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1、经股动脉 VS 经心尖部主动脉瓣置换术-那种创伤更小?,Eric E. Roselli, MD,声明,Medtronic 顾问 Edwards 研究者 Direct Flow Medical 顾问,经皮主动脉瓣置换术,Edwards Sapien US 试验, CE 标志 22-24Fr 鞘管 Corevalve CE 标志 18Fr 鞘管 其他尚未投入使用,主动脉狭窄和PVD,患者的一般情况与胸主动脉瘤疾病类似 鞘管 20 25 Fr 髂动脉导管 7 15%,JACC, 2007,Corevalve,鞘管18Fr 使用21Fr鞘管并发症的发生率为9.6%，使用18Fr鞘管后发生率下降至1.9
2、%,Edwards THV 临床研究,Edwards SAPIEN experience addresses each Clinical research stage,首次应用于人类 人体手术成功率,可行性 合理，安全且有效,随机对照 和对照组相比有效l (AVR & 药物治疗),上市后 评估商业利用情况 长期随访,RECAST I-REVIVE TRAVERCE*,REVIVE II REVIVAL II TRAVERCE PARTNER EU#,PARTNER IDE,PARTNER EU SOURCE,* = Amended from FIM to Feasibility # = Ame
3、nded from Feasibility to Post-Market,REVIVE and REVIVAL II 可行性研究,4个北美研究中心和6个欧洲研究中心 结论 : 70y 症状严重的 EuroSCORE 20 or 不适宜手术 安全重点和有效性终点 REVIVAL II 随访24个月,REVIVAL II 包括 备选入路:经心尖,1/3rd 患者筛查后发现股动脉入路条件较差,12/2006-2/2008 纳入标准: PVD 排除经股动脉途径 STS 15%, 或不适宜手术 AoV 面积 0.7 cm2 70 y NYHA II,经股动脉AVR汇总分析 REVIVE & REVIVA
4、L II (n=161),年龄 (y) 83.5 5.9 (66 - 96) 90 y 14.3% (23) 80 y 75.2% (121) 平均 EuroSCORE对数 30.7% 15.2 平均STS Score (只有REVIVAL) 13.1% 7.2,经心尖部 AVR REVIVAL II (n=40),年龄 (y) 83.7 5.2 (69 93) 90 y 10% 80 y 70% 平均 EuroSCORE对数 35.5 15.3 平均STS评分 (只有REVIVAL) 13.4 7.0 更多CVDz, PVDz, COPD,尽管风险评分类似，但患者群体并不相同,* One p
5、atient on CVVHD prior to valve implantation,经股动脉 AVR汇总分析 REVIVE & REVIVAL II (n=161),经心尖入路,在CCF并没有心室出血 4.8% transverse,血管并发症,Vascular Complications (n=25),Perforations (n=12),Aortic Dissection (n=3),Flow Limiting Iliac Dissection (n=4),Avulsed Iliac Artery (n=3),下肢缺血 (n=4),涂层支架 - 3,手术搭桥 - 9,手术修补- 4,
6、Surgical Bypass - 3,手术 - 1,药物 - 2,手术 - 2,药物 - 2,3 例死亡,2 例死亡,2 例死亡,2 例死亡,Vascular Complications (n=25),Perforations (n=12),主动脉夹层 (n=3),髂动脉夹层，血流受限 (n=4),髂动脉撕脱y (n=3),血管并发症 (n=25),穿孔(n=12),死亡率36% vs 10% w/o,血管并发症,number at risk,13,12,9,6,22,Yes,120,96,88,60,139,No,91.4% 86.7, 96.0,82.9% 76.6, 89.3,78.2
7、% 71.0, 85.4,72.7% 54.1, 91.3,63.3% 43.0, 83.6,46.0% 23.8, 68.3,Log Rank P=0.0004,绝对不能发生血管入路的并发症,手术前的方案制定非常重要 血管成形术 腔内 低估 钙化的分辨率较低 CT 增强扫描分辨率更高 (毒性) 能够显示钙化的轮廓 高分辨率的研究 IVUS,使入路更简便: 髂动脉导管,基本假设,创伤更小 急性风险更少 死亡率 并发症,无法穿过 - 3,纳入161例患者,释放不成功 n = 19,无法进入 - 9,换瓣成功率 88.2%,23 mm Valve (55),心脏穿孔 - 3,26mm 瓣膜 (87
8、),61.3%,38.7%,位置错误/血栓形成- 2,麻醉并发症 - 2,经股动脉 AVR 手术结果,Successful Deployment n = 142,23 mm 瓣膜 (55),释放成功 n = 142,Slide courtesy of Susheel Kodali,RetroFlex II 输送系统 Addresses Crossing,REVIVAL II 经心尖途径 手术成功率,87.5% 移位 /血栓形成 12.5% 无法穿过心尖 0 平均释放时间 11.7 min 平均手术时间 87.1 min,术中与定位相关的事件,冠状动脉堵塞 移植瓣膜返流 由于瓣叶悬吊所致 i.e
