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  • 1-Year Outcomes of Transcat...
    Kodali, Susheel K.; Hahn, Rebecca T.; Davidson, Charles J.; Narang, Akhil; Greenbaum, Adam; Gleason, Patrick; Kapadia, Samir; Miyasaka, Rhonda; Zahr, Firas; Chadderdon, Scott; Smith, Robert L.; Grayburn, Paul; Kipperman, Robert M.; Marcoff, Leo; Whisenant, Brian; Gonzales, Mike; Makkar, Raj; Makar, Moody; O’Neill, William; Wang, Dee Dee; Gray, William A.; Abramson, Sandra; Hermiller, James; Mitchel, Lucas; Lim, D. Scott; Fowler, Dale; Williams, Mathew; Pislaru, Sorin V.; Dahou, Abdellaziz; Mack, Michael J.; Leon, Martin B.; Eleid, Mackram F.

    Journal of the American College of Cardiology, 05/2023, Volume: 81, Issue: 18
    Journal Article

    Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study CLASP TR EFS; NCT03745313) Display omitted