Mid-Term Follow-Up of the Revivent System as a Less-Invasive Ventricular Reconstruction Procedure - Preliminary Results from a Multicenter-Trial

Abstract

Background Surgical ventricular reconstruction to remodel, reshape and reduce ventricular volume is an effective therapy in selected patients with ischemic heart failure (IHF). The BioVentrix Revivent System offers comparable efficacy to conventional surgical ventricular reconstruction aiming to exclude nonfunctioning myocardium, reshape ventricular size and reduce ventricular volume in selected patients with IHF, but is a less-invasive procedure on the beating heart. With this study we aimed to assess its functional effectiveness. Methods Patient were considered eligible for the procedure when they presented with symptomatic (at least NYHA II) left ventricular (LV) dilatation and dysfunction, caused by myocardial infarction (MI) that occurred at least 90 days prior to study enrollment, and with akinetic and/or dyskinetic scarred myocardium of at least 50% transmurality located in the antero-septal, anterolateral, and/or apical regions. The BioVentrix Revivent System consists of polyester-covered titanium anchor pairs that are drawn together to exclude scarred areas of the LV free wall. The anchors were implanted via sternotomy or, alternatively, through a combined mini-thoracotomy and transcatheter procedure. Results Eighty-nine patients were enrolled. At 2 years, a significant improvement in LVEF(30 ± 8% vs 34 ± 9%, p Conclusions Less invasive reconstruction with the BioVentrix Revivent system in patients with symptomatic IHF results in significant and sustained improvement of LV function, reduction in LV volumes with reduction of heart failure symptoms and improved quality of life at mid-term follow-up.