体外反搏与心功能保护课件幻灯

体外反搏与心功能保护 伍贵富 中山大学附属第一医院心内科 卫生部辅助循环重点实验室 2009.8.22 大连 Enhanced External Counterpulsation（EECPEECP） A Non-invasive Therapy for Heart Failure 心力衰竭治疗存在的问题 社会老龄化，心肌梗塞死亡率下降，但心力衰竭患者 增加，健康保障系统不堪重负 目前缺乏治疗心力衰竭的有效手段 心衰死亡率居高不下 （53,000人/年 2001年，USA) 严格定义心力衰竭不易，因其不仅仅是一个单器官病 变，而是一个全身性的临床综合征 心力衰竭的治疗不仅仅局限于心功能改善，还需要强 调系统性的病理生理机制的干预 心力衰竭的非药物治疗 起搏器（Pacemaker） 植入式心脏除颤器（Implantable cardioverter defibrilator） 心室辅助装置/人工心脏（Ventricular assist device / Artifical heart） 超滤（Utrafiltration） 心室再同步化（Cardiac Resynchronization therapy） 体外反搏（EECP） 体内反搏 （IABP） 体外反搏 （EECP） 辅助衰竭的心脏：从内反搏到外反搏 1962年，USA 液压水囊式体外反搏 非序贯式加压 笨重，体积大 未能推广 1972年, 中国中山大学 序贯式气囊加压体外反搏 重量轻，体积小 安全、有效、无创伤 在中国及全球推广 源自中国的体外反搏（EECP）疗法 获得国际主流媒体的关注和正面报道 中国体外反搏技术的国际影响 推广应用20个国家和地区 体外反搏装置系统工作原理 D/S比值1.2 执行机构 电池阀（开/关） 管道（气体传输） 主机系统 D S 囊套（充气/排气） 效果监测 信息反馈 D/S比值 心电图 调节气泵压力 体外反搏的作用原理 Diastolic augmentation Improve coronary perfusion Increase Cardiac Output 三级气囊序贯充气 舒张期充气 Increase Venous return ECG Normal EECP Lower Thigh Cuffs Upper Thigh Cuffs Calf Cuffs 收缩期排气 三级气囊同时排气 Systolic Unloading Reduce Cardiac Workload Increase Cardiac Output Lower Thigh Cuffs Upper Thigh Cuffs Calf Cuffs 血流动力学效应 增加心输出量 Duplex echocardiography Descending Aorta Lawson, Hui: J of Critical Illness 2000;5:629-636 Control EECP 降低收缩期阻力负荷 舒张期主动脉根 部血流增加 增加CO 增加静脉 回心血流 增加心室舒 张期充盈 收缩期舒张期 降低收缩期 阻力负荷 增加冠脉血流 Michaels AD, et al. Circulation 2002; 106: 1237-42. Doppler Flow Velocities obtained with FloWire in the LAD 增加冠脉血流 Increase 150% (N=8) Intracoronary Peak Diastolic Doppler Flow Velocity Increase 92% (N=9) Intracoronary Diastolic Pressure BaselineEECP Katz WE, et al. J Am Coll Cardiol 1998;31Suppl(2):85A(825-31) EECP 1:1 ModeIABP 1:1 ModeIABP 1:1 Mode IMA DOPPLER EECP GroupIABP Group DD-TVIDD-TVI Baseline18 66 420 106 6 Counterpulsation98 21*19 3*95 21*15 7* D: IMA Diastolic Peak VelocityD-TVI: IMA Diastolic Time Velocity Integral * p 1 angina class, 8% had no angina post treatment (p800 Patients Enrolled 228 Discontinued Before Randomization: 41 Randomized: 187 EECP: 93Control: 94 Discontinued: 22 (23.7%) Adverse event: 11 (11.8) Protocol violation: 2(2.2) Refused assignment: 2(2.2) Non-compliance: 1(1.1) Subjects decision: 5(5.4) Lost to follow-up: 2(2.2) Other: 4 (4.3) Discontinued: 13 (13.8%) Adverse event: 3(3.2) Protocol violation: 2(2.1) Refused assignment: 1(1.1) Non-compliance: 0(0) Subjects decision: 6(6.4) Lost to follow-up: 1(1.1) Other: 1 (1.1) Completed: 71 (76.3%)Completed: 81 (86.2%) PEECH J Am Coll Cardiol 2006;48:1198-1205 A Single-Blind, Controlled, Randomized Evaluation of Efficacy and Safety Flow Chart at entry and follow-up PEECH Trial: