Freedom and Smart Solo Stentless Bioprosthesis for Aortic Valve Replacement - clinical and hemodynamic evaluation-systematic review and meta-analysis

Abstract

Introduction: Almost 20 years after the introduction of the Freedom Solo stentless bioprosthesis, it is of utmost relevance to systemize the available evidence on its clinical and hemodynamic outcomes. Objectives: To describe and combine, through a systematic review and meta-analysis, early and long-term outcomes after aortic valve replacement (AVR) with the Freedom Solo or Solo SMART Stentless(FS) bioprostheses. Evidence acquisition: A literature review was performed using 3 databases. Studies that reported at least one of the following outcomes: mortality, immediate complications, need for reoperation or hemodynamic evaluation, were included. Random effects models were used to compute pooled estimates by generalized linear mixed-effects model and logit-transformed for proportions and by inverse variance method for continuous variables. Evidence synthesis: From 355 records screened, 110 studies were selected for eligibility assessment. Out of these, 45 studies were included in this meta-analysis. From a total of 7-869 patients, 48% were men, 95% confidence interval (CI): 45-53%, I2: 78.8% and the pooled mean age was 74 years (95%CI: 73-75), I2: 87.4%. The pooled mean logistic Euroscore was 11.5(95%CI: 8.7-14.3). Early mortality occurred in 3.1% (95%CI: 2.6-3.6) of patients, bleeding problems in 4.1% (95%CI: 2.6-6.3) and neurological events in 2.1% (95%CI: 1.7-2.7). Definitive pacemaker implantation was needed in 1.9% (95%CI: 1.5-2.5). The follow-up time ranged from 5 days to 10 years. Survival rates at 1-, 3- and 5-years ranged between 87.5% and 97.0%, 82.6% and 96.0%, and 58.5% and 94.0%, respectively. Conclusions: AVR with FS bioprosthesis can be considered a safe procedure, as supported by satisfactory early and mid-term outcomes.