1 68 Left Atrial Appendage Occlusion/Exclusion: 2 69 3 70 Procedural Image Guidance with Transesophageal 4 71 5 72 Echocardiography 6 73 7 74 8 75 9 QQQ444 AlanF.Vainrriibb,MD,SergeC.Harrbb,MD,WaelJabbeerr,MD,RicardoJ.Benensteiinn,MD,AAnntthhoonnyyAizzeerr,MD, 76 10 LarryA.Chiniittzz,MD,andMuhamedSarriicc,MD,PhD,NewYork,NewYork;andCleveland,Ohio 77 11 78 12 79 13 80 14 Atrialfibrillationisthemostcommonarrhythmiaworldwideandisamajorriskfactorforembolicstroke.Inthis 81 15 article,theauthorsdescribethecrucialroleoftwo-andthree-dimensionaltransesophagealechocardiography 82 16 in the pre- and postprocedural assessment and intraprocedural guidance of percutaneous left atrial 83 17 appendage(LAA)occlusionprocedures.Althoughrecentadvanceshavebeenmadeinthefieldofsystemic 84 18 anticoagulationwiththenoveloralanticoagulants,thesemedicationscomewithasignificantriskforbleeding 85 19 86 andarecontraindicatedinmanypatients.Becausethromboembolisminatrialfibrillationtypicallyarisesfrom 20 87 thrombi originating in the LAA, surgical and percutaneous LAA exclusion/occlusion techniques have been 21 88 devisedasalternativestosystemicanticoagulation.Currently,surgicalLAAexclusionistypicallyperformed 22 89 as an adjunct to other cardiac surgical procedures, which limits the number of eligible patients. Recently, 23 90 24 severalpercutaneouslydelivereddevicesforLAAexclusionfromthesystemiccirculationhavebeendevel- 91 25 oped,someofwhichhavebeenshowninclinicaltrialstoreducetheriskforthromboembolism.Thesedevices 92 26 useaneitherpurelyendocardialLAAocclusionapproach,suchastheWatchmanandAmuletprocedures,or 93 27 bothanendocardialandapericardial(epicardial)approach,suchastheLariatprocedure.IntheWatchman 94 28 andAmuletprocedures,atransseptallydeliveredstructurecomposedofnitinolisplacedintheLAAorifice, 95 29 therebyexcludingtheLAAfromthesystemiccirculation.IntheLariatprocedure,amagnetlinkiscreatedbe- 96 30 97 tween a transseptally delivered endocardial wire and epicardially delivered pericardial wire, followed by 31 98 epicardialsutureligationoftheLAA.(JAmSocEchocardiogr2017;-:---.) 32 99 33 100 Keywords: Transesophageal echocardiography, 3D, Left atrial appendage occlusion, Lariat device, 34 101 35 Watchmandevice,Amuletdevice,Atrialfibrillation 102 36 103 37 104 38 Atrial fibrillation (AF) is the most common cardiac arrhythmia, agulation but have been shown to have inferior efficacy compared 105 39 106 affecting>3millionpeopleintheUnitedStatesalone.Theprevalence withanticoagulation. 40 107 ofAFincreaseswithage.TheincidenceofAFintheUnitedStatesis Satisfactoryanticoagulationwithoralwarfarinwithatargetinterna- 41 108 projectedtoincreaseto7.56millionby2050because oftheaging tionalnormalizedratioof$2to3hasbeendemonstratedtoreduce 42 109 population.1 theriskforstrokeandsystemicembolismby67%comparedwithpla- 43 110 44 Becauseofitssignificantmorbidityandmortality,AFisassociated cebo4 and by 45% compared with aspirin.5 Newer anticoagulants 111 45 with substantial personal, societal, and economic costs. AF is esti- (such as dabigatran, apixaban, and rivaroxaban) have been shown 112 46 matedtocosttheUnitedStatesapproximately$6billioneachyear.2 tobeatleastnoninferiortowarfarininnonvalvularAF.6-8 113 47 Systemic thromboembolism is the major complication of both Unfortunately,allanticoagulantshavesignificantbleedingriskand 114 48 valvularandnonvalvularAF.Theleftatrialappendage(LAA)isthe maybecontraindicatedincertainpatients.Theriskformajorbleeding 115 49 most common site of thrombus formation, accounting for 91% of (typicallydefinedasareductioninhemoglobin levelof$2mg/dL, 116 50 117 left heart thrombi in patients with nonrheumatic AF and 57% of transfusionof2Uofpackedredcells,orsymptomaticbleedingoccur- 51 118 thrombiinpatientswithrheumaticAF.3 ringatacriticalsiteorresultingindeath)witheitherwarfarinornewer 52 119 Anticoagulation with orally, intravenously, or