Abstract Body: Background: Aortic valve replacement (AVR) remains the gold standard for treating aortic valve disease. While conventional biological prostheses have a long history of durability, the sutureless Perceval valve was introduced to facilitate minimally invasive approaches and reduce cross-clamp and cardiopulmonary bypass (CPB) times. However, concerns regarding paravalvular leak (PVL) and the requirement for permanent pacemaker implantation (PPI) persist
Objective: To systematically analyze the clinical efficacy, hemodynamic performance, and safety profile of the sutureless Perceval prosthesis compared to conventional stented biological prostheses in patients undergoing aortic valve replacement.
Methods: A systematic search was performed on electronic databases for studies comparing Perceval sutureless valves versus conventional bioprostheses. The primary outcomes were operative times (cross-clamp and CPB duration) and early mortality. Secondary outcomes included permanent pacemaker implantation (PPI) rates, paravalvular leak, stroke, and hemodynamic gradients. Mean differences (MD) were used to combine continuous outcomes, and risk ratios (RR) with 95% confidence intervals (CI) were used to look at binary outcomes.
Results: Thirty-four studies comprising 16,471 patients (4,272 Perceval, 12,199 conventional) were included. The Perceval group demonstrated superior operative efficiency with significantly shorter operation (MD -33.51 min), cross-clamp (MD -22.61 min), and bypass times (MD -24.88 min; all P < 0.0001). Perceval was also associated with lower early mortality (OR 0.74; P = 0.02), reduced infection (OR 0.70), and fewer cardiac reoperations (OR 0.56). However, Perceval carried a significantly higher risk of PPI (OR 2.09; P = 0.0001). No significant differences were observed in PVL, stroke, or hemodynamic gradients.
Conclusion: This meta-analysis supports the Perceval sutureless valve's beneficial effect on operative efficiency and early safety, specifically regarding reduced mortality and infection rates. However, the significantly higher incidence of permanent pacemaker implantation warrants cautious interpretation regarding its conduction safety profile. Further large-scale, well-designed trials are needed to clarify strategies for minimizing pacing requirements while maintaining comparable hemodynamic outcomes.