Transfemoral tricuspid valve replacement with the novel EVOQUE system has favorable 30-day and 6-month outcomes in patients with tricuspid regurgitation (TR), new trial data report. The findings, reported Saturday at Transcatheter Cardiovascular Therapeutics (TCT) 2021 in Orlando, Florida, come from the TRISCEND trial, which looked at outcomes from tricuspid valve replacement via a transcatheter approach in patients with TR. "Although there's currently no class-1 indication in the US guidelines to treat severe TR, I think we've learned over the last several decades that severe TR prepends a bad prognosis,” commented lead author Susheel Kodali, MD, from Columbia University Irving Medical Center. Kodali cited data from a 2019 study that demonstrated increased mortality risk with TR severity, adding that multiple studies have shown similar findings. “Prevalence is increasing as the population ages ... but it's not treated that commonly," he said, noting that there are around 2.4 million cases of TR but only 10,000 surgeries per year. "The medical therapy options are limited and consist mainly of just diuretics and blood pressure management," he said, noting that the EVOQUE system is designed for a percutaneous transfemoral approach with a unique valve design. Trial data Kodali presented 6-month results from the TRISCEND study – a prospective, single-arm, multicenter study looking at the safety and performance of the novel transfemoral EVOQUE tricuspid valve replacement system in 132 patients with TR. “To be enrolled in the study, patients needed to have moderate or greater TR and were felt by their local heart team to have signs or symptoms of heart failure despite optimal medical therapy,” explained the researcher. The primary endpoint was a composite of major adverse vents (MAEs) at 30-days, with follow-up at 6 months, 1 year, and annually up to 5 years post-procedure. Kodali revealed that device success was 96.2%, with a procedural time (from implant insertion to release) of 72.8 minutes. "What's remarkable is that 93% of the patients in an elderly cohort – with a mean age of 79 – were discharged home," he said, noting that the average length of stay in hospital was 3 days. The study found that 81.5% of patients had no MAEs at 30 days, with a composite MAE rate of 18.5% - with 23 patients reporting at least one adverse event. Severe bleeding was the most common event, occurring in 17.7% of patients, said Kodali. “Of those 22 events, eight were procedure-related bleeding, but the result of them were this elderly population with GI bleeds, epistaxis, hematuria, and all of those other things,” he said, noting that in a tricuspid patient population that also has risk factors for bleeding, such rates are “not uncommon.” The trial also reported significant reductions in TR severity at both 30 days and 6 months post-procedure. "The valve worked," said the lead investigator, adding, "97% had mild or no TR at 30 days, and at 6-months, 100% had mild or no TR.” “Starting with, we had over 40% of the patients had massive or torrential TR.” Furthermore, he noted that 6-month follow-up data showed 96% survival and 94% freedom from rehospitalization – adding that the same cohort of patients had a 39% hospitalization rate in the year before the procedure. The trial also reported significant improvements in functional and quality-of-life outcomes at 6 months, including New York Heart Association (NYHA) class improvement and 6-minute walk times, which Kodali noted improved by 56 meters (199.5 vs 255.8, p<0.001). Kansas City Cardiomyopathy Questionnaire (KCCQ) scores also saw "a dramatic improvement" of 27 points (48.6 vs 75.6, p<0.001), he said, adding that this is "one of the largest that we've seen in structural heart trials." Concluding his presentation, Kodali noted that while treatment options for TR remain limited, the outcomes from the TRISCEND study show favorable 30-day outcomes, which are sustained at 6 months. "There was significant TR reduction ... with 100% of patients having mild or less TR at 6-months, and significant improvements in NYHA Class, KCCQ and 6-minute walk times.” He also revealed that based on the results of the current study, a randomized pivotal trial (TRISCEND II) is already initiated and ongoing.