Leonardo de Oliveira Harduin, Thiago Almeida Barroso, Julia Bandeira Guerra, Márcio Gomes Filippo, Leonardo Cortizo de Almeida, Brunno Ribeiro Vieira, Renata Silveira Mello, Adriano Martins Galhardo, Jorge Paulo Strogoff-de-Matos
{"title":"治疗血液透析血管通路流出道狭窄的细胞防渗内支架的安全性和性能:巴西多中心回顾性研究。","authors":"Leonardo de Oliveira Harduin, Thiago Almeida Barroso, Julia Bandeira Guerra, Márcio Gomes Filippo, Leonardo Cortizo de Almeida, Brunno Ribeiro Vieira, Renata Silveira Mello, Adriano Martins Galhardo, Jorge Paulo Strogoff-de-Matos","doi":"10.1007/s00270-024-03790-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the safety and performance of Wrapsody™, a cell-impermeable endoprosthesis (CIE), for treating hemodialysis vascular access outflow stenosis.</p><p><strong>Materials and methods: </strong>Investigators retrospectively analyzed 113 hemodialysis patients treated with a CIE (11/2021-12/2022) across four centers in Brazil. De novo or restenotic lesions were treated. The primary efficacy outcome measure was target lesion primary patency (TLPP) at 1, 3, 6, and 12 months; the primary safety outcome measure was the absence of serious local or systemic adverse events within the first 30 days post-procedure. Secondary outcome measures included technical and procedural success, access circuit primary patency (ACPP), and secondary patency at 1, 3, 6, and 12 months post-procedure.</p><p><strong>Results: </strong>Thirty-nine patients (34.5%) had thrombosed access at the initial presentation, and 38 patients (33.6%) presented with recurrent stenosis. TLPP rates at 1, 3, 6, and 12 months were 100%, 96.4%, 86.4%, and 69.7%, respectively. ACPP rates were 100% at 1 month, 89.2% at 3 months, 70.9% at 6 months, and 56.0% at 12 months. The target lesion secondary patency rates at 1, 3, 6, and 12 months were 100%, 97.3%, 93.6%, and 91.7%, respectively. In the adjusted multivariate Cox regression analysis, male sex and endoprosthesis with diameters of 10, 12, 14, and 16 mm were associated with improved primary patency rates. No localized or systemic serious adverse event was observed through the first 30 days post-procedure.</p><p><strong>Conclusion: </strong>The CIE evaluated in this study is safe and effective for treating peripheral and central outflow stenoses in hemodialysis vascular access.</p><p><strong>Level of evidence: </strong>Level 2b, cohort study.</p>","PeriodicalId":9591,"journal":{"name":"CardioVascular and Interventional Radiology","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11303476/pdf/","citationCount":"0","resultStr":"{\"title\":\"Safety and Performance of a Cell-Impermeable Endoprosthesis for Hemodialysis Vascular Access Outflow Stenosis: A Brazilian Multicenter Retrospective Study.\",\"authors\":\"Leonardo de Oliveira Harduin, Thiago Almeida Barroso, Julia Bandeira Guerra, Márcio Gomes Filippo, Leonardo Cortizo de Almeida, Brunno Ribeiro Vieira, Renata Silveira Mello, Adriano Martins Galhardo, Jorge Paulo Strogoff-de-Matos\",\"doi\":\"10.1007/s00270-024-03790-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate the safety and performance of Wrapsody™, a cell-impermeable endoprosthesis (CIE), for treating hemodialysis vascular access outflow stenosis.</p><p><strong>Materials and methods: </strong>Investigators retrospectively analyzed 113 hemodialysis patients treated with a CIE (11/2021-12/2022) across four centers in Brazil. De novo or restenotic lesions were treated. The primary efficacy outcome measure was target lesion primary patency (TLPP) at 1, 3, 6, and 12 months; the primary safety outcome measure was the absence of serious local or systemic adverse events within the first 30 days post-procedure. Secondary outcome measures included technical and procedural success, access circuit primary patency (ACPP), and secondary patency at 1, 3, 6, and 12 months post-procedure.