The American Heart Association ACORN Trial Assessment of a New Mesh Cardiac Support Device (CSD) in Patients with Heart Failure Presented at The American Heart Association Scientific Sessions 2004 Presented by Dr. D.L. Mann

300 Patients with Heart Failure CorCap Cardiac Support Device ACORN Trial 300 Patients with Heart Failure 81.3% NYHA Class III, 3.7% Class IV 55% male, mean age 52.5 years 97% received ACE inhibitor or angiotensin receptor blocker, 85% beta-blockers, 98% diuretic CorCap Cardiac Support Device n=148 91 received mitral valve repair Control n=152 102 received mitral valve repair Primary Endpoint: Composite classification of improved, the same, or worse based on occurrence of death, change in NYHA class, or cardiac procedure indicative of HF progression Presented at AHA 2004

ACORN Trial: Primary Endpoint In the primary composite endpoint, more patients in the CSD group than in the control group were classified as improved, while fewer were classified as worse for a significant odds ratio of 1.73 (p=0.02) Presented at AHA 2004

ACORN Trial: Primary Endpoint The primary composite endpoint was largely driven by a significant reduction in major cardiac procedures and a trend toward improvement in NYHA in the CSD group compared with the control group. There was no difference between the two groups in the third component of the primary endpoint, mortality (p=0.90) p=0.12 p=0.01 Presented at AHA 2004

ACORN Trial Any adverse event p=NS There was no difference in the frequency of adverse events between the CSD and control groups (left), and LV ejection fraction was not statistically different (p=0.45) between the groups However, the CSD was associated with a reduction in LV end diastolic (p=0.009) and end systolic (p=017) volumes, an improvement in sphericity index (p=0.026), and an improvement in quality-of-life, both by the Minnesota Living with HF measure (p=0.05) and the SF-36 score (p=0.015) Presented at AHA 2004

ACORN Trial: Summary Among patients with heart failure and dilated cardiomyopathy, the CorCap cardiac support device was associated with a significantly improved primary endpoint score compared to control. The primary composite endpoint was a classification of improved, the same, or worsened based on rates of death, major cardiac procedures indicative of HF progression, or changes in NYHA class. The primary endpoint was largely driven by a significant reduction in major cardiac procedures and a trend toward improvement in NYHA in the CSD group compared to the control group. There was no difference between the two groups in mortality. The CSD group had significantly lower LV end diastolic and systolic volumes, a significantly greater improvement in sphericity index, and significant improvements in measures of quality-of-life than the control group. However, the groups had similar LV ejection fractions and similar rates of adverse events, including repeat hospitalizations.