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. 2017 Feb 23;2(2):CD012158.
doi: 10.1002/14651858.CD012158.pub2.

Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease

Affiliations

Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease

Joseph Em van Agteren et al. Cochrane Database Syst Rev. .

Abstract

Background: In the recent years, a variety of bronchoscopic lung volume reduction (BLVR) procedures have emerged that may provide a treatment option to participants suffering from moderate to severe chronic obstructive pulmonary disease (COPD).

Objectives: To assess the effects of BLVR on the short- and long-term health outcomes in participants with moderate to severe COPD and determine the effectiveness and cost-effectiveness of each individual technique.

Search methods: Studies were identified from the Cochrane Airways Group Specialised Register (CAGR) and by handsearching of respiratory journals and meeting abstracts. All searches are current until 07 December 2016.

Selection criteria: We included randomized controlled trials (RCTs). We included studies reported as full text, those published as abstract only and unpublished data, if available.

Data collection and analysis: Two independent review authors assessed studies for inclusion and extracted data. Where possible, data from more than one study were combined in a meta-analysis using RevMan 5 software.

Main results: AeriSealOne RCT of 95 participants found that AeriSeal compared to control led to a significant median improvement in forced expiratory volume in one second (FEV1) (18.9%, interquartile range (IQR) -0.7% to 41.9% versus 1.3%, IQR -8.2% to 12.9%), and higher quality of life, as measured by the St Georges Respiratory Questionnaire (SGRQ) (-12 units, IQR -22 units to -5 units, versus -3 units, IQR -5 units to 1 units), P = 0.043 and P = 0.0072 respectively. Although there was no significant difference in mortality (Odds Ratio (OR) 2.90, 95% CI 0.14 to 62.15), adverse events were more common for participants treated with AeriSeal (OR 3.71, 95% CI 1.34 to 10.24). The quality of evidence found in this prematurely terminated study was rated low to moderate. Airway bypass stentsTreatment with airway bypass stents compared to control did not lead to significant between-group changes in FEV1 (0.95%, 95% CI -0.16% to 2.06%) or SGRQ scores (-2.00 units, 95% CI -5.58 units to 1.58 units), as found by one study comprising 315 participants. There was no significant difference in mortality (OR 0.76, 95% CI 0.21 to 2.77), nor were there significant differences in adverse events (OR 1.33, 95% CI 0.65 to 2.73) between the two groups. The quality of evidence was rated moderate to high. Endobronchial coilsThree studies comprising 461 participants showed that treatment with endobronchial coils compared to control led to a significant between-group mean difference in FEV1 (10.88%, 95% CI 5.20% to 16.55%) and SGRQ (-9.14 units, 95% CI -11.59 units to -6.70 units). There were no significant differences in mortality (OR 1.49, 95% CI 0.67 to 3.29), but adverse events were significantly more common for participants treated with coils (OR 2.14, 95% CI 1.41 to 3.23). The quality of evidence ranged from low to high. Endobronchial valvesFive studies comprising 703 participants found that endobronchial valves versus control led to significant improvements in FEV1 (standardized mean difference (SMD) 0.48, 95% CI 0.32 to 0.64) and scores on the SGRQ (-7.29 units, 95% CI -11.12 units to -3.45 units). There were no significant differences in mortality between the two groups (OR 1.07, 95% CI 0.47 to 2.43) but adverse events were more common in the endobronchial valve group (OR 5.85, 95% CI 2.16 to 15.84). Participant selection plays an important role as absence of collateral ventilation was associated with superior clinically significant improvements in health outcomes. The quality of evidence ranged from low to high. Intrabronchial valvesIn the comparison of partial bilateral placement of intrabronchial valves to control, one trial favoured control in FEV1 (-2.11% versus 0.04%, P = 0.001) and one trial found no difference between the groups (0.9 L versus 0.87 L, P = 0.065). There were no significant differences in SGRQ scores (MD 2.64 units, 95% CI -0.28 units to 5.56 units) or mortality rates (OR 4.95, 95% CI 0.85 to 28.94), but adverse events were more frequent (OR 3.41, 95% CI 1.48 to 7.84) in participants treated with intrabronchial valves. The lack of functional benefits may be explained by the procedural strategy used, as another study (22 participants) compared unilateral versus partial bilateral placement, finding significant improvements in FEV1 and SGRQ when using the unilateral approach. The quality of evidence ranged between moderate to high. Vapour ablationOne study of 69 participants found significant mean between-group differences in FEV1 (14.70%, 95% CI 7.98% to 21.42%) and SGRQ (-9.70 units, 95% CI -15.62 units to -3.78 units), favouring vapour ablation over control. There was no significant between-group difference in mortality (OR 2.82, 95% CI 0.13 to 61.06), but vapour ablation led to significantly more adverse events (OR 3.86, 95% CI 1.00 to 14.97). The quality of evidence ranged from low to moderate.

