ABSTRACT
BACKGROUND: We conducted a prospective study of the clinical outcomes and health-related quality of life after implantation of the CorCap support device (Acorn Cardiovascular Inc, St Paul, MN) for dilated cardiomyopathy. METHODS: The criteria adopted for CorCap implantation were dilated cardiomyopathy (left ventricular [LV] end-diastolic diameter≥60 mm, LV ejection fraction≤0.30 and >0.10), and New York Heart Association functional class II or III despite maximal medical therapy. Echocardiographic follow-up and evaluation with the Short Form-36 questionnaire were performed. RESULTS: Included were 39 patients: 5 in New York Heart Association class II and 32 in class III. At 13.3±2.5 months of follow-up, a statistically significant improvement was evident in mean LV volume (LV end-systolic volume from 202±94 to 138±72 ml. p=0.005) and systolic function (LV ejection fraction from 0.26±0.05 to 0.36±0.05, p<0.001). The mean LV sphericity index was significantly increased at the end of the follow-up (p=0.009). Ischemic etiology, diabetes, advanced age, and LV ejection fraction of less than 0.15 predicted lesser reversal of the LV alterations. Operative mortality was 5.1%. Cumulative follow-up mortality was 10.2%. The average Physical Health domain scores (Physical Functioning, Role Physical, General Health) were improved. Average Mental Health domain scores were also increased. CONCLUSIONS: The cardiac support device obtains reverse remodelling of the LV and is useful to improve the quality of life of patients with dilated cardiomyopathy and New York Heart Association class III symptoms of heart failure. The integration of different and complementary strategies (cardiac support device and resynchronization therapy) may represent the key to success for more complex patients, although further studies are required.