34 醫學新知 (II) 2010 TAVI TAVI TAVI FRANCE 2 TAVI 方法 French Ministry of Health TAVI balloon aortic valvuloplastytavi 34 French Mini

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1 醫學新知 (II) 33 高風險性病人行經導管主動脈瓣膜置入術登錄譯者 : 淡水馬偕心臟內科劉彥佑醫師摘要 (TAVI) French national transcatheter aortic-valve implantation registryfrance 2 TAVI ±7.2 49% Edwards SAPIEN Medtronic CoreValve 66.9% 33.1%74.6% 5.8% 1.8%17.8%) 96.9% % 24.0% 4.1% periprosthetic aortic regurgitation 64.5% EuroSCORE NYHA TAVI severe AS TAVI Cribier TAVI TAVI 1 TAVI 2 3

7±7.2 49% Edwards SAPIEN Medtronic CoreValve 66.9% 33.1%74.6% 5.8% 1.8%17.8%) 96.9% 30 9.7% 24.0% 4.

2 34 醫學新知 (II) 2010 TAVI TAVI TAVI FRANCE 2 TAVI 方法 French Ministry of Health TAVI balloon aortic valvuloplastytavi 34 French Ministry of Health aortic-valve area 0.8 cm2mean aortic-valve gradient 40 mm Hg peak aortic jet velocity 4.0 m NYHA Fc 2010 TAVI FRANCE 2 (the French Societies of Cardiology) (the French Societies of Throacic and Cardiovascular Surgery) TAVI balloon-expandable Edwards SAPIEN SAPIEN XT prosthesis (Edwards Lifesciences)self-expandable CoreValve (Medtronic) 30 Edwards SAPIEN 88% TAVI SAPIEN CoreValve TAVI French Ministry of Health Edwards SAPIEN

0 m NYHA Fc 2010 TAVI FRANCE 2 (the French Societies of Cardiology) (the French Societies of Throacic and Cardiovascular Surgery) TAVI

3 醫學新知 (II) 35 balloon-expandable cobalt-chromium open-cellsapien XT mm 23, 26, 29 mm 23-mm 26-mm Retroflex 3 delivery catheter, 22-French 24-French introducer; Novaflex delivery catheter, 18-French 19-French introducerascendra catheter, 24-French introducer 29-mm CoreValve self-expanding nitinol stent 18 F AccuTrak Stability Layer mm 26, 29, 31 mm cut down anteriorminithoracotomy bursts of rapid ventricular pacing Edwards SAPIEN TAVI Prostar XL, Abbott aspirin 160 mg daily clopidogrel 300 mg loading dose, then 75 mg daily aspirin plavix aspirin primary end point secondary safety end points MACEcardiac events cardiac or vascular surgerybleeding or stroke (NYHA) secondary efficacy end points Valve Academic Consortium (VARC) criteria Society of Thoracic Surgeons (STS) score 0 100% STS 10% logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) 0 100% 20%

anteriorminithoracotomy bursts of rapid ventricular pacing Edwards SAPIEN TAVI Prostar XL, Abbott aspirin 160 mg daily clopidogrel 300 mg loading dose, then 75 mg daily aspirin plavix aspirin primary

4 36 醫學新知 (II) VARC Kaplan-Meier Student s t-test variance nonparametric test (chi-square test) Fisher s exact test categorical variables univariate Cox model P 0.20 Cox mode EuroSCORE NYHA estimated hazard ratio Cox mode P 0.05 SAS 8.2 結果 TAVI French health care authorities % ± % 0.7±0.2 cm2 48.1±16.5 mm Hg Table 1) 22.1±2.2 mm logistic EuroSCORE 21.9±14.3% STS 14.4±12.0% % logistic EuroSCORE 20% STS score 10% 8.3% 17.1% 51.4%7.1% TAVI 15.8%

2 結果 2010 2011 3195 34 TAVI French health care authorities 114 31 242 99.8% 94 25 251 82.7±7.2 24 101 49% 0.7±0.2 cm2 48.1±16.

