A bronchoscopic technique to improve lung volume reduction of patients with severe heterogeneous emphysema as an intermediate between drugs and surgery.
1.What is it?
A minimally invasive procedure fitting EndoBronchial Valves (EBV) into bronchioles to prevent air entering diseased portions of the lung. The EBV is a one way valve which also allows trapped air and fluid to escape and control the volume of diseased lobes.
- FDA approved
- NICE approved
- CE mark approved
2. Why is it important?
10 years of clinical evidence shows that this device can help end stage emphysema patients experience:
- improved lung function, FEV1 increase of >15%
- increased exercise tolerance, +40 metre
- improved quality of life, >10 point increase reported through SGRQ results
- acceptable safety profile
- little or no collateral ventilation in target lobe
3. How does it work?
- check the patient fits the inclusion criteria using Pulmonx Chartis and StatX Lung analysis platforms; confirm treatment responders
- review the flow and pressure reading to optimise valve placement
- Guide the flex catheter to the areas required with the associated valve size for controlled delivery
- check the depth marker assist to ensure the correct area is treated
- place 3- 5 valves in 1 procedure
The valves are self expanding and conforms the the bronchiole wall to form and air tight seal to prevent airflow into the diseased area of the lungs being treated.
The following shows the catheter and valve sizes available:
Removal of the valves where necessary is also possible.
Patients are able to continue their medication for emphysema following the treatment but please prescriptive information provided by Zephyr here.
4. Results
Clinical Trials:
Exclusion criteria:
- Current smoker
- bullae >30% of either lung
- allergies to nickel-titanium (Nitinol)/ silicone
- active lung infection
- unable to undergo bronchoscopic procedure
Serious Adverse Events (SAEs) reported include but are not limited to:
- pneumothorax (18%) – most common
- valve replacement (12%)
- valve removal (15%)
- worsening of COPD
- haemoptysis
- pneumonia
- dyspnoea
- death
Clinical summary available here.
5. Who is involved?
Pulmonx
Zephyr valve
Patient stories available here
References
- Press release “New Data from Two Multi-Center Randomized Clinical Trials Demonstrate That Zephyr Endobronchial Valves Deliver Benefit to Both Heterogeneous and Homogenous Emphysema Patients without Collateral Ventilation” – May 23, 2017.
- Valipour A, et al. Am J Respir Crit Care Med. 2016.
- Klooster K, ten-Hacken Nick HT, Hartman JE, Kerstjens Huib AM, van Rikxoort EM, and Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015; 373:2325-2335.
- Davey C, Zoumot Z, Jordan S, McNulty WH, Carr DH, Hind MD, Hansell DM, Rubens MB, Banya W, Polkey MI, Shah PL, and Hopkinson NS. 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.
- Zoumot Z, Davey C, Jordan S, McNulty WH, Carr DH, Hind MD, et al. A randomised controlled study of Bronchoscopic Lung Volume Reduction with endobronchial valves for patients with Heterogeneous emphysema and Intact interlobar Fissures: the BeLieVeR-HIFi study. Efficacy Mech Eval 2015;2(5).
- Herth FJF, Noppen M, Valipour A, Leroy S, Vergnon J-M, Ficker JH, Egan JJ, Gasperini S, Agusti C, Holmes-Higgins D, Ernst A, on behalf of the VENT STUDY Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J 2012; 39: 1334-1342.
- Sciurba S. F, Ernst A, Herth FJF, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, and McLennan G, for the VENT STUDY Research Group. A Randomized study of Endobronchial Valves for Advanced Emphysema. N Engl J Med 2010; 363:1233-1244.
- https://www.pulmonx.com/en/ous/professionals/products/zephyr-endobronchial-valve/
- https://www.pulmonx.com/en/ous/professionals/clinical-evidence/
- http://www.mylungsmylife.com
- Criner G, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T et al. A Multicenter RCT of Zephyr® Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). American Journal of Respiratory and Critical Care Medicine, 2018.
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