經股動脈vs經心尖部主動脈瓣置換術那種創(chuàng)傷更小

1、經股動脈 VS 經心尖部主動脈瓣置換術-那種創(chuàng)傷更小?,Eric E. Roselli, MD,聲明,Medtronic顧問Edwards 研究者Direct Flow Medical顧問,經皮主動脈瓣置換術,Edwards SapienUS 試驗, CE 標志22-24Fr 鞘管CorevalveCE 標志18Fr 鞘管其他尚未投入使用,主動脈狹窄和PVD,患者的一般情況與胸主動脈瘤疾病類似鞘

2、管 20 – 25 Fr髂動脈導管7 – 15%,JACC, 2007,Corevalve,鞘管18Fr使用21Fr鞘管并發(fā)癥的發(fā)生率為9.6%，使用18Fr鞘管后發(fā)生率下降至1.9%,,,,,Edwards THV 臨床研究,Edwards SAPIEN experience addresses each Clinical research stage,首次應用于人類 人體手術成功率,可行性合理，安全且有效,隨機對照

3、 和對照組相比有效l (AVR & 藥物治療),上市后 評估商業(yè)利用情況長期隨訪,,RECAST I-REVIVE TRAVERCE*,REVIVE II REVIVAL II TRAVERCE PARTNER EU#,PARTNER IDE,PARTNER EU SOURCE,* = Amended from FIM to Feasibility# = Amended from Feasibility

4、 to Post-Market,,,,REVIVE and REVIVAL II可行性研究,4個北美研究中心和6個歐洲研究中心結論 : >70y 癥狀嚴重的 EuroSCORE > 20 or 不適宜手術安全重點和有效性終點REVIVAL II 隨訪24個月,REVIVAL II 包括 備選入路:經心尖,1/3rd 患者篩查后發(fā)現(xiàn)股動脈入路條件較差,12/2006-2/2008納入標

5、準:PVD 排除經股動脈途徑STS ≥ 15%, 或不適宜手術AoV 面積 ≤ 0.7 cm2> 70 yNYHA ≥ II,經股動脈AVR匯總分析REVIVE & REVIVAL II (n=161),年齡 (y) 83.5 ± 5.9 (66 - 96) ≥ 90 y 14.3% (23) ≥ 80 y 75.2% (121)平均 E

6、uroSCORE對數30.7% ± 15.2平均STS Score (只有REVIVAL) 13.1% ± 7.2,經心尖部 AVRREVIVAL II (n=40),年齡 (y) 83.7 ± 5.2 (69 – 93) ≥ 90 y 10% ≥ 80 y 70%平均 EuroSCORE對數35.5 ± 15.3 平均S

7、TS評分 (只有REVIVAL) 13.4 ± 7.0更多CVDz, PVDz, COPD,盡管風險評分類似，但患者群體并不相同,* One patient on CVVHD prior to valve implantation,經股動脈 AVR匯總分析REVIVE & REVIVAL II (n=161),經心尖入路,在CCF并沒有心室出血 4.8% transverse,血管并發(fā)癥,,Vascular

8、 Complications (n=25),Perforations (n=12),Aortic Dissection (n=3),Flow Limiting Iliac Dissection (n=4),Avulsed Iliac Artery (n=3),下肢缺血 (n=4),涂層支架 - 3,手術搭橋 - 9,手術修補- 4,Surgical Bypass - 3,手術 - 1,藥物 - 2,手術 - 2,藥物 - 2,3 例死亡

9、,2 例死亡,2 例死亡,2 例死亡,Vascular Complications (n=25),Perforations (n=12),主動脈夾層 (n=3),髂動脈夾層，血流受限 (n=4),髂動脈撕脫y (n=3),血管并發(fā)癥 (n=25),穿孔(n=12),死亡率36% vs 10% w/o,,血管并發(fā)癥,numberat risk,13,12,9,6,22,Yes,120,96,88,60,139,No,91.4%[86

10、.7, 96.0],82.9%[76.6, 89.3],78.2%[71.0, 85.4],72.7%[54.1, 91.3],63.3%[43.0, 83.6],46.0%[23.8, 68.3],Log Rank P=0.0004,絕對不能發(fā)生血管入路的并發(fā)癥,手術前的方案制定非常重要血管成形術腔內 ? 低估鈣化的分辨率較低CT增強掃描分辨率更高 (毒性)能夠顯示鈣化的輪廓高分辨率的研究IVUS,使入路更簡

