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REVIEW
Tricuspid
valve
and
percutaneous
approach:
No
longer
the
forgotten
valve!
Valve
tricuspide
et
traitements
percutanés
:
décidément
plus
la
valve
oubliée
!
Claire
Bouleti
a,b,c,∗,
Jean-Michel
Juliard
a,c,d,
Dominique
Himbert
a,c,d,
Bernard
Iung
a,b,c,d,
Eric
Brochet
a,c,
Marina
Urena
a,c,
Marie-Pierre
Dilly
e,
Phalla
Ou
b,d,f,
Patrick
Nataf
b,d,g,
Alec
Vahanian
a,b,c,daDepartmentofCardiology,AP—HP,BichatHospital,Paris,France bFacultédeMédecine,Paris-DiderotUniversity,Paris,France cDHUFire,Paris-DiderotUniversity,Paris,France
dInsermU-1148,BichatHospital,Paris,France
eDepartmentofAnaesthesiology,AP—HP,BichatHospital,Paris,France fDepartmentofRadiology,AP—HP,BichatHospital,Paris,France gDepartmentofCardiacSurgery,AP—HP,BichatHospital,Paris,France
Received28July2015;accepted3August2015 Availableonline12November2015
KEYWORDS Tricuspidvalve; Heartvalve prosthesis implantation; Valvularheart diseases; Transcathetervalve implantation
Summary Tricuspidvalvediseaseismainlyrepresentedbytricuspidregurgitation(TR),which isapredictorofpooroutcome.TRisusuallysecondary,causedbyrightventriclepressureor volumeoverload,theleadingcausebeingleft-sidedheartvalvediseases.Tricuspidsurgeryfor severeTRisrecommendedduringleftvalvesurgery,andconsistsofeitheravalvereplacement or,mostoften,atricuspidrepairwithorwithoutprostheticannuloplasty.WhenTRpersistsor worsensafterleftvalvularsurgery,redoisolatedtricuspidsurgeryisassociatedwithhigh mortal-ity.Inaddition,asizeableproportionofpatientspresentwithtricuspidsurgerydeterioration over time,andneeda reintervention, which isassociated withhigh morbi-mortality rates. In thiscontext,andgiventherecentmajorbreakthroughinthepercutaneoustreatment of aorticandmitralvalvediseases,thetricuspidvalveappearsanappealingchallenge,althoughit
Abbreviations:BP,bioprosthesis;CT,computedtomography;IVC,inferiorvenacava;NYHA,NewYorkHeartAssociation;RA,ring annulo-plasty;RVP,rapidventricularpacing;TEE,transoesophagealechocardiography;THV,transcatheterheartvalve;TR,tricuspidregurgitation.
∗Correspondingauthor.DepartmentofCardiology,BichatHospital,46,rueHenri-Huchard,75018Paris,France.
E-mailaddress:claire.bouleti@gmail.com(C.Bouleti). http://dx.doi.org/10.1016/j.acvd.2015.08.002
raisesspecificissues.Thefirstapplicationsoftranscathetertechniquesfortricuspidvalve dis-easewerevalve-in-valveandvalve-in-ringimplantationfordegeneratedbioprosthesisorring annuloplasty.Someconcernsremainregardingprosthesissizing, rapidventricularpacingand thebestapproach,buttheseproceduresappeartobesafeandeffective.Morerecently, bicus-pidizationusingatranscatheterapproachforthetreatmentofnativetricuspidvalvehasbeen published,intwopatients.Finally,otherdevicesareinpreclinicaldevelopment.
©2015ElsevierMassonSAS.Allrightsreserved.
MOTSCLÉS Valvetricuspide; Implantationde prothèsevalvulaire; Valvulopathies; Implantation valvulairepercutanée
Résumé Lapathologietricuspideestleplussouventuneinsuffisancetricuspide(IT),quiest unfacteurdemauvaispronostic.L’ITestengénéralsecondaireàunesurchargedepressionou devolumeduventriculedroit,lapremièrecauseenétantunevalvulopathiegauche.Durant unechirurgievalvulairegauche,lacorrectiond’uneITsévèreestrecommandéeetconsiste enunremplacementvalvulairetricuspideouenuneplastie tricuspideavec ousansanneau prothétique.Sil’ITpersisteaprèsuneopérationducœurgauche,unechirurgiereduxdédiée estgrevée d’unelourdemortalité. Parailleurs, uneproportionnonnégligeable depatients présententunedétériorationdeleurchirurgietricuspideaucoursdutempsetrequièrentune réintervention,associéeàunemorbi-mortalitéélevée.Auvudesrécentesavancéesdes tech-niquespercutanéesconcernantlesvalvesaortiquesetmitrales, lavalvetricuspideapparaît commeunchallengedéfimajeur,malgrédesobstaclespropres.Lespremièresapplicationsont étélestechniquespercutanéesde«valve-in-valve »etde«valve-in-ring»pourles dégénéres-cencesdebioprothèseetd’anneautricuspides.Mêmesidesquestionspersistentconcernant l’évaluationoptimaledelatailledeprothèseàimplanter,lastimulationventriculairerapideou l’approchelaplusappropriée,cesprocéduresapparaissentsûresetefficaces.Plusrécemment, labicuspidisationpercutanéeaétépubliéechez 2 patients pourletraitementd’uneITsur valvenative.Enfin,d’autresprocédéssontendéveloppementaustadepréclinique.
