经股动脉vs经心尖部主动脉瓣置换术那种创伤更小

经股动脉经股动脉经股动脉经股动脉 VS VS 经心尖部主动脉瓣置经心尖部主动脉瓣置经心尖部主动脉瓣置经心尖部主动脉瓣置换术换术换术换术-那种创伤更小那种创伤更小那种创伤更小那种创伤更小?Eric E.Eric E.RoselliRoselli,MD,MD声明声明声明声明MedtronicMedtronic顾问顾问顾问顾问Edwards Edwards 研究者研究者研究者研究者Direct Flow MedicalDirect Flow Medical顾问顾问顾问顾问经皮主动脉瓣置换术经皮主动脉瓣置换术经皮主动脉瓣置换术经皮主动脉瓣置换术 Edwards Edwards SapienSapien US US 试验试验试验试验,CE,CE 标志标志标志标志 22-24Fr 22-24Fr 鞘管鞘管鞘管鞘管 CorevalveCorevalve CE CE 标志标志标志标志 18Fr 18Fr 鞘管鞘管鞘管鞘管 其他尚未投入使用其他尚未投入使用其他尚未投入使用其他尚未投入使用主动脉狭窄和主动脉狭窄和主动脉狭窄和主动脉狭窄和PVDPVD 患者的一般情况与胸主动脉瘤患者的一般情况与胸主动脉瘤患者的一般情况与胸主动脉瘤患者的一般情况与胸主动脉瘤疾病类似疾病类似疾病类似疾病类似 鞘管鞘管鞘管鞘管 20 25 Fr20 25 Fr 髂动脉导管髂动脉导管髂动脉导管髂动脉导管7 15%7 15%JACC,2007CorevalveCorevalve 鞘管鞘管鞘管鞘管18Fr18Fr 使用使用使用使用21Fr21Fr鞘管并发症的发生率为鞘管并发症的发生率为鞘管并发症的发生率为鞘管并发症的发生率为9.6%9.6%，使，使，使，使用用用用18Fr18Fr鞘管后发生率下降至鞘管后发生率下降至鞘管后发生率下降至鞘管后发生率下降至1.9%1.9%Edwards THV 临床研究临床研究Edwards SAPIEN experience addresses each Clinical research stageEdwards SAPIEN experience addresses each Clinical research stage首次应用于人类首次应用于人类 人体手术成功率人体手术成功率可行性可行性合理，安全且有效合理，安全且有效随机对照随机对照 和对照组相比有效和对照组相比有效l(AVR&药物治疗药物治疗)上市后上市后 评估商业利用情评估商业利用情况况长期随访长期随访 RECAST I-REVIVE TRAVERCE*REVIVE II REVIVAL II TRAVERCE PARTNER EU#PARTNER IDE PARTNER EU SOURCE*=Amended from FIM to Feasibility#=Amended from Feasibility to Post-MarketREVIVE and REVIVAL IIREVIVE and REVIVAL II可行性研究可行性研究可行性研究可行性研究 44个北美研究中心和个北美研究中心和个北美研究中心和个北美研究中心和66个欧洲研究中心个欧洲研究中心个欧洲研究中心个欧洲研究中心 结论结论结论结论 :70y:70y 症状严重的症状严重的症状严重的症状严重的 EuroSCOREEuroSCORE 20 20 or or 不适宜手术不适宜手术不适宜手术不适宜手术 安全重点和有效性终点安全重点和有效性终点安全重点和有效性终点安全重点和有效性终点 REVIVAL II REVIVAL II 随访随访随访随访2424个月个月个月个月REVIVAL II REVIVAL II 包括包括包括包括 备选入路备选入路备选入路备选入路:经心尖经心尖经心尖经心尖1/31/3rdrd 患者筛查后发现股动脉入路条件较差患者筛查后发现股动脉入路条件较差患者筛查后发现股动脉入路条件较差患者筛查后发现股动脉入路条件较差12/2006-2/2008纳入标准纳入标准:PVD 排除经股动脉途径排除经股动脉途径STS 15%,或不适宜手术或不适宜手术AoV 面积面积 0.7 cm2 70 yNYHA II经股动脉经股动脉经股动脉经股动脉AVRAVR汇总分析汇总分析汇总分析汇总分析REVIVE&REVIVAL II(n=161)REVIVE&REVIVAL II(n=161)年龄年龄年龄年龄年龄年龄 (y)(y)(y)83.5 83.5 83.5 5.9 5.9 5.9(66-96)(66-96)(66-96)90 y 90 y 90 y 14.3%(23)14.3%(23)14.3%(23)80 y 80 y 80 y 75.2%(121)75.2%(121)75.2%(121)平均平均平均平均平均平均 EuroSCOREEuroSCOREEuroSCORE对数对数对数对数对数对数30.7%15.230.7%15.230.7%15.2 平均平均平均平均平均平均STS Score STS Score STS Score(只有只有只有只有只有只有REVIVAL)REVIVAL)REVIVAL)13.1%7.213.1%7.213.1%7.2经心尖部经心尖部经心尖部经心尖部 AVR AVRREVIVAL II(n=40)REVIVAL II(n=40)年龄年龄年龄年龄年龄年龄 (y)(y)(y)83.7 5.2(69 93)83.7 5.2(69 93)83.7 5.2(69 93)90 y 90 y 90 y 10%10%10%80 y 80 y 80 y 70%70%70%平均平均平均平均平均平均 EuroSCOREEuroSCOREEuroSCORE对数对数对数对数对数对数35.5 