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 ComponentsLAA anatomy / assessmentOstium size, LAA type, considerationsIAS crossingSheath navigation/ manipulationWATCHMAN Access SystemDevice deploymentWATCHMAN Delivery SystemDevice Release CriteriaPositionAnchorSize (compression)SealDevice recaptureAnticoagulation
5 1. Procedure Equipment Echo machine and staff Venous Introducer (optional)Standard Transseptal Access System with puncture needleExchange length .035” GuidewireAdjunctive Catheters (6F pigtail)Pressurized saline bag – drip chamber/sterile line (used for air management, control flow, minimal)30-50 cc syringe for catheter/device prepWATCHMAN™ 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 structureAvailable sizes:21, 24, 27, 30, 33 mm (diameter)10 Fixation anchors around device perimeter engage LAA tissueContour shape accommodates most LAA anatomyFabric Cap: (PET) Fabric Polyethyl terephthalatePrevents harmful emboli from exiting during the healing process160 micron filterPET fabricAnchors
7 2. WATCHMAN™ LAA Closure System Components WATCHMAN Access System Transseptal Access SystemDouble, Single, Anterior Curves14F O.D. (4.7 mm), 12F I.D.75 cm working lengthDouble CurveSingle CurvePreformed curve shapes guide position in LAA
8 2. WATCHMAN® LAA Closure System Components WATCHMAN Delivery System Hemostasis ValveCore WireDeployment KnobConstrained DeviceDistal Marker BandThe WATCHMAN Device is pre-loaded into a 12F OD sheathWATCHMAN Delivery SystemThe 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 released12F O.D. (compatible with all 5 device sizes)
9 3. LAA anatomy / assessment Assess the following LAA features:Ostium size and shapeNumber of lobes, locationWorking length in the LAAPectinate featuresAssess less challenging vs. more challenging anatomiesRelationship of LAA to LUPVCategorize by LAA TypeWindsock, Chicken Wing or Broccoli
10 3. Assessment of LAA Dimensions Confirm the absence of LA/LAA thrombusMeasure LAA ostium in at least 4 TEE viewsAt 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 selectionMaximum LAA Ostium (mm)Device Size (mm)(uncompressed diameter)17-192120-222423-252726-283029-3133Device sizing is based on maximum LAA diameterMaximum LAA ostium size should be >17mm or <31mm to accommodate available device sizesAvailable/useable LAA length should be equal to or greater than the ostiumSelect SizeMaximum 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 TypesThe 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 LSPVPreferred option to advance WATCHMAN Access System:Over 6F pigtail catheterExchange in LA, navigate pigtail into LAAInject contrast to assess progressAdvance slowly and carefully in multiple angio and echo views
14 Access Sheath Marker Band 5. Sheath navigation/manipulation (marker bands)Access Sheath Marker BandLoaded Device Length*21mm20.2mm24mm22.9mm27mm26.5mm30mm29.4mm33mm31.5mmRadiopaque marker bands guide initial sheath placement/depth in the LAAAlign 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 andverify access sheath tip position:Obtain multiple views withAngiography (minimum RAO cranial/caudal)TEE (minimum degree sweep)Most important when sheath is advanced nearthe wall or apex of LAA and while advancingmore distally in any anatomy.Marker bandsCarefully 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 SystemAligns the sheath more anteriorlyClockwise torque on the Access SystemAligns the sheath more posteriorlyCarefully 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 bowlAlign device at marker bandPrior to introducing Delivery System into Access SystemConstrained DeviceDistal 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 sheathTactile feel may be decreasedRisk of complications may be increasedIf the access sheath requires more distal advancement into the LAADisconnect the delivery catheter from access sheathRetract delivery catheter and reinsert pigtailManipulate 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 occursNO forward pushing (or repositioning relative to ostium) during unsheathing process
21 7. Device Release Criteria (PASS) All criteria must be met prior to device releasePosition – device is distal to or at the ostium of the LAAAnchor – (stability) fixation barbs engaged / device is stable using tug testSize – device is compressed at least 8-20% of original sizeSeal - device spans ostium so no color flow Doppler is seen, all lobes of LAA are coveredIf necessary, device can be recaptured (partial or full)
23 7a. Device Release Criteria – Position (too distal) Device position too distal relative to LAA ostiumPossible uncovered lobes, incomplete seal or residual flow in LAAConfirm in multiple views
24 7a. Device Release Criteria – Position (too proximal) Device position too proximal relative to LAA ostiumDevice protrudes into LA, low compression or unstable deviceConfirm 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 positionIf the device moves to where position is no longer acceptable or the compression is no longer sufficient, the device should be recapturedTest stability more than once if device stability is questionableHemostasis ValveCore WireDeployment Knob
26 7c. Device Release Criteria - SIZE (compression) Device Size(uncompressed diameter)Maximum (20%) CompressionMeasured Diameter*Minimum (8%) Compression Measured Diameter*2116.8 mm19.3 mm2419.2 mm22.1 mm2721.6 mm24.8 mm3024.0 mm27.6 mm3326.4 mm30.4 mm20.8*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 deviceIf all 4 device release criteria are met, device can be releasedCounter 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 criteriaIf 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 startsRecapture device by retracting device into sheath and pushing sheath over deviceRecapture device with slow and stable motionAvoid inadvertent pulling, pushing implant during recapture processOptions include partial or full (complete) recapture
30 9. Anticoagulation: Key Points Pre-procedure RecommendationsINR optimally ≤ 2.0ACT levels during procedure tightened to ( sec)Heparin to maintain ACTACT every ~30 min during procedurePost-procedurePost procedure heparin not recommendedProtamine post-procedure (optional)Warfarin restarted (if stopped)Achieve and maintain therapeutic level ofMandatory 45 day TEE to assess device sealing
31 FDA Statement upon approval Statement will be inserted when device is FDA approved.