Midterm Hemodynamic and Clinical Results of the SJM Trifecta versus Sorin Freedom Solo Aortic Bioprosthesis

Objectives: The aim of the present study was to compare mid-term hemodynamic and clinical results of the SJM Trifecta (TF) versus Sorin Freedom Solo (SFS) stentless bioprostheses.

Methods: From 2012 to 2016, 196 consecutive patients (53.6% female, 72.4 ± 8.3 years, log EuroSCORE II 4.3 ± 9.4%) received surgical aortic valve replacement (SAVR) with the TF, and from 2004 to 2016, 77 consecutive patients (40.3% female, 68.9 ± 12.5 years, log EuroSCORE II 7.6 ± 12.3%) with the SFS. Mean implanted valve sizes were 23.4 ± 1.8 mm (TF) versus 23.7 ± 2.0 mm (SFS) and was not statistically different (p = 0.191). In the TF group, 24.0% (n = 47) received a ≤ 21 mm prosthesis versus 23.4% (n = 18) in the SFS group. Acute perioperative outcomes and follow-up data (mean follow-up time 43.0 ± 10.8 months, 94% complete) were retrospectively analyzed.

Results: Mid-term valve-related mortality was significant lower in the TF group (2.55%) versus 13% in the SFS group (p < 0.001). Further main issues were structural valve deterioration, which was significantly more frequent in the SFS group (0.5% versus 5.2%; p = 0.043) and a significantly higher reoperation rate due to SVD or prosthetic valve endocarditis in the SFS group (2.0% versus 9.1%; p = 0.029). At final follow-up, echocardiographic findings revealed comparable postprocedural transvalvular pressure gradients (max. 16.2 ± 7.6 versus 17.0 ± 8.2 mm Hg, p = 0.437/ mean 8.1 ± 3.4 versus 8.4 ± 4.1 mm Hg, p = 0.604) in the TF versus SFS group, respectively. When patients were subanalyzed respective to small valve size ≤21mm, postprocedural transvalvular pressure gradients (max. 18.2 ± 6.9 versus 17.4 ± 6.4 mm Hg, p = 0.728/ mean 8.8 ± 7.8 versus 9.4 ± 8.5 mm Hg, p = 0.635) showed no significant differences.

Conclusion: This study showed a non-inferiority regarding hemodynamic results and superiority with regards to SVD, reoperation, and valve-related mortality of the Trifecta valve compared with the Sorin Freedom Solo stentless valve. Even in small aortic annuli, no significant differences in hemodynamic performance were seen among the two bioprostheses.