15.3 35.5 15.3 35.5 15.3 平均平均平均平均平均平均STSSTSSTS评分评分评分评分评分评分 (只有只有只有只有只有只有REVIVAL)REVIVAL)REVIVAL)13.4 7.013.4 7.013.4 7.0 更多更多更多更多更多更多CVDzCVDzCVDz,PVDzPVDzPVDz,COPD,COPD,COPD尽管风险评分类似，尽管风险评分类似，但患者群体并不相但患者群体并不相同同*One patient on CVVHD prior to valve implantationOne patient on CVVHD prior to valve implantation血管并发症25(15.5%)肾功能衰竭需要透析治疗2(1.2%)*永久起博8(4.9%)经股动脉经股动脉经股动脉经股动脉 AVRAVR汇总分析汇总分析汇总分析汇总分析REVIVE&REVIVAL II(n=161)REVIVE&REVIVAL II(n=161)经心尖入路经心尖入路经心尖入路经心尖入路 在在在在CCFCCF并没有心室并没有心室并没有心室并没有心室出血出血出血出血 4.8%transverse4.8%transverse血管并发症血管并发症Vascular Vascular Complications Complications(n=25)(n=25)Perforations Perforations(n=12)(n=12)Aortic Aortic Dissection(n=3)Dissection(n=3)Flow Limiting Flow Limiting Iliac Dissection Iliac Dissection(n=4)(n=4)Avulsed Iliac Avulsed Iliac Artery(n=3)Artery(n=3)下肢缺血下肢缺血下肢缺血下肢缺血 (n=4)(n=4)涂层支架涂层支架-3手术搭桥手术搭桥-9手术修补手术修补-4Surgical Bypass-3手术手术-1药物药物-2手术手术-2药物药物-23 例死亡例死亡2 例死亡例死亡2 例死亡例死亡2 例死亡例死亡Vascular Vascular Complications Complications(n=25)(n=25)Perforations Perforations(n=12)(n=12)主动脉夹层主动脉夹层主动脉夹层主动脉夹层 (n=3)(n=3)髂动脉夹层，血髂动脉夹层，血髂动脉夹层，血髂动脉夹层，血流受限流受限流受限流受限(n=4)(n=4)髂动脉撕脱髂动脉撕脱髂动脉撕脱髂动脉撕脱y y(n=3)(n=3)血管并发症血管并发症血管并发症血管并发症 (n=25)(n=25)穿孔穿孔穿孔穿孔(n=12)(n=12)死亡率死亡率36%vs 10%w/o血管并发症血管并发症numberat risk13129622Yes120968860139No91.4%86.7,96.082.9%76.6,89.378.2%71.0,85.472.7%54.1,91.363.3%43.0,83.646.0%23.8,68.3Log Rank P=0.0004Log Rank P=0.0004绝对不能发生血管入路的并发症绝对不能发生血管入路的并发症绝对不能发生血管入路的并发症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手术前的方案制定非常重要手术前的方案制定非常重要手术前的方案制定非常重要 血管成形术血管成形术血管成形术血管成形术 腔内腔内腔内腔内 低估低估低估低估 钙化的分辨率较低钙化的分辨率较低钙化的分辨率较低钙化的分辨率较低 CTCT 增强扫描分辨率更高增强扫描分辨率更高增强扫描分辨率更高增强扫描分辨率更高(毒性毒性毒性毒性)能够显示钙化的轮廓能够显示钙化的轮廓能够显示钙化的轮廓能够显示钙化的轮廓 高分辨率的研究高分辨率的研究高分辨率的研究高分辨率的研究 IVUSIVUS使入路更简便使入路更简便使入路更简便使入路更简便:髂动脉导管髂动脉导管髂动脉导管髂动脉导管基本假设基本假设基本假设基本假设创伤更小创伤更小创伤更小创伤更小 急性风险更少急性风险更少急性风险更少急性风险更少死亡率死亡率死亡率死亡率并发症并发症并发症并发症 无法穿过无法穿过无法穿过无法穿过-3-3纳入纳入纳入纳入161161例患者例患者例患者例患者释放不成功释放不成功释放不成功释放不成功n=19n=19无法进入无法进入无法进入无法进入-9-9换瓣成功率换瓣成功率换瓣成功率换瓣成功率 88.2%88.2%23 mm 23 mm ValveValve(55)(55)心脏穿孔心脏穿孔心脏穿孔心脏穿孔-3-326mm 26mm 瓣膜瓣膜瓣膜瓣膜(87)(87)61.3%61.3%38.7%38.7%位置错误位置错误位置错误位置错误/血栓形成血栓形成血栓形成血栓形成-2-2麻醉并发症麻醉并发症麻醉并发症麻醉并发症-2-2经股动脉经股动脉 AVR手术结果手术结果Successful Successful DeploymentDeploymentn=142n=14223 mm23 mm 瓣膜瓣膜瓣膜瓣膜(55)(55)释放成功释放成功释放成功释放成功n=142n=142Slide courtesy of Slide courtesy of SusheelSusheel KodaliKodaliRetroFlexRetroFlex II II 输送系统输送系统输送系统输送系统Addresses CrossingAddresses CrossingREVIVAL II REVIVAL II 经心尖途径经心尖途径经心尖途径经心尖途径手术成功率手术成功率手术成功率手术成功率87.5%87.5%移位移位移位移位 /血栓形成血栓形成血栓形成血栓形成12.5%12.5%无法穿过心尖无法穿过心尖无法穿过心尖无法穿过心尖00平均释放时间平均释放时间平均释放时间平均释放时间11.7 min11.7 min平均手术时间平均手术时间平均手术时间平均手术时间87.1 min87.1 min术中与定位相关的事件术中与定位相关的事件术中与定位相关的事件术中与定位相关的事件 冠状动脉堵塞冠状动脉堵塞冠状动脉堵塞冠状动脉堵塞 移植瓣膜返流移植瓣膜返流移植瓣膜返流移植瓣膜返流 由于瓣叶悬吊所致由于瓣叶悬吊所致由于瓣叶悬吊所致由于瓣叶悬吊所致i.e.i.e.