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Worldwide clinical experience with the CorCap Cardiac Support Device
Randall C Starling1, Mariell Jessup
1Section of Heart Failure and Cardiac Transplant Medicine, Kaufman Center for Heart Failure, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio 44195, USA.
Journal of Cardiac Failure
|April 2, 2005
Summary
The CorCap Cardiac Support Device (CSD) shows promise in reducing left ventricular (LV) size and improving ejection fraction in heart failure patients. Early studies indicate sustained benefits and safe implantation, suggesting potential for improved cardiac performance.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Left ventricular (LV) remodeling increases myocardial wall stress, impairing cardiac function and worsening heart failure.
- The CorCap Cardiac Support Device (CSD) is designed to mitigate these effects by providing external myocardial support.
Purpose of the Study:
- To evaluate the safety and efficacy of the CorCap CSD in patients with advanced heart failure.
- To assess the device's impact on LV dimensions, ejection fraction, and clinical status.
Main Methods:
- Initial safety studies involved 48 patients, followed by a randomized controlled trial with 300 patients.
- The trial included arms for mitral valve surgery with CSD and cardiomyopathy with medical therapy alone or with CSD.
- Primary endpoint was a change in clinical composite score from baseline.
Main Results:
- Initial studies showed significant and sustained reductions in LV end-diastolic dimension post-CSD implantation.
- LV ejection fraction significantly improved and was maintained for up to 3 years.
- Hemodynamic data revealed no evidence of constrictive physiology, and implantation was safe.
Conclusions:
- The CorCap CSD can be safely implanted in heart failure patients, demonstrating significant improvements in LV size and function.
- The device shows potential for improving cardiac performance and managing advanced heart failure.
- CE mark approval in Europe and limited market release indicate ongoing clinical evaluation.