Key result
Trifecta bioprosthesis lowers resting mean gradient by ~4 mmHg vs Magna Ease, matching Freestyle.
Why the study?
Does the Trifecta bioprosthesis improve haemodynamics at rest and during exercise compared to Freestyle and Magna Ease bioprostheses in patients undergoing aortic valve replacement for severe aortic stenosis?
Population
60 patients undergoing clinically indicated aortic valve replacement for severe aortic stenosis, median age…
Comparison
Trifecta bioprosthesis vs Freestyle or Magna Ease bioprostheses
Design
RCT, randomly assigned to Freestyle, Magna Ease or Trifecta bioprostheses
Follow-up
6 months
Authors
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Trifecta may be preferred over Magna Ease for lower resting gradients post-AVR; extends RCT evidence comparing bioprosthetic valve haemodynamics.
RCT (n=56)
Randomly assigned to one of three bioprostheses
No
Does the Trifecta bioprosthesis improve haemodynamics at rest and during exercise compared to Freestyle and Magna Ease bioprostheses in patients undergoing aortic valve replacement for severe aortic stenosis?
Absolute Event Rate: 5% vs 9%
p-value: p=0.04
The Trifecta bioprosthesis offers superior haemodynamics compared to Magna Ease and similar haemodynamics to the stentless Freestyle valve at rest and during exercise 6 months post-AVR.
Bach et al. (2016) conducted an RCT in Severe aortic stenosis (n=56). Trifecta bioprosthesis vs. Magna Ease and Freestyle bioprostheses was evaluated on Resting mean gradient (mmHg) (p=0.04). The Trifecta bioprosthesis demonstrated superior resting and exercise hemodynamics compared to Magna Ease (resting mean gradient 5 vs 9 mmHg; P=0.04), and similar hemodynamics to the Freestyle valve.
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