October 14, 2019Catheterization and Cardiovascular Interventions
Outcomes of three different new generation transcatheter aortic valve prostheses
Key result
SAPIEN 3, Evolut R, and ACURATE neo yield similar 1-year MACCE, but Evolut R requires more pacemakers.
- P=0.534
- n=389
Why the study?
Few head-to-head comparisons are available among new-generation transcatheter aortic valve prostheses despite their improved procedural outcomes.
Do different new-generation transcatheter aortic valve prostheses (SAPIEN 3, Evolut R, ACURATE neo) have different clinical and echocardiographic outcomes in patients with severe aortic stenosis?
Population
346 patients undergoing elective TF-TAVI for native, severe aortic stenosis
Comparison
Edwards SAPIEN 3 vs Medtronic Evolut R vs Boston ACURATE neo prostheses
Design
Single-center retrospective cohort study with propensity score weighting
Follow-up
1 year
Authors
Discussion
Loading...
Member takes
Implication
Similar MACCE rates may allow flexible valve selection; Evolut R-associated higher pacemaker rates leave open comparative safety in observational cohorts.
Study Design
Type
Cohort (n=389)
Multicenter
No
Structured PICO
Do different new-generation transcatheter aortic valve prostheses (SAPIEN 3, Evolut R, ACURATE neo) have different clinical and echocardiographic outcomes in patients with severe aortic stenosis?
P
Population
389 patients (mean age 81.4 years) undergoing elective transfemoral transcatheter aortic valve implantation for native, severe aortic stenosis, followed for up to 1 year.
E
Exposure
Transcatheter aortic valve implantation using Edwards SAPIEN 3 (n=134), Medtronic Evolut R (n=111), or Boston ACURATE neo (n=101) prostheses
C
Comparator
Head-to-head comparison among the three different new-generation transcatheter aortic valves
O
Outcome
30-day all-cause and cardiovascular mortality, and 1-year major adverse cardiovascular and cerebrovascular events (MACCE)hard clinical
Main Result
p-value: p=0.534
New-generation TAVI devices offer comparable 1-year clinical outcomes, but differ significantly in rates of pacemaker implantation and paravalvular regurgitation.
Cite This Study
Costa et al. (2019) conducted a cohort in Native, severe aortic stenosis (n=389). Edwards SAPIEN 3, Medtronic Evolut R, or Boston ACURATE neo vs. Head-to-head comparison was evaluated on 1-year major adverse cardiovascular and cerebrovascular events (MACCE) (p=0.534). TAVI using SAPIEN 3, Evolut R, and ACURATE neo valves yielded similar 1-year MACCE rates (P=0.534), but Evolut R had higher pacemaker implantation rates (16.7% vs 8.3% and 2.1%; P<0.05).