Key result
Aortic valve replacement with the P-Magna prosthesis showed significantly better 8-year adjusted overall survival than the Mitroflow LX (69.1% vs 51.9%; HR 1.44, 95% CI 1.01-2.06; P=0.0467).
Why the study?
Does the P-Magna bioprosthesis with anti-calcification treatment improve survival and reduce structural valve disease compared to the Mitroflow LX bioprosthesis in patients undergoing aortic valve replacement?
Cohort (n=625)
Does the P-Magna bioprosthesis with anti-calcification treatment improve survival and reduce structural valve disease compared to the Mitroflow LX bioprosthesis in patients undergoing aortic valve replacement?
Hazard Ratio: 1.44 (95% CI 1.01–2.06)
Absolute Event Rate: 69.1% vs 51.9%
p-value: p=0.0467
The use of P-Magna bioprostheses with anti-calcification treatment is associated with better overall and cardiac-related survival and lower rates of structural valve disease compared to Mitroflow LX.
P-Magna may warrant consideration over Mitroflow LX; leaves open causal benefit pending randomized confirmation.
Objectives: The efficacy of anti-calcification treatment of bioprosthetic heart valves remains unclear. The aim of this study was to compare the clinical outcomes between Mitroflow LX valve, without anti-calcification treatment, and the Carpentier-Edwards Perimount Magna (P-Magna), with anti-calcification treatment. Methods: Between 2005 and 2012, 625 consecutive patients underwent aortic valve replacement either with a Mitroflow LX ( n = 329) or a P-Magna ( n = 296). Variables regarding patient-related risk factors and operative data were accounted for an inverse probability of treatment weighting analysis. Then, adjusted survival outcomes and the rate of structural valve disease (SVD) were assessed for each group. Results: Mean follow-up times were 4.1 ± 2.29 years and 3.9 ± 2.63 years, respectively ( P = 0.34). Adjusted overall survival rate was higher in the P-Magna group than in the Mitroflow LX group at 8 years (69.1% vs 51.9%, respectively) [HR = 1.44, 95% CI: 1.01 to 2.06; P = 0.0467]. Similarly, the 8-year cardiac-related survival rate was also higher in the P-Magna group [HR = 1.99, 95% CI: 1.19 to 3.32; P = 0.0083]. One patient (0.8%) with P-Magna and 23 patients (18.5%) with Mitroflow LX group developed SVD (0.24% per patient-year vs 4.5% per patient-year, respectively; P < 0.001). At 5 and 8 years, valve-related survival rates did not differ significantly between both groups [HR = 1.67, 95% CI: 0.95 to 2.95; P = 0.075]. Conclusions: The P-Magna prosthesis showed significantly better overall and cardiac-related survival than the Mitroflow LX. The higher early SVD and reoperation rates seen with the Mitroflow LX prosthesis did not impact negatively on valve-related survival.
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Blasco-Lucas et al. (2016) conducted a cohort in Aortic valve replacement (n=625). Carpentier-Edwards Perimount Magna (P-Magna) with anti-calcification treatment vs. Mitroflow LX valve without anti-calcification treatment was evaluated on Adjusted overall survival rate at 8 years (HR 1.44, 95% CI 1.01 to 2.06, p=0.0467). Aortic valve replacement with the P-Magna prosthesis showed significantly better 8-year adjusted overall survival than the Mitroflow LX (69.1% vs 51.9%; HR 1.44, 95% CI 1.01-2.06; P=0.0467).
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