In high-risk patients with severe tricuspid regurgitation (TR), tricuspid transcatheter edge-to-edge repair (T-TEER) was found to be safe and effective and associated with substantial clinical improvement, according to a late-breaking clinical trial presented at EuroPCR 2023 and simultaneously published May 17 in JACC: Cardiovascular Interventions.

Philipp Lurz, MD, PhD, et al., examined short-term outcomes in 511 patients enrolled at 26 sites in Europe treated with T-TEER using the TriClip system. The bRIGHT post approval study is, according to the authors, the first prospective, single-arm, open-label, multicenter, post-market registry to evaluate the safety and performance of the Triclip system in a contemporary, unselected real-world cohort.

Results showed the patients were on average 79 years old and 56% were women, with significant comorbidities. At baseline 88% had massive or torrential TR and 80% were in NYHA class III or IV heart failure. Device implantation was successful in 99% of patients and in 77% the TR was reduced to ≤moderate at 30 days. A major adverse event occurred in 14 (2.5%) patients and five patients (1%) died.

The reduction in TR was associated with improvement in functional capacity and quality of life at 30 days. More patients were in NYHA class I-II (79%, up from 20%) and KCCQ scores were higher (mean 19-point improvement) (p<0.0001 for both).

The researchers found that independent predictors of a reduction in TR to ≤moderate at 30 days were smaller right atrial volume (odds ratio [OR], 0.679; p=0.0012) and smaller tethering distance (OR, 0.722; p=0.0072), after removing baseline TR grade as a variable.

Noting the limitations of the single-arm registry without a comparison group and the lack of core lab echocardiographic analysis of TR grades, the study authors concluded T-TEER was safe and effective in treating significant TR in a diverse, real-world population.

Clinical Topics: Heart Failure and Cardiomyopathies, Noninvasive Imaging, Acute Heart Failure, Echocardiography/Ultrasound

Keywords: Heart Failure, Echocardiography, Prospective Studies, Tricuspid Valve Insufficiency

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