Real-World TAVI Experience
Real-World TAVI Experience
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 (n=652) |
S3iCAP (n=652) |
TVT-R (IR) (n=1956) |
| 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%* [2.0%, 3.0%] |
2.0%* [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. 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.