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1、更多经皮瓣膜介入治疗更多经皮瓣膜介入治疗更多经皮瓣膜介入治疗更多经皮瓣膜介入治疗: :循环支持循环支持循环支持循环支持Eric E. Roselli, MDEric E. Roselli, MD声明声明Medtronic咨询机构咨询机构Edwards 研发者研发者Direct Flow Medical咨询机构咨询机构球囊扩张瓣膜成形术球囊扩张瓣膜成形术球囊扩张瓣膜成形术球囊扩张瓣膜成形术快速心室起搏快速心室起搏瓣膜释放瓣膜释放未能送入未能送入未能送入未能送入- 3- 3纳纳入入入入161161名患者名患者名患者名患者释释放失放失放失放失败败n = 19n = 19送入失送入失送入失送入失败败
2、- 9 - 9植入成功植入成功植入成功植入成功88.2%88.2%23 mm 23 mm ValveValve(55)(55)心心心心脏脏穿孔穿孔穿孔穿孔* - 3* - 326mm 26mm 瓣膜瓣膜瓣膜瓣膜(87)(87)61.3%61.3%38.7%38.7%移位移位移位移位/ /栓塞栓塞栓塞栓塞 - 2 - 2麻醉并麻醉并麻醉并麻醉并发发症症症症- 2- 2经股动脉经股动脉 REVIVE and REVIVAL II 操作结果操作结果Successful Successful DeploymentDeploymentn = 142n = 14223 mm23 mm 瓣膜瓣膜瓣膜瓣膜(5
3、5)(55)成功成功成功成功释释放放放放n = 142n = 142Slide courtesy of Susheel KodaliSlide courtesy of Susheel KodaliREVIVAL II 经心尖技术的成功性经心尖技术的成功性87.5%移位移位 / 栓塞栓塞 12.5%送入失败送入失败 0平均释放时间平均释放时间 11.7 min平均操作时间平均操作时间87.1 minTHV 学习曲线学习曲线 成功植入百分比成功植入百分比%Slide courtesy of T. LefvreSlide courtesy of T. Lefvrebaced精确释放至关重要精确释放至
4、关重要REVIVE & REVIVAL II腔内操作事件腔内操作事件因第一个瓣膜关闭不全导致瓣内瓣因第一个瓣膜关闭不全导致瓣内瓣因第一个瓣膜关闭不全导致瓣内瓣因第一个瓣膜关闭不全导致瓣内瓣 1 (0.6%) 1 (0.6%)冠脉闭塞冠脉闭塞冠脉闭塞冠脉闭塞 2 (1.2%)* 2 (1.2%)*瓣膜位置瓣膜位置瓣膜位置瓣膜位置 不正确不正确不正确不正确 1 (0.6%)* 1 (0.6%)*瓣膜栓塞瓣膜栓塞瓣膜栓塞瓣膜栓塞 1 (0.6%) 1 (0.6%)* * 瓣膜位置瓣膜位置瓣膜位置瓣膜位置过过低会低会低会低会导导致重度主致重度主致重度主致重度主动动脉返流和心脉返流和心脉返流和心脉返流和
5、心脏脏停搏；心肺复停搏；心肺复停搏；心肺复停搏；心肺复苏时苏时瓣膜移位至左心室瓣膜移位至左心室瓣膜移位至左心室瓣膜移位至左心室* 一例患者左主干植入支架，一例患者一例患者左主干植入支架，一例患者一例患者左主干植入支架，一例患者一例患者左主干植入支架，一例患者药药物治物治物治物治疗疗TRAVERCE: TA 可行性研究可行性研究(n=168)植入成功率92.8 %30天存活率85 % 6个月 存活率70 %6个月未发生中风95 %6个月未发生心梗98 %不停跳77 %胸骨劈开 (转复)7.1% (n=12)Slide courtesy of T. WaltherSlide courtesy of
6、 T. WaltherTRAVERCE: 转复转复: 7 % 位置不正确位置不正确 低低 高高 422 瓣膜移位瓣膜移位 远端远端 心室心室321 主动脉关闭主动脉关闭 不全不全 中心性返流中心性返流 3+ 瓣环撕裂导致的瓣周漏瓣环撕裂导致的瓣周漏2+ 瓣周或中心性返流瓣周或中心性返流6222 升主动脉升主动脉夹层夹层1 二尖瓣腱索缠结二尖瓣腱索缠结112名患者15个不良事件Slide modified from Thomas WaltherSlide modified from Thomas Walther教训教训传统心脏手术中，二次手术不是死亡的独立预测传统心脏手术中，二次手术不是死亡的独
7、立预测因子因子抢救抢救经导管主动脉置换术中循环支持的作用是什么？经导管主动脉置换术中循环支持的作用是什么？ 抢救抢救Roselli, et al. Adverse events during reoperative cardiac surgery: rescue JTCVS 08Roselli, et al. Adverse events during reoperative cardiac surgery: rescue JTCVS 08经导管主动脉置换术中抢救的适应经导管主动脉置换术中抢救的适应症症血流动力学不稳定血流动力学不稳定累及冠脉累及冠脉BAV后，重度主动脉瓣关闭不全后，重度主动脉
8、瓣关闭不全 升主动脉或瓣环损伤升主动脉或瓣环损伤循环支持的选择循环支持的选择完全心肺股股转流完全心肺股股转流ECMOBiomedicus 离心泵离心泵Tandem 心脏心脏病历病历83 岁老年女性岁老年女性主动脉瓣狭窄并有严重临床症状主动脉瓣狭窄并有严重临床症状瓣膜面积瓣膜面积0.6cm重度重度 COPD, 脑血管意外病史，脑血管意外病史， 肾动能不全肾动能不全, 肺动肺动脉瓣功能障碍脉瓣功能障碍, 虚弱虚弱行经股主动脉瓣置换行经股主动脉瓣置换 23mm低血压难以纠正低血压难以纠正超声心动图示左心扩张，重度左心室功能障碍超声心动图示左心扩张，重度左心室功能障碍经导管主动脉瓣置换术中，循环支经导
