DOI: 10.1161/jaha.125.052158 ISSN: 2047-9980

PASCAL Precision System Outcomes by Implant Location and Lesion Location in Degenerative Mitral Regurgitation Patients From the STS/ACC TVT Registry

P. Kasi Ramanathan, Raj Makkar, Thomas Waggoner, Azeem Latib, Robert M. Kipperman, Ivan Hanson, Anjan K. Sinha, Tarun Chakravarty, Rahul P. Sharma, Jeremiah P. Depta, Jorge A. Castellanos, Susheel Kodali, Amar Krishnaswamy, Brian Whisenant, Daniel Menees, D. Scott Lim, Fahad Gilani, Carlos E. Sanchez, Neil Gheewala, Santiago Garcia, Hemal Gada, Samir Kapadia, Pinak B. Shah, Brian Renard, Gus Theodos, Ricardo Yaryura, Blake Gardner, Daniel H. Steinberg, Eric Gnall, Georges Kaddissi, Adnan K. Chhatriwalla, Antonio H. Frangieh, Mackram F. Eleid, Philippe Géneréux, John T. Saxon, Pedro Villablanca, Fadi Matar, Himanshu Agarwal, Stanley Chetcuti, Tiberio Frisoli, Firas Zahr
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Background

Mitral valve transcatheter edge‐to‐edge repair can be more challenging in noncentral regions of the valve and in anterior or bileaflet lesions. We assess effect of implant location and leaflet lesion location on safety and effectiveness of PASCAL Precision system in degenerative mitral regurgitation (MR).

Methods

Mitral valve transcatheter edge‐to‐edge repair outcomes in patients with degenerative MR treated with PASCAL Precision system (September 2022–October 2024), from the US STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry, were analyzed by implant location (A2P2/non‐A2P2) and leaflet lesion location (anterior/posterior/bileaflet). Procedural, clinical, and echocardiographic outcomes to 30 days were assessed.

Results

At 30 days, both A2P2 (n=1526) and non‐A2P2 (n=299) groups had low event rates (cardiovascular mortality: 1.1% versus 1.0%, mitral valve reintervention: 0.4% versus 0.0% and single leaflet device attachment: 0.5% versus 0.3%; all P >0.05) and demonstrated significant MR reduction ( P <0.001 versus baseline) with no significant difference between groups ( P =0.750) (MR ≤2+: 93.4% versus 95.4%; MR ≤1+: 72.0% versus 73.3%). Kansas City Cardiomyopathy Questionnaire Overall Summary scores improved significantly in both groups (∆19.3, ∆17.7 points; P =0.741). The anterior (n=250), posterior (n=902), and bileaflet (n=192) disease groups also had low event rates (cardiovascular mortality: 0.4%, 1.1%, 0.0%; mitral valve reintervention: 0.8%, 0.1%, 0.5%; and single leaflet device attachment: 0.8%, 0.2%, 0.5%; all P >0.05), and demonstrated significant MR reduction ( P <0.001 versus baseline) with no significant difference across groups ( P =0.459) (MR ≤2+: 94.1%, 93.1%, and 94.5%; MR ≤1+: 79.0%, 69.2%, and 72.4%). All groups experienced significant improvement in Kansas City Cardiomyopathy Questionnaire Overall Summary scores (∆21.4, ∆18.8, ∆12.0 points; P =0.087).

Conclusion

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.

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