• PASCAL Registry Data Show Valve Repair System Is Effective in High-Risk Patients with Complex Anatomy

    Transcatheter edge-to-edge repair (TEER) with the PASCAL valve repair system is both safe and clinically effective in prohibitive-risk patients with degenerative mitral regurgitation (DMR) and complex valve anatomy, according to new 30-day and 6-month follow-up data.

    The findings, reported Saturday at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston, suggest that the PASCAL system is beneficial for prohibitive-risk DMR patients with complex mitral valve anatomy, who have historically been considered less suitable for TEER.

    Speaking on behalf of his fellow investigators at TCT 2022, Jörg Hausleiter, MD, from Klinikum der Universität München, Germany, said the findings may expand treatment options for these high-risk patient groups.

    “The PASCAL IID registry is the first prospective, multinational registry to evaluate M-TEER

    using the PASCAL system in prohibitive-risk DMR patients with complex mitral valve anatomy,” he said, noting that follow-up data now demonstrate favorable safety, with a high survival of 97.9% and composite major adverse events (MAE) rate of 11.2% at 30 days, and significant improvements in symptoms and quality of life.

    Study setup

    Hausleiter noted that the PASCAL IID registry is a prospective, multicenter, multinational, single-arm registry within the construct of the CLASP IID trial. The registry was set up to assess the safety, echocardiographic and clinical outcomes of the PASCAL transcatheter valve repair system in prohibitive-surgical-risk patients with significant symptomatic DMR and complex mitral valve anatomy, he added.

    “The main trial compared in randomized fashion the PASCAL system with the MitraClip system,” he said, noting, however, that for patients who presented with a complex morphology, the study criteria meant they were unable to be randomized in the trial due to a lack of data in these patients for the MitraClip device.

    Those patients, however, could be deemed suitable for the PASCAL device, were enrolled in the PASCAL IID registry, and were followed to assess MAE and a range of clinical outcomes including reduction in mitral regurgitation (MR) and New York Heart Association (NYHA) functional class.

    Key findings

    Hausleiter reported a 30-day composite MAE rate of 11.2% (11 of 98 patients), which persisted to 6-month follow-up (freedom from MAE: 88.8% at 30 days vs. 85.6% at 6 months).

    He noted that 30-day data showed very low cardiovascular mortality, low stroke rate and low myocardial infarction (all 1% incidence) – adding that the higher composite endpoint incidence was driven by rate of bleeding complications, which was 7.1%.

    “After the 30 days, only three additional events occurred, which resulted in still a very high rate of freedom from major adverse events above 85%,” he added.

    Furthermore, Hausleiter noted that MR was found to be significantly reduced (p<0.001) at all follow-up points: citing 92.4% of patients were MR ≤2+ at 6 months (grade 0: 7.6%; 1+: 48.5%; 2+: 36.4%; 3+: 7.6%), while almost all patients were 3+ or 4+ at baseline (2+: %; 3+: 27.3%; 4+: 71.2%).

    There was also a significant improvement in NYHA functional class score at 6 months, he said, noting that at baseline, just 31.6% were Class I or Class II, while at 6-month follow-up, 84.2% were Class I or Class II (p<0.001).

    Image Credit: Jason Wermers/CRTonline.org

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