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Heart Failure: Device Management PDF

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P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Heart Failure Heart Failure: Device Management Edited by Arthur M. Feldman © 2010 Blackwell Publishing Ltd. ISBN: 978-1-405-15258-7 P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome CommissioningEditor:ThomasV.Hartman DevelopmentEditor:KateNewell ProductionEditor:CathrynGates ProductionController:SusanShepherd P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Heart Failure: Device Management EDITED BY Arthur M. Feldman, MD, PhD MageeProfessorandChairman DepartmentofMedicine JeffersonMedicalCollege Philadelphia,PA USA A John Wiley & Sons, Ltd., Publication P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Thiseditionfirstpublished2010,(cid:1)C 2010byBlackwellPublishingLtd BlackwellPublishingwasacquiredbyJohnWiley&SonsinFebruary2007.Blackwell’spublishingprogramhas beenmergedwithWiley’sglobalScientific,TechnicalandMedicalbusinesstoformWiley-Blackwell. Registeredoffice:JohnWiley&SonsLtd,TheAtrium,SouthernGate,Chichester,WestSussex,PO198SQ,UK Editorialoffices:9600GarsingtonRoad,Oxford,OX42DQ,UK TheAtrium,SouthernGate,Chichester,WestSussex,PO198SQ,UK 111RiverStreet,Hoboken,NJ07030-5774,USA Fordetailsofourglobaleditorialoffices,forcustomerservicesandforinformationabouthowtoapplyfor permissiontoreusethecopyrightmaterialinthisbookpleaseseeourwebsiteat www.wiley.com/wiley-blackwell Therightoftheauthortobeidentifiedastheauthorofthisworkhasbeenassertedinaccordancewiththe Copyright,DesignsandPatentsAct1988. Allrightsreserved.Nopartofthispublicationmaybereproduced,storedinaretrievalsystem,ortransmitted, inanyformorbyanymeans,electronic,mechanical,photocopying,recordingorotherwise,exceptas permittedbytheUKCopyright,DesignsandPatentsAct1988,withoutthepriorpermissionofthepublisher. Wileyalsopublishesitsbooksinavarietyofelectronicformats.Somecontentthatappearsinprintmaynotbe availableinelectronicbooks. Designationsusedbycompaniestodistinguishtheirproductsareoftenclaimedastrademarks.Allbrand namesandproductnamesusedinthisbookaretradenames,servicemarks,trademarksorregistered trademarksoftheirrespectiveowners.Thepublisherisnotassociatedwithanyproductorvendormentioned inthisbook.Thispublicationisdesignedtoprovideaccurateandauthoritativeinformationinregardtothe subjectmattercovered.Itissoldontheunderstandingthatthepublisherisnotengagedinrendering professionalservices.Ifprofessionaladviceorotherexpertassistanceisrequired,theservicesofacompetent professionalshouldbesought. Thecontentsofthisworkareintendedtofurthergeneralscientificresearch,understanding,anddiscussion onlyandarenotintendedandshouldnotberelieduponasrecommendingorpromotingaspecificmethod, diagnosis,ortreatmentbyphysiciansforanyparticularpatient.Thepublisherandtheauthormakeno representationsorwarrantieswithrespecttotheaccuracyorcompletenessofthecontentsofthisworkand specificallydisclaimallwarranties,includingwithoutlimitationanyimpliedwarrantiesoffitnessfora particularpurpose.Inviewofongoingresearch,equipmentmodifications,changesingovernmental regulations,andtheconstantflowofinformationrelatingtotheuseofmedicines,equipment,anddevices,the readerisurgedtoreviewandevaluatetheinformationprovidedinthepackageinsertorinstructionsforeach medicine,equipment,ordevicefor,amongotherthings,anychangesintheinstructionsorindicationofusage andforaddedwarningsandprecautions.Readersshouldconsultwithaspecialistwhereappropriate.Thefact thatanorganizationorWebsiteisreferredtointhisworkasacitationand/orapotentialsourceoffurther informationdoesnotmeanthattheauthororthepublisherendorsestheinformationtheorganizationor Websitemayprovideorrecommendationsitmaymake.Further,readersshouldbeawarethatInternet Websiteslistedinthisworkmayhavechangedordisappearedbetweenwhenthisworkwaswrittenandwhenit isread.Nowarrantymaybecreatedorextendedbyanypromotionalstatementsforthiswork.Neitherthe publishernortheauthorshallbeliableforanydamagesarisingherefrom. LibraryofCongressCataloging-in-PublicationData Heartfailure:devicemanagement/editedbyArthurM.Feldman. p.;cm. Includesbibliographicalreferences. ISBN978-1-4051-5258-7 1.Heartfailure–Treatment. 