Efficacy and safety of trans-catheter repair devices for mitral regurgitation: A systematic review and meta-analysis.

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.