250
Views
0
CrossRef citations to date
0
Altmetric
Device Profile

Device profile of the Zephyr endobronchial valve in heterogenous emphysema: overview of its safety and efficacy

& ORCID Icon
Pages 823-832 | Received 27 Apr 2021, Accepted 15 Jul 2021, Published online: 11 Aug 2021

References

  • National Heart, Lung, and Blood Institute. COPD national action plan. 2021. 2021 Mar 28
  • Marsh SE, Travers J, Weatherall M, et al. Proportional classifications of COPD phenotypes. Thorax. 2008;63(9):761–767.
  • Zantah M, Gangemi AJ, Criner GJ. Bronchoscopic lung volume reduction: status quo. Ann Transl Med. 2020;8(21):1469.
  • Rossi A, Aisanov Z, Avdeev S, et al. Mechanisms, assessment and therapeutic implications of lung hyperinflation in COPD. Respir Med. 2015;109(7):785–802.
  • O’Donnell DE, Flüge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004;23(6):832–840.
  • 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(21):2059–2073.
  • Singh D, Agusti A, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease: the GOLD science committee report 2019. Eur Respir J. 2019;53(5):1900164.
  • Hopkinson NS, Molyneux A, Pink J, et al. (GC) GC. Chronic obstructive pulmonary disease: diagnosis and management: summary of updated NICE guidance. BMJ. 2019;366:l4486.
  • Sciurba FC, Ernst A, Herth FJ, et al. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010;363(13):1233–1244.
  • 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(2):302–308.
  • Klooster K, ten Hacken NH, Hartman JE, et al. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med. 2015;373(24):2325–2335.
  • 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(9998):1066–1073.
  • 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(12):1535–1543.
  • 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(9):1073–1082.
  • 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(9):1151–1164.
  • Dransfield MT, Garner JL, Bhatt SP, et al. Effect of Zephyr endobronchial valves on dyspnea, activity levels, and quality of life at one year. Results from a randomized clinical trial. Ann Am Thorac Soc. 2020;17(7):829–838.
  • Pulmonx endobronchial valves used in treatment of emphysema (LIBERATE Study). [cited 2021 Apr 4]. Available from: https://ClinicalTrials.gov/show/NCT01796392.
  • Darwiche K, Karpf-Wissel R, Eisenmann S, et al. Bronchoscopic lung volume reduction with endobronchial valves in low-FEV1 patients. Respiration. 2016;92(6):414–419.
  • van Dijk M, Hartman JE, Klooster K, et al. Endobronchial valve treatment in emphysema patients with a very low DLCO. Respiration. 2020;99(2):163–170.
  • Pulmonx: Patient Selection Guidance. 2020. [cited 2021 Mar 31]. Available from: https://physicians.mylungsmylife.com/patient-selection
  • Criner GJ, Delage A, Voelker K, et al. Improving lung function in severe heterogenous emphysema with the spiration valve system (EMPROVE). A multicenter, open-label randomized controlled clinical trial. Am J Respir Crit Care Med. 2019;200(11):1354–1362.
  • Diso D, Anile M, Carillo C, et al. Correlation between collateral ventilation and interlobar lung fissures. Respiration. 2014;88(4):315–319.
  • 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. 2019;97(5):416–427.
  • Argula RG, Strange C, Ramakrishnan V, et al. Baseline regional perfusion impacts exercise response to endobronchial valve therapy in advanced pulmonary emphysema. Chest. 2013;144(5):1578–1586.
  • Corporation P, Inventor. Zephyr endobronchial valve system protocol.
  • Klooster K, van Dijk M, Koster TD, et al. First in human experience of the performance of the new 5.5-LP size Zephyr endobronchial valve. Respiration. 2020;99(1):50–55.
  • 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(2):138–150.
  • Corporation P, Inventor. Zephyr® endobronchial valve system. Accessed 2021 Apr 4th.
  • Fiorelli A, Poggi C, Anile M, et al. Visual analysis versus quantitative CT analysis of interlobar fissure integrity in selecting emphysematous patients for endobronchial valve treatment. Interact Cardiovasc Thorac Surg. 2019;28(5):751–759.
  • Gesierich W, Samitas K, Reichenberger F, et al. Collapse phenomenon during Chartis collateral ventilation assessment. Eur Respir J. 2016;47(6):1657–1667.
  • Fiorelli A, Santini M, Shah P. When can computed tomography-fissure analysis replace Chartis collateral ventilation assessment in the prediction of patients with emphysema who might benefit from endobronchial valve therapy? Interact Cardiovasc Thorac Surg. 2018;26(2):313–318.
  • Corporation P. PulmonX: the Chartis tablet. 2021 Apr 4th.
  • PulmonX Stratx. cited 2021 Apr 5.
  • Klooster K, Slebos DJ. Endobronchial valves for the treatment of advanced emphysema. Chest. 2021;159(5):1833–1842.
  • Come CE, Kramer MR, Dransfield MT, et al. A randomised trial of lung sealant versus medical therapy for advanced emphysema. Eur Respir J. 2015;46(3):651–662.
  • 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(6):513–521.
  • Fiorelli A, D’Andrilli A, Bezzi M, et al. Complications related to endoscopic lung volume reduction for emphysema with endobronchial valves: results of a multicenter study. J Thorac Dis. 2018;10(Suppl 27):S3315–S3325.
  • Shah PL, Zoumot Z, Singh S, et al. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013;1(3):233–240.
  • Deslée G, Mal H, Dutau H, et al. Lung volume reduction coil treatment vs usual care in patients with severe emphysema: the REVOLENS randomized clinical trial. JAMA. 2016;315(2):175–184.
  • Sciurba FC, Criner GJ, Strange C, et al. Effect of endobronchial coils vs usual care on exercise tolerance in patients with severe emphysema: the RENEW randomized clinical trial. JAMA. 2016;315(20):2178–2189.
  • Herth FJF, Slebos DJ, Shah PL, et al. Protocol of a randomized controlled study of the pneumRx endobronchial coil system versus standard-of-care medical management in the treatment of subjects with severe emphysema (ELEVATE). Respiration. 2019;98(6):512–520.
  • Kontogianni K, Gerovasili V, Gompelmann D, et al. Coil therapy for patients with severe emphysema and bilateral incomplete fissures - effectiveness and complications after 1-year follow-up: a single-center experience. Int J Chron Obstruct Pulmon Dis. 2017;12:383–394.
  • Hartman JE, Klooster K, Gortzak K, et al. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015;20(2):319–326.
  • Herth FJ, Eberhardt R, Ingenito EP, et al. Assessment of a novel lung sealant for performing endoscopic volume reduction therapy in patients with advanced emphysema. Expert Rev Med Devices. 2011;8(3):307–312.
  • Snell G, Herth FJ, Hopkins P, et al. Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema. Eur Respir J. 2012;39(6):1326–1333.
  • Herth FJ, Valipour A, Shah PL, et al. Segmental volume reduction using thermal vapour ablation in patients with severe emphysema: 6-month results of the multicentre, parallel-group, open-label, randomised controlled STEP-UP trial. Lancet Respir Med. 2016;4(3):185–193.
  • Shah PL, Slebos DJ, Cardoso PF, et al. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet. 2011;378(9795):997–1005.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.