中国 TAVR 的临床疗效和经验 Junbo Ge, MD, FACC, FESC, FSCAI Professor of Medicine/Cardiology Chairman, Shanghai Institute of Cardiovascular Diseases Director, Dept. of Cardiology Zhongshan Hospital, Fudan University
October 2010,our center successfully completed the first case of TAVR in China ( second case of TAVR in Asia)using a CoreValve
November 2010, Fuwai hospital in Beijing (CoreValve) February 2011, 301 Hospital in Beijing (CoreValve) May 2011,Changhai Hospital in Shanghai (Edwards) Then, other hospitals
Chinese Valves Venus-A J-valve VitaFlow
Venus-A (Hangzhou Venus Medical equipments Co. Ltd.) first domestic Valve First case, September 2011, Fuwai Hospital 220 cases May be approved by CFDA soon(2016)
Venus-A (Hangzhou Venus Medical equipments Co. Ltd.) Self-expanding Valve Nitonol frame, providing strong radial force in inflow part supra-annulus tri-leaflet valve, using porcine pericardium Coated film outside inflow part to prevent paravalvular leak
Initial results of Venus-A trial 81 cases of AS with prohibitive or high surgical risk 5 centers in China, mean age :75 years Procedure successes rate: 96.3%, 30 days all-cause mortality: 4.9%;pacemaker implantation rate: 20.75% 30 days follow-up: symptoms were relieved, valve function was good Venus-A may be approved by SFDA in 2016 Gao Runlin,2014 CHC
J-valve (Suzhou Jiecheng, CO.) Trans -apically implanted with large sheath Self-expanding Automatic positioning with three locating foots also suitable for AR patients
J-valve (Suzhou Jiecheng, CO.) First case, March 2014, Huaxi Hospital Completed 120 cases enrollment in 3 heart center, with procedure successes rate of 95%, trans-apically implanted by surgery Included AR patients May be approved by SFDA in 2016
VitaFlow (Shanghai Microport CO.) Vavle design Self-expanding nitinol frame Bovine pericardial leaflets with anti-calcification treatment Large cells for improved conformability and coronary access Prolonged skirt beyond inflow for better sealing
VitaFlow (Shanghai Microport CO.) Delivery System Single operator, usercontrolled motorized deployment system Catheter distal Flex feature for trackability and alignment Compatible with low profile 16F-18F Sheath
Project Schedule Bench test & animal study done First in man done(shanghai Zhognshan Hosital) 2014 2015 2016 2017 2018 2019 CFDA submission Safety and effectiveness trial* Feasibility study done(10cases) Launch
First 41 cases for VitaFlow (Shanghai Microport CO.) Baseline Characteristics Characteristic Mean Value (N=41) Age (yrs) 77.4 Gender % Female 56% STS Score (%) 7.39% NYHA class II NYHA class III/IV Aortic valve 24.39% 75.61% bicuspid aortic valve 18/41 normal tricuspid 23/41 Aortic valve area (cm 2 ) 0.616 Mean gradient (mmhg) 61.5 LVEF(%) 57.32
Procedural Information Approach procedure Patients(n=41) Transfemoral 36/41 Ascending Aorta 1/41 Carotid Artery 4/41 Valve-in-valve 4/41 Implanted valve size TAV 24 26/41 TAV 27 15/41 Device success 41/41 术中严重并发症 :1 例发生主动脉夹层术中死亡 ;1 例右冠闭塞转外科搭桥 ; 1 例瓣环破裂转外科 + 支架瓣膜植入 ;1 例转外科换生物瓣
Outcomes at 30 Days(N=35) Event 30 Days All cause mortality 1/35 Device success 35/35 Major stoke 1/35 0 (0/20) Acute kidney injury 0/35 Major bleeding 0/35 Vascular complication 0/35 Coronary artery occlusion 1/35 New pacemaker implantation 1/35
初步技术推广应用显示 :TAVR 在我国患者中安全有效 20 hospitals in 9 provinces About 500 cases Valve : CoreValve (100 cases),edwards Sapien XT (14 cases) Venus-A (220 Cases), J- Valve(140 cases),vitaflow-valve (30) About 1/3 cases were bicuspid aortic valve (BAV ) stenosis
Chinese patients' characteristics (different from western Country) High proportion of BAV Severe calcification Small peripherial artery diameter More AR patients than AS
Percentage of BAV in different age groups Chinese patients Pan W, et al. Zhonghua Xin Xue Guan Bing Za Zhi. 2015;43(3):244-7.
Jilaihawi H, et al. Catheter Cardiovasc Interv. 2015, Suppl 1:752-61.
