the amplatzer03 septal occluder.docx
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theamplatzer03septaloccluder
TheAMPLATZER®SeptalOccluderandDeliverySystem
InstructionsforUse
TableofContents
SectionPage
1BriefDeviceDescription1
2Indications&Usage1
3Contraindications1
4Warnings2
5Precautions2
6AdverseEvents3
7ClinicalStudies5
8IndividualizationofTreatment9
9PatientInformation10
10HowSupplied10
11DirectionsforUse10
AMPLATZER®SeptalOccluderandDeliverySystem
Caution:
Federallaw(USA)restrictsthisdevicetosalebyorontheorderofaphysician(orproperlylicensedpractitioner).
1.BRIEFDEVICEDESCRIPTION
TheAMPLATZERSeptalOccluderisaself-expandable,doublediscdevicemadefromaNitinolwiremesh.ThetwodiscsarelinkedtogetherbyashortconnectingwaistcorrespondingtothesizeoftheASD.Inordertoincreaseitsclosingability,thediscsandthewaistarefilledwithpolyesterpatches.Thepolyesterpatchesaresecurelysewntoeachdiscbyapolyesterthread.
TheAMPLATZERDeliverySystemwasdesignedspecificallytofacilitateattachment,loading,deliveryanddeploymentoftheAMPLATZERSeptalOccluderandiscomprisedofadeliverysheath,dilator,loadingdevice,plasticviseanddeliverycable.
2.INDICATIONSANDUSAGE
TheAMPLATZERSeptalOccluderisapercutaneous,transcatheter,atrialseptaldefectclosuredeviceintendedfortheocclusionofatrialseptaldefects(ASD)insecundumposition.PatientsindicatedforASDclosurehaveechocardiographicevidenceofostiumsecundumatrialseptaldefectandclinicalevidenceofrightventricularvolumeoverload(ie,1.5:
1degreeoflefttorightshuntorRVenlargement)orclinicalsymptomssuchasparadoxicalembolismoratrialdysrhythmiainthepresenceofaminimalshunt.
ThedeviceisalsoindicatedinthosepatientswhohaveundergoneafenestratedFontanprocedureandwhonowrequireclosureofthefenestration.
3.CONTRAINDICATIONS
3.1Anypatientknowntohaveextensivecongenitalcardiacanomalywhichcanonlybeadequatelyrepairedbywayofcardiacsurgery.
3.2Anypatientknowntohavelocalorgeneralizedsepsis,oranysystemicinfectionthatcannotbesuccessfullytreatedpriortodeviceplacement.
3.3Anypatientknowntohaveableedingdisorder,untreatedulceroranyothercontraindicationstoaspirintherapy,unlessanotheranti-plateletagentcanbeadministeredfor6months.
3.4Anypatientknowntohaveademonstratedintracardiacthrombionechocardiography(especiallyleftatrialorleftatrialappendagethrombi).
3.5Anypatientwhosesizeorconditionwouldcausethepatienttobeapoorcandidateforcardiaccatheterization.
3.6Anypatientwherethemarginsofthedefectare<5mmtothecoronarysinus,AVvalvesandrightupperlobepulmonaryvein.
4.WARNINGS
4.1TheAMPLATZERSeptalOccluderandDeliverySystemshouldonlybeusedbythosephysicianstrainedintranscatheterdefectclosuretechniques.
4.2Physiciansmustbepreparedtodealwithurgentsituationswhichrequireremovalofembolizeddevicesthatresultincriticalhemodynamiccompromise.
4.3Embolizeddevicesmustberemoved.Embolizeddevicesshouldnotbewithdrawnthroughintracardiacstructuresunlesstheyhavebeenadequatelycollapsedwithinasheath.
4.4Donotuseifthesterilebarrierhasbeencompromisedinanyway.
5.PRECAUTIONS
5.1Handling
∙TheAMPLATZERSeptalOccluderandDeliverySystemareforsingleuseonly.Donotreuseorresterilize.
