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 2010 2011 34 3195 82.7±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% 4.1% periprosthetic aortic regurgitation 64.5% EuroSCORE NYHA TAVI severe AS TAVI Cribier TAVI TAVI 1 TAVI 2 3
34 醫 學 新 知 (II) 2010 TAVI TAVI TAVI FRANCE 2 TAVI 方 法 2010 33 French Ministry of Health TAVI 1 2 200 3 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
醫 學 新 知 (II) 35 balloon-expandable cobalt-chromium open-cellsapien XT 18 27 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 20 29 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 0 4 2010 2011 Society of Thoracic Surgeons (STS) score 0 100% STS 10% logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) 0 100% 20%
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 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 mm Hg Table 1) 22.1±2.2 mm logistic EuroSCORE 21.9±14.3% STS 14.4±12.0% 835 26.1% logistic EuroSCORE 20% STS score 10% 8.3% 17.1% 51.4%7.1% TAVI 15.8%
醫 學 新 知 (II) 37
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 2 40.8% 24% 4.9±4.8 11.1±8.0 96.9% P=0.35Table 3
醫 學 新 知 (II) 39 (PRIMARY END POINT) Kaplan-Meier mortality from all causes 9.7% Table 3 18.6% 1545 24.0% 725 Fig. 1
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% 30 1822 168 9.2%intraprosthetic aortic regurgitationgrade 1 143 7.8% 22 1.2% 3 0.2% 1846 1191 64.5% periprosthetic aortic regurgitation 875 47.4% 301 16.3% 15 0.8% 156 4.7% 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% periprosthetic aortic regurgitation 452 46.0% 158 16.1% 8 0.8% 458 43 9.4% intraprosthetic aortic regurgitation 36 7.9% 6 1.3% 1 0.2% 426 285 66.9% periprosthetic aortic regurgitation 201 47.2% 79 18.5% 5 1.2% 30 8.5% 13.9% 17.2% 22.4% Fig. 1
醫 學 新 知 (II) 41 VARC minor and life-threatening bleeding logistic EuroSCORE hazard ratio 1% 1.37 95% 1.19 1.58 NYHAhazard ratio 1.49 95% 1.09 2.03 hazard ratio 1.45 95% 1.09 1.92 periprosthetic regurgitationhazard ratio 2.49 95% 1.91 3.25 89.5% NYHA Fc Fig. 2
42 醫 學 新 知 (II) 2010 1551 TAVI 2011 1640 2010 2011 logistic EuroSCORE 2010 22.8±14.8 2011 20.9±13.8 1544 301 [19.5%] 1623 263 [16.2%] 1550 1137 [73.4%] 1604 1042 [65.0%] P 0.001 TAVI 1545 223 [14.4%] 1616 276 [17.1%]P=0.04 Kaplan-Meier 2010 2011 30 2010 1551 155 [10.1%] 2011 1640 138 [9.2%] P=0.49 FRANCE 2 TAVI TAVI
醫 學 新 知 (II) 43 3195 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% 5.4 11.5% 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 2 76.0% 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% 2010 2011 TAVI Logistic EuroSCORE Edward TAVI 14.4% 17.1% P=0.04
44 醫 學 新 知 (II) TAVI 13% TAVI EuroSCORE 20% TAVI TAVI