Courtesy of Dr. Juan Manuel Pérez.
Mitral transcatheter edge-to-edge repair (M-TEER) is an effective option for patients with severe mitral regurgitation who are at high surgical risk. Currently, there are two approved devices for this procedure: the MitraClip system and the PASCAL system. The latter introduces an innovative design that includes a nitinol spacer and the ability to grasp each mitral leaflet independently and in a controlled manner, which optimizes its use in complex valvular anatomies. However, more evidence is needed regarding its efficacy and safety in a broad population.
The OneForAll study was a prospective, observational, single-center analysis that included 80 consecutive patients with grade 3+ or 4+ mitral regurgitation (MR) treated with the PASCAL system, without restrictions based on valvular anatomy.
The primary endpoint was procedural success, defined as successful implantation with MR reduction to ≤2+ at discharge. Secondary endpoints included correction durability, safety, and need for reintervention at one year.
The mean patient age was 74±3.2 years, and most subjects were men (59%). In general, 67.6% of patients had coronary disease, 63.7% experienced atrial fibrillation, and 87.5% had heart failure.
Regarding MR etiology, it was functional in 45.1% of cases (8.8% atrial and 36.3% ventricular), degenerative in 30%, and mixed in 25%. The mean left ventricular end-diastolic diameter was 53.8±6.4 mm, and the left ventricular ejection fraction (LVEF) was 46.2±10.5%. Complex valvular anatomy was identified in 61.3% of cases, characterized by multiple independent jets (41.3%), commissural jets (26.3%), and calcification in the grasping area (21.3%).
The procedure was successful in 98.8% of cases, achieving MR reduction to ≤2+ in 92.5% of subjects at discharge and in 88.7% at one year. In 60% of procedures, each mitral leaflet was grasped independently, with a median of 4.0±3.1 attempts with the first device and 2.8±1.9 with the second.
The mean procedure time was 91.2±35.3 minutes, while fluoroscopy time averaged 15.1±9.2 minutes. The number of implanted clips per patient was 1.5±0.6. In cases with complex anatomies, the procedure was longer (p=0.002) and required more grasping attempts (p=0.010), without affecting the success rate. There were no valvular injuries, partial detachments, or chordal entrapments documented.
Conclusion
The PASCAL system showed a high success rate (98.8%) and significant MR reduction, with stable results at one year. Its technical features, such as independent leaflet grasping, were more frequently applied in cases with complex anatomies, though there were no differences based on MR etiology. These findings suggest that anatomical complexity is a more relevant factor than etiology in predicting technically challenging M-TEER procedures.
Original Title: Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Valve Repair (OneForAll‐Registry).
Reference: Katharina Hellhammer et al. Catheterization and Cardiovascular Interventions, Volumen 18, 2025.
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