Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 1 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房颤治疗房颤治疗左心耳封堵术左心耳封堵术Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 2 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014LAAC:LeftAtrialAppendageClosure左心耳封堵左心耳封堵左心耳封堵左心耳封堵 概述概述概述概述房颤与卒中房颤与卒中左心耳解剖及封堵器选择左心耳解剖及封堵器选择WATCHMAN左心耳封堵器及手术流程左心耳封堵器及手术流程左心耳封堵适应症和禁忌症左心耳封堵适应症和禁忌症左心耳封堵（左心耳封堵（WATCHMAN系统）临床试验系统）临床试验Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 3 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房颤是最常见的心律失常123中国有至少800万的房颤患者房颤发病率随年龄增长而增加什么是房颤？房颤是患者规则有序的心房电活动丧失，代之以快速无序的颤动波， 心房失去了有效的收缩与舒张，心房泵血功能恶化或丧失，加之房室结对快速心房激动的递减传导，引起心室极不规则的反应 。Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 4 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房房颤是最常是最常见的心律失常的心律失常中国30-85岁居民中房颤患病率为0.771，总共约有800万房颤患者，由于部分房颤是症状并不明显或未确诊，因此房颤患者的实际数量可能更高。房颤的患病率随着年龄的增加呈明显的上升趋势。中国不同年龄组人群的房颤发病率1(1)Guidelinesforthemanagementofatrialfibrillation.ThetaskforceforthemanagementofatrialfibrillationoftheEuropeanSocietyofCardiology(ESC).EurHeartJ2010;31:2369-2449.Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 5 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房颤的危害房颤的危害房颤患者卒中风险房颤患者卒中风险非房颤患者卒中风险非房颤患者卒中风险 5 X房颤最主要的并发症是房颤最主要的并发症是脑中风脑中风房颤患者中风风险较非房颤患者高房颤患者中风风险较非房颤患者高5倍倍房颤相关的中风第一年死亡率高达50%；第一年严重致残率高达73%；第一年累计复发率高达6.9%Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 6 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014中风名人榜英国前首相撒切尔夫人2013年4月8日因中风逝世Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 7 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014中风名人榜陈强，著名演员，陈佩斯的父亲因脑中风医治无效，于2012年6月26日21点38分在医院逝世Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 8 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014中风名人榜列宁自1922年5月起数度中风，1923年3月9日，由中风引起右侧瘫痪和言语障碍。Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 9 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳封堵名人榜阿诺施瓦辛格房颤发作多年，2013年底于美国洛杉矶西奈山中心进行左心耳封堵手术，现已恢现已恢复健康，停用抗凝药复健康，停用抗凝药Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 10 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房房房房颤颤 增加增加增加增加卒中卒中卒中卒中风险风险20% 的卒中发生于房颤患者的卒中发生于房颤患者1房颤患者卒中风险较非房颤患者高房颤患者卒中风险较非房颤患者高5倍倍2房颤所致脑卒中具有高致残率、高房颤所致脑卒中具有高致残率、高病死率及高复发率的特点病死率及高复发率的特点3卒中是中国居民第一大死因，同时也是致残的首要原因。卒中是中国居民第一大死因，同时也是致残的首要原因。AFAF:AtrialFibrillation(1)HartRG,HalperinJL.Atrialfibrillationandthromboembolism:adecadeofprogressinstrokeprevention.AnnInternMed.1999.(2)HolmesDR,AtrialFibrillationandStrokeManagement:PresentandFuture,SeminarsinNeurology2010;30:528536(3)YangG,etal.RapidhealthtransitioninChina,1990-2010.Lancet2013;381(9882):19872015.Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 11 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014中国房颤患者卒中发生率中国房颤患者卒中发生率在中国，房颤导致卒中的发生率为大约为13.0%-13.4%1预防房颤导致中风非常重要！预防房颤导致中风非常重要！年份年份试验设计试验设计样本量样本量房颤患者卒中的发生率房颤患者卒中的发生率2003-2004基于社区的前瞻性研究1861513.0%-13.4%1999-2002基于医院的回顾性研究342517.5%24.2%（1）YutaoGuo,etal.TheUnmetNeedofStrokePreventioninAtrialFibrillationintheFarEastandSouthEastAsia,MalaysJMedSci.Jul-Sep2012;19(3):1-7Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 12 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房颤患者为什么容易中风？房颤患者为什么容易中风？1房颤引起血液滞留在左心耳滞留的血液逐渐形成血栓24血栓滞留在大脑的血管中，限制血液流动，引起卒中血栓从左心耳脱落，进入动脉系统3非瓣膜性房颤患者非瓣膜性房颤患者90%的血栓来自于左心耳的血栓来自于左心耳Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 13 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014虽然还没有中风症状，但可能大脑已有梗死灶虽然还没有中风症状，但可能大脑已有梗死灶Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 14 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014房颤治疗房颤治疗消融成功率？终身服药？出血?口服抗凝药:治疗窗窄,需频繁调整剂量及监控受食物、药物相互作用影响疗效长期服用对肾功能影响药物疗法必须面对致命出血风险消融存在一定的复发率房颤治疗，首先要抗凝预防中风房颤治疗，首先要抗凝预防中风Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 15 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014射频消融射频消融起搏治疗起搏治疗药物控制心率药物控制心率血栓管理血栓管理手术结扎手术结扎左心耳切除左心耳切除左心耳封堵左心耳封堵介入治疗介入治疗药物药物(新型口服抗凝药）新型口服抗凝药）AF药物药物(华法林华法林)NOACs:NovelAnticoagulants(Dabigatran,Apixaban,Rivaroxaban)AF:AtrialFibrillation房房房房颤颤治治治治疗选择疗选择和和 / 或或Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 16 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014卒中危卒中危卒中危卒中危险险因素因素因素因素(1)LipGYetal,Chest2010;137(2):263-72(2)CammAJetal,Eur.HeartJ2010;31,23692429C充血性心力衰竭充血性心力衰竭1H 高血压高血压1A 年龄年龄 752D 糖尿病糖尿病1S 中风史中风史/短暂性脑缺血发作短暂性脑缺血发作2V 心血管疾病心血管疾病1A 年龄年龄 65-741Sc 女性女性1CHA2DS2-VASc最高分数最高分数:915%10%0%05%3%13%18%每年卒中发生风险每年卒中发生风险1,21,32,23,24,06,79,89,66,715,2123456789*女性单一因素不计分Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 17 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014出血危出血危出血危出血危险险因素因素因素因素Guidelinesforthemanagementofatrialfibrillation.ThetaskforceforthemanagementofatrialfibrillationoftheEuropeanSocietyofCardiology(ESC).Eur.HeartJ2010;31:2369-2449.H 高血高血压1A 肾/肝功能不全肝功能不全1或2S中中风史史1B出血出血2LINR不不稳定定1E年年龄 651D药物或酒精物或酒精滥用用1或2HAS-BLED最高分数最高分数:9使用药物预防血栓首先要平衡卒中风险和出血风险，尤其是ICH（自发性脑出血）的患者，抗凝治疗易产生严重并发症，致死或致残 (ESC 指南 2012)Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 18 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014华华法法法法林可有效降低林可有效降低林可有效降低林可有效降低卒中卒中卒中卒中风险风险 但华法林治疗也有其局限性但华法林治疗也有其局限性: 华法林常耐受不良华法林常耐受不良治疗范围窗口窄(INRbetween2.03.0)有效性受多种食物和药物影响需要频繁地抽血监测并调整剂量主要并发症主要并发症使用华法林主要出血事件预估发生率高达16%2华法林相关性出血：发生住院死亡、威胁生命的残疾及需干预的事件总比例高达90%236%64%INR治疗区间外INR治疗区间内DianeK.Wysowski,etal.,ARCHINTERNMED/VOL167(NO.13),JULY9,2007(BleedingComplicationsWithWarfarinUse)Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 