Cardiac Transplant Listing Consent SLH.MDP.05.111

CONSENTFORM

Thefollowinginformationisprovidedinordertohelpinformyouofthehearttransplantprocedureincludingthepurpose,treatmentcourse,andpotentialrisksandbenefits.Ifyouhaveanyquestions,pleasedonothesitatetoask.Youarereadytobeplacedonthewaitinglisttoreceiveadonorheart.Inordertodecidewhetherornotyoushouldagreetothistreatmentplan,youshouldunderstandenoughaboutitsrisksandbenefitstomakeaninformedjudgment.Thisconsentformgivesdetailedinformationaboutthetreatment,someofwhichthetransplantteamhasalreadydiscussedwithyouorwillbediscussedatyourlisting.Pleasebeawarethatyouhavetherighttoreviewwithyourtransplantteamanypartofthisconsentthatyoudonotunderstand.Onceyouhavereadthisconsentandhavehadallyourquestionsanswered,youwillbeaskedtosignthisformatthetimeoflistingifyouwishtoproceed.Youwillbegivenacopyofthisconsentformforyourrecords.

PURPOSE

Becauseyouhavebeendiagnosedashavingendstagecardiacdiseasewithnooptionsforothersurgicalormedicaltherapy,ahearttransplanthasbeenidentifiedastheoneremainingtreatmentoptionforyou.Thepurposeofhearttransplantationistorestoreameaningfulqualityoflifetoyouaswellasextendyourlife.

SELECTIONCRITERIA

Thefollowinginformationonselectioncriteriahasbeenprovidedanddiscussedwithyouatthetimeofyourevaluationandwasincludedintheevaluationconsentthatyousigned.

Inclusioncriteriainclude:

• End-stagecardiacdiseasedefinedbyNewYorkHeartAssociationClassIII/IVwithlimitedexpectedsurvivaloflessthan1year.
• Agegenerallylessthanage65.
• Absenceofsystemicdiseaseorinfection.
• Psychosocialstabilityandsupportivefamily/socialstructureasdefinedbysocialassessments.
• Noexpectationofimprovementwithalternativemedicalorsurgicaltreatment.

Exclusioncriteriainclude:

• Sepsisoractiveinfection
• Irreversiblerenalorhepaticdysfunction–considerdualorgantransplantforrenalfailure.
• Historyofchronicnoncompliance
• Recentpulmonaryinfarction–delayactivation
• Extensiveperipheralvasculardisease
• Evidenceofendorgandamageduetodiabetes(retinopathy,nephropathy,neuropathy).
• SevereChronicObstructivePulmonaryDisease
• Activementalillnessorpsychosocialinstability
• Evidenceofdrug,tobaccooralcoholabusecurrentlyorwithinthepastsixmonths.
• Obesity(>150%IBWorBMI42)
• Severepulmonaryhypertensionasevidencedbyafixedpulmonaryvascularresistanceofgreaterthan4Woodunits.
• Malignancy–variesbytypeanddateofdiagnosis

PatientInitials

DateTime

WAITINGPERIOD

Thereisnowaytoknowwhenadonorheartwillbecomeavailable.ThereisasysteminplacethroughUnitedNetworkforOrganSharing(UNOS)toensurethatallpatientsinneedofahearttransplantaregivenfairandequitableaccesstoavailabledonororgans.UNOScoordinateseffortsamongdonorhospitalsandtransplantcentersthroughoutthecountrytoallocatedonatedorgansfortransplantation.Afterthedonorheartismatchedforcompatiblebloodtypeandbodysize,itisallocatedtothesickestpatientwiththelongestwaitingtimewhoisclosesttothedonorheart.Fromthetimeyouareplacedonthewaitinglist,youneedtobereadytoreceiveatransplant.Atsomepointduringthewaitingperiod,youmaybecometoosicktoreceiveatransplant.Thiscouldbeatemporaryconditioninwhichyoucangetbetterandgobackonthelist,oritcouldbecomeapermanentconditionwhereyouwillnolongerbeeligibletoreceiveadonorheart.Ifeitherofthesehappens,theywillbediscussedwithyouatthattime.Ifyourlistingstatusischangedatanytimeduringthewaitingperiod,youwillbenotifiedofthischangeandthereasoningforitwillbediscussedwithyou.Allreasonableeffortswillbemadetoacceptasuitabledonororganforyou.Theremaybeatimeduetobedavailability,surgeonavailability,weather,orsomeotherunforeseencircumstancewhenadonorheartsuitableforyoumayhavetobeturneddown. Thereisnoguaranteethatasuitabledonorheartwilleverbelocated.

