February 1, 2018EuroIntervention
Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry
Why the study?
Does the ACURATE neo transfemoral transcatheter heart valve provide safe and effective outcomes at 30 days in an unselected all-comers population with severe aortic stenosis?
Population
1,000 patients with severe aortic stenosis, mean age 81.1±5.2 years, logistic EuroSCORE II 6.6±7.5%, STS…
Design
Cohort
Follow-up
30-day
Authors
Discussion
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Member takes
Implication
Low event rates support ACURATE neo feasibility in severe AS; leaves open randomized comparisons to current valves.
Key Points
- To evaluate the safety and performance of the ACURATE neo valve in a large cohort with severe aortic stenosis.
- 1,000 patients were enrolled in a prospective European multicentre registry from October 2014 to April 2016.
- Procedures included predilatation in 96.1% of patients and postdilatation in 44.8% of patients.
- The primary endpoint evaluated was 30-day mortality and other clinical outcomes.
- 30-day mortality occurred in 14 patients (1.4% [95% CI: 0.7-2.1]).
- Disabling stroke was observed in 1.2% of patients (95% CI: 0.5-1.9).
- New pacemaker implantation was necessary in 8.3% (95% CI: 6.6-10.0) of the cohort.
Structured PICO
Does the ACURATE neo transfemoral transcatheter heart valve provide safe and effective outcomes at 30 days in an unselected all-comers population with severe aortic stenosis?
P
Population
1,000 patients with severe aortic stenosis, mean age 81.1±5.2 years, logistic EuroSCORE II 6.6±7.5%, STS score 6.0±5.6%, enrolled in a prospective European multicentre registry.
I
Intervention
Self-expanding ACURATE neo transfemoral transcatheter heart valve
O
Outcome
30-day mortalityhard clinical
The ACURATE neo prosthesis demonstrated good clinical outcomes with very low complication rates, including 1.4% 30-day mortality and 8.3% new pacemaker rate, in a real-world all-comers population with severe aortic stenosis.
Cite This Study
Möllmann et al. (2018) studied this question.