9、管主动脉瓣置换术中，循环支持的其他作用持的其他作用?Corevalve 研究结果研究结果91 - 97% 成功成功压差压差 50 5mmHg14% 2+ 主动脉关闭不全主动脉关闭不全患者植入瓣膜不匹配患者植入瓣膜不匹配 9-25%死亡率死亡率 15%（ Feasibility 研究）研究） 9% （CE mark登记注册研究）登记注册研究）*Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)存活率存活率*93.6%NYHA Class INYHA Class I
10、INYHA Class IIINYHA Class IV39.4%50.5%9.1%1.0%心肌梗塞心肌梗塞1.0%中风中风3.4%血管并发症血管并发症7.4%The SOURCE Registry30天天结局局-经股股动脉脉Slide courtesy T. LeFevreSlide courtesy T. LeFevreREVIVE II & REVIVAL II既往冠脉搭桥术后，既往冠脉搭桥术后，FM生存曲线生存曲线0.10.10.20.20.30.30.40.40.50.50.60.60.70.70.80.80.90.91 13 36 69 91212Months past Proce
11、dureMonths past ProcedureFreedom from DeathFreedom from Death0 00 0NoNoYesYesLog Rank P=0.008Log Rank P=0.00893.0%88.3, 97.784.6%77.8, 91.379.7%71.9, 87.678.3%66.3, 90.269.0%55.5, 82.659.5%45.0, 74.0numberat risk100786950114NO3229271646YESREVIVAL II合并二尖瓣关闭患者，合并二尖瓣关闭患者，KM生存曲线生存曲线Freedom from DeathFre
12、edom from DeathMonths past ProcedureMonths past ProcedureLog Rank P=0.0479Log Rank P=0.047997.2%91.8, 10085.8%74.2, 97.382.8%70.3, 95.383.3%66.1, 10077.8%58.6, 97.061.1%38.6, 83.6number at risk432812854部分高危患者，可以通过循环支持部分高危患者，可以通过循环支持减轻左心室负荷减轻左心室负荷结论结论非体外循环下经导管主动脉瓣置换技术操作上已经非体外循环下经导管主动脉瓣置换技术操作上已经成功。成功。
13、循环支持的主要作用是威胁生命并发症发生时的抢循环支持的主要作用是威胁生命并发症发生时的抢救措施。救措施。经导管主动脉瓣置换术死亡的预测因子包括经导管主动脉瓣置换术死亡的预测因子包括NYHA 分级分级,既往行冠脉搭桥术既往行冠脉搭桥术,和二尖瓣狭窄和二尖瓣狭窄 2+高危患者可以行左房高危患者可以行左房-股动脉部分分流股动脉部分分流 (TandemHeart)。June 3-5 2009InterContinental Hotel &Bank of America Conference Center Cleveland, OhioSessions will include: Aortic Dise
14、ase 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.更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持More Percutaneous Valves:More Per
15、cutaneous Valves:Circulatory SupportCirculatory SupportEric E. Roselli, MDEric E. Roselli, MD更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持DisclosureMedtronicConsultantEdwards InvestigatorDirect Flow MedicalConsultant更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Balloon ValvuloplastyBalloon Valvuloplasty更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Rap
16、id Ventricular Pacing更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Valve Deployment更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Unable to cross - 3Unable to cross - 3161 Patients 161 Patients EnrolledEnrolledUnsuccessful Unsuccessful DeploymentDeploymentn = 19n = 19Failed access - 9Failed access - 9Implant Success Implant Success 88.
