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Bronchoscopic lung volume reduction

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Bronchoscopic lung volume reduction (BLVR) is a procedure to reduce the volume of air within the lungs. BLVR was initially developed in the early 2000s[1][2] as a minimally invasive treatment for severe COPD that is primarily caused by emphysema. BLVR evolved from earlier surgical approaches first developed in the 1950s[3] to reduce lung volume by removing damaged portions of the lungs via pneumonectomy or wedge resection. Procedures include the use of valves, coils, or thermal vapour ablation.[citation needed]

Procedures

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BLVR involves the use of valves, coils, or thermal vapour ablation.[citation needed]

Valves

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Endobronchial valves are inserted using a bronchoscope into sections of the lungs damaged by emphysema. Endobronchial valves are medical devices that allow air to exit these sections but not to re-enter. The valves, in effect, cause damaged lung tissue to deflate, thereby reducing the excessive lung volume (hyperinflation) caused by emphysema. Two endobronchial valves have been approved by the FDA for BLVR: Zephyr and Spiration.[citation needed]

Zephyr valve

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Zephyr, manufactured by Pulmonx Corporation, obtained FDA approval in June, 2018,[4] after a clinical research trial (LIBERATE)[5] led by principal investigator Gerard Criner, MD, of Temple University Hospital.[citation needed]

In the trial, a total of 190 subjects were randomized across 24 hospital sites into two groups. One group received an endobronchial valve. The other received “standard of care” (SOC) under the current guidelines for hyperinflation due to emphysema. The trial found the endobronchial valve reduced residual lung volume and improved exercise tolerance as compared to the SOC group.[citation needed]

Spiration valve

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Spiration, manufactured by Spiration, Inc., obtained FDA approval in December, 2018,[6] after a clinical trial (EMPROVE)[7] showed the valve improved pulmonary function scores among trial participants. The Spiration valve subsequently was first used in treatment by Dr. Criner at Temple University Hospital.[citation needed]

The procedure

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BLVR valves are placed into the lungs using a catheter through a bronchoscope. During the one-hour procedure, the patient receives anesthesia through an intravenous line. After the procedure, patients usually remain in the hospital for at least four days. During hospitalization, the patient receives a series of chest X-rays to monitor the position of the valves. An outpatient follow-up appointment is scheduled for seven to 10 days after the procedure. Additional imaging tests, such as X-rays, and bronchoscopies may be required[8] weeks, months or years following the initial BLVR procedure.[citation needed]

Benefits and risks

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Benefits Risks
Improved lung function[9] COPD exacerbation[10]
Improved exercise tolerance[11] Respiratory failure[12]
Reversible Pneumothorax
Lower risk of injury and infection[13] Pneumonia

Clinical research has found that BLVR confers measurable benefits, including:

  • Improved lung function (reduced residual lung volume, as measured by FEV1 in the LIBERATE study)[5][14]
  • Improved exercise tolerance (six-minute walk distance,[14] which improved by nearly 40 meters among patients in the LIBERATE study)
  • Reduced risk of injury and infection, as compared to pneumonectomy
  • Reversible,[15] as compared to pneumonectomy

BLVR also carries risks, among them:

  • Exacerbation of COPD (occurs in as many as 14%[8] of patients)
  • Pneumothorax[5] (occurred in 26.6% of patients in the LIBERATE trial)
  • Pneumonia (occurs in as many as 9% of patients)
  • Valve expectoration (occurs in as many as 16% of patients)

Research

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The first clinical research study of BLVR valve implantation was published in the New England Journal of Medicine in 2010.[16] Since that time, nearly 80 additional papers have been published related to the efficacy[17][18] of BLVR, inclusion criteria,[19] anesthesia management[20] during BLVR, and related topics. Key studies include:

  • LIBERATE
  • EMPROVE
  • NETT[21]
  • VENT
  • STELVIO[22]