瓣膜太低瓣膜太低瓣膜太低瓣膜太低术中处理术中处理手术开始前调整血流动力学状况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谨慎的使用快速心脏起博TEE和和X线辅助定位线辅助定位识别影响瓣膜放置的因素识别影响瓣膜放置的因素:增厚的室间隔增厚的室间隔主动脉根部钙化，没有扩张性的主动脉根部主动脉根部钙化，没有扩张性的主动脉根部窦管交界处狭窄窦管交界处狭窄瓣叶严重钙化瓣叶严重钙化术中处理术中处理体外模拟和灾难性事件的预案体外模拟和灾难性事件的预案危急情况的抢救方案危急情况的抢救方案瓣膜血栓形成瓣膜血栓形成冠状动脉开口堵塞冠状动脉开口堵塞瓣膜功能障碍瓣膜功能障碍BAV后出现重度后出现重度AI导致失代偿导致失代偿循环支持循环支持Slide courtesy of John WebbSlide courtesy of John WebbVancouver Vancouver 的经验的经验的经验的经验经心尖途径手术成功率(n=58)Slide courtesy of John WebbSlide courtesy of John WebbTRAVERCE:换瓣成功率换瓣成功率:93%168 168 例患者例患者例患者例患者换瓣成功换瓣成功换瓣成功换瓣成功N=156N=156换瓣不成功N=1223 mm n=43 26 mmn=113TRAVERCE:中转中转:7%位置错误位置错误 过低过低 过高过高 422 瓣膜返流瓣膜返流 远端远端 心室心室321 主动脉关闭不全主动脉关闭不全 中央返流中央返流 3+瓣周漏瓣周漏 2+由于瓣环撕裂所致由于瓣环撕裂所致 瓣周加中央返流瓣周加中央返流6222 升主动脉夹层升主动脉夹层1 二尖瓣腱锁纠结二尖瓣腱锁纠结112例患者15起事件Slide modified from Thomas WaltherSlide modified from Thomas WaltherTA TA 学习曲线学习曲线学习曲线学习曲线 (n=(n=175175)TRAVERCETRAVERCE98 2%88 3%71 4%73 4%Pat.1-120,2 Pts(CPR)excludedES 29%,STS 14%Pat.121-177ES 37%,STS 13%30 days6 months1 yearSlide courtesy of Thomas WaltherSlide courtesy of Thomas Walther无中风无中风*置换成功=设备成功输送并释放 书后AVA0.9cm，AI 2+PARTNER EU 经股动脉经股动脉心室血栓形成心室血栓形成 (n=1)主动脉血栓形成主动脉血栓形成(n=1)23 mm 23 mm SAPIEN SAPIEN 瓣膜瓣膜瓣膜瓣膜N=25N=2526 mm 26 mm SAPIEN SAPIEN 瓣膜瓣膜瓣膜瓣膜N=27N=27置换失败置换失败置换失败置换失败n=2n=2换瓣的患者数换瓣的患者数换瓣的患者数换瓣的患者数n=54n=54置换成功置换成功置换成功置换成功*n=52n=52计划纳入患者数计划纳入患者数计划纳入患者数计划纳入患者数n=60n=60手术取消手术取消手术取消手术取消n=6n=6血管入口血管入口(n=3)BAV失败失败(n=2)活动性心内膜炎活动性心内膜炎(n=1)96.3%Slide courtesy of T.Slide courtesy of T.LefvreLefvrePARTNER EU TF并发症并发症并发症并发症(n)手术当中手术当中30 天天心肌梗死心肌梗死102 中风中风021肾功能衰竭肾功能衰竭(透析透析)021 心律失常需要治疗心律失常需要治疗6 00新的起博器新的起博器010心源性休克心源性休克1 00充血性心力衰竭充血性心力衰竭001血管事件血管事件8 72瓣膜血栓形成瓣膜血栓形成200Non Hierachical RankingSlide courtesy of T.Slide courtesy of T.LefvreLefvreSAPIEN THV 商业经验商业经验&SOURCE注册注册 治疗的患者人数治疗的患者人数:7232007.11-2008.12Slide courtesy of T.Slide courtesy of T.LefvreLefvre34 心脏介入中心心脏介入中心598 植入植入15%的患者签署代理协议的患者签署代理协议The SOURCE Registry Slide courtesy of T.Slide courtesy of T.LefvreLefvreTHV 学习曲线学习曲线 植入成功的百分数植入成功的百分数%Slide courtesy of T.Slide courtesy of T.LefvreLefvre比较比较经股动脉经股动脉经心尖经心尖切口切口腹股沟腹股沟/经皮经皮胸部微型切口胸部微型切口优点优点 LOS更短更短到瓣膜的途径到瓣膜的途径Retrograde顺行性顺行性优点优点可穿过性可穿过性主动脉弓部的操作主动脉弓部的操作 较多较多较少较少优点优点中风发生率更低中风发生率更低输送长度输送长度长长短短优点优点移位更少移位更少TA是否优于是否优于TF?