Freedom Solo Versus Trifecta Bioprotheses: Clinical and Hemodynamic Evaluation after Propensity Score Matching

To compare stentless Freedom Solo and stented Trifecta aortic bioprostheses regarding hemodynamic profile, left ventricular mass regression, early and late postoperative outcomes and survival.

Longitudinal cohort study of consecutive patients undergoing aortic valve replacement (from 2009 to 2016) with either Freedom Solo or Trifecta at one centre. Local databases and national records were queried. Postoperative echocardiography (3-6 months) was obtained for hemodynamic profile (mean transprosthetic gradient and effective orifice area) and left ventricle mass determination. After propensity score matching (21 covariates), Kaplan-Meier analysis and cumulative incidence analysis were performed for survival and combined outcome of structural valve deterioration and endocarditis, respectively. Hemodynamics and left ventricle mass regression were assessed by a mixed- -effects model including propensity score as a covariate.

From a total sample of 397 Freedom Solo and 525 Trifecta patients with a median follow-up time of 4.0 (2.2- 6.0) and 2.4 (1.4-3.7) years, respectively, a matched sample of 329 pairs was obtained. Well-balanced matched groups showed no difference in survival (hazard ratio=1.04, 95% confidence interval=0.69-1.56) or cumulative hazards of combined outcome (subhazard ratio=0.54, 95% confidence interval=0.21-1.39). Although Trifecta showed improved hemodynamic profile compared to Freedom Solo, no differences were found in left ventricle mass regression.

Trifecta has a slightly improved hemodynamic profile compared to Freedom Solo but this does not translate into differences in the extent of mass regression, postoperative outcomes or survival, which were good and comparable for both bioprostheses. Long-term follow-up is needed for comparisons with older models of bioprostheses.