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 optimized medical therapy1.
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 is the first endobronchial valve to receive approval from the FDA for patients with either heterogeneous or homogeneous emphysema and can be used to treat the upper and lower lobes of either lung.
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
Patients with varying severity of symptoms can benefit from Zephyr Valve treatment — even those who have just begun limiting their activities due to breathlessness.
Spectrum of Qualifying Symptom Burden
| Profiles of Patients who Qualified for Zephyr Valve Treatment |  |  |  |
|---|---|---|---|
| mMRC | 2 | 3 | 4 |
| Shortness of Breath | On activity | On activity & at rest | Continuous |
| Activity Level | Limiting activities | Difficulty with activities of daily living | Inability to perform many activities of daily living |
| Oxygen Therapy | None | As needed | Continuous |
| Quality of Life Challenges | Difficulty keeping up with family and friends | Breathless even walking short distances; limited daily activities | Reliance on help for everyday activities |
Ask your patients how COPD is affecting their quality of life
Asking these questions at clinic visits may help patients better communicate about how breathlessness is impacting their quality of life.
- What activities could you do last year that are no longer possible?
- How often do you have to stop to catch your breath?
- Do you need help in order to do your regular chores and activities?
- Are you able to leave the house and go places without assistance?
By identifying candidates earlier, when they are just beginning to limit their activities due to breathlessness, you may be able avoid situations where patients become too sick to qualify.
Algorithm to determine patient eligibility
| Screening Decision Tree |
|---|
| Is patient still short of breath despite medical management |
| Yes |
| Post-BD FEV ≤ (spirometry) |
| Yes |
| Hyperinflation on imaging or RV ≥ 150% (plethysmography) |
| Yes |
| 6MWD = 100-500m / 328-1640ft |
| Yes |
| Non-smoking or willing to quit |
| Yes |
| Meets referral criteria Treating Physician will determine if patient can benefit from Zephyr Valves with CT Scan analysis |
Identifying Patients for Zephyr Valves
“Thinking about endobronchial valves is part of the checklist that I go through for every single patient that I see.”
Dr. MeiLan Han, Chief of Pulmonology and Critical Care, University of Michigan Health
The Treatment Process
Step 1:
- Full Pulmonary Function Testing using Body Plethysmography
- 6 Minute Walk Test
- High Resolution CT Scan with specialized protocols
- Echocardiogram
- Arterial Blood Gas (optional)
- Perfusion Testing (optional)
Step 2:
- StratX Reports support lobe treatment selection by providing:
- 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