5.2Sizing
∙AccuratedefectsizingiscrucialtoAMPLATZERSeptalOccluderdeviceselection.Theuseofacompliantballooncathetertodeterminedefectsizeisrecommended.Deviceselectionshouldbeequalto,orslightlylargerthan,theballoonstretcheddiameterofthedefect.
5.3Procedural
∙Aspirin(3-5mg/kg/day)istobestartedatleast24hourspriortotheprocedure.Intherarecaseofaspirinintolerance,twotimes200mgofTiclopidinaregiven.Cephalosporintherapyisoptional.
∙Patientshouldfullyheparanizedthroughouttheprocedurewithaminimumactiveclottingtime(ACT)of200secondspriortodeviceinsertion.
∙Transesophogealechocardiography(TEE)orsimilarimagingequipmentisrecommendedasanaidinplacingtheAMPLATZERSeptalOccluder.Ifused,thepatient’sesophogealanatomymustbeadequateforplacementandmanipulationoftheTEEprobe.
∙DonotreleasetheAMPLATZERSeptalOccluderfromthedeliverycableifthedevicedoesnotconformtoitsoriginalconfigurationorifthedevicepositionisunstable.Recapturethedeviceandredeploy.Ifstillunsatisfactory,recapturethedeviceandreplacewithanewdevice.
5.4
Post-Implant
∙Patientsshouldtakeappropriateendocarditisprophylaxisfor6monthsfollowingdeviceimplantation.Thedecisiontocontinueendocarditisprophylaxisbeyond6monthsisatthediscretionofthephysician.
∙Patientsshouldbetreatedwithantiplatelet/anticoagulationtherapy(suchasaspirin)for6monthspostimplant.Thedecisiontocontinueantiplatelet/anticoagulationtherapybeyond6monthsisatthediscretionofthephysician.
6.ADVERSEEVENTS
6.1ClinicalSummary
TheAMPLATZERSeptalOccluderwasevaluatedinamulti-center,non-randomized,pivotalstudycomparingthedevicetosurgicalclosureofatrialseptaldefects;423patientsreceived433deviceswithatotaldeviceexposureof911.5years.Individualpatientexposuretothedeviceaveraged25.6months(rangingfrom0to38.9).
ARegistrygroupwasalsostudiedtoevaluatethedeviceinpatientswithotherconditionsappropriatefordeviceclosure.Forty-eight(48)patientswithFenestratedFontan(communicationinthebafflewithatleast5mmdistancefromthefreeatrialwallandcentralvenouspressurelessthan15Hg)wereenrolledinthestudy.
6.2Deaths
TherewasonenondeviceorprocedurerelateddeathreportedinthepivotalstudyandnodeathswerereportedintheFenestratedFontanRegistryGroup.
