A personalized, 3D printed, polymeric elastic support device for the prevention of post-MI cardiac remodeling

Abstract Introduction Myocardial remodeling and dilatation following myocardial infarction (MI) initiates a vicious cycle leading to heart failure (HF). The anatomy and pathophysiology of every patient is unique. We have developed a 3D printed, biopolymer based personalized Elastic Support Device, that is 3D printed based on patient’s imaging, aiming to restore cardiac physiology. This study aimed to assess the device on rat MI model. Materials and Methods MI was induced in 24 Sprague Dawley rats by permanently ligating the mid LAD artery via midline sternotomy cut. Twelve animals underwent immediate implantation of the elastic support device that was pre-printed from animal specific 3D echocardiography. The animals were followed up with echocardiography at days -2, 7, 14, 28. The animals were sacrificed at day 28, cardiac tissue and plasma were taken for further histological and biochemical analysis. Results and discussion Mortality was similar at both groups (5 vs 4 in the device and control groups respectively). Ejection fraction reduced in both groups from a baseline of 61.9±8.9% to 47.5±12.7%. Left Ventricular End Diastolic Diameter increased from baseline to day 28 in the control (7.0±0.56mm vs 7.7±1mm) but not the device group (6.87±0.2mm vs 6.93±1.1mm, p<0.05). Parameters of diastolic function such as E/E’ were similar in both groups throughout the follow-up. Mason’s Trichrome stained cardiac sections revealed improved infarct size at the device group (7.4±1.9% vs. 10.6±2.8%) and lower overall cardiac fibrosis. Conclusion In this preliminary small animal model study, the capability to 3D print and implant an imaging based, personalized, 3D printed elastic support device. The cardiac diastolic function was not impaired, and no safety issues were noticed. Furthermore, cardiac dilatation was prevented, and infarct size was reduced.Trial design and results