Combined MitraClip implantation and left atrial appendage occlusion using the Watchman device : a case series from a referral center

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www.revportcardiol.org

Revista

Portuguesa

de

Cardiologia

Portuguese

Journal

of

Cardiology

ORIGINAL

ARTICLE

Combined

MitraClip

implantation

and

left

atrial

appendage

occlusion

using

the

Watchman

device:

A

case

series

from

a

referral

center

Ana

Rita

G. Francisco

a,∗

,

Eduardo

Infante

de

Oliveira

a

,

Miguel

Nobre

Menezes

a

,

Pedro

Carrilho

Ferreira

a

_,

_Pedro

_Canas

_da

_Silva

a

_,

_Ângelo

_Nobre

b

_,

_Fausto

_J.

_Pinto

a

a_Cardiology_Department,_Santa_Maria_University_Hospital,_CHLN,_CAML,_CCUL,_Faculty_of_Medicine,_University_of_Lisbon,_Lisbon,

Portugal

b_{Cardiothoracic}_Surgery_Department,_Santa_Maria_University_Hospital,_CHLN,_CAML,_CCUL,_Faculty_of_Medicine,_University_of

Lisbon,Portugal

Received2August2016;accepted11November2016 Availableonline30June2017

KEYWORDS Mitralregurgitation; MitraClip;

Leftatrialappendage occlusion;

Watchman

Abstract

Introduction:Patientsreferredfor percutaneoustranscathetermitralvalverepairusing the MitraClip® systemfrequentlyhaveatrialﬁbrillation,whichimposesadditionalchallengesdue totheneedfororalanticoagulation.Leftatrialappendageocclusioniscurrentlyregardedasa non-inferioralternativetoanticoagulationinpatientswithnon-valvularatrialﬁbrillationand bothhighthromboembolicandbleedingrisk.ConsideringthatbothMitraClipimplantationand leftatrialappendageocclusionarepercutaneoustechniquesthatrequiretransseptalpuncture, itistechnicallyattractivetoconsidertheirconcomitantuse.

Objectives:WeaimtoevaluatethefeasibilityofacombinedapproachwithMitraClip implan-tationandleftatrialappendageocclusioninasingleprocedure.

Methods:Wereporttheﬁrstcaseseriesregardingthisissue,discussingthespeciﬁcadvantages, pitfallsandtechnicalaspectsofcombiningthesetwoprocedures.

Results:FivepatientsunderwentleftatrialappendageocclusionwiththeWatchman® device followedbyMitraClipimplantationinthesameprocedure.Allpatientsexperiencedsigniﬁcant reductioninmitralvalveregurgitationofatleasttwogrades,optimaloccluderposition,no associatedcomplicationsandsigniﬁcantclinicalimprovementassessedbyNYHAfunctionalclass (reductionofatleastonefunctionalclass,withfourpatientsinclassIatone-monthfollow-up).

∗_{Corresponding}_author.

E-mailaddress:ana.r.francisco@gmail.com(A.R.G.Francisco).

http://dx.doi.org/10.1016/j.repc.2016.11.012

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Conclusion:In selectedpatientsrejectedforsurgicalmitralvalverepair,withatrial ﬁbrilla-tionandincreasedriskofbleedingandembolicevents,acombinedapproachwithMitraClip implantationandleft atrialappendageocclusioninasingleprocedureisfeasible, safe and effective.

PALAVRAS-CHAVE Regurgitac¸ãomitral;

MitraClip;

Encerramentodo apêndiceauricular esquerdo;

Watchman

Implantac¸ãosimultâneadeMitraClipeencerramentodoapêndiceauricular esquerdocomWatchman:aexperiênciadeumcentrodereferência

Resumo

Introdução: Osdoentesreferenciadosparareparaçãomitralpercutânea,usandoosistema Mitr-aClip,têmfrequentementefibrilhaçãoauricular,comdesafiosadicionaisdevidoànecessidade deanticoagulação.Oencerramentopercutâneodoapêndiceauricularesquerdoé,atualmente, umaalternativanãoinferioràanticoagulaçãoemdoentescomfibrilhaçãoauricularnãovalvular, comelevadoriscoquertromboembólicoquerhemorrágico.Considerandoqueestasduas técni-cas(MitraClipeencerramentopercutâneodoapêndiceauricularesquerdo)requerempunção transeptal,étecnicamenteatrativoconsideraroseuusoconcomitante.

