Impact of Less Invasive Ventricular Reshaping with the Revivent TM System (Bioventrix) on cardiac volumes and function in patients with ischemic heart disease. A 12-months multi-center CMR analysis

Abstract

Introduction: Ischemic cardiomyopathy accounts for over 50% of patients with heart failure and reduced ejection fraction (HFrEF). Left ventricular ejection fraction (LVEF) and end-systolic volumes (ESV) are established predictors of mortality in this disease. Surgical ventricular reconstruction (SVR) aims to improve myocardial function in HFrEF patients by restoring shape and size of the heart. The Less Invasive Ventricular Enhancement (LIVETM, Bioventrix Inc.) technique with the Revivent TC™ system provides a new hybrid, off pump, catheter based approach to improve symptoms in HFrEF patients with myocardial scarring (akinesia or dyskinesia) and dilated left ventricles. Objectives: To assess the impact of the LIVETM technique on cardiac volumes and function at 12 months post-procedure. Methods: We analyzed data of 16 HFrEF-patients and 19 matched HFrEF-controls included in a multicenter trial. LV reduction with the Revivent TC™ was performed in all patients, whereas the control group participants were pursuing optimal medical treatment (OMT) only. A standardized CMR protocol was performed both at baseline and at 12 month follow up. Results: Mean follow up was 14 ± 14 months. Revivent patients presented a significant reduction in LVESVI (99.6 ± 37.4 ml/m² vs. 76.3 ± 36.3 ml/m², p < 0.001) and LVEDVI (149.3 ± 53.7 ml/m² vs. 115.4 ± 40.2 ml/m², p = 0.001). This change was absent in controls (77.6 ± 21.2 ml/m² vs. 79.3 ± 24.6 ml/m², p = 0.687 and 119.4 ± 23.3 ml/m² vs. 119.4 ± 29.8 ml/m², p= 0.809). LVEF improved by 25% in patients (25.9 ± 10.4 % vs. 32.5 ± 9.8 %; p= 0.09), but did not change in controls (35.4 ± 9.2 % vs 35.5 ± 8.7 %; p = 0.778) at one year follow up. Regarding the RV, an increase in volumes was seen in the surgical group (RVESVI: 37.4 ± 19.3 ml/m² vs. 44.5 ± 21.4 ml/m²; p = 0.099; RVEDVI: 66.8 ± 23.7 ml/m² vs. 78.9 ± 24.6 ml/m²; p = 0.026) but not in the control . [...].