Off-label use of Lifetech KONAR-MF™ ventricular septal defect occluder for large patent ductus arteriosus closure in <6 ​kg infants

Céline Grunenwald Gronier; Nadir Benbrik; Bénédicte Romefort; Solène Prigent; Quentin Hauet; Alban-Elouen Baruteau

doi:10.1016/j.ijcchd.2021.100316

Off-label use of Lifetech KONAR-MF™ ventricular septal defect occluder for large patent ductus arteriosus closure in <6 kg infants

Int J Cardiol Congenit Heart Dis. 2021 Dec 24:7:100316. doi: 10.1016/j.ijcchd.2021.100316. eCollection 2022 Mar.

Authors

Céline Grunenwald Gronier¹, Nadir Benbrik¹, Bénédicte Romefort¹, Solène Prigent¹, Quentin Hauet¹, Alban-Elouen Baruteau^{1

2

3}

Affiliations

¹ Nantes Université, CHU Nantes, Département médico-chirurgical de cardiologie pédiatrique et congénitale, F-44000 Nantes, France.
² Nantes Université, CHU Nantes, INSERM, CIC FEA 1413, F-44000 Nantes, France.
³ Nantes Université, CHU Nantes, CNRS, INSERM, l'institut du thorax, F-44000 Nantes, France.

Abstract

Background: Device PDA closure is increasingly used in smaller patients. Major safety concerns remain when applied to <6 kg infants with large PDA and challenging anatomy. We aimed to report our experience with the new Konar-MF™ ventricular septal defect (VSD) occluder for transcatheter closure of large patent ductus arteriosus (PDA) in infants <6 kg.

Methods: Infants <6 kg in whom PDA occlusion was attempted using the Konar-MF™ VSD occluder were analyzed to review procedural characteristics and outcomes. Prospective follow-up was achieved until August 2021.

Results: A total of 9 implantations were performed in 7 infants [age: 5.3 ± 3.4 (1.7-10.1) months, weight: 4.1 ± 0.8 (2.9-5.8) kg]. All PDAs were large and short [minimal ductal diameter: 5.6 ± 1.0 (4.5-7.0) mm, ductal length: 4.3 ± 0.6 (3.5-5) mm]. Successful device implantation was achieved in all cases without major complication. Early device embolization occurred in 1 case with safe percutaneous device removal. Late percutaneous device retrieval was achieved 5 weeks after implantation because of symptomatic residual shunt. In both cases a second Konar-MF™ VSD occluder was implanted with excellent outcome. Over a median follow-up of 12 (6-25) months, 1 patient died from a device-unrelated cause; all remaining patients are asymptomatic, with complete occlusion and no delayed device-related complication.

Conclusions: Transcatheter closure of large PDA using the Konar-MF™ VSD occluder appears to be feasible, effective and safe in <6 kg infants. This approach might be an alternative to surgical ligation in carefully selected infants, although that remains to be confirmed by extensive experience and long-term outcomes data.

Keywords: Congenital heart disease; Multifunctional occluder; Patent ductus arteriosus; Pulmonary hypertension.