Objectivos: Avaliaraexequibilidadedeefectuarnomesmoprocedimentoimplantac¸ãode Mitr-aClipeencerramentopercutâneodoapêndiceauricularesquerdo.

Métodos: Descriçãodaprimeirasériedecasossobreaaplicaçãodestasduastécnicasnumsó procedimento,comanálisedasvantagens,dificuldadeseaspetostécnicos.

Resultados: Cincodoentesforamsubmetidosaencerramentopercutâneodoapêndiceauricular esquerdocomdispositivoWatchman,seguidodeimplantaçãodeMitraClipnomesmo proced-imento.Emtodososdoentesverificou-sereduçãosignificativadograudaregurgitaçãomitral empelomenosdoisgraus,posiçãoótimadosistemadeoclusãodoapêndice,semcomplicações associadasecommelhoriaclínicasignificativaavaliadapelaclassefuncionaldeNYHA(redução de pelomenos umaclassefuncional, comquatro doentes em classefuncionalInofinaldo primeiromêsdeseguimento).

Conclusão:Em doentesselecionados,recusadosparareparaçãocirúrgicadavalvularmitral, comfibrilhaçãoauriculareriscoelevadodeeventoshemorrágicoseembólicos,umaabordagem combinadacomimplantaçãodeMitraClipeencerramentopercutâneodoapêndiceauricular esquerdonumsóprocedimentoéviável,seguraeeficaz.

ACC AmericanCollegeofCardiology AF atrialﬁbrillation

AHA AmericanHeartAssociation ESC EuropeanSocietyofCardiology

KDOQI KidneyDiseaseOutcomesQualityInitiative LAA leftatrialappendage

LSPV leftsuperiorpulmonaryvein LVEF leftventricularejectionfraction MR mitralregurgitation

MVR mitralvalverepair

NYHA NewYorkHeartAssociation OAC oralanticoagulation

TEE transesophagealechocardiography

Introduction

Percutaneoustranscathetermitralvalverepair(MVR)using the MitraClip® system is an emerging approach to treat selectedcasesofdegenerativeandfunctionalmitral regur-gitation(MR).Itssafetyandefﬁcacyinhighrisk-patientshas been consistentlydemonstrated,bothinclinicaltrialsand in real-world settings.1---3 _The _procedure _has _been

recom-mendedbytheEuropeanSocietyofCardiology(ESC)andthe European Association for Cardio-Thoracic Surgery (EACTS) since 2012 for patients with both primary and secondary severeMR athighsurgicalrisk(classIIb,levelofevidence C).4_Following_approval_by_the_US_Food_and_Drug

Administra-tion(FDA)in2013,theMitraClipwasalsorecommendedin the 2014 AmericanCollege of Cardiology (ACC)/American Heart Association (AHA) guidelines for degenerative MR (classIIb,levelofevidenceB).5

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Patientsreferred for MitraClip implantation frequently have concomitant atrial ﬁbrillation (AF). These patients present highsurgicalriskduetotheassociationofvarious comorbidities, as well asa frailty proﬁle that represents increased risk of thromboembolic and bleeding events. Thesecharacteristicsposeadditionalchallengesduetothe needforchronicoralanticoagulation(OAC).

Left atrial appendage (LAA) occlusion, either percuta-neouslyorsurgically,iscurrentlyregardedasanalternative to OACin patients withnon-valvular AF.6 _Similarly _to_the

MitraClip, this wasasa resultof twotrials7,8 _and _several

registries.9---12 _The _ESC_guidelines_issued _a_class_IIb

recom-mendationregardingthisprocedure,13 _and_it_obtained_FDA

approvalin2015.

