Clinical study protocol for the ARCH project Computational modeling for improvement of outcome after vascular access creation

Despite clinical guidelines and the possibility of diagnostic vascular imaging, creation and maintenance of a vascular access (VA) remains problematic: avoiding short- and long-term VA dysfunction is challenging. Although prognostic factors for VA dysfunction have been identified in previous studies, their potential interplay at a systemic level is disregarded. Consideration of multiple prognostic patient specific factors and their complex interaction using dedicated computational modeling tools might improve outcome after VA creation by enabling a better selection of VA configuration. These computational modeling tools are developed and validated in the ARCH project: a joint initiative of four medical centers and three industrial partners (FP7-ICT-224390). This paper reports the rationale behind computational modeling and presents the clinical study protocol designed for calibrating and validating these modeling tools. The clinical study is based on the pre-operative collection of structural and functional data at a vascular level, as well as a VA functional evaluation during the follow-up period. The strategy adopted to perform the study and for data collection is also described her

Validation of a patient-specific hemodynamic computational model for surgical planning of vascular access in hemodialysis patients

Vascular access dysfunction is one of the main causes of morbidity and hospitalization in hemodialysis patients. This major clinical problem points out the need for prediction of hemodynamic changes induced by vascular access surgery. Here we reviewed the potential of a patient-specific computational vascular network model that includes vessel wall remodeling to predict blood flow change within 6 weeks after surgery for different arteriovenous fistula configurations. For model validation, we performed a multicenter, prospective clinical study to collect longitudinal data on arm vasculature before and after surgery. Sixty-three patients with newly created arteriovenous fistula were included in the validation data set and divided into four groups based on fistula configuration. Predicted brachial artery blood flow volumes 40 days after surgery had a significantly high correlation with measured values. Deviation of predicted from measured brachial artery blood flow averaged 3% with a root mean squared error of 19.5%, showing that the computational tool reliably predicted patient-specific blood flow increase resulting from vascular access surgery and subsequent vascular adaptation. This innovative approach may help the surgeon to plan the most appropriate fistula configuration to optimize access blood flow for hemodialysis, potentially reducing the incidence of vascular access dysfunctions and the need of patient hospitalization