Transvenous implantation of the Occlutech Atrial Flow Regulator: Preliminary results from swine models

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 placed in the PFO closed by day 28 and the other embolized on day 3. Conclusion The Occlutech AFR has shown to be safe and easy to implant with good results [Krizanic et al. J Invasive Cardiol. 2010;22(4):182.]. This study has further shown that histologically the device does not cause any end organ damage, causes minimal inflammation, with almost no thrombus formation and can remain patent and secure in the atrial septum.

Multi-Institutional US Experience of the Occlutech�AFR Device in Congenital and Acquired Heart Disease

“…A recent animal study which we published detailed post-mortem data associated with the implantation of the AFR device in normotensive swine [21]. This report demonstrated satisfactory patency rates in the implanted devices even in the absence of a significant atrial pressure differential.…”

“…This may be further improved upon with optimization of antiplatelet and anticoagulation strategies for this group of patients. Until routine practice evolves, perioperative antiplatelet and anticoagulation management should probably mirror that employed for device occlusion of ASD and patent foramen ovale, whilst accommodating the additional anticoagulatory needs of the patients based on their underlying disease and risk profile [21][22][23]. This should prevent device and fenestration thrombosis as well as diminish the thromboembolic risks associated with the presence of a right to left shunt.…”

Study of the effect of Occlutech Atrial Flow Regulator on symptoms, hemodynamics, and echocardiographic parameters in advanced pulmonary arterial hypertension

“…14 Animal studies show minimal inflammation, non-thrombogenicity, and retained patency. 15 The clinical use of AFR is shown in heterogenous indications including PAH from multiple centers. 16 We performed an observational study on utility of AFR on symptoms, hemodynamics, echocardiographic parameters, and survival with mid-term follow-up in patients with advanced PAH.…”