ThefrequentassociationofMRandAFhasoftenled sur-geonstoexcisetheLAAduringheartsurgery.14_Considering

thatbothMitraClipimplantationandLAAocclusionare per-cutaneoustechniquesthatrequiretransseptalpunctureand accesstotheleftatrium,itistechnicallyattractiveto con-sideremulatingthesurgicalapproachpercutaneously.With theexceptionoftwosinglecasereports,therearenoother publisheddataregardingthefeasibility,safetyandefﬁcacy ofacombinedprocedure.15,16 _In_this_article,_we_report_the

ﬁrst case series regarding this issue, discussing the spe-ciﬁcadvantages,pitfallsandtechnicalaspectsofcombining thesetwoprocedures.

Methods

Weperformedaretrospectivesingle-centerstudyof consec-utivepatientswithsevereMRandAFundergoingMitraClip deviceimplantationplusLAAocclusionwiththeWatchman® device.Baselineclinical,echocardiographic,hemodynamic andproceduraldatawererecordedretrospectivelythrough reviewsofhospitalrecords.Echocardiographic assessment was repeated after the procedure, on the same day and atone-monthfollow-up.Acuteandone-monthresultswere analyzed.

Results

Fivepatients withsevere MR andAF rejectedfor surgical MVR were referred for percutaneous MVR. After assess-mentbytheinterventionalcardiologyteam,theywerealso selectedforLAAocclusiononthebasisofhigh thromboem-bolicrisk combinedwithhighbleedingrisk.Table1shows thebaselinepatientcharacteristics.

Patient1 wasa 57-year-oldmanwithalcoholicdilated cardiomyopathy, severely compromised left ventricular ejectionfraction(LVEF)andseverefunctionalMR.Cardiac resynchronization therapy and atrioventricularnode abla-tion had already been performed. Concomitantly he had permanent AF,liver cirrhosis (Child-Pugh classB)without esophageal varices (with continued alcohol abuse), pre-vious ischemic stroke under OAC, chronic renal disease (KidneyDisease OutcomesQualityInitiative [KDOQI]stage 3b),pulmonaryandsystemichypertension,dyslipidemiaand previousresectionofcoloncancer.

Patient2 wasa 72-year-oldmanwithischemic dilated cardiomyopathyandmoderatelydepressedLVEF,witha car-diacdeﬁbrillatorsystem implantedforprimaryprevention

andseverefunctionalMRwithepisodesofﬂashedema.He hadpreviouslyundergonetriplecoronaryarterybypassgraft surgery.OthercomorbiditieswerepermanentAF,pulmonary andsystemichypertension,dyslipidemia,chronickidney dis-ease(KDOQIstage3a),chronicirondeﬁciencyanemiawith intestinalangiodysplasiaandprevioussmoking.

Patient 3 wasa 76-year-old woman withnon-ischemic dilatedcardiomyopathy,severelydepressedLVEFandsevere functional MR,who hadalready undergone cardiac resyn-chronizationtherapy.ShealsohadpermanentAFwithlabile INR under warfarin (TTR <60%), pulmonary and systemic hypertension,dyslipidemiaandchronickidney dysfunction (KDOQI stage 3a), and chronic use of non-steroidal anti-inﬂammatorydrugsduetoosteoarticulardisease.

Patient 4 was a 78-year-old man with non-ischemic dilatedcardiomyopathy,severelydepressedLVEFandsevere functionalMR.Concomitantcomorbiditieswerepermanent AFwithlabileINRunderwarfarin(TTR<60%),pulmonaryand systemichypertension, chronickidney dysfunction (KDOQI stage3b)anddyslipidemia.

Patient 5was a71-year-old manwithischemic dilated cardiomyopathy, severely depressed LVEF and severe functional MR. Concomitant comorbidities were previous ischemic stroke, permanent AF, systemic hypertension, chronic kidneydysfunction (KDOQIstage3a) and dyslipid-emia.