©2015ElsevierMassonSAS.Tousdroitsréservés.
Background
Dysfunction of a native or previously operated tricus-pid valve encompasses a variety of situations, which are frequentlysourcesofdifficultyinpatientmanagement. Tri-cuspid disease is most often tricuspid regurgitation (TR), whichismainlysecondarytoleft-sidedheartvalvedisease [1].Tricuspidvalvediseasehaslongbeenignored,withthe beliefthat TR would improve after surgical correction of leftvalvedisease.Alargebodyofevidencenowsupportsthe negativeeffectofsignificantTR,andthisrecognitionhasled tomorefrequentindicationsforcombinedtricuspidsurgery, withtheinherentriskofsubsequentdysfunctionoftricuspid repairorreplacement[2,3].Whatevertheclinicalcontext, redo tricuspidvalve surgery is often associated withhigh morbi-mortalityrates.Followingtherecentdevelopmentof transcathetertherapiesforaorticandmitralvalvediseases, thepossibilityof lower-risktricuspidvalveintervention is thereforeparticularlyattractive.
This review presents current status and perspectives regarding transcatheter therapies for tricuspid valve dis-ease,bothforbioprosthesisorringannuloplastyfailureand fornativevalves.
Rationale
for
percutaneous
treatment
of
tricuspid
valve
disease
Native tricuspid valve disease can be either stenotic or regurgitant. The extremely rare stenotic lesions, caused mainlybyrheumaticfeverorcarcinoidsyndrome,willnotbe addressedinthispaper.Themostcommondiseaseofthe tri-cuspidvalveisregurgitation,whichismoreoftensecondary ratherthan causedby aprimary valvelesion, particularly inWesterncountries[1].SecondaryTRiscausedbyannular dilatationandincreasedtricuspidleaflettetheringin rela-tion toright ventricular pressureand/or volume overload
[4]. Pressureoverload is most often caused bypulmonary hypertensionresultingfromleft-sidedheartdiseaseor,less frequently,pulmonary disease,while rightventricular vol-umeoverloadisobservedinleft-to-rightshuntsorintrinsic diseaseoftherightventricle.
TRhasa strong negativeeffectonoutcomes[5—8]. In a study of more than 5200 patients followed for longer than5years[5],both moderateandsevereTRwere asso-ciated withincreasedmortality. ModerateTRmay indeed worsen during long-term follow-up after surgery for left-sidedvalvulardisease,andisalsoassociatedwithdecreased
Figure1. Measurementoftheinnerdiameterofanannuloplastyring(AandB)and bioprosthesis(C)by:(A)fluoroscopy;(B) three-dimensionaltransoesophagealechocardiography;and(C)computedtomography.
survival [9]. Similarly, residual significant TR after mitral surgerywasresponsibleforafour-foldincreaseinlate mor-talityinarecentstudy[10].However,managementofthese patients withisolatedsevere functionalTR afterprevious left-sidedvalvularsurgeryisdifficultbecauseofthe inher-entriskofredointerventions. Indeed,operative mortality was 15% in a series of 82 patients undergoing tricuspid surgery, of whom 73% had had previous left-sided heart surgery[11].
Tricuspidannuloplastyiseffectiveinreducingthe sever-ityoffunctionalTR,improvesrightventriclegeometryand function,andhasafavourableeffectonmortality[12—18]. Tricuspidvalvereplacement is usuallylimited toanatomy unsuitable for repair. Guidelines recommend the consid-eration ofwideindicationsfor combinedtricuspidsurgery inpatientsundergoingleft-sidedheartvalvesurgery[2,3]. However,anumberofpatientsnowpresentwithlate pros-thetic dysfunction after tricuspid repair or replacement. Afterprevioustricuspidvalvesurgery,recurrenceof moder-ateorsevereTRmaybeashighas60%at5years[19],and reoperationis necessary in approximately20% ofpatients within10yearsaftertricuspidvalvesurgery[20].Whileredo surgeryis thetreatment of choicefor a degenerated bio-prosthesis(BP)ordeteriorationofringannuloplasty(RA),it maybeassociatedwithaveryhighmortalityrate[21—24], reaching35%at 30 days[25],particularlyinpatientswith co-morbidities[16,20].
