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.
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。