9、. 瓣膜太低,术中处理,手术开始前调整血流动力学状况 谨慎的使用快速心脏起博 TEE和X线辅助定位 识别影响瓣膜放置的因素: 增厚的室间隔 主动脉根部钙化，没有扩张性的主动脉根部 窦管交界处狭窄 瓣叶严重钙化,术中处理,体外模拟和灾难性事件的预案 危急情况的抢救方案 瓣膜血栓形成 冠状动脉开口堵塞 瓣膜功能障碍 BAV后出现重度AI导致失代偿 循环支持,Slide courtesy of John Webb,Vancouver 的经验,经心尖途径手术成功率 (n=58),Slide courtesy of John Webb,TRAVERCE: 换瓣成功率: 93 %,168 例患者,换瓣成功
10、 N=156,换瓣不成功 N=12,23 mm n = 43,26 mm n = 113,TRAVERCE: 中转: 7 %,12例患者15起事件,Slide modified from Thomas Walther,TA 学习曲线 (n=175) TRAVERCE,98 2%,88 3%,71 4%,73 4%,Pat. 1 - 120, 2 Pts (CPR) excluded ES 29%, STS 14%,Pat. 121 - 177 ES 37%, STS 13%,30 days,6 months,1 year,Slide courtesy of Thomas Walther,无中风
11、,*置换成功 = 设备成功输送并释放 书后AVA0.9cm ，AI 2+,PARTNER EU 经股动脉,心室血栓形成 (n = 1) 主动脉血栓形成 (n=1),23 mm SAPIEN 瓣膜 N=25,26 mm SAPIEN 瓣膜 N=27,置换失败 n = 2,换瓣的患者数 n = 54,置换成功* n = 52,计划纳入患者数 n = 60,手术取消 n = 6,血管入口 (n = 3) BAV失败 (n=2) 活动性心内膜炎 (n=1),96.3%,Slide courtesy of T. Lefvre,PARTNER EU TF 并发症,Non Hierachical Ranki
12、ng,Slide courtesy of T. Lefvre,SAPIEN THV 商业经验 & SOURCE注册,治疗的患者人数: 723 2007.11-2008.12,Slide courtesy of T. Lefvre,34 心脏介入中心 598 植入 15% 的患者签署代理协议,The SOURCE Registry,Slide courtesy of T. Lefvre,THV 学习曲线 植入成功的百分数,%,Slide courtesy of T. Lefvre,TA是否优于TF?,不是!,因为患者往往更喜欢经皮途径! Preclose技术已经变成一种常规术式,腋动脉导管 避免
13、跨越主动脉弓,Conduit,Axillary a.,下一代设备,结构更简单-创伤更小 可以重新定位/可退出 瓣周主动脉瓣返流更少 而且，患者的选择也会不断的变化,结论,最安全的方法最佳 TA和TF各有利弊 随着技术的进步，经股动脉主动脉瓣置换术可能会越来越重要 经心尖入路和经腋动脉入路是某些患者的替代方法 介入科医生 VS 外科医生,手术的成功需要多学科的团队合作,June 3-5 2009,InterContinental Hotel & Bank of America Conference Center Cleveland, Ohio,www.ccfcme.org/CardioCare0
14、9 www.MeetTheB,Sessions will include:, Aortic Disease Coronary Artery Disease Valvular Disease Electrophysiology Heart Failure, Prevention Imaging Heart-Brain Medicine Vascular Disease Transplantation,This activity has been approved for AMA PRA Category 1 Credit.,Transfemoral Vs Transapical Valves W
15、hich is Less Invasive?,Eric E. Roselli, MD,Disclosure,Medtronic Consultant Edwards Investigator Direct Flow Medical Consultant,Percutaneous Aortic Valves,Edwards Sapien US Trial, CE Mark 22-24Fr Sheaths Corevalve CE Mark 18Fr Sheath Others on the way,Aortic Stenosis and PVD,Pt profile similar to tho