References

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  1. ^ Marruchella, Almerico; Faverio, Paola; Bonaiti, Giulia; Pesci, Alberto (October 2018). "History of lung volume reduction procedures". Journal of Thoracic Disease. 10 (Suppl 27): S3326–S3334. doi:10.21037/jtd.2018.04.165. ISSN 2072-1439. PMC 6204342. PMID 30450238.
  2. ^ Sabanathan, S.; Richardson, J.; Pieri-Davies, S. (February 2003). "Bronchoscopic lung volume reduction". The Journal of Cardiovascular Surgery. 44 (1): 101–108. ISSN 0021-9509. PMID 12627080.
  3. ^ DeCamp, Malcolm M.; McKenna, Robert J.; Deschamps, Claude C.; Krasna, Mark J. (2008-05-01). "Lung Volume Reduction Surgery". Proceedings of the American Thoracic Society. 5 (4): 442–446. doi:10.1513/pats.200803-023ET. ISSN 1546-3222. PMC 2645317. PMID 18453353.
  4. ^ Commissioner, Office of the (2020-02-20). "FDA approves novel device for treating breathing difficulty from severe emphysema". FDA. Retrieved 2020-03-18.
  5. ^ a b c Criner, Gerard J.; Sue, Richard; Wright, Shawn; Dransfield, Mark; Rivas-Perez, Hiram; Wiese, Tanya; Sciurba, Frank C.; Shah, Pallav L.; Wahidi, Momen M.; de Oliveira, Hugo Goulart; Morrissey, Brian (2018-11-01). "A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)" (PDF). American Journal of Respiratory and Critical Care Medicine. 198 (9): 1151–1164. doi:10.1164/rccm.201803-0590OC. ISSN 1535-4970. PMID 29787288. S2CID 46894678.
  6. ^ Health, Center for Devices and Radiological (2019-12-20). "Spiration Valve® System - P180007". FDA.
  7. ^ Criner, G.j.; Delage, A.; Voelker, K.g.; for the EMPROVE Trial Investigator Group (2018-05-01), "The EMPROVE Trial - a Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration? Valve System for Single Lobe Treatment of Severe Emphysema", C24. NEW TECHNOLOGIES FOR MANAGING COPD, American Thoracic Society International Conference Abstracts, American Thoracic Society, pp. A7753, doi:10.1164/ajrccm-conference.2018.197.1_meetingabstracts.a7753 (inactive 1 November 2024), retrieved 2020-03-18{{citation}}: CS1 maint: DOI inactive as of November 2024 (link)
  8. ^ a b Klooster, Karin; Hartman, Jorine E.; ten Hacken, Nick H.T.; Slebos, Dirk-Jan (January 2017). "One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial". Respiration. 93 (2): 112–121. doi:10.1159/000453529. ISSN 0025-7931. PMC 5348732. PMID 27974713.
  9. ^ "Lung volume reduction procedures for emphysema". British Lung Foundation. 2015-12-07. Retrieved 2020-03-18.
  10. ^ Fernandez-Bussy, Sebastian; Labarca, Gonzalo; Herth, Felix J. F. (2018). "Bronchoscopic Lung Volume Reduction in Patients with Severe Emphysema". Seminars in Respiratory and Critical Care Medicine. 39 (6): 685–692. doi:10.1055/s-0038-1676774. ISSN 1069-3424. PMID 30641586. S2CID 58559837.
  11. ^ Lee, Eung Gu; Rhee, Chin Kook (2019-05-14). "Bronchoscopic lung volume reduction using an endobronchial valve to treat a huge emphysematous bullae: a case report". BMC Pulmonary Medicine. 19 (1): 92. doi:10.1186/s12890-019-0849-z. ISSN 1471-2466. PMC 6518705. PMID 31088437.
  12. ^ Van Agteren, J. E.; Hnin, K.; Grosser, D.; Carson, K. V.; Smith, B. J. (2017). "Bronchoscopic lung volume reduction procedures for moderate to severe chronic obstructive pulmonary disease". The Cochrane Database of Systematic Reviews. 2017 (2): CD012158. doi:10.1002/14651858.CD012158.pub2. PMC 6464526. PMID 28230230. Retrieved 2020-03-18.
