Safety and Effectiveness of the KA Micro Plug for Treatment of Patent Ductus Arteriosus in Preterm Low-Birth-Weight Infants: Retrospective Analysis From a Multicenter Registry.

Background: Transcatheter occlusion of patent ductus arteriosus (PDA) in preterm infants is becoming a preferred approach when medical therapy fails or is contraindicated. This study was conducted to describe real-world clinical outcomes following transcatheter occlusion of PDA with the KA Micro Plug. Methods: This retrospective analysis was conducted using medical records from preterm infants (600-2500 g) with PDA treated with the Micro Plug Set ("KA Micro Plug") across 4 US hospitals (January 1, 2020 to February 28, 2024). The primary safety end point was freedom from major adverse events through 30 days postprocedure; adverse events >30 days were also reported. The primary effectiveness end point was clinical success 6 months postprocedure (absent or trivial PDA shunt confirmed via transthoracic echocardiography). Results: One hundred sixteen patients were analyzed (median age at catheterization: 29.0 days). The primary safety end point was met in 116/116 patients (100%). Clinical success at 6 months was achieved in 70/71 patients (98.6%). Adverse events reported within 30 days of the procedure included pericardial effusion (n = 1), increased tricuspid regurgitation not requiring intervention (n = 2), and device embolization with successful retrieval (n = 1). Coarctation of the aorta (n = 1) was discovered at a 6-month follow-up echocardiogram. Three deaths occurred that were unrelated to the device or procedure. Conclusions: The KA Micro Plug demonstrated a high rate of clinical success and few adverse events. A prospective trial with the goal of approval by the Food and Drug Administration for use in this unique patient population is underway.