Transcatheter tricuspid repair systems improve short-term outcomes in real-world cohort
Two transcatheter tricuspid edge-to-edge repair systems were associated with reduced tricuspid regurgitation and improved quality of life at 30 days in a real-world cohort, according to results of the bRIGHT study.
“The bRIGHT study was initiated to evaluate in a more real-world cohort the safety and effectiveness of using the TriClip and TriClip G4 devices (Abbott) for tricuspid edge-to-edge repair in patients with at least severe tricuspid regurgitation,” Philipp Lurz, MD, PhD, professor and deputy head of cardiology, Heart Center Leipzig at University of Leipzig, Germany, said during a presentation at EuroPCR.
Lurz and colleagues analyzed 300 patients (mean age, 78 years; 53% women) from the prospective, single-arm, multicenter registry.
The primary endpoint was acute procedural success, defined as survival at discharge with successful implantation of the device and a reduction in tricuspid regurgitation of at least 1 grade. The secondary endpoint was all-cause mortality or reintervention/reoperation at 1 year.
All patients were symptomatic and were at high or worse surgical risk, Lurz said.
“I should say this is a massive or torrential cohort, because 92% of patients had massive or torrential [tricuspid regurgitation], and they also tended to be quite sick, with almost 80% of patients in NYHA class III or IV,” Lurz said during the presentation.
At 30 days, implant success occurred in 98% of patients and acute procedural success occurred in 91%, he said.
Among the 184 patients who had core lab data available, 71% of patients had moderate or less tricuspid regurgitation at 30 days (P < .0001), he said.
Since most patients began with massive or torrential tricuspid regurgitation, “many had at least 2 grades of [tricuspid regurgitation] reduction, and some even 3 grades or [tricuspid regurgitation] reduction,” Lurz said during the presentation.
Among the cohort, 36% had the TriClip G4 device, which was introduced after the registry began, used in their procedure. In that group, among the 64 patients who had core lab data available, 75% had moderate or less tricuspid regurgitation at 30 days (P < .0001), he said.
At 30 days, 1% of patients had a major adverse event, according to the researchers. In addition, Lurz said, major bleeding occurred in 6.7% and single leaflet device attachment occurred in 3.7%.
NYHA class improved at 30 days, with 78% of patients achieving NYHA class I or II, and Kansas City Cardiomyopathy Questionnaire overall summary score improved by 5 points (P for both < .0001), Lurz said.
“The majority of patients experienced symptomatic benefit, and we will continue to enroll patients in the bRIGHT study and will look at the data out to 1 year,” Lurz said during the presentation.
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Lurz P, et al. Late-Breaking Mitral and Tricuspid Studies and Registries. Presented at: EuroPCR; May 17-20, 2022; Paris (hybrid meeting).