Akademik Veri Yönetim Sistemi
Journal of the Society for Cardiovascular Angiography and Interventions, 2026 (Scopus)
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.