YoucouldalsoclinicallydeterioratetothepointwhereIV medicationscannotkeepyoualivetowaitforaheart.Atthispointyoumayneedoneormoreofthefollowingthreemechanicalmeansofkeepingyousuitableforatransplant:

• Intra-AorticBalloonPump(IABP)–Thisisametalwirewithasmallballoonattachedtoitandisinsertedthroughanarteryinyourgroin.Itisplacedinthemainarteryleadingtotheheart.Theendofthewireremainingoutsideofyourbodyisattachedtoamachinewhichwillhelppushbloodthroughtheheartandbodyeachtimethemachinepumps.Youwillreceivesedationandlocalanesthesiafortheinsertionofthedevice.Itisatemporarymeansofstabilizingyourcondition.Youmustremaininbedwhilethisdeviceisinplace.YouhavetherighttorefusetohavetheIABPplaced,atwhichpointyouwilllikelydie.
• Ventilator(Vent)–Thisisadevicethatbreathesforyouwhenyouareunabletobreatheonyourown.Itisalsousedimmediatelyaftersurgeryuntilyouareawakeandabletobreathonyourown.Tobeplacedonavent,youwillhavealargetubeinsertedthroughyourmouthintoyourairway.Thetubeisthenconnectedtotheventilator.Forinsertionofthistube,youwillreceivesedation.Youwillnotbeabletospeakwhilethistubeisinplace.Youwillmostlikelyhavetoremaininbedwhilethisdeviceisinplace.Youhavetherighttorefusetobeplacedontheventilator,atwhichpointyouwilllikelydie.
• VentricularAssistDevice (VAD)– Thisisa deviceordevicesthatmay beused tosupport rightheart function,leftheartfunction,orbothatthesametime.Implantationofventricularassistdevicesrequiresmajorcardiacsurgerywithhavingyourbreastboneopenedandbeingplacedontheheart-lungmachine.Tubesforthesedevicesgointotheaortaandventricle(s)oftheheart–thepumpsattachedtothetubesmaybeeitherimplantedintoyourchestorleftoutsideyourchest.Rarelycanthesepumpsberemovedforanyreasonotherthantransplant.OnceyouhaveaVAD,itwillremainimplanteduntilyouareeithertransplantedordie.Possiblecomplicationsincludebutarenotlimitedtobleeding,needforbloodtransfusions,infection,stroke,anymajororgansystemfailure,anddeath.Afterinsertionofthisdevice(s),youmaynotbeeligibletobeplacedonthelistforatransplantforseveraltomanymonths,andmayexperiencecomplicationsthatwillpreventyoufromeverbeingeligibletobeingplacedonthelist.Youwillbeabletogetupandaroundonceyouhaverecoveredfromtheoperationandmayevenbeabletogohomewiththepump,dependingonwhichoneyouhave.Priortoinsertionofthisdevice,thesurgeonwilldiscussanyadditionalpotentialrisksor

PatientInitials

DateTime

complicationswithyouoryourfamily.YouhavetherighttorefusehavingaVADorVADsimplanted,atwhichpointyouwilllikelydie.

RISKS

Pleaserefertoyourpatienteducationmanualforfurtherinformationrelatedtothetransplantoperation,otherprocedures,andpossiblecomplications.

DonorSelection-Beforethetransplant,bothyouandthepotentialdonorwillbetestedforhepatitisandseveralothervirusesincludingHIV(thevirusthatcausesAIDS).Potentialdonorsgothrougharigorousscreeningprocesstoensurethattheirorgansareappropriatetobetransplanted.Despitethisprocess,donorsarerepresentativeofthegeneralpublicandmayhaveriskfactorsthatpotentiallycouldaffectyourlong-termhealth,including,butnotlimitedto,thedonor’shistory,age,ortheirpotentialriskofcontractingtheHIVvirusandotherinfectiousdiseasesthatcannotyetbedetected.

HighRiskDonor–Whenanappropriatedonorhearthasbeenacceptedforyou,wemayinformyouthatthedonorisconsidered“highrisk”fortransmissionofHIV,asdefinedbytheCentersforDiseaseControlandPrevention(CDC).TheCDCcriteriaforthishighriskgroupareincluding,butnotlimitedto,maletomalesexualcontact,sexuallytransmitteddiseases,needletracksorothersignsofintravenousdrugabuse,knowncontactwithpersonsexposedtoHIV-infectedblood,andinmatesofcorrectionalsystems.Beassuredthatifwehaveacceptedthisheartforyouwiththisremoterisk,wehaveconsideredtherisksandbenefitsspecificallytoyourcase.