subcutaneously agentsisestimatedat1.4%to>3%peryear.9 53 120 administeredcompoundsisthemostcommonmethodofpreventing Because most thrombi related to nonvalvular AF typically 54 121 55 thromboembolism in patients with AF. Antiplatelet agents such as reside in the LAA, surgical or percutaneous techniques of LAA 122 56 aspirinorclopidogrelcanbeusedasanalternativetosystemicantico- exclusionhavebeendevelopedasalternativestosystemicantico- 123 57 agulant and antiplatelet therapy. These exclusion procedures act 124 58 FromtheLeonH.CharneyDivisionofCardiologyNewYorkUniversityLangone locally at the level of the LAA to prevent thrombi from entering 125 59 MedicalCenter,NewYork,NewYork(A.F.V.,R.J.B.,A.A.,L.A.C.,M.S.);andthe the systemic circulation. 126 60 ClevelandClinic,Cleveland,Ohio(S.C.H.,W.J.). SurgicaltechniquesusedforLAAexclusionhaveincludedligation, 127 61 Reprint requests: Muhamed Saric, MD, PhD, New York University, 560 First clipping, stapling, and amputation.10-12 A major limitation of these 128 62 129 Avenue,NewYork,NY10016(E-mail:[email protected]). proceduresisthattheyaretypicallyperformedasadjunctstoother 63 130 64 0894-7317/$36.00 cardiac procedures, and therefore only a small number of patients 131 65 Copyright2017PublishedbyElsevierInc.onbehalfoftheAmericanSocietyof withAFareeligibleforthem. 132 66 Echocardiography. Percutaneous LAA occlusion/exclusion devices (Figure 1) include 133 67 https://doi.org/10.1016/j.echo.2017.09.014 the PLAATO (eV3, Plymouth, MN; no longer on the market), 134 1 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK 2 Vainribetal JournaloftheAmericanSocietyofEchocardiography -2017 135 Watchman (Boston Scientific, TheLAAorificeisseparatedfromtheleft-sidedpulmonaryveins 202 Abbreviations 136 Maple Grove, MN), Amplatzer by the ligament of Marshall (also referred to as the left lateral or 203 137 2D=Two-dimensional LAAoccluders(AmplatzerCardiac ‘‘Coumadin’’ridge).TheLAAmaycontainoneormorelobes,defined 204 138 PlugandAmulet;St.JudeMedical, asprotrusionsfromitsmainbody.19 205 139 3D=Three-dimensional Minneapolis,MN),13-15andLariat AnatomicvariantsoftheLAAarewelldescribed20andinclude 206 140 AF=Atrialfibrillation (Sentre-HEART,PaloAlto,CA).16-18 the windsock, the broccoli (or cauliflower), the cactus, and the 207 141 208 142 ASD=Atrialseptaldefect IntheUnitedStates,currently chicken wing (Figure 3). Of the known LAA variants, the 209 the only device specifically chicken-wing morphology is the most common. However, it is 143 210 144 LAA=Leftatrialappendage approved by the US Food and alsoknowntocausethegreatestproceduraldifficultywithregard 211 145 PDL=Para-deviceleak Drug Administration for LAA to LAA occlusion/exclusion. This is due to its broad width and 212 146 occlusion is the Watchman de- shallow depth, which create a difficult situation regardless of 213 147 PEF=Pericardialeffusion vice,whichwasclearedforgen- the type of device used. 214 148 TEE=Transesophageal eralclinicaluseinMarch2015. LAAanatomyistypicallyestablishedduringthescreeningpro- 215 149 echocardiography TheLariatdevicehasreceived cess using gated cardiac computed tomographic angiography. It 216 150 217 class II clearancefrom theFood may also be confirmed using both intraprocedural TEE and fluo- 151 218 andDrugAdministrationviathe510(k)protocol.Thisdeviceisnot roscopy. 152 219 specifically approved for percutaneous LAA exclusion but rather 153 220 for ‘‘facilitating suture placement and knot tying in surgical applica- 154 CorrespondenceofFluoroscopicandTransesophageal 221 155 tionsinwhichsofttissueisbeingapproximatedand/orligatedwith EchocardiographicViewsoftheLAA 222 156 a pre-tied polyester suture.’’ Nevertheless, the Lariat has entered 223 Itisimportantthatacommonlanguagebedevelopedbetweeninter- 157 into clinical practice. There is increasing use of both devices in the 224 ventionalists, who are typically most familiar with fluoroscopy, and 158 UnitedStates. 