1. In this open-label randomized trial, percutaneous tricuspid transcatheter edge-to-edge repair (TEER) reduced severe tricuspid regurgitation and improved quality of life compared to diuretic therapy.
2. Major adverse events related to the TEER procedure occurred in less than 2% of patients in the group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The standard treatment for tricuspid regurgitation includes medical and surgical therapy. Medical therapy is limited to diuretic agents, while surgical treatment is recommended only for patients with severe tricuspid regurgitation. Surgery can be challenging due to circulatory dysfunctions that are associated with patients who have previously undergone cardiac surgery. Percutaneous TEER has emerged as a safe and potentially effective therapy for tricuspid regurgitation. In this open-label randomized trial, patients with symptomatic severe tricuspid regurgitation were randomly assigned to receive either TEER or control medical therapy. Patients were followed for 12 months. The primary outcome was a composite that included death from any cause or tricuspid-valve surgery, hospitalization of heart failure, and an improvement in quality of life at the 12-month follow-up as measured with at least a 15-point increase in the Kansas City Cardiomyopathy Questionnaire (KCCQ). The between-group difference for the primary outcome significantly favored the TEER group. Patients in the TEER group had a significantly greater positive change in the KCCQ quality-of-life score compared to the control group. As a limitation, this study was open-label, which may result in study bias. In addition, the rigorous patient selection process may result in a study population that does not reflect the general population.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: In this open-label, randomized controlled trial patients with symptomatic severe tricuspid regurgitation (n=350) were randomized to receive TEER (n=175) or control medical therapy (n=175). Patients were followed for 12 months. The primary outcome was a composite of all-cause or tricuspid-valve surgery mortality, hospitalization for heart failure, and improvement in quality of life as measured with the KCCQ. Analysis of the primary outcome used the Finkelstein-Schoenfeld method and a win ratio. The median length of stay for the TEER procedure was 1.0 day (interquartile range, 1.0 to 2.0) and no deaths occurred during the hospital stay. For the primary outcome, the win ratio favored the TEER group (1.48; 95% Confidence Interval, 1.06 to 2.13; p=0.02). Rates of all-cause or tricuspid-valve surgery mortality and hospitalization for heart failure alone were not significantly different between groups. For changes in KCCQ score, 49.7% and 26.4% of the TEER and control groups, respectively, had a 15-point or greater improvement. At the one-year follow-up, patients with moderate severity or less of tricuspid regurgitation as assessed by echocardiogram were 126 of 143 in the TEER Group compared to 8 of 141 in the control group, respectively. These results were functionally corroborated by a higher percentage of patients in the TEER group (83.9%) compared to the control group (59.5%) with NYHA functional class I or II at the one-year follow-up. For major adverse events at 30 days, two patients had new-onset kidney failure and one died from cardiovascular causes. Results from this trial suggest that TEER treatment reduces severe tricuspid regurgitation and confers functional improvements to patients with symptomatic tricuspid regurgitation.
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