Transcatheter edge-to-edge repair system improved severe tricuspid regurgitation
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Key takeaways:
- A tricuspid transcatheter edge-to-edge repair system improved tricuspid regurgitation (TR) grade for adults with severe or worse TR.
- Data show low rates of major adverse CV events and mortality through 30 days.
In older patients with severe or worse tricuspid regurgitation, a tricuspid transcatheter edge-to-edge repair system was safe and improved tricuspid regurgitation grade and quality of life measures for the sickest patients, data show.
Philipp Lurz, MD, PhD, professor and deputy head of cardiology, Heart Center Leipzig at University of Leipzig, Germany, presented findings from the bRIGHT post-approval study, initiated to evaluate the real-world safety and effectiveness of tricuspid valve transcatheter edge-to-edge repair (TEER) using the TriClip devices (Abbott) in patients with severe or worse tricuspid regurgitation (TR). The multicenter registry enrolled more than 500 patients at 30 sites in Europe. The findings were presented at EuroPCR and simultaneously published in the Journal of the American College of Cardiology.
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“bRIGHT is the first and largest post-market registry evaluating the TriClip TEER procedure in a contemporary real-world patient cohort,” Lurz said during a late-breaking clinical trial presentation. “The study demonstrated high implant success and successful TR reduction at 30 days, and it once again confirms the very encouraging safety profile of tricuspid valve TEER procedures. The procedure was associated with significant clinical improvements.”
Lurz and colleagues analyzed data from 511 patients (mean age, 78 years; 56% women) who underwent TEER from the prospective, single-arm, multicenter registry. TR reduction was assessed by a core lab; patients were enrolled into the registry when they had at least severe symptomatic TR, a high risk for surgery. Patients presented at a more advanced stage of disease; 80% of patients had NYHA class III/IV HF and 40% had a previous hospitalization for HF, Lurz said.
“There were very few exclusion criteria, reflecting the real-world nature of the registry,” Lurz said. “The vast majority of patients had massive or torrential TR, with only 10% with severe TR, with a high rate of comorbidities.”
Implantation success was high at 99%. Procedural success, defined as a TR grade reduction of at least 1, was 91% for the cohort. On average, 1.9 clips were implanted per patient.
From baseline to 30 days, researchers observed a significant reduction in TR grade, with 77% of patients achieving moderate or less TR, though results varied based on baseline TR grade. Among patients with severe TR at baseline (n = 37); 95% had a reduction to moderate or less TR, whereas for patients with torrential TR at baseline (n = 103), 59% experienced a reduction to moderate or less TR.
“These results have to be interpreted in light of the baseline TR,” Lurz said. “The lower the baseline TR grade, the higher the percentage of those patients with moderate or less.”
The study again confirmed the safety profile of the tricuspid valve TEER procedure, Lurz said, with a MACE rate of 2.5%, including four patients who died of CV causes and two patients who experienced strokes.
Reduction in TR was associated with “clear signs of clinical improvement,” Lurz said, with a significant reduction in NYHA class and an average 19-point improvement in Kansas City Cardiomyopathy Questionnaire scores after undergoing TEER.
“Encouragingly, improvement in quality of life was clearly related to the quality of the procedure and the TR grade,” Lurz said.
Reference:
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Lurz P, et al. Late-breaking clinical data: Focus on mitral and tricuspid valves disease. Presented at: EuroPCR; May 16-19, 2023; Paris (hybrid meeting).
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