Abstract 133 Percutaneous mitral valve repair with the new PASCAL system – comparison of early and mid-term results with the MitraClip device

OBJECTIVES

The aim of this study was to assess procedural, short and mid-term safety and efficacy of the new PASCAL system after percutaneous mitral valve repair (PMVr) in comparison with the MitraClip device.

INTRODUCTION

Mitral regurgitation (MR) is the second-most frequent indication for valve surgery in Europe. The MitraClip system (Abbott Vascular Devices, Santa Clara, CA, USA) represents the most widely used device for edge-to-edge PMVr in high surgical risk patients with severe MR. In February 2019 the PASCAL system (Edwards Lifesciences, Irvine, California, USA) received CE approval for treatment of severe functional and degenerative MR, respectively, potentially augmenting the toolkit for PMVr.

METHODS

All patients after third generation MitraClip (NTR/XTR) and all patients after PASCAL system implantation as first PMVr were included in this study and matched using a propensity score algorithm according to clinical, echocardiographical and laboratory features. A cohort of 41 PASCAL patients was compared with 82 MitraClip patients. The primary endpoints assessed were procedural success, residual MR, NYHA functional class and a composite endpoint comprising death, hospitalization and mitral valve re-intervention at short- and 1-year follow-up.

RESULTS

No significant differences in technical, device and procedural success rates were found for the PASCAL and the matched MitraClip cohort. The composite endpoint revealed no statistically significant difference between both devices and the overall MR reduction, as well as improvement in NYHA functional class were comparable.

Interestingly, a significantly higher proportion of PASCAL treated patients showed none or only trace MR at both, short- and 1-year follow-up. Conversely, the rate of aborted device implantations due to an elevated trans-valvular gradient was significantly more frequent in PASCAL interventions.

CONCLUSIONS

The overall procedural, short-term and 1-year results for MitraClip and PASCAL are comparable regarding procedural safety, efficacy, as well as clinical improvement in high-risk patients with severe MR undergoing PMVr.

Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9
Percutaneous mitral valve repair with the new PASCAL system – comparison of early and mid-term results with the MitraClip device
P. Crespo López¹, P. Schlegel¹, M. Heckmann¹, H. A. Katus¹, N. Frey¹, P. Raake¹, N. A. Geis¹
¹Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie, Universitätsklinikum Heidelberg, Heidelberg;
OBJECTIVES The aim of this study was to assess procedural, short and mid-term safety and efficacy of the new PASCAL system after percutaneous mitral valve repair (PMVr) in comparison with the MitraClip device. INTRODUCTION Mitral regurgitation (MR) is the second-most frequent indication for valve surgery in Europe. The MitraClip system (Abbott Vascular Devices, Santa Clara, CA, USA) represents the most widely used device for edge-to-edge PMVr in high surgical risk patients with severe MR. In February 2019 the PASCAL system (Edwards Lifesciences, Irvine, California, USA) received CE approval for treatment of severe functional and degenerative MR, respectively, potentially augmenting the toolkit for PMVr. METHODS All patients after third generation MitraClip (NTR/XTR) and all patients after PASCAL system implantation as first PMVr were included in this study and matched using a propensity score algorithm according to clinical, echocardiographical and laboratory features. A cohort of 41 PASCAL patients was compared with 82 MitraClip patients. The primary endpoints assessed were procedural success, residual MR, NYHA functional class and a composite endpoint comprising death, hospitalization and mitral valve re-intervention at short- and 1-year follow-up. RESULTS No significant differences in technical, device and procedural success rates were found for the PASCAL and the matched MitraClip cohort. The composite endpoint revealed no statistically significant difference between both devices and the overall MR reduction, as well as improvement in NYHA functional class were comparable. Interestingly, a significantly higher proportion of PASCAL treated patients showed none or only trace MR at both, short- and 1-year follow-up. Conversely, the rate of aborted device implantations due to an elevated trans-valvular gradient was significantly more frequent in PASCAL interventions. CONCLUSIONS The overall procedural, short-term and 1-year results for MitraClip and PASCAL are comparable regarding procedural safety, efficacy, as well as clinical improvement in high-risk patients with severe MR undergoing PMVr.
https://dgk.org/kongress_programme/ht2021/P511.htm