11、便: 髂動脈導管,基本假設,創(chuàng)傷更小急性風險更少死亡率并發(fā)癥,,,無法穿過 - 3,,,,納入161例患者,釋放不成功n = 19,無法進入 - 9,,換瓣成功率 88.2%,,,23 mm Valve(55),心臟穿孔 - 3,,,26mm 瓣膜(87),61.3%,38.7%,位置錯誤/血栓形成- 2,,麻醉并發(fā)癥 - 2,,經股動脈 AVR手術結果,Successful Depl

12、oymentn = 142,23 mm 瓣膜(55),釋放成功n = 142,Slide courtesy of Susheel Kodali,,RetroFlex II 輸送系統(tǒng)Addresses Crossing,REVIVAL II 經心尖途徑手術成功率,87.5%移位 /血栓形成12.5%無法穿過心尖0平均釋放時間11.7 min平均手術時間87.1 min,術中與定位相關的事件,冠狀動脈堵塞

13、 移植瓣膜返流由于瓣葉懸吊所致i.e. 瓣膜太低,術中處理,手術開始前調整血流動力學狀況謹慎的使用快速心臟起博TEE和X線輔助定位識別影響瓣膜放置的因素:增厚的室間隔主動脈根部鈣化，沒有擴張性的主動脈根部竇管交界處狹窄瓣葉嚴重鈣化,術中處理,體外模擬和災難性事件的預案危急情況的搶救方案瓣膜血栓形成冠狀動脈開口堵塞瓣膜功能障礙BAV后出現(xiàn)重度AI導致失代償循環(huán)支持,Slide courtesy of Joh

14、n Webb,Vancouver 的經驗,經心尖途徑手術成功率 (n=58),Slide courtesy of John Webb,TRAVERCE: 換瓣成功率: 93 %,168 例患者,換瓣成功N=156,換瓣不成功N=12,23 mm n = 43,26 mmn = 113,,,,,,,,TRAVERCE: 中轉: 7 %,12例患者15起事件,Slide modified from Thomas Walther,

15、TA 學習曲線 (n=175)TRAVERCE,,,98 ±2%,88 ±3%,71 ±4%,73 ±4%,,Pat. 1 - 120, 2 Pts (CPR) excludedES 29%, STS 14%,Pat. 121 - 177ES 37%, STS 13%,30 days,6 months,1 year,Slide courtesy of Thomas Walther,無中風,,

16、*置換成功 = 設備成功輸送并釋放 書后AVA>0.9cm² ，AI <2+,PARTNER EU 經股動脈,,,,,心室血栓形成 (n = 1)主動脈血栓形成 (n=1),23 mm SAPIEN 瓣膜N=25,26 mm SAPIEN 瓣膜N=27,置換失敗n = 2,換瓣的患者數n = 54,置換成功* n = 52,計劃納入患者數n = 60,,手術取消n = 6,,血管入口

17、(n = 3) BAV失敗 (n=2)活動性心內膜炎 (n=1),96.3%,Slide courtesy of T. Lefèvre,PARTNER EU TF并發(fā)癥,Non Hierachical Ranking,Slide courtesy of T. Lefèvre,SAPIEN? THV 商業(yè)經驗 & SOURCE注冊,治療的患者人數: 7232007.11-2008.12,,Slid

18、e courtesy of T. Lefèvre,34 心臟介入中心598 植入15% 的患者簽署代理協(xié)議,The SOURCE Registry,,Slide courtesy of T. Lefèvre,THV 學習曲線 植入成功的百分數,,%,Slide courtesy of T. Lefèvre,,,TA是否優(yōu)于TF?,不是!,因為患者往往更喜歡經皮途徑!Preclose技術已經變成一種

19、常規(guī)術式,腋動脈導管 避免跨越主動脈弓,Conduit,Axillary a.,下一代設備,結構更簡單-創(chuàng)傷更小可以重新定位/可退出瓣周主動脈瓣返流更少而且，患者的選擇也會不斷的變化,結論,最安全的方法最佳TA和TF各有利弊隨著技術的進步，經股動脈主動脈瓣置換術可能會越來越重要經心尖入路和經腋動脈入路是某些患者的替代方法介入科醫(yī)生 VS 外科醫(yī)生,手術的成功需要多學科的團隊合作,,June 3-5 2009,Inter

20、Continental Hotel &Bank of America Conference Center Cleveland, Ohio,www.ccfcme.org/CardioCare09www.MeetTheBuildings.com,Sessions will include:,? Aortic Disease? Coronary Artery Disease? Valvular Disease? Electr

