Occlutech AFR (atrial flow regulator)

The Occlutech AFR (atrial flow regulator) (Occlutech AG, Switzerland) is a nitinol device similar to the occluders implanted in the percutaneous treatment of atrial septal defects or patent foramen ovale. It has a double-disc shape with a waist in the center that allows it to anchor into the septal wall. The device has a central fenestration that allows the shunting of blood between the two atria. On the right atrial side of the device there is a welded ball that serves as an anchor and connection hub to the release system.

Implantation of the device requires transseptal access, and the interatrial septum is dilated with a 6-mm balloon. The device’s central fenestration measures between 8 and 10 mm.

A pilot study was performed to determine the safety and the potential for Occlutech AFR implantation. The study was called AFR-PREVIELE1 and was a phase II, prospective, multicenter, nonrandomized trial in symptomatic heart failure patients (New York Heart Association [NYHA] functional class 3-4) with a preserved or reduced ejection fraction and pulmonary capillary pressure over 15 mmHg at rest or over 25 mmHg with exercise. It was possible to implant the device in 100% of the interventions and the shunt remained patent in all cases at 3-month follow-up. 8.3% of the patients had re-admission with acute heart failure and the rest improved clinically in terms of symptoms and surrogate outcomes: NYHA functional class, quality of life questionnaires, and 6-minute walking test.

The Occlutech atrial flow regulator is indicated for cases of pulmonary arterial hypertension, congenital defects, and heart failure.

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Palabras clave: Insuficiencia cardíaca, nuevos dispositivos, fenestración septo auricular. Keywords: Heart failure, new devices, atrial septum fenestration.