225 echocardiographersperformingintraproceduralTEE. 159 TheAmplatzerCardiacPlugUSpivotaltrialbeganenrollmentin 226 160 2013, but it was discontinued because of slower enrollment. The The right anterior oblique caudal view is equivalent to approxi- 227 161 mately 135(cid:127) on TEE and typically reveals the major axis of the 228 second-generation Amplatzer LAA occluder, referred to as the 162 LAAorifice(Figure4). 229 Amulet device, is currently being investigated in the United States 163 The right anterior oblique cranial view is equivalent to approxi- 230 intheAmulettrial. 164 mately45(cid:127) onTEEandtypicallyrevealstheminoraxisoftheLAA 231 TheWatchman,Amplatzer CardiacPlug,and Amuletdeviceare 165 orifice(Figure5). 232 166 delivered using peripheral venous access and transseptal puncture 233 167 (a fully endovascular approach). In contrast, the Lariat procedure 234 168 uses both an endocardial and a pericardial (epicardial) approach to 235 169 createamagnetlinkbetweenendocardialandpericardialwires,fol- OVERVIEWOFPERCUTANEOUSLAAOCCLUSION/ 236 170 lowedbyepicardialsutureligationoftheLAA.Anotherdevicethat EXCLUSIONPROCEDURES 237 171 QQQ111can ligate the LAA ligationusing an endocardial and a pericardial 238 117722 approach is the LASSO device (Aegis Medical Innovations, Irrespective of the LAA occlusion/exclusion device used, the 239 173 240 Vancouver,BC,Canada).Thissystemuseselectricalmappingrather basic steps are common to all percutaneous LAA occlusion/ 174 241 thanamagneticlinktolocateandligatetheLAAandiscurrentlybe- exclusion procedure. All percutaneous LAA occluder implanta- 175 242 ingtestedintheopen-labelLASSOAFtrial. tion procedures begin with peripheral venous access, which is 176 243 177 All percutaneous LAA occlusion/exclusion procedures would typically obtained through the right femoral vein. Subsequently, 244 178 not be possible without two-dimensional (2D) and three- a transseptal puncture is performed to gain access to the left 245 179 dimensional 3D transesophageal echocardiography (TEE). In atrium. Thereafter, specific steps for deployments of individual 246 180 thisreview,wediscusstheroleof2Dand3DTEEforperiproce- occluder devices are taken. 247 181 duralguidanceofthepercutaneousLAAocclusion/exclusionde- 248 182 vices either currently commercially available or under clinical 249 183 250 investigation in the United States, namely, the Watchman, TRANSSEPTALPUNCTUREFORPERCUTANEOUSLAA 184 251 Amulet, and Lariat. OCCLUDERS 185 252 186 253 Overview 187 254 188 LAAANATOMY After peripheral venous access is obtained, typically through the 255 189 femoral vein, a transseptal needle delivery catheter and dilator are 256 190 Detailed knowledge of LAA anatomy is essential for successful passedthroughtheinferiorvenacavaintotherightatriumandtempo- 257 191 percutaneous LAA closure procedures. The LAA is a complex rarilyplacedinthesuperiorvenacava.Thereafter,atransseptalnee- 258 192 ‘‘fingerlike’’ projection from the anterolateral portion of the left dleisadvancedthroughthedeliverycatheter. 259 193 atrium. Internally, it begins with an orifice that is typically ovoid Usingtransesophagealechocardiographicguidance,thewholesys- 260 194 261 and thus has a major and a minor orifice diameter. This orifice tem is then withdrawn from the superior vena cava into the right 195 262 opens to its neck region, then its body, and ultimately ends in atrium and positioned against the inferior and posterior portion of 196 263 its apex (Figure 2). theinteratrialseptum.Thedelivercatheteristhenadvancedagainst 197 264 The anatomic definition of LAA ‘‘orifice’’ is typically different theinteratrialseptumtotenttheinteratrialseptumatanappropriate 198 265 199 from the ‘‘orifice’’ defined as the landing zone for various LAA location. Fluoroscopy and TEE are essential in guiding the proper 266 200 occluder devices. This is addressed in detail with each individual locationoftenting.Theneedleisthenadvanced,creatingatransseptal 267 201 occluder device description below. puncture. 