16、racic aneurysmal disease Sheaths 20 25 Fr Iliac Conduit 7 15%,JACC, 2007,Corevalve,Sheath 18Fr Access complications down to 1.9% from 9.6% with 21Fr,Edwards THV Clinical Investigations,Edwards SAPIEN experience addresses each Clinical research stage,First-in-Man Procedural success in humans,Feasibil
17、ity Demonstrate “reasonable” safety & effectiveness,Randomized Control Effectiveness vs. control (AVR & medical therapy),Post-Market Evaluate transition to commercial use Long-term follow-up,RECAST I-REVIVE TRAVERCE*,REVIVE II REVIVAL II TRAVERCE PARTNER EU#,PARTNER IDE,PARTNER EU SOURCE,* = Amended
18、 from FIM to Feasibility # = Amended from Feasibility to Post-Market,REVIVE and REVIVAL II Feasibility Studies,4 North American and 6 European Centers Inclusion: 70 years old severe symptomatic AS EuroSCORE 20 or non-operable Safety and Efficacy endpoints Follow-up to 24months for REVIVAL II,REVIVAL
19、 II included Alternate Access: Transapical,1/3rd screened poor femoral access,12/2006-2/2008 Inclusion criteria: PVD precluding TF approach STS 15%, or inoperable AoV area 0.7 cm2 70 yrs of age NYHA II,Pooled Transfemoral AVR REVIVE & REVIVAL II (n=161),Age (yrs) 83.5 5.9 (66 - 96) 90 years 14.3% (2
20、3) 80 years 75.2% (121) Mean Logistic EuroSCORE 30.7% 15.2 Mean STS Score (REVIVAL Only) 13.1% 7.2,Transapical AVR REVIVAL II (n=40),Age (yrs) 83.7 5.2 (69 93) 90 years 10% 80 years 70% Mean Logistic EuroSCORE 35.5 15.3 Mean STS Score (REVIVAL Only) 13.4 7.0 More CVDz, PVDz, COPD,Populations are dif
21、ferent despite similar risk scores,* One patient on CVVHD prior to valve implantation,Pooled Transfemoral AVR REVIVE & REVIVAL II (n=161),Transapical Access,Ventricular bleeding 0 CCF 4.8% TRAVERSE,Vascular Complications,Vascular Complications (n=25),Perforations (n=12),Aortic Dissection (n=3),Flow
22、Limiting Iliac Dissection (n=4),Avulsed Iliac Artery (n=3),Lower Extremity Ischemia (n=4),Covered Stent - 3,Surgical Bypass - 9,Surgical Repair - 4,Surgical Bypass - 3,Surgery - 1,Medical - 2,Surgery - 2,Medical - 2,3 Deaths,2 Deaths,2 Deaths,2 Deaths,Vascular Complications (n=25),Perforations (n=12
23、),Aortic Dissection (n=3),Flow Limiting Iliac Dissection (n=4),Avulsed Iliac Artery (n=3),Vascular Complications (n=25),Perforations (n=12),Mortality 36% vs 10% w/o,Vascular Complications,number at risk,13,12,9,6,22,Yes,120,96,88,60,139,No,91.4% 86.7, 96.0,82.9% 76.6, 89.3,78.2% 71.0, 85.4,72.7% 54.
