The PASCAL P10 System was associated with a greater acute reduction in medio-lateral mitral annular diameter compared to MitraClip (MD 2.00 mm; 95% CI 0.57-3.44; p=0.006).
Cohort (n=295)
Yes
Does TEER with the PASCAL system compared to MitraClip improve acute mitral annular geometry reduction in patients undergoing mitral valve repair?
TEER induces acute reductions in mitral annular dimensions regardless of device or etiology, though the central spacer of the PASCAL P10 system is associated with greater medio-lateral reduction compared to MitraClip.
Mean Difference: 2 (95% CI 0.57–3.44)
p-value: p=0.006
Abstract Aims To evaluate the acute effects of the PASCAL P10 System on mitral annular geometry during transcatheter edge-to-edge repair (TEER) and compare its outcomes with other devices, focusing on changes in mitral annular dimensions. Methods and Results A retrospective analysis was conducted on 295 patients from the VEGA Registry who underwent TEER with MitraClip or PASCAL systems across four international centres between December 2019 and July 2024. Three-dimensional transoesophageal echocardiography was used to assess mitral annular geometry pre- and post-procedure. The overall population (n = 295) experienced a significant reduction in the antero-posterior diameter (1.73 ± 3.17mm; p0.001), medio-lateral diameter (0.88 ± 3.01 mm; p0.001) and annulus area (0.65 ± 1.40 cm 2 ; p0.001). Among the entire cohort, 59 (20%) patients were treated with PASCAL and 236 (80%) patients with MitraClip. The reduction in the mitral annular measures was maintained regardless of the type of implanted device and the underneath etiology of the mitral regurgitation. Multivariate analysis identified the presence of a central spacer in the PASCAL P10 as a predictor of greater mediolateral diameter reduction, with a coefficient of 2.00 mm (95% CI: 0.57–3.44; p=0.006). Conclusions TEER with either MitraClip or induces acute reductions in mitral annular dimensions, suggesting an indirect annuloplasty effect irrespective of regurgitation aetiology. The central spacer of the PASCAL P10 System is associated with greater medio-lateral reduction, potentially enhancing annular reshaping. However, further research is required to explore the long-term durability and clinical relevance of these findings.
Mennuni et al. (Sat,) conducted a cohort in Mitral regurgitation (n=295). PASCAL P10 System vs. MitraClip was evaluated on Medio-lateral diameter reduction (coefficient 2.00 mm, 95% CI 0.57-3.44, p=0.006). The PASCAL P10 System was associated with a greater acute reduction in medio-lateral mitral annular diameter compared to MitraClip (MD 2.00 mm; 95% CI 0.57-3.44; p=0.006).
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