You can feel confident that TAVI is an established treatment for symptomatic severe aortic stenosis1

TAVI is an established treatment option, with more than 450,000 transcatheter aortic valves implanted.2-4. In fact, based on the TVT registry, the number of TAVI procedures has surpassed the number of SAVR procedures in the US in the last 5 years.1

TAVI with the Edwards SAPIEN 3 valve is shown to be safe and reproducible in real-world settings5

Event S3i
All-cause Mortality 0.9% 0.9% 0.8%
All Stroke 2.0% 2.3% 2.2%
New Pacemaker 11.1% 12.0%* 10.2%*
Major Vascular Complications 6.9% 5.8%* 4.0%*
Length-of-Stay Median (IQR) 3.0%
[2.0%, 4.0%]
[2.0%, 3.0%]
[2.0%, 3.0%]
PVL (Mod/Sev) 4.6% 4.3%* 1.3%*

* Site reported and unadjudicated.
Edwards AWT data on file. Valves at 800 million cycles tested at nominal deployment.
Requirements per ISO standard 5840-3:2013 except for limited sample size and test configuration.
§ Pressures were ≥100 mmHg for 0 - 200 million cycles and ≥120 mmHg for 200 million - 800 million cycles.

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References:   1. Messenger JC. Trends in United States TAVR practice. Cardiac Interventions Today website. Published April 2018. Accessed February 7, 2019. 2. FDA Letter: SAPIEN approval letter 2011. 3. Mack MJ, Leon MB, Thourani VH. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705. 4. Fifteen Years of TAVR; Where Are They Now? American College of Cardiology, July 20, 2017. 5. Tuzcu E. Real world outcomes of TAVR with the SAPIEN 3 valve in intermediate risk patients: comparison of data from the TVT registry with PARTNER S3 studies. Oral presentation at: EuroPCR 2018; May 2018; Paris, France.