Clinical evaluation of the CorCap Cardiac Support Device in patients with dilated cardiomyopathy

Douglas L Mann1, Michael A Acker, Mariell Jessup

  • 1Baylor College of Medicine, Houston, Texas, USA. dmann@bcm.tmc.edu

Insights

The CorCap Cardiac Support Device (CSD) reduces adverse outcomes in heart failure by attenuating left ventricular remodeling. This implantable device improved patient outcomes and reduced the need for cardiac procedures in the Acorn trial.

Area of Science:

  • Cardiology
  • Biomedical Engineering

Background:

  • Left ventricular (LV) remodeling is a significant contributor to adverse outcomes in heart failure patients.
  • The CorCap Cardiac Support Device (CSD) is designed to mitigate LV remodeling.
  • Understanding the impact of CSD on heart failure progression is crucial.

Purpose of the Study:

  • To assess the safety and efficacy of the CorCap Cardiac Support Device (CSD) in patients with heart failure.
  • To evaluate the CSD's effect on clinical outcomes and LV remodeling.
  • To determine if CSD implantation improves the natural history of heart failure.

Main Methods:

  • The Acorn trial randomized 300 heart failure patients into two groups: those needing mitral surgery and those not.
  • Patients were assigned to either standard treatment or standard treatment plus CSD implantation.
  • The primary endpoint combined vital status, major cardiac procedures for heart failure, and New York Heart Association (NYHA) class.

Main Results:

  • The CSD group showed a statistically significant benefit in the primary endpoint (proportional odds ratio = 1.73, p = 0.024).
  • CSD patients experienced fewer cardiac procedures and improved NYHA class (p = 0.049).
  • Significant reductions in LV end-diastolic and end-systolic volumes and increased LV sphericity were observed in the CSD group, with no significant increase in adverse events.

Conclusions:

  • The Acorn trial results support the use of CSD to prevent LV remodeling in heart failure.
  • The CSD favorably impacts the natural history of heart failure by attenuating adverse remodeling.
  • CSD implantation is a promising therapeutic strategy for managing heart failure patients.
Abstract

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