Background: Mitral transcatheter edge-to-edge repair (M-TEER) is an established treatment for functional mitral regurgitation (FMR) associated with a risk of generating stenosis. Unlike the MitraClip platform, the PASCAL device platform features two distinct devices (Ace and P10) with a central spacer. The impact of the broader P10 device and its larger central spacer on mitral valve orifice area (MVOA) reduction during M-TEER is unclear.  

Methods: Consecutive patients undergoing successful M-TEER for treatment of severe (grade III/IV) FMR between October 2019 and April 2023 at our center were screened. Patients with a single device implantation within the central segments (A2-P2) of the mitral valve leaflets were enrolled. 3D multiplanar reconstruction (MPR) of intraprocedural transesophageal images was used to compare MVOA reduction with direct planimetry. Implantation of a P10 or Ace was within the operator’s discretion. Use of the P10 or Ace did not follow a prespecified preprocedural MVOA threshold. 

Results: Overall 51 patients with FMR (median age: 81.0 years IQR {74.0-85.0}, female: 56.9%) were included. 25 (49%) patients received a P10 device, whereas 26 (51%) had the PASCAL Ace device implanted. Body surface area (1.8±0.2 vs. 1.8±0.4m², p=0.39), body mass index (26.2±4.7 vs. 25.7±5.0, p=0.68) and MVOAs before device implantation were similar (5.3±1.4 vs. 5.0±1.2cm², p=0.43). Relative MVOA reduction was significantly greater in patients treated with the Pascal Ace (-55.3±7.4 vs. -45.4±8.4%, p<0.01). The remaining MVOA tended to be smaller in these patients (2.4±0.7 vs. 2.6±0.8, p=0.09). MV mean pressure gradients (mPG) were similar before (1.6±0.8 vs. 1.5±0.6 mmHg, p=0.46) and after device implantation (3.3±1.1 vs. 3.0±1.1, p=0.45) between these patient groups. 

Conclusion: Use of the PASCAL Ace device leads to significantly greater MVOA reduction compared to the P10. A randomized-controlled trial is warranted to confirm this effect.