Sustained Benefits of the CorCap Cardiac Support Device on Left Ventricular Remodeling: Three Year Follow-up Results From the Acorn Clinical Trial Randall.

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Sustained Benefits of the CorCap Cardiac Support Device on Left Ventricular Remodeling: Three Year Follow-up Results From the Acorn Clinical Trial Randall C. Starling, MD, MPH, Mariell Jessup, MD, Jae K. Oh, MD, Hani N. Sabbah, PhD, ACC, Michael A. Acker, MD, Douglas L. Mann, MD, Spencer H. Kubo, MD, FACC The Annals of Thoracic Surgery Volume 84, Issue 4, Pages 1236-1242 (October 2007) DOI: 10.1016/j.athoracsur.2007.03.096 Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 1 Mortality: June 2006. Kaplan-Meier mortality curves for the CorCap cardiac support device (CSD: Acorn Cardiovascular) treatment group (solid line) and the control group (dotted line) for patients followed out to four years. The CorCap CSD treatment group had a lower crude mortality rate (25.7%) when compared to the control group (27.0%, risk reduction of 4.8%) but this difference was not significant. (— = control [C]; — = treatment [T; cardiac support device].) The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 2 All Patients: June 2006. Changes in left ventricular end-diastolic volume (LVEDV) for the CorCap cardiac support device (Acorn Cardiovascular) treatment group (solid line) and the control group (dotted line). When compared with the control group, the treatment group showed a significantly greater decrease in LVEDV (average difference = 18.8 mL; p = 0.005). The effect of the CorCap CSD to reduce LVEDV was evident early and was maintained throughout the follow-up period. The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 3 Changes in left ventricular end-diastolic volume (LVEDV) in the two strata. In the mitral valve replacement (MVR) stratum (top), the control group (MVR surgery alone) demonstrated a progressive reduction in LVEDV. The treatment group (MVR surgery plus CorCap cardiac support device [CSD; Acorn Cardiovascular) show incremental benefit (average difference = 16.0 mL; p = 0.032). In the no-MVR stratum (bottom), the control group (medical therapy alone) shows no consistent change in LVEDV until an apparent increase during late follow-up. The treatment group (CorCap CSD) shows consistently smaller LV size (average treatment effect = 24.7 mL; p = 0.042). The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 4 All patients: June 2006. Changes in left ventricular end-systolic volume (LVESV) for the CorCap cardiac support device (CSD; Acorn Cardiovascular) treatment group (solid line) and the control group (dotted line). The treatment group showed a significantly greater decrease of approximately 15.6 mL when compared with the control group (p = 0.013). The effect of the CorCap CSD to reduce LVESV was indicated early and was maintained throughout the follow-up period. The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 5 Changes in left ventricular end-systolic volume (LVESV) in the two strata. In the mitral valve replacement (MVR) stratum (top), the control group (MV surgery alone) demonstrated a progressive reduction in LVESV. In the treatment group, the addition of the CorCap cardiac assist device (CSD; Acorn Cardiovascular) to MV surgery led to a significantly smaller LVESV (average difference of 13.8 mL; p = 0.048). In the no-MVR stratum (bottom), the control group (medical therapy alone) showed no consistent change in LVESV. In contrast, the CorCap CSD group shows a smaller LVESV with an average difference of 22.2 mL (p = 0.054). The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 6 Changes in left ventricular ejection fraction (LVEF) for the entire group of 300 patients. There were no consistent differences in EF between the treatment (solid line) and control (dotted line) groups. The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 7 Changes in left ventricular ejection fraction (LVEF) for the two strata. In the mitral valve replacement (MVR) stratum (top) the treatment group tended to have a higher LVEF when compared with the control group, but this difference was not maintained during all follow-up periods and was not statistically significant. In the no-MVR stratum (bottom), there were no consistent differences in LVEF between the treatment and control groups. The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 8 All Patients: June 2006. Changes in left ventricular sphericity index. Both the control (dashed line) and treatment (solid line) groups demonstrated an increase in LV sphericity index. However, the increase was greater in the treatment group (average difference of 0.045 units; p = 0.018). The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions

Fig 9 In the mitral valve replacement (MVR) stratum (top), the control group demonstrated an increase in left ventricular sphericity index, suggesting that MVR surgery by itself could result in a more elliptical shaped ventricle. However, the addition of the CorCap cardiac support device (CSD; Acorn Cardiovascular) to MV surgery (treatment group) led to a significantly greater increase in sphericity index (p = 0.002). In the no-MVR stratum (bottom), the control group demonstrated an early increase in sphericity index that returned to baseline levels by three years. In contrast, the treatment group tended to have a higher sphericity index, although this difference was not statistically significant. The Annals of Thoracic Surgery 2007 84, 1236-1242DOI: (10.1016/j.athoracsur.2007.03.096) Copyright © 2007 The Society of Thoracic Surgeons Terms and Conditions