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OBJECTIVE: To evaluate in a prospective randomized multi-centered trial the safety and efficacy of mitral valve (MV) surgery with and without an Acorn CorCap™ Cardiac Support Device in patients with Class II-IV heart failure (HF), dilated cardiomyopathy and mitral insufficiency (MR). The Acorn Randomized Trial is the largest prospective randomized trial involving cardiac surgery and a permanent device implant. 300 patients with dilated cardiomyopathy and NYHA Class II-IV HF were enrolled into one of two arms: MV repair or replacement or no MV surgery.
MV surgery has been performed successfully in patients with HF but has never been evaluated in a multi-center prospective trial. Debate persists on whether the increase in afterload after elimination of MR results in a prohibitive morbidity and mortality and whether there is a long term benefit in eliminating MR in patients with advanced HF. Cardiac support devices that reduce ventricular wall stress and promote beneficial reverse remodeling have been proposed as a new treatment option by itself and also as an adjunct to MV surgery.
METHODS: A subgroup of 193 patients in the larger study of 300 had MV repair or replacement. (77% NYHA Class III/IV, LVEF 23.9%, 82% had 3 or 4+ mitral regurgitation, peak VO2 14.4 ml, LVEDD 69.7mm). 102 patients were randomly assigned to MV surgery alone and 91 patients were assigned to MV surgery with implantation of the Acorn CorCap™ Cardiac Support Device. All patients were treated with an optimal medical regimen including ACE inhibitors and beta-blockers. Patients were followed for a mean of 22.9 months. MV surgery included replacement in 29 (16%) patients and repair in 155 (84%) patients.
RESULTS:

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