Technique, Risk, and Benefit. T. Santoso University of Indonesia Medical School,
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1 Left Atrial Appendage Closure Technique, Risk, and Benefit T. Santoso University of Indonesia Medical School, Medistra Hospital, Jakarta, Indonesia
2 Percutaneous LAA Closure Devices PLAATO (no longerdeveloped) Watchman Cardiac Plug Amplatzer Cardiac Plug Coherex WaveCrest Occlutech LAA Sideris patch Other Gore
3 Watchman LAA Closure System (Atritech/Boston Scientific) Threaded insert Nitinoll frame 160 µ PET fabric Barbs Various sizes (21, 24, 27, 30, 33 mm) The barbs & radial force ensure fixation in the LAA wall
4 LAA Closure Purpose: To prevent ischemic stroke or systemic embolism caused by embolization of LAA thrombi in pts with AF* To eliminate the need for long term anticoagulation therapy. *91% of all thrombi in patients with NVAF is found in the LAA (SPAF III study).
5 Exclusions: TTE/TEE + Contrast CT Scan Watchman exclusion criteria: 1. Intracardiac thrombus or spontaneous echo contrast (SPEC) on TEE 2. Cardiac tumor 3.Endocarditis 4.Situs inversus abdominalis/thoracalis 5.Maximum LAA ostium width > 32 mm or < 17 mm in at least 3 consecutive views 6.Maximum LAA length insufficient to accommodatethethe device 7. Significant mitral stenosis (MVA < 1.5 mm 2 ) 8. Existing pericardial effusion > 2 mm + 1 mm 9. LVEF < 30% on TTE 10.High risk PFO that presents with either one of the following: 1. atrial septal aneurysm with a total excursion > 15 mm & total length > 15 mm 2. large shunt detected within 3 cardiac cycles 11. Complex atheroma of the aortic arch or descending di aorta with a mobile plaque (thickness > 4 mm)
6 Steps Of The Procedure Baseline TTE/TEE and/or contrast CT scan Choosing the Watchman Device (WD) Transseptal puncture (Fluoro/TEE guided) Access to LAA (Watchman Access System [AS] ) Delivery, positioning & deployment of Watchman Device Checking Watchman Device prior to final deployment Final TEE assessment Management of venous access site
7 LAA Thrombus: One of the most important contraindication ti!!
8 Appropriate Location During Transseptal Puncture Will Ease The Procedure & Prevent Tamponade Fluoroscopy : AP or RAO 20 0 & LAO 90 0 TEE : essential!! (midfossa & posterior) Bicaval view, Short axis view, The sheath/needle tip is indicated by IAS tenting. Avoid excessive tenting. Use of stylet tltor back end of a coronary guide wire may help penetration. If the IAS is very thick & resistant, electrocoagulation may also help
9 TEE & Angio Corelations Following successful transseptal puncture, before doing the measurements: Check LAA pressure. Infuse fluids if < 10 mmhg. Re check until it is > 10 mmhg TEE View Angio view 0 0 AP cranial Maximal diameter measured usually in 0 0 & RAO 30 0 cranial 20 0 Working view: 90 0 RAO 30 0 TEE: Angio: RAO 30 0 caudal RAO caudal 20 0 (maximal angio diameter)
10 Choose Device Size Based On Measurements By TEE Record the measurements of the maximum LAA ostium diameter & length or the primary LAA lobe at 0 0, 45 0, 90 0 and Diameter WATCHMAN Device (WD) Size Options 21 mm 23.5 mm 24 mm 27.5 mm 27 mm 30.5 mm 30 mm 33.9 mm 33 mm 36.0 mm Standard profile length Choose a device 20% bigger than the maximum measurement
11 Access To The LAA Pull out the needle & dilator, then advance extra length support GW into the LUPV. Remove the crossing sheath. Watchman Access System (AS) curve configurations. Most commonly used is the double curvedas After flushing, insert AS & dilator over GW, then advance toward dthe center of LA. Hold dilator & GW in place & continue advancing AS to its initial position in the LA. Remove dilator & GW, leaving AS at initial position
12 Access To The LAA Insert pigtail into AS & advance to LAA. Rotate to desired orientation. Advance sheath. Cine angio. Avoid advancing past pigtail loop (prevent perforation) Make sure the proximal marker band that corresponds to the maximum device diameter is at or just distal to the LAA ostium. Remove pigtail catheter.
