May 23, 2017Interactive Cardiovascular and Thoracic Surgery
Comparison of latest generation transfemoral self-expandable and balloon-expandable transcatheter heart valves
Key result
ACURATE neo linked to ~38% lower mean gradients vs Sapien 3 with similar device success.
- P=0.157
- n=208
Why the study?
Comparison of acute 30-day outcomes between latest-generation self-expandable and balloon-expandable transcatheter heart valves was needed to evaluate differences in device success, haemodynamics, and complications.
Does the self-expandable Symetis ACURATE neo valve improve acute 30-day outcomes compared to the balloon-expandable Edwards Sapien 3 valve in patients undergoing transfemoral TAVI?
Comparison
Self-expandable Symetis ACURATE neo vs balloon-expandable Edwards Sapien 3 transcatheter heart valves
Design
Retrospective matched cohort study
Follow-up
30-day
Authors
Discussion
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Member takes
Implication
Observational data link ACURATE neo to better TAVI hemodynamics; leaves open whether it improves outcomes versus Sapien 3 in randomized trials.
Study Design
Type
Cohort (n=208)
Structured PICO
Does the self-expandable Symetis ACURATE neo valve improve acute 30-day outcomes compared to the balloon-expandable Edwards Sapien 3 valve in patients undergoing transfemoral TAVI?
P
Population
208 patients (mean age 81.7 years, 69.2% female) undergoing transfemoral transcatheter aortic valve implantation with either self-expandable or balloon-expandable valves, evaluated at 30 days.
E
Exposure
Transfemoral transcatheter aortic valve implantation using the self-expandable Symetis ACURATE neo transcatheter heart valve
C
Comparator
Transfemoral transcatheter aortic valve implantation using the balloon-expandable Edwards Sapien 3 transcatheter heart valve (matched control group)
O
Outcome
Acute 30-day outcomes including device success, all-cause mortality, transvalvular gradients, effective orifice area, paravalvular leakage, and permanent pacemaker implantation
Main Result
Absolute Event Rate: 94.2% vs 98.1%
p-value: p=0.157
The self-expandable ACURATE neo valve showed superior post-interventional hemodynamics compared to the balloon-expandable Sapien 3 valve, with similar rates of permanent pacemaker implantation and paravalvular leakage.
Cite This Study
Schaefer et al. (2017) conducted a cohort in Transfemoral transcatheter aortic valve implantation (n=208). Symetis ACURATE neo transcatheter heart valve vs. Edwards Sapien 3 transcatheter heart valve was evaluated on Device success (p=0.157). The self-expandable ACURATE neo valve yielded superior post-interventional hemodynamics (mean gradient 7.3 vs 11.8 mmHg, P<0.001) with similar device success (94.2% vs 98.1%) to the Sapien 3.