RESUMO
A flow diverter (FD) is an effective method for treating wide-necked intracranial aneurysms by inducing hemodynamic changes in aneurysms. However, the procedural technique remains challenging, and it is often not performed properly in many cases of deployment or placements. In this study, three types of FDs that changed the material of the wire were prepared within the same structure. Differences in physical properties, such as before and after delivery loading stent size, radial force, and radiopacity, were evaluated. The performances in terms of deployment and trackability force were also evaluated in a simulated model using these FDs. Furthermore, changes of deployment patterns when these FDs were applied to a 3D-printed aneurysm model were determined. The NiTi FD using only nitinol (NiTi) wire showed 100% size recovery and 42% to 45% metal coverage after loading. The low trackability force (10.9 to 22.9 gf) allows smooth movement within the delivery system. However, NiTi FD cannot be used in actual surgeries due to difficulties in X-ray identification. NiTi-Pt/W FD, a combination of NiTi wire and platinum/tungsten (Pt/W) wire, had the highest radiopacity and compression force (6.03 ± 0.29 gf) among the three FDs. However, it suffered from high trackability force (22.4 to 39.9 gf) and the end part braiding mesh tended to loosen easily, so the procedure became more challenging. The NiTi(Pt) FD using a platinum core nitinol (NiTi(Pt)) wire had similar trackability force (11.3 to 22.1 gf) to NiTi FD and uniform deployment, enhancing procedural convenience. However, concerns about low expansion force (1.79 ± 0.30 gf) and the potential for migration remained. This comparative analysis contributes to a comprehensive understanding of how different wire materials influence the performance of FDs. While this study is still in its early stages and requires further research, its development has the potential to guide clinicians and researchers in optimizing the selection and development of FDs for the effective treatment of intracranial aneurysms.
RESUMO
OBJECTIVES: A polydioxanone (PDO) stent was developed to treat tracheomalacia in pediatric patients. However, its safety and efficacy need to be verified in animal studies before clinical trials in patients can be conducted. This study evaluated the safety and efficacy of a PDO stent in normal and tracheomalacia-model rabbits. METHODS: In total, 29 New Zealand white rabbits were used: 13 for evaluating the biocompatibility of the PDO stent in normal rabbits and 16 for the creation of a tracheomalacia model. The tracheomalacia model was successfully established in 12 rabbits, and PDO stents were placed in eight of those rabbits. RESULTS: The PDO stent was successfully positioned in the trachea of the normal rabbits using an endoscopic approach, and its degradation was observed 10 weeks later. The stent fragments did not induce distal airway obstruction or damage, and the mucosal changes that occurred after stent placement were reversed after degradation. The same procedure was performed on the tracheomalacia-model rabbits. The survival duration of the tracheomalacia rabbits with and without stents was 49.0±6.8 and 1.0±0.8 days, respectively. Thus, the PDO stent yielded a significant survival gain (P=0.001). In the tracheomalacia rabbits, stent degradation and granulation tissue were observed 7 weeks after placement, leading to airway collapse and death. CONCLUSION: We successfully developed a PDO stent and an endoscopic guide placement system. The degradation time of the stent was around 10 weeks in normal rabbits, and its degradation was accelerated in the tracheomalacia model. The mucosal changes associated with PDO stent placement were reversible. Placement of the PDO stent prolonged survival in tracheomalacia-model rabbits.