Authors' conclusions: Results for selected BLVR procedures indicate they can provide significant and clinically meaningful short-term (up to one year) improvements in health outcomes, but this was at the expense of increased adverse events. The currently available evidence is not sufficient to assess the effect of BLVR procedures on mortality. These findings are limited by the lack of long-term follow-up data, limited availability of cost-effectiveness data, significant heterogeneity in results, presence of skew and high CIs, and the open-label character of a number of the studies.

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Conflict of interest statement

Dion Grosser has received payment to attend workshops and to provide education and proctoring for placement of endobronchial valves (Pulmonx) and has received flights and accommodation to attend an education session on implantation of coils (PneumRx). None of the other review authors are aware of any conflict of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 BLVR to medical therapy, outcome: 1.1 Mortality (All methods, end of follow‐up).
5
5
Forest plot of comparison: 1 BLVR to medical therapy, outcome: 1.2 Adverse Events (all methods, end of follow‐up).
1.1
1.1. Analysis
Comparison 1 BVLR (all methods) versus medical therapy, Outcome 1 Mortality (end of follow‐up, all methods).
1.2
1.2. Analysis
Comparison 1 BVLR (all methods) versus medical therapy, Outcome 2 Adverse events (end of follow‐up, all methods).
2.1
2.1. Analysis
Comparison 2 Endobronchial coils versus medical therapy, Outcome 1 Absolute % change in FEV1 (end of follow‐up, endobronchial coils).
2.2
2.2. Analysis
Comparison 2 Endobronchial coils versus medical therapy, Outcome 2 SGRQ change from baseline (end of follow‐up, endobronchial coils).
2.3
2.3. Analysis
Comparison 2 Endobronchial coils versus medical therapy, Outcome 3 RV change from baseline (L, end of follow‐up, endobronchial coils).
2.4
2.4. Analysis
Comparison 2 Endobronchial coils versus medical therapy, Outcome 4 TLC change from baseline (L, end of follow‐up, endobronchial coils).
2.5
2.5. Analysis
Comparison 2 Endobronchial coils versus medical therapy, Outcome 5 RV/TLC change from baseline (end of follow‐up, endobronchial coils).
2.6
2.6. Analysis
Comparison 2 Endobronchial coils versus medical therapy, Outcome 6 6MWD change from baseline (end of follow‐up, endobronchial coils).
3.1
3.1. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 1 % change in FEV1 (end of follow‐up, endobronchial valves).
3.2
3.2. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 2 % change in FEV1 (stratified per follow‐up, endobronchial valves).
3.3
3.3. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 3 % change in FEV1 (stratified per disease distribution, endobronchial valves).
3.4
3.4. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 4 % Change in FEV1 (stratified by collateral ventilation, endobronchial valves).
3.5
3.5. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 5 Mortality (stratified per follow‐up, endobronchial valves).
3.6
3.6. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 6 Mortality (stratified by collateral ventilation, endobronchial valves).
3.7
3.7. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 7 SGRQ change from baseline (end of follow‐up, endobronchial valves).
3.8
3.8. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 8 SGRQ change from baseline (stratified by follow‐up time, endobronchial valves).
3.9
3.9. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 9 SGRQ change from baseline (stratified by collateral ventilation, endobronchial valves).
3.10
3.10. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 10 RV change from baseline (L, end of follow‐up, endobronchial valves).
3.11
3.11. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 11 TLC change from baseline (L, end of follow‐up, endobronchial valves).
3.12
3.12. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 12 RV/TLC change from baseline (end of follow‐up, endobronchial valves).
3.13
3.13. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 13 6MWD change from baseline (end of follow‐up, endobronchial valves).
3.14
3.14. Analysis
Comparison 3 Endobronchial valves versus medical therapy, Outcome 14 6MWD change from baseline (stratified per collateral ventilation,, endobronchial valves).
4.1
4.1. Analysis
Comparison 4 Intrabronchial valves versus medical therapy, Outcome 1 SGRQ change from baseline (end of follow‐up, intrabronchial valves).
4.2
4.2. Analysis
Comparison 4 Intrabronchial valves versus medical therapy, Outcome 2 RV change from baseline (L, end of follow‐up, intrabronchial valves).
4.3
4.3. Analysis
Comparison 4 Intrabronchial valves versus medical therapy, Outcome 3 TLC change from baseline (L, end of follow‐up, intrabronchial valves).
4.4
4.4. Analysis
Comparison 4 Intrabronchial valves versus medical therapy, Outcome 4 PAO2 (end of follow‐up, intrabronchial valves).
4.5
4.5. Analysis
Comparison 4 Intrabronchial valves versus medical therapy, Outcome 5 PACO2 (end of follow‐up, intrabronchial valves).
4.6
4.6. Analysis
Comparison 4 Intrabronchial valves versus medical therapy, Outcome 6 6MWD change from baseline (intrabronchial valves).

