February 1, 2016EuroIntervention
Feasibility and safety of balloon-expandable transcatheter aortic valve implantation with moderate or without predilatation
Key result
Balloon-expandable TAVI without predilatation shows similar survival to moderate predilatation but reduces fluoroscopy time.
Why the study?
Aortic valve preparation by balloon aortic valvuloplasty has been considered mandatory during TAVI, but the feasibility and safety of moderate or no predilatation needed investigation.
Does balloon-expandable TAVI without predilatation maintain safety and procedural success compared to moderate predilatation in patients undergoing TAVI?
Comparison
No predilatation vs moderate predilatation
Design
Cohort study
Follow-up
30 days
Authors
Discussion
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Member takes
Implication
Omitting predilatation may maintain survival with shorter fluoroscopy; leaves open randomized confirmation before changing balloon-expandable TAVI practice.
Study Design
Type
Cohort (n=513)
Structured PICO
Does balloon-expandable TAVI without predilatation maintain safety and procedural success compared to moderate predilatation in patients undergoing TAVI?
P
Population
513 patients undergoing balloon-expandable transcatheter aortic valve implantation with moderate or no predilatation.
E
Exposure
Balloon-expandable TAVI with no predilatation
C
Comparator
Balloon-expandable TAVI with moderate predilatation
O
Outcome
Device success and adverse events according to Valve Academic Research Consortium (VARC)-2 definitions, including 30-day all-cause mortalitysafety
Main Result
Hazard Ratio: 1.33 (95% CI 0.75–2.35)
p-value: p=0.34
Omitting balloon predilatation during balloon-expandable TAVI is feasible and safe, reducing fluoroscopy time and contrast use without compromising procedural success or survival.
Cite This Study
Abramowitz et al. (2016) conducted a cohort in Aortic valve disease requiring TAVI (n=513). TAVI with no predilatation vs. TAVI with moderate predilatation was evaluated on Overall survival (HR 1.33, 95% CI 0.75-2.35, p=0.34). Balloon-expandable TAVI with no predilatation resulted in similar overall survival compared to moderate predilatation (HR 1.33; 95% CI 0.75-2.35; p=0.34), with reduced fluoroscopy time.