1. WATCHMAN™ LAA Closure Technology

2. WATCHMAN™ LAA Closure Technology
Procedure Training

3. IMPORTANT INFORMATION
These materials are intended to describe common clinical considerations and procedural steps for the on-label use of referenced technologies as well as current standards of care for certain conditions. Of course, patients and their medical circumstances vary, so the clinical considerations and procedural steps described may not be appropriate for every patient or case. As always, decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand. Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling. Boston Scientific does not have an FDA-approved ablation catheter for the treatment of atrial fibrillation. The presenter’s experience with BSC products may not be interpreted or relied upon to support clinical claims about BSC devices or product comparison claims regarding BSC and competitive devices. The experiences of other users may vary. All Images on file with BSCI. All case studies presented are not necessarily representative of clinical outcomes in all cases as individual results may vary. All material, graphs, data and charts sourcing is on file with the presenter and are the property of their respective copyright owner.

4. Major Topic Areas Procedure equipment
WATCHMAN™ LAA Closure System Components
LAA anatomy / assessment
Ostium size, LAA type, considerations
IAS crossing
Sheath navigation/ manipulation
WATCHMAN Access System
Device deployment
WATCHMAN Delivery System
Device Release Criteria
Position
Anchor
Size (compression)
Seal
Device recapture
Anticoagulation

5. 1. Procedure Equipment Echo machine and staff
Venous Introducer (optional)
Standard Transseptal Access System with puncture needle
Exchange length .035” Guidewire
Adjunctive Catheters (6F pigtail)
Pressurized saline bag – drip chamber/sterile line (used for air management, control flow, minimal)
30-50 cc syringe for catheter/device prep
WATCHMAN™ Transseptal Access System with Dilator (double, single, anterior curve)
WATCHMAN Delivery System (multiple device sizes include 21, 24, 27, 30, and 33mm – based on TEE)
Target ACT during procedure

6. 2. WATCHMAN™ LAA Closure System Components WATCHMAN Device
Frame: Nitinol structure
Available sizes:
21, 24, 27, 30, 33 mm (diameter)
10 Fixation anchors around device perimeter engage LAA tissue
Contour shape accommodates most LAA anatomy
Fabric Cap: (PET) Fabric Polyethyl terephthalate
Prevents harmful emboli from exiting during the healing process
160 micron filter
PET fabric
Anchors

7. 2. WATCHMAN™ LAA Closure System Components WATCHMAN Access System
Transseptal Access System
Double, Single, Anterior Curves
14F O.D. (4.7 mm), 12F I.D.
75 cm working length
Double Curve
Single Curve
Preformed curve shapes guide position in LAA

8. 2. WATCHMAN® LAA Closure System Components WATCHMAN Delivery System
Hemostasis Valve
Core Wire
Deployment Knob
Constrained Device
Distal Marker Band
The WATCHMAN Device is pre-loaded into a 12F OD sheath
WATCHMAN Delivery System
The WATCHMAN Delivery System consists of 12 Fr OD extruded PEBAX shaft with a stainless steel wire braid reinforcement; a handle assembly is located at the proximal end of the catheter, and a marker band for in situ visualization is installed at the distal end. The constrained WATCHMAN Device is pre-loaded during the manufacturing process just proximal to this marker band; the shaft ID is configured to accept any of the five device sizes. In addition, the distal tip of the catheter has three small slits, referred to as tri-cuts, to facilitate recapture of the Device. Figure 16-2 illustrates Gen 2.5 Delivery System.
The handle assembly of the Delivery System consists of a Y-adapter with attached stopcock and a stiffener hypo tube with deployment knob. A core wire with a reinforced braided jacket is contained within the Delivery System. This core wire attaches to the deployment knob at the proximal end and a screw wire assembly at the distal end. The screw is mated to the threaded insert component of the Device and provides the mechanism for attachment and release of the Closure Device. The core wire provides both the support necessary to deploy the Device and the flexibility necessary to not bias the Device in the LAA until the Device is evaluated and released
12F O.D. (compatible with all 5 device sizes)