2.Heart,Artificial. I.Feldman,ArthurM.(ArthurMichael),1949– [DNLM:1.HeartFailure–therapy. 2.Heart-AssistDevices.WG370H4363052010] RC685.C53H43472010 616.1(cid:2)29–dc22 2009018586 ISBN:9781405152587 AcataloguerecordforthisbookisavailablefromtheBritishLibrary. Setin9.5/12pt.MinionbyAptara(cid:1)R,Inc.,NewDelhi,India PrintedandboundinMalaysia 1 2010 P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Contents Contributors, vi 8 TheUseofEchocardiographyinEvaluatingthe HeartFailurePatientandResponseto Preface, viii Therapy, 88 1 CardiacResynchronizationTherapy, 1 JohnGorscanIII BehzadPavriandArthurM.Feldman 9 RevascularizationforLeftVentricular Dysfunction, 99 2 ImplantableCardioverter-Defibrillator NicholasJ.RuggieroII,ThomasJ.Kiernan, Therapy, 18 JuanM.BernalandIgorF.Palacios ReginaldT.HoandArnoldJ.Greenspon 10 MinimallyInvasiveTreatmentofMitralValve 3 ChronicImplantableMonitoring, 29 Disease, 111 NishaAggarwalandDavidJ.Whellan AndraM.PopescuandPaulJ.Mather 4 CardiacContractilityModulationbyElectrical 11 PercutaneousMechanicalAssistDevices, 120 SignalsAppliedduringtheAbsoluteRefractory SureshMulukutla,LawrenceSchneiderand PeriodasaTreatmentforChronicHeart HowardA.Cohen Failure, 44 12 LeftVentricularAssistDevicesforAcuteand DanielBurkhoff,HaniN.Sabbah, ChronicHeartFailure, 133 ChristianButter,YuvalMikaand DanielMarelli,LouisStein,AbbasArdehali MartinBorggrefe 13 TheRoleofEnhancedExternal 5 TheRoleofCardiacRestraintDevicesinthe CounterpulsationinHeartFailure TreatmentofPatientswithDilated Management, 151 Cardiomyopathy, 59 MarcA.SilverandWilliamE.Lawson DouglasL.Mann 14 UltrafiltrationintheManagementof 6 TheRoleofRightHeartCatheterizationinthe HeartFailure, 165 ManagementofPatientswithHeart MariaRosaConstanzo Failure, 68 Conclusion:FindingtheRightDeviceor SandeepA.KamathandMarkH.Drazner theRightPatient, 172 7 ImpedanceCardiography, 77 Index, 175 SunthoshV.Parvathaneniand IleanaL.Pin˜a ConflictofInterestTable, 183 v P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Contributors Nisha Aggarwal,MD Mark H. Drazner,MD,MSc DivisionofCardiology DonaldW.ReynoldsCardiovascularClinicalResearchCenter DepartmentofMedicine DivisionofCardiology JeffersonMedicalCollege DepartmentofInternalMedicine Philadelphia,PA UniversityofTexasSouthwesternMedicalCenter USA Dallas,TX USA Abbas Ardehali,MD DavidGeffenSchoolofMedicine Arthur M. Feldman,MD,PhD UniversityofCalifornia DepartmentofMedicine LosAngeles,CA JeffersonMedicalCollege USA Philadelphia,PA Juan M. Bernal,MD USA DivisionofInterventionalCardiology Arnold J. Greenspon,MD MassachusettsGeneralHospital DivisionofCardiology Boston,MA DepartmentofMedicine USA JeffersonMedicalCollege Martin Borggrefe,MD Philadelphia,PA Fakulta¨tfu¨rklinische USA MedizinderUniversita¨tHeidelberg John Gorcsan III,MD Mannheim TheCardiovascularInstitute Germany UniversityofPittsburgh Daniel Burkhoff,MD,PhD Pittsburgh,PA ColumbiaUniversity USA NewYork,NY Reginald T. Ho,MD USA;and DivisionofCardiology IMPULSEDynamicsUSA DepartmentofMedicine Orangeburg,NY JeffersonMedicalCollege USA Philadelphia,PA Christian Butter,MD USA HeartCenterBrandenburgBernau/Berlin Bernau Sandeep A. Kamath,MD Germany DonaldW.ReynoldsCardiovascularClinicalResearchCenter