ICD治療進(jìn)展ICD應(yīng)用于心源性猝死-ICD治療目前的困惑

ICD治療進(jìn)展

ICD應(yīng)用于心源性猝死

--ICD治療目前的困惑--持續(xù)性單形性室速?室顫?心搏停止猝死可源于多種情況急性心肌缺血引發(fā)室顫猝死可源于多種情況完全性心臟傳導(dǎo)阻滯?

室顫猝死可源于多種情況與CHF惡化相關(guān)的長間歇依賴性尖端扭轉(zhuǎn)型室性心動(dòng)過速猝死可源于多種情況GuidantServicesEuropeSource:1U.S.CensusBureau,StatisticalAbstractoftheUnitedStates:2001.2AmericanCancerSociety,Inc.,SurveillanceResearch,CancerFactsandFigures

2001.32002

HeartandStrokeStatisticalUpdate,AmericanHeartAssociation.4Circulation.2001;104:2158-2163.*BasedonU.Spublisheddata.PublisheddataforEuropenotavailable;statisticsbelievedtobesimilarforEurope?GuidantServicesEurope2005心源性猝死是頭號(hào)殺手

*

院外心搏停止事件中得以幸存的比例19%西雅圖-198230%AED西雅圖-19880.8%(Blacks)2.6%(Whites)芝加哥-199314%邁阿密-19747%AED邁阿密-2002SCD的二級(jí)預(yù)防

AVID/CIDS/CASH薈萃分析60%MUSTT55年54%MADIT42年20%CIDS33年37%CASH22年31%AVID3年ICD與抗心律失常藥物治療

在降低總死亡率方面的對照0%10%20%30%40%50%60%%死亡率降低程度1TheAVIDInvestigators.NEnglJMed.1997;337:1576-1583.2

KuckK.ACC98NewsOnline.April,1998.Pressrelease.3ConnollyS.ACC98NewsOnline.April,1998.Pressrelease.4MossAJ.NEnglJMed.1996;335:1933-1940.5BuxtonAE.NEnglJMed.1999;341:1882-1890.藥物治療的成本和ICD(1)GuidantServicesEurope每日的成本:ICD治療

≤

常用心血管處方藥及其他藥物Source:1NHSUKMiCentralMedicinesInformationservicefordrugs2EURO-MED-STAT20043Guidantestimates(basedon6yrslongevity)4JimFurniss,3rdSeptember2003,London5Gleevec:successbydesigninoncology,ColumbiaUniversity

6DiffusionofmedicinesinEurope,OlivierSchoffski,December2002?GuidantServicesEurope2005藥物治療的成本和ICD(2)Source:1Guidantestimates2EURO-MED-STAT2004,

3MinistryofHealth-Italy,4PrescriptionPricingAuthority-NHSUK,5OECDHealthWorkingPaper2003ICD治療的成本只是主要心血管藥物支出的一小部分*IncludesFr,Ge,It,UKonly?GuidantServicesEurope2005降低死亡率和SCD的

非抗心律失常藥物β-阻滯劑ACEI類藥物ARB類藥物

他汀類藥物

醛固酮拮抗劑

阿斯匹林二級(jí)預(yù)防臨床研究的提示采用ICD治療有明確室性心律失常病史的患者，每年可以挽救500條生命而這僅占SCD受害者總?cè)藬?shù)的0.1%僅有8%的臨床適應(yīng)證患者最終接受ICD治療

Source:Guidantestimates?GuidantServicesEurope2005心梗后危險(xiǎn)分層1284患者-MI/in1month平均EF–49%隨訪-21個(gè)月Cardiacdeath+cardiacarrest-3.9%LaRovereetal.Lancet1998;351:478

ATRAMI研究心梗后危險(xiǎn)分層

ATRAMI研究LaRovereetal.Lancet1998;351:478

ATRAMIEF值和NSVT與心律失常事件的關(guān)系LaRovereetal.Circulation.2001;103:2072時(shí)間（月）

無事件生存率

JACC2003;42:652700名急性心梗后幸存者95%接受β阻滯劑平均隨訪–43個(gè)月

37非SCD(5.5%) 22SCD(3.2%)JACC2003;42:652幸存者(n=574)Non-SCD(N=37)SCD(N=22)射血分?jǐn)?shù)

