Controlling for the future of TAVI patients

PARTNER 3 Trial low-risk bicuspid nested registry1,2,7

All-cause death, all stroke, or rehospitalization through 1 year1

The need for post-TAVI coronary access is expected to increase in patients with longer life expectancies

Excellent outcomes in appropriate bicuspid patients

TVT registry data4

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Excellent SAPIEN 3 valve durability at 5 years in PARTNER II Trial5

Low rates of SVD and SVD-related BVF

*Stage 2 & 3 (moderate & severe HVD): morphological valve deterioration AND +Δ mean gradient ≥ 10 mmHg with final mean gradient ≥ 20 mmHG§ and any of: -Δ AVA ≥ 0.3 cm2 (or ≥ 25%)§, -Δ DVI ≥ 0.1 (or ≥ 20%)§ OR ≥ 1 grade Δ transvalvular AR with final grade ≥ moderate.

Stage 3 (severe HVD): morphological valve deterioration AND +Δ mean gradient ≥ 20 mmHG with final mean gradient ≥ 30 mmHg§ and any of: -Δ AVA ≥ 0.6 cm2 (or ≥ 50%)§, -Δ ≥ 0.2 (or ≥ 40%)§ OR ≥ 2 grade Δ transvalvular AR with severe final grade.

In this study, we used PARTNER II propensity matched data to analyze SVD rates, there was no statistically significant difference between SAPIEN 3 TAVI and SAVR for all endpoints except for all-cause BVF. The majority of cases within all-cause BVF in SAVR were due to endocarditis, while in TAVI they were due to paravalvular AR, a form of nonstructural valve dysfunction.

§Compared to echocardiographic assessment performed 1 to 3 months post-procedure (or discharge if not available).

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The only valve approved for aortic THV-in-THV and transseptal mitral THV-in-surgical valve*

Treatment options with SAPIEN 3 TAVI

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Designed for future coronary access, validated by data

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1. Robert WC, Janning KG, Ko JM, et al. Frequency of Congenitally Bicuspid Aortic Valves in Patients >80 Years of Age Undergoing Aortic Valve Replacement for Aortic Stenosis (With or Without Aortic Regurgitation) and Implications for Transcatheter Aortic Valve Implantation. Am J Cardiol. 2012;109(11):1632-1636.
2. Pasala TKR, Ruiz CE. Transcatheter Aortic Valve Replacement for All-comers With Severe Aortic Stenosis: Could It Become a Reality?. Rev Esp Cariodl (Engl Ed). 2018;71(3):141-145.
3. Yudi MB, et al. Coronary Angiography and percutaneous coronary intervention after transcatheter aortic valve replacement. JACC Vol 71, No 12, 2018.
4. Makkar R, et al. Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke. JAMA. 2019 Jun 11;321(22):2193-2202.
5. Pibarot, et al. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in PARTNER II Trial. J Am Coll Cardiol. 2020.
6. Tarantini G, Fovino LN, LePrince P, et al. Coronary access and percutaneous coronary intervention up to 3 years after transcatheter aortic valve implantation with a balloon-expandable valve. Circ Cardiovasc Interv. 2020;13(7):e008972.
7. Williams M, Webb J. The PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR Low-risk Patients. Presented at TCT 2020; October 2020,
8. The PARTNER 3 Trial, low-risk bicuspid registry. Data on file at Edwards Lifesciences.