13 Delivery, Positioning & Deployment Of WD Assure that the Watchman device (WD) is securely attached to the core wire. Align the WD with the distal marker band of delivery catheter (DC). ) Flushing of DC, advanceit into the AS. Stop advancing when the marker bands of the DC & AS are aligned with one another. Snap AS to the DC to make it a single AS/DC assembly Secure the position of the AS/DC, loosen the hemostasis valve on DC. Slow, hold respirator. Then slowly retract the AS/DCassembly until the WD is completely deployed (5 seconds)
14 Checking Watchman Device Deployment After deployment of WD, confirm WD position & seal on cine with contrast in multiple li l views. The WD should be positioned at or distal to the LAA ostium & protrude only slightly into the LA Withdraw AS/DC assembly about 1 cm from proximal face of WD, leaving core wire attached. Perform tug test. The WD should move in unison with the LAA.
15 Checking Watchman Device Deployment Check device protrusion into the LA Original size Acceptable protrusion 21 mm < 4.2 mm 24 mm < 4.8 mm 27 mm < 5.4 mm 30 mm < 6.0 mm 33 mm < 6.6 mm Device size : 80 92% of its original size Device seal : Ensure all LAA lobes are distal to the proximal face of the device. With color Doppler, residual jet flow around the margins of the device < 3 mm + 2 mm
16 Avoid Improper Device Deployment Device too distal: Needs partial recapture & repositioning Device too proximal: Needs full recapture & placement of a new device
17 Device Release Rotate t DC control lhandle Obtain final image of the counterclockwise 3 5 full turns implanted WD. Check for to unscrew the core wire from pericardial effusion on echo the WD
18 Final TEE Assessment Baseline TEE at 0 0, 45 0, 90 0 and Final TEE after WD deployment at 0 0, 45 0, 90 0 and 135 0
19 Important Complications of LAA occlusion Risk Tamponade cardiac perforation Stroke air or clot embolism Prevention TEE guided transseptal puncture,,great care in advancement of sheath in LAA, device deployment, or recapturing of device Look of LAA clot, great care in sheath thde airing ii & flushing, adequate anticoagulation (ACT > 200 secs) Inappropriate device TEE & fluoro guided proper device placement placement residual leaks & device embolization Vascular complications 12F venous access sheath, 2 nd small venous line (for bleeding, fluids /autotransfusion), appropriate local hemostasis hematoma, AV fistula (manual compression, figure of 8 subcutaneous suture, or single Proglide). Avoidance of low molecular weight heparin for 12 hrs after procedure Kar S. TCT 2011
20 Follow Up At 45 Days
21 Watchman Clinical Studies Study Patients Sites Remarks Pilot 66 8 PROTECT AF pt yrs of f up 30 pts with 5+ yrs of f up 1,500 pt yrs of f up 27monthsaverage f upperpt per pt Continued Access Registry Significantly improved safety results (CAP) ASAP EVOLVE 69 3 PREVAIL TOTAL 1912 Treat pts contra indicated for warfarin Evaluate next generation WATCHMAN Same endpoints as PROTECT AF Revised inclusion/exclusion criteria Initiate enrollment October 2010
22 PROTECT AF Study WATCHMAN first implanted 2002 Initial human experience in 66 pts reported 2007 PROTECT AF: Prospective study of pts with non valvular AF ; CHADS2 score > 1 randomised 2:1 to WATCHMAN or warfarin Endpoints : Efficacy: stroke, CV death, systemic embolism Safety: major bleeding, pericardial effusion & device embolisation. Warfarin 45 days, dual AP therapy to 6 months, then aspirin alone 707 pts recruited : WATCHMAN 463 / Control 244 Followed for 1065 pt years, mean f up 18 +/ 10 pt months Holmes DR, et al.lancet 2009; 374:534 42
23 PROTECT AF Proof of Concept Per Protocol: Primary Efficacy Results Cohort WATCHMAN Rate (95% CI) warfarin Rate (95% CI) Rel. Risk (95% CI) Posterior Probabilities* Non Inferiority Superiority 600 pt yrs pt yrs > pt yrs > *Closure without t complication and warfarin discontinued d 60% lower relative risk in WATCHMAN Group Holmes DR, et al.lancet 2009; 374:534 42
24 PROTECT AF: Primary Efficacy K M Estimates E vent Free e Probability Watchman Control Control Watchman Days from Randomization Cohort 1 Year Event Rate 2 Year Event Rate 3 Year Event Rate (95% CI) (95% CI) (95% CI) WATCHMAN 3.7 (1.9, 5.4) 6.1 (3.8, 8.5) 7.9 (5.0, 10.9) Control 4.3 (1.7, 6.9) 8.0 (4.5, 11.6) 12.5 (6.9, 18.1) 1500 Patient year Analysis Holmes DR, et al.lancet 2009; 374:534 42