19 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014GallagherAMetal:JThrombHaemost6:1500,2008中断华法林治疗的患者卒中风险增高华法林患者自行停药比例高华法林患者自行停药比例高华法林患者自行停药比例高华法林患者自行停药比例高Years after starting treatment20100806040204640-6465-6970-7475-7980-8485Age%DiscontinuationIndications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014口服抗凝药物使用情况（口服抗凝药物使用情况（CHADS22分）分）11.2%65.7%中国房中国房中国房中国房颤颤患者的抗栓治患者的抗栓治患者的抗栓治患者的抗栓治疗现疗现状状状状Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 21 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Thischartisnotbasedonahead-to-headtrialandisnotintendedtosuggesthead-to-headcomparisonsoftheseparatetrialsorthetherapiesunderstudy.新型口服抗凝药新型口服抗凝药新型口服抗凝药新型口服抗凝药研究研究用药用药主要出血事件主要出血事件出血性卒中出血性卒中中断治疗中断治疗RE-LY1达比加群酯(110mg)2.71%0.12%20.7%达比加群酯(150mg)3.11%0.10%21.2%华法林3.36%0.38%16.6%ROCKET-AF2利伐沙班3.6%0.5%23.7%华法林3.4%0.7%22.2%ARISTOLE3阿哌沙班2.13%0.24%25.3%华法林3.09%0.47%nc优点优点可降低卒中风险无需监测INR，无需频繁调整剂量不易与食物药物发生相互作用缺点缺点出血风险依然存在缺乏拮抗剂，一次漏服将可能导致抗栓治疗失败患者依然存在依从性问题，自行停药比例高服用新型口服抗凝药，每年费用巨大Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 22 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳封堵技术左心耳封堵技术左心耳封堵技术左心耳封堵技术临床上亟需一种治疗方法，可以有临床上亟需一种治疗方法，可以有效降低房颤患者卒中风险，且无需效降低房颤患者卒中风险，且无需担心出血等问题；可以一次性解决担心出血等问题；可以一次性解决房颤患者血栓管理问题，无需终身房颤患者血栓管理问题，无需终身服用抗凝药。服用抗凝药。NOACs:NovelAnticoagulants(Dabigatran,Apixaban,Rivaroxaban)AF:AtrialFibrillation房颤治疗房颤治疗消融成功率？终身服药？出血?Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 23 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳解剖与封堵器选择左心耳解剖与封堵器选择Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 24 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳位置左心耳位置左心耳位置左心耳位置LAAIndications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 25 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳口部形左心耳口部形左心耳口部形左心耳口部形态态-CT-CT图图及不同形及不同形及不同形及不同形态态占比占比占比占比椭圆形，68.9%三角形，7.7%足形，10%足形，10%水滴形，7.7%圆形，5.7%左心耳开口形态多样，通常都是不规则的左心耳开口形态多样，通常都是不规则的Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 26 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳左心耳左心耳左心耳口部形口部形口部形口部形态态圆形，开口平整椭圆，开口不平整类圆形，开口不平整三角形，螺旋开口水滴形，开口不平整足形，开口不平整左心耳开口通常都有立体形态，凹凸不平左心耳开口通常都有立体形态，凹凸不平Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 27 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳与毗左心耳与毗左心耳与毗左心耳与毗邻组织邻组织的关系的关系的关系的关系左心耳与左上肺静脉和二尖瓣毗邻Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 28 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳与毗左心耳与毗左心耳与毗左心耳与毗邻组织邻组织的关系的关系的关系的关系左心耳位置偏高左心耳位置偏高左心耳位置偏中左心耳位置偏中左心耳位置偏低左心耳位置偏低Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 