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1、Prepared by Dr Yat-yin LAM MD FACCVersion_2Date 15 Oct 2016Lifetech LAmbre LAA Occluder: Procedural Tips and TricksStep 1 Indications for LAA occlusionIndications for LAA occlusion: 3 types of patients for LAA closureOAC-contraindicated (e.g. ICH)OAC-eligible but expected high bleeding risks on long

2、 term OAC (HAS-BLED3)OAC-eligible but not taking OAC for whatever reasons (PROTECT-AF CHADS21; PREVAIL CHADS22)ESC guideline 2012 and 2016 (IIb): patients with contraindication to long term oral anticoagulation (Group 1&2)Group 3 are mostly studied in RCTs NVAF patients with CHA2DS2-VASC score2With

3、one of the following situations: Not suitable for long-term anticoagulation Stroke or embolism despite targeted INR in patients taking warfarin HAS-BLED score3Indications for LAAO of CSPE: Step 2 Overview of the DeviceLifetech LAA occluder - LAmbreTMCharacteristics1. Two parts : LA Cover and Umbrell

4、a. “An Umbrella in LA Appendage ”2. Double-membrane design: A distal membrane to seal the appendage if that in the cover fail to do so.3. TiN-coated LA cover with recessed hub to promote faster endothelialization and to reduce delayed thrombus formation.4. Specially-designed umbrella (8 frames+ PET

5、membrane+ 8 hooks) for multiple recapture and repositioning; only smaller sheaths (8-10Fr, Sizes 16-36mm) required. LAmbre Delivery SheathThe 10Fr double-curve sheath should be chosen as the workhorse sheath, this avoids the need of changing the sheath ifchanging to a larger device is necessary duri

6、ng the procedure Deployment RecaptureThe device is deployed by:1/positioning the tip of the sheath at the landing zone2/pushing the delivery cable to deploy the umbrella3/unsheathing the delivery sheath to deploy the coverThe device is fully recapturable by:1/ pulling the delivery cable2/ advancing

7、the delivery sheath at the same timeInfolding the umbrella without damage the stabilizing hooks can be observed3 Anchoring Mechanisms for LAmbre8 small distal hooks (engage into LAA walls)Over-sized umbrella(pushing and stenting against the LAA)8 bigger prox barbs (trapped in trabeculations)Two Spec

8、ifications of LAmbre Standard16-36mmCover 4-6mm largerSpecial16-28mmCover 12-14mm largerCat. Diameter of Umbrella(mm) Diameter of Cover(mm) Delivery system LT-LAA-1622 16228F-9009F-900 10F-900 LT-LAA-1824 1824LT-LAA-2026 20269F-90010F-900 LT-LAA-2228 2228LT-LAA-2430 2430LT-LAA-2632 263210F-900 LT-LA

9、A-2834 2834LT-LAA-3036 3036LT-LAA-3236 3236LT-LAA-3438 3438LT-LAA-3640 3640Cat. Diameter of Umbrella(mm) Diameter of Cover(mm) Delivery system LT-LAA-1630 16309F-90010F-900LT-LAA-1832 183210F-900LT-LAA-2032 2032LT-LAA-2234 2234LT-LAA-2436 2436LT-LAA-2638 2638Device Sizes and Corresponding Delivery S

10、ystems of LAmbreStep 3 Patient PreparationPatient preparationRule out the presence of LAA thrombus by TEE or CT scan of LAA (pls refer to echo protocol)TEE to measure the size of LAA (pls refer to echo protocol)Load aspirin/plavix one day before procedureAdequate IV hydration of patient after fastin

11、gEndocarditis prophylaxis one hour before the procedure (IV cefazolin 1g on call to cath lab) Patient PreparationGeneral anesthesia or deep sedation with propofol TEE and Fluoroscopic guidanceRRA access for BP monitoring (optional)Manifold for: pressure monitoringsaline flushing (pressurized 200mmHg

12、)contrast injection RFV puncture Step 4 Transseptal Puncture Transseptal puncture (TEE)90 degree TEEBicaval View45 degree TEERetroaortic View8 Fr SL 1 Sheath (St Jude Medical) and Brockenbrough needleOptimal puncture site: Inferior and posterior part of the septum Transseptal puncture (Fluoroscopy)R