21、ophysiology? Heart Failure,? Prevention? Imaging? Heart-Brain Medicine? Vascular Disease? Transplantation,This activity has been approved for AMA PRA Category 1 Credit.?,,,Transfemoral Vs Transapical Valves – Which

22、is Less Invasive?,Eric E. Roselli, MD,Disclosure,MedtronicConsultantEdwards InvestigatorDirect Flow MedicalConsultant,Percutaneous Aortic Valves,Edwards SapienUS Trial, CE Mark22-24Fr SheathsCorevalveCE

23、Mark18Fr SheathOthers on the way,Aortic Stenosis and PVD,Pt profile similar to thoracic aneurysmal diseaseSheaths 20 – 25 FrIliac Conduit7 – 15%,JACC, 2007,Corevalve,Sheath 18FrAccess complications down to 1.9%

24、 from 9.6% with 21Fr,,,,,Edwards THV Clinical Investigations,Edwards SAPIEN experience addresses each Clinical research stage,First-in-Man Procedural success in humans,Feasibility Demonstrate “reasonable” safety &am

25、p; effectiveness,Randomized Control Effectiveness vs. control (AVR & medical therapy),Post-Market Evaluate transition to commercial use Long-term follow-up,,RECAST I-REVIVE TRAVERCE*,REVIVE II REVIVAL I

26、I TRAVERCE PARTNER EU#,PARTNER IDE,PARTNER EU SOURCE,* = Amended from FIM to Feasibility# = Amended from Feasibility to Post-Market,,,,REVIVE and REVIVAL IIFeasibility Studies,4 North American and 6 European Centers

27、Inclusion: >70 years old severe symptomatic AS EuroSCORE > 20 or non-operableSafety and Efficacy endpointsFollow-up to 24months for REVIVAL II,REVIVAL II included Alternate Access: Transapical,1/3rd scre

28、ened poor femoral access,12/2006-2/2008Inclusion criteria:PVD precluding TF approachSTS ≥ 15%, or inoperableAoV area ≤ 0.7 cm2> 70 yrs of ageNYHA ≥ II,Pooled Transfemoral AVRREVIVE & REVIVAL II (n=161),Age

29、(yrs) 83.5 ± 5.9 (66 - 96) ≥ 90 years 14.3% (23) ≥ 80 years 75.2% (121)Mean Logistic EuroSCORE30.7% ± 15.2Mean STS Score (REVIVAL Only) 13.1% ± 7.2,Transapical AVRREVIVA

30、L II (n=40),Age (yrs) 83.7 ± 5.2 (69 – 93) ≥ 90 years 10% ≥ 80 years 70%Mean Logistic EuroSCORE35.5 ± 15.3 Mean STS Score (REVIVAL Only) 13.4 ± 7.0More CVDz, PVDz, COPD

31、,Populations are different despite similar risk scores,* One patient on CVVHD prior to valve implantation,Pooled Transfemoral AVRREVIVE & REVIVAL II (n=161),Transapical Access,Ventricular bleeding0 @ CCF 4.8% TR

32、AVERSE,Vascular Complications,,Vascular Complications (n=25),Perforations (n=12),Aortic Dissection (n=3),Flow Limiting Iliac Dissection (n=4),Avulsed Iliac Artery (n=3),Lower Extremity Ischemia (n=4),Covered Stent - 3,Su

33、rgical Bypass - 9,Surgical Repair - 4,Surgical Bypass - 3,Surgery - 1,Medical - 2,Surgery - 2,Medical - 2,3 Deaths,2 Deaths,2 Deaths,2 Deaths,Vascular Complications (n=25),Perforations (n=12),Aortic Dissection (n=3),Flow

34、 Limiting Iliac Dissection (n=4),Avulsed Iliac Artery (n=3),Vascular Complications (n=25),Perforations (n=12),Mortality 36% vs 10% w/o,,Vascular Complications,numberat risk,13,12,9,6,22,Yes,120,96,88,60,139,No,91.4%[8

35、6.7, 96.0],82.9%[76.6, 89.3],78.2%[71.0, 85.4],72.7%[54.1, 91.3],63.3%[43.0, 83.6],46.0%[23.8, 68.3],Log Rank P=0.0004,Zero Tolerance for Vascular Access Complications,Pre-procedural Planning CriticalAngiographyIn

