August 1, 2008EuroIntervention
Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) CoreValve ReValving System: results from the multicentre, expanded evaluation registry 1-year following CE mark approval
Population
646 patients with symptomatic severe aortic stenosis and high surgical risk, mean age 81 +/- 6.6 years.
Design
Cohort
Follow-up
30 days
Authors
Discussion
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Member takes
Implication
Supports TAVI feasibility in high-risk aortic stenosis; leaves open comparative effectiveness versus surgery and long-term durability.
Key Points
- To evaluate procedural performance and 30-day clinical outcomes following transcatheter aortic valve implantation with the 18 Fr CoreValve ReValving System.
- Multicentre expanded evaluation registry enrolled 646 high-risk patients (mean age 81 ± 6.6 years, logistic EuroSCORE 23.1 ± 13.8%) between April 2007 and April 2008.
- Eligible patients presented with symptomatic severe aortic stenosis (mean aortic valve area 0.6 ± 0.2 cm²) and underwent valve implantation supervised by a physician proctor.
- Procedural success reached 97%, and the mean transaortic valve gradient decreased from 49.4 ± 13.9 mmHg to 3 ± 2 mmHg post-implantation.
- Procedural mortality was 1.5%, all-cause mortality at 30 days was 8.0%, and the composite rate of death, stroke, and myocardial infarction was 9.3%.
Structured PICO
P
Population
646 patients with symptomatic severe aortic stenosis and high surgical risk (logistic Euroscore >=15%, or age >=75 years, or age >=65 years associated with pre-defined risk factors), mean age 81 +/- 6.6 years.
I
Intervention
Transcatheter aortic valve implantation (TAVI) using the third generation (18 Fr) CoreValve ReValving System
O
Outcome
Procedural performance and 30-day outcomes including procedural success, procedural mortality, all-cause mortality, and combined rate of death, stroke, and myocardial infarctionhard clinical
TAVI using the 18 Fr CoreValve ReValving System demonstrated a high procedural success rate of 97% and an acceptable 30-day all-cause mortality of 8% in high-risk patients with severe aortic stenosis.
Cite This Study
Piazza et al. (2008) studied this question.