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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
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