BACKGROUND:As the catheter-based device closure of the patent foramen ovale (PFO) is expanding, novel devices aim to address the limitations of first-generation occluders (e.g. bulk, erosion, dislodgment). The second-generation device from Encore Medical (Eagan, MN, USA) features an articulating frame structure which allows the device to better conform to atrial anatomies, has lower disc thickness and metal mass/surface area, and is fully retrievable at any point in the procedure. The aim of the study was to evaluate the feasibility and safety of a novel low-profile, fully retrievable, Encore PFO closure device in the animal model. METHODS:Six swine underwent implantation of the novel PFO occluder under fluoroscopic and intra-cardiac echocardiography guidance and survived for 140 days. Interim transthoracic echocardiography (TTE) was conducted on Day 29. Following terminal angiography and TTE at 140 days, the hearts were subjected to gross and histopathologic analysis. RESULTS:All animals were successfully implanted and survived for 140 days. Interim TTE revealed proper device retention with no blood flow across the septum or thrombus in any of the animals. X-ray and pathology results showed preserved implant integrity with no fractures, and complete integration of the devices into the septum with complete re-endothelialization and nearly complete coverage by a mature, relatively thin neoendocardium. No surface fibrin deposition or thrombosis was reported. CONCLUSIONS:In the standard porcine model, device retention and biocompatibility remained favorable following structural and functional device modifications exemplified by the second-generation PFO occluder from Encore Medical, including marked reduction of metal mass.
A hierarchical threshold secret image sharing (HTSIS) scheme is a method to share a secret image among a set of participants with different levels of authority. Recently, Guo et al. (2012) [22] proposed a HTSIS scheme based on steganography and Birkhoff interpolation. However, their scheme does not provide the required secrecy needed for HTSIS schemes so that some non-authorized subsets of participants are able to recover parts of the secret image. In this paper, we employ cellular automata and Birkhoff interpolation to propose a secure HTSIS scheme. In the new scheme, each authorized subset of participants is able to recover both the secret and cover images losslessly whereas non-authorized subsets obtain no information about the secret image. Moreover, participants are able to detect tampering of the recovered secret image. Experimental results show that the proposed scheme outperforms Guo et al.'s approach in terms of visual quality as well.
Restenosis following endovascular treatment is associated with inflammatory and proliferative responses produced in the artery wall at the time of the procedure which may be ameliorated through delivery of anti-inflammatory or anti-proliferative compounds into the adventitia of the vessel at the
AIMSThe Mitra-Spacer (Cardiosolutions, Bridgewater, MA, USA) is designed to treat mitral regurgitation by introducing a dynamic spacer that constantly adapts to the changing haemodynamic conditions during the cardiac cycle. We aimed to evaluate the performance and safety of this device in the chronic ovine model.METHODS AND RESULTSEight sheep were enrolled in this study. Through a left thoracotomy, the Mitra-Spacer was inserted via the transapical approach and advanced into the left atrium (LA) under imaging guidance. Device performance and safety were evaluated up to 90 days using fluoroscopy, echocardiography and histopathology. The volume within the balloon spacer shifted during the cardiac cycle in all cases. Seven animals survived up to 90 days for terminal imaging and tissue harvest. Echocardiography showed no change in left ventricle (LV) ejection fraction from baseline to 90 days. There were no observations of changes in LV diastolic function, pulmonary vein inflow, or tricuspid valve function. Histological analysis demonstrated no significant injury to the mitral apparatus.CONCLUSIONSIn the healthy ovine model, Mitra-Spacer implantation was feasible and safe. At 90 days, no evidence of structural damage to the mitral apparatus or deterioration of cardiac performance was demonstrated.
The lack of common physiological retention features as well as the varying and challenging anatomy of the mitral valve presents a significant challenge for the development of transcatheter mitral valve replacement system. This study aimed to evaluate the feasibility of acute retention in the mitral