Passive containment and reverse remodeling by a novel textile cardiac support device

Background-Progressive remodeling and dilation of cardiac chambers is respo nsible in part for myocardial dysfunction in chronic heart failure. Preclin ical studies with suitable animal models indicate that a passive cardiac co nstraint device can promote reverse remodeling, with improvement in cardiac function. We hypothesize that such a device could provide benefit for stab le heart failure patients in New York Heart Association (NYHA) class II and III. Methods and Results-From April 1999 to March 2000, 27 patients received Aco rn's Cardiac Support Device (CSD) during an initial safety/feasibility stud y. In 11 patients, the only surgical measure was CSD placement. Most patien ts suffered from idiopathic cardiomyopathy; 4 were in NYHA class II, one wa s in class II/III, and 6 were in class III. All were stable on intensive me dical treatment. The CSD, a textile polyester device, was fitted snugly aro und the heart during surgery. All patients survived surgery and recovered s moothly. Three months after surgery, 56% of patients were in NYHA class I, 33 % were in class II and 11% were in class II/III. Echocardiography showed an improvement in left ventricular ejection fraction from an average of 22 % to 28% and 33% at 3 and 6 months, respectively. Simultaneously, the left ventricular end-diastolic dimension decreased from 74 mm to 68 mm and 65 mm , respectively. Mitral valve regurgitation (on a scale of 0 to 4+) decrease d from 1.3 to 0.7 by 3 months. Quality-of-life indices correlated with the apparent reversal of ventricular remodeling. Preoperative cardiac medicatio ns remained virtually unchanged after implant. Conclusions-In the short- and intermediate-term, CSD implantation seems to ameliorate symptoms and improve cardiac and functional performance in heart failure patients. Worldwide randomized trials are currently underway.