Worldwide clinical experience with the CorCap Cardiac Support Device.

It has been hypothesized that the mechanical burden associated with LV remodeling leads to increased myocardial wall stress and adverse remodeling, all of which serve to further impair cardiac performance and contribute to disease progression. The CorCap Cardiac Support Device (CSD) (Acorn Cardiovascular, Inc., St. Paul, Minnesota) is a mesh-like device that is surgically implanted around the heart. The device is designed to provide circumferential myocardial wall support, and reduce wall stress and myocyte stretch. Clinical experience with CorCap CSD implants in patients with heart failure can be divided into 3 phases: (1) initial safety studies, (2) randomized controlled trials, and (3) limited marketed release. Initial safety studies were undertaken in 48 patients recruited between April 1999 and April of 2001. In 11 patients with complete follow-up, it was noted that LV size, as measured by LV end-diastolic dimension, significantly decreased as early as 3 months postimplant, with an even greater reduction at 6 months. Most importantly, this benefit was sustained, so that the LV end-diastolic dimension stayed smaller at 1, 2, and 3 years of follow-up. There was also an improvement in LV function, as manifested by changes in LV ejection fraction. Ejection fraction was significantly increased by 3 months and appeared to reach a peak improvement by 6 months. This benefit was likewise maintained at 1, 2, and 3 years postsurgery. Hemodynamic data did not show any evidence of constrictive physiology. These preliminary safety studies had shown that the CorCap CSD could be implanted safely and without excess operative morbidity or mortality. The primary objective of the Acorn Randomized Clinical Trial is to assess the efficacy and safety of the CorCap CSD in patients with advanced heart failure despite optimal medical therapy. A randomized trial with 2 arms (mitral valve surgery randomized to CSD and cardiomyopathy randomized to medical therapy alone or with CSD) enrolled 300 patients. The primary endpoint of the trial is a change in clinical status from baseline to the end of the efficacy phase as determined by a clinical composite score. The Acorn CorCap CSD received CE mark approval in Europe in 2001 and has been available to a small number of centers in a Limited Market Release Surveillance Study (LMRSS).

RCT Entities:   Population Interventions Outcomes