AR is more prevalent than AS in Chinese elderly population
Propotions of valve disease in a patients cohort undergoing valve surgery in a large Chinese heart cneter (Group A :1991-2000;Group B:2001-2010) 白一帆. 成人心脏瓣膜病外科治疗 20 年回顾及危险因素变迁. 第二军医大学 ( 长海医院 ),2012. 博士论文
TAVR 中国经验之 二叶式主动脉瓣 (BAV)
BAV 患者 TAVR 的难点 1. 瓣膜难以完全打开 相对于三叶式, 从力学的角度看, 二叶式瓣膜球囊扩张时, 瓣膜难以完全分开 导致球囊扩张效果不明显, 并且瓣膜支架难以完全打开 术后瓣环常常呈椭圆形, 长期可能影响瓣膜的功能
BAV 患者 TAVR 的难点 2. 容易出现瓣周漏 BAV 的瓣膜不对称 钙化重而不均匀等解剖学特点导致置入的瓣膜难以完全贴壁, 容易导致瓣周漏
BAV 患者 TAVR 的难点 3. 容易移位 瓣膜难以打开, 受到挤压力更大, 导致瓣膜容易向下移位 有报道显示 BAV 患者 TAVR 术后瓣膜移位的概率高达 9.3% 1 Yousef A, International journal of cardiology. 2015;189:282-288
BAV 患者 TAVR 的难点 4. 常合并主动脉扩张 主动脉瘤, 瓣膜支架的支撑点减少
BAV 患者的 TAVR 策略 高位释放
BAV 患者的 TAVR 策略 高位释放
BAV 患者的 TAVR 策略 小一号瓣膜 由于 BAV 的瓣膜常常难以完全打开, 按照常规方法选择瓣膜往往出现瓣膜狭窄, 跨瓣压差, 且容易出现瓣膜被挤压移位 针对 BAV 患者瓣膜尺寸的选择, 虽没有明确的循证学依据, 目前常经验性地采用 球囊实时测量 (balloon sizing) 并结合 CT 测量指导下的 降低尺寸 (down sizing) 策略, 即在 TAV 瓣膜尺寸选择指南的基础上, 选择小一号的瓣膜 我们的实践表明, 选择合适大小的瓣膜可以提高手术操作过程中的可控性, 使瓣膜移位 瓣周漏的发生率降低
Case 1 Aortic valve annulus Average 24.5mm Perimeter: 77.0 mm 选择 24mm 瓣膜! Area: 429.2 mm2 Maximum diameter: 29.5 mm
BAV 患者的 TAVR 策略 个体化策略 术前对患者进行超声心动图尤其是多层螺旋 CT 扫描检查, 明确 BAV 的分型 (0 型 1 型 2 型 功能性二瓣化 ) 瓣环的椭圆程度 瓣叶的对称性 瓣叶的钙化程度和分布 冠状动脉的开口分布及高度, 有无主动脉扩张等, 根据不同患者, 选择不同瓣膜, 制定不同手术策略
Meta 分线显示 BAV 患者与 TAV 患者 TAVR 的相关终点无差异 Heart, Lung and Circulation,2015 (24):649 659
指南推荐 1. 欧美心脏瓣膜病管理指南均推荐外科手术禁忌或高危 预期寿命超过 12 个月的症状性主动脉瓣重度狭窄患者作为 TAVR 的适应证 但是在这些研究中,BAV 患者均被排除在外, 指南也将 BAV 列为目前 TAVR 治疗的相对禁忌症 2. TAVR 中国专家共识 :
TAVR 中国经验之 经颈动脉 TAVR 2015 年 11 月, 上海中山完成亚洲首例经颈动脉 TAVR, 之后又完成 2 例 ; 浙二医院亦完成 1 例 4 例手术结果满意
TAVR 各种路入途径的缺点 经股动脉途径 : 某些患者股动脉偏细或者有严重狭窄 扭曲无法送入 18F- 引导鞘管, 而重度肥胖患者股动脉的穿刺 分离以及鞘管送入都存在困难 经心尖途径 : 伤口相对较大, 且对心脏存在损伤, 研究还显示经心尖途径生存率低于经股动脉途径 锁骨下动脉途径 : 虽然理论上较颈动脉途径安全, 不用担心脑部并发症, 但是有时候经锁骨下动脉走行扭曲, 不利于输送鞘管送入 ; 某些肥胖病人不易分离到锁骨下动脉 胸主动脉途径 : 伤口较大, 出血较难处理, 对升主动脉长度有要求, 并且对既往有搭桥者可能损伤桥血管者
经颈动脉途径的优点 1 路入途径短且笔直, 输送系统易于控制, 瓣膜位置容易调整 ; 2 血管表浅, 容易分离 缝合 ; 3 血管较粗大, 可进入较大鞘管 相对于锁骨下途径, 经颈动脉途径入路笔直, 因此不容易损伤血管 易于控制, 而相对于升主动脉途径, 其位置表浅 出血易于处理, 经颈动脉途径 TAVR 也具有一定优势
亚洲人股动脉较西方人比普遍细小, 相当一部分患者无法使用股动脉途径 颈动脉途径对亚洲人群具有较高价值! Jilaihawi H, et al. Catheter Cardiovasc Interv. 2015, Suppl 1:752-61.
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