5 醫學新知 (II) 37

6 38 醫學新知 (II) 74.7%15.3% hybrid room 10.0% Edwards SAPIEN Medtronic CoreValve 74.6% 17.8% 5.8% 1.8% logistic EuroSCORE P<0.001Table % 24% 4.9± ± % P=0.35Table 3

7 醫學新知 (II) 39 (PRIMARY END POINT) Kaplan-Meier mortality from all causes 9.7% Table % % 725 Fig. 1

8 40 醫學新知 (II) (SECONDARY END POINTS) stroke 3.4% 3.8% 4.1% major stroke 1.9% 2.1% 2.2% CoreValve SAPIEN 24.2% vs. 11.5% %intraprosthetic aortic regurgitationgrade % % 3 0.2% % periprosthetic aortic regurgitation % % % % major vascular complications % % %intraprosthetic aortic regurgitation % % % periprosthetic aortic regurgitation % % 8 0.8% % intraprosthetic aortic regurgitation % 6 1.3% 1 0.2% % periprosthetic aortic regurgitation % % 5 1.2% % 13.9% 17.2% 22.4% Fig. 1

7% major vascular complications 72 2.3% 12 0.4% 945 114 12.1%intraprosthetic aortic regurgitation 96 10.2% 18 1.9% 983 618 62.

9 醫學新知 (II) 41 VARC minor and life-threatening bleeding logistic EuroSCORE hazard ratio 1% % NYHAhazard ratio % hazard ratio % periprosthetic regurgitationhazard ratio % % NYHA Fc Fig. 2

58 NYHAhazard ratio 1.49 95% 1.09 2.03 hazard ratio 1.45 95% 1.

10 42 醫學新知 (II) TAVI logistic EuroSCORE ± ± [19.5%] [16.2%] [73.4%] [65.0%] P TAVI [14.4%] [17.1%]P=0.04 Kaplan-Meier [10.1%] [9.2%] P=0.49 FRANCE 2 TAVI TAVI

4%] 1604 1042 [65.0%] P 0.001 TAVI 1545 223 [14.4%] 1616 276 [17.1%]P=0.

11 醫學新知 (II) TAVI 80.4% 19.6% 17.6% 1.8% 66.9% SAPIEN 33.1% CoreValve SAPIEN 47.1% 31.1% SAPIEN 15.6% 4.4% SAPIEN 57.0% 14.3% 9.7% % PARTNER Placement of Aortic Transcatheter Valves trial B cohort B 5.0% A cohort A 5.2% 1 logistic EuroSCORE 234 periprosthetic regurgitation logistic EuroSCORE SOURCE Edwards SAPIEN Aortic Bioprosthesis European Outcome Italian SAPIEN CoreValve FRANCE % SOURCE U.K. PARTNER A 15.6% 13% 16.3% 16.6% SOURCE 6.7% PARTNER B 3.4% A 3.8% 39.9% CoreValve SAPIEN 4.1% PARTNER major vascular complications 5.5%1.9% 4.8% 2.7% PARTNER B 9.3% A 16.8% B 16.2% A 9.3% TAVI Logistic EuroSCORE Edward TAVI 14.4% 17.1% P=0.04

2% 1 logistic EuroSCORE 234 periprosthetic regurgitation logistic EuroSCORE SOURCE Edwards SAPIEN Aortic Bioprosthesis European Outcome Italian SAPIEN CoreValve FRANCE

12 44 醫學新知 (II) TAVI 13% TAVI EuroSCORE 20% TAVI TAVI

32 醫學新知 (I) (adjusted hazard ratio: 0.35; 95% confidence interval: 0.18 to 0.70; p = 0.003) -------------------------------------------------------

32 醫學新知 (I) (adjusted hazard ratio: 0.35; 95% confidence interval: 0.18 to 0.70; p = 0.003) ------------------------------------------------------- 31 A Direct Comparison of Early and Late Outcomes With Three Approaches to Carotid Revascularization and Open Heart Surgery J Am Coll Cardiol 2013;62:1948 56 開心手術與頸動脈狹窄再灌流治療, 三種治療方案

34 醫 學 新 知 (II) 2010 TAVI TAVI TAVI FRANCE 2 TAVI 方 法 French Ministry of Health TAVI balloon aortic valvuloplastytavi 34 French Mini

34 醫學新知 (II) 2010 TAVI TAVI TAVI FRANCE 2 TAVI 方法 French Ministry of Health TAVI balloon aortic valvuloplastytavi 34 French Mini