The PASCAL system is a low-risk transcatheter solution, said researchers in a new study that underlines its low complication and high survival rates, culminating in a higher quality of life after 1 year. The follow-up study concluded that the system is an effective surgical management tool for isolated tricuspid regurgitation (TR), with the team noting significant and sustained improvements in the heart valve disease. “Reduction in TR at one year was significant and sustained with a low major adverse event (MAE) rate in patients at high risk for surgical complications,” said the study published Monday online and in the May 9 issue of the Journal of the American College of Cardiology. “With significant TR reduction and durable outcomes at one year, the PASCAL system is a valuable alternative to surgery or medical management alone in patients with severe TR.” The single-arm, multicenter, prospective format used Edwards Lifesciences’ PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) in the early feasibility study funded by the medical technology company. The new results are in line with the initial 30-day results from the first 34 patients enrolled, which were published in 2021. Patient profile Researchers enrolled 65 patients with a mean age of 77.4 years; 55.4% female; and 97.0% with symptomatic, severe functional or degenerative TR. Patients received heparin during the procedure to ensure an activated clotting time of at least 250 seconds. Those not already taking anticoagulant agents were given 81mg aspirin/day for 30 days after implantation. Patients are followed up at discharge, 30 days, 6 months, 1 year and annually for 5 years post-implantation. The safety endpoint was a composite of clinical events committee-adjudicated MAEs at 30 days that included cardiovascular mortality, myocardial infarction, stroke, and renal complications requiring unplanned dialysis or renal replacement therapy. Performance endpoints included implant, procedural and clinical success. Main results Results revealed that of the 65 enrolled patients, 45 completed the 1-year visit. At 30 days, cardiovascular mortality 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 three cardiovascular deaths (4.8%), two strokes (3.2%), and one unplanned or emergency reintervention (1.6%). One-year post procedure, TR severity was significantly reduced (P<0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR with 100% achieving at least one TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively, at 1 year. The patients’ New York Heart Association functional class significantly improved (P<0.001) with 92% in class I or II, 6-minute walk distance increased by 94m (P=0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P<0.001). PASCAL system compared favorably “The 1-year mortality reported in the CLASP TR study was favorable, at only 10.8% with an HFH [heart failure hospitalization] rate of 18.5% and an annualized reduction in HFH of 56.4%, thus supporting the theory that tricuspid valve repair with the PASCAL system would also compare favorably to patients treated with medical therapy alone,” reported the researchers, led by Susheel K. Kodali, MD, of Columbia University Irving Medical Center, New York. Commenting on the 86% of patients whose procedure resulted in moderate or less TR at 1 year, the team highlights the HFH rate as nearly 40% lower than those with severe or greater residual TR. “The magnitude suggests that resultant moderate or less TR is important when performing leaflet repair,” the researchers said. “This suggestion is in line with additional studies that demonstrated outcomes are dependent on the degree of residual regurgitation.” In an accompanying editorial comment, Wayne B. Batchelor, MD, Abbas Emaminia, MD, and Kelly Epps, MD, from the Inova Heart and Vascular Institute in Falls Church, Virginia, described the results as “encouraging and consistent with those reported following commercial PASCAL approval in Europe.” Despite this, the editorialists advised caution in the interpretation of the results, adding that the nonrandomized and unblinded study design renders it prone to potential bias and placebo effects. Tricuspid valve disease challenges The expert commenters also highlight that 10% of patients did not undergo successful tricuspid valve transcatheter edge to edge repair (T-TEER) as a result of anatomical complexity. Other points of discussion included the treatment failure in another patient due to poor intraprocedural echocardiographic imaging. “This finding reflects the inherent challenges of dealing with the anatomical complexities of tricuspid valve disease and achieving optimal intraprocedural imaging,” the editorial writers said. “With no knowledge of what proportion of patients were excluded by the screening committee (and why), it is difficult to appreciate the generalizability of the results.” While the study and others provide compelling “proof of concept” for T-TEER as a promising treatment modality, the commenters wrote that the study falls short of defining the true incremental benefit of T-TEER with PASCAL over optimal medical therapy. Further insight on this benefit is expected from the results of the CLASP II TR Trial, especially in the wake of the recently published TRILUMINATE Pivotal Trial, the editorialists write. The prospective randomized study showed that TEER with the TriClip device was effective in reducing TR and improving quality of life, but did not influence one-year mortality, HFH, or 6-minute walking test results. Sources: Kodali SK, Hahn RT, Davidson CJ, et al. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol. 2023;81:1766–1776. Batchelor WB, Emaminia A, Epps K. CLASP TR EFS 1-Year Results: Coming of Age of Tricuspid Valve Edge-to-Edge Repair? J Am Coll Cardiol. 2023;81:1777–1779. Image Credit: Edwards Lifesciences