Transcatheter closure of persistent ductus arteriosus in 2 to 6 kg infants: Preliminary results from an international, retrospective study

Abstract

Transcatheter patent ductus arteriosus (PDA) closure has proved to be safe in < 2 kg preterm infants, but major safety concerns remain when applied to the 2 to 6 kg body weight range. The aim of the present work is to assess efficacy and safety of transcatheter PDA occlusion in low-body-weight infants. Patients weighing 2 to 6 kg who underwent attempted transcatheter closure of an isolated PDA in 10 tertiary pediatric cardiology units (5 countries, 2000 to 2022) were retrospectively analyzed to review the outcome. A total of 339 infants (m/f sex ratio: 0.53; 56% ex-preterm, median age: 5.3 months [9 days–41 months], median weight: 4.7 kg [2 kg–6 kg]) were analyzed. Patients were all symptomatic (respiratory support: 33.2%, hospitalization for heart failure: 49.6%, nutrition care: 45.7%) with a hemodynamically significant PDA. Ductus was large (minimal ductal diameter: 4.2 ± 1.6 mm) and mainly conical (Krichenko type A: 57%) or tubular (Krichenko type C: 23%). Procedure was performed under both fluoroscopy (fluoro time: 10.7 ± 7.3 min) and transthoracic echocardiography guidance in all patients, with both arterial and venous femoral access (90%). Successful device implantation and complete PDA occlusion was achieved in 320 (94.4%) patients using devices in 91% (mainly ADO-I: 43.1%, ADO-IIAS: 20.0%, AVP-II: 8.0%, ODO: 5.3%, ADO-II: 3.5%, MFO: 2.1%, AVP-IV: 0.9%) vs. coils in 9%. Moderate to major complications occurred in 27 (8.0%) patients, including one death (0.3%) after delayed device embolization to descending aorta, device embolization (5.3%) and device-related obstruction of the left pulmonary artery (1.5%) or of the aorta (0.3%). These are preliminary data from a wider international study. We plan to collect both surgical and transcatheter cases in a wider series (40 tertiary centers, 20 countries), i.e. the largest cohort to date. This will allow better delineation of risk stratification, to keep refining indications for device closure in low-body-weight infants and achieve ever-safer results.