Illuminating the TRILUMINATE Trial
Structural heart trials have focused on valvular disease of the left heart, where symptoms are easily defined and evidence supports guideline directed treatments.1 In right heart (RH) disease, surgical standards are undeveloped, and medical therapy is limited to diuretics with minimal impact on severe tricuspid regurgitation (TR) correction. Management of TR lingers until late stages, associated with ascites, hepatic/renal failure, hospitalization, and ultimately death.
Embarking on the first RH randomized controlled trial, TRILUMINATE (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal)2 demonstrated that tricuspid transcatheter edge-to-edge repair (TEER) with TriClip™ Transcatheter Tricuspid Valve Repair system (Abbott Laboratories, Chicago, IL) reduces TR (moderate or less in 87%), is safe (98.3% freedom from adverse events), and is better than medical therapy alone, driven only by improved quality of life (QOL). Notably, QOL improved stepwise with TR reduction; >2 grade reduction had 18-point QOL improvement (5 considered clinically important3). This was also associated with diuretic reduction over time, signifying better disease management.
However, a small number of sites contributed the majority of cases, questioning the generalizability of procedural success. TriClip reduced TR, but whether it will prevent end-stage disease, especially in more advanced patients, is unknown. The ultimate question still remains: can TR reduction in the device arm reverse RH dysfunction, and will RH failure progress despite optimal medical therapy in the controls, leading to a difference in hospitalization for heart failure and death emerging at 2 years?
For TR patients who are surgical candidates (excluding nonelective patients and those with endocarditis or high-risk phenotypes), recent data demonstrates that patients can safely undergo isolated TR surgery with very low risk (1.7% mortality)4 especially if the valve is repaired. The surgical patient population was not included in TRILUMINATE, and understanding who will benefit from tricuspid TEER versus surgical tricuspid valve repair or replacement will be reserved for future investigation.
- Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report on the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2021;77:450-500.
- Sorajja P, Whisenant B, Hamid N, et al; TRILUMINATE Pivotal Investigators. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med 2023;388:1902-03.
- Chen Q, Bowdish ME, Malas J, et al. Isolated tricuspid operations: the Society of Thoracic Surgeons Adult Cardiac Surgery Database analysis. Ann Thorac Surg 2023;115:1162-70.
- Spertus JA, Jones, PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in clinical trials and clinical care: JACC State-of-the-Art Review. J Am Coll Cardiol 2020;76:2379-90.
Keywords: ACC Annual Scientific Session, ACC23, Tricuspid Valve Insufficiency, Tricuspid Valve, Diuretics, Quality of Life, Ascites, Laboratories, Heart Failure, Heart Diseases, Endocarditis, Hospitalization, Phenotype, Disease Management
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