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A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
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1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation

Robert L Smith1, D Scott Lim2, Linda D Gillam3

  • 1Baylor Scott and White: The Heart Hospital Plano, Plano, Texas, USA.

JACC. Cardiovascular Interventions
|October 31, 2023
PubMed

Insights

Transcatheter edge-to-edge repair using the PASCAL system is safe and effective for high-risk patients with degenerative mitral regurgitation. One-year results show significant improvement in heart function and quality of life.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Devices

Background:

  • The CLASP IID Registry evaluated the Edwards PASCAL transcatheter valve repair system.
  • Transcatheter edge-to-edge repair (TEER) is an option for degenerative mitral regurgitation (DMR) in patients unsuitable for surgery.

Purpose of the Study:

  • To assess the 1-year safety and clinical outcomes of TEER with the PASCAL system.
  • To evaluate echocardiographic, functional, and quality-of-life improvements in patients with complex mitral valve anatomy and prohibitive surgical risk.

Main Methods:

  • Prospective enrollment of 98 patients with severe DMR (3+ or 4+) and complex anatomy.
  • Assessment of safety, echocardiographic parameters, and clinical endpoints at 1 year post-procedure.
  • Oversight by a central screening committee, echocardiographic core laboratory, and clinical events committee.

Main Results:

  • One-year Kaplan-Meier estimates for freedom from major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively.
  • Significant reduction in mitral regurgitation (MR) was observed, with 93.2% achieving MR ≤2+ and 57.6% achieving MR ≤1+.
  • Substantial improvements in New York Heart Association (NYHA) functional class and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were noted.

Conclusions:

  • The PASCAL system demonstrated safety and efficacy in reducing MR at 1 year in high-risk patients.
  • Continued improvements in clinical, echocardiographic, functional, and quality-of-life outcomes highlight the PASCAL system's value.
  • TEER with the PASCAL system is a viable treatment option for severe DMR in patients with complex anatomy and prohibitive surgical risk.
Abstract

Keywords:
PASCAL systembileaflet/multiscallop prolapsecommissural jetmultiple jetssmall valve

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