Key result
Trifecta bioprosthesis matches Carpentier Edwards in 6-year rates of death, reoperation, and structural valve disease.
Why the study?
Mid-term clinical outcomes and hemodynamic performance comparison between the Trifecta and Carpentier Edwards Magna Ease surgical aortic bioprostheses were lacking.
Does the Trifecta bioprosthesis improve clinical outcomes and hemodynamics compared to the Carpentier Edwards Magna Ease valve in patients undergoing surgical aortic valve replacement?
Cohort (n=486)
Does the Trifecta bioprosthesis improve clinical outcomes and hemodynamics compared to the Carpentier Edwards Magna Ease valve in patients undergoing surgical aortic valve replacement?
Absolute Event Rate: 15.3% vs 15.9%
p-value: p=0.88
The Trifecta bioprosthesis offers similar mid-term safety and durability to the Carpentier Edwards Magna Ease valve, with superior hemodynamic performance, particularly in smaller valve sizes.
Background To compare mid-term clinical outcomes and hemodynamic performance of the stented pericardial Trifecta bioprosthesis for surgical aortic valve replacement (AVR) with a technically comparable commonly used surgical bioprosthesis. Methods Data from consecutive patients implanted with the TF or the Carpentier Edwards Magna Ease valve were retrospectively analyzed. Primary analysis was performed on a propensity score–matched cohort. Primary endpoints included the composite of death or reoperation and structural valve deterioration. The comparison also included echocardiographic assessments at one-week post-AVR and at the last documented follow-up. Results Two propensity score–matched groups of 170 patients each were identified from the overall population ( n = 486). Incidence of postoperative mortality (2.9% vs. 7.1%, respectively, p = 0.08), and patient prosthesis mismatch (1.2% and 2.4%, p = 0.41) were similar. At mean follow-up of 5.84 (Trifecta) and 6.1 (Carpentier Edwards) years, the incidence of all-cause death/reoperation (15.3% vs. 15.9%, p = 0.88 for Trifecta and Carpentier Edwards, respectively) and structural valve disease (1.8% vs. 2.9%, p = 0.47) were similar. Overall, postoperative mean transvalvular pressure gradients were significantly lower in the Trifecta group than in the Carpentier Edwards group (7.7 ± 3.3 vs. 11.3 ± 3.6 mmHg, p < 0.01). Mean transvalvular gradient remained significantly lower through the last follow-up for small-sized Trifecta valves (19/21 mm; 10.5 ± 4.2 vs. 13.8 ± 5.9 mmHg, p = 0.039) but not for larger valves (10.3 ± 4.8 vs. 9.4 ± 3.5 mmHg, p = 0.31). Conclusion The Trifecta valve is a valuable alternative to the Carpentier Edwards valve in terms of safety, hemodynamic performance, and mid-term durability. Smaller-sized valves provide additional clinical benefits, given their persistent hemodynamic advantages through mid-term follow-up.
No takes yet. Share an insight, caveat, or question.
Pfister et al. (2023) conducted a cohort in surgical aortic valve replacement (n=486). Trifecta bioprosthesis vs. Carpentier Edwards Magna Ease valve was evaluated on composite of death or reoperation (p=0.88). The Trifecta bioprosthesis had similar 6-year rates of death or reoperation (15.3% vs 15.9%, p=0.88) and structural valve disease (1.8% vs 2.9%, p=0.47) compared to the Carpentier Edwards valve.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: