SummaryBackground and objectives New arteriovenous fistulas (AVF) are frequently unsuitable for hemodialysis because of AVF nonmaturation. Aggressive endovascular or surgical interventions are often undertaken to salvage nonmaturing AVFs. The effect of early interventions to promote AVF maturation on subsequent long-term AVF outcomes is unknown.Design, setting, participants, & measurements We evaluated 173 hemodialysis patients from two academic centers who received a new AVF. Of these, 96 (56%) required no further intervention, 54 (31%) required one intervention, and 23 (13%) required two or more interventions to achieve suitability for dialysis. We calculated AVF survival and frequency of postmaturation interventions in each group.Results Cumulative AVF survival (access cannulation to permanent failure) in patients with two or more versus one versus zero interventions before maturation was 68% versus 78% versus 92% at 1 year, 57% versus 71% versus 85% at 2 years, and 42% versus 57% versus 75% at 3 years. Using Cox regression analysis with interventions before maturation, age, sex, race, diabetes, peripheral vascular disease, access site, and obesity in the model, intervention before maturation (two or more) was the only factor associated with cumulative AVF survival. The number of interventions required to maintain patency after maturation was 3.51 Ϯ 2.20 versus 1.37 Ϯ 0.31 versus 0.76 Ϯ 0.10 per year in patients with two or more versus one versus zero interventions before maturation. ConclusionsCompared with AVF that mature without interventions, AVF that require interventions have decreased cumulative survival and require more interventions to maintain their patency for hemodialysis.
Our work represents a detailed description of the morphometric and cellular phenotypic lesions present in the veins of CKD and ESRD patients, prior to dialysis access placement. These studies (i) suggest the future possibility of a new predictive marker (pre-existing venous neointimal hyperplasia) for AV dialysis access dysfunction and (ii) open the door for the future development of novel local therapies for optimization of the venous substrate on which the dialysis access is created.
OBJECTIVES Early thrombosis (ET) contributes to autogenous arteriovenous fistula (AVF) failure. We studied patients undergoing AVF placement in the Hemodialysis Fistula Maturation (HFM) Study, a prospective, observational cohort study, using a nested case-control analysis to identify pre-operative and intra-operative predictors of ET. METHODS ET cases were compared to controls who were matched on gender, age, diabetes, dialysis status, and surgeon fistula volume. ET was defined as thrombosis diagnosed by physical exam or ultrasound within 18 days of AVF creation. Conditional logistic regression models were fit to identify risk factors for ET. RESULTS Thirty-two ET cases (5.3%) occurred among 602 study participants; 198 controls were matched. ET was associated with female gender (OR=2.75, CI 1.19–6.38, P=0.018), fistula location (forearm vs. upper arm) (OR=2.76, CI 1.05–7.23, P=0.039), feeding artery (radial vs. brachial) (OR=2.64, CI 1.03–6.77, P=0.043) and arterial diameter (OR=1.52, CI 1.02–2.26, P=0.039, per mm smaller). Draining vein diameter was nonlinearly associated with ET, with highest risk in 2–3 mm veins. Surprisingly, ET risk was lower in diabetics (OR=0.19, CI 0.07–0.47, P=0.0004), lower with less nitroglycerin-mediated brachial artery dilatation (NMD%) (OR=0.42, CI 0.20–1.92, P=0.029 for each 10% lower) and higher with lower carotid-femoral pulse wave velocity (OR=1.49, CI 1.02–2.20, P=0.041, for each m/sec lower). Intraoperative protamine use was associated with a higher ET risk (OR 3.26, CI 1.28-∞, P=0.038). Surgeon’s intraoperative perceptions were associated with ET: surgeons’ greater concern about maturation success (likely, marginal, unlikely) was associated with higher thrombosis risk (OR 8.09, CI 4.03-∞, p<0.0001, per category change), as were absence vs. presence of intraoperative thrill (OR 21.0, CI 5.07-∞, P=0.0002) and surgeons’ reported frustration during surgery (OR 6.85, CI 2.70-∞, P=0.0004). Reduced extent of intraoperative thrill (proximal, mid or distal third of the forearm or upper arm, based on AVF placement) was also associated with ET (OR 2.91, CI 1.31-∞, P=0.014, per diminished level). Oral antithrombotic medication use was not significantly associated with ET. CONCLUSIONS ET was found to be associated with female gender, forearm AVF, smaller arterial size, draining vein diameter of 2–3 mm, and protamine use. Paradoxically, diabetes and stiff, noncompliant feeding arteries were associated with lower frequency of ET. Absent or attenuated intraoperative thrill, and both surgeon frustration and concern about successful maturation during surgery, were strongly correlated with ET.
Multiple processes of care and complications are associated with AVF maturation outcomes.
PurposeTo explore the safety and efficacy of PRT-201.MethodsRandomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.0033 to 9 mg) applied after arteriovenous fistula (AVF) creation. Participants were followed for one year. The primary outcome measure was safety. Efficacy measures were the proportion with intra-operative increases in AVF outflow vein diameter or blood flow ≥25% (primary), changes in outflow vein diameter and blood flow, AVF maturation and lumen stenosis by ultrasound criteria and AVF patency.ResultsThe adverse events in the PRT-201 group (n=45) were similar to those in the placebo group (n=21). There were no differences in the proportion with ≥25% increase in vein diameter or blood flow, successful maturation or lumen stenosis. There was no statistically significant difference in primary patency between the dose groups (placebo n=21, Low Dose n=16, Medium Dose n=17 and High Dose n=12). In a subgroup analysis that excluded three participants with early surgical failures, the hazard ratio (HR) for primary patency loss of Low Dose compared with placebo was 0.38 (95% CI 0.10-1.41, P=0.15). In a Cox model, Low Dose (HR 0.27, 95% CI 0.04-0.79, P=0.09), white race (HR 0.17, 95% CI 0.03-0.79, P=0.02), and age <65 years (HR 0.25, CI 0.05-1.15, P=0.08) were associated (P<0.10) with a decreased risk of primary patency loss.ConclusionsPRT-201 was not different from placebo for safety or efficacy measures. There was a suggestion for improved AVF primary patency with Low Dose PRT-201 that is now being studied in a larger clinical trial.
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