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Mid-Term Follow-Up of the Revivent System as a Less-Invasive Ventricular Reconstruction Procedure - Preliminary Results from a Multicenter-Trial
Journal article   Open access   Peer reviewed

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

Stefan Anker, Patrick Klein, Andrew Wechsler, Horst Sievert and Petr Neuzil
Journal of cardiac failure, v 25(8), pp S161-S162
Aug 2019
DOI: https://doi.org/10.1016/j.cardfail.2019.07.462
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https://doi.org/10.1016/j.cardfail.2019.07.462View
Published, Version of Record (VoR)Maybe Open Access (Publisher Bronze),  Open

Abstract

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. 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. Eighty-nine patients were enrolled. At 2 years, a significant improvement in LVEF(30 ± 8% vs 34 ± 9%, p < 0.001) and reduction of LV-volumes was observed, (both LV end systolic and diastolic volume indices decreased (respectively 72 ± 29 mL/cm² vs 57 ± 21 mL/cm², p < 0.001 and 101 ± 31 mL/cm² vs 85 ± 29 mL/cm², p < 0.001). Four patients (4.5%) died in hospital. At 2 years, survival was 88%, with 85% of patients in NYHA functional class I or II with significant improvement in both quality of life (p < 0.001) and 6-minute walking distance (370 ± 81 m vs 422 ± 95 m, p = 0.002). 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.

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Cardiac & Cardiovascular Systems
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