25 PROTECT AF: Primary Efficacy (By Pt Subgroup) Holmes DR, et al.lancet 2009; 374:534 42
26 PROTECT AF : Ischemic Stroke* Events cohort Device Control Posterior probability Total no pt yr Rate pt yr Events (95% CI) Total no (1.7, 5.2) Rate ptyr Rel. risk (95%CI) Non (95% CI) (0.5, 3.8) Superiority inferiority (0.69, 7.45) pt yr (1.3, 39) 3.9) (0.5, 31) 3.1) (0.64, 5.43) robabilit ty Device Control Randomization (2 device:1 control) Even nt free p patient year analysis *ITT Cohort: pts analyzed based on their randomly assigned group (regardless of treatment received) 0.7 Days
27 PROTECT AF : Hemorrhagic Stroke* Events cohort Device Control Posterior probability Total no pt yr Rate pt yr Events (95% CI) Total no (0.0, 0.9) Rate ptyr Rel. risk (95%CI) Non (95% CI) (0.5, 3.9) Superiority inferiority (0.00, 0.80.) > pt yr (0.0, 0 06) 0.6) (0.7, 37) 3.7) (0.00, ) 0.45) Event t free pro obability patient year analysis Device Control Randomization (2 device:1 control) *ITT Cohort: pts analyzed based on their randomly assigned group (regardless of treatment received) Days
28 PROTECT AF : Primary Safety Results* Device Control Cohort Events Total pt yr Rate (95% Events Total pt yr Rate (95% Rel. risk (no) CI) (no) CI) (95%CI) 900 pt yr (6.4, 11.3) (2.2, 6.7) 2.08 (1.18, 4.13) Control Even nt free prob bability 0.9 WATCHMAN *ITT Cohort: pts analyzed dbased on their randomly assigned group (regardless of treatment received) ,095 Days
29 PROTECT AF & The CAP (Continued Access Registry) Performance Metrics Procedure Time (Mean ± SD) PROTECT AF PROTECT AF Early Late CAP p value* p value± 62 ± ± ± ± 21 <0.001 <0.001 Implant Success 485/542 (89.5%) 239/271 (88.2%) 246/271 (90.8%) 437/460 (95.0%) day Warfarin Discontinuation Among Implanted 414/478 (86.6%) 194/235 (82.6%) 220/243 (90.5%) 352/371 (94.9%) <0.001 <0.001 *From tests comparing the PROTECT AF cohort with CAP ±From o tests for differences e cesacross three eegoups(ea groups (early PROTECT AF, late PROTECT AF, and CAP) Reddy VY, et al. Circulation 2011;123: ; Kar S, TCT 2011
30 PROTECT AF & The CAP (Continued Access Registry) Safety Event Rates Procedure/Device Related Safety Adverse Events within 7 Days PROTECT AF PROTECT AF p p CAP Early Late value* value± 42/542 27/271 15/271 17/460 (7.7%) (10.0%) (5.5%) (3.7%) Serious Pericardial 27/542 17/271 10/271 10/460 Effusions within 7 Days (5.0%) (6.3%) (3.7%) (2.2%) ProcedureRelated Stroke 5/542 3/271 2/271 0/460 (0.9%) (1.1%) (0.7%) (0.0%) *From tests comparing the PROTECT AF cohort with CAP ±From tests for differences across three groups (early PROTECT AF, late PROTECT AF, and CAP) Reddy V, et al. Circulation 2011;123: ; Kar S, TCT 2011
31 ASAP (ASA Plavix Feasibility Study) Implant device w/o Warfarin transition Age 75 in 39% Clopidogrel for 6 months & ASA for life 4 European Centers 127 Contraindicated pts Age 72.2 ±7.9 (53 93); CHADS 2 = (1 5) Successful implantation in 118/127 pts (93%) Periprocedural complications Pericardial tamponade 1 (0.8%) Device embolization 2 (1.6%) Pseudoaneurysm (groin) 1(0.8%) Mean f up = 10.4 months (58 pts to one year) HTN in 90% Diabetes in 31% CHF in 24% Prior TIA/CVA in 38% Sievert H, et al. TCT 2011
32 ASAP Complications During F up Device related thrombus detected in 4/118 pts One within 45 days; 2 in 3 months; 1 in 1 year f up TEE All were successfully treated with LMW heparin Stroke in 3/118 pnts Thrombus on the WATCHMAN device in one patient WATCHMAN device implant without Warfarin overlap is safe & feasible LAA closure may prove to be a viable alternative for AF pts with contraindications to Warfarin Sievert H, et al. TCT 2011
33 Summary Long term warfarin treatment of pts with AF has been found effective, but presents difficulties & risk Technique for Watchman LAA occluder implantation is not difficult In PROTECT AF & CAP, the efficacy of LAA closure was noninferior to that of warfarin therapy In PROTECT AF: Hemorrhagic stroke risk is significantly lower with the device. Even though there are early safety events, specifically pericardial effusion; these events have decreasedover time PROTECT AF/CAP/ASAP suggest that closure of the LAA is an alternative strategy to chronic warfarin or oral anticoagulation therapy for stroke prophylaxis
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