9. 3. LAA anatomy / assessment
Assess the following LAA features:
Ostium size and shape
Number of lobes, location
Working length in the LAA
Pectinate features
Assess less challenging vs. more challenging anatomies
Relationship of LAA to LUPV
Categorize by LAA Type
Windsock, Chicken Wing or Broccoli

10. 3. Assessment of LAA Dimensions
Confirm the absence of LA/LAA thrombus
Measure LAA ostium in at least 4 TEE views
At 0 deg (at level of left coronary artery)
At 45, 90, 135 deg (from the top of the MV annulus)
Measure the approximate LAA usuable length from the ostium line to the apex of the LAA

11. Maximum LAA Ostium (mm)
3. Determine proper device selection
Maximum LAA Ostium (mm)
Device Size (mm)
(uncompressed diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
Device sizing is based on maximum LAA diameter
Maximum LAA ostium size should be >17mm or <31mm to accommodate available device sizes
Available/useable LAA length should be equal to or greater than the ostium
Select Size
Maximum Measured LAA Ostium (mm) Minimum Measured LAA length mm Implant Diameter.
Note: Use TEE and fluoro to confirm baseline measurements and select device size.

12. 3. Major LAA Types
The Wind Sock Type LAA is an anatomy in which one dominant lobe of sufficient length is the primary structure.
The Chicken Wing Type LAA is an anatomy whose main feature is a sharp bend in the dominant lobe of the LAA anatomy at some distance from the perceived LAA ostium.
The Broccoli Type LAA is an anatomy whose main feature is an LAA that has limited overall length with more complex internal characteristics.

13. 4. IAS crossing Suggested crossing location - mid to low and posterior
Preferred exchange of WATCHMAN™ sheath in LSPV
Preferred option to advance WATCHMAN Access System:
Over 6F pigtail catheter
Exchange in LA, navigate pigtail into LAA
Inject contrast to assess progress
Advance slowly and carefully in multiple angio and echo views

14. Access Sheath Marker Band
5. Sheath navigation/manipulation (marker bands)
Access Sheath Marker Band
Loaded Device Length*
21mm
20.2mm
24mm
22.9mm
27mm
26.5mm
30mm
29.4mm
33mm
31.5mm
Radiopaque marker bands guide initial sheath placement/depth in the LAA
Align appropriate marker band with the LAA ostium according to device size selected

15. 5. Sheath navigation/manipulation (advancing in the LAA)
To better visualize complex LAA anatomy and
verify access sheath tip position:
Obtain multiple views with
Angiography (minimum RAO cranial/caudal)
TEE (minimum degree sweep)
Most important when sheath is advanced near
the wall or apex of LAA and while advancing
more distally in any anatomy.
Marker bands
Carefully advance Access Sheath over pigtail catheter until Access Sheath marker band corresponding to Device size is at or just distal to LAA ostium.

16. 5. Sheath navigation/ manipulation
Counter clockwise torque on the Access System
Aligns the sheath more anteriorly
Clockwise torque on the Access System
Aligns the sheath more posteriorly
Carefully advance Access Sheath over pigtail catheter until Access Sheath marker band corresponding to Device size is at or just distal to LAA ostium.

17. 6. Device deployment Preparation
Flush delivery catheter with tip in saline bowl
Align device at marker band
Prior to introducing Delivery System into Access System
Constrained Device
Distal Marker Band

18. Retract WAS and Snap into DC
6. Advancement into WATCHMAN™ Access System (marker band alignment)
Retract WAS and Snap into DC =
Device Deployment:
Retract AS and Snap AS to DC hub to deploy –Deploy Device by holding deployment knob and retracting WAS/WDS assembly until Device is completely deployed leaving core wire attached. Control deployment knob during retraction to maintain Device position.
Note: Using fluoro/TEE, reconfirm position of WAS/WDS assembly tip before deploying Device. Indent of hourglass shape of constrained Device approximates face of Device. If access sheath needs to be advanced. Do not advance AS with DC in place. First withdraw DC into IVC /straight portion of AS. Upon deployment delivery system should be retracted 2cm from Device allowing Device to align freely with LAA. “Find its happy place”. =