Endpoints Primary Percentage of subjects with at least a 60-second increase in exercise duration from baseline to six months OR Percentage of subjects with at least 1.25 ml/min/kg increase in Peak VO2 from baseline to six months Secondary Changes in exercise duration and Peak VO2 Changes in NYHA classification Changes in quality of life Adverse experiences Feldman AM, et al. J Card Fail Apr 2005;11:240-245. N9394 Male72 (77.4%)71 (75.5%)NS Race - Caucasian76 (81.7%)75 (79.8%)NS Age (mean yrs, SD) 62.4 (11.7)63.0 (10.4)NS Etiology - Ischemic 64 (68.8%)66 (70.2%) NS LVEF (mean %, SD) 25.9 (6.1)26.7 (6.5)NS NYHA - Class II - Class III 60 (64.5%) 33 (35.5%) 62 (66.0%) 32 (34.0%) NS NS HF Treatment - ACEI - ARB - Beta blocker 70 (75.3%) 18 (19.4%) 79 (84.9%) 73 (77.7%) 18 (19.1%) 81 (86.2%) All NS EECPControlp-value PEECH: Patient Demographics J Am Coll Cardiol 2006;48:1198-1205 PEECH: Results of Primary End-points J Am Coll Cardiol 2006;48:1198-1205 EECPControl Increase 1.25 mL/kg/min from baseline Peak VO2 10.0 35.4% N=93 25.3% N=94 22.8% N=93 24.1% N=94 0.0 5.0 15.0 20.0 25.0 30.0 35.0 40.0 % Subjects Who Met Threshold p=NSp=0.016 Exercise Duration Increase 60 sec from baseline % responders at 6-month follow- up Congestive Cardiac Failure: 2006, Nov-Dec, 307-311 Subgroup Analysis: Age 65 years 0 5 10 15 20 25 30 35 40 p=0.008 35.1% N=37 25% N=44 11.4% N=44 29.7% N=37 p=0.017 % Subjects Who Met Threshold Peak VO2 Exercise Duration Increase 1.25 mL/kg/min from baseline Increase 60 sec from baseline PEECH: Changes in Exercise Duration and Peak VO2 Change from Baseline (mL/kg/min) -0.1 0.1 0.3 0.5 Note: Error bars represent standard error; Baseline Peak VO2: EECP=14.2 vs OPT=13.8, p=NS 1 Week 3 Months6 Months -0.3 -0.5 -0.7 -0.9 p0.001p=0.09 p=0.02 -1.1-1.1-0.8-0.1 0.3 -0.2 Overall Population Exercise Duration Note: Baseline exercise duration: EECP=611 sec vs OPT=571 sec, p=NS 26.434.5 24.7 Change from Baseline (sec) p = 0.01 p= 0.01 -9.9 -7-5.5 0.0 10.0 20.0 30.0 40.0 -10.0 50.0 -20.0 1 Week3 Months6 Months p= 0.01 EECPControl Patients 65 Years 2352.230 Change from Baseline (sec) p=0.07p0.001p=0.004 -22.3 - 19.1 3.4 0.0 10 20 30 40 -10 50 -20 1 Week3 Months6 Months Note: Error bars represent standard error Baseline exercise duration: EECP=581 vs OPT=552, p=NS Peak VO2 Note: Error bars represent standard error; Baseline Peak VO2: EECP=14.7 vs OPT=14.1, p=NS 1 Week3 Months6 Months Change from Baseline (mL/kg/min) p=NSp=0.07p=NS -0.1 0.1 0.3 0.5 -0.3 -0.5 - 0.7 -0.9 -0.6 -0.4 -0.4 0.1 0.2 -0.3 EECP Control % Patients With Improvement in NYHA Class 33.3 31.6 31.3 11.4 12.2 