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1、更多经皮瓣膜介入治疗: 循环支持,Eric E. Roselli, MD,声明,Medtronic 咨询机构 Edwards 研发者 Direct Flow Medical 咨询机构,球囊扩张瓣膜成形术,快速心室起搏,瓣膜释放,未能送入- 3,纳入161名患者,释放失败 n = 19,送入失败 - 9,植入成功 88.2%,23 mm Valve (55),心脏穿孔* - 3,26mm 瓣膜 (87),61.3%,38.7%,移位/栓塞 - 2,麻醉并发症- 2,经股动脉 REVIVE and REVIVAL II 操作结果,Successful Deployment n = 142,23 m
2、m 瓣膜 (55),成功释放 n = 142,Slide courtesy of Susheel Kodali,REVIVAL II 经心尖技术的成功性,87.5% 移位 / 栓塞 12.5% 送入失败 0 平均释放时间 11.7 min 平均操作时间 87.1 min,THV 学习曲线 成功植入百分比,%,Slide courtesy of T. Lefvre,精确释放至关重要,REVIVE & REVIVAL II 腔内操作事件,因第一个瓣膜关闭不全导致瓣内瓣 1 (0.6%) 冠脉闭塞 2 (1.2%)* 瓣膜位置 不正确 1 (0.6%)* 瓣膜栓塞 1 (0.6%),* 瓣膜位置过低
3、会导致重度主动脉返流和心脏停搏；心肺复苏时瓣膜移位至左心室 * 一例患者左主干植入支架，一例患者药物治疗,TRAVERCE: TA 可行性研究(n=168),Slide courtesy of T. Walther,TRAVERCE: 转复: 7 %,12名患者15个不良事件,Slide modified from Thomas Walther,教训,传统心脏手术中，二次手术不是死亡的独立预测因子 抢救 经导管主动脉置换术中循环支持的作用是什么？ 抢救,Roselli, et al. Adverse events during reoperative cardiac surgery: resc
4、ue JTCVS 08,经导管主动脉置换术中抢救的适应症,血流动力学不稳定 累及冠脉 BAV后，重度主动脉瓣关闭不全 升主动脉或瓣环损伤,循环支持的选择,完全心肺股股转流 ECMO Biomedicus 离心泵 Tandem 心脏,病历,83 岁老年女性 主动脉瓣狭窄并有严重临床症状 瓣膜面积0.6cm 重度 COPD, 脑血管意外病史， 肾动能不全, 肺动脉瓣功能障碍, 虚弱 行经股主动脉瓣置换 23mm 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,经导管主动脉瓣置换术中，循环支持的其他作用?,Corevalve 研究结果,91 - 97% 成功 压差 50 5mmHg 14%
5、 2+ 主动脉关闭不全 患者植入瓣膜不匹配 9-25% 死亡率 15%（ Feasibility 研究） 9% （CE mark登记注册研究）,*Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion),The SOURCE Registry 30天结局-经股动脉,Slide courtesy T. LeFevre,REVIVE II & REVIVAL II 既往冠脉搭桥术后，FM生存曲线,0.1,0.2,0.3,0.4,0.5,0.6,0.7,0.8,0.9,1,
6、3,6,9,12,Months past Procedure,Freedom from Death,0,0,No,Yes,Log Rank P=0.008,93.0% 88.3, 97.7,84.6% 77.8, 91.3,79.7% 71.9, 87.6,78.3% 66.3, 90.2,69.0% 55.5, 82.6,59.5% 45.0, 74.0,number at risk,100,78,69,50,114,NO,32,29,27,16,46,YES,REVIVAL II 合并二尖瓣关闭患者，KM生存曲线,Freedom from Death,Months past Procedu
7、re,Log Rank P=0.0479,97.2% 91.8, 100,85.8% 74.2, 97.3,82.8% 70.3, 95.3,83.3% 66.1, 100,77.8% 58.6, 97.0,61.1% 38.6, 83.6,number at risk,43,28,12,8,54,部分高危患者，可以通过循环支持减轻左心室负荷,结论,非体外循环下经导管主动脉瓣置换技术操作上已经成功。 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。 经导管主动脉瓣置换术死亡的预测因子包括NYHA 分级,既往行冠脉搭桥术,和二尖瓣狭窄 2+ 高危患者可以行左房-股动脉部分分流 (Tandem
8、Heart)。,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
9、Disease Transplantation,This activity has been approved for AMA PRA Category 1 Credit.,More Percutaneous Valves: Circulatory Support,Eric E. Roselli, MD,Disclosure,Medtronic Consultant Edwards Investigator Direct Flow Medical Consultant,Balloon Valvuloplasty,Rapid Ventricular Pacing,Valve Deployment
10、,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%,Malplaced/Embolized - 2,Anesthesia Complication - 2,Transfemoral REVIVE and REVIVAL II Procedural Results,Successful