(平均)46%37%41%MADITI研究的入選標(biāo)準(zhǔn)CADLVEF<35%非持續(xù)性室速(NSVT)可誘發(fā)的室速(VT)

(+EPS)MADITI–生存率1.00.80.60.40.20.0012345年生存率常規(guī)治療ICDMossAJ.NEnglJMed.1996;335:1933-1940.p=.0092年末死亡率39%比16%HR-0.46MUSTT隨機(jī)患者結(jié)果

總死亡率BuxtonAE.NEnglJMed.1999;341:1882-90.入選后時(shí)間

(年)01234500.10.20.30.40.50.6無事件發(fā)生率p<0.001EP-GuidedRx,NoICDNoEP-GuidedAARxEP-GuidedRx,ICDBuxtonAE.etal.NEnglJMed1999;341:1882-90BuxtonAE.etal.NEnglJMed2000;342:1937-45

0.10.20.30.40.50.601224364860死亡率月誘發(fā)出,隨機(jī)化進(jìn)入NoRx未誘發(fā)出,進(jìn)入登記研究p=0.09(未校正)

p=0.005(校正)總死亡率MUSTT登記研究-EPS誘導(dǎo)的地位0MADITII–入選標(biāo)準(zhǔn)LVEF<30%>1次既往心梗史無心律失常依據(jù)心功能NYHAIV級(jí)1個(gè)月內(nèi)發(fā)生急性心梗3個(gè)月內(nèi)行CABG或PTCA術(shù)符合MADITI入選標(biāo)準(zhǔn)入選標(biāo)準(zhǔn)排除標(biāo)準(zhǔn)MADIT-II生存率

MossAJ.NEnglJMed.2002;346:877-83.ICD治療常規(guī)治療P=0.0071.00.90.80.70.60.0生存率01234年No.AtRiskICD治療 742 502(0.91) 274(0.94) 110(0.78) 9常規(guī)治療 490 329(0.90) 170(0.78) 65(0.69) 3MADITII:心梗后患者從ICD治療中的獲益WilberDJ,etal.

NASPE,24thScientificSession,WashingtonDC,

May2003[abstract10085].年齡<65yrs年齡>65yrsHR=0.84P=0.52HR=0.58P=0.01

MADIT-II(年齡)危險(xiǎn)比（Hazardratio）=0.30p=0.001危險(xiǎn)比（Hazardratio）

=0.86p=0.71DINAMIT

DefibrillatorINAcuteMITrial

除顫器應(yīng)用于急性心梗的臨床研究近期心梗(6–40天)LVEF≤35%和HRV降低(SDNN≤70ms或24h平均RR≤750ms)年齡18-80歲累積全因死亡風(fēng)險(xiǎn)累積風(fēng)險(xiǎn)隨機(jī)化后的時(shí)間（月）對照組LVEF和SCA事件deVreede-SwagemakersJJ.JAmCollCardiol.1997;30:1500-1505.LVEF%SCA受害者7.5%5.1%2.8%1.4%有NSVT的患者

無NSVT的患者擴(kuò)心?。―CM）+冠心?。–AD）和心衰（CHF）

EF<35%

心功能NYHAII級(jí)或III級(jí)

6分鐘步行試驗(yàn),Holter

SCDHeFTR安慰劑ICD胺碘酮意向治療（intension-to-treat）死亡率0.40.30.20.10死亡率06121824303642485460隨訪時(shí)間（月）胺碘酮ICD治療安慰劑

HR 97.5%Cl P-Value胺碘酮vs.安慰劑 1.06 0.86,1.30 0.529ICD治療vs.安慰劑 0.77 0.62,0.96 0.007ICD植入指南臨床研究明顯拓寬了ICD植入適應(yīng)證(二級(jí)預(yù)防拓展到一級(jí)預(yù)防)EF值<30%的CADEF值<35%的CHFEF值<40%伴+EPS但在這些人群中，確實(shí)需要ICD治療的比例并不高，既然如此，我們能不能識(shí)別出并不需要ICD治療的低危亞組呢？心源性猝死（SCD）：危險(xiǎn)度和例數(shù)

