New Research Paper
Structural
Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL: A Multicenter Propensity Score–Matched Comparison

https://doi.org/10.1016/j.jcin.2022.10.028Get rights and content
Under a Creative Commons license
open access

Abstract

Background

Since its introduction in 2003, Abbott’s MitraClip (MC) has become the most established catheter-based treatment for mitral regurgitation (MR). Recent approval of Edwards Lifescience’s PASCAL device has extended the field of TEER.

Objectives

The aim of this retrospective multicenter study was to compare the PASCAL and MC regarding procedural results and short- and long-term outcomes after mitral valve transcatheter edge-to-edge repair (TEER).

Methods

Data from 3 high-volume centers were analyzed. The primary endpoint was residual MR at discharge. Secondary endpoints were technical success, MR reduction, and 30-day mortality. After 1 year, all-cause mortality and residual MR were reported.

Results

A total of 412 patients (216 MC, 196 PASCAL) treated between 2018 and 2020 were included. A total of 184 patients (92 in each treatment group) remained after propensity score matching. The rate of baseline MR ≥3 was 98.9% in both groups (P = 1.00). Both TEER systems achieved equally high technical success rates (97.8%; P = 1.00), resulting in residual MR ≤1 in 69.6% vs 77.1% of patients (P = 0.24) and MR reduction by ≥2 grades in 83.7% vs 92.4% of patients (P = 0.13) using the MC and PASCAL, respectively. Thirty-day mortality was 1.1% in both cohorts (P = 0.98), and 1-year follow-up showed similar MR reductions (residual MR ≤1, 78.0% with MC vs 82.3% with PASCAL; P = 0.70) and comparable all-cause mortality (14.1% with MC vs 6.5% with PASCAL; P = 0.14). In multivariate regression analysis, Society of Thoracic Surgeons score independently correlated with an optimal result (MR ≤1), while device choice did not show a significant impact.

Conclusions

In this retrospective multicenter study, the established MC and the novel PASCAL mitral valve TEER systems were safe and offered excellent performance with comparable short- and long-term outcomes.

Key Words

MitraClip
mitral valve
PASCAL
transcatheter edge-to-edge repair

Abbreviations and Acronyms

DMR
degenerative mitral regurgitation
EROA
effective regurgitation orifice area
EuroSCORE
European System for Cardiac Operative Risk Evaluation
FMR
functional mitral regurgitation
LVEF
left ventricular ejection fraction
MC
MitraClip
MR
mitral regurgitation
MV
mitral valve
STS
Society of Thoracic Surgeons
TEER
transcatheter edge-to-edge repair
VC
vena contracta

Cited by (0)

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.