ICT - Call 4 - Objective IST-2009.5.2: ICT for Patient Safety
ICT for safer surgery: Innovative ICT based tools for training, pre-operative planning, and computer-aided surgical interventions. These tools will involve modelling, simulation and visualization techniques using real-time or near real-time accurate, 3-D, anatomical predictive models, and be based on realistic models of tissues and organs capable of capturing the patient-specific and treatment-specific information. The tools will be used to predict the clinical-functional outcome of the surgical intervention while it is being planned or performed. Validation including quantitative indicators relating to improve quality and safety of surgical operation will be included.
State of the art
Cardiovascular disease (CVD) refers to the class of diseases that involve the heart or blood vessels and is the single most common cause of death in the EU. In February 2008, the yearly European Cardiovascular Disease statistics reported that CVD caused over 4.3 million deaths in Europe, which accounted for 42% of all mortality in the EU. The high incidence of CVD incurs a significant cost upon the European health care system with an estimated €192 billion invested in 2006, consisting of €110 billion in health care costs, €40 billion in productivity loss and €42 billion in informal care. Thus the occurrence of CVD has a major socio-economic impact in the EU and enhanced methods for delivering interventional treatment are of critical importance.
For the treatment of CVD, minimally invasive surgery (MIS) and catheter-based approaches are of particular importance as access trauma in the cardio-thoracic anatomy can significantly increase the risk of intra-operative and post-procedural complications. Catheter procedures are among the most common surgical interventions used to treat CVD and they extend the range of patients able to safely receive interventional CVD treatment even in age groups dominated by co-morbidity and unacceptable risks for open surgery (Mirabel 2008).
The risk related to medical errors can be attributed to 1) a deterministic component based on the patient’s risk factor, 2) a deterministic component based on the surgeon’s skill and the quality of procedure planning and procedure execution, and 3) a stochastic component caused due to unpredictable events. The SCATh ICT platform is a powerful and modular framework that allows the medical expert to reduce risk related to both components 2) and 3), by providing multiscale patient-specific data to the interventionalist (improved diagnosis, planning). These models will adapt in real-time to reproduce more faithfully the reality of the surgical theatre (improved response to unforeseen effects), relying on fusion of intra-operative data coming from tool-mounted and/or external sensors, with pre-operative patient-specific data. Safety-related indices will be computed to compress the vast amount of generated data in objective, easy-understandable indicators, allowing the surgeon to act swiftly when necessary. Furthermore, substantial efforts will be made to improve the controllability of the catheter by the interventionalist (improved procedure execution), allowing the latter to select his preferred modus of operandi. These facilities allow the interventionalist to manipulate patient models during short breaks or prior to the procedure (planning, diagnosis) to manipulate and control the catheter itself during the procedure (teleoperation) – to partly automate parts of the interventional procedure (shared autonomy) or manipulate the patient-specific models offline (training). Lastly, for medical errors related to the patient’s risk factor, SCATh refers to the readily available support tools such as EuroSCORE or similar.
The novel catheterization framework emphasizes the importance of real-time modelling through local sensing, by doing so it possesses the additional advantage of becoming less dependent on traditional techniques such as fluoroscopy, i.e. real-time X-ray imaging of catheter and blood vessels, injected with contrast agents, which are known for causing numerous complications including possible allergic reactions, thrombosis, embolization and bleeding, and dangers related to radiation exposure . The alternative MR imaging methods are, apart from being bulky, restrictions for general use, and compatibility problems with certain instruments, also known for their high costs to the health care² system.
The contribution of SCATh to improve patient safety in surgery include amongst others:
- reduced risks for patient and surgeon due to reduced or zero exposure to ionizing radiations;
- ability to develop realistic training tools for surgeon;
- less occurrence of complications during interventional procedure due to improved patient-specific pre-operative planning;
- full support to the surgeon during the procedure through monitoring and control