RESUMEN
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. LEVEL OF EVIDENCE: Level 2b, cohort study.
RESUMEN
BACKGROUND: Vascular stenosis commonly leads to dysfunction in hemodialysis vascular access. Although percutaneous transluminal angioplasty is an established treatment, stent utilization has increased in the last decade as an alternative solution to extend the access function. This study evaluated the safety and initial results of a new impermeable covered stent for treating vascular access outflow stenosis. METHODS: Investigators retrospectively analyzed 114 hemodialysis patients treated with polytetrafluorethylene-covered stents from September 2018 to September 2022 across four centers. Lesions treated were de novo or restenotic and located in the venous graft anastomosis, outflow segment, cephalic arch, and basilic swing point. Patients were followed by in-person physical examination at 1, 3, and 6 months, and Duplex ultrasound was performed to evaluate the vascular access circuit and in-stent restenosis. The primary efficacy endpoint was target lesion primary patency at 1, 3, and 6 months. Secondary endpoints included access circuit primary patency and secondary patency at 1, 3, and 6 months. The primary safety endpoint was freedom from local or systemic serious adverse events through 30 days post-procedure. RESULTS: Forty-four patients had thrombosed access at the initial presentation, and 41 patients presented with recurrent stenosis. The target lesion primary patency rates at 1, 3, and 6 months were 100%, 89.4%, and 74%, respectively. The access circuit primary patency rates were 100% at 1 month, 85% at 3 months, and 62.7% at 6 months. The secondary patency rates at 1, 3, and 6 months were 100%, 96.4%, and 94.6%, respectively. In the adjusted multivariate Cox regression analysis, only recurrent lesions and female gender were associated with reduced primary patency rates. No serious adverse event was observed through the first 30 days post-procedure. CONCLUSION: In this retrospective analysis, a new covered stent was shown to be safe and effective for treating peripheral outflow stenosis in vascular access.
RESUMEN
Chronic kidney disease is a worldwide public health problem, and end-stage renal disease requires dialysis. Most patients requiring renal replacement therapy have to undergo hemodialysis. Therefore, vascular access is extremely important for the dialysis population, directly affecting the quality of life and the morbidity and mortality of this patient population. Since making, managing and salvaging of vascular accesses falls within the purview of the vascular surgeon, developing guideline to help specialists better manage vascular accesses for hemodialysis if of great importance. Thus, the objective of this guideline is to present a set of recommendations to guide decisions involved in the referral, evaluation, choice, surveillance and management of complications of vascular accesses for hemodialysis.
A doença renal crônica é um problema de saúde pública global e em seu estágio terminal está associada à necessidade de terapia dialítica. A grande maioria dos pacientes que necessitam realizar a terapia renal substitutiva, a fazem através da hemodiálise. Portanto, o acesso vascular é de extrema importância para a população dialítica, implicando diretamente na qualidade de vida e na morbimortalidade deste grupo de pacientes. Sendo a confecção, gerenciamento e resgate dos acessos vasculares uma das áreas de atuação do cirurgião vascular, é de grande importância a elaboração de uma diretriz que oriente o especialista no manejo mais adequado do acesso vascular para hemodiálise. Assim, o objetivo desta diretriz é apresentar um conjunto de recomendações para guiar as decisões na referenciação, avaliação, escolha, vigilância e gestão das complicações do acesso vascular para hemodiálise.
RESUMEN
Abstract Chronic kidney disease is a worldwide public health problem, and end-stage renal disease requires dialysis. Most patients requiring renal replacement therapy have to undergo hemodialysis. Therefore, vascular access is extremely important for the dialysis population, directly affecting the quality of life and the morbidity and mortality of this patient population. Since making, managing and salvaging of vascular accesses falls within the purview of the vascular surgeon, developing guideline to help specialists better manage vascular accesses for hemodialysis if of great importance. Thus, the objective of this guideline is to present a set of recommendations to guide decisions involved in the referral, evaluation, choice, surveillance and management of complications of vascular accesses for hemodialysis.
Resumo A doença renal crônica é um problema de saúde pública global e em seu estágio terminal está associada à necessidade de terapia dialítica. A grande maioria dos pacientes que necessitam realizar a terapia renal substitutiva, a fazem através da hemodiálise. Portanto, o acesso vascular é de extrema importância para a população dialítica, implicando diretamente na qualidade de vida e na morbimortalidade deste grupo de pacientes. Sendo a confecção, gerenciamento e resgate dos acessos vasculares uma das áreas de atuação do cirurgião vascular, é de grande importância a elaboração de uma diretriz que oriente o especialista no manejo mais adequado do acesso vascular para hemodiálise. Assim, o objetivo desta diretriz é apresentar um conjunto de recomendações para guiar as decisões na referenciação, avaliação, escolha, vigilância e gestão das complicações do acesso vascular para hemodiálise.