</p><p><strong>Results: </strong>Thirty-nine patients (34.5%) had thrombosed access at the initial presentation, and 38 patients (33.6%) presented with recurrent stenosis. TLPP rates at 1, 3, 6, and 12 months were 100%, 96.4%, 86.4%, and 69.7%, respectively. ACPP rates were 100% at 1 month, 89.2% at 3 months, 70.9% at 6 months, and 56.0% at 12 months. The target lesion secondary patency rates at 1, 3, 6, and 12 months were 100%, 97.3%, 93.6%, and 91.7%, respectively. In the adjusted multivariate Cox regression analysis, male sex and endoprosthesis with diameters of 10, 12, 14, and 16 mm were associated with improved primary patency rates. No localized or systemic serious adverse event was observed through the first 30 days post-procedure.</p><p><strong>Conclusion: </strong>The CIE evaluated in this study is safe and effective for treating peripheral and central outflow stenoses in hemodialysis vascular access.</p><p><strong>Level of evidence: </strong>Level 2b, cohort study.</p>\",\"PeriodicalId\":9591,\"journal\":{\"name\":\"CardioVascular and Interventional Radiology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11303476/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CardioVascular and Interventional Radiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00270-024-03790-1\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CardioVascular and Interventional Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00270-024-03790-1","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/2 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Safety and Performance of a Cell-Impermeable Endoprosthesis for Hemodialysis Vascular Access Outflow Stenosis: A Brazilian Multicenter Retrospective Study.
Purpose: To evaluate the safety and performance of Wrapsody™, a cell-impermeable endoprosthesis (CIE), for treating hemodialysis vascular access outflow stenosis.
Materials and methods: Investigators retrospectively analyzed 113 hemodialysis patients treated with a CIE (11/2021-12/2022) across four centers in Brazil. De novo or restenotic lesions were treated. The primary efficacy outcome measure was target lesion primary patency (TLPP) at 1, 3, 6, and 12 months; the primary safety outcome measure was the absence of serious local or systemic adverse events within the first 30 days post-procedure. Secondary outcome measures included technical and procedural success, access circuit primary patency (ACPP), and secondary patency at 1, 3, 6, and 12 months post-procedure.
Results: Thirty-nine patients (34.5%) had thrombosed access at the initial presentation, and 38 patients (33.6%) presented with recurrent stenosis. TLPP rates at 1, 3, 6, and 12 months were 100%, 96.4%, 86.4%, and 69.7%, respectively. ACPP rates were 100% at 1 month, 89.2% at 3 months, 70.9% at 6 months, and 56.0% at 12 months. The target lesion secondary patency rates at 1, 3, 6, and 12 months were 100%, 97.3%, 93.6%, and 91.7%, respectively. In the adjusted multivariate Cox regression analysis, male sex and endoprosthesis with diameters of 10, 12, 14, and 16 mm were associated with improved primary patency rates. No localized or systemic serious adverse event was observed through the first 30 days post-procedure.
Conclusion: The CIE evaluated in this study is safe and effective for treating peripheral and central outflow stenoses in hemodialysis vascular access.
期刊介绍:
CardioVascular and Interventional Radiology (CVIR) is the official journal of the Cardiovascular and Interventional Radiological Society of Europe, and is also the official organ of a number of additional distinguished national and international interventional radiological societies. CVIR publishes double blinded peer-reviewed original research work including clinical and laboratory investigations, technical notes, case reports, works in progress, and letters to the editor, as well as review articles, pictorial essays, editorials, and special invited submissions in the field of vascular and interventional radiology. Beside the communication of the latest research results in this field, it is also the aim of CVIR to support continuous medical education. Articles that are accepted for publication are done so with the understanding that they, or their substantive contents, have not been and will not be submitted to any other publication.