Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Valve Repair (OneForAll-Registry).

Abstract

Background: Mitral valve transcatheter edge-to-edge repair (M-TEER) is increasingly applied in patients with high surgical risk. We aimed to evaluate whether the PASCAL system can be applied in an all-comers cohort irrespective of the underlying anatomy and whether technical features influence therapeutic success.

Methods: In this prospective, observational study we enrolled consecutive patients (n = 80) with mitral regurgitation (MR) 3+ and 4+ scheduled for M-TEER. All patients were allocated to be treated with the PASCAL system irrespective of the underlying anatomy. Complexity of mitral valve anatomy was assessed according to the proposed complexity scale and the ESC/EACTS complexity scale. All patients underwent intraprocedural analysis of application of technical features of the PASCAL technology and 1-year follow-up.

Results: M-TEER was successful in 98.8% of the patients. Reduction of MR 3+/4+ to MR≤ 2+ was achieved in 92.5%. Independent leaflet grasping was applied in 60.0% of procedures. The median number of grasping attempts was 4.0 ± 3.1 for the first device. Classification in degenerative, functional, or mixed MR did not correlate with procedure time and grasping attempts. In contrast, the presence of complexity criteria was linked with a longer procedure time (p = 0.002) and required more grasping attempts (p = 0.010).

Conclusions: M-TEER with the PASCAL technology was possible in 98.8% of consecutive, all-comers patients irrespective of the underlying anatomy. Technical features were applied frequently with increasing application in complex anatomical cases. Classifications taking the anatomical complexity into account rather than the pathophysiological entity of MR seem superior to predict the technical challenges of a M-TEER procedure.