ICD适应证及-级预防

2014-06ICD适应证及“1.5级”预防Contents•ICD二级预防临床•ICD一级预防临床•缺血性心肌病患者•心衰患者•“1.5级”预防•指南回顾SCD的定义•临床上有心脏骤停（SCA）的证据•从突发症状到死亡的时间在1h之内不明原因的死亡•之前24h内病人情况良好KimSG.StandardizedreportingofICDpatientoutcome:thereportofaNorthAmericanSocietyofPacingandElectrophysiologyPolicyConference,February9-10,1993.PACE1993;16:1358-1362.心脏猝死(suddencardiacdeath,SCD)心脏骤停SCA(suddencardiacarrest)心脏骤停是美国主要的死亡原因之一1AmericanCancerSociety.CancerFactsandFigures2006.2CIA.TheWorldFactbook–rankOrder–HIV/AIDS–deaths.Availableat:http//乳腺癌1162,500肺癌1335,000SCA3中国人口基数大，每年SCD的发病人数超过540,000！国家十五攻关SCD流行病学调查数据：中国SCD发病率为41.8/100KHuaetal.JACCSeptember15,2009:1110–8BAdaptedfromBayesdeLunaA.AmHeartJ.1989;117:151-159.ayésdeLunaA.AmHeartJ.1989;117:151-159.SCD心律失常类型心动过缓17%VT62%原发性VF8%尖端扭转室速13%心律失常88%其他心脏原因12%心脏性猝死的预防他们的猝然离世带给我们什么警示？心脏性猝死的预防•二级预防对已发生过心脏骤停或持续性室速的幸存者实施预防•一级预防对未发生过心脏骤停或持续性室速的高危人群实施预防哪些人需要ICD保护？ICD大型临床试验80’85’2000’90’95’AVIDCASHCIDSSCD-HeFTMADIT-IIMUSTTMADIT二级二级预防一级预防DEFINITESCD二级预防的临床试验•CASH•CIDS•AVID与心脏骤停有关的试验SCD二级预防的临床试验1TheAVIDInvestigators.NEnglJMed.1997;337:1576-83.2KuckK.Circ.2000;102:748-54.3ConnollyS.Circ.2000;101:1297-1302.12331%56%28%59%20%33%%MortalityReductionw/ICDRx二级预防临床结果3Years3Years3YearsICD较抗心律失常药物降低死亡率的程度•CIDS，CASH，AVID三项研究显示：ICD显著降低总死亡率。治疗恶性室性心律失常，预防心源性猝死的效果明显优于抗心律失常药•AVID临床明确了对致命性室性心律失常患者应将植入型心脏除颤器作为首选治疗二级预防临床试验的意义ACC/AHA/HRS2008心律失常器械治疗建议ICD部分：I类治疗建议（二级预防）•非可逆性原因导致的室颤或者血流动力学不稳定的持续性室速造成的心脏性骤停•伴有器质性心脏病的自发性持续性室速，无论血液动力学稳定或者不稳定•晕厥原因不确定，但心脏电生理检查能够诱发出临床相关的、具有明显血流动力学障碍的持续性室速或者室颤IIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIBIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIBIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIAAllprimarySCDpreventionICDrecommendationsapplyonlytopatientswhoarereceivingoptimalmedicaltherapyandhavereasonableexpectationofsurvivalwithgoodfunctionalcapacityformorethan1year.AVIDCASHCIDSCIDS和AVID注册登记标准,Link研究SCD一级预防临床试验SCD一级预防-缺血性心肌病1MossAJ.NEnglJMed.1996;335:1933-40.2BuxtonAE.NEnglJMed.1999;341:1882-90.3MossAF.NEnglJMed.2002;346:877-83.4MossAJ.PresentedbeforeACC51stAnnualScientificSessions,LateBreakingClinicalTrials,March19,2002.020406080MADITMUSTTMADIT-IIOverallDeathArrhythmicDeath123,454%75%55%73%31%61%SCD一级预防-缺血性心肌病临床结果ICD降低死亡率27Months39Months20Months%MortalityReductionw/ICDRx•12个国家，73个医学中心•1998年4月开始•2003年9月结束•674位患者入选•试验目的：评价急性心肌梗死早期预防性植入ICD能否降低死亡率心梗早期是否应植入ICD预防SCD？