不是不是不是不是!因为患者往往更喜欢经皮途径因为患者往往更喜欢经皮途径因为患者往往更喜欢经皮途径因为患者往往更喜欢经皮途径!PreclosePreclose技术已经变成一种常规术式技术已经变成一种常规术式技术已经变成一种常规术式技术已经变成一种常规术式腋动脉导管腋动脉导管腋动脉导管腋动脉导管 避免跨越主动脉弓避免跨越主动脉弓避免跨越主动脉弓避免跨越主动脉弓ConduitAxillary a.下一代设备下一代设备下一代设备下一代设备 结构更简单结构更简单结构更简单结构更简单-创伤更小创伤更小创伤更小创伤更小 可以重新定位可以重新定位可以重新定位可以重新定位/可退出可退出可退出可退出 瓣周主动脉瓣返流更少瓣周主动脉瓣返流更少瓣周主动脉瓣返流更少瓣周主动脉瓣返流更少 而且，患者的选择也会不断的变化而且，患者的选择也会不断的变化而且，患者的选择也会不断的变化而且，患者的选择也会不断的变化结论结论结论结论 最安全的方法最佳最安全的方法最佳最安全的方法最佳最安全的方法最佳 TATA和和和和TFTF各有利弊各有利弊各有利弊各有利弊 随着技术的进步，经股动脉主动脉瓣置换术可能随着技术的进步，经股动脉主动脉瓣置换术可能随着技术的进步，经股动脉主动脉瓣置换术可能随着技术的进步，经股动脉主动脉瓣置换术可能会越来越重要会越来越重要会越来越重要会越来越重要 经心尖入路和经腋动脉入路是某些患者的替代方经心尖入路和经腋动脉入路是某些患者的替代方经心尖入路和经腋动脉入路是某些患者的替代方经心尖入路和经腋动脉入路是某些患者的替代方法法法法 介入科医生介入科医生介入科医生介入科医生 VS VS 外科医生外科医生外科医生外科医生手术的成功需要多学科的团队合作手术的成功需要多学科的团队合作June 3-5 2009InterContinental Hotel&Bank of America Conference Center Cleveland,Ohiowww.ccfcme.org/CardioCare09www.MeetTheBSessions will include:Aortic Disease Coronary Artery Disease Valvular Disease Electrophysiology Heart Failure Prevention Imaging Heart-Brain Medicine Vascular Disease TransplantationThis activity has been approved for AMA PRA Category 1 Credit.Transfemoral Vs Transapical Valves Which is Less Invasive?Eric E.Roselli,MDDisclosureMedtronicConsultantEdwards InvestigatorDirect Flow MedicalConsultantPercutaneous Aortic ValvesEdwards SapienUS Trial,CE Mark22-24Fr SheathsCorevalveCE Mark18Fr SheathOthers on the wayAortic Stenosis and PVDPt profile similar to thoracic aneurysmal diseaseSheaths 20 25 FrIliac Conduit 7 15%JACC,2007CorevalveSheath 18FrAccess complications down to 1.9%from 9.6%with 21FrEdwards THV Clinical InvestigationsEdwards SAPIEN experience addresses each Clinical research stageEdwards SAPIEN experience addresses each Clinical research stageFirst-in-Man Procedural success in humansFeasibility Demonstrate“reasonable”safety&effectivenessRandomized 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 from FIM to Feasibility#=Amended from Feasibility to Post-MarketREVIVE and REVIVAL IIFeasibility Studies4 North American and 6 European CentersInclusion:70 years old severe symptomatic AS EuroSCOREEuroSCORE 20 20 or non-operable or non-operableSafety and Efficacy endpointsFollow-up to 24months for REVIVAL IIREVIVAL II included Alternate Access:Transapical1/31/3rdrd screened