Historically, tricuspid valve disease has often been overlooked, frequently presenting alongside left-sided valve diseases and thus receiving lower priority for intervention. However, it is now recognized that significant tricuspid regurgitation (TR) is an independent predictor of adverse clinical outcomes in these patients. TR is also associated with the development of heart failure (HF) and a deterioration in patients’ quality of life. Furthermore, isolated surgical treatment for TR is challenging, primarily due to other factors that elevate surgical risk in these patients, such as right ventricular dysfunction, hepatorenal impairment, pulmonary hypertension, and a history of previous cardiac surgery, which is common in this pathology. According to large North American registries, mortality for this type of surgery is approximately 8–10%.
In recent years, transcatheter tricuspid valve repair (TTVR) with edge-to-edge devices has emerged as a safe and potentially effective alternative for specific cases of TR. Recent studies have shown that TTVR can successfully reduce the degree of valvular insufficiency and alleviate patient symptoms. However, it remains undetermined whether TTVR is superior to optimized medical therapy.
The TRILUMINATE study discussed in this review was a randomized clinical trial conducted across 65 centers in the United States, Europe, and Canada. It included 350 patients with symptomatic severe TR (NYHA functional class II–IV), a systolic pulmonary artery pressure below 70 mmHg, stable HF medication for at least 30 days prior to enrollment, and classified as moderate- or high-risk surgical candidates, excluding conditions necessitating surgical intervention. The study aimed to demonstrate a clinical benefit of TTVR compared to pharmacological treatment over a one-year follow-up. For all patients assigned to the tricuspid repair arm, the TriClip® device was used, introduced via a 25 Fr catheter through femoral venous access, enabling clip placement on the tricuspid leaflets with transesophageal echocardiographic and fluoroscopic guidance. All procedures were performed under general anesthesia.
The study’s primary outcome was a hierarchical composite including all-cause mortality, tricuspid valve surgery, HF hospitalizations, and quality-of-life impact assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Additional evaluated outcomes included renal failure development, endocarditis, procedure-related complications, reduction in TR severity, and the six-minute walk test performance.
The enrolled patients had an average age of 78 years, with a slight predominance of females, and 94% presented functional TR associated with right ventricular dilation. Left ventricular function was preserved in both groups, with 70% of patients showing massive or torrential TR severity. There were no significant procedure-related complications, such as device embolization, major bleeding, significant tricuspid stenosis, or intraprocedural or periprocedural mortality. Patients undergoing the procedure were discharged after an average stay of one day, with an average of two clips per patient.
Results were analyzed using the win ratio method, which enables treatment superiority assessment by ranking events in a pre-established hierarchical order by importance. The win ratio result for the primary outcome favored the tricuspid repair group with TriClip® (1.48, p=.02). However, this outcome was primarily achieved through KCCQ score improvement, without demonstrating superiority in terms of mortality, surgical need, or HF hospitalizations. At 30 days, 87% of the percutaneous group showed less than moderate-severe TR compared to 4.8% of the control group (p<.001).
The authors conclude that edge-to-edge TTVR for severe TR reduces TR severity and is associated with improved quality of life.
COMMENTARY:
Given that patients with severe TR frequently present high surgical risk, developing new minimally invasive techniques for tricuspid repair has become essential. With the advent of edge-to-edge devices like TriClip®, a range of options opens up for certain patients who otherwise would rely increasingly on diuretics as their sole therapy. Current evidence reinforces that, in carefully selected patients, this is a safe and effective technique with a significant TR reduction sustained over follow-up.
Based on the findings of this study, comparing percutaneous intervention in severe TR patients with conventional pharmacologic management, the technique appears beneficial for quality of life. Although superiority in “hard” clinical events (mortality, intervention necessity, or HF decompensation admissions) was not demonstrated, the symptomatic burden of cardiopathy—and thus, patient quality of life—should always be a priority for healthcare providers interacting with these patients. However, on closer examination of study results, an intriguing detail arises: the objective quantification of functional capacity (six-minute walk test) did not reach statistical significance between the treatment groups, contrasting with the subjective improvement perceived by study participants via the KCCQ. Given the nature of the intervention and the open study design, where patients knew their treatment arm and no placebo or simulated intervention was performed, patients undergoing interventional treatment may have perceived an erroneous subjective improvement, which could explain the lack of correlation with the six-minute walk test results. If true, this would represent a significant design bias.
Despite its limitations, this is among the first prospective, randomized studies assessing this type of percutaneous device in treating severe TR, demonstrating its potential as a viable treatment alternative for this valvulopathy. Further studies with larger sample sizes and longer follow-up periods are required to reach more robust conclusions on the true benefit of this technique. Similarly, it would be interesting to see results comparing percutaneous repair with surgical approaches for tricuspid pathology in different populations, such as those with low surgical risk.
REFERENCE:
Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, et al. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 Mar 4. doi: 10.1056/NEJMoa2300525.
