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Peer-reviewedCC BY-NCJournal of the American Heart Association

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

29 more authors
34 affiliations
  1. 1Promedica Toledo Hospital
  2. 2Cedars‐Sinai Medical Center
  3. 3US Heart & Vascular Tucson Medical Center
  4. 4Montefiore Medical Center
  5. 5Atlantic Health System Morristown Medical Center
  6. 6William Beaumont University Hospital
  7. 7Indiana University
  8. 8Stanford University
  9. 9Rochester Regional Health
  10. 10Our Lady of the Lake Regional Medical Center
  11. 11Columbia University Medical Center
  12. 12Cleveland Clinic Foundation
  13. 13Intermountain Medical Center
  14. 14University of Michigan
  15. 15University of Virginia Health System Hospital
  16. 16Catholic Medical Center
  17. 17Riverside Methodist Hospital, Ohio Health
  18. 18Pima Heart & Vascular
  19. 19The Christ Hospital
  20. 20UPMC Pinnacle
  21. 21Brigham and Women's Hospital
  22. 22Missouri Baptist Medical Center
  23. 23Sarasota Memorial Hospital
  24. 24Intermountain Saint George Regional Hospital
  25. 25Medical University of South Carolina
  26. 26Lankenau Medical Center
  27. 27University Hospital
  28. 28Saint Luke's Mid America Heart Institute University of Missouri‐Kansas City
  29. 29University of California Irvine
  30. 30Mayo Clinic
  31. 31Henry Ford Health System
  32. 32Tampa General Hospital
  33. 33Creighton University School of Medicine
  34. 34Oregon Health & Science University

Abstract

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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BibTeX
@article{ramanathan2026pascal,
  title = {{PASCAL Precision System Outcomes by Implant Location and Lesion Location in Degenerative Mitral Regurgitation Patients From the STS/ACC TVT Registry}},
  author = {P. Kasi Ramanathan and Raj Makkar and Thomas Waggoner and Azeem Latib and Robert M. Kipperman and Ivan Hanson and Anjan K. Sinha and Tarun Chakravarty and Rahul P. Sharma and Jeremiah P. Depta and Jorge A. Castellanos and Susheel Kodali and Amar Krishnaswamy and Brian Whisenant and Daniel Menees and D. Scott Lim and Fahad Gilani and Carlos E. Sanchez and Neil Gheewala and Santiago Garcia and Hemal Gada and Samir Kapadia and Pinak B. Shah and Brian Renard and Gus Theodos and Ricardo Yaryura and Blake Gardner and Daniel H. Steinberg and Eric Gnall and Georges Kaddissi and Adnan K. Chhatriwalla and Antonio H. Frangieh and Mackram F. Eleid and Philippe Géneréux and John T. Saxon and Pedro Villablanca and Fadi Matar and Himanshu Agarwal and Stanley Chetcuti and Tiberio Frisoli and Firas Zahr},
  journal = {Journal of the American Heart Association},
  year = {2026},
  month = oct,
  doi = {10.1161/jaha.125.052158},
  url = {https://www.ahajournals.org/doi/10.1161/JAHA.125.052158},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - PASCAL Precision System Outcomes by Implant Location and Lesion Location in Degenerative Mitral Regurgitation Patients From the STS/ACC TVT Registry
AU  - P. Kasi Ramanathan
AU  - Raj Makkar
AU  - Thomas Waggoner
AU  - Azeem Latib
AU  - Robert M. Kipperman
AU  - Ivan Hanson
AU  - Anjan K. Sinha
AU  - Tarun Chakravarty
AU  - Rahul P. Sharma
AU  - Jeremiah P. Depta
AU  - Jorge A. Castellanos
AU  - Susheel Kodali
AU  - Amar Krishnaswamy
AU  - Brian Whisenant
AU  - Daniel Menees
AU  - D. Scott Lim
AU  - Fahad Gilani
AU  - Carlos E. Sanchez
AU  - Neil Gheewala
AU  - Santiago Garcia
AU  - Hemal Gada
AU  - Samir Kapadia
AU  - Pinak B. Shah
AU  - Brian Renard
AU  - Gus Theodos
AU  - Ricardo Yaryura
AU  - Blake Gardner
AU  - Daniel H. Steinberg
AU  - Eric Gnall
AU  - Georges Kaddissi
AU  - Adnan K. Chhatriwalla
AU  - Antonio H. Frangieh
AU  - Mackram F. Eleid
AU  - Philippe Géneréux
AU  - John T. Saxon
AU  - Pedro Villablanca
AU  - Fadi Matar
AU  - Himanshu Agarwal
AU  - Stanley Chetcuti
AU  - Tiberio Frisoli
AU  - Firas Zahr
PY  - 2026
DA  - 2026/10/23
JO  - Journal of the American Heart Association
DO  - 10.1161/jaha.125.052158
UR  - https://www.ahajournals.org/doi/10.1161/JAHA.125.052158
AB  - 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.
SN  - 2047-9980
ER  -