11、 Deployment n = 142,23 mm Valve (55),Successful Deployment n = 142,Slide courtesy of Susheel Kodali,REVIVAL II Transapical Technical Success,87.5% Migration / Embolization 12.5% Failure to cross 0 Mean deployment time 11.7 min Mean procedure time 87.1 min,THV Learning Curve Percent Successful Implan
12、t,%,Slide courtesy of T. Lefvre,Accurate Deployment is Critical,REVIVE & REVIVAL II Intra-Procedural Events,Valve-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
13、 arrest; valve migrated into LV during CPR * One patient treated with left main stent, one patient managed medically,TRAVERCE: TA Feasibility study (n=168),Slide courtesy of T. Walther,TRAVERCE: Conversion: 7 %,15 events in 12 patients,Slide modified from Thomas Walther,Lessons Learned,Reoperation i
14、s not an independent predictor of mortality in conventional cardiac surgery RESCUE What is the role of circulatory support in transcatheter AVR? RESCUE,Roselli, et al. Adverse events during reoperative cardiac surgery: rescue JTCVS 08,Indications for Rescue in Transcatheter AVR,Hemodynamic Instabili
15、ty Coronary impingement Severe AI after BAV Ascending aorta or annulus injury,Circulatory Support Options,Full Cardiopulmonary Fem-fem bypass ECMO Biomedicus centrifugal pump Tandem heart,Case,83 y/o female Severe symptomatic AS Valve area 0.6cm Severe COPD, h/o CVA, renal insufficiency, PVD, frail
16、Underwent transfemoral AVR 23mm Hypotension did not recover Echo showed dilatation and severe LV dysfunction,Is there another role for circulatory support during transcatheter AVR?,Corevalve Results,91 - 97% technical success Gradients 50 5mmHg 14% 2+ AI PPM 9-25% Mortality 15% Feasibility trial 9%
17、CE mark Registry,*Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion),The SOURCE Registry 30 Day Outcome-TF,Slide courtesy T. LeFevre,REVIVE II & REVIVAL II TF KM Survival if Prior CABG,0.1,0.2,0.3,0.4,0.5,0.6,0.7,0.8,0.9,1,3,6,9,12,Months past Procedure,Free
18、dom from Death,0,0,No,Yes,Log Rank P=0.008,93.0% 88.3, 97.7,84.6% 77.8, 91.3,79.7% 71.9, 87.6,78.3% 66.3, 90.2,69.0% 55.5, 82.6,59.5% 45.0, 74.0,number at risk,100,78,69,50,114,NO,32,29,27,16,46,YES,REVIVAL II TF KM Survival by Baseline MR,Freedom from Death,Months past Procedure,Log Rank P=0.0479,9
19、7.2% 91.8, 100,85.8% 74.2, 97.3,82.8% 70.3, 95.3,83.3% 66.1, 100,77.8% 58.6, 97.0,61.1% 38.6, 83.6,number at risk,43,28,12,8,54,In select high risk patients, there may benefit to unloading the LV with circulatory support,Conclusions,Transcatheter AVR has become a technically successful off-pump proc
20、edure Prime role for circulatory support is to facilitate RESCUE from life-threatening complications NYHA class, Prior CABG, and MR 2+ trend as predictors of death in TAVR There may be a role for LA-Fem partial bypass (TandemHeart) in these high risk patients,June 3-5 2009,InterContinental Hotel & B
21、ank 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.,