The Acorn CorCap cardiac support device is a simple, yet profound, new investigational strategy for treating moderate heart failure. It is intended to be an adjunctive therapy with standard medical and surgical heart failure management for patients with dilated cardiomyopathy. The biocompatible, mesh-like jacket is slipped around the heart during surgery. By supporting the heart and reducing stress-mediated myocardial stretch, the CorCap is designed to stabilize or reduce heart size and improve cardiac function.
The first human implant in April 1999 launched clinical safety studies in Germany and Australia. Since then, over 315 implantations of the cardiac support device have been performed worldwide. Promising results from the clinical safety studies, plus extensive pre-clinical testing and scientific discovery paved the way to begin worldwide, multi-center, randomized clinical trials. These trials are designed to confirm the safety and further evaluate the efficacy seen in earlier, non-randomized studies of the CorCap.
The randomized trial in the United States began in June of 2000. The Cleveland Clinic was included in the first centers to enroll patients, as cardiologist Randall Starling, MD and cardiothoracic surgeon, Nicholas Smedira, MD, were among the world-wide trial's Principal Investigators. This multicenter prospective trial expanded to include 300 patients from 29 centers across North America. This trial was conducted to evaluate the effectiveness of CorCap therapy in the treatment of heart failure patients with an enlarged heart and progressive symptoms in spite of aggressive medical management.
Patients enrolled in the trial had NYHA class III-IV heart failure and dilated cardiomyopathy, the majority of whom were class III (81%). Of the patients, 193 underwent mitral valve repair/replacement (MVR) and were randomized to MVR alone (n=102) or MVR plus CorCap (n=91). The remaining 107 patients were randomized to either continuing optimal medical therapy alone (n=50) or with the CorCap (n=57).
Results of the study, reported at the American Heart Association Scientific Sessions on November 7, 2004, showed that compared with the control group, those that had the cardiac support device had improvement in size and shape of the heart, and quality of life. They were also less likely to require additional procedures in the future, due to worsening heart failure. Although mortality, systolic function, and hospitalizations were similar in both groups, those with CorCap tended to have more improvement in overall clinical score.
The study concluded CorCap therapy provides modest improvements in patients with heart failure who are symptomatic despite optimal medical therapy as indicated by an improvement in the size and shape of the left ventricle, improved clinical scores, fewer major cardiac procedures related to heart failure, and improvements in quality of life. The device is not suitable for those whose heart failure is so severe that they require LVAD therapy .
The trial sponsor has submitted these results to the FDA for approval so that this viable treatment option can be made available to appropriate heart failure patients in the United States.The ACORN CorCap® is currently approved in Europe. Future studies will look at this device in combination with other treatments, such as resynchronization therapy, to see if CorCap offers further benefit. Less invasive approaches to implement the therapy will also be studied.
Additional information is also available on the Acorn web site*. As Acorn Cardiovascular continually updates this site, it is a good source of information. You may also contact Acorn Cardiovascular by e-mail: info@acorncv.com or mail: ATTN:CORCAP INFO, Acorn Cardiovascular, 601 Campus Drive, St. Paul, MN 55112.
For more information on the treatment of Heart Failure See: The Kaufman Center for Heart Failure website or the Heart Guide
References:
Lisa Nainggolan. New mesh cardiac support device generates much interest. theheart.org, Nov 7, 2004, http://www.theheart.org/viewArticle.do?primaryKey=360263*
Acorn Cardiovascular Announces Positive Clinical Trial Results at American Heart Association Scientific Sessions, Acorn Cardiovascular, http://pub.psbpr.com/acorn/MediaKit/November2004/NewsRelease.pdf *
American Heart Association Scientific Sessions
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