36、traluminal ? underestimatesPoor resolution of calcium burdenCTMore accurate with contrast (toxic)Can delineate calciumHigh resolution studyIVUS,Facilitated Access: Iliac conduit,Fundamental Assumption,Less Invasiv

37、eLess Acute RiskMortalityMorbidity,,,Unable to cross - 3,,,,161 Patients Enrolled,Unsuccessful Deploymentn = 19,Failed access - 9,,Implant Success 88.2%,,,23 mm Valve(55),Cardiac Perforation* - 3,,,

38、26mm Valve(87),61.3%,38.7%,Malplaced/Embolized - 2,,Anesthesia Complication - 2,,Transfemoral AVRProcedural Results,Successful Deploymentn = 142,23 mm Valve(55),Successful Deploymentn = 142,Slide courtesy of Susheel

39、 Kodali,,RetroFlex II Delivery SystemAddresses Crossing,REVIVAL II TransapicalTechnical Success,87.5%Migration / Embolization12.5%Failure to cross0Mean deployment time11.7 minMean procedure time87.1 min,Oth

40、er Intra-Procedural Events Related to Positioning,Coronary Occlusion Prosthetic valve insufficiencyDue to leaflet overhangi.e. Valve too low,Intra-operative Management,Hemodynamic optimization prior to startingJudici

41、ous rapid ventricular pacingTEE and fluoroscopy facilitate positioningRecognition of factors affecting placement:Hypertrophied ventricular septumCalcified root non-distensible rootNarrow sino-tubular junctionBulky

42、calcium on leaflets,Intra-operative Management,Dry runs and disaster planningRescue plans for emergenciesValve embolizationCoronary ostial occlusionProsthesis malfunctionSevere AI after BAV leading to decompensation

43、Circulatory Support,Slide courtesy of John Webb,Vancouver Experience,Transapical Procedural success (n=58),Slide courtesy of John Webb,TRAVERCE: Implant Success: 93 %,168 Patients,Successful ImplantsN=156,Unsuccessful

44、 Implants with conversionN=12,23 mm n = 43,26 mmn = 113,,,,,,,,TRAVERCE: Conversion: 7 %,15 events in 12 patients,Slide modified from Thomas Walther,TA Learning Curve (n=175)TRAVERCE,,,98 ±2%,88 ±3%,71

45、77;4%,73 ±4%,,Pat. 1 - 120, 2 Pts (CPR) excludedES 29%, STS 14%,Pat. 121 - 177ES 37%, STS 13%,30 days,6 months,1 year,Slide courtesy of Thomas Walther,No Strokes,,*Implant success = Successful device delivery and

46、deployment resulting in an AVA>0.9cm² with AI <2+,PARTNER EU TF,,,,,Ventricular embolization (n = 1)Aortic embolization (n=1),23 mm SAPIEN valveN=25,26 mm SAPIEN valveN=27,Implant failuresn = 2,Patient

47、s Implantedn = 54,Successful Implants* n = 52,Patients Plannedn = 60,,Implant abortedn = 6,,Vascular access (n = 3)Unsucessfull BAV (n=2)Active endocarditis (n=1),96.3%,Slide courtesy of T. Lefèvre,PARTNER

48、EU TFComplications,Non Hierachical Ranking,Slide courtesy of T. Lefèvre,SAPIEN? THV Commercial Experience & The SOURCE Registry,Number of patients treated: 723November 2007- September 2008,,Slide courtesy o

49、f T. Lefèvre,34 cardiac intervention centers598 implants15% of cases proctored,The SOURCE Registry Site Information,,Slide courtesy of T. Lefèvre,THV Learning Curve Percent Successful Implant,,%,Slide court

50、esy of T. Lefèvre,,,Does TA win over TF?,NO!,Because a percutaneous option will always be preferred by patients!Preclose technique is becoming routine,Axillary Conduit Avoids Arch Transit,Conduit,Axillary a.,Next

51、 Generation Devices,Lower profile – less traumaticRepositionable / retrievableLess paravalvular ARAlso, patient selection will continue to evolve,Conclusion,Safest approach is bestAdvantages to both TA and TFTransf

52、emoral will most likely dominate as devices evolveTransapical and transaxillary may continue as complementary options in select patientsShould NOT be interventionalist vs surgeon,Success requires multidisciplinary team

53、work,,June 3-5 2009,InterContinental Hotel &Bank of America Conference Center Cleveland, Ohio,www.ccfcme.org/CardioCare09www.MeetTheBuildings.com,Sessions will include:,? Aortic Disease? Coronary Artery Disease?