人工生物瓣膜的应用及策略.pptx

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1、HANCOCK II 第二代生物瓣技术第二代生物瓣技术Carpentier-Edwards Perimount BioprosthesesMagna valve PERIMOUNT valve(CEP)保存方法：在在压压力下力下应应用戊二用戊二醛醛，促，促进进胶原胶原纤维纤维之之间间的交的交联联胶原胶原纤维纤维交交联联可避免胶原可避免胶原纤维纤维断裂断裂胶原胶原纤维纤维断裂最断裂最终终可以可以导导致致钙钙化形成，化形成，进进而而导导致瓣膜失效致瓣膜失效生理固定对Valsalva窦和瓣叶功能的作用瓣叶以生理的瓣叶以生理的 45 连接连接瓣叶可以很好的开到窦中瓣叶可以很好的开到窦中生理压力固定流出

2、孔平面附着的天然角度附着的天然角度Valsalva 窦没有保留窦没有保留 没有空间使瓣叶活动到没有空间使瓣叶活动到Valsalva窦中去中去 潜在的血流受阻潜在的血流受阻附着角度变平使得瓣叶尖部需要活动的更远，附着角度变平使得瓣叶尖部需要活动的更远，并改变了瓣叶的应力状态并改变了瓣叶的应力状态流出孔平面附着角度变平附着角度变平影响血流动力学和耐久性减轻减轻 生物生物机械机械性性 失效失效新鲜瓣叶新鲜瓣叶戊二醛固定方法的进步戊二醛固定方法的进步低压低压Hancock IIIntact第二代第二代高压高压Hancock MOHancock Std.第一代第一代生理固定生理固定MosaicFrees

3、tyle第三代第三代放射显像：取出的猪生物瓣Lentz D et al.Inhibition of Mineralization of Glutaraldehyde-Fixed Hancock Bioprosthetic Heart Valves.In:Cohn LH,Galucci V(ed)Cardiac Bioprostheses,Proceedings of the 2nd Intl Symp.York Med Books,NY 1982 306-19T6 处理后（左）未处理（右）流出道面。在植入4个月后取出的 Hancock瓣膜。标准瓣膜(right)，和T6处理后的(left).A

4、mino groupAOA 法法至少从三个方面减少钙化:1.降低了钙离子弥散到组织中的速度2.在戊二醛固定的组织上形成了性能良好且耐久性强的结合。（共价结合）3.可能可以洗脱一些脂质来自天然产生带油酸来自天然产生带油酸AOA-treatedNon-treatedDuarte;Emory University,Atlanta,GA放射显像提示了钙化组放射显像提示了钙化组织的位置织的位置AOA处理的瓣膜及对处理的瓣膜及对照组的大体外观照组的大体外观Mosaic 瓣羊研究瓣羊研究:植入植入5个月后取出：个月后取出：第一代支架第一代支架HK I聚丙烯第二代支架第二代支架HKII 聚甲醛支架变薄圆形凸起

5、侧高降低2 mm X线可探查的环及孔 瓣环下缝合圈和瓣环下瓣架瓣环上缝合圈和瓣环下瓣架瓣环上缝合圈 和瓣环上瓣架瓣环内人工瓣瓣环内人工瓣真正的瓣真正的瓣环环上上(Supra-X)Supra-X真正的环上环外瓣Supra X:瓣孔面积瓣架在孔内孔径相当于瓣架内径瓣环内没有任何阻碍中央孔和瓣环面积匹配需要全新的测瓣概念瓣环支架孔面积Supra-X瓣环上缝合环CEPHK II,Mosaic瓣膜开闭更接近真实人体瓣膜拼合式生物瓣拼合式生物瓣（牛心包瓣或猪瓣膜等）（牛心包瓣或猪瓣膜等）Hancock II二尖瓣位-安全、迅速、不挂线主动脉瓣位主动脉瓣位全球专利CINCHTM旋转收缩瓣角机制其他产品其他产

