Predictability of post-delivery mitral regurgitation with a new generation transcatheter edge-to-edge device.

Abstract

Background: Ensuring stable MR reduction post-device release is critical for procedural success, as applying a second device may not always be feasible. Incidence of change in residual MR and influencing factors using the PASCAL Precision system have not been evaluated. This study evaluates the intraprocedural incidence of changes in residual mitral regurgitation (MR) after device release during transcatheter edge-to-edge repair (TEER) and potential factors influencing changes in residual MR using the PASCAL Precision system.

Methods: In this multicenter, retrospective analysis of 251 patients (mean age: 77.2 ± 10.8 years, 58.2% male), we assessed the predictability of intraprocedural post-release residual MR. MR grading before and after release as well as MR etiology and presence of complexity characteristics were evaluated in a central core lab in a blinded manner. MR changes were classified as "unchanged," "improved," or "deteriorated" based on pre- to post-release observations.

Results: Procedural success was achieved in 97.2% of cases. Baseline MR was severe (4 +) in 75.7% and moderate to severe (3 +) in 24.3%. After release of the device from the implant catheter, residual MR improved in 13.5% of cases, remained unchanged in 78.5%, and worsened in 8%. Mitral valve mean pressure gradients were stable pre- and post-release (3.0 ± 1.2 vs. 2.9 ± 1.2 mmHg, p = 0.183). MR etiology or presence of complexity criteria did not differ among groups.

Conclusions: M-TEER using the PASCAL Precision system demonstrates stable intraprocedural MR outcomes, with over 90% of cases showing no deterioration from pre- to post-release, irrespective of valve complexity or etiology.