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
|Major Vascular Complications||6.9%||5.8%*||4.0%*|
|Length-of-Stay Median (IQR)||3.0%
* 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. citoday.com/2018/04/trends-in-united-states-tavr-practice. 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. https://www.acc.org/latest-in-cardiology/articles/2017/07/19/15/42/fifteen-years-of-tavr-where-are-we-now. 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.