The PASCAL transcatheter valve repair system showed a high survival rate, with significant and sustained tricuspid regurgitation (TR) reduction and clinical, functional and quality-of-life improvements, 1-year follow-up data show. Data from CLASP-TR trial are reported Monday at the American College of Cardiology’s 71st Annual Scientific Session in Washington, D.C. Led by Adam B. Greenbaum, MD, associate professor of medicine and co-director of the Structural Heart and Valve Center at the Emory University School of Medicine, the team noted that TR affects an estimated 1.6 million people in the U.S. and increases as each generation ages. “At one year of follow-up, the repair procedure appears to be safe and significantly reduced the severity of patients’ tricuspid regurgitation and improved their ability to function in daily life, maintaining gains that we previously saw at 30 days of follow-up,” said Greenbaum in a press release. The data offer further validation for transcatheter edge-to-edge repair, a minimally invasive approach to the treatment of patients with the disease, he said. An alternative to surgery The authors noted that patients with TR are commonly treated with diuretics that are also used to treat high blood pressure. However, surgery to repair or replace the tricuspid valve is often done at the same time a patient undergoes cardiac surgery for other problems. Greenbaum noted that because most patients with TR are older and may have other health problems, many people who suffer from TR are poor candidates for open-heart surgery. As such, he said that other minimally invasive options are needed – adding that transcatheter valve repair systems, such as the PASCAL, present an alternative to surgery to address this need. The CLASP-TR trial is a single-arm, multicenter trial funded by Edwards Lifesciences Corp., the maker of the PASCAL tricuspid valve repair system used in the study. Early data from 30-day follow-up of the trial reported that the PASCAL repair system substantially reduced TR, produced few adverse events, and significantly improved patients’ ability to function, exercise capacity and quality of life. Greenbaum and colleagues presented data from 1-year follow-up at the conference Monday. COVID complications The CLASP-TR trial enrolled a total of 65 patients with severe symptomatic TR – 70% of whom had TR rated “massive” or “torrential” despite optimal medical therapy. The team assessed major adverse events and echocardiographic, clinical, and functional endpoints to 1 year. At baseline, 14% of patients had pacemakers/implantable cardioverter defibrillators, 89% atrial fibrillation, 53% pulmonary hypertension and 43% renal insufficiency. However, Greenbaum said that the COVID-19 pandemic affected the researchers’ ability to obtain 1-year follow-up data for all treated patients; for example, he noted that some patients completed follow-up questionnaires that could be done remotely but did not complete tests that had to be done at the hospital, such as the echocardiogram and 6-minute walk test. Furthermore, he noted that several patients died, although none died because of the repair procedure. The procedure was unsuccessful because the device failed to attach to the flaps in the tricuspid valve in a few patients, and a few others were lost to follow-up, he said. 1-year data Ultimately, 1-year follow-up results were available for 49 patients, he said, noting that seven patients (10.8%) died and 12 (18.5%) were rehospitalized for heart failure. These results compare with an expected 1-year mortality rate of about 30% for patients with TR, Greenbaum said. 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 (p<0.001). Eleven patients (16.9%) experienced a major adverse event, while significant improvements were seen in heart failure severity with a New York Heart Association class I/II was achieved in 92% (p<0.001) of patients. In 6-minute walk test, patients saw an average increased distance of 94 m (p<0.001), while patient-reported quality of life (via the Kansas City Cardiomyopathy Questionnaire score) improved a mean of 18 points (p<0.001). Statistical analysis showed that freedom from all-cause mortality was 87.9% and freedom from heart failure hospitalization was 78.5% at 1 year by Kaplan-Meier analysis. The authors said that longer follow-up is now needed to determine how well the device continues to perform and how well patients do at 2 years or 5 years of follow-up. Greenbaum noted that a randomized trial is underway that will compare outcomes for patients treated with the PASCAL device and patients who receive optimal medical therapy with diuretics.