Balata Mahmoud, Gbreel Mohamed Ibrahim, Elkasaby Mohamed Hamouda, Hassan Marwa, Becher Marc Ulrich
Friedrich-Alexander-Universität Erlangen-Nürnberg, Nürnberg, Germany.
Faculty of Medicine, October 6 University, Giza, Egypt.
J Cardiothorac Surg. 2025 Jan 3;20(1):3. doi: 10.1186/s13019-024-03218-4.
Despite the promising results of both MitraClip and PASCAL systems for the treatment of mitral regurgitation (MR), there is limited data on the comparison of both systems regarding their safety and efficacy. We aim to compare both systems for MR.
Five databases were searched until October 2024. Original studies were only included and critically appraised using an adapted version of the Newcastle-Ottawa scale for observational cohort studies and the Cochrane risk of bias tool for randomized controlled trials. The risk ratio (RR) and mean difference (MD) with their corresponding 95% confidence interval (95% CI).
From the database search, we identified 197 studies, of which eight studies comprising 1,612 patients who underwent transcatheter edge-to-edge repair with either MitraClip or PASCAL were included in this meta-analysis. The statistical analysis revealed no significant difference between the two devices in achieving a two-grade reduction in MR severity (RR = 0.95; 95% CI: [0.86, 1.04]; p = 0.28), one-grade reduction (RR = 1.17; 95% CI: [0.92, 1.49]; p = 0.19), or in cases with no improvement (RR = 1.23; 95% CI: [0.79, 1.90]; p = 0.36). Additionally, there were no significant differences between PASCAL and MitraClip regarding procedure time, procedural success, reinterventions, or all-cause mortality. However, PASCAL trended towards better residual MR reduction, although this was accompanied by moderate heterogeneity. Both devices demonstrated comparable safety profiles and were effective in reducing MR and improving cardiac function.
MitraClip and PASCAL devices showed comparable safety profiles and procedural success rates. However, the analysis did not reveal a statistically significant difference between the two devices in reducing the severity of MR.
尽管MitraClip和PASCAL系统在治疗二尖瓣反流（MR）方面都取得了令人鼓舞的结果，但关于这两种系统在安全性和有效性方面的比较数据有限。我们旨在比较这两种用于治疗MR的系统。
检索了五个数据库直至2024年10月。仅纳入原始研究，并使用适用于观察性队列研究的纽卡斯尔-渥太华量表和适用于随机对照试验的Cochrane偏倚风险工具进行严格评估。计算风险比（RR）和平均差（MD）及其相应的95%置信区间（95%CI）。
通过数据库检索，我们识别出197项研究，其中八项研究共纳入1612例接受了使用MitraClip或PASCAL进行经导管缘对缘修复的患者，并纳入了本荟萃分析。统计分析显示，在使MR严重程度降低两级方面（RR = 0.95；95%CI：[0.86, 1.04]；p = 0.28）、降低一级方面（RR = 1.17；95%CI：[0.92, 1.49]；p = 0.19）或无改善的情况方面（RR = 1.23；95%CI：[0.79, 1.90]；p = 0.36），两种装置之间没有显著差异。此外，在手术时间、手术成功率、再次干预或全因死亡率方面，PASCAL和MitraClip之间也没有显著差异。然而，PASCAL在进一步降低残余MR方面有一定趋势，尽管伴有中度异质性。两种装置都显示出相当的安全性，并且在降低MR和改善心功能方面是有效的。
MitraClip和PASCAL装置显示出相当的安全性和手术成功率。然而，分析未显示两种装置在降低MR严重程度方面有统计学上的显著差异。
