Transcatheter valve repair with the PASCAL system demonstrated significant reductions in tricuspid regurgitation (TR) and improved quality of life at one year, based on findings from the CLASP TR study presented April 4 at ACC.22. The findings offer further validation for transcatheter edge-to-edge repair, according to researchers.

The prospective, single-arm multicenter study was designed to evaluate the safety and performance of the PASCAL transcatheter valve repair system in patients with symptomatic severe TR. The primary endpoint was the composite of major adverse events at 30 days, with follow-up at six months, one year and annually up to five years. The current analysis reflects the follow-up results at one year.

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” 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. Of the initial patient cohort, one-year follow-up data was available for only 46 of the 65 patients as a result of the COVID-19 pandemic.

Of those patients with one-year data, researchers said seven (10.8%) died, 12 (18.5%) were rehospitalized for heart failure and a total of 11 (16.9%) experienced a major adverse event. 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, researchers said. Significant improvements were also seen in heart failure severity, the six-minute walk test and patient-reported quality of life. Researchers noted that survival and freedom from heart failure hospitalization rates were 88% and 79%, respectively, at one year.

“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 Adam Greenbaum, MD, FACC, the study’s lead author. He added that the study was limited by low treatment numbers and an absence of a comparison group. However, he said that the randomized CLASS II TR trial is underway that will compare outcomes for patients treated with the PASCAL and those receiving optimal medical therapy with diuretics.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and Structural Heart Disease

Keywords: ACC Annual Scientific Session, ACC22, Tricuspid Valve Insufficiency, Tricuspid Valve, Transcatheter Aortic Valve Replacement

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