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

https://doi.org/10.1016/j.athoracsur.2007.03.095Get rights and content

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.

Section snippets

Overall Study Design

The primary objective of the Acorn trial was to determine the safety and efficacy of the CorCap CSD in patients with heart failure who were receiving optimal medical therapy. Patients who had significant mitral regurgitation and a clinical indication for mitral valve replacement (MVR), as determined by the site clinician, were prospectively enrolled in the MVR stratum (193 patients), and were randomized to either treatment (MVR surgery plus CSD) or control (MVR surgery alone). Patients without

Results

The study enrolled 300 patients at 29 centers. At the common closing date (July 4, 2004) the median duration of follow-up was 22.9 months, with a range of 12 to 48 months. The total patient-years of follow-up were 504 years. Table 1 summarizes baseline demographics. Overall the treatment and control groups were well-balanced; there were, however, small but statistically significant differences with respect to gender and peak oxygen consumption. In addition, diastolic blood pressure was

Comment

The Acorn trial demonstrates that use of a CSD in patients with heart failure leads to salutary changes in LV structure (decreased LV volumes and decreased LV sphericity) and significant improvements in patient functional status and quality of life. The primary endpoint showed that CSD-treated patients had a 73% better odds of having a better clinical outcome relative to patients in the control arm (1.73 [CI: 1.07 to 2.79; p = 0.024]). The individual components of the clinical composite

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*

On behalf of the Acorn Trial Principal Investigators and Study Coordinators. Participating investigators and study centers are listed in Appendix 1.

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