TransplantOperation–Oneofthehearttransplantsurgeonshasdiscussedthesurgicalrisksofthetransplantoperationwithyou.Aswithanycardiothoracicsurgery,therearepotentialrisks,including,andnotlimitedto,bleeding,needforbloodtransfusions,infection,stroke,anymajororganfailure,and/ordeath.Youwillsignaconsentforthehearttransplantsurgicalprocedureimmediatelybeforetransplant.Therisksassociatedwithgeneralanesthesiawillbespecificallydiscussedwithyoubyyouranesthesiologistatthetimeofyourtransplant.Afteryouaretakentotheoperatingroom,itwilltakeabouthalfanhouruntilyouaregivengeneralanesthesia.Thishalfhourwillbespentpreparingyoutoreceiveyournewheart.Afteryouareasleep,thetransplantteambeginsyoursurgery.Anincisionismadedownthecenterofyourchestandthebreastboneisopened.Atthepropertime,youwillbeplacedontheheartlungmachinewhichwillmechanicallytakeoverthefunctionofyourheartandlungsduringthesurgery.Afteryourdonorheartarrivesintheoperatingroom,mostofyouroldheartwillberemoved.Aportionoftheleftandrightatriaarelefttoattachyournewheart.Duringtheprocessofremovingyouroldheart,connectionsofthenervestotheheartarecut.Aftersurgery,itwilltakeaverylongtimefor someofthenervestogrowback.Inmostpatients,theyneverdo.Moreimportantly,thesenerveshelpregulateyourheartbeat.Aftersurgeryyouwillhavesmallpacingwiresattachedtoyournewheart.Thewireswillcomeoutthroughtheskinandmaybeattachedtoasmallboxcalledapacemaker.Thesewiresaretemporaryand willberemovedbeforeyouleavethehospital.Duringyouroperation,yourfamilywillbeupdatedregardingyourprogress.Theaveragetransplantoperationtakesaboutfourtofivehours.Whenthesurgeryisfinished,thesurgeonwillcometotalkwithyourfamily.Yourfamilywillbeallowedtoseeyouintheintensivecareunit,butnotvisitinyourroomuntilyouareawake.Itwillbeaboutanhourbeforethenursewillcallyourfamilytocomeseeyou.

PatientInitials

DateTime

Biopsies–Abiopsyoftheheartmuscleistheonlywaytoaccuratelydiagnoserejection.Youwillexperiencebiopsiesonascheduledbasis,morefrequentlythefirstsixmonthsaftertransplant.Clinicalsuspicionof rejectionmaymeanthatyourequireabiopsyonanunplannedbasis.Todoabiopsy,thecardiologistwillfirstinjecttheareaontherightsideofyourneck(orinyourgroin)withalocalanesthesia,whichwillsting.Hewilltheninsertatube into your neck (orgroin) and thread abiopsyforcep through the tube into theright side ofyour heart.He willtakefourorfivesmalltissuesamples,called biopsies.Youmayfeelyourheartfluttering,oroccasionally tugging,butthisisnotpainful. Whenthebiopsieshavebeenobtained,thebiopsyforcepandtubewillbewithdrawn,andabandageplacedoverthesite.Complicationsofabiopsyareveryrareandincludeaholeintheheartoryourheartchangingintoadifferentrhythm.

BloodDraws-Wheneverpossible,bloodwillbedrawnatthetimeofyourbiopsy.Whenyouhaveyourveinstuckdirectlywithaneedletodrawblood,youmayfeelslightdiscomfortandhaveasmallamountofbleedingorbruisingatthesitewheretheneedleisinserted.Asmallriskthatyoucouldgetaninfectionorclotintheveinexistswithanybloodcollection.

RisktotheUnborn–Becauseoftheimmunosuppressiveandotherdrugsthatyoumusttakefollowingahearttransplant,itis not recommended that femalerecipientsbecome pregnant.Males whohave had atransplantcanfatherchildren.

Rejection–Manypatientsexperienceatleastonerejectioninthefirstthreemonthsaftertransplant.Achangeinmedication is usually enough toreversethe rejectionalthough rejection canbefatal.Theincidence of rejection isneverzero.Therearenospecificsignsandsymptomsofrejection.YoucannotdoanythingtocauserejectionEXCEPTnottakeyourmedicationasprescribed.