Update of

References

References to studies included in this review

ASPIRE 2015 {published data only}
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Eberhardt 2012 {published data only}
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IBV Valve trial 2014 {published data only}
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IMPACT 2016 {published data only}
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Ninane 2012 {published data only}
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RENEW 2016 {published data only}
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RESET 2015 {published data only}
    1. Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, et al. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respiratory Medicine 2013;1(3):233‐40. [DOI: 10.1016/S2213-2600(13)70047-X] - DOI - PubMed
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Revolens 2016 {published data only}
    1. Deslee G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, et al. Lung volume reduction coil treatment vs usual care in patients with severe emphysema: the REVOLENS randomized clinical trial. JAMA 2016;315(2):175‐84. [DOI: 10.1001/jama.2015.17821] - DOI - PubMed
STELVIO 2015 {published data only}
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STEP‐UP 2016 {published data only}
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VENT EU 2012 {published data only}
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VENT US 2010 {published data only}
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References to studies excluded from this review

Abumossalam 2016 {published data only}
    1. Abumossalam AM, El‐Halaby HA, Abd El‐khalek AM. Poor man medical pneumoplasty: bronchoscopic lung volume reduction with hot saline versus dissolved doxycycline as a neoteric remedy of pulmonary emphysema. Egyptian Journal of Chest Diseases and Tuberculosis 2016;65(1):71‐9.
Cardoso 2007 {published data only}
    1. Cardoso PFG, Snell GI, Hopkins P, Sybrecht GW, Stamatis G, Ng AW, et al. Clinical application of airway bypass with paclitaxel‐eluting stents: early results. Journal of Thoracic and Cardiovascular Surgery 2007;134(4):974‐81. - PubMed
Choong 2005 {published data only}
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Choong 2006 {published data only}
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Choong 2008 {published data only}
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Criner 2009 {published data only}
    1. Criner GJ, Pinto‐Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, et al. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. American Journal of Respiratory and Critical Care Medicine 2009;179(9):791‐8. [DOI: 10.1164/rccm.200810-1639OC] - DOI - PubMed
De Oliveira 2006 {published data only}
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Deslee 2014 {published data only}
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Emery 2010 {published data only}
    1. Emery MJ, Eveland RL, Eveland K, Couetil LL, Hildebrandt J, Swenson ER. Lung volume reduction by bronchoscopic administration of steam. American Journal of Respiratory and Critical Care Medicine 2010;182(10):1282‐91. - PubMed
Faisal 2016 {published data only}
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Falkenstern‐Ge 2013 {published data only}
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Fann 2003 {published data only}
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Fruchter 2016 {published data only}
    1. Fruchter O, Rosengarten D, Goldberg E, Ben‐Zvi H, Tor R, Kramer MR. Airway bacterial colonization and serum C‐reactive protein are associated with chronic obstructive pulmonary disease exacerbation following bronchoscopic lung volume reduction. Clinical Respiratory Journal 2016;10(2):239‐45. [DOI: 10.1111/crj.12211] - DOI - PubMed
Gompelmann 2010 {published data only}
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Gompelmann 2012 {published data only}
    1. Gompelmann D, Heussel CP, Eberhardt R, Snell G, Hopkins P, Baker K, et al. Efficacy of bronchoscopic thermal vapor ablation and lobar fissure completeness in patients with heterogeneous emphysema. Respiration 2012;83(5):400‐6. [DOI: 10.1159/000336239] - DOI - PubMed
Gompelmann 2013 {published data only}
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Hartman 2015 {published data only}
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Herth 2010 {published data only}
    1. Herth FJF, Eberhard R, Gompelmann D, Slebos D‐J, Ernst A. Bronchoscopic lung volume reduction with a dedicated coil: a clinical pilot study. Therapeutic Advances in Respiratory Disease 2010;4(4):225‐31. [DOI: 10.1177/1753465810368553] - DOI - PubMed
Herth 2011 {published data only}
    1. Herth FJF, Gompelmann D, Stanzel F, Bonnet R, Behr J, Schmidt B, et al. Treatment of advanced emphysema with emphysematous lung sealant (AeriSeal). Respiration 2011;82(1):36‐45. [DOI: 10.1159/000322649] - DOI - PubMed
Herth 2012 {published data only}
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Hopkinson 2005 {published data only}
    1. Hopkinson NS, Toma TP, Hansell DM, Goldstraw P, Moxham J, Geddes DM, et al. Effect of bronchoscopic lung volume reduction on dynamic hyperinflation and exercise in emphysema. American Journal of Respiratory Critical Care Medicine 2005;171(5):453‐60. - PubMed
Hopkinson 2011 {published data only}
    1. Hopkinson NS, Kemp SV, Toma TP, Hansell DM, Geddes DM, Shah PL, et al. Atelectasis and survival after bronchoscopic lung volume reduction for COPD. European Respiratory Journal 2011;37(6):1346‐51. - PubMed
Klooster 2014 {published data only}
    1. Klooster K, Hacken NHT, Franz I, Kerstjens HAM, Rikxoort EM, Slebos D‐J. Lung volume reduction coil treatment in chronic obstructive pulmonary disease patients with homogeneous emphysema: a prospective feasibility trial. Respiration 2014;88(2):116‐25. [DOI: 10.1159/000362522] - DOI - PubMed
Kontogianni 2014 {published data only}
    1. Kontogianni K, Gerovasili V, Gompelmann D, Schuhmann M, Heussel CP, Herth FJ, et al. Effectiveness of endobronchial coil treatment for lung volume reduction in patients with severe heterogeneous emphysema and bilateral incomplete fissures: a six‐month follow‐up. Respiration 2014;88(1):52‐60. - PubMed
Kotecha 2011 {published data only}
    1. Kotecha S, Westall GP, Holsworth L, Pham A, Williams TJ, Snell GI. Long‐term outcomes from bronchoscopic lung volume reduction using a bronchial prosthesis. Respirology 2011;16(1):167‐73. - PubMed
Kramer 2012 {published data only}
    1. Kramer MR, Refaely Y, Maimon N, Rosengarten D, Fruchter O. Bilateral endoscopic sealant lung volume reduction therapy for advanced emphysema. Chest 2012;142(5):1111‐7. - PubMed
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Kramer 2013 {published data only}
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Magnussen 2012 {published data only}
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    1. Venuta F, Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, et al. Bronchoscopic lung‐volume reduction with one‐way valves in patients with heterogenous emphysema. Annals of Thoracic Surgery 2005;79(2):411‐6; discussion 6‐7. - PubMed
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References to ongoing studies