DivisionofCardiology Howard A. Cohen,MD DepartmentofInternalMedicine LenoxHillHeartandVascularInstitute UniversityofTexasSouthwesternMedicalCenter NewYork,NY Dallas,TX USA USA Maria Rosa Costanzo,MD Thomas J. Kiernan,MD MidwestHeartFoundation DivisionofInterventionalCardiology EdwardHeartHospital MassachusettsGeneralHospital Naperville,IL Boston,MA USA USA vi P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Contributors vii William E. Lawson,MD Ileana L. Pin˜a,MD SUNY,StonyBrook Harrington-McLaughlinHeart&VascularInstitute StonyBrook,NY DepartmentofInternalMedicine USA UniversityHospitalsCaseMedicalCenter CaseWesternReserveUniversity Cleveland,OH Douglas L. Mann,MD USA;and WintersCenterforHeartFailureResearch LouisStokesClevelandVAMedicalCenter SectionofCardiology Cleveland,OH DepartmentofMedicineandDepartmentof USA MolecularPhysiologyandBiophysics BaylorCollegeofMedicine Behzad Pavri,MD Houston,TX DivisionofCardiology USA DepartmentofMedicine JeffersonMedicalCollege Philadelphia,PA Daniel Marelli,MD USA DivisionofCardiothoracicSurgery Andra M. Popescu,MD DepartmentofSurgery DepartmentofMedicine JeffersonMedicalCollege JeffersonMedicalCollege Philadelphia,PA Philadelphia,PA USA USA Nicholas J. Ruggiero II,MD Paul J. Mather,MD DivisionofInterventionalCardiology DivisionofCardiology MassachusettsGeneralHospital DepartmentofMedicine Boston,MA JeffersonMedicalCollege USA Philadelphia,PA USA Hani N. Sabbah,PhD HenryFordHealthSystem Detroit,MI Yuval Mika,PhD USA IMPULSEDynamicsUSA Orangeburg,NY Lawrence Schneider,MBBS USA LenoxHillHeartandVascularInstitute NewYork,NY USA Suresh Mulukutla,MD Marc A. Silver,MD UniversityofPittsburghMedicalCenter DepartmentofMedicine Pittsburgh,PA HeartFailureInstitute USA AdvocateChristMedicalCenter OakLawn,IL Igor F. Palacios,MD USA;and DivisionofInterventionalCardiology UniversityofIllinois MassachusettsGeneralHospital Chicago,IL Boston,MA USA USA Louis Stein,MHS,PhD DivisionofCardiothoracicSurgery Sunthosh V. Parvathaneni,MD DepartmentofSurgery JeffersonMedicalCollege Harrington-McLaughlinHeart&VascularInstitute Philadelphia,PA DepartmentofInternalMedicine USA UniversityHospitalsCaseMedicalCenter CaseWesternReserveUniversity David J. Whellan,MD,MHS,FACC Cleveland,OH DivisionofCardiology USA;and DepartmentofMedicine LouisStokesClevelandVAMedicalCenter JeffersonMedicalCollege Cleveland,OH Philadelphia,PA USA USA P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Preface Heart failure is a disease of epidemic proportions failureas50%ofthemdiedsuddenly,presumably affectingover5millionpeopleintheUnitedStates secondarytoatachyarrhythmia.However,itwould and close to 30 million worldwide. Over the last benearly25yearsbeforetheuseofthedevicewas threedecadesenormousstrideshavebeenmadein shown to improve survival when used for either ourabilitytoimprovesymptomsandprolonglife primaryorsecondaryprotection.Overthepast30 inpatientswithheartfailure.Inthepreviousvol- years,thesizeofthedevicehasbeendecreasedal- ume of Heart Failure we discussed the traditional lowingittobemovedfromthepatient’sabdomento drugtreatmentsavailableforheartfailurepatients thesubclavianposition,leadscannowbeimplanted as well as the many new and innovative pharma- percutaneouslyratherthanbeingplacedsurgically cologictherapiesthathavebeenorwillshortlybe on the epicardial surface of the heart, the battery addedtoourtherapeuticarmamentarium.Inthis life has been greatly extended, the devices can be volumeofHeartFailurewewillfocusonthemany interrogated telephonically to assess extensive in- newandnovel“device”technologiesthatenhance formationaboutboththedeviceandcardiacfunc- ourabilitytocareforpatientswiththisprogressive tion,andthedefibrillatorcanbecombinedwitha