Background
Transcatheter edge-to-edge repair (TEER) of the
mitral valve has emerged as standard treatment in selected patients
with clinically relevant mitral regurgitation (MR) and increased surgical risk.
We aimed to compare the current two available TEER systems, the MitraClip with
the PASCAL repair system in terms of their effectiveness and safety.
Methods
This
pseudo-randomised prospective study enrolled 214 patients who were treated with
TEER at the University Hospital Düsseldorf between June 2019 and August 2021.
The type of device system used was not randomized but was determined by the
operational structuring of our mitral valve program such that patients were
scheduled for the next available implantation date with weekly alternating time
slots for MitraClip and PASCAL
Results
From
June 2019 to August 2021, 112 patients were treated using the MitraClip system
and 102 patients were treated using the PASCAL repair system. Both groups were
comparable in baseline characteristics and comorbidities. Functional MR was more common than degenerative
MR (72% in the MitraClip group, 71% in the PASCAL group (p= 0.9501). The
procedural safety and efficacy were high and comparable in both groups. Successful
device implantation was established in 98 out of 102 patients (96%) in the
MitraClip group, and in 110 out of 112 patients (98%) in the MitraClip group
(p= 0.3445). One month after TEER, 84 out of 112 patients in the MitraClip
group (75%), and 78 out of 101 patients in the PASCAL group (77%) had mild MR
or less (each p< 0.0001 compared to baseline and p = 0.5964 between groups).
In both groups, New York Heart Association (NYHA) functional class improved in the
vast majority of patients. NYHA functional Class III or worse was present in 15
out of 111 patients (14%) in the MitraClip group, and in 22 out of 101 patients
(22%) in the PASCAL group (each p< 0.0001 compared with baseline, p= 0.369
between the groups).
Conclusion
Both
systems, the MitraClip and the Pascal repair system were comparable safe and
effective for the treatment of severe MR.