Reverse remodeling of the failing ventricle: surgical intervention with the Acorn Cardiac Support Device.

Preclincial studies have shown that an innovative meshlike cardiac support device (CorCap, Acorn Cardiovascular, Inc., St. Paul, MN) can provide end diastolic support to reduce mechanical stress, improve function, and reverse cardiac remodeling. The CorCap device has been implanted worldwide in more than 130 patients with dilated cardiomyopathy (idiopathic or ischemic), with or without concomitant cardiac surgery. A series of 48 patients was implanted in initial safety and feasibility studies (33 received concomitant cardiac surgery, 15 patients received the CorCap device only). At implant, 33 patients were in New York Heart Association functional class III, 11 in class II, and four in class IV. There were no device-related intraoperative complications, deaths, or adverse events. Eight early and nine late deaths occurred during follow-up extending to 18-24 months. During follow-up, chamber dimensions decreased, and ejection fraction and New York Heart Association functional class improved. The CorCap device is correlated with improvements in patient functional status. Randomized clinical trials are underway in Europe, Australia, and North America.