248782 SCATh

Aa B Part
B.1

Concept and objectives, progress beyond state-of-theart, S/T methodology and work plan.
Objectives

Concept and project objectives

B.1.1.1
The primary objective of SCATh is to enhance the safety, repeatability and precision of catheter-based interventional treatments. This will be achieved by bringing recent innovations in sensing and scanning technologies together with novel methods for data fusion, visualisation, surgical navigation and real-time modelling into a complete catheter system targeting four specific cardiovascular interventions. 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 statistics1 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 downside lies at the increased complexity of the minimally invasive procedure, which is mainly caused by the loss of direct access to and sight upon the area of treatment. This results in: a lack of correspondence between pre-operatively formed models and the real interventional site caused by inaccuracies of the employed registration procedures, by the dynamic nature of the surgical site, or caused by insufficient knowledge of the local site at the catheter tip (lack of accurate real-time geometric, mechanical or physiological information); a heavy mental load to navigate the tool through an uncertain, complex and fragile environment. The interventionalist should also possess sufficient expertise to mentally map the one or two dimensional pictures into three dimensional models while performing the procedures, and should possess superior manual skills to manoeuvre the catheter to the desired location; few possibilities to detect and respond to unforeseen adverse situations (Kono 2005).

European cardiovascular disease statistics 2008, published by the European Heart Network, Feb. 2008.

FP7-ICT-2009-4

248782 SCATh

All these factors lead to the fact that at this instant the chance of making medical errors in catheter-based diagnosis or during intervention simply remains too high2,3. Above elements clearly indicate why training of skilled interventionalists is such a long and difficult process. Summary: Urgent investments are necessary to design and construct advanced ICT tools that can build intrinsic safety into the catheter-procedures and as such allow the interventionalist to maintain a high standard for both quality and safety. The massive importance of CVD towards the European society and each single subject suffering from it, the need to constantly reinforce European leadership and medical innovation, the inherent complexity of current and future treatment procedures call for immediate and interdisciplinary action at a European level.

B.1.1.2

Concept

SCATh proposes, in line with the IST-2009.5.2 objective ICT for Patient Safety, a) ICT for safer surgery, the creation of an innovative ICT-platform for training, pre-operative planning and computer-aided surgical interventions. To realize maximal clinical impact, within the SCATh project, the focus will lie entirely upon catheter-based interventions and more specifically upon CVD-related catheter interventions. The main objective of SCATh is the creation of an ICT platform that closes the existing gap between the reality of the catheter inside the cardiovascular system and the manner in which this reality is presented and made accessible to the interventionalist.

The risk related to medical errors can be attributed to 1) a deterministic component based on the patients risk factor, 2) a deterministic component based on the surgeons 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

The Institute of Medicine in Washington, D.C., published a report titled To Err is Human, according to which more people in the U.S. die from medical errors every year than from traffic accidents. Figures vary between 50.000 and 100.000 fatalities. 3 http://yourtotalhealth.ivillage.com/balloon-angioplasty.html?pageNum=5#5 explains that in 2-5% of the cases where balloon angioplasty is performed an emergency bypass surgery is needed, also in 0.5% of the cases where stents are placed emergency bypass procedures are necessary.

FP7-ICT-2009-4

248782 SCATh

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 patients risk factor, SCATh

refers to the readily available support tools such as EuroSCORE4 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 exposure5. 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 care system.

The main advantages of the SCATh approach are: detailed real-time information of the catheter and its local environment; reduced mental load on the interventionalist; improved manoeuvrability of the catheter and control by the interventionalist; faster observation (2) of adverse events and better response (2,3) to such events; reduced dependency on harmful and/or costly imaging techniques.

To achieve the ambitious sub goal of developing real-time multiscale cardiovascular models, SCATh opts for an approach along three distinctive but complementary research lines: A. Top-down approach:
This approach investigates a series of methods that adapt and process global models of the cardiovascular system (obtained by means of traditional pre-operative imaging) in order to represent the real-time and specific nature of the local environment of the catheter-tip within the patient lying on the operation table. For anatomical models, this approach elaborates on previous experience obtained during participation to a MarieCurie Training Network (ARIS*ER)6. The previous expertise (UPM, IVS, and K.U.Leuven) will be extended towards the development of parameterized models for online updating complementing for real-time sensory data (UPM) and automatic processing of safety-related indices. TUG, the expert in mechanical modelling of the endovascular system will hereto derive indices describing the danger of occurrence of tissue-damage due to mechanical loads during intervention.

B. Bottom-up approach:
This approach investigates the feasibility of building up a global patient-specific, up-to-date model of the cardiovascular system from local scans taken from the tip of the catheter while it advances within the cardiovascular system. This is an entirely novel approach for catheterization, inspired by similar techniques for mobile robotic navigation, a so-called simultaneous localization and mapping (SLAM) method. Researchers from ICL who worked on SLAM for other surgical applications will develop this new technique, which if successful could cause a revolution in medical catheterization imaging techniques. K.U.Leuven will develop methods to compare results from both approaches and derive measures to quantify the quality of respective methods, and also derive safety-related indices extracted from them.

C. Pragmatic approach:

http://www.euroscore.org/ A study by the National Radiological Protection Board in the UK, one in every 1000 children will develop a tumour within five years after a catheterization. 6 www.ariser.info.
5

FP7-ICT-2009-4

248782 SCATh

A third, pragmatic approach will be taken in parallel to and benefiting from the information of approaches A and B. The two SMEs belonging to this consortium (EndoS and AngioC) each introducing their unique and novel sensing technology (catheter tip force sensing based on fiber bragg gratings, and infrared visualisation, respectively) will give support to employ these new sensor techniques for the benefit of approaches A and B. Simultaneously they will profit from the experience of the multidisciplinary consortium when investigating ways to fuse their sensory data with complementary data in order to develop real-time maps for a set of specific interventional procedures. The consortium will definitely benefit from the practical viewpoint from these SMEs. The developments made during this project will unlikely remain limited to theory. The challenge to fuse the data from different research lines (A, B, C) will take place under coordination of ICL. Whereas K.U.Leuven together with UPM coordinates the activities aimed at presenting the assembled real-time information in an intuitive and easy to handle form to the interventionalist. The patient-specific multiscale data acquired during real experiments, and during real procedures in a later stage can serve as input for more realistic catheter simulations which can be used for training purposes. The set of technological objectives put forward for SCATh are detailed in section 1.1.3. To steer the developments towards advancements that actually make their way through up into everydays interventional theatre, a set of interventional scenarios were carefully selected. These scenarios are described in section 1.1.4, together with their specific objectives. They will be used by SCATh to measure the achieved progress with respect to the state of the current medical practice.

B.1.1.3
Topic Pre-operative planning

Technological project objectives

Project Objectives Processing of pre-operative data - automatic segmentation of the aorta and the left heart atriums wall and detection of diseased abnormalities, - anatomical model parameterization for real-time adaptive registration, - automatic derivation of mechanical patient-specific models - calculation of mechanical, geometrical and physiological based safetyindices to monitor during the surgery Reduce dependency on intra-operative radiation-based imaging modalities ( to decrease radiation to less than 1 Gy): - navigation in top-down approach - the first fully bottom-up based navigation up to the heart Select the most suitable technique/configuration for acquiring relevant data. Interest goes towards - local environment scanning (based on novel techniques (InfraRed vision)) - position tracking - intravascular force measurements - physiological parameters Real-time anatomical modelling, based on parameterized anatomical model and real time adaptability. Bottom-up real-time endovascular modelling Online model quality measurement Safety-related indexes and thresholds Intuitive visualisation and interaction with multiscale models, resulting in a faster interpretation by the interventionalist Scenario-specific catheter control, getting at least 70% acceptance by 4