6、品Hancock II 二尖瓣二尖瓣 缝合圈与支架缝合圈与支架均置于环间均置于环间:缝合圈置于环上缝合圈置于环上支架置于环间支架置于环间:真正的环上瓣真正的环上瓣(Supra-X):缝合圈与支架缝合圈与支架均置于环上的均置于环上的St.Jude 瓣环外径CEP 支架外径Hancock II 瓣内径测瓣:真正的环上瓣HKII vs 环内瓣CEPHancock II 测瓣器测瓣器底部=Hancock II 生物瓣的内径=病人瓣环内径凸起=代表瓣膜支架柱的大小和位置，有助于确定正确植入方位CEP的环内瓣的环内瓣测瓣器测瓣器HKII 侧高HKII 外径HKII 内径瓣号大小CEP支架外径测瓣器底部21

7、mm19.1mm21mm19.1mm21mmHancock II 内径20.5mm23mmHKII瓣号=支架外径HKII 内径=病人瓣环内径23mm Hancock IICEP瓣号=CEP支架外径=病人瓣环内径 21mm CEPCEP 外径21mm病人瓣环病人瓣环21mmFeatureHancock IISJM BiocorSJM Epic第几代？2nd1st2nd 抗钙化处理T6(十二烷基硫酸钠十二烷基硫酸钠)无无Linx(95%酒精酒精)固定技术低压低压低压支架聚甲醛聚甲醛FlexFit 共聚物共聚物FlexFit 共聚物共聚物性能对比组成设计组成设计三个瓣叶都是无冠瓣瓣叶三个瓣叶都是无冠

8、瓣瓣叶低压固定低压固定戊二醛戊二醛 1mmHg接合处有牛心包保护接合处有牛心包保护减少瓣叶在织物上的磨损减少瓣叶在织物上的磨损 Celcon 支架支架 比乙缩醛均聚物（比乙缩醛均聚物（HK II 支支架架）的抗张强度小，柔软性差）的抗张强度小，柔软性差无抗钙化处理无抗钙化处理Biocor 生物瓣连接处犹打结般，挡在流出道，跨瓣压差升高连接处犹打结般，挡在流出道，跨瓣压差升高薄弱环节，是血栓形成和钙化的潜在发生位点薄弱环节，是血栓形成和钙化的潜在发生位点Biocor 主动脉瓣主动脉瓣EpicLinx 处理处理 仅采用乙醇仅采用乙醇 与与Biocor相比，相比，并没有减少钙化并没有减少钙化一项一项

9、20周的利用小羊二尖瓣置换模型进行的研究，周的利用小羊二尖瓣置换模型进行的研究，用于研究用于研究(Biocor vs Epic)的安全性和有效性，以的安全性和有效性，以及银的释放速率和营养不良性钙化的程度及银的释放速率和营养不良性钙化的程度结果：结果：20周的羊模型无法检测出周的羊模型无法检测出Epic和和Biocor生物生物瓣之间钙沉积的差别瓣之间钙沉积的差别*无有效远期数据无有效远期数据*Langanki et al;Journal of Heart Valve Disease:1998 Nov;7(6):633-8.+=BiocorLinxEpic SJ说他们的侧瓣高只有11mm但是过低

10、的侧瓣高但是过低的侧瓣高=更差的血流动力学更差的血流动力学HancockII侧高过低的瓣膜侧高过低的瓣膜瓣号(mm)品牌21232527Biocor26212117HK II121211 813131212(mmHg)mmHg)跨瓣压差跨瓣压差芬兰心脏中心因为高跨瓣压差停止使用芬兰心脏中心因为高跨瓣压差停止使用芬兰心脏中心因为高跨瓣压差停止使用芬兰心脏中心因为高跨瓣压差停止使用Biocor Biocor 转用低跨瓣压差的转用低跨瓣压差的转用低跨瓣压差的转用低跨瓣压差的Hancock IIHancock IIMyken P等 St.Jude Medical Biocor 猪心瓣15年随访结果“心

11、脏瓣膜疾病杂志”2000年第9卷415-422页高跨瓣压差导致过高跨瓣压差导致过早衰败！早衰败！Biocor与与Hancock II 15年瓣膜结构衰败年瓣膜结构衰败率比较率比较Biocor-Kirali Biocor-Myken HK II HK II 1.Myken P,Bech-Hanssen,Phipps B,Caidahl K.Fifteen Years Follow Up with the St.Jude Medical Biocor Porcine Bioprosthesis.J Heart Valve Dis 2000;9:415-4222.David et.al;Later

