The following is a summary of “1-Year Outcomes of Transcatheter Tricuspid Valve Repair,” published in the May 2023 issue of Cardiology by Kodali, et al.
Isolated tricuspid regurgitation (TR) often requires surgical management, associated with high morbidity and mortality. Therefore, there was a need for a lower-risk transcatheter solution for TR. For a CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study), researchers sought to evaluate the 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) for treating TR.
The single-arm, multicenter, prospective study enrolled patients with a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study assessed primary safety and performance outcomes and echocardiographic, clinical, and functional endpoints. The study investigators reported 1-year all-cause mortality and heart failure hospitalization rates.
A total of 65 patients were enrolled, with a mean age of 77.4 years. Of the participants, 55.4% were female, and 97.0% had severe torrential TR. At 30 days, the cardiovascular mortality rate was 3.1%, and the stroke rate was 1.5%. No device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One year after the procedure, TR severity significantly decreased (P < 0.001), with 31 out of 36 patients (86.0%) achieving moderate or less TR. All patients experienced at least a one-grade reduction in TR. Kaplan-Meier analyses showed a freedom from all-cause mortality rate of 87.9% and a freedom from heart failure hospitalization rate of 78.5%. There was a significant improvement in New York Heart Association functional class (P < 0.001), with 92% of patients in class I or II. The 6-minute walk distance increased by 94 meters (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001).
The PASCAL system demonstrated low complication rates and high survival rates. It resulted in significant and sustained improvements in TR severity, functional status, and quality of life at the 1-year follow-up.