6.3ObservedAdverseEvents
6.3.1PivotalClinicalStudy
Table1Complications–PivotalStudy
MajorComplication
AMPLATZER
Patients
SurgicalControl
Patients
p-value
CardiacArrhythmiarequiringmajortreatment
2/442(0.5%)
0/154(0.0%)
1.00
DeviceEmbolizationwithsurgicalremoval
3/442(0.7%)
0/154(0.0%)
0.57
DeviceEmbolizationwithpercutaneousremoval
1/442(0.2%)
0/154(0.0%)
1.00
DeliverySystemFailure
1/442(0.2%)
0/154(0.0%)
1.00
PericardialEffusionwithtamponade
0/442(0.0%)
3/154(1.9%)
0.017
PulmonaryEdema
0/442(0.0%)
1/154(0.6%)
0.26
RepeatSurgery
0/442(0.0%)
2/154(1.3%)
0.066
SurgicalWoundComplication
0/442(0.0%)
2/154(1.3%)
0.066
TotalMajorComplicationsPatients
7/442(1.6%)
8/154(5.2%)
0.030
Table1Complications–PivotalStudy(continued)
MinorComplications
AMPLATZER
Patients
SurgicalControl
Patients
p-value
Anemia
0/442(0.0%)
1/154(0.6%)
0.26
Allergicreaction(drug)
2/442(0.5%)
0/154(0.0%)
1.00
Atelectasis
0/442(0.0%)
1/154(0.6%)
0.26
CardiacArrhythmiasMinorTreatment
15/442(3.4%)
9/154(5.8%)
0.23
DeviceEmbolizationwithpercutaneousremoval
1/442(0.2%)
0/154(0.0%)
1.00
ExtremityTingling/Numbness
1/442(0.2%)
0/154(0.0%)
1.00
Headaches/PossibleTIA
2/442(0.5%)
0/154(0.0%)
1.00
DeliverySystemFailure
2/442(0.5%)
0/154(0.0%)
1.00
PericardiotomySyndrome
0/442(0.0%)
2/154(1.3%)
0.066
Pericardialeffusion
0/442(0.0%
6/154(3.9%)
<0.001
PleuralEffusion
0/442(0.0%)
1/154(0.6%)
0.26
Pneumothorax
0/442(0.0%)
3/154(1.9%)
0.017
StaphInfection
0/442(0.0%)
1/154(0.6%)
0.26
SurgicalWoundComplications
0/442(0.0%)
1/154(0.6%)
0.26
Thrombusformation
3/442(0.7%)
0/154(0.0%)
0.56
Transfusions
0/442(0.0%)
2/154(1.3%)
0.066
UpperRespiratoryInfection/Fever
0/442(0.0%)
2/154(1.3%)
0.066
UrinaryTractDisturbance
1/424(0.2%)
0/154(0.0%)
1.00
TotalMinorComplications(Patients)
27/442(6.1%)
29/154(18.8%)
<0.001
6.3.2RegistryGroup–FenestratedFontan
Table2:
Complications-FF
AMPLATZER
Patients
Upper95%Confidence
Bound
MajorComplication
RepeatSurgery
1/48(2.1%)
0.095
Hemothorax
1/48(2.1%)
0.095
MinorComplication
Vomiting(required2nightsinhospital)
1/48(2.1%)
0.095
Atrialfibrillation/cardioversion
1/48(2.1%)
0.095
TotalComplications
4/48(8.3%)
0.181
6.4PotentialAdverseEvents
PlacementoftheAMPLATZERSeptalOccluderinvolvesusingstandardinterventionalcardiaccatheterizationtechniques.Thefollowingadverseevents(listedinalphabeticalorder)mightbeexpectedfrominterventionalcardiaccatheterizationtechniques.
∙Airembolus
∙Allergicdyereaction
∙Anesthesiareactions
∙Apnea
∙Fever
∙Hypertension/hypotension
∙Infectionincludingendocarditis
∙Perforationofvesselormyocardium
∙Pseudoaneurysmincludingbloodlossrequiringtransfusion
∙Valvularregurgitation
7CLINICALSTUDIES
TheAMPLATZERSeptalOccluderwasevaluatedinamulti-center,non-randomizedcontrolledstudytocomparetheclinicalperformanceofthedeviceforASDclosurewiththatdocumentedfortheASDSurgicalrepairprocedure.Additionally,thedevicewasstudiedinpatientswithuncommonconditionswhereintranscatheterclosurewiththedevicemayalsobebeneficial(RegistryGroup).
7.1PatientsStudied
7.1.1Pivotalstudy–AtrialSeptalDefects
Attempttotreatwasinitiatedin442devicepatientsand154surgicalpatients.Enrolledpatientshadechocardiographicevidenceofostiumsecundumatrialseptaldefect(devicegroup:
defectsize<38mm)andclinicalevidenceofrightventricularvolumeoverloadorhadclinicalsymptomssuchasparadoxicalembolismoratrialdysrhythmiainthepresenceofaminimalshunt.Exclusioncriteriaincluded:
∙Patientswithmultipledefectsthatcouldn