PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis

Clin Res Cardiol. 2021 Mar;110(3):451-459. doi: 10.1007/s00392-020-01784-w. Epub 2020 Dec 12.


Background: Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). Data comparing the performance of novel edge-to-edge devices (PASCAL and MitraClip-XTR) are scarce.

Methods: We identified 80 consecutive patients who underwent TTVR using either the PASCAL or MitraClip-XTR system to treat symptomatic TR from July 2018 to June 2020. To adjust for baseline imbalances, we performed a propensity score (PS) 1:1 matching. The primary endpoint was a reduction in TR severity by at least one grade at 30 days.

Results: The PS-matched cohort (n = 44) was at high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR) 4.8-12.1%]) with a mean TR grade of 4.3 ± 0.8 and median coaptation gap of 6.2 mm [IQR 3.2-9.1 mm]. The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99). No periprocedural death or conversions to surgery occurred, and 30-day mortality (5.0% vs. 5.0%, log-rank p = 0.99) and 3-month mortality (10.0% vs. 5.0%, log-rank p = 0.56) were similar between both groups. During follow-up, functional NYHA class, 6-min walking distance, and health status improved in both groups.

Conclusions: Both TTVR devices, PASCAL and MitraClip-XTR, appeared feasible and comparable for an effective TR reduction. Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system.

Keywords: Edge-to-edge; MitraClip; PASCAL; Propensity score matching; Transcathether; Tricuspid regurgitation.

MeSH terms

  • Aged
  • Cardiac Catheterization / instrumentation*
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Humans
  • Male
  • Propensity Score*
  • Prospective Studies
  • Recovery of Function
  • Time Factors
  • Treatment Outcome
  • Tricuspid Valve Insufficiency / diagnosis
  • Tricuspid Valve Insufficiency / physiopathology
  • Tricuspid Valve Insufficiency / surgery*