disease.Forthepurposesofthistexttheterm“de- biventricularpacemaker. vice”willbegivenarelativelyliberaldefinitionas Interestingly,theparadigmforthedevelopment it will apply to “equipment” or “technology” that ofdevicesforthetreatmentofheartfailureisquite isimplantedwithinthepatienttomeasureoren- differentfromthedevelopmentalparadigmfornew hancecardiacfunction,isattachedtothepatientfor drugs.Withrareexceptions,pharmacologicagents diagnosticinformationortherapeuticeffects,oris developedforthetreatmentofheartfailureundergo usedtoevaluatethepatientinawaythatprovides rigorous clinical evaluation in Phase I, Phase II, fundamentalinformationinrealtimeregardingthe andPhaseIIIclinicaltrials.Theprimaryendpoint physiologyoftheheart—informationthatcanthen of most Phase III clinical trials (e.g. β-blockers, beutilizedtomodifytherapyorto“tune”theeffec- angiotensin-converting enzyme inhibitors, aldos- tivenessofanimplanteddeviceorpharmacologic teroneantagonists)hasbeentheeffectofapharma- therapy. cologicagenteitheronthecombinedendpointof Drugs have been available for the treatment of hospitalizationforworseningheartfailureordeath heartfailuresinceWilliamWitheringfirstdiscov- or on the single endpoint of all-cause mortality. eredthesalutarybenefitsofthefoxgloveplant(later By contrast, devices are often evaluated and ap- recognized as digoxin) during the 1700s. By con- proved based on their ability to effectively fulfill trast,thefirstuseofa“device”forthetreatmentof theirproposedneedinasafeandreliablemanner. heartfailureoccurredon4February1980whenDr Forexample,ventricularpacemakerswerenotap- LeviWatkinsimplantedanautomaticimplantable provedbecausetheysavedlives,butratherbecause defibrillatorinventedbyDrMichelMirowskiinthe they demonstrated the ability to initiate a signal abdominalcavityofapatientattheJohnsHopkins thatwouldeffectivelyinduceacontractileresponse Hospital.Thehopewasthatthedefibrillatorwould inthepresenceofablockinthenormalelectrome- prevent sudden death in a patient with a history chanicalsignalingpathway.Insomecases,thevalue of ventricular tachycardia. This was an enormous of individual devices has come after, rather than leapforwardinthetreatmentofpatientswithheart beforetheapprovalofthedevice.Oneexampleis viii P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome Preface ix biventricularpacing,firstapprovedonthebasisof cardiacremodeling(ImpulseTherapyandCardiac earlystudiesdemonstratingthatresynchronization Restraint).Thenextthreechaptersdescribeexter- oftheheartcouldimproveheartfailuresymptoms, nal devices that have the potential to assess car- exercise tolerance, and quality of life in patients diacriskand/ortheabilitytohelpphysicianstitrate with heart failure. The role of resynchronization both drug and device therapy. These include The therapy in improving both survival and the com- RoleofRightHeartCatheterizationintheManage- binedendpointofsurvivalandhospitalizationfor ment of Patients with Heart Failure, the value of worseningheartfailurecameinsubsequentPhase Bioimpedance for serial monitoring of heart fail- IV studies. However, studies of resynchronization ure patients, and the Use of Echocardiography in were surprising as they demonstrated that a de- EvaluatingtheHeartFailurePatientandResponse vice could actually enhance cardiac remodeling, to Therapy. The final group of chapters provides alter the molecular biology of the heart, and im- adiscussionofinvasivetechnologies—bothsurgi- provesurvival.Thus,thelong-heldviewthata“de- cal and nonsurgical—that can provide urgent or vice”couldnotinfluencethebiologyoftheheart chronicsupportinpatientswithsevereleftventric- was challenged not just by the results of a single ular dysfunction, including