Infection–Becauseyourimmunesystemissuppressedwithmedicines,youareatincreasedriskforalltypesofinfections.Risksofinfectionincludewoundinfectionatthetimeorsurgery,pneumonia,oronerelatedtoanyofthetubesyouwillhaveatthetimeofsurgery.Theriskofinfectionisthegreatestinthefirstfewmonthsaftersurgery,butriskremainsthroughoutyourlife.Althoughwithtreatmentyoucanrecoverfrommostinfections,sometimesinfectionresultsindeath.

GraftArteriosclerosis–Thisisthedevelopmentofcoronaryarterydiseaseinyournewheart–eventhoughyoudidnothavecoronaryarterydiseasebeforetransplant,youmaydevelopitinyournewheart.Thisisdifferentthanregularcoronaryarterydiseasewhichconsistsofadistinctnarrowinginonepartofabloodvessel.Graftarteriosclerosisisanarrowingofthebloodvesselthroughoutthelengthofthevessel–theentirelumenofthevesselbecomessmaller.Diet,exercise,andcontrolofcholesterolcanhelpinreducingthechance,butyoucanstilldevelopit.Occasionallysomepatientswithgraftarteriosclerosiscanbetreatedbyplacingastentinthecoronaryartery.Coronaryarterybypasssurgeryisalmostneveranoption.Occasionallyapatientwithgraftarteriosclerosismaybeacandidateforasecondtransplant.Youcanliveforseveralyearswithgraftarteriosclerosis,butitmayalsobefatalinashortperiodoftime.

Osteoporosis–ThisisweakeningofthebonesduetothesteroidPrednisonethatyoutaketohelppreventrejection.Osteoporosiscanleadtocompressionfracturesofthebonesinyourback,ormayresultintheneedforreplacementofjointssuchaships,knees,orshoulders.

PatientInitials

DateTime

Cancer–Afteratransplant,youareathigherriskfordevelopingcancersduetobeingonimmunosuppressivemedications. Skincancer isthe mostcommon type,followed bylymphoma –a cancerof thelymph system.Youcanalsodevelopanyothertypeofcancer–breast,lung,colon,prostate,brainorothers.Otherthansomeskincancers,cancerinatransplantpatientisnearlyalwaysfatal.

Psycho-Social–Hearttransplantationisstressfulforbothyouandyourfamily.Youmayexperiencestressesrelatedtoandincluding,butnotlimitedtodepression,bodyimagechanges,changesininter-personalrelationships,andfinances.Thesocialworkerandtransplantfinancialspecialistcanhelpyoudealwiththese.

Medications–forinformationonadditionalmedications,pleaserefertoyourtransplanteducationmanual.

• TacrolimusorCyclosporine-Thismedicationwillcauseimmunesuppressionwithincreasedriskofinfectionandmayalsocausekidneyandliverdamage,headache,tremorsinhands,animbalanceofsodiumandpotassium(electrolyte)levels,andhighbloodpressure.
• Mycophenolate–Thismedicationwillcauseimmunesuppressionwithincreasedriskofinfectionandmayalsocauselowwhitebloodcellcounts,stomachupset,ordiarrhea.
• Prednisone/Methylprednisolone-Thismedicationwillcauseimmunesuppressionwithincreasedriskofinfectionandmaycausefluidretention,weightgain,highbloodpressure,highbloodsugar,increasedappetite,moodchanges,lossofcalciumfrombone(osteoporosis)withincreasedriskofbrokenbones,anderosionofthebone(bonedamage).Diabetesorvisionabnormalities(cataracts)arerare,butmayoccur.
• Thymoglobulin-Thisdrugwillcauseimmunesuppressionwithincreasedriskofinfection,allergicreactions,fever,musclepain,jointpain,andrash.Itisusedspecificallytotreatrejectionandisnotaneverydaymedicine.

BENEFIT

Whenthehearttransplantissuccessful,youmayexperienceimprovementinyourqualityoflifeandalongerlifespan.Currently,accordingtoSRTR,theScientificRegistryforTransplants,patientandgraftsurvivalratesforhearttransplantationareasfollows:

• Nationaloneyearpatientsurvivalrate
• Nationaloneyeargraftsurvivalrate
• Ourprogramoneyearexpectedsurvivalrate
• Ourprogramoneyearactualsurvivalrate
• Ourprogramoneyearexpectedgraftsurvivalrate
• Ourprogramoneyearactualgraftsurvivalrate

%

%

%

%

%

_%.Date _/

ALTERNATIVES

Ifyouchoosenottoproceedwithtransplantation,youmaycontinuetohavethecurrentmedicaltreatmentthatyouhavenow.Youmayalsochoosetoreceivenotreatmentforyourdisease,inwhichcaseyourdoctorwillcontinuetoprovidecaretoyou.