12、results of heart valve replacement with Hancock II Bioprosthesis;The Journal of Thoracic and Cardiovascular Surgery:Vol 121,Number 2 Pg 268-278 3.Kirali et al;Fifteen year clinical experience with the Biocor Porcine Bioprosthesis in the Mitral position;Ann Thoracic Surgery 2001;71:811-815 二尖瓣二尖瓣主动脉瓣

13、主动脉瓣Epic是什么是什么?SJM Epic 没有长期或短期的长期或短期的临床研究证据！Linx 抗钙化处理可能使血流动力学表现进一步降低可能使血流动力学表现进一步降低，因为酒精可以逐渐使组织干燥和变硬。(Linx 使用的是95%的酒精）研究未能证实研究未能证实经过 Linx 处理的瓣膜比没有处理过的Biocor瓣膜具有任何优势。（同时也没有人类研究证据）Epic 只不过是额外增加了只不过是额外增加了Linx处理的处理的Biocor瓣瓣ACC AHA 指南对生物瓣使用的建议：AVR:Patients 65:With discussion with surgeon about strong r

14、isk of reoperation versus the risk of anticoagulationWomen of child bearing ageMVR:Patients 65 who:Are in sinus rhythm andWith discussion with surgeon about strong risk of reoperation versus the risk of anticoagulationAny age:Patients who will not or can not take wafarin anticoagulation病人年纪越大，耐久性越好P

15、atient ages不同病人年龄的换瓣选择不同病人年龄的换瓣选择MechanicalTissuePatient AgeAveragepatientageNo.of Pt.228(MVR:54%)Mean Age(range)27+/-7.6(11-40)Follow upLost to follow up10.5 years3%Actuarial Freedom from Structural Valve Deterioration(SVD)85.2 4.8%Actuarial Freedom from total TE97.6 1.1%Actuarial Freedom from Endo

16、carditis96.7 1.4%Actuarial Freedom from Reoperation72 5.9%Actuarial Survival at 10.5 years91 2.2%Z.Al Halees,B Gometza,A Al Sanel,CM Duran Behavior of the Hancock II Bioprosthesis in Young Population.World Symposium on Heart Valve Disease,1999 London.From the King Faisal Specialist Hospital and Rese

17、arch Centre,Riyadh,Saudi Arabia and International Heart Institute of Montana foundation,Missoula,Montana,USA HANCOCK IIPerformance in Patients Ages 11-40Benefits of Physiologic FixationPhysiologic FixationPressure FixationHinge sitePhysiologic FixationSupra-X Positioning Supra-X positioning ensures

18、the Mosaic bioprosthesis is seated supra-annularly while aligning the internal diameter of the valve with the patients annulus No intra-annular component Increases area available to flowIntra-annular sewing ring with intra-annular valveSupra-annular sewing ring with intra-annular valveTrue Supra-ann

19、ular(Supra-X):Supra-annular sewing ring with supra-annular valve Intra-annular valvesSupra-annular valveSupra-XPositioning经导管肺动脉瓣膜经导管肺动脉瓣膜Philippe Bonhofer -90年代后期可用年代后期可用 -首次在人类应用首次在人类应用 可以为婴儿赢得时间，可以为婴儿赢得时间，可以延后接受外科手术的时间可以延后接受外科手术的时间上腔静脉路线上腔静脉路线从从10月月1日起已经日起已经超过超过800例病人例病人经导管主动脉瓣膜置换经导管主动脉瓣膜置换CoreVa

20、lve.可能还有更多可能还有更多 !Cribier,EdwardsActuarial Freedom From SVD at 12 years Mosaic1CEP2Patients(n)255310Patient Age(mean)6764.212-Year Actuarial Surival64.1 5.6%34 3%Freedom From Explant due to SVD90.2 4.1%82 4%REFERENCES1 Riess,FC et al.,Hemodynamic Performance and Clinical Follow-up of the Medtronic M

