Late-Breaking Clinical Trials Abstracts

Abstract

Douglas L. Mann, MD, The Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas Background: Progressive left ventricular (LV) remodeling is part of the unfavorable natural history in patients with heart failure (HF). The CorCap Cardiac Support Device (CSD) is a mesh device that is implanted around the heart to reduce wall stress and the first therapy specifically designed to address LV remodeling. Early clinical studies have shown that the CSD is safe and associated with improvements in LV structure and function and patient symptoms. Design: This multicenter prospective trial enrolled 300 patients with NYHA Class III-IV HF and dilated cardiomyopathy. 193 patients underwent mitral valve repair/replacement (MVR) and were randomized to either MVR alone or MVR plus CSD. 107 patients were randomized to either continued optimal medical therapy alone or with the CSD. Patients were followed to a common closing date 12 months after the last patient was enrolled (median follow up 22 months). Results: The primary endpoint was a clinical composite with patients classified as improved, same or worsened based upon the occurrence of death, a major cardiac procedure indicative of HF progression and a change in NYHA class. Compared to the control group, the CSD group had more patients “improved” (38% vs. 27%) and fewer patients “worsened” (37% vs. 45%), yielding an odds ratio of 1.73 (1.07, 2.79; p = 0.02). The CSD group had fewer major cardiac procedures (e.g. transplant, LVAD) compared to controls (19 vs. 33; p = 0.01), a greater reduction in LV end diastolic (p = 0.009) and systolic volumes (p= 0.017) and a greater improvement in sphericity index (p=0.026). Quality of life (Minnesota Living with HF and SF 36) was significantly improved in the CSD group (p=0.05 and p = 0.015 respectively). Repeat hospitalizations and adverse events …