Arteriovenous fistula can be successfully created in most incident haemodialysis patients. Routine vein mapping is not necessary if veins are suitable on physical examination alone, and vein sizes of <2 mm on ultrasound is not associated with lower AVF maturation rate.
In conclusion, prolonged duration of catheter insertion is found to be a risk factor for catheter-related bloodstream infection in hemodialysis patients, and its development is associated with increased mortality. Early referral to a nephrologist and creation of arteriovenous fistula in pre-end-stage renal disease patients are pivotal in improving the outcomes of patients.
Background: The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage. Methods and results: This is an investigator-initiated prospective single-center, non-blinded single-arm trial. Forty patients with clinically significant de novo or recurrent stenoses in a mature AVF circuit will be recruited. All stenotic lesions will be prepared with high pressure non-compliant conventional balloon angioplasty (CBA) prior to deployment of the Sustained-Release Selution™ sirolimus drug-eluting balloon. The primary efficacy endpoint is 6-month target lesion primary patency and the primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days. Secondary endpoints of interest include technical and clinical success rates and circuit access patency at 3 and 6 months. Follow-up will occur for 2 years for those patients whose AVFs remain patent. Pharmacokinetic and histological animal safety studies performed with the Selution™ coating formulation showed prolonged arterial tissue retention of sirolimus with therapeutic levels up to 60 days and non-toxic and rapidly declining blood levels. Histological results in animal models demonstrated safety, freedom from intraluminal thrombus, reduction in restenosis by sirolimus elution compared to CBA, and no evidence of embolic phenomena indicative of adverse particulate effects. Discussion: Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas.
was observed on the posterior wall, once again with the highest correlation of all segments (R=0.314, p=0.015).Conclusions The automated VHA tool demonstrated the posterior wall as the only anatomical segment to be significantly higher in LVAs consistent with dense scar burden (i.e. £0.2mV), when mapped in AF. Mapping rhythm has a substantial impact on surrogate readings of both 'Diseased Tissue' 0.21-0.5mV and 'Dense Scar' £0.2mV on the posterior wall. These findings mandate careful interrogation of posterior wall voltages and may partially explain the debated outcome for posterior wall ablation. It is best interrogated in both rhythms to confirm the presence of arrhythmogenic substrates over artifactitious rhythm effect.
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