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WATCHMAN™ LAA Closure Technology

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Presentation on theme: "WATCHMAN™ LAA Closure Technology"— Presentation transcript:

1 WATCHMAN™ LAA Closure Technology

2 WATCHMAN™ LAA Closure Technology
Procedure Training

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.

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