左心耳封堵.ppt

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1、举“卒”轻重 话左心耳封堵,背 景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题,房颤发病率在6585岁年龄组最高,不同性别与年龄的房颤发病率,房颤的发病率,死亡率,住院率,脑卒中,生活质量,运动耐力,心功能,房颤的危害,房颤卒中的危害性,轻度,中到重度,致死性,非瓣膜性房颤卒中90%以上的栓子来自左心耳,左心耳的解剖&作用,胚胎时期原始左心房残余狭长、弯曲管状形态内有梳状肌、肌小梁，小梁间有缝隙颈部 位于左上肺静脉和二尖瓣瓣环之间回旋支靠近左心耳开口基底部,压力和容量负荷的调节作用电生理作用内分泌作用 分泌ANP、BNP介导口渴调节,LAA解剖,漩涡 流速,左心耳易形成血栓

2、原因,左心耳的形态&卒中风险,房颤卒中的预防,出血影响因素多依从性差OAC费用,背 景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题,左心耳封堵术,使用特制的封堵器闭塞左心耳，从而达到预防房颤血栓栓塞的目的,外科术中闭合左心耳可明显减少房颤患者发生卒中事件,PLAATO（ev3 Inc)Percutaneous Left Atrial Appendage Transcatheter Occlusion,第一种封堵LAA装置（2002）,15-32mm,Watchman(Boston Scientific,Natick,Massachusetts),14F,Amplatzer

3、cardiac plug St.Jude Medical，St.Paul，Minnesota,ACP,Amulet,Lifetech LAmbreTM Device,1636 mm,810 French,a hook-embedded umbrella a cover connected with a short central waist waist=an articulating,compliant connectioncover is 4 to 6 mm larger distal umbrella comprises 8 claws with individual stabilizin

4、g hookscomplete collapse and repositioning,A Flexible Self-Apposing LAAC Device,Ultrasept,(Cardia Inc.,Eagan,MN),Cheng Y,et al.Catheter Cardiovasc Interv.2013.,12 F delivery catheterSize of distal side of the device 16,20,and 24mmFlexible articulation,self-orient to the cardiac wall Proximal sail is

5、 4 mm larger the distal bulb in diameters 20,24,and 28 mmSix pairs(total 12)of hooksseveral different components,其他用于左心耳封堵器械,Kanthan A,et al.Heart,Lung and Circulation.2013.,Chiam P,et al.The Journal of invasive cardiology.2008;20(4):E109.,左心耳封堵器械植入过程,左心耳封堵器械植入过程,背 景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题,

6、Block PC et al.JACC:Cardiovascular Interventions.2009;2(7):594-600,Percutaneous Left Atrial Appendage Occlusion for Patients in Atrial Fibrillation Suboptimal for Warfarin Therapy,5-Year Results of the PLAATO(Percutaneous Left Atrial Appendage Transcatheter Occlusion)Study,61/64 patients 9 sites in

7、the U.S.And 1 Canadian site.November 18,2003.,死亡7例，重症中风5例，小中风3例，可能的脑出血1例，心梗1例，心包压塞1例,Initial Worldwide Experience With the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Atrial Fibrillation,Peter B.Sick et al.J Am Coll Cardiol 2007;49:14905,open-label nonrandomized pilot study,Conclu

8、sions LAA occlusion with the WATCHMAN device appears to be safe with preliminary results consistent with low stroke risk despite discontinuation of anticoagulation.in whom anticoagulation carries a high risk or is contraindicated,these devices may offer an attractive solution to the AF-related embol

9、i problem,2例发生心脏压塞，1例发生空气栓塞，1例发生输送导丝断裂需外科手术取出。6个月，4例出现装置表面血栓，97.1的患者在6个月内可停用华法林，随访2年时仅2例发生一过性脑缺血,David R Holmes.et al.Lancet 2009;374:53442,PROTECT AF,Thus,our strategy for closing the LAA was non-inferior to warfarin therapy in terms of the primary efficacy endpoint of all stroke,cardiovascular dea

10、th,and systemic embolism.Although there is a higher initial safety event rate for device implantation,adverse events were without long-term sequelae for most patients.Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with nonvalvu

11、lar atrial fibrillation.,Interpretation,Circulation.2011;123:417-424,ConclusionsThe LAA closure trials have demonstrated that,complications associated with Watchman implantation are typically clustered early in the periprocedural period and significantly decrease in frequency with operator experienc

12、e.In addition,despite a higher overall complication rate associated with LAA closure than warfarin treatment,the functional impact of these events favors LAA closure.Together,these data suggest a favorable safety profile for Watchman implantation.,Left Atrial Appendage Closure With the Watchman Devi

13、ce in Patients With a Contraindication for Oral Anticoagulation,Reddy et al.JACC Vol.61,No.25,2013,the ASAP registry has demonstrated that the Watchman device can be safely implanted without a warfarin transition.That allows the application of this therapy to the patient population at greatest clini

