A retrospective study investigating the safety and efficacy of the PASCAL and PASCAL Ace System in treating tricuspid regurgitation (TR), published on July 4 in JACC: Cardiovascular Interventions, found that the leaflet repair system has “high technical and procedural success rates with efficient TR reduction.” The study also noted significant clinical and echocardiographic improvement during follow-up.

Mirjam G. Wild, MD, et al., looked at a total of 235 high-risk patients (mean age, 78 years; 49% women) from eight centers in Europe, collecting both observational and echocardiographic data, in what they say is the first report of a multicenter study with a large patient cohort after the system received European approval and with centralized echocardiographic and long-term follow-up.

TR was functional in 87% of patients and classified as severe or higher in 91%. TR was reduced to moderate or less in 78% of patients, and this rate was sustained during follow-up. The study also included a device-specific analysis, which found no difference in TR reduction between the PASCAL and PASCAL Ace.

Overall, the researchers found that use of the PASCAL and PASCAL Ace leaflet repair system resulted in high technical and procedural success rates with few complications, and patient symptoms decreased significantly with 63% in NYHA functional class I or II at follow-up.

To address “large knowledge gaps” on how sex can affect transcatheter treatment outcomes for valvular heart disease, the study additionally conducted a sex-specific analysis which showed women tended to experience more efficient TR reduction, but results were generally comparable among sexes.

In an accompanying editorial comment, Neil P. Fam, MD, MSc, and Geraldine Ong, MD, MSc, note limitations due to the retrospective, observational design of the study. “These generally positive results reinforce the existing data that tricuspid [transcatheter edge-to-edge repair (TEER)] is a safe and moderately effective option to alleviate symptoms and possibly reduce heart failure hospitalization and mortality,” state Fam and Ong. “Although promising, the true place of TEER in the management of patients with TR will be clearly established only by randomized controlled trials compared with medical therapy, which are ongoing.”

Clinical Topics: Heart Failure and Cardiomyopathies, Valvular Heart Disease, Acute Heart Failure

Keywords: Heart Failure, Cardiomyopathies, Aortic Valve Disease

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