1-Year Outcomes of Transcatheter Tricuspid Valve Repair
Recommended Citation
Kodali SK, Hahn RT, Davidson CJ, Narang A, Greenbaum A, Gleason P, Kapadia S, Miyasaka R, Zahr F, Chadderdon S, Smith RL, Grayburn P, Kipperman RM, Marcoff L, Whisenant B, Gonzales M, Makkar R, Makar M, O'Neill W, Wang DD, Gray WA, Abramson S, Hermiller J, Mitchel L, Lim DS, Fowler D, Williams M, Pislaru SV, Dahou A, Mack MJ, Leon MB, and Eleid MF. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol 2023; 81(18):1766-1776.
Document Type
Article
Publication Date
5-9-2023
Publication Title
Journal of the American College of Cardiology
Keywords
Humans, Female, Aged, Male, Tricuspid Valve Insufficiency, Tricuspid Valve, Heart Valve Prosthesis Implantation, Prospective Studies, Quality of Life, Treatment Outcome, Cardiac Catheterization, Heart Failure, Severity of Illness Index
Abstract
BACKGROUND: 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.
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
Medical Subject Headings
Humans; Female; Aged; Male; Tricuspid Valve Insufficiency; Tricuspid Valve; Heart Valve Prosthesis Implantation; Prospective Studies; Quality of Life; Treatment Outcome; Cardiac Catheterization; Heart Failure; Severity of Illness Index
PubMed ID
37137586
Volume
81
Issue
18
First Page
1766
Last Page
1776
Comments
(Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313).