268 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK JournaloftheAmericanSocietyofEchocardiography Vainribetal 3 Volume-Number- 269 336 270 337 271 338 272 339 273 340 274 341 275 342 276 343 277 344 278 345 279 346 280 347 281 348 282 349 283 350 284 351 285 352 286 353 287 354 288 355 289 356 290 357 291 358 292 359 293 360 294 361 295 362 296 363 297 364 298 365 O 299 P 366 F 300 = 367 C 301 4 368 b 302 e 369 w 303 & 370 304 nt 371 305 pri 372 Figure 1 Percutaneous LAA occlusion/exclusion devices. Images of percutaneously delivered LAA occluder devices. (A) The 306 373 PLAATOLAAoccluderisnolongeronthemarket.(B)TheWatchmandeviceiscurrentlyapprovedbytheFoodandDrugAdminis- 307 374 trationandisinuseintheUnitedStates.(C)TheAmplatzercardiacplug(left)isnotavailableintheUnitedStates.TheAmplatzer 308 375 Amulet device (right)is currently undergoing clinical investigation inthe United States. (D) TheLariat device iscurrently in use in 309 376 theUnitedStatesbywayofa510(k)approval. 310 377 311 378 312 379 313 380 314 381 315 382 316 383 317 384 318 385 319 386 320 387 321 388 322 389 323 390 324 391 325 392 O 326 P 393 F 327 = 394 C 328 4 395 b 329 e 396 w 330 & 397 331 nt 398 332 pri 399 Figure2 LAAdiameteranatomy.LAAanatomyisdemonstratedongrosspathology(A)and2DTEE(B).Correspondingstructuresare 333 400 labeledonpathologyand2DTEE(yellowarrows). 334 401 335 402 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK 4 Vainribetal JournaloftheAmericanSocietyofEchocardiography -2017 403 470 404 471 405 472 406 473 407 474 408 475 409 476 410 477 411 478 412 479 413 480 414 481 415 482 416 483 417 484 418 485 419 486 420 487 421 488 O 422 P 489 F 423 C= 490 424 4 491 b 425 we 492 426 & 493 427 nt 494 428 pri 495 Figure3 LAAshapes.ThreemainLAAmorphologiesaredemonstratedon2DTEEandpathologicspecimencasts.Thecastimages 429 aremodifiedwithpermissionfromErnstG,Sto€llbergerC,AbzieherF,Veit-DirscherlW,BonnerE,BibusB,SchneiderB,SlanyJ. 496 430 497 Morphologyoftheleftatrialappendage.AnatRec1995;242:553–561. 431 498 432 499 433 500 434 501 435 502 436 503 437 504 438 505 439 506 440 507 441 508 442 509 443 510 444 511 445 512 446 513 447 514 448 515 449 516 450 517 451 518 452 519 453 520 454 521 455 522 456 523 457 524 458 525 459 526 460 527 461 528 462 529 463 530 464 531 465 532 466 533 Figure4 TEEversusfluoroscopy,rightanterioroblique(RAO)caudalview.Transesophagealechocardiographicequivalentviewsof 467 534 theRAOcaudalfluoroscopicviewaredemonstrated.TheRAOcaudalviewcanbesimulatedon2DTEEbyobtainingalong-axisview 468 535 oftheLAA(typicallyabout135(cid:127))andthenrotatingtheimagecounterclockwise. 469 536 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK JournaloftheAmericanSocietyofEchocardiography Vainribetal 5 Volume-Number- 537 604 538 605 539 606 540 607 541 608 542 609 543 610 544 611 545 612 546 613 547 614 548 615 549 616 550 617 551 618 552 619 553 620 554 621 555 622 556 623 557 624 558 625 559 626 560 627 561 628 562 629 563 630 564 631 565 O 632 P 566 F 633 = 567 C 634 4 568 b 635 e 569 w 636 & 570 637 nt 571 pri 638 572 Figure5 TEEversusfluoroscopy,rightanterioroblique(RAO)cranialview.Transesophagealechocardiographicequivalentviewsof 639 573 theRAOcranialfluoroscopicviewaredemonstrated.TheRAOcranialviewcanbesimulatedon2DTEEbyobtainingashort-axisview 640 574 oftheLAA(typicallyabout45(cid:127))andthenrotatingtheimagecounterclockwise. 