29 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳体部形左心耳体部形左心耳体部形左心耳体部形态态- -超声超声超声超声/ /造影造影造影造影/CT/CT图图菜花型风向标仙人掌 鸡翅型Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 30 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014封堵器选择封堵器选择左心耳开口形态、体部形态千变万化，左心耳开口形态、体部形态千变万化，毗毗邻重要解剖结构邻重要解剖结构左心左心耳较薄，容易发生穿孔等并发症耳较薄，容易发生穿孔等并发症器器械植入体内内皮化时间要短械植入体内内皮化时间要短左心左心耳封堵器的要求高！耳封堵器的要求高！“盖子盖子”式式（以（以ACP、Lambre为代表）为代表）“塞子塞子”式式（以（以WATCHMAN为代表）为代表）Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 31 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014WATCHMAN左心耳封堵器左心耳封堵器及手术流程及手术流程Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 32 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014辐射自膨、径向支撑自适应开口形态顺应性好固定钩：柔且韧优势镍钛骨架、柔韧固定钩获益可行MRI安全、稳固、易回收、不易脱落适应多数左心耳形态安全、稳固、自适应多种开口形态Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 33 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014经试验最亲内皮细胞可透红细胞造影下即刻显影优势160umPET膜获益内皮化迅速器械表面血栓几率极低抗凝时间短1.DataonfileBostonScientific2.Schwartzetal.,HealingStagesofIntracardiacDevices.JACCvol.3.870-7.20103.Karetal.AnatomicalImpactofLAAClosureDevices.JACC:CardiovascularInterventions.Vol.7:801-9,2014Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 34 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN20142种弯度、5种尺寸、选择容易：单弯/双弯，21,24,27,30,33mm(直径)适应99%以上的左心耳针对左心耳的针对左心耳的解决方案解决方案镍钛骨架、柔韧固定钩安全、稳固、自适应多种开口形态如“内”贯“耳”不破坏外围组织160um黄金比例PET膜可透红细胞内皮化迅速、器械表面血拴几率极低WATCHMANWATCHMAN 左心耳封堵器左心耳封堵器Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 35 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014包藏于左心耳内不在心耳外形成腔室优势全置于心耳内获益不与心房壁接触、不磨损外围组织不压迫二尖瓣环、左上肺静脉内皮化面积最小、术后血栓风险最低1.DataonfileBostonScientific2.Schwartzetal.,HealingStagesofIntracardiacDevices.JACCvol.3.870-7.20103.Karetal.AnatomicalImpactofLAAClosureDevices.JACC:CardiovascularInterventions.Vol.7:801-9,2014全置于心耳内、不影响毗邻组织Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳封堵术工作原理左心耳封堵术工作原理右心房左心房通过穿刺房间隔途径植入堵闭左心耳，防止血栓脱落达到血栓管理的目的Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳鞘管操作2房间隔穿刺1封堵器表面内皮化4即刻封堵3手术关键步骤手术关键步骤手术关键步骤手术关键步骤Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014犬类模型30天犬类模型45天人类病理学-植入后9个月SchwartzJAmCollCardiolInv2010:3封堵器表面内皮化封堵器表面内皮化封堵器表面内皮化封堵器表面内皮化LAAO病例TEE & X-rayIndications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014CaseCase耿耿XXXX40Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Case1Case1术前术前TEETEE41术前术前LAAIndications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Case1Case1术中术中X-rayX-ray42LAA造影造影Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Case1Case1术中术中X-rayX-ray43LAAO 