Severalotherrecentstudieshaveshowngoodoutcomeswithlongertimeson
temporarydevicepumpsandasbridgetotransplant.22,23AreviewoftheOrgan
ProcurementandTransplantationNetworkdatafoundthatpriorto2011,fewer
thanthreeofthesedeviceswereusedperyearasabridgetotransplant,withan
explosioninuseto50ofthesetemporarydevicesbeingusedasbridgeto
transplantin2015.Inthisreview,CentriMag/PediMagwasbyfarthemost
common,usedin65%ofpatients,followedbytheTandemHeartpump(not
system),usedin18%.Importantly,incomparisontotheECMOcohort,a
propensityscore-matchedshort-termMCScohorthadlongersurvivalto
transplant,aswellaslongeroverallsurvival.Datahavealsoshownthat,if
temporarysupportisusedforachronicheartfailurepatientwithacute
cardiogenicfailure,thevastmajorityofthesepatientswillnotrecoverandwill
requireconversiontolong-termVADsupport.
CurrentDevicesforLong-Term
MechanicalCirculatorySupportin
Children
BerlinHeartEXCOR
TheBerlinHeartEXCORisaparacorporealpulsatile,pneumatically
compressed,volumedisplacementpump.Itisavailablein10-,15-,25-,30-,50-,
and60-mLbloodchambersizes(Fig.66.3).23Itisthemoststudiedpediatric
VAD,withmorethan1800implants,theonlytobeFDAapproved,andthemost
commonlyusedworldwide.25Useofcustomizedpolyurethanevalveshas
allowedthemanufactureofsmallerbloodpumpsizesthanareavailablewith
“adult”pumps,whichhaveusedcommerciallyavailablemechanicalvalves.Its
firstreportedsuccessfuluseasabridgetotransplantationoccurredin1990.26
Thelongestknownsupporttimehasbeen877daystosuccessfultransplant.27
TheexperienceattheBerlinHeartInstitutehasbeenextensivelyreported.28–30A
totalof74pediatricpatientsweresupportedtherefrom1990to2006,witha
meanageof7.6years(range,2daysto17years)andameansupporttimeof36
days.Fifteenpercentofthesepatientswereweanedfromthedevice,with43%
receivingahearttransplant;41%ofthechildrendiedduringVADsupport.The
groupnotessignificantimprovementfromtheyear2000onward,witha74%
survivalratetotransplantationordischargedespiteayoungerpatientpopulation.
Theauthorsnotethatchangesintheirdecision-makingprocessfromearlierto
laterintheexperienceincludedearlierimplementationofsupportbeforethe
developmentofsignificantend-organfailure,improvementsincannuladesign,
apicalleftventricleratherthanatrialcannulation,fewerbiventricularVADs
(BiVADs),andafocusontheanticoagulationprotocol.
FIG.66.3 TheBerlinHeartEXCORdevicehassixbloodchambersizes
(10,15,25,30,50,and60mL)andmultiplecannulaoptionstospanthe
pediatricagegroup.(CourtesyRobertKroslowitz,BerlinHeart,Inc.,Berlin,
Germany.)
ThedevicewasfirstusedinNorthAmericain2000,andby2004therewas
widespreaduse.TheinitialEXCORexperienceintheUnitedStatesfrom2000
to2007(n=73)wasreportedtohaveapositiveoutcomein77%ofpatients31
andpavedthewayforaprospective,multicenter,clinicalcohortinvestigational
deviceexemption(IDE)study.TheIDEstudyenrolled48patientsfrom2007to
2010andconclusivelydemonstratedEXCORtobesuperiortoECMOin
bridgingchildrentotransplantation.25Theoutcomesofall204childrenwho
underwentEXCORimplantationduringthedurationoftheIDEstudywasalso
publishedandwasbelievedtorepresentthereal-worlduseofEXCORinNorth
America.32Inthisstudy,75%ofpatientssurvivedtotransplantationorrecovery,
withlowerweight,higherbilirubinvalues,andBiVADsupportpredictingearly
mortality(<2months).Bilirubinextremesanddecreasedglomerularfiltration
rateatimplantpredictedlatemortality(>2months).Themostcommoncauseof
deathwasstroke(33%),mostoftenofthromboembolicorigin.Lowerweightat
implantationandlargepumpsizetobodysurfacearea(BSA)havebeen
associatedwithneurologicinjuryinotherstudies.33,34Importantly,onlyone
deathintheNorthAmericanexperiencewasattributedtodevicemalfunction.
Recentstudiescomparingposttransplantsurvivalinthosebridgedtotransplant
withEXCORversusnoMCSshowedcomparablesurvivalbetweenthegroups,
with94%,90%,and72%survivalat30days,1year,and5years,respectively,
intheEXCORgroup.35Thiswascongruentwithpreviousfindings,which
additionallyidentifiedsimilar1-yearsurvivalbetweenEXCORpatientswithand
withoutcomplications.36Thelatterstudyalsonotedasignificantlyhigher
incidenceofdeathaftertransplantinpatientswithCHDcomparedwiththose
withcardiomyopathy(26.1%vs.7.2%).