SCD的年發(fā)生率%SCD的實(shí)際發(fā)生例數(shù)一般人群高CAD危險(xiǎn)高危CAD事件EF值

30％,CHF心臟停搏幸存者心肌梗死后的高?；颊?02010521100K200K 300KModifiedfromMyerburgetal.Ann.Int.Med.1993;119:1187SCD-HeFT,MADIT2AVIDMADIT,MUSTT

MADIT-II:

ICD對VT/VF的一次或一次以上準(zhǔn)確治療

36%年電擊復(fù)律的比例SCDHeFT:從植入至VT/VF電擊復(fù)律時(shí)間0.000.050.100.150.200.250.3001234581170740162223679NumberatriskYearsProportionwithshockSCDHeFT:根據(jù)病因從植入至VT/VF電擊復(fù)律時(shí)間非缺血性缺血性非缺血性缺血性3914203443592001983043131231134435例數(shù)ConsumerReports.org10overusedtestsandtreatments1.BACKSURGERY2.HEARTBURNSURGERY3.PROSTATETREATMENTS4.IMPLANTEDDEFIBRILLATORS.Thisdevices,whichautomaticallyshocktheheartbacktonormalrhythm,costsome$90000overalifetime.Yetone-thirdofpeoplewhogetthemmightnotreallyneedthem,accordingtoresearchreportedin2007.ThisyearMedicarewillpayforanestimated50000ofthedevices.5.CORONARYSTENTS6.……...7.……..HRSRespondstoConsumerReportsArticle

BruceD.Lindsay,PresidentofHeartRhythmSociety

Itwouldbetragicifapatientwithaaseriousheartrhythmdisorderdecidednottoreceiveapotentiallylifesavingimplantablecardioverterdefibrillator(ICD)afterreadingyourarticle.“10OverusedTestsandtreatments”.StudiesofICDsshowtheyare99percenteffectiveindetectingandstoppingdeadlyheartrhythmdisorderssuchassuddencardiacarrest,whichkillsmorethan250,000peopleeveryyearintheUnitedStatealone.Infact,clinicaltrialshavefoundthedevicestobethemostsuccessfultherapytopreventsuddencardiacdeathincertaingroupsofhigh-riskpatients.ThedecisiontoimplantanICDisbasedonwell-designedscientifictrialsinvolvingthousandsofpatients.OnekeytrialwasconductedincollaborationwiththeNationalInstituteofHealth.Inaddition,theNationalICDRegistrywascreatedtoprovidevaluablefeedbacktophysiciansandtoimprovepatientcare.TheobjectiveistomonitoroutcomesandimproveselectionofpatientswhobenefitfromICDtherapy.Therealtragedyisthatmanypeoplewhomeettheevidence-basedcriteriaandcouldbenefitfromthesedevicesdonotreceivethem,resultinginthousandsofdeatheachyear.Youmisleadyourreader,especiallyheartpateints,bysuggestingthatthesedevicearenotneededorthatphysiciansarenotfollowingevidence-basedguidelines.Patientsshouldmakeaninformeddecisionaboutthislifesavingtechnologybasedondiscussionswiththeirphysician.如何更好選擇ICD患者?對于隨機(jī)化進(jìn)入常規(guī)治療組患者進(jìn)行的多變量Cox模型分析中，非侵入性的ECG參數(shù)對總死亡率的預(yù)測值Late-BreakingClinicalTrials,NASPE2002MADITIIMADIT-II:常規(guī)治療中危險(xiǎn)因素?cái)?shù)量與心臟性死亡風(fēng)險(xiǎn)的關(guān)系未校正的P值患者的危險(xiǎn)因素?cái)?shù)量心源性死亡率年ALPHAlendssupportforTWAtestinginnonischemicHF

EventsduringFollow-upEventAllptsAbnormalTWANormalTWA(n=446)(n=292)(n=154)

TotalMortality28253CardiacDeath1816