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Multicenter Study
. 2025 Aug 25;18(16):2036-2046.
doi: 10.1016/j.jcin.2025.07.019.

Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data

Thomas Waggoner  1 , Santiago Garcia  2 , Tarun Chakravarty  3 , Moody Makar  3 , Azeem Latib  4 , Robert M Kipperman  5 , Firas Zahr  6 , Ivan Hanson  7 , Anjan K Sinha  8 , Rahul P Sharma  9 , Jeremiah P Depta  10 , Jorge A Castellanos  11 , Susheel Kodali  12 , Amar Krishnaswamy  13 , Brian Whisenant  14 , Daniel Menees  15 , D Scott Lim  16 , Fahad Gilani  17 , Carlos E Sanchez  18 , Neil Gheewala  19 , Hemal Gada  20 , Samir Kapadia  21 , P Kasi Ramanathan  22 , Pinak B Shah  23 , Brian Renard  24 , Gus Theodos  25 , Ricardo Yaryura  26 , Blake Gardner  27 , Daniel H Steinberg  28 , Eric Gnall  29 , Georges Kaddissi  30 , Adnan K Chhatriwalla  31 , Antonio H Frangieh  32 , Mackram F Eleid  33 , Philippe Géneréux  34 , John T Saxon  16 , Pedro Villablanca  35 , Fadi Matar  36 , Himanshu Agarwal  37 , Stanley Chetcuti  15 , Tiberio Frisoli  35 , Raj Makkar  3
Affiliations
Multicenter Study

Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data

Thomas Waggoner et al. JACC Cardiovasc Interv. .

Abstract

Background: The PASCAL Precision transcatheter valve repair system provides a new option for treating prohibitive surgical risk patients with significant, symptomatic degenerative mitral regurgitation (DMR).

Objectives: The authors report early U.S. commercial experience with the PASCAL Precision system.

Methods: Patients with DMR treated with the PASCAL Precision system in the United States were analyzed from the STS/ACC TVT Registry. Procedural, clinical, echocardiographic, functional, and quality-of-life outcomes to 30 days were assessed. All outcomes, including echocardiographic assessments, were site-assessed.

Results: In 1,995 DMR patients, the median age was 81.6 years, and 57.0% were male. Median STS-PROM for mitral valve repair was 3.6%, and 69.4% were in NYHA functional class III/IV. Mixed etiology (DMR + other etiology) was present in 11.4%, and 66.9% had complex anatomy (annular/leaflet calcification, mitral valve area <4 cm2, bileaflet flail/prolapse/tethering, or mitral stenosis). The device was successfully implanted in 97.7%. MR reduction was significant at 30 days with 94.2% achieving ≤moderate MR and 72.6% ≤mild MR (P < 0.001 vs baseline). Patients experienced significant functional and quality-of-life improvements with a mean 21.0-point increase in Kansas City Cardiomyopathy Questionnaire score and 84.6% in NYHA functional class I/II (all P < 0.001). Mitral valve reintervention and single-leaflet device attachment rates were 0.4% and 0.5%, respectively, and all-cause mortality, cardiovascular mortality, and heart failure readmission rates were 2.2%, 1.2%, and 2.6%, respectively, at 30 days.

Conclusions: Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.

Keywords: DMR; M-TEER; PASCAL system; degenerative mitral regurgitation; mitral valve transcatheter edge-to-edge repair.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Waggoner serves as a consultant, serves on the Speakers Bureau, and receives educational grants and research grants from Abbott Vascular, Alta 4C Medical, Bolt Medical, Boston Scientific, Edwards Life Sciences, GE, HighLife J&J MedTech, Medtronic, Philipps, Shockwave Medical. Dr Garcia is a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, Anteris, Capstan Medical and B. Braun; is a proctor for Edwards Lifesciences and Abbott Vascular; serves on the advisory board for Medtronic, Capstan Medical and Boston Scientific; and has stock options for Capstan Medical. Dr Chakravarty is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, NeoChord, Shifamed, and Philips. Dr Zahr is a consultant for and receives research and educational grants from Edwards Lifesciences and Medtronic. Dr Sharma has served as a consultant and advisor for Edwards Lifesciences, Boston Scientific, Abbott, Philips, Siemens, and egnite, Inc. Dr Castellanos is a consultant and proctor for Edward Lifesciences and Abbott; and receives research grants from Edwards Lifesciences, Abbott and Ancora Heart. Dr Kodali receives consulting fees or honoraria from Anteris, Dura Biotech, Shifamed, Tricares, Phillips, Nyra Medical, and Helix Valve Repair; receives grant or research support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and JenaValve; and has equity in Thubrikar Aortic Valve Inc, Dura Biotech, MID, Supira, TriFlo, Adona, Tioga, Moray Medical, Cardiomech, and X-Dot. Dr Whisenant has served as a consultant for Edwards Lifesciences and Abbott. Dr Lim has served as a consultant for Laguna Tech, Nyra Medical, Opus Medical, Philips, Venus, and Valgen; and has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Trisol. Dr Gada has served as a consultant for Medtronic, Boston Scientific, Abbott, and Becton Dickinson. Dr Ramanathan serves as a consultant and speaker for Medtronic; and is the CMO with equity in ValCor. Dr Shah has received grant support, consulting, and/or proctoring fees from Edwards Lifesciences. Dr Theodos has served as consultant for Edwards Lifesciences, Boston Scientific, and Asahi; and has served on the advisory board and as proctor for Boston Scientific. Dr Chhatriwalla has served on the Speakers Bureau and has been a consultant for Abbott Vascular, Edwards Lifesciences, and Medtronic. He receives research funding from Boston Scientific and serves as a clinical events committee member for Abiomed. Dr Frangieh has served as a consultant and received educational grant support from Edwards Lifesciences. Dr Généreux has served as a consultant Abbott Vascular, Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, GE Healthcare, iRhythm Technologies, OpSens, Siemens, and Teleflex, Cardiovascular System Inc, Pi-Cardia, Puzzle Medical, Saranas, Soundbite Medical Inc, Shockwave, 4C Medical, and egnite, Inc; has served as an advisor for Abbott Vascular, Abiomed, Edwards Lifesciences, Medtronic, and egnite, Inc; has received speaker fees from Abbott Vascular, Abiomed, Edwards Lifesciences, Shockwave, and Medtronic; has served as a proctor for Edwards Lifesciences; has served as a PI of the Eclipse Trial for Cardiovascular System Inc, the EARLY-TAVR and PROGRESS trials for Edwards Lifesciences, and the ALTA Valve feasibility study for 4C Medical; has received research grants from Edwards Lifesciences; and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc. Dr Chetcuti has served as a consultant for Edwards Lifesciences, MDT, Abbott, and Emstop. Dr Makkar is a consultant and receives research grants from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, and Protembo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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