心臟植入器械國際專家共識

1、會計學(xué)1心臟植入器械國際專家共識心臟植入器械國際專家共識起搏治療指南的發(fā)展歷程起搏治療指南的發(fā)展歷程1984198419971997199820022002ACC/AHA/NASPE20082008ACC/AHA/HRSpacemakerICDCRTCRTDCHFAFHOCMLQTSSyncopeSSSAVB心臟器械治療適應(yīng)證心臟器械治療適應(yīng)證-Dr. S. Furman (1960, NY)V V I病態(tài)竇房結(jié)綜合證房室傳導(dǎo)阻滯心動過緩心動過緩起搏是否必需！起搏是否必需！JACC Vol. 51, No. 21, 20082008 AHA/ACC/HRSAtrio-Atrio-ventric

2、ularventricularInter-Inter-ventricularventricularIntra-Intra-ventricularventricularCazeau, et al. PACE 2003; 26Pt. II: 137143 實際實際 計劃計劃心臟再同步治療與對照組比較，所有原心臟再同步治療與對照組比較，所有原因死亡率下降因死亡率下降36%36%二級研究終點（所有原因死亡率二級研究終點（所有原因死亡率）CRT 療效InsyncPath-CHFMIRACLEMUSTICMIRALCE ICDCONTAK-CDInsync ICD改善心功能改善心功能降低死亡率降低死亡率薈

3、萃分析 + COMPANION + CARE-HF研究研究HF 程度程度對照組對照組(n)治療組治療組 (n)總死亡率降總死亡率降低低對照組中對照組中猝死占總猝死占總死亡率比死亡率比例例治療組中治療組中猝死占總猝死占總死亡率比死亡率比例例MERIT-HF1(Metoprolol)II, III, IV2001199034%60%54%BEST2(Bucindolol)III, IV1354135410%45%44%CIBIS-II3(Bisoprolol)III, IV1320132734%36%31%CARVEDILOL(US)4II, III, IV39869665%48%54%RALES

4、5III, IV84188230%28%29%1 MERIT-HF Investigators. Lancet. 1999;353:2001-2007. 4 Packer M. N Engl J Med. 1996;334:1349-1355.2 BEST Investigators. N Engl J Med. 2001;344:1659-1667. 5 Pitt B. N Engl J Med. 1999;341:709-717. 3 CIBIS-II Investigators. Lancet. 1999;353:9-13. 心臟猝死心臟猝死 42%HF 惡化惡化36%其他心血管死亡其他

5、心血管死亡Publications reporting all-cause mortality, CV death, SCD, death by progression of HF (N= 20728 pts, control groups, 16 studies)Consensus, Solvd T, Solvd P, Save, Aire, Trace, Rales, Ephesus, Cibis, US Carvedilol, Merit HF, Cibis II, Best, Capricorn, Copernicus, Comet1 MERIT-HF Study Group. LAN

6、CET. 1999;353:2001-2007. 12%24%64%CHF其他其他猝死猝死(N = 103)NYHA II26%15%59%CHF其他其他猝死猝死(N = 103)NYHA III56%11%33%CHF其他其他猝死猝死(N = 27)NYHA IVMERIT-HF研究死亡模式分析發(fā)現(xiàn),NYHA II/III的患者猝死比例高于心衰惡化Moss AJ. N Engl J Med. 2002;346:877-83.除顫器組傳統(tǒng)組P = 0.0070.90.80.70.60.0生存率01234YearNo. At Risk除顫器組 742502 (0.91)274 (0.94)110

7、 (0.78)9傳統(tǒng)組 490329 (0.90)170 (0.78) 65 (0.69)3傳統(tǒng)組2年死亡率25%0.40.30.20.10Mortality06121824303642485460Months of follow-upAmiodaroneICD TherapyPlaceboHR97.5% ClP-ValueAmiodarone vs. Placebo1.060.86, 1.300.529ICD Therapy vs. Placebo0.770.62, 0.960.007MOST 試驗:DDDR模式下當右室心尖起搏時，心衰住院風險性是右室心尖起搏時的2.6倍Risk of HF

8、HCumulative % Ventricular PacingRisk of HFH Relative to DDDR Patient with Cum%VP=0Within 95% confidenceSweeney MO, et al. Circulation 2003;23:2932-2937MOST 試驗: 當VP40%時, 右心室心尖起搏比例每增加10%,心衰風險增加54% (up to 40%VP)Risk of HFH5Cumulative % Ventricular PacingRisk of HFH Relative to DDDR Patient with Cum%VP=