植入植入Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Case1Case1术中术中X-rayX-ray44LAAO 植入术后造影植入术后造影Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Case1Case1术中术中TEETEE45LAAO 植入植入Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Case1Case1术中术中TEETEE46LAAO植入后超声血流植入后超声血流Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014患者需要术后服用华法林45天（有效INR内）45天以后，食道超声评估是否有分流、器械表面血栓。如果左心耳封堵完全，或者残存血流小于5mm，则可停止服用华法林病人应继续服用阿司匹林（81mg/d)和氯吡格雷（75mh/d)直至术后六个月，然后超声复查。如果残存血流大于5mm，则应继续服用华法林超声下确定残存血流小于5mm后再继续阿司匹林治疗术后抗凝治疗术后抗凝治疗术后抗凝治疗术后抗凝治疗华法林禁忌的患者华法林禁忌的患者：阿司匹林（81mg/d)和氯吡格雷（75mh/d)至术后六个月45天和6个月时分别复查食道超声Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 48 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014WATCHMAN 左心耳封左心耳封堵堵术适适应证Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 49 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014不愿意长期服用抗凝药服用华法林，INR不稳定或INR达标仍发生中风华法林禁忌（HAS-BLED3分）左心耳封堵适应症左心耳封堵适应症Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 50 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014非瓣膜性房颤患者，非瓣膜性房颤患者，CHA2DS2-VASc=1分分1、房颤发作、房颤发作7年以上，预期消融成功率不高年以上，预期消融成功率不高2、消融失败、放弃再次消融的患者、消融失败、放弃再次消融的患者3、患者拒绝或不能坚持抗凝治疗、患者拒绝或不能坚持抗凝治疗4、对生活质量有较高要求的老年患者、对生活质量有较高要求的老年患者拓展适应症拓展适应症Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 51 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳封堵禁忌症左心耳封堵禁忌症NYHA心力衰竭分级IV级急性心肌梗死未控制的高血压LAA结扎术史左室射血分数30%食道超声可疑或已知左房内血栓房间隔显著异常心瓣膜修补术后下腔静脉滤器放置术后活动性感染1月内脑卒中（只要患者可以使用抗凝药就可以做左心耳封堵）瓣膜性房颤患者心耳形态不合适（开口直径31mm）Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 52 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014左心耳封堵左心耳封堵临床试验结果临床试验结果Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 53 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014研究研究患者例数患者例数中心数量中心数量备注备注Pilot668随访随访402 患者年患者年随访超过随访超过6年年PROTECT AF80059随访超过随访超过4年年平均随访平均随访2.3年年3CAP (Continued Access Registry )46026显著改善手术安全性结果显著改善手术安全性结果1, 2ASAP1504入组华法林禁忌的病人入组华法林禁忌的病人PREVAIL46141和和PROTECT AF终点一致终点一致病人入组病人入组/排除标准调整排除标准调整CAP213627前瞻性前瞻性, 多中心多中心, 单组注册研究单组注册研究(进行中）进行中）共入组来自共入组来自60个中心的个中心的300位病人位病人 (PROTECT AF or PREVAIL)4CAP (Continued Access Registry )46026显著改善手术安全性结果显著改善手术安全性结果1, 2WATCHMAN WATCHMAN 循循证证医学医学临床试验研究已随访超过24002400名患者及60006000患者*年。Pilot、ProtectAF、CAP、ASAP、PREVAIL等研究已从多个方面证实了其安全性及有效性。