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Patient Selection for the Zephyr® Valve

A Proven Treatment for Breathlessness From Severe COPD/Emphysema

A Proven Treatment for Breathlessness
From Severe COPD/Emphysema

The Zephyr Valve is a clinically-proven bronchoscopic treatment for patients with severe COPD/emphysema who suffer from shortness of breath despite optimized 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 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

Zephyr Valve Treatment: Position in Care Pathway38

Zephyr Valves can be placed bronchoscopically without many of the risks associated with major surgery, so patients are often evaluated for this treatment before surgery is considered.1

Zephyr Valve Treatment Position in Care Pathway-Resize

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 liters.

 Contradictions42

  • 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

 Warnings42

The Zephyr Valve should be used with caution and only after careful consideration with patients with:
  • 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

“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

Clinical Work Up
Clinical
Work Up
<h3><b>Clinical Work Up</b></h3>

Clinical Work Up

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)
StratX Platform
StratX®*
Platform
<h3><b>StratX</b><b><sup>®</sup></b><b><sup>*</sup> Platform</b></h3>

StratX®* Platform

Step 2:
  • StratX Report to support lobe selection:
  • Lobar volume
  • Emphysema destruction score
  • Fissure completeness
Chartis System
Chartis®
System
<h3><b>Chartis<sup>® </sup>System</b></h3>

Chartis® System

Step 3:
  • Chartis System
    procedure
  • Confirm target lobe has no collateral ventilation
Zephyr Valve
Zephyr®
Valve
<h3><b>Zephyr<sup>® </sup>Valve</b></h3>

Zephyr® Valve

Step 4:
  • Zephyr Valves placed to completely occlude the target lobe
Post-procedure Management
Post-procedure Management
<h3><b>Post- procedure Management</b></h3>

Post- procedure Management

Step 5:
  • Patient should remain in the hospital for a minimum of 3 nights following the procedure for observation

Patient Treatment Preference

Patients with severe emphysema perceive that a procedure with risks and benefits of the Zephyr Valve is desirable over continued medical management or LVRS.

US-EN-2235-v1

In a study conducted before Zephyr Valves were widely available or well-known, researchers identified a strong preference for a treatment with its clinical benefits and risks.8

  • 76% of respondents said they would select a treatment option similar to Zephyr Valve when compared with their current treatment.
  • 294 severe emphysema patients surveyed.

Patient Treatment Preference

Patients with severe emphysema perceive that a procedure with risks and benefits of the Zephyr Valve is desirable over continued medical management or LVRS.

US-EN-2235-v1

In a study conducted before Zephyr Valves were widely available or well-known, researchers identified a strong preference for a treatment with its clinical benefits and risks.8

  • 76% of respondents said they would select a treatment option similar to Zephyr Valve when compared with their current treatment.
  • 294 severe emphysema patients surveyed.
Valve open and closed- 22-1080x1080-px

Training & Education

Access educational resources about Zephyr Endobronchial Valves for your own education or share with your team or network of physicians.

Valve open and closed- 22-1080x1080-px

Training & Education

Access educational resources about Zephyr Endobronchial Valves for your own education or share with your team or network of physicians.