Transcatheter valve repair system for tricuspid regurgitation improves outcomes at 1 year
WASHINGTON — In the CLASP TR study, transcatheter treatment of tricuspid regurgitation with a novel repair system demonstrated significant tricuspid regurgitation reduction and durable outcomes at 1 year.
“A minimally invasive, transcatheter leaflet strategy for tricuspid regurgitation appears feasible, safe and in selected patients achieves a significant reduction in regurgitation with associated improvements in functional status,” Adam B. Greenbaum, MD, associate professor of medicine and co-director of the Structural Heart and Valve Center at Emory University School of Medicine, told Healio.
Transcatheter valve repair with the Pascal system (Edwards Lifesciences) was also associated with improvements in functional status and quality of life measures, Greenbaum said during a late-breaking clinical trial presentation at the American College of Cardiology Scientific Session.
Severe tricuspid regurgitation is progressive and life-threatening; transcatheter valve repair systems, such as Pascal, present an alternative to surgery to address this need, Greenbaum said.
The prospective, single-arm CLASP TR study enrolled 65 patients (mean age, 77 years; 55% women) with severe symptomatic tricuspid regurgitation despite optimal medical therapy. At baseline, 14% of patients had pacemakers or implantable cardiac devices, 89% had AF, 53% had pulmonary hypertension and 43% had renal insufficiency. Researchers assessed major adverse events and echocardiographic, clinical and functional endpoints at 1 year.
The COVID-19 pandemic affected the researchers’ ability to obtain 1-year follow-up data for all treated patients, Greenbaum said; some patients completed follow-up questionnaires but did not complete echocardiograms and six-minute walk tests. Ultimately, follow-up results were available for 49 patients; 10.8% died and 18.5% were rehospitalized for HF. These results compare with an expected 1-year mortality rate of about 30% for patients with tricuspid regurgitation, Greenbaum said.
The composite rate of major adverse events at 1 year was 16.9%.
At 1 year, the rate of event-free survival was 88% and the rate of freedom from HF hospitalization was 79%.
Among 36 patients with available data at 1 year, all achieved a reduction of at least one grade in the severity of their tricuspid regurgitation; 75% saw a reduction of at least two grades; and 86% achieved an overall grade of moderate or less.
Researchers observed significant improvements in HF severity, with 92% with NYHA class I or II HF (P < .001), as well as a mean 94-minute improvement in 6-minute walk test (P < .001) and a mean 18-point improvement in Kansas City Cardiomyopathy Questionnaire score (P < .001), Greenbaum said.
“The 1-year data shows no adverse events related to the device or procedure past 30 days and that the improvements initially achieved are maintained at least to 1 year,” Greenbaum told Healio. “What we need in future research is to better understand which patients and which types of anatomies benefit the most, how much improvement in regurgitation is needed and if we are changing the natural history of the disease.”
Greenbaum said the study offers further validation for transcatheter edge-to-edge repair.
Longer follow-up is needed to determine how well the device continues to perform and how well patients do at further follow-up.
Greenbaum said a randomized trial is ongoing that will compare outcomes for patients treated with the investigational device and patients who receive optimal medical therapy with diuretics.
Collapse
Greenbaum A, et al. Late Breaking Clinical Trials IV. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).