the amplatzer03 septal occluderWord下载.docx

the amplatzer03 septal occluderWord下载.docx

《the amplatzer03 septal occluderWord下载.docx》由会员分享，可在线阅读，更多相关《the amplatzer03 septal occluderWord下载.docx（17页珍藏版）》请在冰豆网上搜索。

8IndividualizationofTreatment9

9PatientInformation10

10HowSupplied10

11DirectionsforUse10

AMPLATZER®

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

p-value

CardiacArrhythmiarequiringmajortreatment

2/442（0.5%）

0/154（0.0%）

1.00

DeviceEmbolizationwithsurgicalremoval

3/442（0.7%）

0.57

DeviceEmbolizationwithpercutaneousremoval

1/442（0.2%）

DeliverySystemFailure

PericardialEffusionwithtamponade

0/442（0.0%）

3/154（1.9%）

0.017

PulmonaryEdema

1/154（0.6%）

0.26

RepeatSurgery

2/154（1.3%）

0.066

SurgicalWoundComplication

TotalMajorComplicationsPatients

7/442（1.6%）

8/154（5.2%）

0.030

Table1Complications–PivotalStudy（continued）

MinorComplications

Anemia

Allergicreaction（drug）

Atelectasis

CardiacArrhythmiasMinorTreatment

15/442（3.4%）

9/154（5.8%）

0.23

ExtremityTingling/Numbness

Headaches/PossibleTIA

PericardiotomySyndrome

Pericardialeffusion

0/442（0.0%

6/154（3.9%）

<

0.001

PleuralEffusion

Pneumothorax

StaphInfection

SurgicalWoundComplications

Thrombusformation

0.56

Transfusions

UpperRespiratoryInfection/Fever

UrinaryTractDisturbance

1/424（0.2%）

TotalMinorComplications（Patients）

27/442（6.1%）

29/154（18.8%）

6.3.2RegistryGroup–FenestratedFontan

Table2:

Complications-FF

Upper95%Confidence

Bound

1/48（2.1%）

0.095

Hemothorax

1/48（2.1%）

MinorComplication

Vomiting（required2nightsinhospital）

Atrialfibrillation/cardioversion

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