Uncertainties concerning the risk—benefit ratio of surgeryinseverefunctionalTRordysfunctionafter tricus-pid surgery therefore justify the search for less invasive approaches.
Sinceitsfirststeps[26],theefficacyoftransaorticvalve implantationhasledovertimetotransitiontovalve-in-valve implantationforafailingaorticBPand,morerecently,for mitral BP and RA deterioration, with favourable immedi-ateandmid-termoutcomes[27,28].Tricuspidvalve-in-valve andvalve-in-ringimplantationmaythereforepresentanew therapeuticoption.Morerecently,transcatherrepair tech-niques have been described to correct functional TR in nativevalves.
Tricuspid
bioprosthesis,
ring
annuloplasty
and
percutaneous
interventions
Transcatheterheartvalve(THV)implantationhasrecently beenreportedforthetreatmentofadegeneratedtricuspid BPorfailureofRA[29—49].
Whereasthetechniqueforvalve-in-valvesharesfeatures withprocedures for aortic or mitralvalves, the valve-in-ringimplantationpresentsspecificchallengesbecauseofthe tricuspidposition[30].
Tricuspid
bioprosthesis
failure
and
valve-in-valve
implantation
Prosthesis
measurements
Oneofthemaindifficultiesassociatedwiththeprocedure is the proper evaluation of prosthesis size. For tricuspid BP, as for aortic or mitral valve-in-valve, the prosthesis size may be derived from an integrated approach, tak-ing into account the manufacturer’s inner diameters and themean diameter determined by computed tomography (CT), three-dimensional transoesophageal echocardiogra-phy (TEE) and fluoroscopy. Whenever possible, the three available techniques should beused systematicallyin the absenceof recommendations for the assessment of pros-thesissize(Fig.1).However,giventheroundshapeofthe prostheses, and based on the experience of the centre, areliable CT scanmeasurement maybe sufficient.Based onourexperience,fluoroscopyusuallyprovidesthelargest dimensionswhileTEEgivesthesmallestones[30].
Transcatheter
heart
valve
implantation
procedures
The routes reported so far for tricuspid implantations have been mainly transatrial or transjugular accesses [29,32—34,36,37,40,42,43,46,48,49]. However, the trans-femoral route has also provided good results, confirming the technical feasibility of this approach [30,31]. The
Figure2. Transcatheterheartvalve(THV)implantationinadegeneratedbioprosthesisinthetricuspidposition.A. Afterthetricuspid bioprosthesisvalvehasbeencrossedwithaJudkinsrightdiagnosticcatheteroraballoonflotationcatheter,astiffwireisplacedattheapex oftherightventricle.B. TheTHVisplacedwithinthetricuspidvalveandinflatedusingrapidventricularpacing.Finalresultaftertricuspid valve-in-valveimplantation inthecatheterizationlaboratory(C,D)and usingcomputedtomography(E,G)and computedtomography three-dimensionalreconstruction(F,H,I).
avoidance of a thoracotomy, with its potential complications, is deemed desirable given the high-risk profile of the candidates regarding such techniques. In the published transfemoral approach series of the Bichat centre,notechnicaldifficultywasobserved[27].
In our institution, transfemoral procedures are per-formedundergeneralanaesthesiaandTEEguidance.After crossingthetricuspidvalve,aJ-shapedguidewireisplaced attheapexoftherightventricle(Fig.2);then,anEdwards SAPIENTMXTvalve(andmorerecentlytheSAPIENTM3valve)
(Edwards Lifesciences, Irvine, CA, USA), mounted upside down onthe catheter, is deployed by slow balloon infla-tionunderrapidventricularpacing(RVP)(140—180beatsper minute).RVPisperformedusingeitheratemporaryleadin theleftventricleorinthecoronarysinus,orusinga perma-nent pacemaker implantedbeforethe procedure (Fig.3). PredilatationoftheBP shouldbeavoidedasoftenas pos-sible topreventthe risk ofcusp rupture or embolization, although theirconsequencesareless severethan for left-sidedvalves.Theresultsareassessedinthecatheterization
Figure3. Differentoptionsforrapidventricularpacingwhenimplantingavalve-in-valveorvalve-in-ringinthetricuspidposition:(A) leadinthecoronarysinus;(B)leadintheleftventricle;and(C)epicardialpacemaker.
Figure4. Finalresultaftertricuspidvalve-in-ringimplantationin thecatheterizationlaboratory(A,B),withpost-implantation com-putedtomographyscancontrol(C,D)andcomputedtomography three-dimensionalreconstruction(E,F).
laboratorybyhaemodynamics,TEEandfluoroscopy,thena CTscanwiththree-dimensionalreconstructionisperformed beforedischarge(Fig.4).
