• CLASP TR Reports Favorable 1-Year Safety and Performance Data for Transcatheter Tricuspid Valve Repair with PASCAL System

    Transcatheter tricuspid valve repair with the PASCAL system showed favorable safety and performance at 1-year follow-up in the CLASP TR feasibility study.

    The data, presented Thursday as late-breaking clinical research at EuroPCR 2022 in Paris, reported a significant and sustained tricuspid regurgitation (TR) reduction and reduction in the rate of annualized heart failure hospitalization at 1-year follow-up.

    Presenting the data on behalf of the CLASP TR study investigators, lead author Rebecca Hahn, MD, from Columbia University Irving Medical Center, New York, noted that it is clear that mortality risk increases with TR severity and that previous studies have shown a “near linear relationship” between a between effective regurgitant orifice area (cm2) and regurgitant volume (mL).

    “We also know that outcomes with both medical and surgical therapies are suboptimal,” she said.

    As a result, the study sought to look at the efficacy and safety of the PASCAL repair system for TR.

    Study details

    The CLASP TR study was a prospective, single-arm, multicenter study, with 14 sites in the United States, with the aim of evaluating the safety and performance of the PASCAL transcatheter valve repair system in TR. The primary endpoint was a composite of major adverse events (MAE) at 30 days. Follow-up was planned for 30 days, 6 months, and 1 year and annually through 5 years.

    Hahn noted that 30-day follow-up data were previously reported and that the trial is now reporting a total of 65 patients enrolled, with a 1-year follow up in 46 patients.

    Baseline characteristics showed that 55% of patients were female, with an average Society of Thoracic Surgeons (STS) mortality risk score of 7.7%, while 89% had atrial fibrillation (AF), 37% had prior aortic or mitral valve intervention, and 31% had prior coronary artery bypass grafting.

    “In addition 97% of the patients had severe regurgitation,” she said, noting that “just one patient was deemed by the Core Lab to have moderate to severe.”

    The trial reported a successful implant rate of 91%, with procedural success (defined as a reduction of at least one grade of TR with no further intervention) of 88%, and clinical success (defined as procedural success without MAE at 30 days) of 77%. Hahn added that 95% of patients were discharged to home, with an average length of stay of 2.6 days.

    She noted that a sustained TR reduction was seen in the study: from severe, massive, and torrential, in nearly all patients at baseline, to moderate or less in 75% of patients at 30-day follow-up.

    At 1 year, Hahn said that 100% of patients had improved by at least one TR grade, 75% by at least two TR grades, and 86% reached moderate or less TR classification.

    Significant improvements were also seen in New York Heart Association (NYHA) functional status, 6-minute walking distance, and Kansas City Cardiomyopathy Questionnaire scores, all of which were sustained at 1 year. Indeed, Hahn noted that at 1-year follow-up, 92% achieved NYHA class I or II (P<0.001).

    Cardiovascular mortality was reported to be 3.1% at 30-day and 7.7% at 1-year follow-up. No myocardial infarctions were reported in the trial, and no patients had need for dialysis or renal replacement.

    Hahn noted one reintervention related to a single leaflet device attachment, while severe bleeding was reported at a 9.2% incidence at 1 year, with an overall composite MAE rate of 16.9% at 1 year.

    Survival at 1-year follow-up was 88%, while 1-year freedom from heart-failure rehospitalization was 79%: “This meant that the annualized heart failure hospitalization rehospitalization rate was reduced by 56% in this cohort,” (p=0.005), said Hahn

    The study was funded by Edwards Lifesciences, manufacturer of the PASCAL Transcatheter Repair System.

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