Broad Applicability, Efficacy, and Safety of Atrial Flow Regulators in Acquired and Congenital Heart Disease

Background: The atrial flow regulator (AFR) is a self-expandable double-disk device with a central fenestration. Here, we describe the use of the AFR for three different indications in patients with acquired and congenital heart disease.

Methods: The database of the University Heart and Vascular Center Hamburg was retrospectively reviewed for patients who underwent implantation of an AFR. Six patients were included in the study. Implantations were performed under the guidance of transesophageal echocardiography and fluoroscopy. Clinical, demographical, and follow-up data were collected until September 2024.

Results: Four patients (median age and weight: 11.5 years; IQR: 5.2–15.6) and 34.8 kg [IQR: 16.8–52] at the time of implantation) with dilated (three out of four patients) and restrictive cardiomyopathy underwent implantation of an AFR (8 mm fenestration) for decompression of the left atrium. The first patient improved significantly in terms of left ventricular ejection fraction (LVEF), pulmonary capillary wedge pressure (PCWP), and NYHA stage, whereas there was only minor improvement in these parameters for the other three patients. Twenty-three months after implantation, LV assist device implantation became necessary for Patient 1. Patients 2 to 4 underwent heart transplantation after a median duration of 9.3 months (IQR: 7.3–11) after implantation. A 57-year-old patient with a type II atrial septal defect (ASD) with pulmonary arterial hypertension (pulmonary vascular resistance of 4.3 WU) underwent closure with an AFR (5 mm fenestration). The patient remains clinically stable after 1 year of follow-up. In our fifth case, echocardiography of a term newborn male demonstrated a large muscular ventricular septal defect (mVSD), type II ASD, and a hypoplastic RV. At the age of 10 days, the mVSD was closed with an 8–6 Konar-MF-Occluder. At the age of 15 months (weight: 12 kg), there was a predominant right-to-left shunt across the ASD and the RV was still hypoplastic. The ASD was closed with a 4-mm fenestrated AFR to stimulate RV growth. Subsequently, oxygen saturation improved from 84 to 95%. RV function remained stable during follow-up. Echocardiography demonstrated an increase in RV volume 1 year after implantation.

Conclusion: AFRs can be used for different anatomies and indications, such as a bridge-to-transplant measure, promotion of growth of borderline ventricles, and fenestrated ASD closure in our study. To the best of our knowledge, this is the first report on the use of the AFR for the promotion of the growth of borderline ventricles. Thus, this study demonstrates the great versatility of AFR in the field of pediatric cardiology.

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Artikel online veröffentlicht:
11. Februar 2025