ArticleJournal of the Society for Cardiovascular Angiography & Interventions2026
Safety and Efficacy of a Novel Atrial Flow Regulator in Patients With Severe Pulmonary Arterial Hypertension: The AFR-Prophet Study.
Article in Journal of the Society for Cardiovascular Angiography & Interventions, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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Who cites it
2 citing papers in PubMed.
- Safety and Efficacy of a Novel Atrial Flow Regulator in Patients With Severe Pulmonary Arterial Hypertension: The AFR-Prophet Study.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Therapeutic Manipulation of the Atrial Septum: Tearing Down the Wall.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
Corrections and comments
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Authors and funding
6 authors.
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No grant is acknowledged in the PubMed record.
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.
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