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1-Year Outcomes of Transfemoral Transcatheter Mitral Valve Replacement With the Eos System: The MISCEND Study

Raj Makkar1, Moody M Makar1, Sabah Skaf1

  • 1Cedars-Sinai Medical Center, Los Angeles, California, USA.

JACC. Cardiovascular Interventions
|September 24, 2025
PubMed
Abstract

Insights

Transcatheter mitral valve replacement (TMVR) using the Eos system shows feasibility and improves patient function. However, left ventricular pseudoaneurysm concerns led to study cessation, guiding future device development.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Devices

Background:

  • Transcatheter mitral valve replacement (TMVR) offers a potential solution for high-risk patients suffering from mitral regurgitation (MR).
  • The Eos system represents a novel transcatheter device for TMVR.

Purpose of the Study:

  • To evaluate the 30-day and 1-year safety and performance outcomes of the transfemoral Eos TMVR system.
  • To assess clinical, echocardiographic, functional, and quality-of-life improvements in patients undergoing TMVR.

Main Methods:

  • The MISCEND study prospectively evaluated the Eos TMVR system in a single-arm, multicenter setting.
  • Key endpoints included device success, procedural success, MR severity, and major adverse events at 30 days.
  • Long-term outcomes through 1 year included functional status and quality of life.

Main Results:

  • 100% device and procedural success rates were observed in 60 patients.
  • Significant improvements in 6-minute walk distance and quality of life were noted at 1 year.
  • The 30-day composite major adverse event rate was 43.3%, with a 1-year mortality of 20.3% and a 10.0% rate of left ventricular pseudoaneurysm.

Conclusions:

  • The Eos TMVR system demonstrated feasibility and functional improvement in patients with mitral regurgitation.
  • Left ventricular pseudoaneurysm emerged as a safety concern, leading to study enrollment cessation.
  • Learnings from this study will inform the development of future TMVR technologies.
Keywords:
degenerative mitral regurgitationearly feasibility studyfirst-in-humanfunctional mitral regurgitationtranscatheter mitral valve intervention

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