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Ann Thorac Surg 2007;84:1226-1235
© 2007 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Clinical Evaluation of the CorCap Cardiac Support Device in Patients With Dilated Cardiomyopathy

^a Baylor College of Medicine, Houston, Texas
^b University of Pennsylvania, Philadelphia, Pennsylvania
^c Henry Ford Health Care System, Detroit, Michigan
^d The Cleveland Clinic Foundation, Cleveland, Ohio
^e Acorn Cardiovascular Inc, St. Paul, Minnesota

Accepted for publication March 19, 2007.

^_* Address correspondence to Dr Mann, Winters Center for Heart Failure Research, MS F524, 6565 Fannin, Houston, TX 77030 (Email: dmann{at}bcm.tmc.edu).

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.

Related Article

Sustained Benefits of the CorCap Cardiac Support Device on Left Ventricular Remodeling: Three Year Follow-up Results From the Acorn Clinical Trial

Randall C. Starling, Mariell Jessup, Jae K. Oh, Hani N. Sabbah, Michael A. Acker, Douglas L. Mann, and Spencer H. Kubo
Ann. Thorac. Surg. 2007 84: 1236-1242. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

				R. C. Starling, M. Jessup, J. K. Oh, H. N. Sabbah, M. A. Acker, D. L. Mann, and S. H. Kubo Sustained Benefits of the CorCap Cardiac Support Device on Left Ventricular Remodeling: Three Year Follow-up Results From the Acorn Clinical Trial Ann. Thorac. Surg., October 1, 2007; 84(4): 1236 - 1242. [Abstract] [Full Text] [PDF]