14.3 0 5 10 15 20 25 30 35 p0.001 p0.02 p0.01 1 Week3 Months6 Months After EECP Treatment Improvement in NYHA PEECH: Secondary EndpointsPEECH: Secondary Endpoints J Am Coll Cardiol 2006;48:1198-1205 Total Changes in Score From Baseline -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 Week6 Months3 Months Improvement p=0.01p=0.01p=NS -8.9 -3.4 -7.1 -2.9 -3.7 -2.9 Quality of Life (Minnesota Living with HF) PEECH: Subjects with Ischemic Etiology -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 Change from Baseline (sec) 1 Week3 Months6 Months EECPControl -16.7-17.3 -25.8 34.2 20. 6 p=0.010p=0.007p=0.017 24. 6 Change in Exercise DurationChange in Peak VO2 Change from Baseline (mL/kg/min) -0.9 -0.6 -0.3 0.0 0.3 0.2 -0.7 -0.4 -0.9 p=NSp=0.07 0.0 -0.3 p=NS 1 Week3 Months6 Months N = 53 (EECP) vs. 54 (Control) Feldman AM, et al. presented at ACC 2005 EECPControl Improvement in NYHA Class PEECH: Subjects with Ischemic Etiology 0 5 10 15 20 25 30 35 40 % Patients with Improvement in NYHA Class 1 Week3 Months6 Months 37.0 12.712.315.5 p=0.026p=0.004 34.536.4 p=0.025 N = 54 (EECP) vs. 55 (Control) Minnesota Living with HF -8 -1.1 -6.5 -1.5 -4 -1.7 -8 -6 -4 -2 0 1 Week3 Months6 Months Feldman AM, et al. presented at ACC 2005 Improvement p=NSp=0.094p=0.046 35.8 40.7 35.2 24.5 24.6 21.1 34.6 29.2 36.0 33.033.3 41.7 0 5 10 15 20 25 30 35 40 45 1 Week3 Months6 Months % Subjects Who Met Threshold p=0.05p=0.03p=0.04p=NSp=0.01p=NS % Responders by Etiology (increased 60 seconds from baseline) PEECH: Exercise Duration 19/5 3 7/24 8/24 13/54 22/54 14/57 19/54 12/579/25 10/24 9/26 9/27 Feldman AM, et al. presented at ACC 2005 Control (Non-ischemic) EECP (Ischemic)Control (Ischemic) EECP (Non-ischemic) PEECH: Peak VO2 34 29.2 31.5 29.2 24.1 19.6 20 33.3 14 21 28 35 42 % Subjects Who Met Threshold 1 Week3 Months6 Months p=0.03p=NS p=NSp=NSp=NSp=NS % Responders by Etiology (increased 1.25 mL/kg/min from baseline) Feldman AM, et al. presented at ACC 2005 18.9 24 23.2 26.9 53 (EECP) vs. 54 (Control) N = Control (Non-ischemic) EECP (Ischemic)Control (Ischemic) EECP (Non-ischemic) Cost effectiveness Potential Cost Savings Scenario # HF pts Total # Hospital Visits Average Cost per Hospital Visit Total Cost to Healthcare System /1,000 pts Before ECP 1, 0003,000*$5,456$16,368,000 After ECP 1,000500*$5,456$2,728,000 Reduction in hospitalization costs after treated with ECP $13,640,000 Cost to treat with ECP $3,640,000 Annual savings to healthcare $10,000,000 Saving per patient$10,000 *Average # of hospital visits before ECP over 12 months is 3.6 * Average # of hospital visits after E