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1 WATCHMAN™ LAA Closure Technology. 2 INTRODUCING WATCHMAN WATCHMAN™ LAA Closure Technology Procedure Training.

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Presentation on theme: "1 WATCHMAN™ LAA Closure Technology. 2 INTRODUCING WATCHMAN WATCHMAN™ LAA Closure Technology Procedure Training."— Presentation transcript:

1 1 WATCHMAN™ LAA Closure Technology

2 2 INTRODUCING WATCHMAN WATCHMAN™ LAA Closure Technology Procedure Training

3 3 SH-153515-AA April 2013 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. IMPORTANT INFORMATION

4 4 SH-153515-AA April 2013 Major Topic Areas 1. Procedure equipment 2.WATCHMAN™ LAA Closure System Components 3.LAA anatomy / assessment –Ostium size, LAA type, considerations 4.IAS crossing 5.Sheath navigation/ manipulation –WATCHMAN Access System 6.Device deployment –WATCHMAN Delivery System 7.Device Release Criteria –Position –Anchor –Size (compression) –Seal 8.Device recapture 9.Anticoagulation

5 5 SH-153515-AA April 2013 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 200-300 during procedure

6 6 SH-153515-AA April 2013 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 Anchors PET fabric 2. WATCHMAN™ LAA Closure System Components 2. WATCHMAN™ LAA Closure System Components WATCHMAN Device

7 7 SH-153515-AA April 2013 Double Curve Single Curve Transseptal Access System Double, Single, Anterior Curves 14F O.D. (4.7 mm), 12F I.D. 75 cm working length Preformed curve shapes guide position in LAA 2. WATCHMAN™ LAA Closure System Components WATCHMAN Access System

8 8 SH-153515-AA April 2013 Constrained Device Distal Marker Band Hemostasis Valve Core Wire Deployment Knob 12F O.D. (compatible with all 5 device sizes) 2. WATCHMAN® LAA Closure System Components WATCHMAN Delivery System

9 9 SH-153515-AA April 2013 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 10 SH-153515-AA April 2013 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 11 SH-153515-AA April 2013 Maximum LAA Ostium (mm) Device Size (mm) (uncompressed diameter) 17-1921 20-2224 23-2527 26-2830 29-3133 3. Determine proper device selection 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

12 12 SH-153515-AA April 2013 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. 3. Major LAA Types

13 13 SH-153515-AA April 2013 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 14 SH-153515-AA April 2013 Access Sheath Marker Band Loaded Device Length* 21mm20.2mm 24mm22.9mm 27mm26.5mm 30mm29.4mm 33mm31.5mm 5. Sheath navigation/manipulation (marker bands) 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 15 SH-153515-AA April 2013 5. Sheath navigation/manipulation (advancing in the LAA) Marker bands To better visualize complex LAA anatomy and verify access sheath tip position: Obtain multiple views with Angiography (minimum RAO cranial/caudal) TEE (minimum 0-135 degree sweep) Most important when sheath is advanced near the wall or apex of LAA and while advancing more distally in any anatomy.

16 16 SH-153515-AA April 2013 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

17 17 SH-153515-AA April 2013 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 18 SH-153515-AA April 2013 = = Retract WAS and Snap into DC 6. Advancement into WATCHMAN™ Access System (marker band alignment)

19 19 SH-153515-AA April 2013 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 20 SH-153515-AA April 2013 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 6. Device Deployment PROCESS

21 21 SH-153515-AA April 2013 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) 7. Device Release Criteria (PASS)

22 22 SH-153515-AA April 2013 7a. Device Release Criteria – OPTIMAL POSITION Fixation anchors engage LAA wall

23 23 SH-153515-AA April 2013 Device position too distal relative to LAA ostium Possible uncovered lobes, incomplete seal or residual flow in LAA Confirm in multiple views 7a. Device Release Criteria – Position (too distal)

24 24 SH-153515-AA April 2013 Device position too proximal relative to LAA ostium Device protrudes into LA, low compression or unstable device Confirm in multiple views 7a. Device Release Criteria – Position (too proximal)

25 25 SH-153515-AA April 2013 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 7b. Device Release Criteria – ANCHOR (pass or fail test) Hemostasis Valve Core Wire Deployment Knob

26 26 SH-153515-AA April 2013 7c. Device Release Criteria - SIZE (compression) Device Size (uncompressed diameter) Maximum (20%) Compression Measured Diameter* Minimum (8%) Compression Measured Diameter* 2116.8 mm19.3 mm 2419.2 mm22.1 mm 2721.6 mm24.8 mm 3024.0 mm27.6 mm 3326.4 mm30.4 mm *Measure in-situ device diameter at approximate TEE angles of 0, 45, 90 and 135 degrees to accurately assess device compression 20.8

27 27 SH-153515-AA April 2013 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 28 SH-153515-AA April 2013 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 29 SH-153515-AA April 2013 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 8. Device recapture PROCESS

30 30 SH-153515-AA April 2013 9. Anticoagulation: Key Points Pre-procedure Recommendations INR optimally ≤ 2.0 ACT levels during procedure tightened to (200 - 300 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 2.0-3.0 Mandatory 45 day TEE to assess device sealing

31 31 SH-153515-AA April 2013 FDA Statement upon approval Statement will be inserted when device is FDA approved.

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