19. 6. Manipulation of WAS/DC system
Do not advance the access sheath more distal into the LAA after the delivery system has been snapped into the access sheath
Tactile feel may be decreased
Risk of complications may be increased
If the access sheath requires more distal advancement into the LAA
Disconnect the delivery catheter from access sheath
Retract delivery catheter and reinsert pigtail
Manipulate access sheath to improve position in LAA

20. 6. Device Deployment PROCESS
Unsheath device with slow stable motion for optimal control
(at least 3-5 seconds)
Observe distal end of device to ensure NO forward advancement occurs
NO forward pushing (or repositioning relative to ostium) during unsheathing process

21. 7. Device Release Criteria (PASS)
All criteria must be met prior to device release
Position – device is distal to or at the ostium of the LAA
Anchor – (stability) fixation barbs engaged / device is stable using tug test
Size – device is compressed at least 8-20% of original size
Seal - device spans ostium so no color flow Doppler is seen, all lobes of LAA are covered
If necessary, device can be recaptured (partial or full)

22. 7a. Device Release Criteria – OPTIMAL POSITION
Fixation anchors engage LAA wall

23. 7a. Device Release Criteria – Position (too distal)
Device position too distal relative to LAA ostium
Possible uncovered lobes, incomplete seal or residual flow in LAA
Confirm in multiple views

24. 7a. Device Release Criteria – Position (too proximal)
Device position too proximal relative to LAA ostium
Device protrudes into LA, low compression or unstable device
Confirm in multiple views

25. 7b. Device Release Criteria – ANCHOR
(pass or fail test)
To test stability, gently retract deployment knob and let go, observe device returns to original position
If the device moves to where position is no longer acceptable or the compression is no longer sufficient, the device should be recaptured
Test stability more than once if device stability is questionable
Hemostasis Valve
Core Wire
Deployment Knob

26. 7c. Device Release Criteria - SIZE (compression)
Device Size
(uncompressed diameter)
Maximum (20%) Compression
Measured Diameter*
Minimum (8%) Compression Measured Diameter* 21
16.8 mm
19.3 mm 24
19.2 mm
22.1 mm 27
21.6 mm
24.8 mm 30
24.0 mm
27.6 mm 33
26.4 mm
30.4 mm
20.8
*Measure in-situ device diameter at approximate TEE angles of 0, 45, 90 and 135 degrees to accurately assess device compression

27. 7d. Device Release Criteria - SEAL
No residual flow noted around device
If all 4 device release criteria are met, device can be released
Counter clockwise on proximal handle 3-5 turns

28. 7d. Residual LAA jet examples
Residual jet around device noted (re-assess position, size or device orientation)
Jet must be < 5mm for acceptable release criteria
If device not yet released, improve position or sealing through partial recapture and reposition or full recapture and replacement

29. 8. Device recapture PROCESS
Advance sheath to device BEFORE recapture starts
Recapture device by retracting device into sheath and pushing sheath over device
Recapture device with slow and stable motion
Avoid inadvertent pulling, pushing implant during recapture process
Options include partial or full (complete) recapture

30. 9. Anticoagulation: Key Points
Pre-procedure Recommendations
INR optimally ≤ 2.0
ACT levels during procedure tightened to ( sec)
Heparin to maintain ACT
ACT every ~30 min during procedure
Post-procedure
Post procedure heparin not recommended
Protamine post-procedure (optional)
Warfarin restarted (if stopped)
Achieve and maintain therapeutic level of
Mandatory 45 day TEE to assess device sealing

31. FDA Statement upon approval
Statement will be inserted when device is FDA approved.