Implantable Septal Shunt Improves Cardiac Function

An implantable atrial flow regulator (AFR) substantially reduces intra-cardiac pressure resulting from pulmonary arterial hypertension (PAH).

The Occlutech (Schaffhausen, Switzerland) AFR is a nickel-titanium (nitinol) shunt placed into the septum between the left and right atriums via balloon atrial septostomy (BAS), in order to create a permanent interatrial fenestration. By selecting and maintaining correct sizing of the created shunt (between six and 10 mm), the AFR allows for a controlled, restricted flow of blood between the atria, thus reducing intra-cardiac pressure and improving the heart's function.

The AFD is intended for heart failure patients with a preserved ejection fraction (HFpEF) that includes diminished left ventricle relaxation and elevated filling pressures. By creating a communication between both atria using BAS, decompression of the left atrium is achieved. The design of the device was based on the concept of the Lutembacher syndrome, a medical condition defined as a combination of mitral stenosis and atrial septal defect (ASD).

PAH is a rare, progressive disorder characterized by high blood pressure in the pulmonary artery for no apparent reason. Symptoms of PAH include shortness of breath (dyspnea) especially during exercise, chest pain, and fainting episodes. Advanced stages of PAH may manifest in cyanosis due to low levels of circulating oxygen. In severe cases of PAH, the right ventricle is abnormally enlarged, potentially leading to right heart failure.

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