Intra-operative imaging/sensing

Intra-operative modelling

User interface Catheter FP7-ICT-2009-4

248782 SCATh

manoeuvrability

interventionalists - augmented manual control , - immersive teleoperation control, - robust and safe full-autonomous control. Experimentation Prototyping, validation and testing of the overall system on the selected catheter procedures
Table 1. SCATh technical objectives

B.1.1.4

Surgical scenarios and objectives

The SCATh focus lies on catheter-based interventions. Although many of the developed techniques will be generally applicable in this field, four catheter procedures were identified as case studies based upon which the main project goals have been set. They are discussed below. Case Study 1: Positioning of endovascular grafts A common treatment in the case of an abdominal aortic aneurysm (AAA) is a transfemoral intraluminal graft implantation (Parodi 1991). Once in position, this endograft effectively diverts the flow of blood away from the aneurysm wall, thus excluding the aneurysm from circulation. This procedure does not remove the aneurysm, but allows it to shrink over a period of time. The positioning of the endograft in the aorta requires its careful attachment to a safe landing zone, where it does not obstruct side branches leading to vital organs. This is typically identified on pre-procedural CT or MRI images. During the procedure, the endografts position is monitored with intra-operative X-ray imaging, consequently applying high doses of contrast agent and Figure 2. Medtronic Talent thoracic stent radiation. graft SCATh objectives: Provide intra-operative navigation and accurate positioning based on the fusion of pre-operative models and intravascular sensing information. Reduce (and, in the long term, even eliminate) the need for intra-operative X-ray imaging and the use of contrast agents. Provide a pre-operative check of the procedure, pinpointing the weak spots to enable the implementation of damage thresholds for the stent navigation and expansion. Reducing the occurrence paraplegia, due to spinal cord ischemia, from 32% (Bafort 2002) to less than 5%.

Case Study 2: Transcatheter aortic valve replacement

FP7-ICT-2009-4

248782 SCATh

Valve replacement is the definitive therapy for patients with severe aortic stenosis. Transcatheter aortic valve replacement is a new experimental procedure that eliminates surgery by placing a stent-mounted bioprosthetic aortic valve (see figures), via a catheter (Vahanian 2008). Such a procedure requires an initial balloon positioning and dilatation of the valve, followed by an accurate placement of the prosthetic device (Walther08a, Walther08b). It is of course essential that the device is placed correctly in all three planes, Figure 3. SAPIEN transcatheter heart valve, Edwards Lifesciences, LLC making the placement under two-dimensional fluoroscopy with limited catheter control challenging and potentially dangerous, since the coronary ostia may be occluded (Davidson 2006). SCATh objectives: Provide intra-operative navigation and accurate positioning based on the fusion of pre-operative models and intravascular sensing information to allow easy and accurate placement in the frontal, saggital and transverse plane. Reduce (and, in the long term, even eliminate) the need for intra-operative X-ray imaging and the use of contrast agents. Develop accurate and safe model-based methods to automatically stabilize the implants position. Avoid injuries to the heart caused by the catheters; this includes a perforation of the muscle or damage to one of the valves within the heart

Case Study 3: Positioning and deployment of endoclamp balloon

FP7-ICT-2009-4

248782 SCATh

Cardiopulmonary bypass (CPB) is used to avoid the difficulty of operating on a beating heart in cardiac procedures. To provide occlusion of blood flow from the surgical field and deviate it towards the CPB, in minimally invasive approaches, the aorta can be occluded by an endoclamp balloon (e.g. Heartport, see figure), instead of externally clamping it with a mechanical clamp (Gravlee 2007). The initial positioning, the inflation of the balloon and the monitoring of the position during the procedure are very delicate and complex tasks that the surgeon has to perform. Monitoring the balloon is currently done using either fluoroscopy or Transesophageal Echography (TEE) and requires a very experienced surgical team. The control of the endoclamp balloon is not part of the actual cardiac procedure and should therefore not take up too much of the surgeons time.
Figure 4. Heartport Endoartic Clamp, Redwood city, USA SCATh objectives: Develop a fully autonomous system for positioning the endoclamp balloon

Autonomous control of the pressure in the balloon based on measurements and a physiological model of the compliance of the aorta.

