SUMMARY
Over the last decade, minimally invasive interventions based on transcatheter techniques have dramatically changed the treatment of cardiac valve dysfunction avoiding open-heart surgery. The spread of these technologies depends on limiting the procedural risks of the currently available devices and on developing novel devices that are suitable for a larger cohort of patients. Bioengineering tools can be applied in this context to support a wider use of this technique and safely spread the related advantages. Realistic patient-specific models will be created as a suitable option to accurately test possible interventions. Cardiac magnetic resonance (MR) imaging will be integrated with computer analyses and navigation systems to plan and execute such interventions on a patient-specific basis. This project involves clinical centres and bioengineering laboratories which will work in synergy to support a translation of patient-specific modelling towards clinical benefits.
PARTNERS
FTGM, Pisa/Massa, Italy
The Foundation is a specialized public entity of the Regional Health Service (law no. 85/2009) constituted by the National Council for Research (CNR) and by the Tuscany Region for the management and further development of specialized healthcare and research activities of interest to the public health services, previously carried out by the Institute of Clinical Physiology of the CNR.
UCL, London, UK
The engineering team at the Centre for Cardiovascular Imaging, embedded within Great Ormond Street Hospital for Children and UCL Institute of Cardiovascular Science in London, employ both experimental and computational techniques for modelling cardiovascular diseases and devices to study the function and performance of the heart.
ENDOCAS, Pisa, Italy
The mission of EndoCAS is to develop breakthrough technologies based on engineering and information technologies to improve the current surgical procedures and reduce their invasiveness by means of an optimal use of medical imaging.
PLANNING
A software application will be implemented providing planning of TVI procedures as based on realistic simulations of catheter insertion, movement, operation and device implantation.
The TVI-PLAN will include the input of MR data set, as it is standardly acquired prior to the intervention in patients scheduled for TVI. Hence, the patient-specific vascular tract will be modelled by mean of a geometrical mesh.
Distensibility of cardiovascular structures will be also modelled by combining imaging data with physiological parameters. Finite element analysis will be performed to simulate the implantation of the TVI device. The simulation will allow a prediction of the interventional feasibility including assessment of mechanical stability of each specific implant.
PROCEDURAL ASSISTING DEVICE
A TVI procedural assisting device (TVI-AD) will be developed. Purpose of this device is reducing the need of X-rays and to accurately guide the valve implantation as optimized by TVI-PLAN. TVI-AD will integrate the graphic user interface (GUI) of a navigator system to monitor the real time position and orientation of the endovascular tools (guidewires, catheters and stent) in respect to a 3D model of the patient specific implantation site and to show the instruments in the virtual model of the arteries.
TVI-AD can be used in combination with a so called XMR suite, a system which integrates MRI and fluoroscopy in the same laboratory, improving the registration between virtual and real patient’s data. MRI data acquired immediately before the intervention could be used to create a virtual model of the arteries by 3D computer reconstruction. The bed can be shifted on a rail from the MR to the treatment area, where an electromagnetic localizer will localize the sensorized endovascular instruments. The system will model anatomy movements, due to breathing and cardiac cycle.