December 1, 2008Circulation Cardiovascular Interventions
Progress and Current Status of Percutaneous Aortic Valve Replacement: Results of Three Device Generations of the CoreValve Revalving System
Key result
Percutaneous aortic valve replacement with the third-generation CoreValve system improved procedural success to 91.2% compared to 70.0% and 70.8% in earlier generations (P=0.003).
Why the study?
Does percutaneous aortic valve replacement with the CoreValve prosthesis improve procedural outcomes and clinical status in high-risk patients with severe aortic valve stenosis?
Population
136 consecutive high-risk patients with severe symptomatic aortic valve stenosis
Design
Cohort
Follow-up
up to 1 year
Authors
Discussion
Loading...
Member takes
Implication
Supports generational CoreValve improvements in TAVR success; leaves open randomized confirmation of clinical outcomes in high-risk aortic stenosis.
Study Design
Type
Observational (n=136)
Multicenter
No
Structured PICO
Does percutaneous aortic valve replacement with the CoreValve prosthesis improve procedural outcomes and clinical status in high-risk patients with severe aortic valve stenosis?
P
Population
136 consecutive high-risk patients with severe symptomatic aortic valve stenosis (logistic EuroScore: 23.1+/-15.0%)
I
Intervention
Percutaneous aortic valve replacement using the self-expanding CoreValve Revalving prosthesis (first, second, and third generations)
O
Outcome
Procedural outcome, complications and clinical status up to 1 yearcomposite
Main Result
Absolute Event Rate: 91.2% vs 70.8%
p-value: p=0.003
Percutaneous aortic valve replacement with the CoreValve system demonstrates increasing procedural success and decreasing complication rates across device generations in high-risk patients with severe aortic stenosis.
Limitations
- Requires head-to-head comparisons with surgical valve replacement in different risk populations
- Nonrandomized
- Single-center
- Lack of head-to-head comparison with surgical valve replacement
Cite This Study
Grube et al. (2008) conducted an observational in Severe aortic valve stenosis (n=136). CoreValve Revalving prosthesis (Generation 3) vs. CoreValve Revalving prosthesis (Generations 1 and 2) was evaluated on Procedural success rate (p=0.003). Percutaneous aortic valve replacement with the third-generation CoreValve system improved procedural success to 91.2% compared to 70.0% and 70.8% in earlier generations (P=0.003).