Overall,thepatientshadsigniﬁcantcomorbidities,LVEF <35% and severe functional MR, and were severely symp-tomatic(NYHAclassIIIorIV).Theyhadahighriskofboth thromboembolicandbleedingevents,withmean CHA2DS2-VAScscoreof4.5±0.6andmeanHAS-BLEDscoreof3.5±0.6. ThemeanannualstokeriskpredictedbyCHA2DS2-VAScwas 6.0±1.4%,withahigherannualriskofmajorbleedingevents predictedbyHAS-BLED(6.2±2.9%).

Proceduraldetails

The procedure was performed under general anes-thesia in the cardiac catheterization laboratory, with three-dimensionaltransesophagealechocardiography(TEE) guidance for MitraClip deployment and ﬂuoroscopic guid-ance. In all cases LAA occlusion was performed ﬁrst. ProceduraldetailsaredisplayedinTable2.

Vascularaccess

By protocol, right radial arterial access (4F sheath) was establishedforinvasiveblood pressuremonitoring, except foronecaseinwhichaccesswasviatherightfemoralartery (4Fsheath)duetoinabilitytoobtainradialaccess.Venous accesswasviatherightfemoralvein(6Fsheath)inallcases. Afterestablishmentofarterialandvenousaccess,an intra-venousunfractionatedheparinboluswasadministered(50% ofthetotalrecommendeddose---100U/kg).

Transseptalpuncture

Transseptal puncture, guided by TEE, was performed through an 8F SL1 sheath (St. Jude Medical) with a BRK transseptal needle (St. Jude Medical). The puncture was

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Table1 Baselinepatientcharacteristics.

Patient1 Patient2 Patient3 Patient4 Patient5

Age,years 57 72 76 78 71

Gender Male Male Female Female Male

AFclassiﬁcation Permanent Permanent Permanent Permanent Permanent

LVEF,% 24 35 20 30 23

NYHAclass III/IV III/IV III/IV II/IV III/IV

Cardiomyopathyetiology Alcoholic

dilated Ischemic dilated Non-ischemic dilated Non-ischemic dilated Ischemic dilated Comorbidities

Hypertension Yes Yes Yes Yes Yes

Pulmonaryhypertension Yes Yes Yes Yes Yes

Diabetes No Yes No No No

Previousstroke Yes No No No Yes

Renaldisease,KDOQIstage 3b 3a 3a 3b 3a

Previousopenheartsurgery No Yes No No Yes

Chronicliverdisease Yes No No No No

Chronicanemia No Yes No No No

Malignancy Yes No No No No

CHADS2score 4 3 3 3 4

Annualstrokerisk,%15 _8.5 _5.9 _5.9 _5.9 _8.5

CHA2DS2-VAScscore 4 5 5 4 6

Annualstrokerisk,%17 ₄ _6.7 _6.7 ₄ _9.7

PreviousemboliceventunderOAC Yes No No No Yes

HAS-BLEDscore 4 3 3 3 3

Annualbleedingrisk,%18 _8.9 _5.8 _5.8 _5.8 _5.8

Age>65years No Yes Yes Yes Yes

Previousstroke Yes No No No Yes

Priorbleedingorpredisposition No Yes No No No

Renaldysfunction(Cr>2.36mg/dl) Yes No No Yes No

Liverdysfunction(cirrhosis) Yes No No No No

LabileINR(TTR<60%) No No Yes Yes No

Drugspredisposingtobleeding Yes No No No Yes

Alcoholabuse Yes No No No No

PreviousbleedingeventunderOAC No No No No No

AF:atrialﬁbrillation;Cr:serumcreatinine;INR:internationalnormalizedratio;KDOQI:KidneyDiseaseOutcomesQualityInitiative;LVEF: leftventricularejectionfraction;NYHA:NewYorkHeartAssociation;OAC:oralanticoagulation;TTR:timeintherapeuticrange.

performed aiming for the optimal position for MitraClip implantation.