ISRCTN19684749 {published data only}
    1. ISRCTN19684749. The CELEB trial: comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement. www.isrctn.com/ISRCTN19684749 (accessed 23 May 2016). - PMC - PubMed
NCT01457833 {published data only}
    1. NCT01457833. Implantation of endobronchial valves versus intrabronchial valves in patients with severe heterogeneous emphysema. clinicaltrials.gov/ct2/show/NCT01457833 (accessed 19 October 2011).
NCT01796392 {published data only}
    1. NCT01796392. Pulmonx endobronchial valves used in treatment of emphysema (LIBERATE Study). clinicaltrials.gov/ct2/show/record/NCT01796392 (accessed 20 February 2013).
NCT01812447 {published data only}
    1. NCT01812447. Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function (EMPROVE). clinicaltrials.gov/ct2/show/record/NCT01812447 (accessed 7 March 2013).
NCT01989182 {published data only}
    1. Li S, Wang G, Wang C, Jin F, Gao X, Yang H, et al. LATE‐BREAKING ABSTRACT: The REACH study, a randomized controlled trial assessing the safety and effectiveness of the spiration valve system intra‐bronchial therapy for severe emphysema. European Respiratory Journal 2016;48:OA3013.
    1. NCT01989182. The spiration valve system for the treatment of severe emphysema. clinicaltrials.gov/ct2/show/record/NCT01989182 (accessed 6 November 2013).
NCT02022683 {published data only}
    1. NCT02022683. To improve lung function and symptoms for emphysema patients Using Zephyr EBV (TRANSFORM). clinicaltrials.gov/ct2/show/record/NCT02022683 (accessed 17 December 2013).
NCT02823223 {published data only}
    1. NCT02823223. Endobronchial valve in patients With heterogeneous emphysema. clinicaltrials.gov/ct2/show/record/NCT02823223 (accessed 29 June 2016).

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