PASCAL Repair Reduces Tricuspid Regurgitation: CLASP TR Study

Tricuspid regurgitation affects an estimated 1.6 million people in the U.S. and increases as each generation ages. Recent retrospective studies suggest high in-hospital mortality of w9% with isolated tricuspid valve (TV) surgery, resulting in the growing interest in transcatheter solutions for TR. However, there are limited Conformité Européene (CE mark)-approved transcatheter devices to treat TR (15–17). In a compassionate use experience, the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, California) demonstrated high procedural success, acceptable safety and significant clinical improvement in patients with challenging tricuspid anatomy and severe TR. Recently Dr Adam B. Greenbaum presented a one-year follow-up outcome on the safety and performance of the PASCAL transcatheter valve repair system in patients with symptomatic severe TR.

The CLASP-TR prospective, single-arm multicenter feasibility study in which 65 patients received the investigational device, 70% of whom had tricuspid regurgitation that was rated "massive" or "torrential" despite treatment with diuretics. Of the initial patient cohort, one-year follow-up data were available for only 46 of the 65 patients as a result of the COVID-19 pandemic. The major outcomes assessed were a composite of major adverse events at 30 days (e.g., 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 six minutes and scores on two measures of heart failure severity.

Key findings of the study:

• Among 46 patients, the researchers observed seven (10.8%) died, 12 (18.5%) were rehospitalized for heart failure and a total of 11 (16.9%) experienced a major adverse event.
• They noted that all patients achieved a reduction of at least one grade in the severity of their tricuspid regurgitation, with 75% seeing a reduction of at least two grades and 86% achieving an overall grade of moderate or less.
• They also found significant improvement in heart failure severity, the six-minute walk test and patient-reported quality of life.
• They noted that survival and freedom from heart failure hospitalization rates were 88% and 79%, respectively, at one year.

The authors concluded, "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. Longer follow-up is needed to determine how well the device continues to perform and how well patients do at two years or five years of follow-up."

They further added, "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."

For further information:

Greenbaum A. Transcatheter treatment of tricuspid regurgitation: one-year results of the CLASP TR study. ACC 2022. April 4, 2022. Press release.

Keywords: ACC Annual Scientific Session, ACC22, Tricuspid Valve Insufficiency, Tricuspid Valve, Transcatheter Aortic Valve Replacement, CLASP-TR Study, PASCAL, tricuspid regurgitation, heart failure.