Outcomes of transcatheter closure of patent ductus arteriosus with the off-label use of large occluders (≥16 mm)

Abstract

Objective Transcatheter closure is the first-choice strategy for the management of appropriate patients with patent ductus arteriosus (PDA). The management of large PDAs is challenging due to the limited available sizes of approved devices and the inherent risks of surgical ligation, especially in adults with calcified PDAs. This study aimed to assess the outcomes of the off-label use of large occluders at a tertiary center. Methods This retrospective review included patients who underwent transcatheter PDA closure with large occluders (≥16 mm) over 16 years. The baseline patient data, procedural details, angiograms, and immediate outcomes were recorded and patients were followed up at 3, 6, 12 months after the intervention and annually thereafter. Results Of the 685 patients who underwent transcatheter PDA closure, 36 patients (mean age 16.6 ± 12.5 years) needed occluders ≥ 16 mm in size. Cocoon duct occluder, Cera duct occluder, Amplatzer atrial septal occluder (ASO), and Cera muscular ventricular septal defect occluders were used for PDA closure. There was no device embolization, one patient in whom ASO was used had residual shunt with intravascular hemolysis requiring surgery, and one patient had mild left pulmonary artery narrowing after the intervention, which was managed conservatively. No patient had residual shunt and one patient had persistent pulmonary hypertension at an intermediate duration of follow-up. Conclusion Transcatheter PDA closure with the use of large devices, which are available in Asia and Europe, is an effective and safe method, especially in adolescents and adults. However, a close follow-up of these patients is mandatory.

Dealing With a Nightmare: A Case Report of Successful Percutaneous Treatment of an Embolized Occluder Device Complicating a Minimal-Fluoroscopy Patent Ductus Arteriosus Closure

“…The majority of operators choose to insert devices that are at least 2 mm larger than the narrowest point of the duct [ 10 ]. Kanabar et al (2020) suggested that in children, the size of the pulmonary end of the device should be at least 2 mm greater than the narrowest diameter of the PDA [ 11 ]. In adolescents and adults with severe pulmonary arterial hypertension, it should be twice the narrowest diameter [ 11 ].…”

Patent Ductus Arteriosus in Pregnancy: Cardio-Obstetrics Management in a Late Presentation

“…The Amplatzer VSD muscular occluder, used off-label in this case, is approved for congenital VSD closure and has a diameter from 4 to 18 mm but has a long history of being used off-label to close large PDAs due to its larger maximum diameter. 11,12 A retrospective analysis of 447 patients with PDA and normal LVEF showed that 22.7% of patients had LV dysfunction after closure. The larger the PDA, the higher the risk of LV dysfunction, with 91% of patients having LV dysfunction when PDA sizes are >9 mm, but only 2.8% of patients with PDA of <3 mm had LV dysfunction.…”

“…The Amplatzer VSD muscular occluder, used off-label in this case, is approved for congenital VSD closure and has a diameter from 4 to 18 mm but has a long history of being used off-label to close large PDAs due to its larger maximum diameter. 11 , 12 …”

Outcome Transcatether Patent Ductus Arteriosus Closure in Children

“…A study on the comparison of outcomes for transcatether PDA closure in children and adults showed a decrease in EF values in both (13) .…”