Choice
of
valve:
Melody
®or
Edwards
SAPIEN
TM?
THV implantation in a degenerated tricuspid BP has been reported using two different valves: the Melody®
valve(Medtronic,Minneapolis, MN, USA) andthe Edwards SAPIENTMvalve.
A series of 15 Melody® valveimplantations in
biopros-thetic tricuspid valves in patients with a median age of 31.5 years, most of whom had congenital heart disease, reportedgoodresults[45].Thevalvewassuccessfullyplaced in all patients and the median follow-up was 4 months. Complicationswereonedeathinapatientwith preproce-duralmultiorgan failure,onethird-degreeatrioventricular block requiring pacemaker implantation and one case of endocarditis2monthsafterimplantation.However,recent concerns havebeen raised regardingthe increasedriskof infectiveendocarditisintheMelody®valve,althoughmainly
inthepulmonaryposition[50,51].
A number of cases and series have also been published using the Edwards SAPIENTM valve [29,31—34,36,39—44,46,47,49]. A recent review of the literature [52] reported eight case reports using the Edwards SAPIENTM valve in patients aged 8—74 years. All
procedureshadgoodresultswithoutcomplications,andthe valveperformanceafterimplantationwasgood,similarto theresultsofthe serieswithMelody® valveimplantations [45],butthemeanreportedfollow-upwasonly3months.
Arecentseriesof 16patientsimplanted between2008 and2014hasbeen publishedwithboth theMelody® valve
(n=7) and the Edwards SAPIENTM valves (SAPIENTM XT 26,
n=4; SAPIENTM XT 29, n=6) [53]. The procedural success
reached100%in thisseriesofyoungpatients (medianage 31 years),mostofwhomhadcongenitalheartdisease(14 patients)and only two of whomhad an initially acquired tricuspiddysfunction.
In Bichat hospital, we implanted four patients with a BP failure, all of whom had acquired tricuspid dys-function(three of rheumatic origin andone endocarditis) (unpublishedresults).This wasaverydifferentpopulation comparedtopatients withcongenital heart disease, with amean age of 56 years,and all patientswere implanted withanEdwards SAPIENTM XT valve(26mm, n=2; 29mm,
n=2).Ofthesefourpatients,twowerealreadytridux,one wasalreadyreduxandthelastpatienthadahistoryofdrug useandinfectiveendocarditis.ForthedegeneratedBP,two hadstenoticimpairment,andtwohadbothregurgitantand stenoticBPfailure.Theproceduralsuccess was100% with noconversiontosurgery.Duringin-hospitalfollow-up,two complicationsoccurred:onemajorgastrointestinalbleeding relatedtooesophagealulcerationandoneseverevascular complicationneeding surgical management as a result of venoussubcutaneousbleedingatthepuncturesite.Noother complicationoccurredat30-dayfollow-up.
Both the Melody® valve and the Edwards SAPIENTM XT
valveseemtogivegoodresultsforTHVimplantationinthe tricuspidposition.However,giventhesmallsizesavailable fortheMelody®valve(maximaldiameterof22mm),itmay
belessadequateforadultpatientswithacquiredvalve dis-ease.Inourseries,forexample,thesizesofthefailedBPs werebetween25and31mm,whichisnotcompatiblewith Melody® valveimplantation. Moreover,largerstudies with
alongerfollow-upneedtobeconductedtoassesswhether therisk ofinfective endocarditis isreally moreimportant withtheMelody® valve.
Rapid
ventricular
pacing:
specificities
for
tricuspid
transcatheter
heart
valve
implantation
ForTHVimplantationin thetricuspidposition,RVPshould notbeperformed viaatemporaryrightventricularpacing lead,shouldtheleadbejailedordamagedduringthe proce-dure.Severalotherstrategiesmaybeproposed[31,34,49]. Forpatientswithapreviouspermanentpacemaker,RVP maybeperformedusingthelatter.Implantationofan addi-tionalleadinthecoronarysinus mayalsobediscussed to preventanyadverseevent.
Whenthepatientsdonothaveapacemaker,thedifferent optionsforRVPareeitheratemporaryleadinthecoronary
sinusorintheleftventricle,ordirectpacingusingthewire attheapexoftherightventricleandcrocodileforceps.
In some particular cases, when the risk of pacemaker implantation is very high, a permanent epicardial pace-makermaybeproposedbeforetheprocedure.Theseoptions arefeasiblewithoutmajordifficultiesandthechoicemust beindividualizedtopatients’characteristics(Fig.3).
Annuloplasty
rings
failure:
specificities
of
valve-in-ring
implantation
All the challenges previously described for valve-in-valve implantationalsoapply tovalve-in-ringprocedures. Addi-tionally,tricupid annuloplasty ringspresent some specific difficulties.
Annulus
measurements
Prosthesissizingis particularlydifficult for prosthetic tri-cuspid rings, which are non-circular, as illustrated in Figs.1and4, andsurroundedby valvulartissuethat can-notbedetectedbyCTscanorfluoroscopy.Inthissetting,it isthereforemandatorytosystematicallyusethethree avail-abletechniques(CTscan,TEEandfluoroscopy)todetermine the most appropriate size of prosthesis by using an inte-gratedapproach.Theaimistoimplantthevalvewiththe diameterthatisclosesttothemeaninnerdiameterofthe ring,toavoidover-orunder-valveexpansion.
Moreover,carefulballoonsizingat thebeginningofthe procedure may be used to help determine the annulus dimensionmoreprecisely[54].
Valve-in-ring
implantations:
mind
the
gap!
Only three case reports have been published so far with theEdwardsSAPIENTMvalve,usingthetransatrial[42]andtransfemoral[55,56]approaches.
Arecentseriesofthreevalve-in-ringimplantationswith an Edwards SAPIENTM XT valve through the transfemoral
approachhasbeen published[30]. The sizesof the failed RAswerebetween30and32mm,allowingforimplantation of three26mm Edwards SAPIENTM XT stents. The authors
reported one patient with a moderate-to-severe residual regurgitationimmediatelyaftertheprocedure,inarigidand incompletering(Carpentier-EdwardsClassicRing;Edwards Lifesciences,Irvine,CA,USA).Theregurgitationwascaused byaparavalvularleakattheleveloftheopenportionofthe ring.Anotherpatienthadmildpost-proceduralparavalvular regurgitation,inthesametypeofrigidandopenring.
In a recent case report, a 22mm Melody® valve was
implanted in a 26mm failed RA in a 21-year-old young women [54]. A severe paravalvular leak occurred in the regionwherethetricuspidring wasincomplete.This case alsoconcernedaCarpentier-EdwardsClassictricuspid annu-loplastyring.The authorsreportthe successfulclosureof theparavalvularleakusingan AMPLATZERTM VascularPlug
II (St.JudeMedical, St.Paul, MN, USA),withonly a mild residualleakasthefinalresult[54].
The presenceofaprosthetic ringhastheadvantageof providingthefluoroscopiclandmarksandnecessary anchor-ing for a percutaneous valve, but also has the drawback ofcreatinga non-circularlanding zone,withthe inability to completely seal the open segment with the THV, and
inducingunderexpansionofthetranscatheter valvein the smalldiameterofthering.Thesefindingsaremorelikelyto appearwiththeCarpentier-EdwardsClassictricuspidrings, whicharerigid,makingitdifficulttocircularizethistypeof ring(Fig.4).
ResidualTRis,however,probablylessclinicallyrelevant than inthemitralor aortic position.Indeed,wereported a sustained improvement in the functional status of the patientwithsevereparavalvularregurgitation,whowasin NewYorkHeartAssociation(NYHA)classIIat1-year follow-up[30].
THVimplantationshould, however, beconsidered with caution in these particular rigid and open rings. In this setting, semirigidor flexible ringsaremorefavourable as theyareeasiertocircularizeduringprosthesisdeployment, whichlimitsparavalvularregurgitations.However,theyare usedlessofteninthetricuspidposition.
Theseemergingtechniques ofvalve-in-valveand valve-in-ring interventions are currently limited to extremely high-riskpatients;untilnow,150patientshavebeentreated aroundtheworld.Thesenewpercutaneoustreatmentshave been proposed for two very different populations: young patients withcongenital heart diseases who have already beenoperatedonseveraltimes,orolderpatientswith co-morbiditiesandacquiredvalvediseasewhoareexposedto theriskofaredosurgeryatleast.Inallcases,patientseither hadacontraindicationtosurgeryorwereconsideredatvery high-riskafterevaluationbytheheartteam.
Giventhelimited experiencewithTHVimplantation in thetricuspidposition,thepatientswhobenefitfromthese techniquesshouldhaveaclosefollow-up,includingatleast anannualvisitwithTEEandCTscanevaluationinthecentre wheretheywereimplanted.Itismandatorytoensurethat theimplantedprosthesisremainsfunctionaloveranumber of years,without anydeinsertion,deteriorationor throm-bosis,beforeconsideringlargerindicationsinthefuture.