13、AO viewLAO View8 Fr SL 1 Sheath (St Jude Medical) and Brockenbrough needleOptimal puncture site: Inferior and posterior part of the septumTransseptal puncture (General Tips)Must see septal tenting on echo before puncture!Dont use PFO tunnel if possibleGiven Heparin 100IU/kg, aim ACT250sMeasure mean

14、left atrial pressure, aim12mmHg (give IV fluid if necessary)Step 5 LAA engagement for LAA AngiogramLAA engagement Pigtail Technique (to avoid parking of a stiffwire in LAA and hence minimize the risk of stiffwire-related LAA perforation) 260cm Amplatz stiffwire to LUPVExchange the transseptal sheath

15、 with a 10 Fr LAmbre double-curve delivery sheath Insert a 110cm long 5 or 6 Fr pigtail into the delivery sheath via a wire connector connecting to the sheath En-bloc pull back of Sheath-Pigtail from LUPV ed into until the tip of pigtail drop to LAA ostiumAdvance the pigtail into LAA Track the sheat

16、h via pigtail into LAAPerform LAA angiogram LAA engagement for LAA angiogramStep 6 LAA angiogram and selection of device sizeAP, lateral, and LAO projections are not helpful in vast majority of cases.RAO Caudal view helps in demonstrating the lobes of the LAA.RAO Cranial View helps in demonstrating

17、the ostium and neck of the LAA.Very important to appreciate the AV groove housing the LCx !LAA Angiograms: Optimal Fluroscopic ProjectionsRAO 20/ CAU 20RAO 20/CRAN 20LAmbre Sizing TEE or LAA Angiogram Measurements?Should consider both measurementsDiscrepancies 2-4mm, angio measurement tends to be la

18、rgerAngio measurement is preferred4. RAO Caudal projection best Ostial measurement usually the largestAll lobes can be well visualized LAA angiogram: Best PracticesUse 2 marks (10mm, leading-to-leading edge) at the tip of delivery sheath OR marked pigtail for calibration Measure at RAO 20 caudal 20

19、view Ostial lineCover lineShould have good correlation with TEE (in general angio 2-4mm larger)Ostial lineCover line10mm Size Selection for LAmbre DeviceOstial lineCover line10mm RAO 20 Caudal 20TEE 135 degreeDevice Size (Diameter of Umbrella): 2-6mm (or 10-25%) larger than the measured ostial diame

20、terThe device umbrella (blue rectangular box) should be positioned just distal to the ostial lineThe device cover should be deployed at the cover lineLAmbre Sizing Case Example (1) 31mmRAO 20 Caudal 20 ProjectionOstial line 31mmLAmbre 3640 mm device (umbrella 36mm, cover 40mm) LAmbre Sizing consider

21、ationsIn general 2-6mm larger than measured ostial lineFactors leading to more oversizingLarge ostial line 26mmLarge cover lineCertain LAA morphologies (less oversizing for windsock morphology and more oversizing for cauliflower or chickenwing morphologies)Special device type (small umbrella with la

22、rge cover) should be considered in special anatomies (bilobed, shallow etc.)LAA morphologiesWindsockChickenwingSpecialMulti-lobeShallowExtreme SizesTheir combinationsLAA sizing Case Example (2)Umbrella can be compressed up to 40% in bench testBoth LAA have same ostial line 20mm but different cover l

23、ine 28mm vs 23mmWide opening (28mm Cover line): 26 (32) deviceNarrowing opening (23mm Cover line): 22 (28) or 24 (30) deviceLAA Sizing Case Example (3) Chickenwing Morphology Different Options24 device (standard device): Cal de sac in proximal LAA ?clinical relevance 26 or 28 device (standard device

24、): preferred option, sandwich technique18 device (special device): not feasible if LAA is longStep 7 Device preparation flushing very important to minimize air embolismContinuous Flushing to Lower Risk of Air Embolism while Advancing the device in the sheath Step 8 Device ImplantationStandard implan

25、tation techniqueModified technique for patients with dense SEC in LAASandwich technique for patients with chickenwing morphologyLAmbre Standard Implantation ProcedureAdvance the delivery sheath to the ostium of the LAA with the support of the pigtail catheter Push the delivery cable to deploy the um

