Transcatheter edge-to-edge repair in mitral regurgitation: A comparison of device systems and recommendations for tailored device selection. A systematic review and meta-analysis

Abstract

Background: Mitral valve transcatheter edge-to-edge repair (M-TEER) is a minimally invasive method for the treatment of mitral regurgitation (MR) in patients with prohibitive surgical risks. The traditionally used device, MitraClip, showed both safety and effectiveness in M-TEER. PASCAL is a newer device that has emerged as another feasible option to be used in this procedure.

Methods: We searched for observational studies that compared PASCAL to MitraClip devices in M-TEER. The electronic databases searched for relevant studies were PubMed/MEDLINE, Scopus, and Embase. The primary outcomes were technical success and the grade of MR at follow-up. Secondary outcomes included all-cause mortality, bleeding, device success and reintervention.

Results: Technical success (PASCAL: 96.5% vs MitraClip: 97.6%, p = 0.24) and MR ≤ 2 at 30-day follow-up (PASCAL: 89.4vs MitraClip 89.9%, p = 0.51) were comparable between both groups. Both devices showed similar outcomes including all-cause mortality (RR: 0.68 [0.34, 1.38]; P = 0.28), major bleeding (RR: 1.87 [0.68, 5.10]; P = 0.22) and reintervention (RR: 1.02 [0.33, 3.16]; P = 0.97). Device success was more frequent with PASCAL device (PASCAL: 86% vs MitraClip 68.5%; P = 0.44), however, the results did not reach statistical significance.

Conclusion: Clinical outcomes of PASCAL were comparable to those of MitraClip with no significant difference in safety and effectiveness. The choice between MitraClip and PASCAL devices should be guided by various factors, including mitral valve anatomy, etiology of regurgitation, and device-specific characteristics.

Keywords: MitraClip; Mitral regurgitation; Mitral valve; PASCAL; Transcatheter edge-to-edge repair.