Revascularization for studybutbymultiplestudiesinavarietyofpatient LeftVentricularDysfunction,theuseofMinimally populations. Invasive Treatment for Mitral Valve Disease, Per- Anotherimportantdifferencebetweendrugsand cutaenous Mechanical Assist Devices in patients devicesisthatanindividualphysiciancanadmin- with acute cardiac decompensation or as a sup- isteradrugtotheirpatient.However,theuseofa portdeviceduringhigh-riskrevascularization,the deviceoftenrequiresthecollaborationofamulti- useofLeftVentricularAssistDevicesasabridgeto disciplinaryteam.Forexample,theplacementofan transplantationorabridgetorecovery,andtheuse internalcardioverterdefibrillatorrequiresthecol- ofCounterpulsationandUltrafiltrationinpatients laborationofacardiologist(orinternist),anelec- withbothacuteandchronicheartfailure. trophysiologist,andoccasionallyasurgeonspecial- Thetreatmentofpatientswithheartfailureisa izinginthethorascopicplacementofleadsonthe continuouslymovingtargetasnewdevicesarebe- epicardium of the heart. For other devices, there ingdeveloped.Inthistextwehavefocusedonthose mayonlybeasinglephysicianataninstitutionthat technologiesthatinsomecasesareavailableatmost can implant a specific device. For example, some hospitalsthathaveprogramsinelectrophysiology percutaneous devices require skills in transseptal andcardiacsurgeryaswellasnewtechnologiesthat procedures—atechnologyaroundwhichonlysome areavailableorundergoinglate-stageinvestigation interventionalcardiologistsareskilledandonethat at quaternary hospitals with surgical and medical requiresthecollaborationofheartfailurespecialists heartfailureprograms.Withtheincreasingnumber andinterventionalists.Similarly,valvereplacement ofoptionsavailabletophysicians,therewillbean orrepaircanbeacriticalfeatureinthetreatment increasing need to identify the right intervention of a patient with heart failure—but one that also for the right patient. Thus, we have tried to pro- requiresamultidisciplinaryteamapproachtothe vide guidelines within each chapter that will help patient. to define those patients that will be benefited the The various chapters in this text can be subdi- mostbyeachofthesedifferenttherapies.However, videdbasedontheroleofthedeviceinthecareof decisionsregardingeachofthesenewtherapeutic patientswithheartfailure.Thefirstfivechaptersde- optionswillinmanycasesbebasedonthepresen- tailagroupofdevicesthatarechronicallyimplanted tationandneedsofeachindividualpatient.Unlike toeitherimprovecardiacfunctionorincreasesur- drugtherapywherepracticeguidelineshavedefined vival(CardiacResynchronizationTherapyandIm- boththelistofoptimalmedicationsandthetarget plantableCardioverter-DefibrillatorTherapy),pro- therapeuticlevelsforheartfailuremedications,we vide online and real-time monitoring of cardiac willseethattheuseofdevicetherapyisfarlessclear. function (Chronic Implantable Monitoring), or Hopefully,futurestudieswillbetterdefinetheeffec- newimplantabledevicesthatmayhavetheability tivenessofthesevarioustherapiesandmoreclearly to improve cardiac function or delay maladaptive definetheirroleinthecareofheartfailurepatients. P1:OJL/OTE/SPH P2:OTE BLBK215-FM BLBK215-Feldman October15,2009 11:5 PrinterName: YettoCome x Preface Thistextwouldnothavebeenpossiblewithout internist. Thanks go to Kate Newell at Wiley- thecontributionofthemanyexpertswhogaveof Blackwell who has nursed this book through the theirtimeandenergytoaddresseachofthesecom- editorial process. Special thanks go to Marianne plex technologies in a manner that will be useful LaRussawithoutwhoseeditorialsupportthisbook for the cardiologist,the surgeon, and the general wouldnothavebeenpossible. ArthurM.Feldman

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