Key result
INSPIRIS Resilia valve demonstrates comparable hemodynamics to Perimount Magna Ease at 3 years post-AVR.
Why the study?
Does the INSPIRIS Resilia valve provide comparable hemodynamic performance to the Perimount Magna Ease valve in patients under 70 years undergoing aortic valve replacement?
Cohort (n=430)
Does the INSPIRIS Resilia valve provide comparable hemodynamic performance to the Perimount Magna Ease valve in patients under 70 years undergoing aortic valve replacement?
The INSPIRIS Resilia valve demonstrates comparable mid-term hemodynamic performance to the established Perimount Magna Ease valve in patients under 70 undergoing aortic valve replacement.
Answers are grounded in this paper and cite their sources.
Comparable hemodynamics may support INSPIRIS Resilia consideration in younger AVR patients; leaves open need for randomized durability data.
Background: During the past decade, the Perimount Magna Ease (PME) bioprosthesis has been implanted worldwide for aortic valve replacement (AVR). Recently, the INSPIRIS Resilia (IR) valve has been introduced as the newest generation of pericardial bioprostheses. However, few data have been reported about patients ≤70 years, and no comparisons in terms of hemodynamic performance between these two bioprostheses have been ever reported. Methods: Patients aged <70 years undergoing AVR were considered for comparison between PME (n = 238) and IR (n = 192). Propensity score (PS) matching was performed by logistic regression with adjustment for eight key baseline variables. The two prostheses were compared in terms of hemodynamic performances up to 3 years postoperatively. Sub-analysis according to prosthetic size-category was accomplished. Results: A total of 122 pairs with similar baseline characteristics were obtained from the PS-matching. The two prostheses showed comparable hemodynamic performances at one year (Gmean: 11.3 ± 3.5 mmHg vs. 11.9 ± 5.4 mmHg; p = 0.8) and at 3 years postoperatively (Gmean: 12.2 ± 7.9 mmHg vs. 12.8 ± 5.2 mmHg for; p = 0.3). The sub-analysis of size-category confirmed no statistical differences concerning the hemodynamic performances for each annulus size. Conclusions: This first PS-matched analysis demonstrated that the newly developed IR valve achieves the same safety and efficacy of the PME valve during mid-term follow-up in patients aged <70 years.
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Francica et al. (2023) conducted a cohort in Aortic valve replacement (n=430). INSPIRIS Resilia (IR) valve vs. Perimount Magna Ease (PME) bioprosthesis was evaluated on Mean transvalvular gradient (Gmean) at 3 years postoperatively (p=0.3). The INSPIRIS Resilia valve demonstrated comparable hemodynamic performance to the Perimount Magna Ease valve at 3 years post-AVR in patients <70 years (mean gradient 12.8 vs 12.2 mmHg; p=0.3).
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