Native
tricuspid
valve
Valve-in-native
valve
implantation
Besides tricuspid valve-in-valveand valve-in-ringin failed BPorRA,Keferetal.reportedthefirstcaseofTHV implan-tation in a native tricuspid valve[57]. The patientwas a 47-year-oldwomanwithcongenitalheartdiseasewhowas already tridux. She had had, in addition to mitral valve replacement and aortic valve replacement, three tricus-pid valve repair interventions, but without any RA. Her native tricuspid valve was both stenotic and regurgitant. Therewasnorigidtargetzonetoanchorthepercutaneous valveandnofluoroscopicmarkertohelpTHVimplantation. Therefore, prestenting was performed with two covered 34mmCPStentsTM(NuMED,Hopkinton,NY,USA)tocreatea
rigidlandingzone.AnEdwardsSAPIENTMvalve(26mm)was
implanted throughthe transfemoral approach,under gen-eral anaesthesia,withfluoroscopic andthree-dimensional TEEguidance.Ofnote,theprocedurewasperformedunder extracorporealmembraneoxygenationassistancein antici-pationofhaemodynamicinstability.Thepatientneededthe implantation of a second 26mm Edwards SAPIENTM valve
Figure5. KayRepairTechnique(AandA’)andcorrespondingpercutaneousapproachusingtheMitralignsystemTM(MitralignInc., Tewks-bury,MA,USA)(BandB’).A. Tricuspidvalvebicuspidizationisaccomplishedbyplicatingtheannulusalongtheposteriorleaflet(A’);the suturesaretied,obliteratingtheposteriorleaflet,creatingabicuspidvalve.B. Imageofthenativetricuspidannulusbeforerepairand(B’) afterpositioningofthetwopledgetedsutures.
importantregurgitation.Finally,theresultwasgood,with nostenosisandonlyatrivialcentralleak.At5-month follow-up, theauthors reported persistenceof good clinical and haemodynamicresults.
Thisfirst-in-manimplantationisencouraging,butlarger studies are needed to confirm the feasibility, safety and durabilityofthistherapy.
Caval
valve
implantation
against
severe
tricuspid
regurgitation
Atechniqueinvolvingheterotopicplacementof transcathe-teraoticvalves intheinferiorvena cava(IVC)inpatients with refractory ascites and lower extremity oedema has been described [58,59]. The aim was to reduce venous hypertensioninthehepatorenalsystemandtoprotectfrom the systolic backflow encountered in severe TR, in end-stage patients. Short-term results showed reductions in ascites,hepaticcongestion andperipheral oedema,which areencouraging,although long-termfollow-upofthis pal-liativetreatmentisneeded.Currently,thistherapyisbeing evaluatedin ‘The Treatment of Severe Secondary TRIcus-pid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards SAPIENTM
XT VALve’ (TRICAVAL) study (ClinicalTrials.gov identifier: NCT02387697).
Bicuspidization
techniques:
concept
and
first
results
TheMitralignsystemTM(MitralignInc.,Tewksbury,MA,USA)
wasinitiallyusedforfunctionalmitralregurgitation,andhas
recentlybeenadaptedforfunctionalTR.Thissystemmimics thesurgicalKayRepairTechniqueleadingtobicuspidization ofthetricuspidvalve(Fig.5)[60],byplacingpledgetsutures throughatransjugularvenousapproach.The finalresultis asuturesupportedonboththeventricularandatrialsides oftheannulus,withfoldedpledgets.
A successfulprocedure was reportedin an 89-year-old womanwithrecurrentheartdecompensationcausedby iso-latedTR[61].The patient’s logisticEuroSCORE(European System for Cardiac Operative Risk Evaluation) was 28%, and surgical intervention was deemed too high-risk. The procedure wasperformed under generalanaesthesia with fluoroscopyandtwo- andthree-dimensionalTEEguidance. There wasa significant reduction in annular area by 57% (from14.1cm2to6.05cm2)andineffectiveregurgitant
ori-ficeareaby53%(from1.35to0.65cm2)asmeasuredusing
three-dimensionalTEE.Afterdischarge,thepatientneeded continuationof her usual aggressivemedical therapy,but feltbetter,withlessoedemaandimprovementinrenal func-tion.
Another device, the TriCinch SystemTM (4TECH Cardio
Ltd,Galway,Ireland), alsoleads tobicuspidizationof the tricuspid valve (Fig. 6) [62]. The percutaneous device is specifically dedicated to tricuspid valve remodelling, by means of thefixation of a stainless steel corkscrew close tothe anteroposteriorcommissure of thetricuspid valve. The corkscrew is connected through a Dacron band to a self-expandingnitinolstentimplantedintheIVC(Fig.6).By pullingthesystemtowardstheIVC,theanchoringcorkscrew reduces the anteroposterior annulus, and the tension is maintainedbypositioningthestentintheIVC.Thestentis availableindifferentsizes (27—43mmin diameter,66mm
Figure6. TheTriCinchSystemTM(4TECHCardioLtd,GalwayIreland).A. Theanchorisattachedontheanteroposteriorcommissure.B. TensionisappliedviatheDacronbandinordertobicuspidizethetricuspidvalve.C. Tensionismaintainedviaastentimplantedinthe inferiorvenacava.
