The Mitroflow aortic bioprosthesis was associated with an increased risk of structural valve deterioration compared to the Carpentier-Edwards Magna Ease valve (HR 2.59; 95% CI 1.69-3.98; P<0.01).
Cohort (n=1,184)
No
Does the Mitroflow aortic bioprosthesis increase the risk of early structural valve deterioration and reoperation compared to a contemporary bioprosthesis in patients undergoing aortic valve replacement?
The Mitroflow aortic bioprosthesis is associated with significantly higher rates of early structural valve deterioration, reoperation, and reduced survival compared to a contemporary bioprosthesis, warranting enhanced follow-up.
Hazard Ratio: 2.59 (95% CI 1.69–3.98)
p-value: p=< 0.01
BACKGROUND: Structural valve deterioration (SVD) is a known limitation of bioprosthetic valves. Recent reports have suggested a concerning rate of early SVD in patients receiving a Mitroflow aortic bioprosthesis. We therefore compared the incidence of SVD and SVD requiring reoperation among patients receiving a Mitroflow versus a common contemporary bioprosthesis. METHODS: A retrospective cohort analysis was performed on 592 patients receiving a Mitroflow aortic bioprosthesis at our institution between 2010 and 2014. Patients were matched 1:1 using a coarsened exact matching algorithm with patients receiving a Carpentier-Edwards Magna Ease aortic bioprosthesis (Edwards Lifesciences, Irvine, CA) during the same period. The incidence of SVD (defined as a mean transprosthetic gradient ≥30 mmHg or moderate to severe intraprosthetic regurgitation), reoperation for SVD, and cumulative survival were compared between prosthesis types. RESULTS: The cumulative incidence of SVD at 5 years for all patients receiving a Mitroflow aortic bioprosthesis was 16% (13-21%) and 5% underwent reoperation for SVD. Implantation of a Mitroflow valve was associated with an increased risk of SVD compared to the comparator valve (hazard ratio HR 2.59 1.69-3.98, P < 0.01). Older age had a protective effect against SVD (HR 0.95 0.93-0.96, P < 0.01). Patients who received a Mitroflow valve had reduced long-term survival compared to those who received a comparator valve (P = 0.03). CONCLUSION: The Mitroflow aortic bioprosthesis is associated with increased rates of early SVD and reoperation for valvular dysfunction as well as reduced survival compared to a contemporary valve. Enhanced clinical and echocardiographic follow-up is advisable after Mitroflow implantation.
Axtell et al. (2018) conducted a cohort in Aortic valve replacement (n=1,184). Mitroflow aortic bioprosthesis vs. Carpentier-Edwards Magna Ease aortic bioprosthesis was evaluated on Structural valve deterioration (SVD) (HR 2.59, 95% CI 1.69-3.98, p=< 0.01). The Mitroflow aortic bioprosthesis was associated with an increased risk of structural valve deterioration compared to the Carpentier-Edwards Magna Ease valve (HR 2.59; 95% CI 1.69-3.98; P<0.01).