• PASCAL Shows Excellent Short-Term, Sustained Survival, MR Reduction

    The CLASP study shows low complication rates, with a sustained reduction in mitral regurgitation and improved clinical outcomes, with the PASCAL transcatheter valve repair system.

    John G. Webb, MD, of St. Paul’s Hospital, Vancouver, British Columbia, and colleagues presented the results Thursday at the PCR e-Course. The study was simultaneously published online in JACC: Cardiovascular Interventions.

    Mitral regurgitation (MR) is the most prevalent valvular disease worldwide, and the COAPT study showed significant benefit with transcatheter mitral valve repair using the MitraClip system (Abbott Vascular). The PASCAL transcatheter valve repair system (Edwards Lifesciences) uses two clasps and paddles to achieve plication of the mitral valve leaflets with an anatomical spacer to fill the regurgitant orifice. The 30-day outcomes of this novel device showed sustained MR reduction with improved functional status, increased exercise capacity, and improved quality of life.

    CLASP is an ongoing multicenter, multinational, single-arm, prospective study of the safety, performance and outcomes of the PASCAL repair system. Eligible patients with MR grade >3+ who were receiving optimal medical therapy and were deemed candidates for transcatheter mitral repair were included in the study.

    A total of 109 patients who were treated between June 2017 to September 2019 at 14 sites worldwide were included in the study. Their mean age was 75.5 years, 54% were men, and their mean Society of Thoracic Surgeons score was 4.7%. All patients had MR grade 3+ or grade 4+; 67% had functional MR and 33% had degenerative MR. Procedural success was achieved in 94% of the patients. The mean number of implants was 1.4 per patient, with 49% receiving only one implant. The mean procedural time was 128 minutes.

    The primary safety endpoint, defined as a composite of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and reintervention, was 8.3% at 30 days. There was one cardiovascular death at 30 days and two additional deaths at 1 year. At 1 year, MR grade <1 was achieved in 79% of patients and <2 in 100% of patients. The one-year survival rate was 92%, with a high rate of freedom from rehospitalization (80% for functional MR and 100% for degenerative MR). Functional improvements were sustained at 1 year, with 88% of patients in New York Heart Association class I or II. The patients’ average Kansas City Cardiomyopathy Questionnaire score improved by 16 points at 30 days and showed sustained improvement of 14 points at 1 year.

    The authors concluded that the PASCAL transcatheter valve repair system shows high survival and low complication rates with excellent sustained MR reduction and significant improvement in functional status. They added that the CLASP IID/IIF randomized clinical, which compares the PASCAL system with MitraClip, is ongoing. 

    In an accompanying editorial, Dr. Stephan Windecker, MD, and colleagues of Bern University Hospital, Switzerland, noted the novelty of the PASCAL transcatheter mitral valve repair system, which is designed to overcome the technical limitations of previous repair systems.

    “There is certainly enough space for multiple devices with different characteristics in the toolbox of transcatheter mitral valve repair,” the editorialists wrote.

    The study received funding from Edwards Lifesciences.

    PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.

    They added that further studies showing head-to-head comparison between the PASCAL system and fourth-generation MitraClip are needed. The PASCAL system might also be a good option in the treatment of tricuspid regurgitation due to thinner leaflets and larger coaptation gaps, the authors wrote.

    PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.

     

    Sources:

    Webb JG, Hensey M, Szerlip M, Schäfer U, et al. One-Year Outcomes for Transcatheter Repair in Patients with Mitral Regurgitation from the CLASP Study. JACC Cardiovasc Interv 2020 Jun 25. https://doi.org/10.1016/j.jcin.2020.06.019

    Windecker S, Winkel MG, Praz F. Adding a Clasp to the Toolbox for Transcatheter Mitral Valve Repair. JACC Cardiovasc Interv 2020 Jun 25. https://doi.org/10.1016/j.jcin.2020.06.021

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