October 1, 2017EuroIntervention
Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre “CE-approval cohort”
Why the study?
Does transfemoral TAVI using the self-expanding ACURATE neo prosthesis have favorable safety and performance outcomes at one year?
Population
Patients undergoing transfemoral TAVI in a multicentre CE-approval cohort (first-in-human experience)
Design
Cohort
Follow-up
one year
Authors
Discussion
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Member takes
Implication
Supports evaluation of ACURATE neo for TAVI; leaves open confirmation of safety and performance in randomized trials.
Key Points
- This research aims to evaluate the safety and performance outcomes of the ACURATE neo prosthesis in transfemoral TAVI.
- This is a multicenter trial evaluating the first-in-human use of the ACURATE neo prosthesis.
- Outcomes assessed include procedural mortality, major stroke, and pacemaker implantation rates.
- Low rates of procedural mortality observed.
- Major stroke occurred infrequently, indicating enhanced safety.
- Pacemaker implantation rates were acceptable, showcasing device efficacy.
Structured PICO
Does transfemoral TAVI using the self-expanding ACURATE neo prosthesis have favorable safety and performance outcomes at one year?
P
Population
Patients undergoing transfemoral TAVI in a multicentre CE-approval cohort (first-in-human experience)
I
Intervention
Transfemoral TAVI using the self-expanding ACURATE neo prosthesis
O
Outcome
Procedural mortality, major stroke, pacemaker implantation, and performance outcomes at one yearsafety
This first-in-human experience demonstrated that the self-expanding ACURATE neo prosthesis for transfemoral TAVI has favorable safety and performance at one year.
Cite This Study
Möllmann et al. (2017) studied this question.