1HolmesDRetal.Lancet2009;374:53442;2ReddyVYetal.Circulation.2011;123:417-424;3Reddy,JACC2013;4HolmesPREVAILMar2013Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 54 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014PROTECT AF (随机临床试验随机临床试验)CAP2(Registry)ASAP3(Registry)PREVAIL4(Randomized Clinical Trial)18个月14年5Design前瞻性的RCT，入组可服用华法林的受试者前瞻性的注册研究，入组可服用华法林的受试者前瞻性的注册研究，入组华法林禁忌的受试者前瞻性的RCT，入住可服用华法林的受试者试验结果试验结果血栓栓塞高风险病人中，WATCHMAN相比于华法林为非劣效WATCHMAN在主要疗效终点，全因死亡率以及心血管死亡率上优于华法林相比于PROTECTAF早期经验，安全性结果大幅改善华法林禁忌病人中缺血性中风率显著降低WATCHMAN左心耳封堵器可以被新的术者安全地植入平均年龄平均年龄/CHADS2评分评分72/2.274/2.472.4/2.874/2.6总入组病人总入组病人707例随机病人193例预手术2460150461总植入病人总植入病人463437142269植入成功率植入成功率88%95.0%94.7%95.1%主要疗效终点主要疗效终点 (所有中风,CV/不明原因死亡,全身性栓塞)与华法林相比降低38%1与华法林相比降低40%(优于华法林)5降低29%vs.warfarinN/A0.06418个月发生率。华法林和WATCHMAN相同所有中风所有中风与华法林相比降低29%1与华法林相比降低32%(优于华法林)5降低23%vs.warfarin77%reductionvs.expectedrateperCHADSscore数据暂时不可得安全性安全性(7天术程相关事件*)8.7%44.1%5降低53%vs.PROTECTAF心包填塞=1.3%大出血=2.7%4.4%降低49%vs.PROTECTAFWATCHMAN WATCHMAN 主要临床研究主要临床研究心血管复合并发症包括心脏穿孔,心包填塞,缺血性中风,器械栓塞,以及不需要干预的心包积液,动静脉瘘,需要输血的大出血,假动脉瘤,血肿和腹股沟出血1HolmesDRetal.Lancet2009;374:53442;2ReddyVYetal.Circulation.2011;123:417-424;3Reddy,JACC2013;4HolmesPREVAILMar2013;5Reddy,etal.HRSLBCT2013SH-208801-AAJan2014Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 55 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014WATCHMAN PROTECT AF WATCHMAN PROTECT AF 随访四年随访四年随访四年随访四年Reddy, et al., HRS LBCT 2013Events in PROTECT AF trial at 2,621 patient yearsRate per 100 patient yearsWATCHMAN组N=463Warfarin组N=244PS 82.5%降低40%降低32%降低60%降低34%P=0,0379P=0.0045PS = 0.96WATCHMAN组发生组发生率率/100患者年患者年Warfarin组发生率组发生率/100患者年患者年% 降低降低 (vs Warfarin)主要有效性终点主要有效性终点2.33.840%优效优效心血管死亡心血管死亡1.02.460%优效优效全因死亡全因死亡3.24.834%优效优效ProtectAF四年随访数据显示，相对口服华法林治疗，WATCHMANTM在主要有效性终点（所有的中风和系统性栓塞、心血管性或不明原因的死亡率）皆优于华法林。Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 56 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014WATCHMAN WATCHMAN 手术成功率及手术时间手术成功率及手术时间ImplantsuccessdefinedasdeploymentandreleaseofthedeviceintotheleftatrialappendageHolmesTCTMD2013PROTECT-AFandCAPdata:Reddy,VYetal.Circulation.2011;123:417-424.SH-AA-153902-APR2013WATCHMAN左心耳封堵系统手术成功率高、器械相关急性安全性事件发生左心耳封堵系统手术成功率高、器械相关急性安全性事件发生率低。率低。随着研究的深入，手术平均时间从67分钟降低到50分钟PREVAIL临床研究显示，WATCHMANTM左心耳封堵手术成功率为95.1%95.1%，即使是新术者手术成功率也高达93.2%93.2%，有经验的术者手术成功率更可达96.3%96.3%。Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 57 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014结论结论结论结论房颤患者的血栓栓塞是致死、致残的主要原因虽然口服抗凝药有效，但大量患者由于出血风险而无法耐受，且中国房颤患者依从性差，自行停药比例高，而新型口服抗凝药花费高昂，左心耳封堵术操作简单安全，成功率高，一次性解决房颤患者的血栓管理问题。术后无需终身服用抗凝药左心耳封堵（WATCHMAN系统）相对口服华法林治疗，在有效终点、心血管事件死亡及全因死亡方面分别可降低40%、60%及34%，是房颤患者预防脑卒中的优选解决方案Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014Page 58 of 32Indications,contraindications,warningsandinstructionsforusecanbefoundintheproductlabelingsuppliedwitheachdevice.Informationfortheuseonlyincountrieswithapplicablehealthauthorityproductregistrations.SH-218301-AAJAN2014谢谢