Prospective analysis of the feasibility of the PASCAL spacer technology for transcatheter mitral valve repair in an all-comers cohort (OneForAll-registry)  

Katharina Hellhammer (Essen)1, F. Schindhelm (Essen)1, M. Riebisch (Essen)1, L. Michel (Essen)1, S. Wernhart (Essen)1, A.-A. Mahabadi (Essen)1, T. Rassaf (Essen)1, P. Lüdike (Essen)1

1Universitätsklinikum Essen Klinik für Kardiologie und Angiologie Essen, Deutschland



Background: Transcatheter edge-to-edge repair (TEER) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. The 2019 introduced Pascal technology represents a novel concept and is characterized by a central spacer as compared to the established MitraClilp TEER system. Since anatomical limitations for TEER are similar for both MitraClip and Pascal it is unclear whether the spacer technology can be applied irrespective of the underlying anatomy and if technical features influence therapeutic success. (NCT04473092).


Methods: In this prospective, single-arm, observational, study we enrolled consecutive patients (n=80) with MR 3+ and 4+ scheduled for TEER after interdisciplinary heart team consensus at the West German Heart and Vascular Center (WHGZ) after October 2020. All patients were allocated to be treated with the Pascal System irrespective of the underlying anatomy unless the patients explicitly claimed to be treated with the Mitraclip System. All patients underwent intraprocedural analysis of application of technical features of the Pascal technology (independent grasping, leaflet optimization) and complications like Leaflet injury, single leaflet device attachement (SLDA) or chordal entrapment and final 1 year follow-up.


Results: From 10/2020 to 08/2021 eighty patiens were included in the study. 5 patients claimed to be treated with the Mitraclip technology. TEER was successful in 98.8 % of the patients. In n=1 patient, TEER was aborted due to an increased intraprocedural gradient >8 mmHg. Mean age was 74 years, 59 % were male. Reduction of MR 3+/4+ to MR <2+ was achieved in 92.3 % at discharge and 88.7 % after one year. Independent leaflet grasping was applied in 60.0 % of cases. The median number of grasping attemps was 4±3.1 for the 1st device, and 2.8±1.9 for the 2nd device. Leaflet optimization was performed in 60.0 % of cases for the 1st device, and 13.8% of the cases for the 2nd device. No cases with leaflet injury, SLDA or chordal entrapment were documented. While classification in degenerative MR, functional MR or mixed MR did neither correlate with complexity of procedure as illustrated by grasping attempts nor procedure length, classification according to the proposed Hausleiter-complexity scale or the ESC/EACTS complexity scale were statistically associated with procedural factors (grasping attemps (p=0.010; p=0.014), procedure time (p=0.002; p=0.005)).


Conclusion: TEER with the Pascal technology was possible in 98.8% of consecutive, unselected patients irrespective of the underlying anatomy. Technical features like independent grasping or leaflet optimization were applied frequently with increasing application in complex anatomical cases. Classifications taking the anatomical complexity into account ratheter than the pathophysiological entitiy of MR seem superior to predict the technical challenges of a TEER procedure.

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