641 575 642 576 643 Theinferoposteriorpuncturepositionallowsthemostdirectroute and 3D transesophageal biplane imaging) can improve transseptal 577 644 totheanterolaterallylocatedLAA.Thisisincontrasttoothertrans- puncturesafetyandoverallproceduralsuccess.22 578 645 579 septal procedures suchas MitraClip (Abbott Vascular, Abbott Park, Using 2D and 3D TEE, assessment of the interatrial septum 646 580 IL) implantation and transcatheter mitral valve replacement, which firstincludesidentificationoftheposition,thickness,andmobility 647 581 require a superior and posterior transseptal puncture to ensure of the fossa ovalis. Subsequently, color Doppler imaging is used 648 582 adequateheightabovethemitralvalve. to assess for baseline patent foramen ovale or atrial septal defect 649 583 Two commonly used transseptal delivery catheters are the (ASD). 650 584 Mullins introducer (Medtronic, Minneapolis, MN), and the Usingbiplaneimagingoftheinteratrialseptum(anterior-posterior 651 585 652 Agilis steerable introducer (St. Jude Medical). The most inoneplane,superior-inferiorintheother)thetransseptalneedleis 586 653 commonly used transseptal needle is the Brockenbrough needle guidedtowardtheinferiorandposteriorportionofthefossaovalis. 587 654 (Medtronic), but a radiofrequency needle (Baylis Medical, After slight needle assembly advancement toward the left atrium, 588 655 Montreal, QC, Canada) can be helpful to cross thick, fibrotic, thetentingoftheinteratrialseptumidentifiesthelocationofthetrans- 589 656 590 or patched septa.21 Transseptal catheters and needles are de- septal needle on echocardiography (Figure 7, Video 1 available at 657 591 picted in Figure 6. http://www.onlinejase.com). It is of utmost importance to do the 658 592 Once the transseptal puncture of the procedure has been transseptalpunctureintheinferiorandposterioraspectoftheintera- 659 593 completed, the dilator and sheath are then advanced to avoid left trialseptum(Figure8). 660 594 atrial wall injury. Awire is subsequently passed into the left atrium Whenthe echocardiographer providesreal-timeTEEtoaninter- 661 595 and typically positioned in the left superior pulmonary vein; the ventionalist,itisusefultolabelsuperior,inferior,anterior,andposte- 662 596 663 dilatorandsheatharethenremoved. riorlocationsontheechocardiographicimage. 597 664 Aftertransseptalpuncturehasbeenperformed,3DTEEusing3D 598 665 zoom of the interatrial septum may be helpful to confirm that the 599 666 EchocardiographicGuidanceofTransseptalPuncture transseptalpuncturehasoccurredinafavorablelocation.Astep-by- 600 667 601 Although transseptal puncture can be performed with adequate stepapproachfortheproductionofhigh-qualityviewsoftheintera- 668 602 safetyusingacombinationofoperatortactilefeedbackandfluoros- trial septum by 3D TEE has been previously described using the 669 603 copy, echocardiography (2D TEE, intracardiac echocardiography, TUPLE(tiltup,thenleft)maneuver.23 670 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK 6 Vainribetal JournaloftheAmericanSocietyofEchocardiography -2017 671 738 672 739 673 740 674 741 675 742 676 743 677 744 678 745 679 746 680 747 681 748 682 749 683 750 684 751 685 752 686 753 687 754 688 755 689 756 690 757 691 758 692 759 693 760 694 761 695 762 696 763 697 764 698 765 699 766 700 767 701 768 702 769 703 770 704 771 705 772 O 706 P 773 707 F= 774 C 708 4 775 b 709 e 776 w 710 & 777 711 nt 778 712 pri 779 Figure6 Transseptaldevices.Commonlyuseddevicesfortransseptalpunctureworldwide. 713 780 714 781 715 782 716 Atrialseptalaneurysmandmarkedlipomatoushypertrophyof TheWatchmanprocedurebeginswithvenousaccessandtranssep- 783 717 the interatrial septum may present anatomic challenges to suc- tal puncture, as described previously. Subsequently, the Watchman 784 718 cessful transseptal puncture. The presence of a large atrial septal 12-Fr delivery system with a pigtail catheter is advanced into the 785 719 aneurysm should be communicated to the interventionalist, as leftatriumoverthewireandthenplacedintotheLAA.Next,iodin- 786 720 787 excessive advancement of the transseptal needle may lead to atedcontrastisinjectedintotheLAAtodefineitsanatomyonfluo- 721 788 perforation of the left atrial free