ReproducedwithpermissionfromJACCCardiovascInterv[62].
inlength)toguaranteeoversizinginthehepaticregionof theIVC.
We recently published the first-in-man implantation in a72-year-oldwoman,NYHAclassIII,asaresultofsevere TR (grade 4), a 9mm lack of coaptation and a septolat-eraldimension of 46mm, according toTEE [63]. She had had a previous aortic valve replacement with a BP. The procedurewasperformed undergeneralanaesthesia,with fluoroscopy,two-andthree-dimensionalTEEand intracar-diac echocardiographic imaging guidance. The procedure usedatransfemoralapproach.Thetipofthedeliverysystem wassuccessfullysteeredonthetricuspidannulus,and ten-sionwasappliedandmaintainedbyimplantationofa43mm self-expandingnitinolstentintheIVC.TRwasreducedfrom grade4to3, andtheseptolateraldimensionwasreduced from46mmto38mm[63].
Theresultsofthreesuccessfulimplantationsperformed inMilanandParisin2014werepresentedatthelastEuroPCR meetinginParis(May2015)[64].Thefinalresultinoneofthe patients,withthestentimplantedintheIVCanda reduc-tionintricuspidannulardimensionfrom41mmto34mm,is illustratedinFig.7.Follow-upat6monthsfortwopatients and3monthsforthethirdshowedimprovementofatleast one class in terms of functional NYHA evaluation, and a substantialimprovement inthe 6-minute walktest in the threepatients.Thereductioninseptolateraldimensionwas maintainedandthedevicewasstableinallthreepatients. Therewasneithermigrationnorstentthrombosis.The PRE-VENTStudy(PercutaneousTreatmentoftheTricuspidvalve RegurgitationwiththeTricinchSystemTM;ClinicalTrials.gov
identifier NCT02098200) is still ongoing and is aiming to enroll24patientsforCEmarking.
Transcatheter tricuspid valve repair for severe symp-tomatic functional TR is still in the initial stages of development.Regardingefficacy,thesenewproceduresonly resultedinaslightreductioninTR,whichmaybesufficient
Figure7. Dimensionsofthetricuspidannulus(A)beforeand(B) afterthebicuspidizationtechnique,using theTriCinch SystemTM (4TECH CardioLtd,GalwayIreland). Thestent implanted inthe inferiorvenacavaisvisibleon(C)thefinalcomputedtomography scanand(D)thethree-dimensionalreconstruction.
Figure8. Computedtomographyscantricuspidvalve(TV) analy-siswiththeexpectedidealtargetfortheanchoringsystemofthe TheTriCinchSystemTM(4TECHCardioLtd,GalwayIreland).APC: anteroposterior commissure; ASC: anteroseptalcommissure; MV: mitralvalve;PSC:posteriosuperiorcommissure;RCA:rightcoronary artery.
forsymptomaticimprovementinthesepatients.Thereare stillmanyunsolvedtechnicalissues.Long-termfollow-upis requiredtoassessthedurabilityofthedeviceandits long-term efficacy. More patients areneeded to test both the safetyandthereproducibilityoftheprocedurebeforewider use.
RegardingtheTriCinchSystemTM,theaccuratelocationof
theanchoronthetricuspidannulusisthemostdifficultstep to achieve under echocardiographic guidance (even using bothTEEandintracardiacimaging)inordertoavoid screw-ing in the free wall of the right atrium (with the risk of haemopericardium)orintherightcoronaryarterythat sur-rounds the tricuspidannulus. CTscan analysisbefore the procedureiscrucialtodeterminetheoptimaltargetforthe anchorimplantation,farfromtherightcoronaryarteryand theaorticroot(Fig.8).
The
future
has
begun
Asforthemitralvalve,transcathetertricuspidintervention isthenatural evolutionofmoderntricuspidvalvesurgery. Currentlybasedonbicuspidization,newtechnologiesneed tobedevelopedtoexpandthepossibilitiesoftranscatheter intervention,suchasedge-to-edgerepairsorannuloplasty (director indirect),specificallydedicated tothe anatomy ofthetricuspidvalve.
Forexample, theuseof theMitraClip® System (Abbott
Vascular,Abbott Park, IL, USA) in the tricuspid valvewas first reportedin one patientwith corrected transposition ofthegreatarteries,throughatransjugularaccess[65].In thiscase,thepatienthadananatomicallyleft-sided tricus-pidmitralvalve.Thistechniqueiscurrentlybeingexplored to attempt leaflet tethering and decrease functional TR innormallyright-sidedtricuspidvalves(B. Maini,personal communication, January 2015). However, there areoften widemalcoaptationgapsresultingfromtheimportant tri-cuspid annular dilation in severe secondary TR, and the MitraClipSystemmaythusbeaquestionablesolution.
