Why the study?
Increasing reports of early failure in externally mounted pericardial Trifecta bioprostheses prompted a comparison with Carpentier–Edwards Perimount Magna Ease valves to determine the failure mechanism.
Does the Trifecta aortic bioprosthesis compared to the Carpentier-Edwards Perimount Magna Ease valve increase the risk of early failure and redo aortic valve replacement?
Does the Trifecta aortic bioprosthesis compared to the Carpentier-Edwards Perimount Magna Ease valve increase the risk of early failure and redo aortic valve replacement?
The Trifecta aortic bioprosthesis is associated with significantly higher rates of early failure, major aortic regurgitation, and redo aortic valve replacement compared to the Carpentier-Edwards Perimount Magna Ease valve.
Trifecta recipients may need intensified early surveillance; leaves open the hemodynamic drivers of excess SVD versus Magna Ease.
Background There are increasing reports of early externally mounted pericardial Trifecta bioprosthesis failure. We compared the hemodynamic performance of Trifecta and Carpentier–Edwards Perimount Magna Ease valves to determine the failure mechanism. Methods We retrospectively included 270 consecutive patients (age: 73.4 ± 8.2 years; 57.5% male; mean follow-up: 48.0 ± 20.3 months) who underwent aortic valve replacement from 2014 to 2021 at a single center and compared the Trifecta ( N = 137) and Carpentier–Edwards Perimount Magna Ease valve ( N = 133) patients. Results The prosthetic valve major aortic regurgitation incidence was higher for the Trifecta than that for the Carpentier–Edwards Perimount Magna Ease valve (6.3% vs. 0%, P < 0.009). Among the Trifecta failures, 33% developed structural valve deterioration, but all requiring redo aortic valve replacement developed major prosthetic valve aortic regurgitation. Freedom at 5 years from redo aortic valve replacement due to structural valve deterioration was significantly lower for Trifecta (89.4% vs. 100%, P = 0.003). The reoperation hazards were determined for Trifecta (vs. Carpentier–Edwards Perimount Magna Ease): 11.6 (1.47–90.9; P = 0.02), prosthetic valve aortic regurgitation: 2.38 (1.70–3.32; P < 0.01), structural valve deterioration: 20.82 (4.08–106.2; P < 0.01), 5-year mean transprosthetic pressure gradient: 1.14 per 1-point increase (1.03–1.24; P = 0.007), and urgent surgery: 10.1 (2.59–39.0; P = 0.001). The Cox regression analysis identified that prosthetic valve aortic regurgitation solely contributed to redo aortic valve replacement (hazard ratio: 2.38; confidence intervals: 1.70–3.32). Conclusions Significantly, more early failures occurred with the Trifecta valve than the Carpentier–Edwards Perimount Magna Ease valve but the Trifecta showed reasonable mean transprosthetic pressure gradient over time. Prosthetic valve aortic regurgitation and calcific structural valve deterioration synergistically contributed to Trifecta valve failure alternatively.
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Suzuki et al. (2022) studied this question.
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