Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial.

BACKGROUND

Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR).

OBJECTIVES

We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients.

METHODS

The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models.

RESULTS

The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone.

CONCLUSIONS

Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062).

Informations de copyright

Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The TRISCEND II pivotal trial and this analysis were funded by Edwards Lifesciences. Analyses were designed and conducted independently by the academic investigators. Dr Arnold has received research grants from the U.S. Food and Drug Administration and National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts with no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry sponsored valve trials with no direct industry compensation. Dr Thourani has received research/advisor fees from Abbott Vascular, Artivion, CroíValve, Boston Scientific, and Edwards Lifesciences; has received research grants from Medtronic, Highlife, Innovalve, JenaValve, and HalfMoon; and owns equity in Dasi Simulation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, and Medtronic; and has received travel support from Edwards Lifesciences, JenaValve, Abbott Vascular, and Boston Scientific. Dr Makar has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare, and PiCardia. Dr Sharma has received consulting fees from Edwards Lifesciences. Dr Haeffele has received consulting fees from Edwards Lifesciences and Shifamed. Dr Davidson has served as an uncompensated advisor for and received research grant support from Edwards Lifesciences. Dr Narang has received speaker fees from Edwards Lifesciences, Abbott Laboratories, and Bristol Myers Squibb. Dr O’Neill has received consulting fees from Edwards Lifesciences. Dr Lee has received consulting fees from Edwards Lifesciences. Dr Yadav has received consulting and speaker fees from Edwards Lifesciences, Abbott Vascular, and Boston Scientific; has received advisory board honoraria from Dasi Simulations and Trisol; and owns equity in Dasi Simulations and Opus. Dr Zahr has received consulting fees, research grants, and educational grants from Edwards Lifesciences and Medtronic. Dr Chadderdon has received consulting fees from Edwards Lifesciences and Medtronic; and has received research funding from GE Healthcare and Siemens Healthineers. Dr Smith has received research grants from Edwards Lifesciences, Medtronic, and Artivion, which are managed through the Baylor Scott & White research institute; has received speaker fees from Edwards Lifesciences and Medtronic; and has received advisory board honoraria from Edwards Lifesciences and Enable CV. Dr Szerlip has received consulting fees from Edwards Lifesciences; has received speaker fees from Edwards Lifesciences, Cardiovascular Innovations, the Society for Cardiovascular Angiography and Interventions, and Boston Scientific; and has received advisory board honoraria from Abbott Vascular. Dr Whisenant has received consulting fees from Edwards Lifesciences and Abbott Vascular. Dr Garcia has received consulting and proctor fees from Edwards Lifesciences, Medtronic, Abbott Structural Heart, JC Medical, and Boston Scientific. Dr Grayburn has received research grants from Abbott Vascular, CardioValve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received advisory board honoraria from Abbott Vascular, CardioValve, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Sannino has received research grants from Edwards Lifesciences and Venus Medtech. Dr Mack has received consulting fees and research grants from Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and owns stock options in Innoventric. Dr Kodali has received consulting fees from Anteris, TriCares, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; has received advisory board honoraria from Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, Boston Scientific, and Abbott; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Cohen has received research grants from the U.S. Food and Drug Administration, National Institutes of Health/National Heart, Lung, and Blood Institute, Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, Philips, Corvia, Zoll Medical, and iRhythm; and has received consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.