Cardiovascular

Transcatheter Edge-to-Edge Repair With MitraClip G4 System Compared With PASCAL System in Patients With Functional Mitral Regurgitation: A Propensity Score-Matched Analysis.

TL;DR

In patients with functional mitral regurgitation, MitraClip G4 and PASCAL demonstrated similarly high procedural success, durable MR reduction, and comparable clinical outcomes at 1 year.

Key Findings

Procedural success rates were nearly identical between MitraClip G4 and PASCAL systems in patients with functional mitral regurgitation.

  • Procedural success was defined as MR grade ≤2
  • Success achieved in 98.1% of MitraClip G4 group versus 97.3% of PASCAL group
  • Difference was not statistically significant (P=0.61)
  • Analysis performed after propensity score matching of 116 matched pairs

One-year survival was comparable between patients treated with MitraClip G4 and those treated with PASCAL.

  • Estimated 1-year survival was 86.7% for MitraClip G4 and 87.8% for PASCAL
  • Difference was not statistically significant (P=0.84)
  • Analysis based on propensity score-matched cohort of 116 pairs
  • Patients were consecutive cases treated between 2021 and 2023 at a single center

Freedom from heart failure hospitalization at 1 year did not differ significantly between the two transcatheter edge-to-edge repair systems.

  • No significant difference in freedom from heart failure hospitalization between groups (P=0.41)
  • Freedom from heart failure hospitalization was a coprimary end point along with 1-year survival
  • Comparison made after propensity score matching to adjust for baseline differences

Residual mitral regurgitation at 1 year was similar between MitraClip G4 and PASCAL groups.

  • No significant difference in residual MR between groups at 1 year (P=0.83)
  • MR reduction was assessed as a secondary end point
  • Results suggest durable MR reduction with both devices through 1 year of follow-up

New York Heart Association functional class at 1 year was not significantly different between the two device groups.

  • No significant difference in NYHA functional class between MitraClip G4 and PASCAL groups (P=0.41)
  • NYHA class was a secondary end point in the study
  • NYHA class improvement reflects symptomatic benefit from the procedure

The study population consisted of 319 consecutive patients with severe symptomatic functional mitral regurgitation treated at a single center.

  • 150 patients (47.0%) were treated with MitraClip G4 and 169 patients (53.0%) with PASCAL
  • Patients were treated between 2021 and 2023
  • All patients were at high surgical risk
  • Propensity score matching yielded 116 matched pairs for the primary analysis
  • Functional MR resulted from left ventricular dysfunction or left atrial dilation

What This Means

This research suggests that two commonly used minimally invasive heart valve repair devices — MitraClip G4 and PASCAL — produce very similar results when used to treat a condition called functional mitral regurgitation (FMR). FMR occurs when the mitral valve leaks blood backward due to heart muscle weakness or an enlarged heart chamber. Both devices use a catheter-based approach to clip the leaky valve shut without open-heart surgery, making them options for patients considered too high-risk for traditional surgery. The study followed 319 patients treated at a single hospital over two years and used a statistical technique called propensity score matching to fairly compare 116 patient pairs treated with one device or the other. The findings showed that both devices were highly effective at reducing the valve leak during the procedure (roughly 98% success in both groups), and these improvements held up over one year of follow-up. Survival rates at one year were nearly identical — about 87% in both groups — and rates of rehospitalization for heart failure and symptom improvement were also statistically indistinguishable between the two devices. This research suggests that clinicians and patients can expect similar outcomes from either system, meaning the choice between devices may come down to other factors such as operator experience, specific patient anatomy, or device availability rather than meaningful differences in effectiveness or safety.

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Citation

Ackermann P, de Waha S, Otto W, Rotta Detto Loria J, van Kampen A, Leontyev S, et al.. (2026). Transcatheter Edge-to-Edge Repair With MitraClip G4 System Compared With PASCAL System in Patients With Functional Mitral Regurgitation: A Propensity Score-Matched Analysis.. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.125.044698