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1、卵圆孔未闭封堵术：争论与发展May9,2009AndrewD.Michaels,MD,MAS,FACC,FAHADirector,CardiacCatheterizationLaboratoryandInterventionalCardiologyUniversityofUtah,SaltLakeCity,Utah胎儿循环 胎儿期，氧合血液由脐静脉经下腔静脉进入右房 血流由下腔静脉经过Eustachian瓣流到卵圆窝.出生后房间隔发育宫内出生后Hagen,Scholz.MayoClinProc1984;59:17-20.人口的75 人口的25%PFO 相关临床综合症 体位相关呼吸困难Platy
2、pneaorthodeoxia 减压病/高原性肺水肿 脑血管事件/TIA 偏头痛PlatypnoeaOrthodeoxia 罕见 直立体位引起的呼吸困难，伴有低氧血症 机制：右向左房间分流Aigneretal.EurJCardiothorSurg2008;33:268.Medinaetal.Circulation2001;104:741.PlatypneaOrthodeoxia 1949年至今已有文献报道近100例 PFO 常伴有:主动脉瘤 胸廓畸形 肺切除术后 约50例已接受封堵术减压病 对230名无症状潜水者进行研究 27%有PFO 需要减压舱治疗者:19%有PFO 2%无PFOTorti
3、etal.EurHeartJ2004;25:1014-20.隐匿性脑卒中 40岁男性，突发失语 既往史无特殊.无明显脑卒中病因.TEE:发现房间隔瘤与PFO.常见伴发症:50%隐匿性脑卒中患者有PFO.推测机制:静脉血栓反常性体循环栓塞症.PFO 通道内原位血栓形成造成栓塞血栓流经PFO首例 PFO 伴血栓形成报道于1876.既往通过超声心动图及术中见到嵌顿于PFO 的血栓.但无法观察到小栓子的流程。服用阿司匹林的PFO 患者脑血管事件/TIA 复发率较高Masetal.NEJM2001;345:1740-6.581名患者有隐匿性脑卒中 均接受阿司匹林治疗华法林阿司匹林复发性脑卒中研究Mohr
4、etal.NEJM2001;345:1444-51.N=2206 缺血性脑血管事件(56%腔梗;25%隐匿性;13%大血管性)随机接受阿司匹林325mg 或华法林治疗 结论:抗血小板及抗凝治疗有效（无效）率相当。药物治疗vs.PFO 封堵术Windeckeretal.JACC2004;44:750-8.308名隐匿性脑卒中伴PFO 患者 随机接受药物治疗或PFO 封堵术治疗药物治疗vs.PFO 封堵术:观察性研究的荟萃分析Khairyetal.AnnIntMed2003;139:753-60.药物治疗(6 个研究)N=8953.8-12.0%4.9PFO 封堵术(10 个研究)N=13550-
5、4.9%3.01年脑卒中/TIA复发率死亡/脑卒中/TIA事件/100 人年PFO 封堵器PFOASDAmplatzerPFOSTARFlexAmplatzerASO CardioSEALHelexAmplatzerCribiformASD左房伞植入右房伞植入植入前 植入后偏头痛与PFO 的关系 12人口患有偏头痛(女性18%;男性6%)偏头痛患者中存在PFO 的占：48%的偏头痛伴视觉先兆1 23%的偏头痛不伴视觉先兆 20%正常人 隐匿性脑卒中伴PFO 患者中偏头痛发生率 52%有偏头痛伴视觉先兆2 71%封堵术后症状缓解3 偏头痛患者较正常人MRI 检查病变阳性率高13倍41.Anzol
6、a.Neurology1999;52:1622-5.2.Sztajzel.CVDiseases2002;13:102-6.3.Wilmshurst.Lancet2000;356:1648-51.4.Kruit.JAMA2004;294:427-34.卵圆孔未闭与偏头痛之间可能的病理生理相关性 经过PFO 的微小栓子可引起偏头痛.体液因子（如5HT)免受肺降解,引起偏头痛.MIST 研究结果DowsonA,etal.Circulation2008;117:1397-404.无偏头痛发作患者,n 0 3 1 3 1.0偏头痛发作频率/月,meanSD4.822.443.231.804.512.17
7、3.532.130.14MIDAS 总评分,median(range)36(3108)17(0270)34(2189)18(0240)0.88头痛天数/3 月(MIDAS),median(range)27(070)18(090)30(580)21(080)0.79HIT-6 总评分,meanSD 67.24.759.59.366.25.158.58.60.77术前 术前术后术后Pvalue手术组(n=74)假手术组(n=73)偏头痛随机临床试验 NMTMedicalclosedMISTII(January24,2008).PREMIUM(AGAMedical)及ESCAPE(StJudeMed
8、ical)仍在进行中.PFO 封堵器技术现况与展望 目前封堵器技术的局限性 大型，永久性植入物.远期并发症：心率失常，炎症，糜烂，血栓形成，过敏反应.未来的封堵器技术 小型封堵器.生物可吸收(BioSTAR).可缝合封堵器.射频消融.Mullenetal.Circulation2006;114:1962-7.结论 目前隐匿性脑卒中的药物治疗疗效欠佳.研究提示存在高危复发脑卒中的亚组.尚无随机临床试验支持任何药物治疗 经皮PFO 封堵术可能成为隐匿性脑卒中预防的主要干预手段.安全.非随机临床试验资料提示对可有效预防脑卒中.有待关于脑卒中与偏头痛的进一步临床研究结果.结论PatentForamen
9、OvaleClosure:ControversiesandAccomplishmentsMay9,2009AndrewD.Michaels,MD,MAS,FACC,FAHADirector,CardiacCatheterizationLaboratoryandInterventionalCardiologyUniversityofUtah,SaltLakeCity,UtahFetalCirculationDuringfetallife,oxygenatedbloodreturningfromtheumbilicalveinenterstheRAthroughtheIVC.Bloodflowis
10、directedbytheEustachianvalvefromtheIVCtothefossaovalisandthroughthePFO.Post-NatalSeptalDevelopmentInUteroAfterBirthHagen,Scholz.MayoClinProc1984;59:17-20.75%ofPopulation 25%ofPopulationClinicalSyndromesAssociatedwithPFO Platypneaorthodeoxia Decompressionsickness/high-altitudepulmonaryedema CV A/TIA
11、MigrainePlatypnoeaOrthodeoxia Uncommonsyndrome Dyspneainducedbyuprightposture,withassociatedhypoxemia Mechanism:right-to-leftinteratrialshuntingAigneretal.EurJCardiothorSurg2008;33:268.Medinaetal.Circulation2001;104:741.PlatypneaOrthodeoxia 100casesinliteraturesince1949 PFOassociatedwith:Aorticaneur
