Abstract

Introduction: After an acute coronary syndrome many patients with ischemic cardiomyopathy (ICM) suffer from heart failure with reduced ejection fraction (HFrEF). Beside surgical ventricular reconstruction (SVR) by open-chest-surgery as an option to improve myocardial function by restoring the shape and size of the heart in HFrEF patients, first results demonstrated a significant reduction of LV volumes and LVEF using the Revivent TC TM System compared to optimal medical therapy (OMT) in patients with aneurysms in the anterior region of the LV. Objectives: To assess the impact of the Revivent TC™ system (Bioventrix Inc.) as a Less Invasive Ventricular Enhancement (LIVE™) technique to improve systolic and diastolic LV-function in patients with HFrEF compared to treatment of patients with OMT. Methods: We analyzed data from 10 patients and 10 controls with ICM and LVEF ≤ 45% from a multi-center-trial as well as 12 healthy subjects. In total, 10 patients underwent LV reduction with the new LIVE™ technique. The control group patients received OMT only (natural course of disease). Global longitudinal strain (GLS) as advanced, quantitative CMR measurement has been performed both at baseline and 12 months to quantitatively assess LV function. In addition, hemodynamic forces (HF) as an equivalent to intraventricular pressure gradients derived from CMR-data have been evaluated. Results: After 12 months follow-up, LVEF improved after using the Revivent TM System (27.8 ± 10.6 % vs. 31.5 ± 10.9 %), but not in controls (31.8 ± 8.2 % vs 31.3 ± 6.7 %). Minimal invasive treated patients showed a significant reduction in HF (33.6 ± 9.4 vs. 28.5 ± 10.5, p=0.04) and improved GLS (-9.4 ± 3.5 % vs. -11.4 ± 4.7 %; p=0.08). No change was observed in controls (31.5 ± 7.3 vs. 31.9 ± 6.9, p=0.37 and -12.8 ± 2.8 % vs. -12.6 ± 2.1 %; p=0.38) (see Figure). Conclusion: We demonstrate an improvement of LV strain and hemodynamic forces 12 months after using the Revivent TC TM System in HFrEF-patients compared to OMT. The impact on outcome and exercise capacity of HFrEF-patients has to be proven in larger trials with longer follow-up.

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