wall. In the presence of lipoma- roscopy. TheWatchman device is then positioned and delivered in 722 789 tous hypertrophy, it is important to guide the transseptal punc- the LAA ostium. Finally, the device is released after stability and 723 790 ture through the thin central portion of the fossa ovalis rather optimalpositionare confirmedbybothechocardiographyandcine 724 791 725 than the hypertrophied limbs.24 fluoroscopy with intravenous contrast. An animated description of 792 726 the Watchman procedure can be viewed on YouTube: https:// 793 727 www.youtube.com/watch?v=8O2Hba-JQoQ&feature=youtu.be&list 794 728 =PL63i2jgsqsT_Jzpx5tTAI_rM56xo6JDUj. 795 WATCHMANPROCEDURE 729 OfallpercutaneousLAAoccluderdevices,theWatchmanhasthe 796 730 Overview mostoutcomesdata,whichhavedemonstrateditsnoninferiorityto 797 731 TheWatchmanisatransseptallydelivered,self-expandingnickeltita- chronicwarfarintherapyinarandomizedtrial.15Possibleprocedural 798 732 799 nium device with fixation barbs, covered by a permeable polyester complicationsincludepericardialeffusion(PEF),deviceembolization, 733 800 fabric. The device is delivered under fluoroscopic and echocardio- and procedure-related stroke.25 After device implantation, patients 734 801 735 graphic guidance and is available in five sizes (21, 24, 27, 30, and typically require warfarin therapy for 45days, followed by dual- 802 736 33mm) on the basis of the device diameter on its left atrial side antiplatelettherapy(withaspirinandclopidogrel)for6monthsand 803 737 (Figure9). thenaspirinaloneforlifetopreventclotformation.15 804 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK JournaloftheAmericanSocietyofEchocardiography Vainribetal 7 Volume-Number- 805 872 806 873 807 874 808 875 809 876 810 877 811 878 812 879 813 880 814 881 815 882 816 883 817 884 818 885 819 886 820 887 821 888 822 889 823 890 824 891 825 892 826 893 827 894 828 895 829 896 830 897 831 898 832 899 833 900 834 901 835 902 836 903 837 904 838 905 839 906 840 907 841 908 842 909 843 O 910 P 844 F 911 = 845 C 912 4 846 b 913 e 847 w 914 & 848 nt 915 849 pri 916 850 Figure 7 Transseptal puncture guidance by TEE: part 1. Two-dimensional TEE with biplane imaging demonstrates the interatrial 917 851 septuminthemidesophagealshort-axisandbicavalviewsduringthetransseptalpunctureportionofanLAAocclusion/exclusion 918 852 procedure(A,B).Notethetentingintheinferiorandposteriorportionofthefossaovalis,whichistheideallocationforpuncture. 919 853 Video1correspondsto(A)and(B).Three-dimensionalTEEoftheinteratrialseptumfromtherightatrialperspectiveatbaselinebefore 920 854 transseptalpuncture(C)andfollowingtransseptalpuncture(D).Thisviewdemonstratestheanatomiclocationofthefossaovalis 921 855 (whitedottedcircles)atbaseline(C)andcatheter-relateddropout(D).AV,Aorticvalve;IVC,inferiorvenacava;LA,leftatrium;RA, 922 856 rightatrium;SVC,superiorvenacava;TV,tricuspidvalve. 923 857 924 858 925 859 BaselineComprehensiveAssessment LAASizingSpecifictotheWatchman 926 860 AllpercutaneousLAAocclusion/exclusiondevicesrequirecompre- LAAlandingzonesizeandLAAdeptharemeasuredduringthebaseline 927 861 hensive baseline intraprocedural 2D and 3DTEE. This echocardio- proceduralassessmentfortheWatchmanprocedure.On2DTEE,the 928 862 graphicassessmentfocusesonestablishingthepresence orabsence LAAis imagedat 0(cid:127),45(cid:127), 90(cid:127),and135(cid:127) (Figure10). Measurements 929 863 930 ofanypreexistingintracardiacthrombus(whichwouldleadtopro- of the LAA are performed at these imaging angles to determine the 864 931 cedurecancellation),baselinedegreeofPEF,aswellasanatomicchar- maximal diameter of the anticipated landing zone and appendage 865 932 acteristicsoftheLAAandinteratrialseptum.Thesizeandpositionof depth. For the Watchman, the LAA landing zone is measured from 866 933 867 theLAAbodyandLAAorifice,thepresenceorabsenceofvalvular thetopofthemitralvalveannulusorcircumflexcoronaryarterytoa 934 868 abnormalities, mobile aortic atheroma (>4mm), and intracardiac point 2cm below the tip of the left upper pulmonary vein limbus. 