Abstract：
BACKGROUND: Several repair strategies emerged as possible treatment for severe mitral regurgitation (MR). A systematic review and meta-analysis was performed to compare the different percutaneous mitral valve repair approaches.
METHODS: PubMed and Scopus electronic databases were scanned for eligible studies until December 11th, 2023. Clinical efficacy endpoints were all-cause mortality, major adverse cardiovascular events, and post-procedural NYHA functional class <3; the echocardiographic efficacy endpoint was a post-intervention residual MR less than moderate. Safety endpoints and procedural outcome measures were also assessed.
RESULTS: Eleven studies were included: 8 [N = 1662 patients, mean follow-up (FUP) 294 days] compared MitraClip® vs Pascal® device, 2 (N = 195 patients) MitraClip® vs Carillon® and 1 study (N = 186 patients) evaluated MitraClip® against Cardioband®. The Pascal®-treated group had lower MR degree compared to the MitraClip®-treated group, without difference in post-intervention mean trans-mitral gradient and in clinical and safety endpoints. A longer procedure time was observed in the Pascal® group, albeit with a lower average number of implanted devices per procedure. The two studies comparing MitraClip® and Carillon® were inconsistent in terms of both efficacy and safety outcomes, while the study evaluating MitraClip® vs Cardioband® showed that the latter might confer a significant clinical benefit, with a similar reduction in MR.
CONCLUSIONS: Pascal® is as safe and clinically effective as MitraClip® in treating patients with MR, with an apparent greater reduction in the magnitude of residual valve insufficiency over the long term. Data on Cardioband® and Carillon® are not robust enough to draw conclusions from the use of such devices.
METHODS: PubMed and Scopus electronic databases were scanned for eligible studies until December 11th, 2023. Clinical efficacy endpoints were all-cause mortality, major adverse cardiovascular events, and post-procedural NYHA functional class <3; the echocardiographic efficacy endpoint was a post-intervention residual MR less than moderate. Safety endpoints and procedural outcome measures were also assessed.
RESULTS: Eleven studies were included: 8 [N = 1662 patients, mean follow-up (FUP) 294 days] compared MitraClip® vs Pascal® device, 2 (N = 195 patients) MitraClip® vs Carillon® and 1 study (N = 186 patients) evaluated MitraClip® against Cardioband®. The Pascal®-treated group had lower MR degree compared to the MitraClip®-treated group, without difference in post-intervention mean trans-mitral gradient and in clinical and safety endpoints. A longer procedure time was observed in the Pascal® group, albeit with a lower average number of implanted devices per procedure. The two studies comparing MitraClip® and Carillon® were inconsistent in terms of both efficacy and safety outcomes, while the study evaluating MitraClip® vs Cardioband® showed that the latter might confer a significant clinical benefit, with a similar reduction in MR.
CONCLUSIONS: Pascal® is as safe and clinically effective as MitraClip® in treating patients with MR, with an apparent greater reduction in the magnitude of residual valve insufficiency over the long term. Data on Cardioband® and Carillon® are not robust enough to draw conclusions from the use of such devices.
摘要：
背景：出现了几种可能的治疗重度二尖瓣返流（MR）的修复策略。进行了系统评价和荟萃分析，以比较不同的经皮二尖瓣修复方法。
方法：PubMed和Scopus电子数据库在12月11日之前对符合条件的研究进行扫描，2023年。临床疗效终点是全因死亡率，主要不良心血管事件，术后NYHA功能分级<3;超声心动图疗效终点为介入后残余MR小于中度。还评估了安全性终点和程序结果指标。
结果：包括11项研究：8[N=1662例患者，平均随访（FUP）294天]比较MitraClip®与Pascal®装置，2例（N=195例患者）MitraClip®vsCarillon®和1例研究（N=186例患者）评估了MitraClip®对抗Cardioband®。与MitraClip®治疗组相比，Pascal®治疗组的MR程度较低，干预后平均跨二尖瓣梯度以及临床和安全性终点均无差异。在Pascal®组中观察到更长的手术时间,尽管每个手术的平均植入设备数量较低。两项比较MitraClip®和Carillon®的研究在疗效和安全性方面均不一致。而评估MitraClip®与Cardioband®的研究表明，后者可能会带来显著的临床益处，MR也有类似的减少。
结论：Pascal®在治疗MR患者方面与MitraClip®一样安全有效，从长远来看，残余瓣膜功能不全的幅度明显减少。关于Cardioband®和Carillon®的数据不足以从此类设备的使用中得出结论。
方法：PubMed和Scopus电子数据库在12月11日之前对符合条件的研究进行扫描，2023年。临床疗效终点是全因死亡率，主要不良心血管事件，术后NYHA功能分级<3;超声心动图疗效终点为介入后残余MR小于中度。还评估了安全性终点和程序结果指标。
结果：包括11项研究：8[N=1662例患者，平均随访（FUP）294天]比较MitraClip®与Pascal®装置，2例（N=195例患者）MitraClip®vsCarillon®和1例研究（N=186例患者）评估了MitraClip®对抗Cardioband®。与MitraClip®治疗组相比，Pascal®治疗组的MR程度较低，干预后平均跨二尖瓣梯度以及临床和安全性终点均无差异。在Pascal®组中观察到更长的手术时间,尽管每个手术的平均植入设备数量较低。两项比较MitraClip®和Carillon®的研究在疗效和安全性方面均不一致。而评估MitraClip®与Cardioband®的研究表明，后者可能会带来显著的临床益处，MR也有类似的减少。
结论：Pascal®在治疗MR患者方面与MitraClip®一样安全有效，从长远来看，残余瓣膜功能不全的幅度明显减少。关于Cardioband®和Carillon®的数据不足以从此类设备的使用中得出结论。