poor femoral access screened poor femoral access12/2006-2/2008Inclusion criteria:PVD precluding TF approachSTS 15%,or inoperableAoV area 0.7 cm2 70 yrs of ageNYHA IIPooled Transfemoral AVRREVIVE&REVIVAL II(n=161)Age(yrs)83.5 5.9(66-96)90 years 14.3%(23)80 years 75.2%(121)Mean Logistic EuroSCORE30.7%15.2Mean STS Score(REVIVAL Only)(REVIVAL Only)13.1%7.2Transapical AVRREVIVAL II(n=40)Age(yrs)83.7 5.2(69 93)90 years 10%80 years 70%Mean Logistic EuroSCORE35.5 15.3 Mean STS Score(REVIVAL Only)(REVIVAL Only)13.4 7.0More CVDz,PVDz,COPDPopulations are different despite similar risk scores*One patient on CVVHD prior to valve implantationOne patient on CVVHD prior to valve implantationVascular Complications25(15.5%)Renal Failure req.Dialysis2(1.2%)*Permanent Pacemaker8(4.9%)Pooled Transfemoral AVRREVIVE&REVIVAL II(n=161)Transapical AccessVentricular bleeding0 CCF 4.8%TRAVERSEVascular ComplicationsVascular Vascular Complications Complications(n=25)(n=25)Perforations Perforations(n=12)(n=12)Aortic Aortic Dissection(n=3)Dissection(n=3)Flow Limiting Flow Limiting Iliac Dissection Iliac Dissection(n=4)(n=4)Avulsed Iliac Avulsed Iliac Artery(n=3)Artery(n=3)Lower Extremity Lower Extremity Ischemia(n=4)Ischemia(n=4)Covered Stent-3Surgical Bypass-9Surgical Repair-4Surgical Bypass-3Surgery-1Medical-2Surgery-2Medical-23 Deaths2 Deaths2 Deaths2 DeathsVascular Vascular Complications Complications(n=25)(n=25)Perforations Perforations(n=12)(n=12)Aortic Aortic Dissection(n=3)Dissection(n=3)Flow Limiting Flow Limiting Iliac Dissection Iliac Dissection(n=4)(n=4)Avulsed Iliac Avulsed Iliac Artery(n=3)Artery(n=3)Vascular Vascular Complications Complications(n=25)(n=25)Perforations Perforations(n=12)(n=12)Mortality 36%vs 10%w/oVascular Complicationsnumberat risk13129622Yes120968860139No91.4%86.7,96.082.9%76.6,89.378.2%71.0,85.472.7%54.1,91.363.3%43.0,83.646.0%23.8,68.3Log Rank P=0.0004Log Rank P=0.0004Zero Tolerance for Vascular Access ComplicationsPre-procedural Planning CriticalAngiographyIntraluminal underestimatesPoor resolution of calcium burdenCTMore accurate with contrast(toxic)Can delineate calciumHigh resolution studyIVUSFacilitated Access:Iliac conduitFundamental AssumptionLess Invasive Less Acute RiskMortalityMorbidityUnable to cross-3Unable to cross-3161 Patients 161 Patients EnrolledEnrolledUnsuccessful Unsuccessful DeploymentDeploymentn=19n=19Failed access-9Failed