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.
Asunto(s)
Oclusión de Injerto Vascular , Diálisis Renal , Grado de Desobstrucción Vascular , Humanos , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Brasil , Anciano , Oclusión de Injerto Vascular/terapia , Constricción Patológica , Resultado del Tratamiento , Derivación Arteriovenosa Quirúrgica , Prótesis Vascular , AdultoRESUMEN
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
BACKGROUND: The functional autologous arteriovenous fistula is considered the best vascular access for patients on hemodialysis. Some fistulae exhibit maturation problems after creation and do not reach adequate vessel diameter and flow in dialysis. The aim of this study was to describe our technique of oversized balloon angioplasty for assisted maturation of arteriovenous fistulae to accelerate the cannulation and to decrease the time of catheter use and its outcome. METHODS: A retrospective analysis of balloon-assisted procedures for maturation failure was performed in a single center between October 2011 and January 2019. Patients underwent imaging procedures to identify stenosis, followed by angioplasty using oversized high-pressure balloons from the anastomosis to the deep venous outflow tract. The flow volume, time interval of use of the fistula and removal of the catheter, patency rates, and complications rates were evaluated. RESULTS: Seventy-eight patients underwent 124 balloon angioplasty procedures. Technical and clinical success was achieved in 91% of the cases. In patients in whom maturation was successful, the fistula was cannulated in a mean time of 5 days after the procedure (range, 1-20 days). On average, catheter removal was performed 14 days (range, 5-33 days) after the maturation procedure. The mean flow volume in the fistula before the procedure was 276 ml/min (range, 122-488 ml/min) and 24 h after the maturation was 1014 ml/min (range, 760-1800 ml/min).The primary patency rate at 3, 6, and 12 months was 87.3%, 66.2%, and 50.7%, respectively. Assisted primary patency was 100% at 3 months, 92.9% at 6 months, and 90.0% at 12 months. Minor complications occurred in 18% of cases, and major complications in 4.8%. CONCLUSIONS: The oversized balloon-assisted arteriovenous fistula maturation technique is safe and effective, allowing the cannulation of the fistulae a few hours or days after the procedure and decreasing the time of catheter use.