Datasheet1_Comparison of middle-term valve durability between transcatheter aortic valve implantation and surgical aortic valve replacement: an updated systematic review and meta-analysis of RCTs.docx

BackgroundThis study aims to compare valve durability between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR).
MethodsWe conducted a systematic review and meta-analysis using data from randomized controlled trials (RCTs). The primary outcome was structural valve deterioration (SVD). Secondary outcomes were bioprosthetic valve failure, reintervention, effective orifice area (EOA), mean pressure gradient, and moderate–severe aortic regurgitation (AR, transvalvular and/or paravalvular).
ResultsTwenty-five publications from seven RCTs consisting of 7,970 patients were included in the analysis with follow-up ranges of 2–8 years. No significant difference was found between the two groups with regard to SVD [odds ratio (OR) 0.72; 95% CI: 0.25–2.12]. The TAVI group was reported to exhibit a statistically significant higher risk of reintervention (OR 2.03; 95% CI: 1.34–3.05) and a moderate–severe AR (OR 6.54; 95% CI: 3.92–10.91) compared with the SAVR group. A trend toward lower mean pressure gradient in the TAVI group [(mean difference (MD) −1.61; 95% CI: −3.5 to 0.28)] and significant higher EOA (MD 0.20; 95% CI: 0.08–0.31) was noted.
ConclusionThe present data indicate that TAVI provides a comparable risk of SVD with favorable hemodynamic profile compared with SAVR. However, the higher risk of significant AR and reintervention was demonstrated.
Systematic Review RegistrationPROSPERO (CRD42022363060).

背景 本研究旨在对比经导管主动脉瓣植入术（transcatheter aortic valve implantation, TAVI）与外科主动脉瓣置换术（surgical aortic valve replacement, SAVR）的瓣膜耐久性。
方法 本研究采用随机对照试验（randomized controlled trials, RCT）的数据开展系统评价与荟萃分析。主要结局指标为结构性瓣膜退化（structural valve deterioration, SVD）；次要结局指标包括生物瓣膜失效、再次干预、有效瓣口面积（effective orifice area, EOA）、平均跨瓣压差以及中重度主动脉瓣反流（aortic regurgitation, AR，含跨瓣及/或瓣周反流）。
结果 本分析共纳入7项随机对照试验的25项公开研究，涉及7970名患者，随访时长范围为2~8年。两组在结构性瓣膜退化方面未观察到显著差异[比值比（odds ratio, OR）=0.72；95%置信区间（confidence interval, CI）：0.25~2.12]。与外科主动脉瓣置换术组相比，经导管主动脉瓣植入术组的再次干预风险（OR=2.03；95%CI：1.34~3.05）与中重度主动脉瓣反流风险（OR=6.54；95%CI：3.92~10.91）均具有统计学意义的升高。经导管主动脉瓣植入术组的平均跨瓣压差呈降低趋势[均数差（mean difference, MD）=-1.61；95%CI：-3.5~0.28]，且有效瓣口面积显著更高（MD=0.20；95%CI：0.08~0.31）。
结论 本研究数据表明，与外科主动脉瓣置换术相比，经导管主动脉瓣植入术的结构性瓣膜退化风险相当，且血流动力学特性更优。但该术式的显著主动脉瓣反流与再次干预风险更高。
系统评价注册 PROSPERO（CRD42022363060）。