1-Year Outcomes of Transcatheter Tricuspid Valve Repair

• DOI: 10.1016/j.jacc.2023.02.049
• Publication Date: 2023-05-01T17:59:22Z
• Authors: Susheel K. Kodali; Rebecca T. Hahn; Charles J. Davidson; Akhil Narang; Adam Greenbaum; Patrick Gleason; Samir Kapadia; Rhonda Miyasaka; Firas Zahr; Scott Chadderdon; Robert L. Smith; Paul Grayburn; Robert M. Kipperman; Leo Marcoff; Brian Whisenant; Mike Gonzales; Raj Makkar; Moody Makar; William O’Neill; Dee Dee Wang; William A. Gray; Sandra Abramson; James Hermiller; Lucas Mitchel; D. Scott Lim; Dale Fowler; Mathew Williams; Sorin V. Pislaru; Abdellaziz Dahou; Michael J. Mack; Martin B. Leon; Mackram F. Eleid
• Keywords: Male; Heart Valve Prosthesis Implantation; Heart Failure; Cardiac Catheterization; Severity of Illness Index; Tricuspid Valve Insufficiency; 3. Good health; Treatment Outcome; Quality of Life; Humans; Female; Tricuspid Valve; Prospective Studies; Aged

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).