1. Zephyr® Endobronchial Valve Product Training

2. Indications for Use
The Zephyr® Endobronchial Valve (EBV) is an implantable bronchial valve intended to control airflow in order to improve lung function in patients with heterogeneous emphysema and/or to reduce air leaks.
zephyr [|zefə(r)]는 산들바람이라는 뜻으로 one way endobronchial valve로 emphysema 환자에서 airflow를 조정하기위해 만들어진 implantatble bronchial valve로

3. Zephyr® Endobronchial Valve (EBV) System Overview
Zephyr EBV System consists of:
Endobronchial valve
Loading system
Endobronchial Delivery Catheter (EDC)
Zephyr endobronchial valve는 valve와 valve를 장착하여 삽입하는 delivery catheter로 구성이 되며 3

4. Zephyr® Endobronchial Valve Design
Self-expanding retainer
Linked rings engineered to stabilize device in airway
Multiple airway contact points intended to ensure air-tight seal
Silicon webbing intended to prevent tissue in-growth
One-way valve
Isolated in center of the device
Engineered to open at low pressures but close quickly when airflow reversed
valve 중앙에 silicone One way valve로 air와 secretion은 내보내고, air는 안으로 들어가는 것을 막는 역할을 하며
Self exanding retainer가 존재하여 airway안에서 고정되며, silicone web으로 tissue in-growth를 막아줍니다. 4 4

5. Zephyr® 4.0 and 5.5 Functional Size Range: 4.0 – 7.0 mm

6. Delivery Catheter System
Zephyr®EBV Loaded into Catheter
Delivery
Through the Scope delivery
Ergonomic handle for steering and deployment
Works with flexible bronchoscope with >2.8 mm working channel
Deployment
- Valve compressed and retained in housing
- Positioned at target site, sizing verified using diameter gages
- Housing retracts releasing valve
Delivery Catheter handle actuation
Delivery Catheter System은 접혀있는 valve를 안에 장착한 채로 target site에 valve를 releasing 시키는 역할을 하며
Partially deployed Zephyr®EBV 6

7. Zephyr® EBV Procedure 7

8. Zephyr® EBV Procedure Steps
Sizing
Placement
Deployment
Removal (if necessary)
Procedure는 target bronchus의 size를 확인하고, tip을 꺼내 위치시키고, valve를 release하여 deployment시키는 순서로 진행하며 필요에 따라서 removal하는 것입니다.

9. Zephyr® EBV Sizing 9

10. Method to Measure Target Diameter
Verify target bronchus within Zephyr® size range using sizing gauge located on the proximal end of the delivery housing
Minimum Bronchial Diameter
Ensure bronchial diameter is smaller than large sizing gauge
Maximum Bronchial Diameter
Delivery catheter에는 bronchial diameter를 측정 할수 있는 gauging tip이 붙어 있어 bronchial diameter를 확인하여 size를 확인하며
Required Segment Depth
Ensure bronchial diameter is larger than small sizing gauge

11. Zephyr® EBV Placement 11

12. Zephyr® EBV Placement
Position housing at tip of bronchoscope prior to accessing target bronchus
Housing difficult to advance or retract through an articulated bronchoscope and may cause the valve to prematurely protrude from housing, damage the delivery catheter
Target bronchus 앞에서 bronchus tip에 housing을 position하며

13. Zephyr® EBV Placement: Minimum Bronchial Length
Distal carina
Length of retention portion of Zephyr EBV retainer corresponds to minimum depth mark on housing
Minimum depth mark must be distal to carina of targeted bronchus
Minimum bronchial length
Target
Bronchus
Target bronchus 앞에서 bronchus tip에 housing을 위치시켜 minimum depth mark를 확인하여 valve가 들어갈 수 있는 minimum bronchial length를 확인하고
이 minimum depth는 distal carina에서 target bronchus까지의 거리를 의미하며
Minimum Depth Mark

14. Zephyr® EBV Placement – Important Points!!
Warning: Do not place the Zephyr EBV such that the distal end of the retainer is placed beyond the distal carina of the target bronchus
This leaves one branch untreated
This may also result in proximal migration of the implanted Zephyr EBV
Precaution: Attempting to reposition the Zephyr EBV by grasping the valve protector portion of the retainer may result in device damage X
만약 placing이 잘못되어 distal carina를 벗어나서 위치하게 되면, 치료가 제대로 되지 않고 valve자체가 migration할 수 있기때문에 주의를 하여야하겠습니다.

