ABSTRACT
Objective: Literature presents conflicting results on the pros and cons of pledget-reinforced sutures during surgical aortic valve replacement (SAVR). We aimed to investigate the effect of pledget-reinforced sutures versus sutures without pledgets during SAVR on different outcomes in a systematic review and meta-analysis. Methods: A literature search was performed in five different medical literature databases. Studies must include patients undergoing SAVR and must compare any pledget-reinforced with any suturing technique without pledgets. The primary outcome was paravalvular leakage (PVL), and secondary outcomes comprised thromboembolism, endocarditis, mortality, mean pressure gradient (MPG) and effective orifice area (EOA). Results were pooled using a random-effects model as risk ratios (RRs) or mean differences (MDs) for which the no pledgets group served as reference. Results: Nine observational studies met the inclusion criteria. The risk of bias was critical in seven studies, and high and moderate in two other. The pooled RR for moderate or greater PVL was 0.59 (95 % confidence interval [CI] 0.13, 2.73). The pooled RR for mortality at 30-days was 1.02 (95 % CI 0.48, 2.18) and during follow-up was 1.15 (95 % CI 0.67, 2.00). For MPG and EOA at 1-year follow-up, the pooled MDs were 0.60 mmHg (95 % CI -4.92, 6.11) and -0.03 cm2 (95 % CI -0.18, 0.12), respectively. Conclusions: Literature on the use of pledget-reinforced sutures during SAVR is at high risk of bias. Pooled results are inconclusive regarding superiority of either pledget-reinforced sutures or sutures without pledgets. Hence, there is no evidence to support or oppose the use of pledget-reinforced sutures.