Transcatheter aortic valve replacement (TAVR)
Medtronic real-world results
The CoreValve™/Evolut™ platform provides reproducible results from clinical trial to the real world.
Explore our STS/ACC TVT Registry™* data that supports the excellent clinical performance seen in our trials.
Decreasing permanent pacemaker implantation rates in the STS/ACC TVT Registry1
At TVT 2022, Dr. James Harvey presented real-world experience highlighting the continued downward trend of permanent pacemakers (PPI) with the Evolut platform.
The data suggests the adoption of procedural techniques, such as cusp overlap, coupled with advancements in valve design, contribute to declining PPI rates (14.7% in 2018 Q3 to 8.8% in 2021 Q2 for in-hospital PPI rate).
In-hospital pacemaker rates by quarter
These rates exclude baseline PPI/ICD and include TAV-in-SAV and TAV-in-TAV treated patients.
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Evolut PRO+ self-expanding valve: 30-day outcomes from the U.S. TVT Registry2
At EuroPCR 2021, Dr. Bajwa presented the first large report of the Evolut PRO+ system, including comparisons between the Evolut R and Evolut PRO+ 34 mm valve size.
Evolut PRO+ valves, with a pericardial wrap on all valve sizes, demonstrated lower total aortic regurgitation (AR) compared to Evolut R valves with low rates of moderate AR (1.9% versus 2.0%) and mild AR (27.8% versus 34.8%) at one month.
Among 34 mm valves, ≥ mild AR was numerically lower at one month in patients treated with the Evolut PRO+ system compared to those treated with Evolut R valves (p = 0.071).
Sample size
N = 525 Evolut R; N = 3,963 Evolut PRO+
Devices
Evolut R 11.7%/Evolut PRO+ 88.3%
Total AR at 30 days
†p-value is comparing milder or greater total aortic regurgitation between groups.
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Key Medtronic trials
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*
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References
1
Harvey JE. Decreasing Permanent Pacemaker Implantation Rates in the STS/ACC TVT Registry with a Supra-annular Self-expanding Transcatheter Heart Valve. Presented at TVT2022; June 9, 2022; Chicago, IL.
2
Bajwa T, Rammohan C, Puri R, et al. The next-generation self-expanding transcatheter device: 30-day outcomes from the TVT-Registry. Presented at EuroPCR2021; May 2021.