دورية أكاديمية
Results of the multicenter early feasibility study (EFS) of the Renata Minima stent as treatment for branch pulmonary artery stenosis and coarctation of aorta in infants.
| العنوان: | Results of the multicenter early feasibility study (EFS) of the Renata Minima stent as treatment for branch pulmonary artery stenosis and coarctation of aorta in infants. |
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| المؤلفون: | Berman DP; Heart Institute, Children's Hospital Los Angeles, Los Angeles, California, USA., Morray B; Division of Pediatric Cardiology, Seattle Children's Hospital, Seattle, Washington, USA., Sullivan P; Heart Institute, Children's Hospital Los Angeles, Los Angeles, California, USA., Shahanavaz S; Department of Pediatrics, Heart Institute, Cincinnati Children's Hospital University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Zahn EM; Smidt Heart Institute and Guerin Children's, Cedars Sinai Medical Center, Los Angeles, California, USA. |
| المصدر: | Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2024 Jul; Vol. 104 (1), pp. 61-70. Date of Electronic Publication: 2024 May 12. |
| نوع المنشور: | Multicenter Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Liss Country of Publication: United States NLM ID: 100884139 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1522-726X (Electronic) Linking ISSN: 15221946 NLM ISO Abbreviation: Catheter Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Wiley-Liss, c1999- |
| مواضيع طبية MeSH: | Feasibility Studies* , Aortic Coarctation*/diagnostic imaging , Aortic Coarctation*/therapy , Aortic Coarctation*/physiopathology , Stents* , Prosthesis Design* , Stenosis, Pulmonary Artery*/diagnostic imaging , Stenosis, Pulmonary Artery*/physiopathology , Stenosis, Pulmonary Artery*/therapy , Stenosis, Pulmonary Artery*/etiology, Humans ; Infant ; Prospective Studies ; Male ; Female ; Treatment Outcome ; Time Factors ; Child, Preschool ; Pulmonary Artery/diagnostic imaging ; Pulmonary Artery/physiopathology ; Age Factors ; Angioplasty, Balloon/instrumentation ; Angioplasty, Balloon/adverse effects |
| مستخلص: | Background: Stent implantation has become standard of care in older children and adults for treatment of branch pulmonary artery stenosis (BPAS) and coarctation aorta (CoAo). There are no stents approved or available for infants that have the potential to be dilated to adult diameters. The Minima stent was designed to fulfill this unmet need. Methods: Multicenter, prospective, nonrandomized early feasibility study evaluating safety and effectiveness of the Minima stent for treatment of BPAS and CoAo. Primary endpoints included: (1) successful deployment across lesion, (2) stenosis relief defined by an increase in angiographic diameter of >50% and (3) freedom from stent explant, embolization or migration at 30 days and 6 months. Results: Between 2/2022 and 5/2022, 10 pts underwent Minima stent implantation with a median age and weight of 9 months (4-43 months) and 7.6 kg (5.1-16.9 kg). Procedural success and predefined stenosis relief was achieved in all cases (CoAo [n = 4], BPAS [n = 6]). Adverse events occurred in 3 pts: transient diminished lower extremity pulse (n = 2), distal stent on-balloon displacement successfully managed in the catheterization suite (n = 1). There were no deaths or major adverse events. All patients were free from stent explant and migration at 30 days and 6 months with no evidence for significant restenosis at latest follow-up. Conclusions: Implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during early follow-up. Based on these early results, an expanded study with longer follow-up is warranted. (© 2024 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.) |
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| فهرسة مساهمة: | Keywords: coarctation of aorta; congenital heart disease; pulmonary artery stenosis; stents |
| تواريخ الأحداث: | Date Created: 20240513 Date Completed: 20240712 Latest Revision: 20240712 |
| رمز التحديث: | 20240712 |
| DOI: | 10.1002/ccd.31074 |
| PMID: | 38736246 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1522-726X |
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| DOI: | 10.1002/ccd.31074 |