The remainingdose ofintravenous unfractionated hep-arinwasthenadministeredandanactivatedclotting time of250-300swasmaintainedthroughouttheprocedure.

Once access to the left atrium was achieved, an Amplatzer stiff wire was advanced into the left superior pulmonaryvein(LSPV).

Leftatrialappendageocclusion

For LAA occlusion, a Watchman 14F double curve access sheathwasusedfollowedby angiographyof theLAAwith apigtailcatheter.TheLAAclosuredevicesizewasselected afterassessing the following LAAfeatures byTEE: ostium sizeandshape,andnumberoflobesandlengthinatleast fourTEEviews(0◦_,₄₅◦_,₉₀◦_and₁₃₅◦_)._These_measurements werecomplementedbyangiographyoftheLAA.Thedevice

was implanted under angiographicand echocardiographic (TEE)guidanceusingthestandardtechnique.Criteriaof suc-cesswereachievedinallﬁvepatients.Onlyonedeviceper patient was used,with appropriatestability, compression andsealing.Noresidualleaksorimmediatecomplications werenoted.

MitraClipprocedure

TheWatchman14Fdoublecurvesheathwasexchangedfor a24FMitraClipGuideCatheter,overanAmplatzersupport wirepositionedintheLSPV.Astandardtechniquewasused, underangiographicandTEEguidance.

TheprocedurestepsaresummarizedinFigure1. Threepatients received only oneclip, while the other tworequiredtwoandthreeclips,respectively.Allpatients showedsigniﬁcantimprovementinMR,threeofthemwith residual grade I/IV regurgitation and the other two with

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Table2 Proceduraldetails.

Proceduretime, min 194 67 76 75 81 Fluoroscopytime, min 21.7 20.4 15.9 27.7 16.4 Radiationdose, ␮Gy/cm2 18.8 14.3 5.9 14.6 10.2

Arterialaccess Rightfemoral,4F Rightradial,4F Rightradial,4F Rightradial,4F Rightradial,4F Venousaccess Rightfemoral Rightfemoral Rightfemoral Rightfemoral Rightfemoral MitraClipimplantation

Numberof

devices

3 1 2 1 1

MR

Etiology Functional Functional Functional Functional Functional

Pre-procedure grade

III/IV IV/IV IV/IV III/IV III/IV

Post-procedure grade

I-II/IV II/IV I/IV I/IV I/IV

Mean post-procedure gradient,mmHg

2.0 3.8 2.8 2.0 2.2

LAAocclusion(Watchmandevice)

Sizeof implanted device(mm) 27 27 30 27 27 Numberof devices 1 1 1 1 1 Compression rate,% 15 11 26 13 18 Residualleak No No No No No

Success Yes Yes Yes Yes Yes

Antithrombotic therapy

Warfarin Dabigatran Warfarin Warfarin Dabigatran

Complications No No No No No

LAA:leftatrialappendage;MR:mitralregurgitation.

gradeII/IV.Thisgoalwasachievedwithoutsigniﬁcant steno-sis,meanﬁnaltransvalvulargradientbeing2.7±0.9mmHg. Nocomplicationsoccurred.Ofnote,therewasno interfer-ence of theMitraClip delivery system withthe implanted Watchmandevice.

Hemostasis

In allpatients,thePerclose Proglidesuture-mediated clo-sure system (Abbott Vascular) was used for hemostasis of the femoral vein access site (two systems were pre-deployed, before insertion of the transseptal puncture sheath). Hemostasis of the arterial access site was per-formedbymanualcompression.

