Decreasing permanent pacemaker implantation rates in the STS/ACC TVT Registry™*1

Published data with the TVT Registry™* highlighted the continued downward trend of permanent pacemakers (PPI) with the Evolut™ platform.

The data suggest 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).


Sample size

N = 54,014

Devices

Evolut™ R/Evolut™ PRO/Evolut™ PRO+ 


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 Registry™*2

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.


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