Mid-Term Preliminary Results for Safety and Patency of the Occlutech Atrial Flow Regulator in an Animal Model
作者机构：Division of CardiologyDepartment of PediatricsStead Family Children’s HospitalUniversity of Iowa Hospitals and ClinicsIowa CityUSA Division of CardiologyDepartment of PediatricsMedical College of WisconsinMilwaukeeUSA Division of CardiologyHeart InstituteChildren’s Hospital of ColoradoUniversity of Colorado at DenverAuroraUSA
出 版 物：《Congenital Heart Disease》 (先天性心脏病（英文）)
年 卷 期：2022年第17卷第3期
页 面：269-280页
核心收录：
学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学]
主 题：Atrial flow regulator animal model atrial septal defect interventional cardiology device
摘 要：Objective:The Atrial Flow Regulator(AFR)is a double disc device made of self-expanding Nitinol wire mesh,structured around a central *** deployed via the transfemoral route,the device stents the atrial septum leaving a preselected fixed diameter atrial *** sought to evaluate the mid-term performance of the AFR by implanting the device in 5 healthy porcine hearts to assess safety and patency of the device fenestration over a period of 150 ***:Five AFR devices were implanted in 5 female Yucatan adult *** animals were survived to 150 days with periodic assessments at days+3,+30,+60,+90,+120,and+*** assessments consisted of transesophageal echocardiography and fluoroscopic *** animals were sacrificed at day+*** and pathological assessments were carried out to characterize neointimal tissue growth,inflammation,thrombus formation,endothelial coverage,endothelial maturity,and the presence of any luminal ***:There were no unscheduled *** was maintained in all 5 animals across the 150-day *** was no statistically significant difference in the lumen diameter over the study *** growth was mild to moderate in all specimens and occurred mostly on the surfaces of the device in direct contact with the atrial *** was no evidence of any significant inflammatory response on routine blood work or by imaging or histological *** electron microscope(SEM)examination showed nearly complete surface coverage with endothelial *** animals were in a healthy condition for the duration of the study with no attributable pathology and no adverse effects noted on distant organs in any of the 5 ***:As a continuation of our earlier work,this 150-day midterm animal study provides important safety and feasibility *** preliminary results show that the AFR is both safe and effective in maintaining a sustainable atrial level communicati
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