21、osaic Bioprosthesis up to 12 Years.ABSTRACT,presented at the SHVD,New York,NY,2007.2Banbury MK et al.,Long-Term Results of the Carpentier-Edwards Pericardial Aortic Valve:A 12-Year Follow-Up.Ann Thorac Surg 1998;66:S736.3Banbury MK et al.,Age and Valve Size Effect on the Long-Term Durability of the

22、Carpentier-Edwards Aortic Pericardial Bioprosthesis.Ann Thorac Surg 2001;72:753-7.Explants due to SVD at 10 years Mosaic1CEP2Patients(n)797310Patient Age(mean sd)69 965 12Number of Reoperations due to SVD1721Percent of Patients with Reoperations due to SVD2%7%ConfidentialMitral RegurgitationPossible

23、 ReasonsIthasaholeinitUnequalleafletelasticityLowstentpostsCausesleafletcoaptationzonetobeverysmallTriangle of leakCEP ValveSizing and ImplantationSizingImplantInflow ViewHancock IICEPStent IDStent IDStent ODAnnulusStentOrifice AreaNotallsizersarethesame25mm28mmHancock II mitral valve sizer25mmCEP m

24、itral valve sizer25mmNotallsizersarethesameNotallsizersarethesame UpsizePlastic is more Flexible than MetalHancock II valvePlastic(acetal homopolymer)stent.Low memory and flexibleCEPMetal stentMetal has memory and can breakPlastic Metal VSCEP IFU:Due to the relative flexibility of the frame,care mus

25、t be exercised to prevent folding or deformation of the stent,that might lead to regurgitation,altered hemodynamics,and/or leaflet disruption rendering the valve incompetent.Ease of Implant Aortic Position:CINCHTM Holder Profile Comparison23 mm Carpentier Edwards Perimount 23 mm HII with the CINCHTM

26、Ease of Implant:CINCHTM In Aorta Profile ComparisonHemodynamic Comparison EOAHemodynamic ComparisonMean Gradient MosaicHemodynamic ComparisonMean Gradient CEPWeighted average of Mean Gradient MOSAICCEP#of Patients n=2804Mean Gradient#of Patients n=998Mean Gradient19mm718.512920.321mm55814.639917.523

27、mm115413.431913.625mm75211.712512.127mm27410.22610.929mm598.90No dataPORCINE vs PORCINE?What makes a difference?SJM Biocor Stented Tissue ValveBiocor is a registered trademark of St.Jude Medical Inc.BiocorEpic History 1978 Biocor porcine valve developed by Dr.Mario Vrandecic in Brazil.1982 Biocor va

28、lve released.1996 September:SJM acquires Biocor tissue valve company.1998 Biocor receives CE Mark.2003 US clinical study begins on the SJM Epic with Linx AC 2003 European launch of the Epic Supra 2004 First North American implant of its SJM Epic Supra valve.2005 August 8th Biocor approved for sale i

29、n United States.Valve Feature ComparisonFeatureMosaicMosaic ULTRAHancock IIHancock II ULTRASJM BiocorSJM EpicGeneration3rd 2nd1st2nd Anti-mineralizationTreatmentAOAT6(Sodium dodecyl sulfate)NONELinx(95%ethanol)FixationPhysiologic FixationLow/High PressureLow PressureLow PressureStentAcetal Homopolym

30、erAcetal HomopolymerFlexFit CopolymerFlexFit CopolymerSewing cuffPolyesterPolyesterPolyesterSilicone insertPolyesterSilicone insertComposite designThree non-coronary cuspsLow pressure fixationGlutaraldehyde 1mmHgPericardial shield on the outflow edge reduce leaflet abrasion against fabricCelcon sten

31、t lower tensile strength and less flexible than acetal homopolymer(HK II stent).No anti-calcification treatmentBiocor bioprosthesesEpicLinx treatment just ethanol no reduction in calcification vs BiocorA 20-week juvenile sheep mitral valve implant model was used to determine safety and efficacy of t

