In real-world patients with degenerative mitral regurgitation, treatment with the PASCAL Precision system was associated with favorable safety and effectiveness at 30 days, regardless of implant location or leaflet lesion location.
Thirty-day safety event rates were low and not significantly different between A2P2 and non-A2P2 implant location groups.
MR was significantly reduced from baseline at 30 days in both implant location groups, with no significant difference between groups.
KCCQ Overall Summary scores improved significantly in both implant location groups, with similar improvement.
Thirty-day safety event rates were low and not significantly different across anterior, posterior, and bileaflet lesion groups.
MR reduction at 30 days was significant in all lesion location groups, with no significant difference across groups.
KCCQ Overall Summary scores improved significantly in all lesion location groups, with no significant difference in improvement between groups.
Most patients were treated in the central A2P2 location, and posterior lesions were the most common lesion type.
This study used data from a large US registry to look at patients with degenerative mitral regurgitation (a leaky mitral valve caused by wear or damage to the valve itself) who were treated with the PASCAL Precision device, a catheter-based clip that repairs the valve without open-heart surgery. Repair can be harder when the clip is placed away from the center of the valve, or when the damaged part involves the front leaflet or both leaflets. The researchers compared outcomes by where the clip was placed (central A2P2 versus other locations) and by where the valve problem was (anterior, posterior, or bileaflet) over the first 30 days. In all groups, serious events were uncommon. Death from cardiovascular causes was around 1%, and repeat valve procedures or a clip attaching to only one leaflet were rare, with no significant differences between groups. Leakage dropped significantly in every group, with about 93-95% of patients reaching mild or lower leakage (2+ or less), and quality-of-life scores (KCCQ) improved meaningfully in all groups. Differences between groups were not statistically significant. This research suggests that, at 30 days, the PASCAL Precision system performed similarly well in real-world practice regardless of clip location or lesion type, including the more technically challenging situations. The study covers only 30 days of follow-up and is observational, so it cannot speak to longer-term durability or prove that the groups would do equally well in every circumstance.
Ramanathan P, Makkar R, Waggoner T, Latib A, Kipperman R, Hanson I, et al.. (2026). PASCAL Precision System Outcomes by Implant Location and Lesion Location in Degenerative Mitral Regurgitation Patients From the STS/ACC TVT Registry.. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.125.052158