medwireNews: Transcatheter tricuspid-valve replacement is superior to medical therapy alone in the treatment of patients with severe tricuspid regurgitation, a study suggests.
Specifically, the treatment achieved a win ratio of 2.02 with respect to medical therapy alone at 12 months. This measure was calculated based on systematic comparisons between patient pairs for a composite of outcomes that included death from any cause, patient-reported quality of life, and investigator-adjudicated functional status.
“Tricuspid regurgitation was reduced to a mild degree or less in nearly all the patients who underwent valve replacement, with associated improvements in symptomatic, functional, and quality-of-life outcomes, as well as favorable numerical trends in mortality and hospitalization for heart failure at 1 year,” write Rebecca Hahn (Columbia University Irving Medical Center, New York, USA) and colleagues in The New England Journal of Medicine.
They add that the periprocedural risks associated with the treatment “must be considered in the context of these benefits.”
The trial enrolled 400 adult patients with severe tricuspid regurgitation, with severities ranging from severe (3) to torrential (5) on a 5-point scale, as measured using transesophageal and transthoracic echocardiography. The participants had symptoms of tricuspid regurgitation or had been hospitalized for associated heart failure despite medical therapy and were eligible for valve replacement.
In all, 259 patients were randomly assigned to undergo transcatheter tricuspid-valve replacement plus medical therapy, including stable oral diuretic medications, warfarin or another anticoagulant plus aspirin, while 133 were assigned to receive diuretic medications alone.
The patients were a mean of 79.2 years old, 74.8% were White, and 75.5% were women. The vast majority, at 94.9%, had atrial fibrillation, and they had a mean of 9.7% on the Society of Thoracic Surgeons mortality score for mitral valve replacement, a prediction of mortality and morbidity after cardiac surgery ranging from less than 4% (low risk) to more than 8% (high risk).
Hahn et al found that for the individual components of the primary composite outcome at 1 year, there were more wins for the treatment group versus the control group for death from any cause (14.8 vs 12.5% wins) and post-index tricuspid-valve intervention (3.2 vs 0.6% wins). And for improvements of at least 30 m on the 6-minute walk distance test (1.1 vs 0.9% wins), of at least 10 points on the quality-of-life measure Kansas City Cardiomyopathy Questionnaire overall summary score (23.1 vs 6.0% wins), and of at least one New York Heart Association (NYHA) functional class improvement (10.2 vs 0.8% wins).
By contrast, patients receiving valve replacements had fewer wins than the control group in terms of the annualized rate of hospitalization for heart failure (9.7 vs 10.0% wins), and no patients in either group underwent implantation of a right ventricular assist device or heart transplantation.
However, the researchers note that the trial was not powered to detect differences in individual components of the composite primary outcome.
At 1 year, most of the participants receiving valve replacements had no, mild, or moderate residual tricuspid regurgitation, at respective rates of 72.6%, 22.6%, and 3.8%. By contrast, only 16.1% of patients in the control group had moderate or less severe regurgitation, with most still experiencing severe (41.1%), massive (19.5%), or torrential (23.0%) regurgitation.
Severe bleeding was one of the main safety issues associated with valve replacement, affecting 15.4% of the treatment group compared with just 5.3% of the control group at 1 year, a significant difference. Patients given valve replacements were also significantly more likely to develop arrhythmia and conduction disorders requiring a permanent pacemaker than controls (17.8 vs 2.3%), and to have a new pacemaker implanted (27.8 vs 3.8%).
In a related editorial, Patrick O’Gara, from Brigham and Women’s Hospital in Boston, Massachusetts, USA, says that the results are directionally consistent with a previous trial of tricuspid transcatheter edge-to-edge repair (T-TEER).
“T-TEER reduces regurgitation less effectively, although the procedure is associated with substantially lower rates of periprocedural bleeding and pacemaker implantation,” he says.
While it is “early in the evolution of transcatheter tricuspid-valve replacement,” O’Gara adds that “[t]he daunting task of attempting to improve the fate of patients at late stages in their disease course has been more sharply focused. Earlier recognition and timely referral for treatment are needed, along with improvements in device design, procedural skills, pacemaker-lead management, and postprocedural care.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group
N Engl J Med 2024; doi:10.1056/NEJMoa2401918
N Engl J Med 2024; doi:10.1056/NEJMe2413200
