BACKGROUND: The CorCap cardiac support device (Acorn Cardiovascular, Inc, St Paul, Minn) is the first device that specifically addresses ventricular remodeling in heart failure by reducing wall stress. We previously reported outcomes from the Acorn randomized trial to a common closing date (22.9 months of follow-up). This report summarizes results of extended followup to 5 years. METHODS: A total of 107 patients were enrolled in the no-mitral valve repair/replacement stratum including 57 in the CorCap treatment group and 50 in the control (optimal medical therapy alone) group. Patients were assessed every year, until completing 5 years of follow-up, for survival, adverse events, major cardiac procedures, New York Heart Association (NYHA) functional status, and echocardiograms, which were read at a core laboratory. RESULTS:Overall survivals were similar between the treatment and control groups, demonstrating no late adverse effect on mortality. The treatment group had significant reductions in left ventricular end-diastolic volume (P = .029) as well as a small increase in sphericity index. More patients in the treatment group improved by at least 1 NYHA functional class (P = .0005). There was no difference in rates of adverse events. In a subgroup of patients with an intermediate left ventricular end-diastolic dimension, there was a significant reduction in the Kaplan-Meier estimate of the freedom from the composite end point of death and major cardiac procedures (P = .04). CONCLUSIONS: These cumulative data demonstrate the sustained reverse remodeling of the left ventricle and the long-term safety and efficacy of the CorCap cardiac support device as an adjunctive therapy for patients with heart failure who remain symptomatic despite optimal medical therapy.
RCT Entities:
BACKGROUND: The CorCap cardiac support device (Acorn Cardiovascular, Inc, St Paul, Minn) is the first device that specifically addresses ventricular remodeling in heart failure by reducing wall stress. We previously reported outcomes from the Acorn randomized trial to a common closing date (22.9 months of follow-up). This report summarizes results of extended followup to 5 years. METHODS: A total of 107 patients were enrolled in the no-mitral valve repair/replacement stratum including 57 in the CorCap treatment group and 50 in the control (optimal medical therapy alone) group. Patients were assessed every year, until completing 5 years of follow-up, for survival, adverse events, major cardiac procedures, New York Heart Association (NYHA) functional status, and echocardiograms, which were read at a core laboratory. RESULTS: Overall survivals were similar between the treatment and control groups, demonstrating no late adverse effect on mortality. The treatment group had significant reductions in left ventricular end-diastolic volume (P = .029) as well as a small increase in sphericity index. More patients in the treatment group improved by at least 1 NYHA functional class (P = .0005). There was no difference in rates of adverse events. In a subgroup of patients with an intermediate left ventricular end-diastolic dimension, there was a significant reduction in the Kaplan-Meier estimate of the freedom from the composite end point of death and major cardiac procedures (P = .04). CONCLUSIONS: These cumulative data demonstrate the sustained reverse remodeling of the left ventricle and the long-term safety and efficacy of the CorCap cardiac support device as an adjunctive therapy for patients with heart failure who remain symptomatic despite optimal medical therapy.
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