Jozef Bartunek, Emiliano Fiori, Grzegorz Kopec, Teoman Kilic, Joseph Pattathu, Nikolaus A. Haas
AZORG, Sapienza University. University Medical College and John Paul II Hospital in Krakow. Kocaeli University. Ludwig-Maximilians-University Munich.
Belgium, Italy, Poland, Turkey and Germany
Journal of the Society of Cardiovascular Angiography and Interventions
J Soc Cardiovasc Angiogr Interv 2026;
DOI: 10.1016/j.jscai.2026.104390
Abstract
Background: Pulmonary arterial hypertension (PAH) is a progressive, often fatal disease. Balloon atrial septostomy may relieve symptoms or serve as a bridge to transplant, but carries risks of variable shunting and reocclusion. The atrial flow regulator (AFR) provides a sustained interatrial shunt with a defined shunt size.
Methods: AFR-Prophet is a prospective, multicenter study evaluating the mechanism of action and safety of AFR in high-risk PAH. Of 32 screened patients, 25 underwent the procedure. The primary end point was serious adverse device effects or procedure-related events at 90 days. Secondary end points included longer-term safety and changes in functional, hemodynamic, and structural parameters.
Results: Among 25 patients, 24 received the implant. One patient died prior to implantation because of iatrogenic pericardial tamponade. At 90 days, 7 serious adverse device effects occurred (28%): 3 device-related (oxygen desaturation) and 4 procedure-related. At 3 months, AFR implantation reduced pulmonary vascular resistance and improved cardiac index, despite lower arterial oxygen saturation. Echocardiography showed a smaller right ventricular (RV) end-diastolic diameter and RV/left ventricular ratio, a higher tricuspid annular plane systolic excursion and RV fractional area change, and improved RV-pulmonary artery coupling. Shunt flow was detected in all but 1 patient. NT-proBNP levels decreased, New York Heart Association class improved (>1 class) in 66% of patients, and 6-minute walk distance increased. During the 1-year follow-up, 9 patients died and 3 underwent lung transplantation.
Conclusions: Atrial flow regulator therapy in PAH was associated with improved RV function, enhanced RV-pulmonary artery coupling, and better overall cardiac performance. Despite the dismal prognosis of advanced PAH, signals of improved symptoms and physical capacity support interatrial shunting as a potential therapeutic option for carefully selected, even high-risk patients.
Category
Surgical and Catheter-mediated Interventions for Pulmonary Vascular Disease
Age Focus: Adult Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes