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Long-term results of the Mitroflow aortic pericardial bioprosthesis in over 800 patients: limited durability and mechanisms of dysfunction

Fabio Ius, Julia Schulz, Mazen Roumieh, Felix Fleissner, Issam Ismail, Igor Tudorache, Gregor Warnecke, Andreas Martens, Malakh Shrestha, Dietmar Boethig, Axel Haverich, Serghei Cebotari
European Journal of Cardio-thoracic Surgery 2017 August 1, 52 (2): 264-271

OBJECTIVES: The Mitroflow aortic pericardial bioprosthesis was widely employed in the past. However, some authors have recently reported early structural valve deterioration (SVD) of the Mitroflow LA/LXA model. Thus, we reviewed our experience with the Mitroflow bioprosthesis and studied the risk factors for SVD and mortality.

METHODS: Records of patients who underwent aortic valve replacement with a Mitroflow bioprosthesis between November 2005 and January 2015 were retrospectively evaluated with Kaplan-Meier, Cox-regression and multistate analysis. Only patients with a complete clinical follow-up were included in the study. Average follow-up was 45 months and ended on 1 April 2016.

RESULTS: Between November 2005 and January 2015, among the 916 patients undergoing aortic valve replacement with the Mitroflow prosthesis at our Institution, the 832 (90.8%) patients with follow-up information were included into the study. Fifty-two (6.2%) patients developed SVD (stenosis, n  = 38; regurgitation, n  = 7; mixed, n  = 7). Freedom from SVD was 95.4% and 67.9%, at 5 and 9 years, respectively, without differences after stratification according to the prosthesis model ( P  = 0.87) and prosthesis size ( P  = 0.70). At the multivariable analysis, increasing age was identified as a protective factor against SVD (hazard ratio = 0.94, P  < 0.001). Twenty (38.4%) patients with SVD underwent redo aortic valve replacement. At 5 and 9 years, survival was 64.5% and 43.1%, repectively. According to the multistate analysis, the fraction of patients living with degenerated valves at 9 years was 10.0%; 7.1% died following degeneration.

CONCLUSIONS: The LA/LXA Mitroflow model showed limited long-term durability. Degenerated prostheses showed more stenosis than regurgitation. Patient age played an important role in the development of SVD.


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