24、1, 91.3,63.3% 43.0, 83.6,46.0% 23.8, 68.3,Log Rank P=0.0004,Zero Tolerance for Vascular Access Complications,Pre-procedural Planning Critical Angiography Intraluminal underestimates Poor resolution of calcium burden CT More accurate with contrast (toxic) Can delineate calcium High resolution study I
25、VUS,Facilitated Access: Iliac conduit,Fundamental Assumption,Less Invasive Less Acute Risk Mortality Morbidity,Unable to cross - 3,161 Patients Enrolled,Unsuccessful Deployment n = 19,Failed access - 9,Implant Success 88.2%,23 mm Valve (55),Cardiac Perforation* - 3,26mm Valve (87),61.3%,38.7%,Malpla
26、ced/Embolized - 2,Anesthesia Complication - 2,Transfemoral AVR Procedural Results,Successful Deployment n = 142,23 mm Valve (55),Successful Deployment n = 142,Slide courtesy of Susheel Kodali,RetroFlex II Delivery System Addresses Crossing,REVIVAL II Transapical Technical Success,87.5% Migration / E
27、mbolization 12.5% Failure to cross 0 Mean deployment time 11.7 min Mean procedure time 87.1 min,Other Intra-Procedural Events Related to Positioning,Coronary Occlusion Prosthetic valve insufficiency Due to leaflet overhang i.e. Valve too low,Intra-operative Management,Hemodynamic optimization prior
28、to starting Judicious rapid ventricular pacing TEE and fluoroscopy facilitate positioning Recognition of factors affecting placement: Hypertrophied ventricular septum Calcified root non-distensible root Narrow sino-tubular junction Bulky calcium on leaflets,Intra-operative Management,Dry runs and di
29、saster planning Rescue plans for emergencies Valve embolization Coronary ostial occlusion Prosthesis malfunction Severe AI after BAV leading to decompensation Circulatory Support,Slide courtesy of John Webb,Vancouver Experience,Transapical Procedural success (n=58),Slide courtesy of John Webb,TRAVER
30、CE: Implant Success: 93 %,168 Patients,Successful Implants N=156,Unsuccessful Implants with conversion N=12,23 mm n = 43,26 mm n = 113,TRAVERCE: Conversion: 7 %,15 events in 12 patients,Slide modified from Thomas Walther,TA Learning Curve (n=175) TRAVERCE,98 2%,88 3%,71 4%,73 4%,Pat. 1 - 120, 2 Pts
31、(CPR) excluded ES 29%, STS 14%,Pat. 121 - 177 ES 37%, STS 13%,30 days,6 months,1 year,Slide courtesy of Thomas Walther,No Strokes,*Implant success = Successful device delivery and deployment resulting in an AVA0.9cm with AI 2+,PARTNER EU TF,Ventricular embolization (n = 1) Aortic embolization (n=1),
32、23 mm SAPIEN valve N=25,26 mm SAPIEN valve N=27,Implant failures n = 2,Patients Implanted n = 54,Successful Implants* n = 52,Patients Planned n = 60,Implant aborted n = 6,Vascular access (n = 3) Unsucessfull BAV (n=2) Active endocarditis (n=1),96.3%,Slide courtesy of T. Lefvre,PARTNER EU TF Complica
33、tions,Non Hierachical Ranking,Slide courtesy of T. Lefvre,SAPIEN THV Commercial Experience & The SOURCE Registry,Number of patients treated: 723 November 2007- September 2008,Slide courtesy of T. Lefvre,34 cardiac intervention centers 598 implants 15% of cases proctored,The SOURCE Registry Site Info
34、rmation,Slide courtesy of T. Lefvre,THV Learning Curve Percent Successful Implant,%,Slide courtesy of T. Lefvre,Does TA win over TF?,NO!,Because a percutaneous option will always be preferred by patients! Preclose technique is becoming routine,Axillary Conduit Avoids Arch Transit,Conduit,Axillary a.
35、,Next Generation Devices,Lower profile less traumatic Repositionable / retrievable Less paravalvular AR Also, patient selection will continue to evolve,Conclusion,Safest approach is best Advantages to both TA and TF Transfemoral will most likely dominate as devices evolve Transapical and transaxilla
36、ry may continue as complementary options in select patients Should NOT be interventionalist vs surgeon,Success requires multidisciplinary teamwork,June 3-5 2009,InterContinental Hotel & Bank of America Conference Center Cleveland, Ohio,www.ccfcme.org/CardioCare09 www.MeetTheB,Sessions will include:, Aortic Disease Coronary Artery Disease Valvular Disease Electrophysiology Heart Failure, Prevention Imaging Heart-Brain Medicine Vascular Disease Transplantation,This activity has been approved for AMA PRA Category 1 Credit.,