PercutaneousPulmonaryValves:TheNevadaExperience

Dr.Galindo

Dr.Rothman

ValveFunction

l Allowflowinonlyonedirection:

l Opentoallowflowwithoutobstruction

l Closetokeepflowfromgoingbackwards

CardiacValves

l AtrioventricularValvesTricuspidMitral

l SemilunarValvesPulmonaryAortic

IndicationsforPulmonaryValveReplacement:PreserveRVFunction

l Stenosis(obstruction)l Gradient>35mmHgl RVsystolicpressures>75%ofsystemicwithnormalPApressures

l RVhypertrophyl Insufficiency

l Moderatetoseverepulmonaryinsufficiencyl DilatedRV

DiseaseStates

l Stenosisl Post-operativeconduitstenosis

l Insufficiencyl Post-operativeconduitinsufficiencyl Post-operativeTetralogyofFallotrepair–transannularpatch

l Followingpulmonaryballoonvalvuloplasty

RepairofTetralogyofFallot:RVOutflowTractPatchvs.Conduit

RV-PAConduitsareUsedtoPalliateComplexHeartDefects

l SevereTetralogyofFallotl PulmonaryatresiawithVSDl Rossprocedureforaorticvalvediseasel TranspositionofgreatarterieswithpulmonarystenosisandVSD(Rastelliprocedure)

l Truncusarteriosusl Someformsofdouble-outletrightventricleassociatedwithpulmonarystenosisoratresia

HomograftStenosis/Insufficiency

ManagementManagmentOptions

l Surgicall OpenheartsurgerytoplaceaconduitorbioprostheticvalvebetweentheRVandPA

l Percutaneousortransapicalpulmonaryvalvel MelodyValvel SapienValve

SurgicalRevisionofRV-PAHomograft

l Mayberequiredevery5–10yearsl Patientgrowthl Homograftstenosis/insufficiency

l Open-heartsurgeryoncardiopulmonarybypass

l Riskofmorbidityormortality~3%l Attimeofsurgerythereissignificantriskofhemorrhageifhomograftadherenttosternum

Melody®TranscatheterPulmonaryValve

l 18mmModifiedContegraBovineJugularVeinValve

l SuturedonaCPPlatinumIridiumFramel 28mmlength(outofthejar)l Hand-crimpeddownto6mml Re-expanded18mmupto22mm

MedtronicEnsemble®DeliverySystem

l ProprietaryBalloon-In-Balloon(BIB)deliverysysteml RetractablesheathcoversMelodyvalveonceitiscrimpedovertheballoon(balloonsizes:18,20,22mm)

l 100cmlengthl 22Frsize(outerdiameter)

MelodyValveDeployment

MelodyValvePost-Deployment

EdwardsSapienValve

SapienXTandNovaFlexDeliverySystem:UniqueAspects

Internal use only

Unique Design for Low Profile Delivery� Edwards SAPIEN XT THV is initially crimped

off the balloon during preparation� NovaFlex+ Delivery System allows the

Edwards SAPIEN XT THV to be alignedonto the balloon

� Compatible with 16 / 18 / 20 French eSheaths

NovaFlex+ Delivery SystemCobalt-chromium Alloy Frame

Tissue LeafletsGuidewire Lumen

Valve Crimp Section

EDWARDS LIFESCIENCES CONFIDENTIAL DOC-0022359 Rev: B Issued: 2/2016

ValveSelection

Internal use only

Edwards SAPIEN XT THV

23 mm 26 mm 29 mm

Tissue Bovine Pericardium, Carpentier-Edwards ThermaFix1 Anti-Calcification

Frame Cobalt-Chromium Alloy

Tissue Thickness 0.3 mm - 0.4 mm 0.3 mm - 0.4 mm 0.4 mm - 0.5 mm

Pulmonic THV sizing: Non-Compliant Landing Zone Diameter During

Balloon Predilation20 – 23 mm 23 – 26 mm 26 – 29 mm

Crimped Height 17 mm 20 mm 22 mm

Expanded Height 14 mm 17 mm 19 mm

Foreshortening 3 mm 3 mm 3 mm

Fabric Skirt Height2 6 mm 8 mm 11 mm

14 mm 17 mm 19 mm

6 mm 8 mm 11 mm

1No clinical data is available with which to evaluate the long-term impact of the Carpentier-Edwards ThermaFix tissue process in patients2Fabric skirt height for bottom zigzag

EDWARDS LIFESCIENCES CONFIDENTIAL DOC-0022359 Rev : B Issued: 2/2016

Pulmonary/CoronaryAngiogram

BalloonSizing

SapienValveDeployment

PulmonaryAngiogramPostSapienValve

NevadaExperience

•  PercutaneouspulmonaryvalveprogrambeganwiththeMelodyValve10/07/10

•  Sapienvalveintroduced8/02/13•  Bothvalvesinusefrom8/13to8/15•  Inlast2yearswehavebeenusingtheSapienvalveexclusively

MelodyValve:TheNevadaExperienceChangeinRightVentricularVolume

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PATIENT

RVI PRE

RVI POST

Endocarditis•  HasonlyoccurredwithuseofMelodyvalve•  Timefromvalveimplanttoendocarditis

–  Rangefrom17monthsto76months– Averagetimeframe44.2months

•  Bacteria:EnterococcusfaecalisStaphylococcusaureusStreptococcus(gamellasanguis)StreptococcusviridansAlpha-hemolyticstreptococcus

EndocarditisRiskFactors

•  MelodyValve•  Stentfracture/stenosis•  Hemodialysis•  Homograft

PercutaneousValves:FutureDirections

•  Systemstoaddressdilatedoutflowtracts:– Diameters>29mm

•  Useinaorticposition•  Useinmitralandtricuspidpositions