RESUMO
PURPOSE: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. MATERIALS AND METHODS: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. RESULTS: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6-98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0-94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4-98.1) and 93.8% (95% CI, 89.9-97.6) at 12 and 24 months, respectively. CONCLUSIONS: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).
Assuntos
Artéria Femoral , Doença Arterial Periférica , Masculino , Humanos , Feminino , Artéria Femoral/diagnóstico por imagem , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Estudos Prospectivos , Grau de Desobstrução Vascular , Desenho de Prótese , Resultado do Tratamento , Stents , Sistema de Registros , Artéria PoplíteaRESUMO
This paper presents a framework to explore multi-field data of aneurysms occurring at intracranial and cardiac arteries by using statistical graphics. The rupture of an aneurysm is often a fatal scenario, whereas during treatment serious complications for the patient can occur. Whether an aneurysm ruptures or whether a treatment is successful depends on the interaction of different morphological such as wall deformation and thickness, and hemodynamic attributes like wall shear stress and pressure. Therefore, medical researchers are very interested in better understanding these relationships. However, the required analysis is a time-consuming process, where suspicious wall regions are difficult to detect due to the time-dependent behavior of the data. Our proposed visualization framework enables medical researchers to efficiently assess aneurysm risk and treatment options. This comprises a powerful set of views including 2D and 3D depictions of the aneurysm morphology as well as statistical plots of different scalar fields. Brushing and linking aids the user to identify interesting wall regions and to understand the influence of different attributes on the aneurysm's state. Moreover, a visual comparison of pre- and post-treatment as well as different treatment options is provided. Our analysis techniques are designed in collaboration with domain experts, e.g., physicians, and we provide details about the evaluation.
RESUMO
We present a framework to manage cerebral aneurysms. Rupture risk evaluation is based on manually extracted descriptors, which is time-consuming. Thus, we provide an automatic solution by considering several questions: How can expert knowledge be integrated? How should meta data be defined? Which interaction techniques are needed for data exploration.