15. Zephyr® EBV Placement: Proper Placement
Ideal Positioning
Retention struts
Valve is centered within bronchus
Valve의 ideal positioning은 valve가 밖으로 배출되는 것을 방지하기 위해 bronchus내 valve가 중앙에 위치하는 것을 의미하며

16. Zephyr® EBV Deployment

17. Zephyr® EBV Deployment
Once delivery catheter housing in proper position:
Press down and forward on the handle actuator to deploy the Zephyr EBV
Use only moderate force to deploy the Zephyr EBV. If excessive resistance is met while deploying, stop and remove the system. Discard and load another new Zephyr valve and delivery catheter
Actuator in fully retracted / locked position
Valve positioning이 완료되며 delivery catheter 끝에 tip을 눌러서 catheter 끝의 valve를 deployment(배치)시키고
Press down and forward to deploy Zephyr EBV

18. Zephyr® EBV Removal

19. Zephyr EBV Removal
Designed to be easily removed if clinically necessary
Oral (not nasal) bronchoscopic procedural is required for valve removal
Grasp valve protector with rat-tooth graspers
Advance scope over graspers so the valve is at distal tip of scope
Retract scope/graspers as single unit
Use care when passing valve through vocal cords
Valve Protector
Valve를 제거가 필요한 경우 valve를 쉽게 제거할 수 있도록 제작되었으며, nasal approach가 아닌 oral bronchoscopic procedure로 진행해야하며, scope안으로 grasper를 삽입하여 valve를 잡고 scope이나 grasper를 retract 하면됩니다.

20. Pre- Procedure
Confirm CT determination of target lobe based on destruction score or evidence of disease heterogeniety
Schedule the Chartis® Pulmonary Assessment System screening to determine whether lobe has collateral ventilation
Patients with significant collateral ventilation are not expected to achieve significant improvement from EBV therapy
Recommendation: Zephyr EBV placement can be done directly following completion of the Chartis assessment
Recommendation: Discuss Chartis results with patient and family to appropriately set expectations
시술 전에는 CT로 target lobe을 확정해야하며

21. Post Procedure
Recommendation: Keep patients with radiographic evidence of atelectasis in-hospital under observation for at least 2 days post-procedure
Warning: Pneumothorax is an expected response to atelectasis. Be prepared to observe and/or treat a subsequent pneumothorax
Recommendation: Bronchoscopic aspiration of mucous should be considered if there is evidence of an increase in mucous production post-procedure
Recommendation: Fill out an Zephyr® Implant Card and provide to the patient
시술 후에는 적어도 2일이상 입원해서 atelectasis 여부를 확인해야하고, pneumothorax 발생 여부도 확인해야하며,
시술 후 객담 생성이 증가하면 bronchoscopic aspiration을 고려해야합니다.

22. Contraindications The Zephyr® EBV is contraindicated for:
Patients for whom bronchoscopic procedures are contraindicated
Evidence of active infection in patient’s lungs
If patient is being treated under an Pulmonx clinical trial protocol, eligibility criteria outlined in the Investigational Plan must be adhered to
Endobronchial valve 시술의 금기는 환자가 bronchoscopy 시행의 contraindication이거나, active infection 이 있는 경우 시행하면 안되고

23. Patient Consideration
The Zephyr EBV should be used with caution and only after careful consideration in patients with
Prior lung transplant, LVRS, median sternotomy, or lobectomy
Congestive heart failure or recent Myocardial Infarction
Large bullae in the non-targeted area of lung
FEV1<15% of predicted value
The Zephyr EBV has not been clinically validated specifically in patients with
Alpha-1 antitrypsin deficiency
과거 폐이식술, lung volume reduction surgery나 lobectomy를 시행한 경우나 CHF 또는 최근 MI가 있었거나 non-targeted lung에 large bullae가 있는 경우 FEV1이 15% 미만인 경우 시술에 주의를 해야겠으며

24. Complications Potential complications include, but are not limited to, the following:
Empyema
Hemoptysis
Pneumonia
Pneumothorax
Respiratory Failure
Acute Respiratory Distress Syndrome
COPD Exacerbation
Infection
Heart Arrhythmia / Heart Failure / Chest Pain
Hypercapnea
Hypoxemia
Iatrogenic Injuries
Pleural Effusion
Pulmonary Embolism
Sepsis
Stroke (CVA / TIA)
Aphonia
Bowel Function Impairment
Granulation Tissue / Ulceration Formation
Nausea / Vomiting
Disorientation / Anxiety
Fever
Valve migration/expectoration
Acute bronchospasm
Airway stenosis
Residual volume increase
Wheeze / Whistling
Pain
Death
다음과 같은 다양한 complication이 발생할 수 있으므로 시술 후에도 주의를 기해야 할것 같습니다.