
6Depat of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
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Karin Klooster
1Dept of Pulmonary diseases, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
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Dirk-Jan Slebos
1Dept of Pulmonary diseases, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
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    FIGURE 1

    Endobronchial valve (EBV) treatment for emphysema, summary of treatment selection and outcome. The key selection criteria for success (do) and restraints for treatment (don't) are shown. The criteria for success (do) are: severe emphysema; complete interlobar fissure (no collateral flow); severe hyperinflation (residual volume (RV) >175% pred, RV/total lung capacity (TLC) >55%); symptomatic; non-smoking; on optimal treatment; and stable condition. The criteria for restraints (don't) are: presence of a suspect nodule; pleural pathology; severe bronchiectasis; incomplete fissure; fibrosis; severe cardiac comorbidity (i.e. pulmonary arterial hypertension (PAH), congestive heart failure (CHF) and coronary artery disease (CAD)); infectious lung disease; chronic bronchitis or asthma; prior lobectomy or lung volume reduction surgery (LVRS) on treatment side; hypercapnia/hypoxaemia; and immunocompromised. The figure also shows the mean responder rates and percentage of risk related to EBV treatment from the four published randomised controlled trials. Responder rates are the percentage of patients who reached the earlier established minimal important difference: forced expiratory volume in 1s (FEV1) ≥12% (STELVIO ≥10%), RV ≥430 mL (LIBERATE ≥310 mL), 6-min walk distance (6MWD) ≥25 m, St George's Respiratory Questionnaire (SGRQ) ≥4 points. #: modified Medical Research Council scale ≥2 or 100 m<6MWD<500 m; ¶: partial pressure of carbon dioxide >60 mmHg/partial pressure of oxygen <45 mmHg.

Tables

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  • TABLE 1

    Overview of results of the four randomised controlled trials performed to date using the Chartis measurement

    STELVIO [3]IMPACT [4]TRANSFORM [1]LIBERATE [2]
    Patients nEBV: 34; SoC: 34EBV: 43; SoC: 50EBV: 65; SoC: 32EBV: 128; SoC: 62
    Emphysema distributionHeterogeneous and homogeneousHomogeneousHeterogeneousHeterogeneous
    Procedure
     Procedure time min18 (6–51)NRNR29 (4–123)
     Valves used n4 (2–7)44 (2–8)4 (2–8)
     Hospital stay days1 (1–13)6 (3–40)4 (1–49)NR
    Efficacy
     Target lobe volume reduction# mL−1366−1195−1090−1142
     Between group difference6 months follow-up3 months follow-up6 months follow-up12 months follow-up
      Change in lung function
       FEV1+17.8%§+17%§+29%§+18%§
       RV mL−831−480§−700§−522§
      Change in exercise capacity
       6MWD m+74§+40§+79§+39§
      Change in patient-centred outcomes
       SGRQ total score−14.7−9.7§−6.5§−7.1§
       mMRC change−0.61−0.57§−0.6§−0.8§
       Physical activity steps per day+1340 (+57%)NRNRNR
    Responder rates¶
     FEV172%40%66%56%
     RV71%44%68%62%
     6MWD79%57%66%42%
     SGRQ87%50%65%56%
    Safety+
     Pneumothorax18%26%29%34%
     Valve retainment79%93%97%94%
     Re-bronchoscopy35%19%28%27%
     Deaths3%0%2%4%

    Data are presented as median (range) or mean change, unless otherwise stated. FEV1: forced expiratory volume in 1 s; RV: residual volume; 6MWD: 6-min walk distance; SGRQ: St George's Respiratory Questionnaire; mMRC: modified Medical Research Council scale; EBV: endobronchial valve; SoC: standard of care; NR: not reported. #: change in the EBV group only; ¶: percentage of patients who reached the earlier established minimal important difference: FEV1 ≥12% (STELVIO ≥10%), RV ≥430 mL (LIBERATE ≥310 mL), 6MWD ≥25 m, SGRQ ≥4 points; +: EBV group only; §: intention to treat analyses.

    • TABLE 2

      Challenges and future directions of endobronchial valve (EBV) treatment

      Advanced patient selection
       Clinical patient characteristicsTo define the cut-offs regarding clinical patient characteristics such as degree of obstruction, static hyperinflation, diffusion capacity, blood oxygen tension, exercise capacity, pulmonary hypertension, comorbidities, etc. for procedure-related risk estimation and efficacy outcome.
       Emphysema severityTo define the exact role of quantitative lobar tissue destruction scores related to outcomes.
       Prediction of collateral ventilationTo define the optimal cut-off (both lower and upper limit) for the degree of fissure integrity calculated on CT.
      To establish the optimal method of measurement and interpretation of the Chartis system signal in the measurement of collateral ventilation.
       Prediction of response using quantificationTo further develop quantitative HRCT software analysis with accurate assessment of fissure integrity, emphysema scores, the amount of air trapping and lung perfusion, all on a lobar level.
       Multidisciplinary teamTo establish a solid base for an emphysema multidisciplinary team like our lung cancer and ILD multidisciplinary team meetings.
      Therapeutic challenges
       The positioning of LVRS versus EBV treatmentNot all patients that are good candidates for surgery are good candidates for valves and vice versa.
      To create decision making guidance for candidate patients for both techniques.
      To create a step-up treatment guidance for initial good responders to EBV treatment.
       Closing the interlobar collateral channelsTo develop treatments that successfully close the collateral channels which would significantly increase the patient population that could potentially benefit from EBV treatment.
       Treatment decisions in patients with homogeneous diseaseTo identify the best treatment option for patients with real homogeneous disease. EBV treatment or coil treatment?
       Granulation tissueTo identify predictors or risk factors for the development of granulation tissue after EBV treatment (and in fact after every implantable device in the human airways).
      Burning questions
       Long-term effectsTo establish the long-term efficacy, cost-efficiency, effect on exacerbations, hospitalisations, survival and adverse events.
       The interaction with pulmonary rehabilitation.The combination of EBV treatment and pulmonary rehabilitation could strengthen the effect of the EBV treatment. The best timing of the rehabilitation programme has not been investigated to date.
      A look in the crystal globe
       Potential future developmentsTo develop new or customised valves.
      To develop an advanced Chartis device that could be helpful in target lobe selection.
      To establish the role of advanced functional imaging with patient selection
      To combine different endoscopic and/or surgical techniques.

      LVRS: lung volume reduction surgery; CT: computed tomography; HRCT: high-resolution CT; ILD: interstitial lung disease.

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      Endobronchial valves for severe emphysema
      Jorine E. Hartman, Lowie E.G.W. Vanfleteren, Eva M. van Rikxoort, Karin Klooster, Dirk-Jan Slebos
      European Respiratory Review Jun 2019, 28 (152) 180121; DOI: 10.1183/16000617.0121-2018

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      Endobronchial valves for severe emphysema
      Jorine E. Hartman, Lowie E.G.W. Vanfleteren, Eva M. van Rikxoort, Karin Klooster, Dirk-Jan Slebos
      European Respiratory Review Jun 2019, 28 (152) 180121; DOI: 10.1183/16000617.0121-2018
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