Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation
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 pallia...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2022-01-01
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| Series: | Annals of Pediatric Cardiology |
| Subjects: | |
| Online Access: | http://www.annalspc.com/article.asp?issn=0974-2069;year=2022;volume=15;issue=2;spage=147;epage=153;aulast=Mood |
| _version_ | 1797998954215899136 |
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| author | Marhisham Che Mood Khalil Ahmad Niazy Mazeni Alwi Hasri Samion Koh Ghee Tiong Sivakumar Sivalingam Deyuan Zhang |
| author_facet | Marhisham Che Mood Khalil Ahmad Niazy Mazeni Alwi Hasri Samion Koh Ghee Tiong Sivakumar Sivalingam Deyuan Zhang |
| author_sort | Marhisham Che Mood |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T10:56:57Z |
| format | Article |
| id | doaj.art-eedd4b04d7f549eaa4aebc7e2a0e3154 |
| institution | Directory Open Access Journal |
| issn | 0974-2069 |
| language | English |
| last_indexed | 2024-04-11T10:56:57Z |
| publishDate | 2022-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Annals of Pediatric Cardiology |
| spelling | doaj.art-eedd4b04d7f549eaa4aebc7e2a0e31542022-12-22T04:28:44ZengWolters Kluwer Medknow PublicationsAnnals of Pediatric Cardiology0974-20692022-01-0115214715310.4103/apc.apc_187_21Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulationMarhisham Che MoodKhalil Ahmad NiazyMazeni AlwiHasri SamionKoh Ghee TiongSivakumar SivalingamDeyuan ZhangIntroduction: 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.http://www.annalspc.com/article.asp?issn=0974-2069;year=2022;volume=15;issue=2;spage=147;epage=153;aulast=Moodductal morphologyductal stentingiron bioresorbable scaffold |
| spellingShingle | Marhisham Che Mood Khalil Ahmad Niazy Mazeni Alwi Hasri Samion Koh Ghee Tiong Sivakumar Sivalingam Deyuan Zhang Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation Annals of Pediatric Cardiology ductal morphology ductal stenting iron bioresorbable scaffold |
| title | Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation |
| title_full | Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation |
| title_fullStr | Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation |
| title_full_unstemmed | Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation |
| title_short | Feasibility, safety, and efficacy of iron bioresorbable scaffold in neonates with duct-dependent pulmonary circulation |
| title_sort | feasibility safety and efficacy of iron bioresorbable scaffold in neonates with duct dependent pulmonary circulation |
| topic | ductal morphology ductal stenting iron bioresorbable scaffold |
| url | http://www.annalspc.com/article.asp?issn=0974-2069;year=2022;volume=15;issue=2;spage=147;epage=153;aulast=Mood |
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