17、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/Embolized - 2Malplaced/Embolized - 2Anesthesia Complication - 2Anesthesia Complication - 2Transfemoral REVIVE and REVIVAL II Procedural ResultsSuccessful Suc
18、cessful DeploymentDeploymentn = 142n = 14223 mm 23 mm ValveValve(55)(55)Successful Successful DeploymentDeploymentn = 142n = 142Slide courtesy of Susheel KodaliSlide courtesy of Susheel Kodali更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持REVIVAL II TransapicalTechnical Success87.5%Migration / Embolization12.5%Failure
19、 to cross0Mean deployment time11.7 minMean procedure time87.1 min更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持THV Learning Curve Percent Successful Implant%Slide courtesy of T. LefvreSlide courtesy of T. Lefvre更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持bacedAccurate Deployment is Critical更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持REVIVE & REVIVA
20、L IIIntra-Procedural EventsValve-in-valve due to incompetent valve 1 (0.6%)Coronary Occlusion 2 (1.2%)*Valve Malplacement 1 (0.6%)*Valve Embolization 1 (0.6%)* * Valve placed too low resulting in severe AR and cardiac arrest; valve Valve placed too low resulting in severe AR and cardiac arrest; valv
21、e migrated into LV during CPRmigrated into LV during CPR* One patient treated with left main stent, one patient managed medicallyOne patient treated with left main stent, one patient managed medically更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持TRAVERCE: TA Feasibility study (n=168)Implant Success92.8 %30-day Surviv
22、al85 % 6-month Survival70 %Freedom from Stroke 6 mo.95 %Freedom from MI 6 mo.98 %off-pump77 %Sternotomy (conversion)7.1% (n=12)Slide courtesy of T. WaltherSlide courtesy of T. Walther更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持TRAVERCE: Conversion: 7 % Malposition Low High 422 Valve migration Distal Ventricular321
23、Aortic Insufficiency Central regurgitation 3+ Paravavlular leak 2+ due to annular tear Paravalvular & central regurgitation6222 Ascending aorta dissection1 Mitral chordae entanglement115 events in 12 patientsSlide modified from Thomas WaltherSlide modified from Thomas Walther更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环
24、支持支持Lessons LearnedReoperation is not an independent predictor of mortality in conventional cardiac surgeryRESCUEWhat is the role of circulatory support in transcatheter AVR? RESCUERoselli, et al. Adverse events during reoperative cardiac surgery: rescue JTCVS 08Roselli, et al. Adverse events during
25、 reoperative cardiac surgery: rescue JTCVS 08更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Indications for Rescue in Transcatheter AVRHemodynamic InstabilityCoronary impingementSevere AI after BAVAscending aorta or annulus injury更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Circulatory Support OptionsFull Cardiopulmonary Fem-fem bypas
26、sECMOBiomedicus centrifugal pumpTandem heart更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Case83 y/o femaleSevere symptomatic ASValve area 0.6cmSevere COPD, h/o CVA, renal insufficiency, PVD, frailUnderwent transfemoral AVR 23mmHypotension did not recoverEcho showed dilatation and severe LV dysfunction更多更多经经皮瓣膜介入治皮瓣膜
27、介入治疗疗循循环环支持支持更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Is there another role for circulatory support during transcatheter AVR?更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持Corevalve Results91 - 97% technical successGradients 50 5mmHg14% 2+ AIPPM 9-
28、25%Mortality 15% Feasibility trial9%CE mark Registry更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持*Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)Survival*93.6%NYHA Class INYHA Class IINYHA Class IIINYHA Class IV39.4%50.5%9.1%1.0%MI1.0%Stroke3.4%Vascular Complications 7.4%
29、The SOURCE Registry30 Day Outcome-TFSlide courtesy T. LeFevreSlide courtesy T. LeFevre更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持REVIVE II & REVIVAL IITF KM Survival if Prior CABG0.10.10.20.20.30.30.40.40.50.50.60.60.70.70.80.80.90.91 13 36 69 91212Months past ProcedureMonths past ProcedureFreedom from DeathFreedo
30、m from Death0 00 0NoNoYesYesLog Rank P=0.008Log Rank P=0.00893.0%88.3, 97.784.6%77.8, 91.379.7%71.9, 87.678.3%66.3, 90.269.0%55.5, 82.659.5%45.0, 74.0numberat risk100786950114NO3229271646YES更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持REVIVAL IITF KM Survival by Baseline MRFreedom from DeathFreedom from DeathMonths
31、past ProcedureMonths past ProcedureLog Rank P=0.0479Log Rank P=0.047997.2%91.8, 10085.8%74.2, 97.382.8%70.3, 95.383.3%66.1, 10077.8%58.6, 97.061.1%38.6, 83.6number at risk432812854更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持In select high risk patients, there may benefit to unloading the LV with circulatory support
32、更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持ConclusionsTranscatheter AVR has become a technically successful off-pump procedurePrime role for circulatory support is to facilitate RESCUE from life-threatening complicationsNYHA class, Prior CABG, and MR 2+ trend as predictors of death in TAVRThere may be a role for L
33、A-Fem partial bypass (TandemHeart) in these high risk patients更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持June 3-5 2009InterContinental Hotel &Bank of America Conference Center Cleveland, OhioSessions 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.更多更多经经皮瓣膜介入治皮瓣膜介入治疗疗循循环环支持支持
