TAVI Quick Review_0111.ai

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1 TAVI

2 1 Aortic Stenosis, AS 652 4% ,2 AS 2 4 % % 65 3, 2 A S AS 3 3 AS A S Renu Virmani, M.D. (CV Path Institute) A S A S 1

3 2 A S AS 2

4 3 A S AS AS 5 22% 5 7, AS 3

5 4 A S AS AS ASAS TTE X AS AS 1.cm 2 AVAi.6cm 2 /m 2 mmhg 4.m/s low-flow low-gradient AS 4

6 5 TAV I AS AS AS SAVRSAVR TAVI TAVI Transcatheter Aortic Valve Implantation TAV I BAV ASSAVR SAVR AS %SAVR TAVI Bouma Pellikka 1 25 Charlson Varadarajan Jan Bach Freed SAVR SAVR 5

7 TAVI AS TAVI [ SAVR or TAVI? ] SAVR AS TAVI COPD Porcelain Aorta Age STSEuro STS Porcelain Aorta 6

8 6 TAV I TAVI HEART TEAM TAVI TAVI AS AS TAVI SAVR 1 TAVI SAVR 1 BAV 2 SAVR 1 TAVI

9 7 PARTNER Trial 16,17 AS TAVI TFTA SAVR A TF B 2 PARTNER Trial AS N 3,15 Cohort A N Cohort N 1,57 Cohort B N 358 TF N 492 TA N 27 1:1 1:1 1:1 TF TAVI N 244 SAVR N 248 TA TAVI N 14 SAVR N 13 TF TAVI N 179 N 179 TA TF 16,17 TAVI SAVR5A 8 2 SAVR (n=351) TAVI (n=348) 67.8% 62.4% HR[95%CI] =1.4[.86,1.24] P(log rank)= TAVI 5B 8 2 (n=179) TAVI (n=179) 93.6% 71.8% HR[95%CI] =.5.39,.65] P(log rank)< Number at risk SAVR TAVI Number at risk TAVI In an age and gender matched US population without comorbidities, the mortality at 5 years is.5%. ASSAVR ASAVR 62.4%TAVI 67.8% B5 93.6%TAVI 71.8% 8

10 16,17 SAVR group 9 TAVI group Time months Number at risk SAVR group Probability TAVI group 348 TAVI SAVR5 A Probability TAVI group Number at risk Standard treatment group 8 2 Standard treatment group TAVI group TAVI 5 B Time months A5 SAVR 14.7TAVI 15.9 B5 18.2TAVI 16. TAVI Quality of Life QOL 18 8 (n=157) TAVI (n=17) KCCQQOL Number available (eligible) (174) 92 (126) 7 (91) TAVI (167) 121 (138) 11 (124) TAVI QOL 36 1 AS QOL TAVI PARTNERTAVI 9

11 PARTNER Trial S3 Cohort 19 TAVI 3 AS TF PARTNER Trial S3 Cohort PII S3i =176 2 PII S3HR =583 TF TA TAo TF / TA TAo TF TAVI SAPIEN 3 TAA TAVI SAPIEN 3 TF TAVI SAPIEN 3 TAA TAVI SAPIEN 3 TA TF PVL 19 % 8% % % 2% % TF31.6 % SAPIEN3 3 PARTNER 1

12 8 XT23 26mm TF TA / TAo STS 25 2 TF TA / TAo TFTA/TAo 11

13 %88.7% TAVITF 399.1% 191.7% TA % 178.9% P(log rank)< TF TA / TAo Number at risk Number at risk TF TA/TAo TFTA/TAo NYHA NYHA TF TA / TAo 8 6.4% 21.5% 2.%.2% 16.1% 1.7%.4% 8 7.4% 4.7% 23.3% 3.1% 14.3% 1.6% 42.% 45.9% 76.2% 81.7% 69.% 84.1% 2 5.2% % 1.4% NYHA 12

14 9 TAV I TAVI TAVITransfemoral Transapical 1 TA TRANSAPICAL TF TRANSFEMORAL 1 13

15 TAVI

16 OPEN TAVI TAVI TAVI TAVI 1. TAVI 2. TAVI.TAVI-web.com TAVI CLICK References : 1. Freeman RV, Otto CM. Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies. Circulation 25;111; Available from Dare AJ, Veinot JP, Edwards WD, et al. New observations on the etiology of aortic valve disease: a surgical pathologic study of 236 cases from 199. Hum Pathol 1993; 24: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38: Lester SJ, Heilbron B, Gin K, et al. The natural history and rate of progression of aortic stenosis. Chest. 1998;113: Otto CM. Timing of aortic valve surgery. Heart. 2;84: National Institutes of Health. National Cancer Institute. Surveillance epidemiology and end results. Cancer stat fact sheets - Cited 216 Jun Varadarajan P, Kapoor N, Bansal RC, et al. Survival in elderly patients with severe aortic stenosis is dramatically improved by aortic valve replacement: Results from a cohort of 277 patients aged 8 years. Eur J Cardiothorac Surg. 26;3: Bouma BJ, Van Den Brink RB, Van Der Meulen JH, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences.heart. 1999;82: Pellikka PA, Sarano ME, Nishimura RA, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged follow-up. Circulation. 25;111: Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis. 26;15: Varadarajan P, Kapoor N, Banscal RC, et al. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 26;82: Jan F, Andreev M, Mori N, et al. Unoperated patients with severe symptomatic aortic stenosis. Circulation. 29;12:S Bach DS, Siao D, Girard SE, et al. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 29;2: Freed BH, Sugeng L, Furlong K, et al. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis and potential solutions. Am J Cardiol. 21;15: Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis PARTNER 1 : A randomised controlled trial. Lancet 215; 385: Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis PARTNER 1 : A randomised controlled trial. Lancet 215; 385: Reynolds MR, Magnuson EA, Lei Y, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 211;124: Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 216 Mar 31. [Epub ahead of print] XT 225BZX BZX Tel Edwards Lifesciences Corporation. All rights reserved. edwards.com/jp

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