Recently, initialexperiencewiththeFORMA repair sys-tem (Edwards Lifesciences, Irvine, CA, USA) has been
reportedatcongresses (unpublisheddata).Thisnew tech-nologyisdesignedtorestoreleafletcoaptationinpatients withfunctional TR.The device consistsof aspacer anda rail. The spacer is positioned into the regurgitant orifice andcreates aplatformfor leafletcoaptation,andtherail tracksthespacer intoposition. Untilnow, the devicehas beenimplanted inseven patientswithfunctional TR.The useofthisdevice wasassociatedwithamild-to-moderate reductioninTR,diureticdoseandperipheraloedema,and animprovementinqualityoflife. However,theseresults, althoughencouraging,arepreliminary.Theongoing‘‘Early Feasibility Study of the Edwards Tricuspid Transcatheter RepairSystem’’(ClinicalTrials.govidentifierNCT02471807) willdeterminethefeasibility,safetyandefficacyofthisnew technology.
Different devices for the tricuspid valve are currently underdevelopmentinpreclinicaltrials.
The MillipedeTM system (Millipede, LLC, Ann Arbor,
Michigan, USA) involves the placement of a tricuspid annular ring with an attachment system via percuta-neous methods to restore the native tricuspid annular shape and diameter. This device could be repositioned beforedeployment andmay offersimpler device delivery
[66].
A novel transcatheter tricuspidannuloplasty technique usingtransatrialpericardialaccesshasalsobeenpublished (theTRAIPTAsystem)[67].Thisdevicehasbeensuccessfully implantedin16swine,includingfourwithsecondarysevere TR.Under generalanaethesiaandmechanical ventilation, theTRAIPTAsystemisintroducedthroughthefemoralvein andpericardial accessis gained via puncture of the right atrial appendage. The TRAIPTA device is then deployed circumferentially in the pericardial space to encircle the heart along the atrioventricular groove, under the guid-anceofpericardialcontrastinfusion.Thecontrastproduct is then washed out, the right atrial appendage puncture is closed and the TRAIPTA implant is then left in place permanently.Nocomplicationoccurredexceptfor moder-ate pericardial effusion. The dimensions of the tricuspid annulushave been significantly reduced (from49% in the septolateraldimensionandfrom31%intheanteroposterior diameter).Duringafollow-upof7to14days,theTRAIPTA devicestayedinaproperpositionandthepericardial effu-sion decreased without any drainage. So, this preclinical studyshows thatTRAIPTAdevice maybesuccessfully pos-itionedintheatrioventriculargroovethrougharightatrial appendagepuncture,andleadstoasignificantdecreasein annulardimensions.
Theseresultsareencouraging,butchallengesremainto beovercome before itsuse in humans,such as the need foraprophylacticpericardialdrainandtheriskofcoronary compression.
The ultimate goal of transcatheter therapy is total transcatheter tricuspid valve replacement. However, the first attempts with the mitral valve highlight the numer-ousandspecificdifficultiesencounteredinatrioventricular valves[68].Thistreatmentwouldbeapplicabletopatients with previous left-sided heart valve surgery who require anextremelyhigh-risk redo isolatedtricuspidsurgery,but mightalsobefeasibleduringtransaorticvalveimplantation orpercutaneousmitralvalveimplantation,tobeinkeeping withsurgicalguidelines.
Conclusions
Inrecentyears,thetricuspidvalvehasbeenrecognizedasa challengefornewpercutaneoustreatments,giventhe com-bination of high-risk dedicated surgery and deterioration of surgical results over time. THV implantation is feasi-ble in failed tricuspid surgical valves, and may improve haemodynamic and functional status. The differences in reportedapproaches show that there is no consensus for thebeststrategyinthesecomplexprocedures.Largerseries and long-term follow-up areneeded to better assess the role of this technique in the future. Moreover, whereas resultsforvalve-in-valveproceduresaregood,paravalvular leaksoccurringwithrigidannuloplastyringsareasourceof concern.Thisissuemayimproveinthenearfuturewith ded-icateddevices,whichshouldofferlongercoveredlengths.
Forthenative tricuspid valve, preliminaryresults with thetwobicuspidizationtechniquesvalidatetheirfeasibility. More experience is needed to assess their clinical bene-fit and define the best candidates. Finally, a number of otherdevicesarein preclinicaldevelopment,andthereis nodoubtthatthenextdecadewillseethefullrecognitionof thetricuspidvalveinthefieldoftranscathetertreatments.
Disclosure
of
interest
D.H. and P.N.: proctors for the company Edwards Life-sciences.
B.I.andA.V.:speaker’sfeesfromthecompanyEdwards Lifesciences.
Theotherauthorsdeclarethattheyhavenoconflictsof interestconcerningthisarticle.
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