32、he device(Biocor vs Epic),as well as the rate of silver release and degree of dystrophic calcification Results:the 20-week sheep model unable to detect differences in calcium accumulation between the Epic and the Biocor*No long-term data available*Langanki et al;Journal of Heart Valve Disease:1998 N

33、ov;7(6):633-8.+=BiocorLinxEpicBiocor How is it produced?Hemodynamics Notallporcinevalvesarethesame-BiocorLowerProfile,WorseHemodynamics FeaturesProfile:Leaflets Are STUFFED into stents that are too smallHigher leaflet stressesLeaflet protrusion Pericardial shield obstructing flow area.Shield inhibit

34、s leaflets from opening fully.Biocor Aortic ValveStress folds are evident radiating from the base of the commisures as well as coaptation mis-alignment.BiocorHKII,MosaicAcceptable Hemodynamics?Mykn PS et al.,LONG-TERM DOPPLER ECHOCARDIOGRAPHIC RESULTS OF AORTIC OR MITRAL VALVE REPLACEMENT WITH BIOCO

35、R PORCINE BIOPROSTHESIS.J Thorac Cardiovasc Surg 1998;116:599-608.Would gradients of up to 60 mmHg be acceptable with a Mosaic or Hancock II?Durability Notallporcinevalvesarethesame-AnotherwaytolookatthedataComparison of SVD between Biocor and Hancock II at 15 yrs Biocor-Kirali Biocor-Myken HK II HK

36、 II 1.Myken P,Bech-Hanssen,Phipps B,Caidahl K.Fifteen Years Follow Up with the St.Jude Medical Biocor Porcine Bioprosthesis.J Heart Valve Dis 2000;9:415-4222.David et.al;Later results of heart valve replacement with Hancock II Bioprosthesis;The Journal of Thoracic and Cardiovascular Surgery:Vol 121,

37、Number 2 Pg 268-278 3.Kirali et al;Fifteen year clinical experience with the Biocor Porcine Bioprosthesis in the Mitral position;Ann Thoracic Surgery 2001;71:811-815 VSClinical ComparisonAorticBiocorHKIINo.of Patients4551010Mean Ages7296711NYHA class III or IV45%77%Follow-up mean yr7.44.98.2Follow-u

38、p competency99.6%99.9%Comparison of SVD between Biocor and Hancock II at 20 yrs AorticBiocorHKIISurvival10 yr45%61%20 yr9%19%Freedom from SVD15 yr88%93%20 yr70%80%Implantability Notallporcinevalvesarethesame-TheCinchMakesADifferenceThe Biocor plastic stent is less flexible than the HKII stent.The Bi

39、ocor stent post are unable to deflect as well as the HKII stent post.The Biocor has a bulky holder which makes it difficult for the surgeon to visualize and to secure the knots during the procedureBiocorHancock II Theory:Reduces glutaraldehyde toxicity Removes cholesterol and lipids Reduces uptake o

40、f lipids from the patient into the prosthesis Testing:Connolly,Levy RJ et al.J Heart Valve Dis 2004;13(3):487-93.Vyavahare,Levy RJ et al.J Biomed Mater Res 1998 40;577585.Flameng,et al.Ann Thorac Surg 2001;71:S401-5.Langanki,et al.J Heart Valve Dis 1998;7:633-638.Shoen,Levy RJ et al.Ann Thorac Surg

41、2005;79:1072 80).Linx TechnologyWhat we know about Linx?The Linx anticalcification treatment is a simple 95%ethanol treatment.The Linx treatment has been developed by Dr.Robert Levy at the University of Michigan and is licensed by SJM.21-day rat subdermal tests were performed(No human studies!)20-da

42、y juvenile sheep studies showed no difference than untreated Biocor samples.Studies found abnormally high amounts of cuspal hematomas.Proof Source?Vyavahare 2000 Paper“Our initial studies explored ethanol pretreatment,but only after glutaraldehyde fixation.We also did not examine questions of storag

43、e in glutaraldehyde solution after ethanol pretreament.“In conclusion,glutaraldehyde storage following ethanol pretreatment of glutaraldehyde-fixed bioprosthetic heart valves negates inhibition of calcification,and would appear to be contraindicated in the fabrication of such valves for clinical use