Follow-up

All patients were discharged 24-36 hours after the pro-cedure. They started anticoagulation with warfarin or

non-vitaminKantagonistoralanticoagulants,accordingto thechoiceoftheattendingcardiologist,withlater transi-tiontoantiplatelettherapy afterTEEfollow-up(PROTECT AFstrategy).10

Patientsunderwentclinicalandechocardiographic(TEE) follow-up one month after the procedure. Results were excellentinallpatients,withclinicalsymptomatic improve-ment(NYHAclassI-II/IV),signiﬁcantMRreduction(without signiﬁcant stenosis), optimaloccluder position,no throm-busandnoclinicalevents. The interatrialseptum showed asmall,nothemodynamicallyrelevant,left-to-rightshunt. DetailsareshowninTable3.Inameanclinicalfollow-upof 243±70.7days, the symptomatic improvement was main-tained,withoutadverseevents.

Discussion

and

limitations

In thiscase series, we demonstrate thesafety and effec-tivenessofcombiningpercutaneousMVRusingtheMitraClip

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Figure1 Proceduresteps:(1)transseptalpunctureguidedbytransesophagealechocardiography(TEE)(1a)andfluoroscopy(1b); (2)theWatchman14FdoublecurvesheathisadvancedoveranAmplatzerstiffwirepositionedintheleftsuperiorpulmonaryvein; (3)theleftatrialappendageismeasuredbyangiography(3a)andTEE(3b);(4)theWatchmanisimplantedguidedbyfluoroscopy (4a)andgoodappositionandabsenceofleaksandcomplicationsareconfirmedbyTEE(4b);(5)theWatchman14Fdoublecurve sheathisexchangedfora24FMitraClipguidecatheter,overanAmplatzersupportwire;(6)theclipdeliverysystemisdirected tothemidscallopsoftheanteriorandposteriormitralvalveleaflets,andguidedbythree-dimensionalTEE,theclipispositioned abovetheoriginofthemitralregurgitation(MR)jet;(7)leafletinsertion,MRreduction,andabsenceofsignificantmitralvalve stenosisareconfirmedbyTEE(7aand7b);(8)additionalclipsaredeployedifnecessary.

Table3 Resultsatone-monthfollow-up.

NYHAclass I/IV II/IV I/IV I/IV I/IV

Embolicevents No No No No No

Bleedingevents No No No No No

Mitralvalve

MRgrade I/IV II/IV I/IV I/IV II/IV

Meangradient,mmHg 1.0 4.6 1.7 1.6 2.1

LAAocclusion---Watchmandevice

Leaks No No No No No

Thrombus No No No No No

LAA:leftatrialappendage;MR:mitralregurgitation;NYHA:NewYorkHeartAssociation.

device and LAA occlusion with the Watchman device. It is shouldbe noted thatthis approachproduced excellent immediateand short-termresults despite the severe car-diac and non-cardiac comorbidities of this cohort. These

resultsareinagreementwiththefewpublishedsinglecase reports.15,16

SurgeonshavelongperformedthecombinationofMVR, mazeoperationandLAAexclusioninpatientswithMRand

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AF,andLAAocclusionisrecommendedinpatientswithAF whoundergoheartsurgery.13_The_LAA_is_easily_accessible_to

thesurgeon,theocclusionprocedureisreasonablysafeand itisbelievedtodecreaseembolicriskeveninthepresence of valvularAF.However,variability in surgical approaches meansthatremnantsoftheLAAareoftenleftbehind,which mightexplainthepoorlong-termresultsofthisapproach.14

DuringMitraClipimplantation,theLAAisalsoeasily acces-sible to the interventional cardiologist and the etiology of AF is non-rheumatic. In summary, the patient is anes-thetized,thetransseptalpuncturehasbeenperformedand theLAAis easily accessibletocathetertreatment. Percu-taneousLAAocclusionhasasolidscientiﬁcbasisandgood long-termresultsregardingbothsafetyandefﬁcacy. There-fore, combining MitraClip implantation and percutaneous LAAocclusionseemsatleastasappealingascombining sur-gicalMVRandLAAexcision.