9、0Within 95% confidenceSweeney MO, et al. Circulation 2003;23:2932-2937 LVEF/LVFS降低 LVEDD增加 ESV增加 左室重構(gòu) 左房直徑增加 引起二尖瓣反流右室起搏右室起搏 房室結(jié)房室結(jié)竇房結(jié)竇房結(jié)右室心尖部起搏導(dǎo)致心臟失同步右室起搏的風險 導(dǎo)致電學(xué)失同步RethinQ研究研究N Engl J Med. 2007 ;357(24):2461-71 N Engl J Med. 2007 ;357(24):2461-71 N Engl J Med. 2007 ;357(24):2461-71 輕度心衰患者再同步治療輕度心衰

10、患者再同步治療(REVERSE試驗試驗Lind C et al.J Am Coll Cardiol. 2008;52(23):1834-43.REVERSE 研究研究Lind C et al.J Am Coll Cardiol. 2008;52(23):1834-43.Cardiac-Resynchronization Therapy for the Preventionof Heart-Failure Events（MADIT-CRT)（心臟再同步化治療預(yù)防心衰事件）（心臟再同步化治療預(yù)防心衰事件）2009，10October 1, 2009 vol. 361 no. 14N=1820p0.

11、001731 (1.00)621 (0.89)379 (0.78)173 (0.71)43 (0.63)1089 (1.00)965 (0.92)651 (0.86)279 (0.80)58 (0.73)ICDCRT-D1.00.90.80.70.60.0Heart Failure Free Survival Probability01234Years from RandomizationPatients at riskCRT-D ICD-only Kaplan-Meier Estimate of Heart Failure Free Survival ProbabilityCurves di

12、verge within the 2 first months & continue their separate paths thereafterMoss AJ, Hall WJ, Cannom DS, et al. serial online. NEJM. Sept 2009. In press.a Class of recommendation.b Level of evidence.d The guideline indication has been restricted to patients with HF in NYHA function class II with a

13、 QRS width 150 ms, a population with a high likelihood of a favorable response.CRT = cardiac resynchronization therapy; CRT-D = CRT with defibrillator function; HF = heart failure; LVEF = left ventricular ejection fraction; NYHA = New York HeartAssociation; SR sinus rhythm.Adapted from Bays de Luna

14、A. Am Heart J. 1989;117:151-159.Bradycardia17%(probability of survival)0.780.690.69(probability of survival)P=0.007Kaplan-Meier Survival by Treatment GroupSCD-HeFT中國中國2005二級預(yù)防二級預(yù)防 (89.4%)一級預(yù)防一級預(yù)防 (10.6%)0100200300400500600700USAGermanyNetherlandsItalyDenmarkAustriaIrelandWestern EuropeBelgiumSwitzer

15、landAustraliaFinlandNorwayFranceSwedenUKPortugalSpainNZJapanSingaporeHong KongTaiwanKorea (south)ThailandMalaysiaChina植入量/百萬全球全球ICD和和CRT-P 植入情況植入情況ICDCRTD植入量植入量/百萬百萬2007年年來源來源: Eucomed, Industry19952000200220052007電生理檢查*3.84.86.5?永久起搏器*600835850946950ICD*80185250536596CRT (D or P)*254Pop263 m 285 m

16、290 m 295 m302m* 每百萬人口每百萬人口來自美國的數(shù)據(jù)來自美國的數(shù)據(jù)永久起搏器ICDsCRTs北美564,074234,780148,092歐洲683,47287,74761,0102007年心臟植入性電子設(shè)備應(yīng)用情況年心臟植入性電子設(shè)備應(yīng)用情況Heart Rhythm, June 20081 MERIT-HF Study Group. LANCET. 1999;353:2001-2007. 12%24%64%CHF其他其他猝死猝死(N = 103)NYHA II26%15%59%CHF其他其他猝死猝死(N = 103)NYHA III56%11%33%CHF其他其他猝死猝死(N = 27)NYHA IVMERIT-HF研究死亡模式分析發(fā)現(xiàn),NYHA II/III的患者猝死比例高于心衰惡化N Engl J Med. 2007 ;357(24):2461-71 輕度心衰患者再同步治療輕度心衰患者再同步治療(probability of survival)0.780.690.69(probability of survival)P=0.007Kaplan-Meier Survival by Treatment Group0100200300400500600700USAG