14、cal need for an alternative to oral anticoagulation therapy:AF patients at high risk for stroke but with contraindications to systemic oral anticoagulation.,随访14.2月，有4例发生卒中，1例发生全身性栓塞，TEE记录6例发生装置相关性血栓。所观察到的缺血性卒中发生率为1.8，意味着相较于阿司匹林单药治疗（7.1）和阿司匹林联合终身氯吡格雷治疗（5.0）降低了卒中发生75和64,.CONCLUSION:The implantation o

15、f the ACP device is a feasible method for percutaneous occlusion of the LAA.,Park JW.Catheter Cardiovasc Interv.2011 Apr 1;77(5):700-6,BACKGROUND:In most patients with atrial fibrillation(AF)and stroke,This study details the initial experience with the Amplatzer Cardiac Plug(ACP)in humans.,METHODS:I

16、nvestigator-initiated retrospective preregistry data collection to evaluate procedural feasibility and safety up to 24 hr after implantation of the ACP,a nitinol device designed for percutaneous trans-septal implantation in LAA of patients with paroxysmal,permanent,or persistent AF.,RESULTS:In 137 o

17、f 143 patients,LAA occlusion was attempted,and successfully performed in 132(96%).There were serious complications in 10(7.0%)patients(three patients with ischemic stroke;two patients experienced device embolization,both percutaneously recaptured;and five patients with clinically significant pericar

18、dial effusions).Minor complications were insignificant pericardial effusions in four,transient myocardial ischemia in two,and loss of the implant in the venous system in one patient,Left atrial appendage closure with Amplatzer cardiac plug for stroke prevention in atrial fibrillation:Initial Asia-Pa

19、cific experience,BACKGROUND:LAA is the main source of left atrial thrombus that causes stroke in patients with NVAF.This study reported the initial safety,feasibility,and 1-yr clinical outcomes following ACP implantation in Asia-Pacific region.,METHODS:Twenty NVAF patients(16 males,age 68 9 yr)with

20、high risk for developing cardioembolic stroke(CHADS2 score:2.3 1.3)and contraindications to warfarin received ACP implants from June 2009 to May 2010.Patients received general anesthesia(n=9)or controlled propofol sedation(n=11)and the procedures were guided by fluoroscopy and transesophageal echoca

21、rdiography(TEE).Clinical follow-up was arranged at 1 month and then every 3 months after implantation,whereas,a TEE was scheduled at 1 month upon completion of dual anti-platelet therapy.,Lam YY,et al.Catheter Cardiovasc Interv.2012 Apr 1;79(5):794-800,Conclusions:Our preliminary data suggested LAA

22、closure with ACP is safe,feasible with encouraging 1-yr clinical outcomes.Further are needed to confirm the efficacy of this device.,RESULTS:The LAA was successfully occluded in 19/20 patients(95%)at two Asian centers.One procedure was abandoned because of catheter-related thrombus formation.Other c

23、omplications included coronary artery air embolism(n=1)and TEE-attributed esophageal injury(n=1).The median procedural and fluoroscopic times were 79(IQR:59100)and 18(IQR 1227)minutes,respectively.The mean size of implant was 23.6 3.1 mm.The average hospital stay was 1.8 1.1 days.Follow-up TEE showe

24、d all the LAA orifices were sealed without device-related thrombus formation.No stroke or death occurred at a mean follow-up of 12.7 3.1 months.,Left atrial appendage closure with Amplatzer cardiac plug for stroke prevention in atrial fibrillation:Initial Asia-Pacific experience,Percutaneous Left At

25、rial Appendage Closure With the AMPLATZER Cardiac Plug Device in Patients With Nonvalvular Atrial Fibrillation and Contraindications to Anticoagulation Therapy,Marina Urena et al.JACC.2013:62,No.2,52 patients with NVAFcontraindications to OACCHADS2 score 1 CHA2DS2-VASc score 2 Canadian centers,Concl

26、usions In patients with NVAF at high risk of cardioembolic events and with contraindications to anticoagulation therapy,percutaneous LAAC with the ACP device followed by dual-/single-antiplatelet therapy was associated with a low rate of cardioembolic and bleeding complications at a mean follow-up o

27、f 20 months.LAAC was successful in 98%of patients,with a small proportion having mild residual leak,and no cases of severe residual leak or device thrombosis were observed.,背 景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题,左心耳封堵存在的问题,封堵器设计,LAA解剖变异大，LAA开口 形状 弯曲程度 内腔大小,封堵 堵,ACP不能完全回收 watchman 位置不理想只能回撤不能前送,watchman残留前庭 内皮化不全,房颤病人的卒中预防至关重要 左心耳封堵预防房颤卒中，安全有效，尤其是适用于有抗凝禁忌的房颤卒中高危患者现有的左心耳封堵器械与技术均存在一定的不足及并发症，相关器械的改进及术者操作经验的提升是经皮左心耳封堵术今后发展的方向左心耳封堵术对心脏功能的影响仍需进一步探索,小 结,THANKS!,