The early TriClip G4 experience at 30 days in the ongoing real-world European bRIGHT study suggests improved tricuspid regurgitation (TR) reduction versus the earlier-generation TriClip device, “despite worse TR severity at baseline.” These findings were reported in a Thursday late breaking session at EuroPCR 2022 in Paris by principal investigator Philipp Lurz, MD, PhD, from the Heart Center Leipzig, Germany. The bRIGHT study – sponsored by TriClip manufacturer Abbott – was set up to evaluate safety and effectiveness in severe TR patients (despite medical therapy) at high risk for tricuspid valve surgery who were treated with the TriClip and TriClip G4 transcatheter edge-to-edge repair (TEER) systems in a real-world post-market setting. The prospective, single-arm, multicenter registry recruited 300 patients across approximately 30 European sites, said Lurz, with the primary endpoint of acute procedural success (APS), defined as survival to discharge with successful implantation of the TriClip device with resulting TR reduction of at least one grade. At baseline, the cohort included “quite severe patients,” with 92% suffering either “massive” or “torrential” TR, “a reflection of the real-world, unselected nature of the cohort,” according to Lurz. Besides “a high grade of tricuspid regurgitation, they also tended to be quite sick, with [79%] of patients in NYHA [New York Heart Association] class III or IV,” he added, highlighting a “clearly limited quality of life.” The patients’ mean age was 78.5 years, and the majority (53%) were female, had hypertension (84.7%) and atrial fibrillation (85%). Patients with severe pulmonary hypertension and severe mitral regurgitation were excluded from the study. The diversity of the anatomy of the patients treated in the cohort was otherwise “quite broad,” said Lurz. “The primary jet location was found in all three commissures [anteroseptal, posteroseptal and anteroposterior], and we learned that the tricuspid valve can have three leaflets, but this is not [a] given. “Sometimes we can only see two leaflets [in 7%], but we also saw about 21% of patients that had four or even more leaflets.” Annular diameter ranged from 2.5 to 7.6 mm and gap size from 2.6 to 20.8 mm. 30-day results Implant success at 30 days was achieved in 98% of patients, while acute procedural success was seen for 91%, with a “very reasonable” device time of 78 minutes and a total procedure time of 101 minutes, said Lurz. Core lab-adjudicated change in TR grade data were available in 184 patients. “We see that the new reference standard for these trials – the percentage of patients who ended the procedure with moderate or less [TR] – was 71%,” (P < 0.001 from baseline), he added. “However, it is of utmost importance when interpreting these results that they are always related to the baseline,” he stressed. “As said, we have a very high percentage of patients who started off with massive intervention, which means that many had at least two grades of TR reduction and some even three grades of TR reduction.” Two clips were used on average (± 0.7), and though clips were implanted in all three commissures, the majority of procedures used an anteroseptal-only clipping strategy. The majority (64%) received the TriClip; however, 36% received the next-generation TriClip G4 device, which became available during the study, said Lurz. The newer device “brings us four different clip sizes” and allows for independent grasping, he said. For the TriClip G4 patients specifically, 75% had moderate or less TR grade at 30 days (P < 0.0001) – an increased number vs. the general population despite the fact 95% of those given the G4 device had massive or torrential TR. “That suggests that we [can] treat even more severe tricuspid regurgitation,” Lurz said. Independent grasping was used in almost 70% of these patients. The patients’ NYHA functional class scale improved significantly, going from 79% in class III or IV to 78% in class I/II (NYHA functional class change: P < 0.0001), while the Kansas City Cardiomyopathy Questionnaire improved by a mean 18 points from baseline (P < 0.0001). Safety Meanwhile, the safety findings were that “only 1% of subjects experienced a major adverse event through 30 days, confirming the safety of the TriClip procedure.” Major adverse events occurred in three patients (1%) at 30 days, with one all-cause mortality (a cardiovascular death), one stroke, one case of new-onset renal failure and one patient undergoing device-related non-elective cardiovascular surgery. “As in all of these trials, there is some degree of bleeding complications after the procedure,” said Lurz, with 20 patients (6.7%) subject to major bleeding. There were also 11 cases (3.7%) of single leaflet device attachment. The findings show that “the procedure is safe also in unselected patients,” said Lurz. The bRIGHT study will continue to enroll up to 500 subjects to further evaluate the newer G4 system, he added. Remaining high-grade TR During the session, Corrado Tamburino, MD, of Università di Catania, Italy, highlighted the fact that 16% of the G4 patients still had massive or torrential TR post-procedurally, while 13% of the overall population stayed in these high grade TR categories at 30 days. Lurz highlighted several potential factors behind this, including that a high number of patients already had very high-grade TR, meaning that even with a reduction, they could still remain in high-grade categories. “Although we always say that we want to bring [TR] down to moderate, there is a certain suggestion from data, and also clinical experience, that when you bring it down from torrential to severe, that [patients] can still benefit.” He added that edge-to-edge procedures are still “a bit of a learning curve” for operators, stressing “the field just started a couple of years ago,” and that, “I think it will get better.” Nevertheless, Lurz conceded that: “Eventually, we will also understand that some pathologies just cannot be treated with edge-to-edge, but we are not there yet. That’s one of the tasks in the future – to find out and improve the patient selection upfront.”