经股动脉vs经心尖部主动脉瓣置换术-那种创伤更小课件(PPT 81页).pptx

1、经股动脉经股动脉 VS 经心尖部主动脉瓣置换经心尖部主动脉瓣置换术术-那种创伤更小那种创伤更小?Eric E.Roselli,MD第1页，共81页。声明声明Medtronic顾问顾问Edwards 研究者研究者Direct Flow Medical顾问顾问第2页，共81页。经皮主动脉瓣置换术经皮主动脉瓣置换术Edwards SapienUS 试验试验,CE 标志标志22-24Fr 鞘管鞘管CorevalveCE 标志标志18Fr 鞘管鞘管其他尚未投入使用其他尚未投入使用第3页，共81页。主动脉狭窄和主动脉狭窄和PVD患者的一般情况与胸主动脉患者的一般情况与胸主动脉瘤疾病类似瘤疾病类似鞘管鞘管

2、20 25 Fr髂动脉导管髂动脉导管7 15%JACC,2007第4页，共81页。Corevalve鞘管鞘管18Fr使用使用21Fr鞘管并发症的发生率为鞘管并发症的发生率为9.6%，使，使用用18Fr鞘管后发生率下降至鞘管后发生率下降至1.9%第5页，共81页。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 评估商业利用情况评估商业利用情况长期随访长期随访 RECAST I-REVIVE TRAVERCE*REVIVE II REVIVAL II

3、TRAVERCE PARTNER EU#PARTNER IDE PARTNER EU SOURCE*=Amended from FIM to Feasibility#=Amended from Feasibility to Post-Market第6页，共81页。REVIVE and REVIVAL II可行性研究可行性研究4个北美研究中心和个北美研究中心和6个欧洲研究中心个欧洲研究中心结论结论 :70y 症状严重的症状严重的第7页，共81页。REVIVAL II 包括包括 备选入路备选入路:经心尖经心尖1/3rd 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第8页，共81

4、页。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第9页，共81页。第10页，共81页。尽管风险评分类似，尽管风险评分类似，但患者群体并不相同但患者群体并不相同第11页，共81页。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%)第12页，共81页。经心尖入路经心尖入路在在CCF并没有心室并没有心室出血出血 4.8%transverse第13页，共81页。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-4Surg

5、ical 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 例死亡例死亡死亡率死亡率36%vs 10%w/o第14页，共81页。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%23.8,68.3第15页，共81页。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血管成形术血管成形

6、术腔内腔内 低估低估钙化的分辨率较低钙化的分辨率较低CT增强扫描分辨率更高增强扫描分辨率更高(毒性毒性)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IVUS第16页，共81页。使入路更简便使入路更简便:髂动脉导管髂动脉导管第17页，共81页。基本假设基本假设创伤更小创伤更小急性风险更少急性风险更少死亡率死亡率并发症并发症 第18页，共81页。Slide courtesy of Susheel Kodali第19页，共81页。RetroFlex II 输送系统输送系统Addresses Crossing第20页，共81页。REVIVAL II 经心尖途径经心尖途径手术成功率手

7、术成功率87.5%无法穿过心尖无法穿过心尖0平均释放时间平均释放时间11.7 min平均手术时间平均手术时间87.1 min第21页，共81页。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 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i.e.瓣膜太低瓣膜太低第22页，共81页。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

8、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第23页，共81页。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第24页，共81页。Slide courtesy of John WebbVancouver 的经验的经验第25页，共81页。经心尖途径手术成功率(n=58)Slide courtesy of John Webb第26页，共81页。TRAVERCE:换瓣成功率换瓣成功率:9

9、3%换瓣不成功N=1223 mm n=43 26 mmn=113第27页，共81页。TRAVERCE: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 Walther第28页，共81页。TA 学习曲线学习曲线(n=175)TRAVERCE98 2%88 3%71 4%73

10、 4%Pat.1-120,2 Pts(CPR)excludedES 29%,STS 14%Pat.121-177ES 37%,STS 13%30 days6 months1 yearSlide courtesy of Thomas Walther无中风无中风第29页，共81页。*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)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.Lefv

11、re第30页，共81页。PARTNER 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.Lefvre第31页，共81页。SAPIEN 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:7232007.11-2

12、008.12Slide courtesy of T.Lefvre第32页，共81页。34 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.Lefvre第33页，共81页。THV 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.Lefvre第34页，共81页。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

13、性可穿过性主动脉弓部的操主动脉弓部的操作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?第35页，共81页。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!Preclose技术已经变成一种常规术式技术已经变成一种常规术式第36页，共81页。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ConduitAxillary a.第37页，共81页。第38页，共81页。结论结论最安全的方法最佳最安全的方法最佳TA和和TF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

14、主动脉瓣置换术可能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法法介入科医生介入科医生 VS 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第39页，共81页。June 3-5 2009InterContinental Hotel&Bank of America Conference Center Cleveland,Ohiowww.ccfcme.org/CardioCare09www.MeetTheBSessions will include:Aortic Disease Coronary Arte

15、ry Disease Valvular Disease Electrophysiology Heart Failure Prevention Imaging Heart-Brain Medicine Vascular Disease TransplantationThis activity has been approved for AMA PRA Category 1 Credit.第40页，共81页。第41页，共81页。Transfemoral Vs Transapical Valves Which is Less Invasive?Eric E.Roselli,MD第42页，共81页。D

