Congress Reports

ESHonline Coverage, based on selected sessions at the:
American Heart Association 2004 Annual Scientific Sessions
November 7 - 10, 2004, New Orleans, Louisiana

This activity is not sanctioned by, nor a part of, the Americann Heart Association.



 
 


Novel Device Improves Outcomes and Functional Capacity in Heart Failure Patients

November 7, 2004 (eshonline.org) – The novel investigational CorCap™ Cardiac Support Device (CSD) reversed the natural history of heart failure, as indicated by improvements in the size and shape of the left ventricle, and improvements in the clinical score, fewer major cardiac procedures, and improvements in quality of life, in a study reported at the American Heart Association Scientific Sessions 2004. The CSD is a proprietary mesh wrap that is implanted around the heart to support the myocardium, and by unloading the heart helps it to regain its size and shape. By stretching longitudinally, it encourages the myocardium towards a more elliptical shape when pumping.

In the multicenter, prospective Clinical Evaluation of the CORCAP Cardiac Support Device in Patients with Dilated Cardiomyopathy trial of patients with NYHA class III-IV heart failure, 193 patients had mitral valve replacement/repair (MVR) and were then randomized to either MVR alone or to MVR plus cardiac support device (CSD); and 107 patients who did not need MVR were randomized to either optimal medical therapy alone or to optimal medical therapy plus CSD. The median follow-up was 22 months. Patients had to have an LVEF less than 35% and an LVEDD > 60 mm. Exclusions included planned cardiac surgery other than MVR, patient CABG, or planned LVAD or on transplant list. Mean age was 52.5 years, 55% of patients were male, and 81.3% were NYHA class III.

The primary endpoint was a clinical composite of death, a major cardiac procedure indicative of progression of heart failure, and a change in NYHA class. Patients were classified, based on this clinical composite, as improved, same, or worsened. More patients “improved” in the CSD group compared to control (38% vs 27%), and fewer patients “worsened” in the CSD group compared to control (37% vs 45%); odds ratio was 1.73, p=0.02.

In the CSD group, compared to controls, there were fewer major cardiac procedures (19 vs 33, p=0.01); a greater reduction in left ventricular end diastolic diameter (LVEDD; p=0.009); a greater reduction in systolic volumes (p=0.017), and a greater improvement in the sphericity index (p=0.026). Notably, there were no device-related events related to cardiac restriction.

 
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