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1、再同步治疗的挑战和思考,王东琦 西安交通大学医学院第一附属医院,Evidence For Heart Failure,在美国,每年因心衰就诊3.4百万,死亡30万。 一年再住院率50%,中重度心衰年死亡率近30%。 65岁者患病率610%。 QRS120ms患者全因死亡率增加约33%。 ,Evidence For CRT,EF35%, QRS120ms , 经理想药物治疗, NYHA IIIIV : 提高心功能分级,改善生活质量,增加活动耐量。 降低死亡率和住院率。 提高生存率。,如何让更多患者受益?,IMPROVE HF,To examine patient and cardiology p
2、ractice characteristics predictive of CRT use in eligible patients in an outpatient registry of systolic heart failure patients,Fonarow GC, et al. Circ Heart Fail. 2008;1:98106.,Percent of Indicated Patients (%),Percent of Indicated Patients Receiving CRT (CRT-D/CRT-P) at Baseline,IMPROVE HF Baselin
3、e Performance on CRT,All Practices (Baseline Review),39.39%,Fonarow GC, et al. Circ Heart Fail. 2008;1:98106.,IMPROVE HF Registry,Less than 40% of CRT-eligible patients received a device at baseline assessment In 1/3 of IMPROVE HF outpatient practices, not a single eligible patient received a CRT de
4、vice at baseline,手术成功率,在RCTS纳入的4000多例中,CRT(经CS植入LV电极技术)的成功率8892: 鞘管难以插入CS 冠状静脉狭窄或闭锁 难以进入靶血管分支或脱位 膈肌刺激,115,135,Amp CS,60,Straight,115,60,135,Amp CS,Attain StarFix,First active fixation left-heart lead More placement options Vein sizes Vein locations Soft, polyurethane deployable lobes 5 Fr lead body,
5、 5.3 Fr electrode with tip seal,For CRT-D devices, the available LV pace polarities are: LV tip to LV ring LV tip to RV coil LV ring to RV coil For CRT-P devices, the available LV pace polarities are: LV tip/RV ring Unipolar (LV tip/Can) Bipolar (LV tip/LV ring),Pacing Vector Programmability,LV环至RV线
6、圈,LV头端至RV线圈,LV头端至LV环,Non-responder, true or false ?,40 consecutive CRT-D patients admitted to Cleveland Clinic HF ICU Met CRT indications at implant Implanted for at least 3 months (mean 19 months) Increased LVEDV from pre-implant baseline Averaged 1.2 HF hospitalizations 87.5% with LV lead in later
7、al or postero-lateral position Biventricular paced 96% of time Acute, serial echo and invasive hemodynamic measurements in CRT ON and CRT OFF modes,Hidden benefit: when CRT turned off, hemodynamic, ECG & echo parameters worsened,PCWP,P 0.001,Cardiac Output,P 0.001,P 0.001,QRS Width,P 0.001,LV Fillin
8、g Time,Mullens W, et al. J Am Coll Cardiol 2009;53:600-607,启示,RCTS并未观察反映CRT疗效的敏感指标。 对于某些急性疾病,一种指标就容易反映其疗效。但对于那些慢性疾病则不敏感。,窄QRS波心衰,心功能3级、4级,左室射血分数减低,窄QRS波心衰患者中,30%UCG提示有收缩失同步。 仍而,对于窄QRS波心衰患者是否可以从双室起搏治疗中受益,目前仍无明确的答案。,IIB适应证(中国2006),符合常规心脏起搏适应证并心室起搏依赖的患者,合并器质性心脏病或心功能III级及以上 常规心脏起搏并心室起搏依赖者,起搏治疗后出现心脏扩大,心功
9、能III级或以上 QRS140ms 心室间机械延迟40ms 左心室后外侧璧激动延迟,Beshai J et al. N Engl J Med 2007;357:2461-2471,RethinQ 研究 Subgroup Analysis According to the QRS Interval at 6 Months,RethinQ 研究,对于QRS0.12S的患者,CRT能增加高峰氧耗量,改善NYHA分级。 对于QRS0.12S的患者,CRT并不能增加高峰氧耗量。 但是,对于QRS0.12S的患者, CRT可以改善NYHA分级(p=0.04);有增加六分钟步行距离的趋势(p=0.31)。
10、Echo-CRT研究。,% of Patients Hospitalised for HF,Number at Risk CRT OFF 191 187 181 176 119 CRT ON 419 415 411 409 251,P=0.03,Hazard Ratio=0.47,CRT OFF,CRT ON,Months Since Randomisation,REVERSE: CRT delays time to first HF hospitalisation,53% reduction with CRT,Linde C, Abraham WT, Gold WR et al for RE
11、VERSE Study Group. J Am Coll Cardiol 2008 Dec 2;52(23):1834-43.,Ongoing Studies,MADIT CRT Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Study Objective Determine if CRT-D will reduce the risk of mortality and heart failure events in mild-to-moderate he
12、art failure patients (NYHA Class I and II) compared to ICD-only therapy. Key Inclusion Criteria Ischemic or nonischemic heart disease and NYHA Class I or II Ejection fraction 130ms Sample Size: 1,820,MADIT CRT,CRT was dramatically effective in this large study population, with a 34% reduction in the
13、 risk of all-cause mortality or heart failure. The benefit is dominated by a 41% reduction in heart failure events. This results validate a new indication for cardiac resynchronisation therapy in the prevention of heart failure in at-risk asymptomatic or mildly symptomatic cardiac patients.,DAVID Tr
14、ial Protocol,760 assessed for eligibility,250 excluded 149 Did not meet Rx criteria 55 refused 46 Other,510 eligible,4 Not randomized 2 Required pacing 1 Inadequate defibrillation threshold 1 Decided not to implant,VVI-40 (n=256),DDDR-70 (n= 250),1 had pacing mode set to DDD 1 LTF 10 Discontinued in
15、tervention 5 Bradycardia 1 CHF and AF 1 Brady induced Torsade 1 Heart Tx workup 1 AF w rapid V response 1 multiple shocks due to double counting,3 had pacing mode set to VVI 2 LTF 5 Discontinued intervention 1 Angina 1 CHF and Lead Failure 1 CHF Hospitalization 1 Exacerbation of VT 1 Lead Migration,
16、Wilkoff B, et al. JAMA. 2002; 288: 3115-3123.,Death or First Hospitalization for New or Worsened CHF,Hazard ratio (95% CI), 1.61 (1.06-2.44),0,6,12,18,Months,Cumulative Probability,0.4,0.3,0.2,0.1,0,250 256,159 158,76 90,21 25,No. at Risk DDDR VVI,Wilkoff B, et al. JAMA. 2002; 288: 3115-3123.,DDDR,V
17、VI,DAVID Trial Results,Wilkoff B, et al. JAMA. 2002; 288: 3115-3123.,DAVID Trial Results,DAVID 试验结论,DAVID 试验显示对于没有起搏适应证(AV传导正常)的LVEF40%的ICD治疗患者,双腔起搏过高的心室起搏比例,增加死亡率和心衰住院率。,Ongoing Studies,BLOCK HF Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (continued) Key Inclusion Criteria AV block NYHA Class I, II, or III LVEF 50% First-time implant of CRT-P or CRT-D To receive CRT-D, must be indicated for an ICD,提出的问题回答的疑问,
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