  13. ^ Gordon, Matthew; Duffy, Sean; Criner, Gerard J. (August 2018). "Lung volume reduction surgery or bronchoscopic lung volume reduction: is there an algorithm for allocation?". Journal of Thoracic Disease. 10 (Suppl 23): S2816–S2823. doi:10.21037/jtd.2018.05.118. ISSN 2072-1439. PMC 6129811. PMID 30210836.
  14. ^ a b Criner, Gerard J.; Sue, Richard; Wright, Shawn; Dransfield, Mark; Rivas-Perez, Hiram; Wiese, Tanya; Sciurba, Frank C.; Shah, Pallav L.; Wahidi, Momen M.; de Oliveira, Hugo Goulart; Morrissey, Brian (2018-05-22). "A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)" (PDF). American Journal of Respiratory and Critical Care Medicine. 198 (9): 1151–1164. doi:10.1164/rccm.201803-0590OC. ISSN 1073-449X. PMID 29787288. S2CID 46894678.
  15. ^ "Bronchoscopic Lung Volume Reduction Benefits and Risks". Temple Health. Retrieved 2020-03-18.
  16. ^ Sciurba, Frank C.; Ernst, Armin; Herth, Felix J. F.; Strange, Charlie; Criner, Gerard J.; Marquette, Charles H.; Kovitz, Kevin L.; Chiacchierini, Richard P.; Goldin, Jonathan; McLennan, Geoffrey; VENT Study Research Group (2010-09-23). "A randomized study of endobronchial valves for advanced emphysema". The New England Journal of Medicine. 363 (13): 1233–1244. doi:10.1056/NEJMoa0900928. hdl:20.500.12613/6399. ISSN 1533-4406. PMID 20860505.
  17. ^ Kumar, Abhishek; Dy, Rajany; Singh, Kanwaljit; Jeffery Mador, M. (February 2017). "Early Trends in Bronchoscopic Lung Volume Reduction: A Systematic Review and Meta-analysis of Efficacy Parameters". Lung. 195 (1): 19–28. doi:10.1007/s00408-016-9969-x. ISSN 1432-1750. PMID 28005150. S2CID 1753916.
  18. ^ Wang, Yong; Lai, Tian-Wen; Xu, Feng; Zhou, Jie-Sen; Li, Zhou-Yang; Xu, Xu-Chen; Chen, Hai-Pin; Ying, Song-Min; Li, Wen; Shen, Hua-Hao; Chen, Zhi-Hua (2017-09-29). "Efficacy and safety of bronchoscopic lung volume reduction therapy in patients with severe emphysema: a meta-analysis of randomized controlled trials". Oncotarget. 8 (44): 78031–78043. doi:10.18632/oncotarget.19352. ISSN 1949-2553. PMC 5652834. PMID 29100445.
  19. ^ May, Nadine; Niehaus-Gebele, Christa; Reichenberger, Frank; Behr, Jürgen; Gesierich, Wolfgang (February 2020). "Screening for Bronchoscopic Lung Volume Reduction: Reasons for Not Receiving Interventional Treatment". Lung. 198 (1): 221–228. doi:10.1007/s00408-019-00303-7. ISSN 1432-1750. PMID 31832749. S2CID 209331149.
  20. ^ Grande, Bastian; Loop, Torsten (August 2018). "Anaesthesia management for bronchoscopic and surgical lung volume reduction". Journal of Thoracic Disease. 10 (Suppl 23): S2738–S2743. doi:10.21037/jtd.2018.02.46. ISSN 2072-1439. PMC 6129807. PMID 30210826.
  21. ^ "National Emphysema Treatment Trial (NETT) | National Heart, Lung, and Blood Institute (NHLBI)". www.nhlbi.nih.gov. Retrieved 2020-03-18.
  22. ^ Klooster, Karin; ten Hacken, Nick H.T.; Hartman, Jorine E.; Kerstjens, Huib A.M.; van Rikxoort, Eva M.; Slebos, Dirk-Jan (2015-12-10). "Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation". New England Journal of Medicine. 373 (24): 2325–2335. doi:10.1056/NEJMoa1507807. hdl:2066/152186. ISSN 0028-4793. PMID 26650153.
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