Key result
PASCAL ACE matches standard PASCAL in mitral valve orifice area reduction and procedural success.
Why the study?
Comparative data on 3D mitral valve remodeling and procedural outcomes between PASCAL and PASCAL ACE devices for TEER in mitral regurgitation are limited.
Does TEER with the PASCAL ACE device compared to the PASCAL device improve 3D mitral valve remodeling and procedural outcomes in patients with moderate-to-severe or severe mitral regurgitation?
Cohort (n=366)
No
Does TEER with the PASCAL ACE device compared to the PASCAL device improve 3D mitral valve remodeling and procedural outcomes in patients with moderate-to-severe or severe mitral regurgitation?
In real-world TEER, post-procedural mitral valve orifice area is dictated by baseline valve anatomy rather than device configuration (PASCAL vs PASCAL ACE), supporting anatomy-guided device selection.
Comparable remodeling and success with PASCAL ACE in complex anatomies; leaves open need for randomized trials to guide device choice.
Background The PASCAL® transcatheter edge-to-edge repair system (TEER) is established for mitral regurgitation (MR), with the ACE iteration tailored for complex anatomies. Comparative data are limited. Aims To compare 3D mitral valve remodeling and procedural outcomes in patients undergoing TEER with PASCAL or PASCAL ACE device at a high-volume tertiary center. Methods This retrospective, single-center study included 366 consecutive patients (mean age 77.7 ± 10.2 years; 57.9% male) with moderate-to-severe or severe MR treated between 2019 and 2024. Patients were stratified by device (ACE, n = 128, PASCAL, n = 238). Procedural outcomes and 3D echocardiographic remodeling were evaluated. Results ACE-treated patients had more complex mitral anatomies and larger baseline mitral valve orifice areas (3D-MVOA, 6.55 [5.74–7.96] vs. 5.87 [4.86–7.38] cm 2 ; p = 0.001). Relative reduction in 3D-MVOA following the first device was similar between groups (ACE − 44.5 ± 6.55% vs. PASCAL − 45.9 ± 6.61%; p = 0.066) and consistent across functional, degenerative, and mixed MR subgroups (all p > 0.05). ACE cases had a modestly smaller mean pressure gradient increase (+ 1[0–1] vs. + 1[1, 2] mmHg, p = 0.046), likely reflecting larger residual MVOAs (3.81 ± 1.11 vs. 3.38 ± 1.07 cm 2 ; p < 0.001). Post-procedural annular remodeling by annular sphericity index was comparable (ACE 0.67 ± 0.09 vs. PASCAL 0.69 ± 0.09; p = 0.119). Both devices achieved similarly high procedural success (ACE 100% vs. PASCAL 99.6%, p = 1.00) with no procedural complications. Conclusions In this real-world cohort, the ACE device was preferentially used in more complex mitral anatomies. Post-procedural MVOA was dictated by baseline valve anatomy rather than device configuration, with comparable relative MVOA reduction, annular remodeling, and procedural success, advocating for an anatomy-guided device selection.
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Abusharekh et al. (2026) conducted a cohort in Moderate-to-severe or severe mitral regurgitation (n=366). PASCAL ACE device vs. PASCAL device was evaluated on Relative reduction in 3D mitral valve orifice area (3D-MVOA) following the first device (p=0.066). The PASCAL ACE device achieved a comparable relative reduction in mitral valve orifice area (-44.5% vs -45.9%) and procedural success (100% vs 99.6%) compared to the PASCAL device.
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