Marhisham Che Mood1, Khalil Ahmad Niazy1, Mazeni Alwi1, Hasri Samion1, Koh Ghee Tiong2, Sivakumar Sivalingam1, Deyuan Zhang3. 1. Paediatric and Congenital Heart Centre, Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia. 2. Department of Paediatric, Hospital Serdang, Selangor, Malaysia. 3. National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Lifetech Scientific (Shenzhen) Co., Ltd., Shenzhen, China.
Abstract
Introduction: Bioresorbable stent has the theoretical advantage in the pediatric age group; however, experience in the literature is very limited. Objectives: This pilot study sought to evaluate the feasibility, safety, and performance of iron bioresorbable scaffold (IBS Angel™) as short-term palliation in lesions with noncomplex patent ductus arteriosus (PDA). Materials and Methods: Nine neonates with duct dependent but dual-source pulmonary blood flow (PBF) were included. Major stent-related complications, in-hospital course, stent patency up to 6 months, and unplanned re-interventions were studied, as well the percentage of stent material resorbed in patients in whom the stents were explanted at the surgery. Results: IBS Angel™ was successfully implanted in all nine patients (mean weight range 3.4 ± 0.4 kg). Six were pulmonary atresia with an intact ventricular septum and 1 critical pulmonary stenosis patients where PDA stenting was done together or after balloon dilation. The mean procedure and fluoroscopy times were 89 ± 39 min and 16.3 ± 6.9 min, respectively. There were no major complications such as stent thrombosis or embolization and there were no in-hospital deaths. Post procedure overshunting and prolonged ventilatory support was a prominent feature. The median ventilation days was 3 (1-11 days). One patient died after 1 month due to respiratory syncytial virus pneumonia at the referring hospital. At 6 months follow-up, four had patent stents and four had blocked or restrictive stent flow. One patient received re-stenting at 4 months for restrictive stent flow. In three patients where microcomputed tomography of explanted stent was available, resorption of iron was 15% at 6 months and >65% at 16 months. Conclusions: Ductal stenting with IBS Angel™ is feasible and safe in selected patients. Because of early luminal loss, its use may be recommended for lesions with dual-source PBF with noncomplex PDA morphology that requires a short duration of palliation. Copyright:
Introduction: Bioresorbable stent has the theoretical advantage in the pediatric age group; however, experience in the literature is very limited. Objectives: This pilot study sought to evaluate the feasibility, safety, and performance of iron bioresorbable scaffold (IBS Angel™) as short-term palliation in lesions with noncomplex patent ductus arteriosus (PDA). Materials and Methods: Nine neonates with duct dependent but dual-source pulmonary blood flow (PBF) were included. Major stent-related complications, in-hospital course, stent patency up to 6 months, and unplanned re-interventions were studied, as well the percentage of stent material resorbed in patients in whom the stents were explanted at the surgery. Results: IBS Angel™ was successfully implanted in all nine patients (mean weight range 3.4 ± 0.4 kg). Six were pulmonary atresia with an intact ventricular septum and 1 critical pulmonary stenosis patients where PDA stenting was done together or after balloon dilation. The mean procedure and fluoroscopy times were 89 ± 39 min and 16.3 ± 6.9 min, respectively. There were no major complications such as stent thrombosis or embolization and there were no in-hospital deaths. Post procedure overshunting and prolonged ventilatory support was a prominent feature. The median ventilation days was 3 (1-11 days). One patient died after 1 month due to respiratory syncytial virus pneumonia at the referring hospital. At 6 months follow-up, four had patent stents and four had blocked or restrictive stent flow. One patient received re-stenting at 4 months for restrictive stent flow. In three patients where microcomputed tomography of explanted stent was available, resorption of iron was 15% at 6 months and >65% at 16 months. Conclusions: Ductal stenting with IBS Angel™ is feasible and safe in selected patients. Because of early luminal loss, its use may be recommended for lesions with dual-source PBF with noncomplex PDA morphology that requires a short duration of palliation. Copyright:
Authors: Timothy F Feltes; Emile Bacha; Robert H Beekman; John P Cheatham; Jeffrey A Feinstein; Antoinette S Gomes; Ziyad M Hijazi; Frank F Ing; Michael de Moor; W Robert Morrow; Charles E Mullins; Kathryn A Taubert; Evan M Zahn Journal: Circulation Date: 2011-05-02 Impact factor: 29.690
Authors: Dana M Boucek; Athar M Qureshi; Bryan H Goldstein; Christopher J Petit; Andrew C Glatz Journal: Congenit Heart Dis Date: 2019-01 Impact factor: 2.007
Authors: Andrew C Glatz; Christopher J Petit; Bryan H Goldstein; Michael S Kelleman; Courtney E McCracken; Alicia McDonnell; Timothy Buckey; Christopher E Mascio; Subi Shashidharan; R Allen Ligon; Jingning Ao; Wendy Whiteside; W Jack Wallen; Christina M Metcalf; Varun Aggarwal; Hitesh Agrawal; Athar M Qureshi Journal: Circulation Date: 2017-10-17 Impact factor: 29.690
Authors: Mazeni Alwi; K K Choo; Haifa Abdul Latiff; Geetha Kandavello; Hasri Samion; M D Mulyadi Journal: J Am Coll Cardiol Date: 2004-07-21 Impact factor: 24.094
Authors: G Santoro; G Gaio; M T Palladino; C Iacono; M Carrozza; R Esposito; M G Russo; G Caianiello; R Calabrò Journal: Heart Date: 2007-07-30 Impact factor: 5.994