935 869 shuntarealsoestablished. DepthismeasuredfromtheplaneoftheLAAorificetotheLAAapex. 936 870 937 871 938 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK 8 Vainribetal JournaloftheAmericanSocietyofEchocardiography -2017 939 1006 940 1007 941 1008 942 1009 943 1010 944 1011 945 1012 946 1013 947 1014 948 1015 949 1016 950 1017 951 O 1018 P 952 F 1019 = 953 C 1020 4 954 b 1021 e 955 w 1022 & 956 1023 nt 957 pri 1024 958 Figure8 TransseptalpunctureguidancebyTEE:part2.(A)Three-dimensionalTEEdemonstratingtheLAAinitsanatomicorientation 1025 959 andrelationshiptotheinteratrialseptum.(B)TheidealpathtotheLAAisdemonstrated,whichisfacilitatedbytransseptalpuncturein 1026 960 theinferiorandposteriorportionoftheinteratrialseptum.AV,Aorticvalve;PA,pulmonaryartery. 1027 961 1028 962 1029 963 1030 964 1031 965 1032 966 1033 967 1034 968 1035 969 1036 970 1037 971 1038 972 1039 O 973 P 1040 F 974 C= 1041 975 4 1042 b 976 we 1043 977 & 1044 978 print 1045 979 1046 Figure 9 Watchman device sizes. Chart demonstrating available Watchman device sizes (21-to 33-mm diameter), maximal LAA 980 1047 orificerangeforeachWatchmandevicesize,andcompressedWatchmandiametersafterimplantation. 981 1048 982 1049 Becauseofthetomographicnatureof2Dimaging,thereisadegree OtherPossibleExclusionCriteriafortheWatchman 983 1050 ofuncertaintythatthe2Dtransesophagealechocardiographicland- Device 984 1051 ing zone diameter measurements are done in the same plane. This 985 1052 limitation can be overcome using multiplanar reconstruction 3D Atrialseptalaneurysmexcursiondistance>15mm.Atrialseptal 986 1053 987 TEE. In multiplanar reconstruction mode, two long axes of the aneurysmmaybeconsideredanindicationforanticoagulation 1054 988 LAAarealignedtovisualizetheshort-axisplaneoftheLAA,allowing evenifLAAisexcluded. 1055 989 precisemeasurementofthelandingzonediameter(Figure11). Large interatrial shunt. This is a semiquantitative criterion; no 1056 990 Onceechocardiographicmeasurementshavebeenperformed,the specific definition for a large shunt on color Doppler or after 1057 991 largestLAAlandingzonediameterisselectedfordevicesizing.The agitatedsalineinjectionisgiven. 1058 992 device is typically oversized compared with the largest measured Mobileaorticplaque>4mminthickness. 1059 993 LAAdiameterby8%to20%. Significantmitralstenosis(mitralvalvearea<1.5cm2). 1060 994 PEFwiththickness>2mm. 1061 995 1062 996 LAAAnatomicExclusionCriteriafortheWatchmanDevice 1063 997 EchocardiographicGuidancefortheWatchman 1064 998 LAAorificediameterthatiseithertoosmall(<16.8mm)ortoo Procedure 1065 999 1066 large(>30.4mm). After transseptal puncture has been guided by fluoroscopy and 1000 1067 LAAdepththatistooshallow(LAAdepthlessthanlargestLAA echocardiography, the Watchman 12-Fr delivery system with a 1001 1068 orificediameter). pigtail catheter is advanced into the left atrium. The delivery sys- 1002 1069 1003 ThedepthofasecondaryLAAlobe(ifpresent)cannotbetoo tem is then guided into the left atrium with both fluoroscopic 1070 1004 close to the LAA orifice (must be >1cm away), which could and 2D or 3D transesophageal echocardiographic guidance. 1071 1005 leadtoanuncoveredportionoftheLAA. Three-dimensionalTEEhastheadvantageofallowingvisualization 1072 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK JournaloftheAmericanSocietyofEchocardiography Vainribetal 9 Volume-Number- 1073 1140 1074 1141 1075 1142 1076 1143 1077 1144 1078 1145 1079 1146 1080 1147 1081 1148 1082 1149 1083 1150 1084 1151 1085 1152 1086 1153 1087 1154 1088 1155 1089 1156 1090 1157 1091 1158 1092 1159 1093 1160 1094 1161 1095 1162 1096 1163 1097 1164 1098 O 1165 1099 FP 1166 1100 C= 1167 4 1101 b 1168 e 1102 w 1169 1103 & 1170 1104 print 1171 1105 Figure10 LAAsizingforWatchmandeviceon2DTEE.Two-dimensionalTEEdemonstratessizingfortheWatchmandevice.TheLAA 1172 1106 orificediameteranddeptharemeasuredat0(cid:127)(A),45(cid:127) (B),90(cid:127) (C),and135(cid:127)(D). 