access-9Implant Success Implant Success 88.2%88.2%23 mm 23 mm ValveValve(55)(55)Cardiac Perforation*-3Cardiac Perforation*-326mm 26mm ValveValve(87)(87)61.3%61.3%38.7%38.7%Malplaced/EmbolizedMalplaced/Embolized-2-2Anesthesia Complication-2Anesthesia Complication-2Transfemoral AVRProcedural ResultsSuccessful Successful DeploymentDeploymentn=142n=14223 mm 23 mm ValveValve(55)(55)Successful Successful DeploymentDeploymentn=142n=142Slide courtesy of Slide courtesy of SusheelSusheel KodaliKodaliRetroFlex II Delivery SystemAddresses CrossingREVIVAL II TransapicalTechnical Success87.5%Migration/Embolization12.5%Failure to cross0Mean deployment time11.7 minMean procedure time87.1 minOther Intra-Procedural Events Related to PositioningCoronary Occlusion Prosthetic valve insufficiencyDue to leaflet overhangi.e.Valve too lowIntra-operative ManagementHemodynamic optimization prior to startingJudicious rapid ventricular pacingTEE and fluoroscopy facilitate positioningRecognition of factors affecting placement:Hypertrophied ventricular septumCalcified root non-distensible rootNarrow sino-tubular junctionBulky calcium on leafletsIntra-operative ManagementDry runs and disaster planningRescue plans for emergenciesValve embolizationCoronary ostial occlusionProsthesis malfunctionSevere AI after BAV leading to decompensationCirculatory SupportSlide courtesy of John WebbSlide courtesy of John WebbVancouver ExperienceTransapical Procedural success(n=58)Slide courtesy of John WebbSlide courtesy of John WebbTRAVERCE:Implant Success:93%168 Patients168 PatientsSuccessful Successful ImplantsImplantsN=156N=156Unsuccessful Implants with conversionN=1223 mm n=43 26 mmn=113TRAVERCE:Conversion:7%Malposition Low High 422 Valve migration Distal Ventricular321 Aortic Insufficiency Central regurgitation 3+Paravavlular leak 2+due to annular tear Paravalvular¢ral regurgitation6222 Ascending aorta dissection1 Mitral chordae entanglement115 events in 12 patientsSlide modified from Thomas WaltherSlide modified from Thomas WaltherTA Learning Curve(n=175)TRAVERCE98 2%88 3%71 4%73 4%Pat.1-120,2 Pts(CPR)excludedES 29%,STS 14%Pat.121-177ES 37%,STS 13%30 days6 months1 yearSlide courtesy of Thomas WaltherSlide courtesy of Thomas WaltherNo Strokes*Implant success=Successful device delivery and deployment resulting in an AVA0.9cm with AI 2+PARTNER EU TFVentricular embolization (n=1)Aortic embolization(n=1)23 mm 23 