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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 lumen.Once deployed via the transfemoral route,the device stents the atrial septum leaving a preselected fixed diameter atrial communication.We 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 days.Method:Five AFR devices were implanted in 5 female Yucatan adult minipigs.The animals were survived to 150 days with periodic assessments at days+3,+30,+60,+90,+120,and+150.These assessments consisted of transesophageal echocardiography and fluoroscopic evaluation.The animals were sacrificed at day+150.Histological and pathological assessments were carried out to characterize neointimal tissue growth,inflammation,thrombus formation,endothelial coverage,endothelial maturity,and the presence of any luminal thrombus.Result:There were no unscheduled deaths.Patency was maintained in all 5 animals across the 150-day study.There was no statistically significant difference in the lumen diameter over the study duration.Neointimal growth was mild to moderate in all specimens and occurred mostly on the surfaces of the device in direct contact with the atrial septum.There was no evidence of any significant inflammatory response on routine blood work or by imaging or histological assessment.Scanning electron microscope(SEM)examination showed nearly complete surface coverage with endothelial tissue.The 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 animals.Conclusion:As a continuation of our earlier work,this 150-day midterm animal study provides important safety and feasibility information.Our preliminary results show that the AFR is both safe and effective in maintaining a sustainable atrial level communication for the duration of the study.

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

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Peripheral vascular bifurcation： features and techniques

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Chinese Medical Journal 2012年第19期125卷 3561-3564页

作者： Gianluca Rigatelli Paolo Cardaioli Dell Avvocata Dan Le Hung Phan Katrina Nguyen Quoc Nguyen James Nguyen Thach Nguyen Massimo Giordan Unit of Cardiovascular Diagnosis and Endoluminal Interventions Unit Rovigo General Hospital Rovigo Italy cardiology Fellow Heart Failure Program the University of Alabama in Birmingham (UAB) Birmingham Alabama USA Weiss Memorial Hospital Chicago Illinois USA University of California at San Diego San Diego California USA University of Indianapolis Indianapolis Indiana USA The University of Arizona Medical Center Tucson Arizona USA cardiology Department Community Healthcare System St Mary Medical Center Hobart Indiana USA

The systemic nature of vascular atherosclerosis involves all vascular territories.. As interventional cardiologists, we are familiar with coronary artery bifurcation treatment. In other parts of the human body, the vascular tree develops similar bifurcation in the carotid, renal, aortoiliac and tibio-peroneal segments. Even with some differences depending on specific vascular wall composition, the atherosclerotic process affects all such bifurcations in a similar way.

关键词： peripheral vascular interventions systemic atherosclerosis interventional cardiology stenting angioplasty

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Pulmonary artery catheterization in acute myocardial infarction complicated by cardiogenic shock:A review of contemporary literature

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World Journal of cardiology 2021年第12期13卷 720-732页

作者： Shiva P Ponamgi Muhammad Haisum Maqsood Pranathi R Sundaragiri Michael G DelCore Arun Kanmanthareddy Wissam A Jaber William J Nicholson Saraschandra Vallabhajosyula Division of Cardiovascular Medicine Department of MedicineCreighton University School of MedicineOmahaNE 68154United States Department of Medicine Lincoln Medical Center/Cornell UniversityBronxNY 10451United States Department of Primary Care Internal Medicine Wake Forest Baptist HealthHigh PointNC 30260United States Section of interventional cardiology Division of Cardiovascular MedicineDepartment of MedicineEmory University School of MedicineAtlantaGA 30322United States Section of Cardiovascular Medicine Department of MedicineWake Forest University School of MedicineHigh PointNC 27262United States

Acute myocardial infarction(AMI)with left ventricular(LV)dysfunction patients,the most common cause of cardiogenic shock(CS),have acutely deteriorating hemodynamic status.The frequent use of vasopressor and inotropic pharmacologic interventions along with mechanical circulatory support(MCS)in these patients necessitates invasive hemodynamic monitoring.After the pivotal Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial failed to show a significant improvement in clinical outcomes in shock patients managed with a pulmonary artery catheter(PAC),the use of PAC has become less popular in clinical practice.In this review,we summarize currently available literature to summarize the indications,clinical relevance,and recommendations for use of PAC in the setting of AMI-CS.

关键词： Pulmonary artery catheter Swan-ganz catheter Acute myocardial infarction Cardiogenic shock Hemodynamic monitoring interventional cardiology Critical care cardiology

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