7.5%6.9%0%1%2%3%4%5%6%7%8%ICDTherapyNoICDTherapyAll-causeMortalityHR1.08,p=0.66DeathduetoNonarrhythmiaHR1.75,p=0.0166.1%3.5%0%1%2%3%4%5%6%7%ICDTherapyNoICDTherapyDINAMIT结果PresentedatACCScientificSessions20041.5%3.5%0.0%0.5%1.0%1.5%2.0%2.5%3.0%3.5%4.0%ICDTherapyNoICDTherapyDeathduetoArrhythmiaHR0.42,p=0.00948小时内48小时到40天大于40天与MI相关的心律失常，非ICD适应证没有进一步心肌缺血的证据，VT/VF与本次MI无关无VT/VF事件，陈旧性心梗，左室功能显著性不全，最佳药物治疗，预计良好生存率ICD在AMI不同时间不同的角色Europace（2008）10，536-53910.1093/europace/eun070二级预防一级预防IIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIBIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIAIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIAAllprimarySCDpreventionICDrecommendationsapplyonlytopatientswhoarereceivingoptimalmedicaltherapyandhavereasonableexpectationofsurvivalwithgoodfunctionalcapacityformorethan1year.ACC/AHA/HRS2008心律失常器械治疗建议ICD部分：I类治疗建议（一级预防）•心肌梗死后40天，纽约心功能在II级或III级，LVEF35%•LVEF30%,纽约心功能I级，心梗后40天，左室功能不良的患者（原为IIa类，现为I类）•陈旧性心梗，LVEF40%，非持续性室速，电生理检查可诱发室颤或者持续性室速MADIT-IIMUSTTDINAMIT+SCD-HeFTICD应用于一级预防时，仅适用于已接受最佳药物治疗，生存状态良好，预期寿命超过1年的患者SCD一级预防-心衰高危患者DEFINITE结果•与药物治疗组相比，ICD组的总死亡率降低了34%(P=0.06)•与药物治疗组相比，ICD组的心律失常死亡率降低74%(P=0.006)SCD-HeFT结果•ICD有效减少23%的总死亡率•胺碘酮作为主要预防药物，不增加生存率IIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIBAllprimarySCDpreventionICDrecommendationsapplyonlytopatientswhoarereceivingoptimalmedicaltherapyandhavereasonableexpectationofsurvivalwithgoodfunctionalcapacityformorethan1year.•心肌梗死后40天，纽约心功能在II级或III级，LVEF小于35%•EF值≤35%,纽约心功能在II级或III级的非缺血性心肌病患者SCD-HeFTDINAMIT+SCD-HeFTACC/AHA/HRS2008心律失常器械治疗建议ICD部分：I类治疗建议（一级预防）IIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIIIA60%MUSTT55years54%MADIT42years20%CIDS33years37%CASH22years31%AVID13yearsICD与抗心律失常药物治疗在降低总死亡率方面的对照0%10%20%30%40%50%60%%MortalityReduction1TheAVIDInvestigators.NEnglJMed.1997;337:1576-1583.2Kuck,etal.Circulation.2000;102:748-754.3Connolly,etal.Circulation.2000;101:1247-1302.4MossAJ.NEnglJMed.1996;335:1933-1940.5BuxtonAE.NEnglJMed.1999;341:1882-1890.6Moss.InvestorConferenceCall.November27,2001.30%MADITII62years23%SCD-HeFT75years020406080MADITMUSTTMADIT-IIOverallDeathArrhythmic