Patient Selection for the Zephyr® Valve
The Zephyr Valve is a clinically-proven bronchoscopic treatment for patients with severe COPD/emphysema who suffer from shortness of breath despite optimised medical therapy.
Appropriate patient selection is critical to the success of Zephyr Valve treatment. Over time, clinical trial data have helped define the successful patient profile. 1-4,6,7 The Zephyr Valve treatment is included in emphysema treatment guidance documents issued by leading health organizations worldwide, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD)9-10 and the UK’s National Institute for Health Care and Excellence (NICE).11
Patient Eligibility for Zephyr Valve Treatment
If shortness of breath is not controlled with medical management, patients may qualify for Zephyr Valve Treatment.
Medical History
- Full medical treatment for COPD
- With or without supplemental oxygen
- Stable or unstable
- Persistent COPD symptoms
Clinical Presentation
- Severe COPD/emphysema
- Shortness of breath upon activity or rest
- Limited in daily functions
- Dissatisfied with activity level and quality of life
Diagnostic Checklist for Zephyr Valve Treatment Eligibility
Zephyr Valves have been clinically proven in:
- Heterogeneous and homogeneous emphysema
- Upper lobe and lower lobe predominant emphysema
Diagnosis and Symptoms
Severe COPD/emphysema
Shortness of breath upon activity or rest
Evidence of Obstruction
Spirometry: FEV1 < 50% predicted, post-bronchodilator
Evidence of Hyperinflation
Hyperinflation confirmed by one of the following:
- Body Plethysmography: RV >150% predicted
Nitrogen Washout Lung Volumes are not recommended* - Imaging: Chest X-ray: Flattened diaphragm
- HRCT: Evidence of emphysematous tissue
6 Minute Walk Test
100 to 500m / 328 to 1640 ft
Smoking Status
Non-smoking or willing to quit smoking
*Gas dilution PFT tests, like Nitrogen Washout or Helium Dilution, have been shown to underestimate TLC & RV because only communicating gas volume is measured in these tests. In the presence of severe airflow obstruction, TLC can be underestimated by a gas dilution method by as much as 3 litres.
Contradictions 42
- Patients for whom bronchoscopic procedures are contraindicated
- Patients with evidence of active pulmonary infection
- Patients with known allergies to Nitinol, Nickel, Titanium, or Silicone
- Patients who have not quit smoking
- Patients with large bullae encompassing greater than 30% of either lung
Warnings 42
- Prior lung transplant, LVRS, median sternotomy, or lobectomy
- Congestive heart failure (left ventricular ejection fraction <45%); myocardial infarction
- FEV1 < 15% of predicted value
Identifying Patients for Zephyr Valves
“The sorts of patients you should be thinking about referring for lung volume reduction are patients with severe COPD/emphysema.”
Dr. Samuel Kemp, Consultant Respiratory Physician, Royal Brampton Hospital
The Treatment Process
Step 1:
- Full Pulmonary Function Testing using Body Plethysmography
- 6 Minute Walk Test
- High Resolution CT Scan with specialised protocols
- Echocardiogram
- Arterial Blood Gas (optional)
- Perfusion Testing (optional)
Step 2:
- StratX Report to support lobe selection:
- Lobar volume
- Emphysema destruction score
- Fissure completeness
Step 3:
- Chartis System
procedure - Confirm target lobe has no collateral ventilation
Step 4:
- Zephyr Valves placed to completely occlude the target lobe
Step 5:
- Patient should remain in the hospital for a minimum of 3 nights following the procedure for observation
