Tricuspid valve transcatheter edge-to-edge repair (T-TEER) is currently under development, with an increasing number of conducted procedures.
While the TRILUMINATE Study did not reveal benefit regarding major events, it did show improvements in quality of life.
In the real world, we encounter numerous patients who do not meet the study criteria but still experience symptoms and require hospitalization due to heart failure. Currently, we do not know if T-TEER would be beneficial or provide significant advantages that would justify the procedure.
This study included 962 patients with moderate or severe tricuspid regurgitation who were symptomatic under medical treatment. Of these, 527 (54.8%) met the eligibility criteria for the TRILUMINATE Study (TE), while 435 did not meet them (TI). Devices such as TriClip, MitraClip, and PASCAL were used. The primary endpoint was survival at 1 year.
Mean patient age was 78 years, the EuroScore was 6.5%, and 85% were secondary. Tricuspid regurgitation was classified as severe in 50% of cases, followed by massive (32.5%), torrential (15.3%), and moderate (1.8%).
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Patients who met the TI criteria showed a greater renal impairment, elevated liver enzymes, more admissions and hospitalizations due to heart failure in the last year, a shorter 6-minute walking distance, and a higher use of diuretics.
The primary endpoint favored patients with TE criteria (84.7% vs. 74.9%; log-rank P <0.001; hazard ratio [HR]: 1.71; 95% confidence interval [CI]: 1.27-2.30; P <0.001), and this trend persisted at two and three years of follow-up (two years 73.8% vs. 62.7%; three years 64.5% vs. 51.2%; P < 0.001). The need for hospitalizations due to heart failure was also lower in patients with TE criteria (14% vs. 22%; P <0.001), and so was the need for surgery and reintervention.
The reduction of tricuspid regurgitation and its durability, as well as improved quality of life, functional class, and performance in the 6-minute walk test, favored patients with TE criteria.
Conclusion
There were significant differences in survival and hospitalizations due to heart failure, suggesting limited generalization of the TRILUMINATE Study in the real world. This highlights the need to evaluate additional studies on the evolution of T-TEER in the population.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair.
Reference: Lukas Stolz, et al. J Am Coll Cardiol Intv 2024;17:535–548.
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