1173 1107 1174 1108 1175 1109 1176 1110 1177 1111 1178 1112 1179 1113 1180 1114 1181 1115 1182 1116 1183 1117 1184 1118 1185 1119 1186 1120 1187 1121 1188 1122 1189 1123 1190 1124 O 1191 1125 FP 1192 = 1126 C 1193 4 1127 b 1194 e 1128 w 1195 1129 & 1196 nt 1130 pri 1197 1131 Figure11 LAAsizingforWatchmandeviceon3DTEE.Three-dimensionalTEEmultiplanarreconstruction(MPR)demonstratingLAA 1198 1132 orificesizing.Usingasingle-beat3Dzoomcapture,theentireLAAandsurroundingstructuresareacquired.Using3DQsoftware 1199 1133 withinQLAB(PhilipsHealthcare,Amsterdam,theNetherlands),anMPRisobtained.Itisadvantageoustohavetheredandgreen 1200 1134 planeslocked,leavingtheblueplanefreeforadjustment.TheredandgreenplanesareorientedtowardtheLAAapex.Theblueplane 1201 1135 isthenorientedtowardtheplaneoftheLAAorifice,typicallyattheleveloftheleftcircumflexcoronaryartery(LCx).Thisallowscor- 1202 1136 respondingmeasurementstobeperformedinmultipleaxes.LUPV,Leftupperpulmonaryvein. 1203 1137 1204 1138 1205 1139 1206 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK 10 Vainribetal JournaloftheAmericanSocietyofEchocardiography -2017 1207 1274 1208 1275 1209 1276 1210 1277 1211 1278 1212 1279 1213 1280 1214 1281 1215 1282 1216 1283 1217 1284 1218 1285 1219 1286 1220 1287 1221 1288 1222 1289 1223 1290 1224 1291 1225 1292 1226 1293 1227 1294 1228 1295 1229 1296 1230 1297 1231 O 1298 1232 FP 1299 1233 C= 1300 4 1234 b 1301 e 1235 w 1302 1236 & 1303 1237 print 1304 1238 Figure12 Watchmandevicedeployment.Two-dimensionalTEEwithbiplaneimagingand3DTEEdemonstratingpartial(A,B)and 1305 1239 complete(C,D)deploymentoftheWatchmanLAAoccluderdevicewithintheLAA.Video2correspondsto(A)and(C),whileVideo3 1306 1240 correspondsto(B)and(D).LA,Leftatrium;LV,leftventricle;MV,mitralvalve. 1307 1241 1308 1242 1309 1243 1310 1244 1311 1245 1312 1246 1313 1247 1314 1248 1315 1249 1316 1250 1317 1251 O 1318 P 1252 F 1319 = C 1253 4 1320 1254 eb 1321 w 1255 1322 & 1256 nt 1323 1257 pri 1324 1258 Figure13 WatchmandevicePASSimplantationcriteria.BeforereleaseoftheWatchmanLAAoccluderdevice,thefourso-called 1325 1259 PASS criteria (position, anchor, size, and seal) must be met. (A) First, the Watchman device must be properly positioned within 1326 1260 theLAAorifice(i.e.,nottilted).(B)Second,thedevicecannotdemonstrateexcessivemotiononthe‘‘tugtest’’(thedeviceispulled 1327 1261 backwardwhilestillattachedtothethreadedinsertandvisualizedusingfluoroscopyandechocardiography).Video4correspondsto 1328 1262 (B).(C)Third,compressionmeasurementsareperformedat0(cid:127),45(cid:127),90(cid:127),and135(cid:127).Alineisdrawnfromshouldertoshoulderwiththe 1329 1263 threadedinsertinview(thisislocatedatthecenterofthedevice)toensurethatthedeviceismeasuredatthelocationofitsmaximal 1330 1264 width.(D)Finally,aPDLof<5mmisconsideredanadequatesealbetweenthedeviceandtheLAA.IfanyofthePASScriteriaarenot 1331 1265 met,theWatchmandevicecanberecapturedandthenrepositioned,oranewdevicesizemaybeselected. 1332 1266 1333 1267 oftheentirelengthsofcathetersastheytraversetheleftatriumto After the guide catheter is advanced toward the LAA orifice, a 1334 1268 reachtheLAA. pigtailcatheteristhreadedthroughtheguidecatheter,andcontrast 1335 1269 1336 Italsoprovidesclearimagingofthedistancebetweenthetipofthe angiographyisperformedtofluoroscopicallyevaluatetheLAA.On 1270 1337 guidecatheterintheleftatriumrelativetotheatrialseptumtopreventacci- 2D and 3D echocardiography, this produces copious amounts of 1271 1338 dentaltransseptalpuncturesitedecannulationbackintotherightatrium. bubblesthatobscureimaging. 1272 1339 1273 1340 REV5.5.0DTD YMJE3902_proof 28October2017 12:28pm ceJK
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