Fromaclinicalstandpoint,patientsreferredforMitraClip implantation frequentlypresent a proﬁle suitablefor LAA occlusion(AF withhighthromboembolicand bleedingrisk duetothecomorbiditiesthatexcludedthemfromsurgical MVR).Exposingthesepatients totwoseparateprocedures wouldpresent severaldisadvantages.Itis wellrecognized that transseptal puncture carries a small but important risk of signiﬁcant complications.19 _Furthermore, _the _use

of large sheaths in two different locations may increase the risk of signiﬁcant residual septal shunting. A single procedure involves a single transseptalpuncture, thereby minimizing bothrisks.Also,both proceduresrequirelarge sheaths placed in femoral veins. Combining the two pro-cedures streamlines vascular access and reduces the risk of complications.Finally, overall ﬂuoroscopytimemaybe reducedcomparedtotwoindividualprocedures,duetothe commoninitialpathwayofbothtechniques.

Our results seem to conﬁrm these advantages, as there were nocomplications regarding any of the above-mentioned issuesandtotalﬂuoroscopytimeandradiation dosageswereacceptable.

Ontheotherhand,theoreticallytherearepotential dis-advantages. First, the high transseptal puncture for the MitraClip is less well suited for LAA occlusion. Second, overall procedure time maybe prolonged, withan added risk ofvolume overloador hemodynamic instability, espe-cially considering theseverely depressedsystolicfunction of many ofthese patients.We experienced nodifﬁculties witheitherissue, andoverallprocedure timewas accept-able(103.0±60.8min). Nonetheless,acknowledgingthese pitfallsisessentialforavoidingcomplications.

Anotheraspect ofthe technique thatis the subjectof debate is the appropriatesequence of procedures in this combined approach. Our team decided to perform LAA occlusionbeforeMitraClipimplantationbasedonthe ratio-naleofusingsheathswithsequentiallyincreasingdiameters. We consideredthat thisstrategy wouldreduce therisk of bleedingattheaccesssiteandwouldimposelesstraumaon theatrialseptum.Reversingtheorderoftheproceduresmay havetheadvantageofeliminatingtheriskofinterferenceof theMitraClipdeliverysystemwiththeimplantedWatchman device.However,wefoundthatthepresenceofthe Watch-mandeviceservedasausefulanatomicalreferenceduring manipulation ofthe MitraClipdelivery system. Performing theMitraClipimplantationﬁrstwouldrequireanexchange

for a shorter sheath compatible with the 14F Watchman delivery sheath, to avoid massive bleeding at the access site.Alternatively,the24Fcouldbeexchangeddirectlyfor the 14F usingthe pre-deployed Perclose Proglide systems toclosetheoriﬁcearoundthesheath.This approachmay compromiseﬁnalaccessocclusionsuccess.

Conclusion

InselectedpatientsathighriskforMRsurgerywho concomi-tantlypresentAFandanincreasedriskofbothbleedingand embolic events, a combined approachwith MitraClip and WatchmanOccluder implantation in a single procedure is feasible,safeandeffective,inboth immediateand short-termfollow-up,whenundertakenbyanexperiencedteam.

Ethical

disclosures

Protection of human and animal subjects.The authors declarethatnoexperimentswereperformedonhumansor animalsforthisstudy.

Conﬁdentialityofdata.Theauthorsdeclarethattheyhave followedtheprotocolsoftheirworkcenteronthe publica-tionofpatientdata.

Righttoprivacyandinformed consent.Theauthorshave obtained thewritten informedconsentof the patients or subjectsmentionedinthearticle.Thecorrespondingauthor isinpossessionofthisdocument.

Funding

Nospeciﬁcfundinggrantswereusedregardingthisstudy.

Conﬂicts

of

interest

AnaRitaG.Franciscohasnoconflictsofinteresttodeclare; Eduardo Infante deOliveira has receivedspeaker/proctor honoraria and research grants from Boston Scientific and speaker honoraria from Abbott Vascular; Miguel Nobre Menezeshasnoconflictsofinteresttodeclare;Pedro Car-rilhoFerreirahasreceivedspeakerhonorariaandresearch grants from Boston Scientific; Pedro Canas da Silva has receivedspeakerhonorariaandresearchgrantsfromBoston ScientificandAbbottVascular.

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