16、isclosureMedtronicConsultantEdwards InvestigatorDirect Flow MedicalConsultant第43页，共81页。Percutaneous Aortic Valves Edwards Sapien US Trial,CE Mark 22-24Fr Sheaths Corevalve CE Mark 18Fr Sheath Others on the way第44页，共81页。Aortic Stenosis and PVD Pt profile similar to thoracic aneurysmal disease Sheaths

17、 20 25 Fr Iliac Conduit 7 15%JACC,2007第45页，共81页。Corevalve Sheath 18Fr Access complications down to 1.9%from 9.6%with 21Fr第46页，共81页。First-in-Man Procedural success in humansFeasibility Demonstrate“reasonable”safety&effectivenessRandomized Control Effectiveness vs.control(AVR&medical therapy)Post-Mark

18、et 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-Market第47页，共81页。REVIVE and REVIVAL IIFeasibility Studies 4 North American an

19、d 6 European Centers Inclusion:70 years old severe symptomatic AS第48页，共81页。REVIVAL II included Alternate Access:Transapical1/3rd screened poor femoral access第49页，共81页。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第50页，共81页。第5

20、1页，共81页。Populations are different despite similar risk scores第52页，共81页。Vascular Complications25(15.5%)Renal Failure req.Dialysis2(1.2%)*Permanent Pacemaker8(4.9%)第53页，共81页。Transapical Access Ventricular bleeding0 CCF 4.8%TRAVERSE第54页，共81页。Covered Stent-3Surgical Bypass-9Surgical Repair-4Surgical Byp

21、ass-3Surgery-1Medical-2Surgery-2Medical-23 Deaths2 Deaths2 Deaths2 DeathsMortality 36%vs 10%w/o第55页，共81页。Vascular 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%23.8,68.3第56页，共81页。Zero Tolerance for Vascular Access Compli

22、cations Pre-procedural Planning Critical Angiography Intraluminal underestimates Poor resolution of calcium burden CT More accurate with contrast(toxic)Can delineate calcium High resolution study IVUS第57页，共81页。Facilitated Access:Iliac conduit第58页，共81页。Fundamental AssumptionLess InvasiveLess Acute Ri

23、skMortalityMorbidity第59页，共81页。Slide courtesy of Susheel Kodali第60页，共81页。RetroFlex II Delivery SystemAddresses Crossing第61页，共81页。REVIVAL II TransapicalTechnical Success87.5%Failure to cross0Mean deployment time11.7 minMean procedure time87.1 min第62页，共81页。Other Intra-Procedural Events Related to Posit

24、ioning Coronary Occlusion Prosthetic valve insufficiency Due to leaflet overhangi.e.Valve too low第63页，共81页。Intra-operative Management Hemodynamic optimization prior to startingJudicious rapid ventricular pacingTEE and fluoroscopy facilitate positioningRecognition of factors affecting placement:Hyper

25、trophied ventricular septumCalcified root non-distensible rootNarrow sino-tubular junctionBulky calcium on leaflets第64页，共81页。Intra-operative Management Dry runs and disaster planning Rescue plans for emergencies Valve embolization Coronary ostial occlusion Prosthesis malfunction Severe AI after BAV

26、leading to decompensation Circulatory Support第65页，共81页。Slide courtesy of John WebbVancouver Experience第66页，共81页。Transapical Procedural success(n=58)Slide courtesy of John Webb第67页，共81页。TRAVERCE:Implant Success:93%Unsuccessful Implants with conversionN=1223 mm n=43 26 mmn=113第68页，共81页。TRAVERCE:Conver

27、sion: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

28、 Walther第69页，共81页。TA 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 WaltherNo Strokes第70页，共81页。*Implant success=Successful device delivery and deployment resulting in an AVA0.9cm with A

29、I 2+PARTNER EU TFVentricular embolization (n=1)Aortic embolization(n=1)Vascular access(n=3)Unsucessfull BAV(n=2)Active endocarditis(n=1)96.3%Slide courtesy of T.Lefvre第71页，共81页。PARTNER EU TFComplicationsComplication(n)Intraprocedural30 DaysMyocardial Infarction102 Stroke021Renal Failure(Dialysis)021

30、 Arrhythmias requiring intervention6 00New Pacemaker010Cardiogenic Shock1 00Congestive Heart Failure001Vascular Events8 72Valve Embolization200Non Hierachical RankingSlide courtesy of T.Lefvre第72页，共81页。SAPIEN THV Commercial Experience&The SOURCE Registry Number of patients treated:723November 2007-S

31、eptember 2008Slide courtesy of T.Lefvre第73页，共81页。34 cardiac intervention centers 598 implants 15%of cases proctoredThe SOURCE Registry Site Information Slide courtesy of T.Lefvre第74页，共81页。THV Learning Curve Percent Successful Implant%Slide courtesy of T.Lefvre第75页，共81页。ComparisonTransfemoralTransapi

32、calIncisionGroin/percutaneousMini-thoracotomyAdvantageShorter LOSApproach to ValveRetrogradeAntegradeAdvantageCrossabilityArch manipulationConsiderableMinimalAdvantageLess StrokeDelivery lengthLongShortAdvantageLess migrationDoes TA win over TF?第76页，共81页。NO!Because a percutaneous option will always

33、be preferred by patients!Preclose technique is becoming routine第77页，共81页。Axillary Conduit Avoids Arch Transit ConduitAxillary a.第78页，共81页。第79页，共81页。Conclusion Safest approach is best Advantages to both TA and TF Transfemoral will most likely dominate as devices evolve Transapical and transaxillary m

34、ay continue as complementary options in select patients Should NOT be interventionalist vs surgeon Success requires multidisciplinary teamwork第80页，共81页。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.第81页，共81页。