12、ysm Chestdeformity Post-pneumonectomy 50haveundergonedeviceclosureDecompressionSickness 230asymptomaticdiverssurveyed 27%hadaPFO Decompressionchamberrequired:19%withaPFO 2%withoutaPFOTortietal.EurHeartJ2004;25:1014-20.CryptogenicStrokeCase 40yomanwithsuddenaphasia.Nomedicalhistory.Noobviouscauseofst
13、roke.TEE:atrialseptalaneurysmandPFO.Associations:50%ofpeoplewithcryptogenicstrokehaveaPFO.Presumedmechanism:Paradoxicalembolismofvenousthrombus.In-situthrombosiswithinPFOtunnelwithembolization.ThrombusintransitthroughPFOFirst case of PFO with thrombus described in 1876.Thrombus caught in PFO has bee
14、n seen by echo and at surgery.However,passages of small emboli are impossible to prove.HigherCV A/TIARecurrenceRateinPatientswithPFO+ASAMasetal.NEJM2001;345:1740-6.581patientswithcryptogenicstrokeAlltreatedwithaspirinWarfarin-AspirinRecurrentStrokeStudyMohretal.NEJM2001;345:1444-51.N=2206withischemi
15、cCV A(56%lacunar;25%cryptogenic;13%largevessel)RandomizedtoASA325mgvsWarfarinConclusion:Antiplateletandanticoagulanttherapyequally(in)effectiveMedicalTherapyvs.PFOClosureWindeckeretal.JACC2004;44:750-8.N=308withcryptogenicCV AandPFORandomizedtomedicaltherapyorPFOclosureMedicalTherapyvs.PFOClosure:Me
16、ta-AnalysisofObservationalStudiesKhairyetal.AnnIntMed2003;139:753-60.MedicalTherapy(6studies)N=8953.8-12.0%4.9PFOClosure(10studies)N=13550-4.9%3.0Recurrent CV A/TIA1-YearDeath/CV A/TIAEvents/100 pt yrsPFODevicesPFOASDAmplatzerPFOSTARFlexAmplatzerASO CardioSEALHelexAmplatzerCribiformASDLeft Atrial Di
17、sc DeploymentRight Atrial Disc DeploymentPre PostAssociationBetweenMigraineandPFO Migraineheadacheaffects12%ofpopulation(18%F;6%M)IncidenceofPFOinpatientswithmigraine 48%ifmigrainewithaura1 23%ifmigrainewithoutaura 20%incontrols IncidenceofmigraineincryptogenicstrokewithPFO 52%hadmigrainewithaura2 7
18、1%hadsuppressionpost-closure3 Migrainepatientshave13timeshigherincidenceofMRIlesions41.Anzola.Neurology1999;52:1622-5.2.Sztajzel.CVDiseases2002;13:102-6.3.Wilmshurst.Lancet2000;356:1648-51.4.Kruit.JAMA2004;294:427-34.PotentialPathophysiologicAssociationBetweenPFOandMigraine MicroembolismthroughPFOtr
19、iggersmigraine.Humoralfactors(i.e.,serotonin)escapepulmonarydegradation,triggeringmigraine.PublishedMISTResultsDowsonA,etal.Circulation2008;117:1397-404.Patientswithnomigraineattacks,n0 3 1 3 1.0Frequencyofmigraineattacks/mo,meanSD4.822.443.231.804.512.173.532.130.14TotalMIDASscore,median(range)36(3
20、108)17(0270)34(2189)18(0240)0.88Headached/3mo(MIDAS),median(range)27(070)18(090)30(580)21(080)0.79HIT-6totalscore,meanSD 67.24.759.59.366.25.158.58.60.77Baseline BaselinePostPost PvalueImplant(n=74)Sham(n=73)MigraineRandomizedClinicalTrials NMTMedicalclosedMISTII(January24,2008).PREMIUM(AGAMedical)a
21、ndESCAPE(StJudeMedical)stillenrolling.CurrentandFuturePFODeviceTechnologies LimitationsofCurrentDeviceTechnologies Large,permanentimplants.Latecomplications:arrhythmia,inflammation,erosions,thrombus,allergicreactions.FutureDeviceTechnologies Smallerprofiledevices.Bioabsorbable(BioSTAR).Suture-basedd
22、evices.Radiofrequencyablation.Mullenetal.Circulation2006;114:1962-7.Currentmedicaltherapyinsufficientforpatientswithcryptogenicstroke.Subgroupsathigh-riskforrecurrentCV Aareidentifiable.NoRCTdatainsupportofany treatment.PercutaneousPFOclosureislikelytobecomeacornerstoneofcryptogenicCV Aprevention.Safe.Non-randomizeddatasuggestsefficacyforCV Aprevention.AwaitclinicaltrialresultsforCV Aandmigraine.Conclusions