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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.
Background:
Left ventricular (LV) remodeling is related to adverse outcomes in heart failure. The CorCap Cardiac Support Device (CSD; Acorn Cardiovascular, Inc, St. Paul, MN) is an implantable device that attenuates LV remodeling.
Methods:
The Acorn trial assessed the safety and efficacy of the CSD in 300 heart failure patients. Patients needing mitral surgery (n = 193) were randomized to mitral surgery alone or mitral surgery plus CSD. Patients who did not need mitral surgery (n = 107) were randomized to medical therapy or medical therapy plus CSD. The primary endpoint was a clinical composite based on changes in patient vital status, the need for major cardiac procedures for worsening heart failure, and a change in New York Heart Association (NYHA) class.
Results:
The proportional odds ratio for the primary endpoint favored treatment with the CSD (1.73 confidence interval [CI]: 1.07 to 2.79; p = 0.024). The CSD-treated patients received significantly (p = 0.01) fewer cardiac procedures indicative of worsening heart failure and had an improvement in New York Heart Association class (p = 0.049). There was no significant difference in survival between groups (p = 0.85). Treatment with the CSD led to a decrease in LV end-diastolic (p = 0.009) and end-systolic volumes (p = 0.017), an increase in the LV sphericity index (p = 0.026), an improvement in the Minnesota Living with Heart Failure score (p = 0.04), and the Short Form-36 Questionnaire (p = 0.015). There was no evidence for a significant difference (p = 0.43) in serious adverse events between the treatment and control groups.
Conclusions:
The results of the Acorn trial support the hypothesis that preventing LV remodeling with a CSD favorably impacts the untoward natural history of heart failure.
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