Clinical study protocol for the ARCH project - computational modeling for improvement of outcome after vascular
Aron Bode1, Anna Caroli, Wouter Huberts
1Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. a.bode@mumc.nl
Insights
Creating and maintaining vascular access (VA) is difficult. Computational modeling may improve VA outcomes by analyzing patient-specific factors and their interactions, leading to better configuration selection.
Area of Science:
- Biomedical Engineering
- Vascular Surgery
- Medical Informatics
Background:
- Vascular access (VA) creation and maintenance present significant clinical challenges, often leading to dysfunction despite existing guidelines and imaging technologies.
- Previous studies identified prognostic factors for VA dysfunction but often overlook their complex systemic interactions.
- Improving patient outcomes requires a more integrated approach to understanding and predicting VA performance.
Purpose of the Study:
- To present the rationale for employing computational modeling in vascular access.
- To introduce the clinical study protocol for calibrating and validating these predictive modeling tools.
- To enhance the selection of vascular access configurations through patient-specific factor analysis.
Main Methods:
- Development and validation of computational modeling tools within the ARCH project.
- Pre-operative collection of structural and functional vascular data.
- Post-operative functional evaluation of vascular access during follow-up periods.
Main Results:
- The study protocol focuses on integrating diverse patient-specific data for computational analysis.
- Validation of computational models is planned using clinical data from a multi-center initiative.
- The approach aims to identify optimal vascular access configurations based on predicted performance.
Conclusions:
- Computational modeling offers a promising avenue to address the complexities of vascular access dysfunction.
- Integrating patient-specific factors and their interactions can lead to improved vascular access outcomes.
- This research protocol lays the groundwork for validating advanced predictive tools in vascular surgery.
Abstract:
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 here.
