Barry O’Callaghan¹, Jenny Zablah¹, Joseph Vettukattil², Daniel Levi^3,4, Morris Salem⁴, Allison Cabalka⁵, Jason Anderson⁶, Makram Ebeid⁶, Ryan Alexy⁷, Gareth J. Morgan^1,*

Congenital Heart Disease, Vol.17, No.1, pp. 107-116, 2022, DOI:10.32604/CHD.2022.018590 - 26 October 2021

Abstract Objectives: To detail the US multi-institutional experience with the Occlutech^© (Occlutech International AB, Helsingborg, Sweden) atrial flow regulator (AFR) in children and adults with acquired or congenital heart disease. Background: The creation of a long-term atrial communication is desirable in several cardiovascular disease phenotypes, most notably pulmonary arterial hypertension, disorders of increased left ventricular filling and increased cavopulmonary pressures in patients with a Fontan type circulation. Methods: Patients were identified for inclusion from the AFR device manufacturer database. Data was collected using a RedCap database following IRB approval. 8 weeks of follow up data was sought for… More >

Daniel McLennan, Dunbar Ivy, Gareth J. Morgan

Congenital Heart Disease, Vol.14, No.5, pp. 819-831, 2019, DOI:10.1111/chd.12816

Abstract Aims: To evaluate in domestic pigs the histopathological processes after implanting the Occlutech Atrial Flow Regulator (AFR).
Methods and Results: Eleven pigs were chosen and had successful implantation of the AFR. Five pigs were sacrificed at 28 days, and 5 pigs at 90 days. One pig was sacrificed at day 3 after device embolization. Each pig had echocardiography performed at 3 weeks to check patency. Post mortem evaluation included Gross evaluation, radiographic evaluation, histology, and electron microscopy. Nine of the 10 devices implanted remained patent at time of autopsy with no thrombus and minimal inflammation. One device More >