Three-dimensional mitral valve geometry after transcatheter edge-to-edge repair: PASCAL versus PASCAL-ACE-implications for devices selection.

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] cm2; 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 cm2; 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.