Edwards’ Pascal Tricuspid Valve Repair System Evaluated in CLASP TR EFS at 1 Year

April 4, 2022—The American College of Cardiology (ACC) announced 1-year follow-up findings from the Edwards CLASP TR EFS, an early feasibility study assessing the safety and performance of Edwards Lifesciences’ investigational Pascal transcatheter tricuspid valve repair system in tricuspid regurgitation. The study was funded by Edwards Lifesciences.

According to ACC, patients with tricuspid regurgitation who received the Pascal device to repair the defective valve experienced significant improvements in blood flow through the heart and in quality of life at 1 year.

The findings were presented at ACC.22, the college’s 71st annual scientific session held April 2-4 in Washington, DC.

In the ACC press release, Adam B. Greenbaum, MD, commented, “At 1 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.” Dr. Greenbaum is Associate Professor of Medicine and Codirector of the Structural Heart and Valve Center at Emory University School of Medicine in Atlanta, Georgia.

The study offers further validation for transcatheter edge-to-edge repair, a minimally invasive approach to the treatment of patients with the disease, advised Dr. Greenbaum. He further noted that minimally invasive options are needed to treat tricuspid regurgitation, as most patients with the condition are older and may have other health problems that make them poor candidates for open heart surgery.

The CLASP TR EFS endpoints included a composite of major adverse events at 30 days (eg, death due to cardiovascular disease, heart attack, stroke, kidney failure, severe bleeding); evidence on an echocardiogram of a reduction in backward blood flow; and death from any cause, distance walked in 6 minutes and scores on two measures of heart failure severity. ACC noted that a preliminary report published in February 2021 found that at 30 days of follow-up, the repair system substantially reduced tricuspid regurgitation, produced few adverse events, and significantly improved patients’ ability to function, exercise capacity and quality of life. Susheel Kodali, MD, et al published the findings in Journal of the American College of Cardiology (2021;77:345-356).

In the study, a total of 65 patients (average age 77, 55% women) received the investigational device, 70% of whom had tricuspid regurgitation that was rated “massive” or “torrential” (the two highest grades of severity on a five-point scale) despite treatment with diuretics. In addition, most had other health problems that made them poor candidates for surgery, including atrial fibrillation, liver or kidney disease, and pulmonary hypertension.

Dr. Greenbaum noted that the COVID-19 pandemic affected the investigators’ ability to obtain 1-year follow-up data for all treated patients. For example, 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. In addition, several patients died (although none died because of the repair procedure). In a few patients, the procedure was unsuccessful because the device failed to attach to the flaps in the tricuspid valve; and a few patients were lost to follow-up.

As summarized in the ACC press release, the 1-year follow-up results were available for 49 patients. 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 approximately 30% for patients with tricuspid regurgitation, reported Dr. Greenbaum.

The investigators found that 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. Eleven patients (16.9%) experienced a major adverse event. Significant improvements were seen in heart failure severity, the 6-minute walk test, and patient-reported quality of life.

Dr. Greenbaum advised that longer follow-up is needed to determine how well the device continues to perform and how well patients do at 2 years or 5 years of follow-up. Limitations of the study include low patient treatment numbers and an absence of a comparison group. A randomized trial is now underway that will compare outcomes for patients treated with the investigational device and patients who receive optimal medical therapy with diuretics, noted Dr. Greenbaum in the ACC press release.