Key result
The Sorin Freedom Solo stentless aortic valve was associated with a significantly higher rate of valve explantation due to structural deterioration or endocarditis (9.1% vs 1.3%) compared to the Carpentier Edwards Perimount stented valve.
Why the study?
Does surgical aortic valve replacement with the Sorin Freedom Solo stentless bioprosthesis improve clinical and hemodynamic outcomes compared to the Carpentier Edwards Perimount stented bioprosthesis?
Cohort (n=154)
No
Does surgical aortic valve replacement with the Sorin Freedom Solo stentless bioprosthesis improve clinical and hemodynamic outcomes compared to the Carpentier Edwards Perimount stented bioprosthesis?
While the Sorin Freedom Solo stentless valve provides superior hemodynamics compared to the Carpentier Edwards Perimount stented valve, it is associated with higher rates of structural valve degeneration, re-operation, and worse survival in patients with native valve endocarditis.
BACKGROUND: Current retrospective evidence suggests similar clinical and superior hemodynamic outcomes of the Sorin Freedom Solo stentless aortic valve (SFS) (LivaNova PLC, London, UK) compared to the Carpentier Edwards Perimount stented aortic valve (CEP) (Edwards Lifesciences Inc., Irvine, California, USA). To date, no reports exist describing case-matched long-term outcomes and analysis for treatment of native valve endocarditis (NVE). METHODS: From 2004 through 2014, 77 consecutive patients (study group, 59.7% male, 68.9 ± 12.5 years, logEuroSCORE II 7.6 ± 12.3%) received surgical aortic valve replacement (SAVR) with the SFS. A control group of patients after SAVR with the CEP was retrieved from our database and matched to the study group regarding 15 parameters including preoperative endocarditis. Acute perioperative outcomes and follow-up data (mean follow-up time 48.7±29.8 months, 95% complete) were retrospectively analyzed. RESULTS: No differences in early mortality occurred during 30-day follow up (3/77; 3.9% vs. 4/77; 5.2%; p = 0.699). Echocardiographic findings revealed lower postprocedural transvalvular pressure gradients (max. 17.0 ± 8.2 vs. 24.5 ± 9.2 mmHg, p< 0.001/ mean pressure of 8.4 ± 4.1 vs. 13.1 ± 5.9 mmHg, p< 0.001) in the SFS group. Structural valve degeneration (SVD) (5.2% vs. 0%; p = 0.04) and valve explantation due to SVD or prosthetic valve endocarditis (PVE) (9.1% vs. 1.3%; p = 0.04) was more frequent in the SFS group. All-cause mortality during follow-up was 20.8% vs. 14.3% (p = 0.397). When patients were divided into subgroups of NVE and respective utilized bioprosthesis, the SFS presented impaired outcomes regarding mortality in NVE cases (p = 0.031). CONCLUSIONS: The hemodynamic superiority of the SFS was confirmed in this comparison. However, clinical outcomes in terms of SVD and PVE rates, as well as survival after NVE, were inferior in this study. Therefore, we are reluctant to recommend utilization of the SFS for treatment of NVE.
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Schaefer et al. (2018) conducted a cohort in Aortic valve disease requiring surgical replacement (including native valve endocarditis) (n=154). Sorin Freedom Solo stentless aortic valve vs. Carpentier Edwards Perimount stented aortic valve was evaluated on Valve explantation due to structural valve deterioration or prosthetic valve endocarditis (p=0.04). The Sorin Freedom Solo stentless aortic valve was associated with a significantly higher rate of valve explantation due to structural deterioration or endocarditis (9.1% vs 1.3%) compared to the Carpentier Edwards Perimount stented valve.
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