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. 2024 Jan 2;83(1):1-13.
doi: 10.1016/j.jacc.2023.10.008. Epub 2023 Oct 26.

Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation

Suzanne V Arnold  1 , Scott Goates  2 , Paul Sorajja  3 , David H Adams  4 , Ralph Stephan von Bardeleben  5 , Samir R Kapadia  6 , David J Cohen  7 ; TRILUMINATE Pivotal Trial Investigators
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Free article

Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation

Suzanne V Arnold et al. J Am Coll Cardiol. .
Free article

Abstract

Background: In the TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal), tricuspid transcatheter edge-to-edge repair (T-TEER) reduced tricuspid regurgitation (TR) and improved health status compared with medical therapy alone with no benefit on heart failure hospitalizations or survival.

Objectives: The purpose of this study was to better understand the health status benefits of T-TEER within the TRILUMINATE Pivotal trial.

Methods: TRILUMINATE randomized patients with severe TR to T-TEER (n = 175) or medical therapy (n = 175). Health status was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) (range 0-100; higher = better), which was compared between treatment groups using mixed effects linear regression. Alive and well was defined as KCCQ overall summary score ≥60 and no decline from baseline of >10 points at 1 year.

Results: Compared with medical therapy, T-TEER significantly improved health status at 1 month (mean between-group difference in KCCQ overall summary score 9.4 points; 95% CI: 5.3-13.4 points), with a small additional improvement at 1 year (mean between-group difference 10.4 points; 95% CI: 6.3-14.6 points). T-TEER patients were more likely to be alive and well at 1 year (T-TEER vs medical therapy: 74.8% vs 45.9%; P < 0.001), with a number needed to treat of 3.5. Interaction analyses demonstrated that the benefit of T-TEER diminished as baseline KCCQ overall summary score increased (Pint < 0.001). Exploratory analyses suggested that much of the health status benefit of T-TEER could be explained by TR reduction and that improvement in health status after T-TEER was strongly correlated with reduced 1-year mortality and heart failure hospitalization.

Conclusions: T-TEER with the TriClip system resulted in substantial and sustained health status improvement in patients with severe TR compared with medical therapy alone.

Keywords: quality of life; transcatheter valve; tricuspid valve regurgitation.

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Conflict of interest statement

Funding Support and Author Disclosures The TRILUMINATE Pivotal trial was sponsored by Abbott and designed collaboratively by the principal investigators and the sponsor. The present analysis was conducted by Abbott under the direction of the academic authors. Dr Goates is an employee of Abbott. Dr Sorajja has performed unpaid trial activity with Abbott and HighLife; and has received consulting fees from 4C Medical, Abbott Structural, Biosense Webster, Boston Scientific, Edwards Lifesciences, Foldax, Medtronic, Phillips, Shifamed, Siemens, VDyne, and WL Gore. Dr Adams has performed unpaid trial activity with Abbott, NeoChord, and Medtronic; and has received royalty payments for intellectual property with Edwards Lifesciences and Medtronic. Dr von Bardeleben has performed unpaid trial activity with Abbott, DZHK German Center for Cardiovascular Research, Edwards Lifesciences, University of Göttingen IIT trials, Jenscare, Medtronic, Neochord, and Siemens; and has received consulting fees from Abbott, Edwards Lifesciences, Medtronic, Neochord, Philips, and Siemens. Dr Cohen has received research grant support from Abbott, Edwards Lifesciences, Boston Scientific, and Abbott; and has received consulting fees from Abbott, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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