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Mid-Term Preliminary Results for Safety and Patency of the Occlutech Atrial Flow Regulator in an Animal Model

Congenital Heart Disease 2022年第3期17卷 269-280页

作者： kamel shibbani Daniel McLennan Dunbar Ivy Gareth Morgan Division of Cardiology Department of PediatricsStead Family Children’s HospitalUniversity of Iowa Hospitals and ClinicsIowa CityUSA Division of Cardiology Department of PediatricsMedical College of WisconsinMilwaukeeUSA Division of Cardiology Heart InstituteChildren’s Hospital of ColoradoUniversity of Colorado at DenverAuroraUSA

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

关键词： Atrial flow regulator animal model atrial septal defect interventional cardiology device

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