1-Year Outcomes of Transcatheter Tricuspid Valve Repair

• Published in: Journal of the American College of Cardiology 2023-05, Vol.81 (18), p.1766-1776
• Main Authors: 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.
• Format: Article
• Language: English
• Subjects: Aged; Cardiac Catheterization - methods; Female; Heart Failure; Heart Valve Prosthesis Implantation - methods; Humans; Male; PASCAL; Prospective Studies; Quality of Life; Severity of Illness Index; transcatheter tricuspid valve repair; Treatment Outcome; tricuspid regurgitation; Tricuspid Valve - diagnostic imaging; Tricuspid Valve - surgery; Tricuspid Valve Insufficiency
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2023.02.049

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]