Reductions in tricuspid regurgitation (TR) with the TriClip system (Abbott) were maintained and no new safety signals identified with continued follow-up in the multicenter TRILUMINATE study.
The percentage of patients with moderate or less TR increased from 60% at 30 days to up to 70% at 1 year.
TR reduction was also associated with "sustained symptomatic improvements, alongside robust quality-of-life improvements, and consistent signs of reverse right ventricular remodeling, and reduced hospitalizations at 1 year," Philipp Lurz, MD, PhD, University of Leipzig Heart Center, Germany, said at PCR e-Course 2020, the virtual congress of the European Association of Percutaneous Cardiovascular Interventions.
The single-arm, prospective study enrolled 85 patients with symptomatic, moderate or greater TR and, as previously reported, at least 86% had TR severity reduced by one grade or more, and no deaths, strokes, or reinterventions at 30 days.
Follow-up at 6 months identified five major adverse events and 5% all-cause mortality. Based on these results, the TriClip received CE mark approval in Europe in April. The device remains investigational in the United States.
Although the primary safety and effectiveness endpoints were successfully met, questions remain about durability, clinical benefit of TR reduction, and safety, Lurz noted.
At 1 year, 87.1% of patients showed at least one grade improvement in TR and 71% had a reduction of at least two grades.
Lurz pointed out that the study utilized a five-grade TR scheme, such that "some patients started off at baseline with a TR grade of 5 and then had a reduction to TR grade 3 at 1 year, meaning that those patients still had two grades of TR reduced."
In terms of safety, there were six major adverse events through 1 year (7.1%), of which four were cardiovascular deaths. All-cause mortality was low at 7.1%, and "this in a certainly fragile and high-risk patient population," he said.
There were 10 major bleeds and one new-onset atrial fibrillation. Five patients had single-leaflet device attachment with no clinical consequence or worsening of TR and, "importantly, all these cases occurred early on within the first 30 days, with apparently no risk for late device attachment," Lurz said.
"Reductions in tricuspid regurgitation were accompanied by marked early, but then also sustained, improvements in patient symptoms and NYHA class," he said. At 1 year, 83% of patients were in New York Heart Association I/II, up from 31% at baseline (P < .0001).
Quality-of-life scores on the Kansas City Cardiomyopathy Questionnaire also continued to improve from 52 at baseline to 66 at 30 days and 72 at 1 year (Δ from baseline, P < .0001; Δ from 30 days, P = .0290).
Hospitalizations were reduced by 40% from 1 year before the procedure to 1 year after.
Echocardiography core lab analysis indicated evidence of positive right ventricular (RV) remodeling, including a significant reduction in RV size from baseline to 30 days (5.3 cm to 4.9 cm) and an additional reduction between 30 days and 1 year to 4.8 cm (Δ from baseline, P < .0001; Δ from 30 days, P = .0319).
Likewise, an initial increase in RV function at 30 days (1.44 cm to 1.49 cm), as measured by tricuspid annular plane systolic excursion, was followed by a significant improvement from 30 days to 1 year to 1.59 cm (Δ from baseline, P = .0002; Δ from 30 days, P = .0069), suggesting a "positive physiological response to TR reduction," Lurz said.
Taken together, "these results suggest transcatheter therapies for the treatment of TR is a safe and effective alternative to surgery, especially in this high-risk population," he concluded.
Discussant Nicolo Piazza, MD, PhD, McGill University Health Centre, Montreal, said the 1-year mortality rate was very impressive given the morbidity characteristics of the patients and that the results "confirm the proof of concept."
Some of the most important questions that remain for the TriClip and other tricuspid repair techniques are the relation between TR reduction and clinical response, the role of guideline-directed medical therapy, optimal patient selection criteria, and how futility is defined, Piazza said.
The study was sponsored by Abbott. Lurz reported serving as a consultant to Abbott, Edwards Lifesciences, and Medtronic.
PCR e-Course 2020, the virtual congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR). Presented June 25, 2020.
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Cite this: TRILUMINATE: TriClip Tricuspid Valve Repair Durable at 1 Year - Medscape - Jul 03, 2020.