Endobronchial valves for severe emphysema

Jorine E Hartman, Lowie E G W Vanfleteren, Eva M van Rikxoort, Karin Klooster, Dirk-Jan Slebos, Jorine E Hartman, Lowie E G W Vanfleteren, Eva M van Rikxoort, Karin Klooster, Dirk-Jan Slebos

Abstract

The results of the randomised controlled trials investigating the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) are promising, and have led to their inclusion in treatment guidelines, US Food and Drug Administration approval and inclusion in routine care in an increasing number of countries. The one-way valve treatment has advanced and is now a regular treatment option. However, this new phase will lead to new challenges in terms of implementation. We believe that key issues in future research concern advanced patient selection, improved methods for target lobe selection, increased knowledge on the predictive risk of a pneumothorax, positioning of pulmonary rehabilitation in conjunction with the EBV treatment, the positioning of lung volume reduction surgery versus EBV treatment, and the long-term efficacy, adverse events, impact on exacerbations and hospitalisations, costs and survival. Hopefully, the increasing number of patients treated, the setup of (inter)national registries and future research efforts will further optimise all aspects of this treatment.

Conflict of interest statement

Conflict of interest: J.E. Hartman has nothing to disclose. Conflict of interest: L.E.G.W. Vanfleteren reports personal fees from PulmonX, outside the submitted work. Conflict of interest: E.M. van Rikxoort reports other funding from Thirona, during the conduct of the study. Conflict of interest: K. Klooster has nothing to disclose. Conflict of interest: D-J. Slebos reports grants, personal fees, non-financial support and other funding from PulmonX Inc., CA, USA, during the conduct of the study; and grants, personal fees, non-financial support and other funding from PneumRx/BTG, CA, USA, outside the submitted work.

Copyright ©ERS 2019.

Figures

FIGURE 1
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.

