Abstract

More than 940 patients affected by end-stage renal disease (ESRD) per million population in Europe live on chronic renal replacement therapy, and about 80% of these patients are treated chronically by hemodialysis (HD). To date, short- and longterm dysfunctions of vascular access (VA) used to connect patient blood circulation to the artificial kidney are still the major cause of morbidity and hospitalisation in HD patients, likely due to sudden and sustained hemodynamic changes involved in VA creation. During the recently ended EU-funded ARCH project, coordinated by Mario Negri Institute, computational tools for predicting hemodynamic changes induced by different configurations of arteriovenous fistula (AVF) surgery at patient-specific level were calibrated, preliminary validated, and finally embedded in a prototypical clinical application (AVF.SIM). The availability of patientspecific predictions could be of crucial importance for best planning vascular surgery, in order to have adequate increase in blood flow rate. Given preliminary evidence of clinical validity and given the relevance of potential clinical implication, the current project will move one step forward, investigating the efficacy, usability and impact of using the AVF.SIM tool in clinical practice. Clinical validation will be performed through a multicenter, stratified, randomized and controlled clinical study aimed at providing clinical evidence of the benefits of the use of the AVF.SIM computational modeling tool as decision support tool for best planning vascular access surgery in hemodialysis patients. Primary objective will be to compare the incidence of vascular access blood flow adequate for HD treatment (in a safe threshold, e.g. 400-1500 ml/min) between a group of patients undergoing computer-aided surgical planning based on AVF.SIM modeling tool and US investigation (Intervention group), and a control group undergoing conventional surgical planning based on US investigation only. Secondary objectives will be to compare the incidence of AVF dysfunctions between the two groups. The clinical study will foresee two ad-interim analyses aimed at preliminary assessing efficacy, usability and impact of the tool as well as surgical planning compliance with the model, and preliminary results will be shared with clinicians and used to improve the tool by further modeling and software engineering activity, in view of a fully usable and cost-effective prototype.