26、brella distal to the ostial line of LAA (Make sure the umbrella is fully opened!)Unsheath the delivery system to deploy the cover for better LAA sealing Recapture/Repositioning +/- device change if necessary (no need to change the sheath)Check signs for optimal device placement and perform tug test

27、for stabilityLA angiogram for leak assessment TEE to assess any encroachment of surrounding structures e.g. MV, LUPV, quantification of leak) pls refer to echo protocol - Opening up the umbrella at proximal LAA (active roll-in of stabilizing hooks)- Distal positioning of delivery catheter is not req

28、uired!- Less demanding on catheter alignment in perpendicular to ostial axis!Procedural Steps Lam YY. A new left atrial appendage occluder (Lifetech LAmbreTM Device) for stroke prevention in atrial fibrillation. Cardiovasc Revasc Med 2013; 14:134-6Umbrella PARTIALLY openedUmbrella FULLY openedLA cov

29、er deployedUmbrella Just openedFluroscopic vs. Ex-Vivo AppearancesImaginary line between nadir of the framesRadio-opaque markerPotential consequences of poorly opened umbrella Risks of pericardial effusion, leak, thrombusPoorly opened umbrellaFully opened umbrellaSigns of Optimal Device PlacementRec

30、tangular-shaped umbrella (indicates compression) 2. Lowest frame level same as radio-opaque marker (indicates optimal opening of umbrella)3. Umbrella deployed beyond the left circumflex artery level 4. Concave-shaped cover Modified implantation technique for patient with dense SECThis technique is m

31、ended for patients with: dense SECPossible LAA thrombus Modified stepsNo LAA angiogramNo delivery sheath or pigtail in LAATEE for sizing and guidance during implantationUmbrella partially opens outside LAA Sheath rotation (usu counter-clockwise) to engage LAA to complete umbrella deployment Standard

32、 vs. Modified TechniquesDevice Deployment in proximal LAAPartial Device Deployment in LADense SECStandard AnatomyChickenwing Morphology Different Options24 device (standard device): Cal de sac in proximal LAA ?clinical relevance 26 device (standard device): My preferred option, sometimes need even b

33、igger device18 device (special): not feasible if appendage is longChickenwing LAA morphologySpecial device Umbrella ranged from 16-28mm Cover 12-14mm largerBeing used in about 10% of LAmbre implantsPotential suitable anatomiesBilobed or multi-lobed ShallowExtreme sizes (small or large)Combinations o

34、f the above Special: Small Appendage Case10.4mm10.2mm8.2mmSmall Appendage Closure strategy16-26mmCover 12mm larger10.4mmSpecial: Shallow CaseSpecial: Shallow CaseSpecial: Another Shallow Appendage (LAA depth10mmHgMeticulous device preparation to expel airOngoing saline flushing during device advance

35、ment in sheathCareful selection of device size Always look for it !PROTECT-AF Causes of Pericardial Effusions (mostly related to wire/catheter/device manipulation in LAA)Prevention of pericardial effusionSafe transspetal puncturePigtail technique to engage LAA Leaving pigtail in LAA while preparing

36、the deviceAvoid engagement of sheath at distal LAAStart deploying the device at LAA ostium and gently push the device towards the intended landing zoneManagement of pericardial effusionAlways think of it when hypotenion occurs!Heparin reversal with IV protamineInform surgeon immediately!Bailout depl

37、oyment of device if due to LAA perforationBlood transfusion!Immediate pericardio-centesisEpidural needlePericardial drainage setBiplane FluoroscopyLarge Sheath (14Fr preferred)Large SnareBiopsy ForcepDevice embolization has not occurred in any human implants (300 worldwide) so far with LAmbreBut alw

38、ays be prepared!Step 10 Post-implantation CareLAAO After ProcedureMedications2 commonly used regimes:Anti-platelets (Usually for OAC-contraindicated patients): Aspirin + Clopidogrel 6 months then Aspirin indefinitelyAnticoagulant (PROTECT-AF protocol): Warfarin for 45 days then Aspirin + Clopidogrel 6 months then Aspirin indefinitelyLimited data with NOACNo evidence about difference in thrombus rates with different regimesTra

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