PatientInitials

DateTime

CONFIDENTIALITY

Wearerequiredbylawtomaintaintheprivacy/confidentialityofyourhealthinformation.Allinformationthatisobtainedinconnectionwiththisprocedure,whichcanbelinkedtoyou,willremainasconfidentialaspossiblewithintherequirementsofstateandfederallaw.Theresultsofthisprocedurewillbereviewedandmaybepublishedinascientificjournalorbookwithoutidentifyingyoubyname.Recordswillbekeptregardingthisprocedureandwillbemadeavailableforrequiredreviews/auditbyrepresentativesoftheFoodandDrugAdministration (FDA),members of XXX hearttransplant program,membersoftheHeartmate/ThoratecRegister,andrepresentativesofUnitedNetworkforOrganSharing(UNOS)undertheguidelinesestablishedbytheFederal PrivacyAct.FederalandStatereviewers/auditorsmayalsohaveaccesstoyourmedicalrecords,whichcontainyouridentityhowevertheyarerequiredtomaintainconfidentiality.Yourinsurancecompanymayalsoreviewyourrecord.

LIABILITYANDCOMPENSATION

Adversecomplications andoutcomesarepossibleinanytransplantproceduredespitetheuse ofhighstandards.Complicationsandoutcomesthatweareawareofaredescribedinthisconsentform.However,weareunabletopredictallcomplicationsthatmayoccurandcouldrequirecare.Sometimes,despiteallthebesteffortsbybothyouandthehearttransplantteam,unexpectedcomplicationsoroutcomesoccur.Ifyoubecomesickorhurtbecauseyoureceivedatransplant,thehospitalanddoctorswilltreatyou.Thehospitalanddoctorswillalsosendthebilltoyouoryourinsurancecompany.Youdonotgiveupanyofyourlegalrightsbysigningthisform.Bysigning thisform,youindicate that membersofthe transplantteamhaveinformedyou aboutthisprocedure,yourquestionshavebeenansweredsufficiently,andthatyouagreetoproceed.

YoucanobtainfurtherinformationbycallingtheHeartTransplantOfficeat816-932-3264.

ILLEGALSALEOFORGANS

Thesaleorpurchaseofhumanorgansisafederalcrimeanditisunlawfulforanypersontoknowinglyacquire,receive,orotherwisetransferanyhumanorganforvaluableconsiderationforuseinhumantransplantation.

VOLUNTARYPARTICIPATION

Yourparticipationisvoluntary,andyoumaychoosetonotparticipateormaywithdraw–betakenoffthelistatyourrequest-atanytimewithoutadverselyaffectingyourrelationshipwithyourdoctorsandnurses.Thetreatmentplanyoureceivefromyourdoctorsandnursesisbasedupontheirexperienceplusongoingreviewofthescientificliteraturerelatedtocareofhearttransplantpatients.Ifyouelecttochangedosagesordiscontinueanyorallofyourimmunosuppressivemedicationsonyourown,youwilllikelydie.

PatientInitials

DateTime

CMSINFORMATION

Specificoutcomerequirementsneedtobemetbytransplantcentersandwearerequiredtonotifyyouifwedonotmeetthoserequirements.Currently,XXX meetsallCenterofMedicareMedicaidServices(CMS)requirementsandisanapprovedMedicareheartandkidneytransplantcenter.Ifatsomepointduringthetimeyouarewaitingforahearttransplant,thehospitaldoesnotmeetCMStransplantcriteria,wewillnotifyyouinwriting.Ifyoureceiveatransplantatanon-Medicare-approvedtransplantcenter,itcouldaffectyourabilitytohaveyourimmunosuppressivedrugspaidforunderMedicarePartB.

AUTHORIZATION

Yoursignaturecertifiesthatyouhavedecidedtoproceed,havingreadtheinformationcontainedintheconsentform,havingreceived and readthepatienteducational manual provided to youatthetimeofyourevaluation,andhavinghadtherisksandbenefitsexplainedtoyou,eithertodayorpreviously.Uponsigningthisform,youwillreceiveacopy.

PatientSignatureDateTime

TransplantTeamPhysicianSignatureDateTime

TransplantCoordinatororNursePractitionerSignatureDateTime

TransplantSurgeonSignatureDateTime