Key result
Stentless Sorin Freedom Solo shows lower transvalvular gradients but similar mid-term mortality versus stented Carpentier Edwards.
Why the study?
Does the Sorin Freedom Solo stentless bioprosthesis improve haemodynamic and clinical outcomes compared to the Carpentier Edwards Perimount stented bioprosthesis in patients undergoing aortic valve replacement?
Cohort (n=238)
Does the Sorin Freedom Solo stentless bioprosthesis improve haemodynamic and clinical outcomes compared to the Carpentier Edwards Perimount stented bioprosthesis in patients undergoing aortic valve replacement?
Absolute Event Rate: 16.4% vs 21.3%
p-value: p=0.3
The Sorin Freedom Solo stentless bioprosthesis provides superior short- and mid-term haemodynamic performance compared to the Carpentier Edwards Perimount stented bioprosthesis, with comparable safety and mid-term mortality.
Lower gradients without mortality benefit observed; leaves open superiority in randomized aortic valve replacement trials.
OBJECTIVES: The aim of this study was to investigate the mid-term haemodynamic and clinical results after aortic valve replacement (AVR) using the Sorin Freedom Solo (SFS) stentless bioprosthesis, compared with the standard Carpentier Edwards Perimount (CEP) stented bioprosthesis. METHODS: In this retrospective cohort study of prospectively collected data, 116 patients were included in the SFS group (53 males; median age 74 years, range 56-85 years), and 122 patients in the CEP group (85 males; median age 73 years, range 43-88 years) between July 2007 and January 2013. Echocardiography was performed at 6 weeks after surgery in our centre, and the most recent echocardiography (in our centre or in referring cardiology departments) was requested. Between September 2013 and April 2014, all patients were called by the same researcher to gain clinical follow-up data. RESULTS: Mid-term mortality was 16.4% in the SFS group (19 patients) and 21.3% in the CEP group (26 patients); (P = 0.3). The mean transvalvular gradient was 7.4 ± 3.1 mmHg in the SFS group, and 11.6 ± 3.2 mmHg in the CEP group at 6 weeks postoperatively (P < 0.001). When stratified by labelled valve size, mean gradients were significantly lower in the SFS group for every size (P ≤ 0.03). After 3.3 ± 1.4 years of follow-up, the mean gradient was still significantly lower in the SFS group than that in the CEP group (P < 0.001). Clinical follow-up showed relatively low complication rates. CONCLUSION: These data suggest that the Sorin Freedom Solo stentless bioprosthesis is as safe as the Carpentier Edwards bioprosthesis, and provides better short- and mid-term haemodynamic performance than the Carpentier Edwards bioprosthesis.
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Straaten et al. (2015) conducted a cohort in Aortic valve replacement (n=238). Sorin Freedom Solo stentless bioprosthesis vs. Carpentier Edwards Perimount stented bioprosthesis was evaluated on Mid-term mortality (p=0.3). The Sorin Freedom Solo stentless bioprosthesis showed similar mid-term mortality (16.4% vs 21.3%; P=0.3) and lower transvalvular gradients compared to the Carpentier Edwards stented bioprosthesis.
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