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Real-World 1-Year Results of Tricuspid TEER
Quick Takes
- In a prospective, single-arm, open-label, multicenter post-market registry of patients with severe symptomatic tricuspid regurgitation (TR), tricuspid transcatheter edge-to-edge repair (T-TEER) was associated with a durable reduction in TR severity and improved quality of life at 1 year.
- In addition to baseline serum creatinine and higher baseline RV tricuspid annular plane systolic excursion, reduction of TR to moderate or less at 30 days was associated with lower 1-year mortality.
Study Questions:
What are the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip system in a contemporary real-world setting?
Methods:
The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) post-approval study is a prospective, single-arm, open-label, multicenter post-market registry of outcomes associated with the TriClip system (Abbott Cardiovascular) for the treatment of severe tricuspid regurgitation (TR) conducted at 26 sites in Europe, with echocardiographic core-laboratory assessment and central event adjudication.
Results:
Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects had New York Heart Association (NYHA) functional class III/IV symptoms. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21-75% class I/II, p < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, p < 0.0001) were observed at 1 year.
One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days compared to those with severe or higher (massive, torrential) TR; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, independent associates of 1-year mortality were baseline serum creatinine (odds ratio [OR], 2.169; 95% confidence interval [CI], 1.494-3.147; p < 0.0001) and baseline right ventricular (RV) tricuspid annular plane systolic excursion (OR, 0.636; 95% CI, 0.415-0.974; p = 0.0375). Mortality was not associated with baseline TR grade or with center volume.
Conclusions:
The authors conclude that, in a diverse real-world population of patients with significant TR and advanced disease, T-TEER using the TriClip system was safe and effective through 1 year.
Perspective:
Untreated severe TR is associated with poor quality of life and increased mortality. Previously published data from the TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) randomized controlled trial demonstrated that T-TEER is associated with a high rate of reduction in TR severity and improvement in quality of life. Compared to patients in the TRILUMINATE trial, patients in the bRIGHT registry more often had massive or torrential TR, more complex tricuspid valve anatomy, a higher proportion of advanced (NYHA class III/IV) symptoms, and lower KCCQ scores.
Although this study did not have a control group and did not report concomitant medical therapy during follow-up, it demonstrated a sustained reduction in TR severity and quality of life improvement at 1 year, and an association between reduction in TR to moderate or less at 30 days with improved survival. Additional analyses in multiple patient populations undergoing T-TEER are needed to better understand its mortality benefits and to help guide efforts to optimize procedural outcomes.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and Structural Heart Disease, Valvular Heart Disease
Keywords: Tricuspid Valve Insufficiency, Transcatheter Aortic Valve Replacement
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