Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries
Key result
Over time, TAVR with Evolut PRO/PRO+ showed improved 30-day device success (81.2% to 88.0%, P=0.023) and early safety (66.8% to 77.6%, P<0.001), with fewer pacemaker implantations.
Why the study?
Data regarding the impact of continuous improvements in TAVR techniques and technology on outcomes in large real-world settings remain limited.
Does transcatheter aortic valve replacement with Evolut PRO/PRO+ self-expanding valves improve procedural outcomes over time in patients undergoing transfemoral TAVR?
Population
1616 patients undergoing transfemoral TAVR across 28 centers
Comparison
Temporal trends across procedural date quartiles (August 2017 through November 2021)
Design
Multicenter registry-based observational cohort study
Follow-up
1-year
Authors
Discussion
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Member takes
Implication
Improved TAVR outcomes with Evolut PRO/PRO+ over time support iterative device use; leaves open generalizability beyond this cohort.
Study Design
Type
Observational (n=1,616)
Multicenter
Yes
Structured PICO
Does transcatheter aortic valve replacement with Evolut PRO/PRO+ self-expanding valves improve procedural outcomes over time in patients undergoing transfemoral TAVR?
P
Population
1,616 patients from 28 centers who underwent transfemoral TAVR with Evolut PRO/PRO+ self-expanding valves, evaluated for temporal trends up to 1 year.
E
Exposure
Transfemoral transcatheter aortic valve replacement (TAVR) with Evolut PRO/PRO+ supra-annular self-expanding valves.
O
Outcome
Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes (including technical success, all-cause mortality, device success, early safety, permanent pacemaker implantation, and paravalvular leaks).composite
Procedural outcomes for TAVR with Evolut PRO/PRO+ self-expanding valves have improved over time, with higher device success and fewer complications despite treating more heavily calcified anatomies.
Cite This Study
Scotti et al. (2023) conducted an observational in Aortic valve disease (n=1,616). Transfemoral TAVR with Evolut PRO/PRO+ vs. Earlier procedural quartiles was evaluated on Temporal trends in TAVR outcomes including 30-day device success and early safety. Over time, TAVR with Evolut PRO/PRO+ showed improved 30-day device success (81.2% to 88.0%, P=0.023) and early safety (66.8% to 77.6%, P<0.001), with fewer pacemaker implantations.