References

    1. Kemp SV, Slebos DJ, Kirk A, et al. . A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med 2017; 196: 1535–1543.
    1. Criner GJ, Sue R, Wright S, et al. . A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (LIBERATE). Am J Respir Crit Care Med 2018; 198: 1151–1164.
    1. Klooster K, ten Hacken NH, Hartman JE, et al. . Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med 2015; 373: 2325–2335.
    1. Valipour A, Slebos DJ, Herth F, et al. . Endobronchial valve therapy in patients with homogeneous emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med 2016; 194: 1073–1082.
    1. Davey C, Zoumot Z, Jordan S, et al. . Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet 2015; 386: 1066–1073.
    1. US Food and Drug Administration . FDA approval: Zephyr Endobronchial Valve System. Date last updated: June 29 2018. Date last accessed: October 14, 2018.
    1. National Institute for Health and Care Excellence . Endobronchial valve insertion to reduce lung volume in emphysema. Date last updated: December 2017. Date last accessed: October 14, 2018.
    1. Vogelmeier CF, Criner GJ, Martinez FJ, et al. . Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med 2017; 195: 557–582.
    1. Slebos DJ, Shah PL, Herth FJ, et al. . Endobronchial valves for endoscopic lung volume reduction: best practice recommendations from Expert Panel on Endoscopic Lung Volume Reduction. Respiration 2017; 93: 138–150.
    1. Sterman DH, Mehta AC, Wood DE, et al. . A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. Respiration 2010; 79: 222–233.
    1. Levin A, Sklyuev S, Felker I, et al. . Endobronchial valve treatment of destructive multidrug-resistant tuberculosis. Int J Tuberc Lung Dis 2016; 20: 1539–1545.
    1. Galluccio G, Lucantoni G. Bronchoscopic lung volume reduction for pulmonary emphysema: preliminary experience with a new NOVATECH endobronchial silicone one-way valve. Interact Cardiovasc Thorac Surg 2010; 11: 213–215.
    1. Hartman JE, Klooster K, Groen H, et al. . Cost-effectiveness of endobronchial valve treatment in patients with severe emphysema compared to standard medical care. Respirology 2018; in press [10.1111/resp.13295].
    1. Criner GJ, Cordova F, Sternberg AL, et al. . The National Emphysema Treatment Trial (NETT) part II: lessons learned about lung volume reduction surgery. Am J Respir Crit Care Med 2011; 184: 881–893.
    1. Fishman A, Martinez F, Naunheim K, et al. . A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003; 348: 2059–2073.
    1. Hartman JE, Klooster K, Slebos DJ, et al. . Improvement of physical activity after endobronchial valve treatment in emphysema patients. Respir Med 2016; 117: 116–121.
    1. Herth FJ, Eberhardt R, Gompelmann D, et al. . Radiological and clinical outcomes of using Chartis to plan endobronchial valve treatment. Eur Respir J 2013; 41: 302–308.
    1. Sciurba FC, Ernst A, Herth FJ, et al. . A randomized study of endobronchial valves for advanced emphysema. N Engl J Med 2010; 363: 1233–1244.
    1. Gompelmann D, Benjamin N, Bischoff E, et al. . Survival after endoscopic valve therapy in patients with severe emphysema. Respiration 2019: 145–152.
    1. Valipour A, Slebos DJ, de Oliveira HG, et al. . Expert statement: pneumothorax associated with endoscopic valve therapy for emphysema – potential mechanisms, treatment algorithm, and case examples. Respiration 2014; 87: 513–521.
    1. Li S, Wang G, Wang C, et al. . The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration Valve System in the Treatment of Severe Emphysema. Respiration 2018; in press [10.1159/000494327].
    1. Wang G, Li S, Wang C, et al. . The REACH study, a randomized controlled trial assessing the safety and effectiveness of the Spiration Valve System endobronchial therapy for severe emphysema: 12 month follow-up results. Eur Respir J 2017: 50; Suppl. 61, OA1465.
    1. Criner G, Delage A, Voelker K. Endobronchial Valves for Severe Emphysema – 12-month results of the EMPROVE Trial. Eur Respir J 2018: 52: Suppl. 62, OA4928.
    1. Pietzsch JB, Garner AM, Herth FJ. Cost-effectiveness of endobronchial valve therapy for severe emphysema: a model-based projection based on the Vent study. Value Health 2014; 17: A598.
    1. Charbonnier JP, Brink M, Ciompi F, et al. . Automatic pulmonary artery-vein separation and classification in computed tomography using tree partitioning and peripheral vessel matching. IEEE Trans Med Imaging 2016; 35: 882–892.
    1. Charbonnier JP, Rikxoort EMV, Setio AAA, et al. . Improving airway segmentation in computed tomography using leak detection with convolutional networks. Med Image Anal 2017; 36: 52–60.
    1. Koster TD, van Rikxoort EM, Huebner RH, et al. . Predicting lung volume reduction after endobronchial valve therapy is maximized using a combination of diagnostic tools. Respiration 2016; 92: 150–157.
    1. Gompelmann D, Lim HJ, Eberhardt R, et al. . Predictors of pneumothorax following endoscopic valve therapy in patients with severe emphysema. Int J Chron Obstruct Pulmon Dis 2016; 11: 1767–1773.
    1. van Geffen WH, Klooster K, Hartman JE, et al. . Pleural adhesion assessment as a predictor for pneumothorax after endobronchial valve treatment. Respiration 2017; 94: 224–231.
    1. Hartman JE, Vanfleteren LEGW, van Rikxoort EM, et al. . Bronchoscopic lung volume reduction treatment using endobronchial valves for emphysema: emerging questions. Respiration 2018; 96: 588–589.
    1. Klooster K, Hartman JE, ten Hacken NHT, et al. . One-year follow-up after endobronchial valve treatment in patients with emphysema without collateral ventilation treated in the STELVIO trial. Respiration 2017; 93: 112–121.
    1. Venuta F, Anile M, Diso D, et al. . Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J 2012; 39: 1084–1089.
    1. Fiorelli A, Santoriello C, De Felice A, et al. . Bronchoscopic lung volume reduction with endobronchial valves for heterogeneous emphysema: long-term results. J Vis Surg 2017; 3: 170.
    1. Garner J, Kemp SV, Toma TP, et al. . Survival after endobronchial valve placement for emphysema: a 10-year follow-up study. Am J Respir Crit Care Med 2016; 194: 519–521.
    1. Klooster K, Hartman JE, Ten Hacken NHT, et al. . Improved predictors of survival after endobronchial valve treatment in patients with severe emphysema. Am J Respir Crit Care Med 2017; 195: 1272–1274.
    1. Hopkinson NS, Kemp SV, Toma TP, et al. . Atelectasis and survival after bronchoscopic lung volume reduction for COPD. Eur Respir J 2011; 37: 1346–1351.
    1. Skowasch D, Fertl A, Schwick B, et al. . A long-term follow-up investigation of endobronchial valves in emphysema (the LIVE Study): study protocol and six-month interim analysis results of a prospective five-year observational study. Respiration 2016; 92: 118–126.
    1. BreathGroup . Registry. Date last accessed: January 30, 2019.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera