Mitral valve repair in heart failure: Five-year follow-up from the mitral valve replacement stratum of the Acorn randomized trial

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 142; no. 3; pp. 569 - 574.e1
• Main Authors: Acker, Michael A., MD, Jessup, Mariell, MD, Bolling, Steven F., MD, Oh, Jae, MD, Starling, Randall C., MD, Mann, Douglas L., MD, Sabbah, Hani N., PhD, Shemin, Richard, MD, Kirklin, James, MD, Kubo, Spencer H., MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.09.2011; Elsevier
• Subjects: Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Cardiology. Vascular system; Cardiomyopathy, Dilated - mortality; Cardiomyopathy, Dilated - physiopathology; Cardiomyopathy, Dilated - surgery; Cardiothoracic Surgery; Comorbidity; Endocardial and cardiac valvular diseases; Female; Heart; Heart Failure - epidemiology; Heart Failure - mortality; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Heart-Assist Devices; Humans; Intention to Treat Analysis; Male; Medical sciences; Middle Aged; Mitral Valve - surgery; Mitral Valve Insufficiency - epidemiology; Mitral Valve Insufficiency - physiopathology; Mitral Valve Insufficiency - surgery; Pneumology; Stroke Volume; Ventricular Function, Left; Ventricular Remodeling; 22; ACE; MR; mitral regurgitation; mitral valve repair; cardiac support device; MVr; MV; LV; 35.4.1; CSD; mitral valve; left ventricular; 18.1; mitral valve replacement; 35.4; angiotensin-converting enzyme; Heart failure; Randomization; Mitral valve; Cardiac valvular disease; Follow up study; Cardiovascular disease; Anesthesia; Replacement; Circulatory system; Cardiology; Mitral valve disease
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2010.10.051

Objective The study objective was to evaluate the long-term (5-year) safety and efficacy of mitral valve surgery with and without the CorCap cardiac support device (Acorn Cardiovascular, St Paul, Minn) in patients with dilated cardiomyopathy and New York Heart Association class II–IV heart failure. Background The Acorn trial provided a unique opportunity to assess the long-term safety and efficacy of mitral valve surgery because clinical visits and echocardiograms (read by a core laboratory) were completed for 5 years of follow-up. Further, this study provided follow-up data on the long-term effect of the CorCap cardiac support device as an adjunct to mitral valve surgery. Methods From the original Acorn trial (n = 300 patients), 193 patients were enrolled in the mitral valve repair/replacement stratum. A total of 102 were randomized to mitral valve surgery alone (control group) and 91 were randomized to mitral valve surgery with implantation of the CorCap cardiac support device (treatment group). Patients were followed up for 5 years. Results As previously reported, 30-day operative mortality was only 1.6%. At 5 years, the total mortality was 30% with an average annual mortality rate of approximately 6% per year. The effects of mitral valve surgery led to a progressive decrease in left ventricular end-diastolic and end-systolic volumes, which were highly significant at all time points. At the end of 5 years, there was an average reduction in left ventricular end-diastolic volume of 75 mL, which represents a 28% reduction from baseline. During 5 years of follow-up, 29 patients had recurrent mitral regurgitation and 5 patients underwent repeat mitral valve surgery. The addition of the CorCap device led to greater decreases in left ventricular end-diastolic volume (average difference of 16.5 mL; P  = .05), indicating that the CorCap device had an additive effect to the mitral valve operation. Conclusions This study demonstrates long-term improvement in left ventricular structure and function after mitral valve surgery for up to 5 years. These data provide evidence supporting mitral valve repair in combination with the Acorn CorCap device for patients with nonischemic heart failure with severe left ventricular dysfunction who have been medically optimized yet remain symptomatic with significant mitral regurgitation.