mm SAPIEN valveSAPIEN valveN=25N=2526 mm 26 mm SAPIEN valveSAPIEN valveN=27N=27Implant failuresImplant failuresn=2n=2Patients ImplantedPatients Implantedn=54n=54Successful Implants*Successful Implants*n=52n=52Patients PlannedPatients Plannedn=60n=60Implant abortedImplant abortedn=6n=6Vascular access(n=3)Unsucessfull BAV(n=2)Active endocarditis(n=1)96.3%Slide courtesy of T.Slide courtesy of T.LefvreLefvrePARTNER EU TFComplicationsComplication(n)Intraprocedural30 DaysMyocardial Infarction102 Stroke021Renal Failure(Dialysis)021 Arrhythmias requiring intervention6 00New Pacemaker010Cardiogenic Shock1 00Congestive Heart Failure001Vascular Events8 72Valve Embolization200Non Hierachical RankingSlide courtesy of T.Slide courtesy of T.LefvreLefvreSAPIEN THV Commercial Experience&The SOURCE Registry Number of patients treated:723November 2007-September 2008Slide courtesy of T.Slide courtesy of T.LefvreLefvre34 cardiac intervention centers598 implants15%of cases proctoredThe SOURCE Registry Site Information Slide courtesy of T.Slide courtesy of T.LefvreLefvreTHV Learning Curve Percent Successful Implant%Slide courtesy of T.Slide courtesy of T.LefvreLefvreComparisonTransfemoralTransapicalIncisionGroin/percutaneousMini-thoracotomyAdvantageShorter LOSApproach to ValveRetrogradeAntegradeAdvantageCrossabilityArch manipulationConsiderableMinimalAdvantageLess StrokeDelivery lengthLongShortAdvantageLess migrationDoes TA win over TF?NO!Because a percutaneous option will always be preferred by patients!Preclose technique is becoming routineAxillary Conduit Avoids Arch Transit ConduitAxillary a.Next Generation DevicesLower profile less traumaticRepositionable/retrievableLess paravalvular ARAlso,patient selection will continue to evolveConclusionSafest approach is bestAdvantages to both TA and TFTransfemoral will most likely dominate as devices evolveTransapical and transaxillary may continue as complementary options in select patientsShould NOT be interventionalist vs surgeon Success requires multidisciplinary teamworkJune 3-5 2009InterContinental Hotel&Bank of America Conference Center Cleveland,Ohiowww.ccfcme.org/CardioCare09www.MeetTheBSessions will include:Aortic Disease Coronary Artery Disease Valvular Disease Electrophysiology Heart Failure Prevention Imaging Heart-Brain Medicine Vascular Disease TransplantationThis activity has been approved for AMA PRA Category 1 Credit.