The TriClip device may be safe and effective for lowering tricuspid regurgitation by 1 grade or more, according to study results published in The Lancet.
Although tricuspid regurgitation is a highly prevalent condition, affecting more than 4.5 million people in the United States and Europe, there are very few treatment options, and most existing treatments are controversial. The objective of this study was to evaluate the safety and efficacy of TriClip, a transcatheter tricuspid valve repair system in patients with tricuspid regurgitation who are at high risk for tricuspid valve surgery.
Researchers evaluated 6-month data from the TRILUMINATE trial (Clinicaltrials.gov identifier: NCT03227757), a prospective multicenter single-arm study evaluating the safety and efficacy of TriClip in patients with moderate or greater tricuspid regurgitation, New York Heart Association class II or higher. Tricuspid regurgitation was graded using a 5-class grading scheme: mild, moderate, severe, massive, and torrential. The primary safety end point was a composite of major adverse events (ie, cardiovascular mortality, stroke, and myocardial infarction) at 6 months, with a performance goal of 39%. The primary efficacy end point was a reduction in tricuspid regurgitation severity by at least 1 grade at 30 days, with a performance goal of 35%.
Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not experience a major adverse event during previous follow-ups. In total, 85 patients were included in the study (mean age, 77.8 years±7.9; 66% women). In 71 of 83 participants (86%) who had available echocardiogram data and imaging, tricuspid regurgitation severity was reduced by at least 1 grade at 30 days. The one-sided 97.5% lower confidence limit was 77.3%, which was greater than the performance goal of 35% (P <.0001) and met the primary efficacy end point. At 6 months, 3 patients experienced a major adverse event, which was lower than the safety end point performance goal of 39% (P <.0001). At 6 months, there were no reported cases of stroke, myocardial infarction, or device embolization, and all-cause mortality occurred in 4 patients.
Study limitations include the fact that only patients with coaptation gaps <10 mm were included, its nonrandomized nature, and the fact that no clear evidence was provided indicating an association between the reduction of tricuspid regurgitation and reduced morbidity and mortality.
“In this study, we have shown that edge-to-edge treatment with the TriClip device is effective and safe in patients with moderate tricuspid regurgitation or greater and is associated with clinical improvement,” concluded the study authors. “These findings warrant further randomized trials investigating the effect of catheter-based reduction of tricuspid regurgitation on long-term patient outcome.”
Disclosure: This clinical trial was supported by Abbott Laboratories. Please see the original reference for a full list of authors’ disclosures.
Nickenig G, Weber M, Lurz P, et al. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019;394(10213):2002-2011.