44、Vyavahare,et al.Prevention of glutaraldehyde-fixed bioprosthetic heart valve calcification by alcohol pretreatment:further mechanistic studies.J Heart Val Dis 2000:9(4);561-6.Where does that leave Epic?There is no long or short-term clinical data available on the SJM Epic!Linx anticalcification tr

45、eatment might further reduce hemodynamic performance since alcohol generally dries and stiffens the tissue.(Linx is 95%ethanol).Studies have not been able to prove that valves treated with Linx performed any better than non-treated Biocor valves(Nor any human studies).Epic is simply the Biocor valve

46、 with the addition of LinxSJM说生物瓣侧瓣越低越好，真是这样吗？生物瓣Newsletter两种不同的猪主动脉瓣完整猪主动脉瓣瓣叶组合瓣完整的猪主动脉瓣和人主动脉瓣膜结构对比Data Source:FDA Approved Instructions for Use.Valve19 mm21 mm23 mm25 mmHancock II(n=)NA12.9 4.2(9)13.2 4.6(47)11.3 4.4(50)Biocor&Supra(n=)NA18.8 6(40)17.3 9(97)15.2 5(61)Epic&Supra(n=)NA19.1 8(49)13.9

47、 6(120)12.1 5(121)主动脉血流动力学FDAFDA审批审批IFUIFU数据：术后一年平均跨瓣压差比较数据：术后一年平均跨瓣压差比较侧瓣越低，瓣叶张力越大AorticBiocorHKIINo.of Patients4551010Mean Ages7296711NYHA class III or IV45%77%Follow-up mean yr7.44.98.2Follow-up competency99.6%99.9%20年生存率和耐久性的比较AorticBiocorHKIISurvival10 yr45%61%20 yr9%19%Freedom from SVD15 yr88%

48、93%20 yr70%80%|MDTConfidential86总结HKII 采用猪的完整主动脉瓣，解剖更加接近人体瓣膜结构，采用猪的完整主动脉瓣，解剖更加接近人体瓣膜结构，瓣叶运动更符合生理情况瓣叶运动更符合生理情况Biocor降低了侧瓣高度，导致瓣叶无法完全打开，牺牲了降低了侧瓣高度，导致瓣叶无法完全打开，牺牲了血液动力学血液动力学生物瓣侧瓣越低，瓣叶承受的张力越大，耐久性下降。而生物瓣侧瓣越低，瓣叶承受的张力越大，耐久性下降。而耐久性是生物瓣最重要的考虑因素耐久性是生物瓣最重要的考虑因素美美敦敦力的力的CINCH 技术，能有效地避免二尖瓣植入时造成的技术，能有效地避免二尖瓣植入时造成的心

49、肌损伤。只要植入角度符合要求，左室流出道受阻极少心肌损伤。只要植入角度符合要求，左室流出道受阻极少发生。发生。竞争对手临床实验比较竞争对手临床实验比较Freedom From SVD 比比较耐久性总结：60岁及以上患者 FFSVD 85%60岁及以上患者 AVR FFSVD 88%65岁及以上患者 AVR FFSVD 97%指南建指南建议年年龄生物瓣患者首生物瓣患者首选！患者生存率患者生存率生存率生存率为什么重要？什么重要？一切数据一切数据结果的基果的基础！免予结构性衰败率免予结构性衰败率FFSVD60-70岁患者 植入20年总体FFSVD 85%主动脉 FFSVD 88%60-70岁患者 植

50、入20年总体FFRSVD 90%主动脉 FFRSVD 92%FeatureHancock IIosaicSJM BiocorSJM EpicEdwards SAV第几代？2nd3rd 1st2nd 2nd 抗钙化处理T6(Sodium dodecyl sulfate)无无Linx(95%酒精酒精)Xenologix固定技术低低压压/微微压压生理生理压压力力低压低压低压支架Acetal HomopolymerAcetal HomopolymerFlexFit CopolymerFlexFit CopolymerAlgiloy 合合金支架金支架瓣膜的分类瓣膜的分类HKII 和Perimount 瓣