CorCap™: A Support Device for the Failing Heart

CorCap™ is a supportive device that is sewn around the heart to help normalize its shape and function. It may improve quality of life for some patients with heart failure.

The CorCap™ Cardiac Support Device

Photo courtesy of Acorn Cardiovascular, Inc.

Heart Failure

In heart failure, the heart becomes progressively enlarged and less efficient at pumping blood. Patients become tired and short of breath with everyday activities. Heart failure is common with aging, can be hard to treat, and is a leading cause of hospital admission.[1]

How It Works

The CorCap™ Cardiac Support Device (CSD) is a pliable mesh-like structure that is sutured into place around the heart during open heart surgery.

Who Might Benefit

More than 400,000 Canadians have heart failure, and about 50,000 new cases are diagnosed each year.[1] The prevalence of heart failure is increasing as the population ages and the management of other heart diseases improves. New drugs and technologies have helped, although survival rates have improved little over recent decades.[1] The CorCap device is intended for patients with moderate to severe heart failure that is worsening despite drug therapy.[2]

Regulatory Status

CorCap CSD (Acorn Cardiovascular) is not licensed in Canada and is approved only for investigational use in the US. In 2005, the US Food and Drug Administration did not approve the device due to lack of clear evidence of effectiveness, possible increased surgical risk, and concerns about the difficulty of subsequent heart surgery.[2] According to Acorn Cardiovascular, an additional study has been initiated to assess the device’s safety and efficacy in 50 to 75 patients undergoing concomitant mitral valve repair; results are anticipated in 2008. The CorCap CSD is available in Europe.

Evidence

The Acorn CSD study included 300 patients in North America (almost equally men and women; average age of 52 years); 193 of the patients (64%) also required mitral valve surgery. By 2003, all patients had entered the study and half were randomly assigned to receive CorCap. After three years of follow-up, patients with CorCap devices showed statistically significant improvements in some (but not all) aspects of cardiac function, had better quality of life, and needed fewer additional heart operations; however, survival and the rate of repeat hospitalizations were no better.[3-5]

Cost

No device cost information is available. As open heart surgery is required, device insertion would be costly, although the procedure takes less than 30 minutes and in some patients could be done along with other necessary heart surgery.[5] Costs may be offset if further heart procedures are avoided — particularly heart transplantation, which is expensive, has poor outcomes, and is limited by the lack of available organs.[6]

References

[1] Rich MW. CMAJ 2005;173(1):53-4. Available: http://www.cmaj.ca/cgi/reprint/173/1/53
[2] Weinstein L. Ombudsman's summary of the scientific issues in dispute for the Medical Devices Dispute Resolution Panel Meeting on Acorn Cardiovascular, Inc.'s CorCap CSD. Rockville (MD): U.S. Food and Drug Administration; 2006. Available: http://www.fda.gov/ohrms/dockets/ac/06/questions/2006-4269q1_final.pdf
[3] Starling RC, et al. Ann Thorac Surg 2007;84(4):1236-42.
[4] Mann DL, et al. Ann Thorac Surg 2007;84(4):1226-35.
[5] Starling RC, et al. J Card Fail 2004;10(6 Suppl):S225-33.
[6] Olsson A, et al. Eur J Cardiothorac Surg 2005;28(3):448-53.