Provide a pre-operative check of the procedure, pinpointing the weak spots to enable the implementation of damage thresholds for the balloon navigation and inflation.

FP7-ICT-2009-4

248782 SCATh

Case Study 4: Percutaneous radiofrequency catheter ablation for atrial fibrillation treatment Radiofrequency catheter ablation is a procedure that is performed to correct a disturbance in heart rhythm (arrhythmia) caused by abnormalities in electrical conduction of the heart. An ablation catheter is used to ablate cardiac tissue that may be the source or the conduction channel for the arrhythmia. The main difficulty of this procedure lies in the localisation of the spot to be ablated. Therefore, a morphologic map of the chamber is being made by probing the catheter over the chamber and fitting a TM catheter during RF surface through the sequence of contact points. Apart Figure 5. Endosense Touch ablation in the atrium. from the risk of perforation, current mapping systems are also subject to tenting (Knecht 2008). This effect is caused by the elasticity of wall of the chamber as it will tent when a force is applied on it by the catheter. This results in a map that is up to 40% larger in volume than the real organ, which compromises the treatment quality when using traditional (non force sensor mounted) catheters. A second difficulty is the delivery of a well-dosed ablation. This depends on the interaction force with the cardiac wall. Too large interaction forces can result in a perforation while too little interaction forces (or no contact at all) will cause insufficient ablation. This means that the problematic conduction channels will not be destroyed. SCATh objectives: To speed up the generation of a morphologic map of the heart chamber based on intraoperative tracking of the catheter and force measurement. To use force measurements to control the interaction force during the ablation and therefore increase safety. To increase the current success rate of cardiac RF ablation from 50% ( Haegeli 2008) to 75%

FP7-ICT-2009-4

248782 SCATh

B.1.2

Progress beyond the state-of-the-art

This section contains a compact description of the current practice and existing level of technology in the different domains covered by this project, as well as a description of the prevalent challenges. The focus lies on those technologies that are closely related to the methods employed and advanced during this project. At the end of each paragraph, an overview is given of the advances with respect to the state-of-the-art that will be achieved in the SCATh project.

B.1.2.1

Real-time sensing technologies for catheter guidance

a. Angiography for catheter guidance: Angiography is the classical medical imaging technique used to visualize the lumen of blood vessels for diagnostic and interventional purposes. In the latter case it is also used to track the instruments used in the intervention. It is based on either X-ray fluoroscopy, computed tomography (CT) or magnetic resonance imaging (MRI) and often uses contrast agent7. X-ray Fluoroscopy: Fluoroscopy is a technique to obtain real-time X-ray images of the internal structure of a living patient. When applied to arteries and veins, the technique is referred to as fluoroscopic angiography. Although fluoroscopy provides excellent visualization of bone structures, contrast agent is required to visualize tubular structures (Pfirrmann2001). Lead shutters and lead drapes are needed to minimize radiation exposure to patient and interventionalist, making the technique quite time-consuming for vascular interventional procedures. The two major risks associated with fluoroscopy are radiationinduced injuries to the skin and underlying tissues (burns) and the possibility of developing a radiation-induced cancer in a later stage of life (Shope1996, Hall2008). Thus, radiation dose strongly limits the application of fluoroscopy in interventional procedures. Computed Tomography: CT imaging uses X-rays in conjunction with computing algorithms to Figure 6. X-ray (with contrast medium) image the body. Combined with intravenous contrast it can allow 3D outlining the central arteries shows reconstructions of arteries and veins and is then referred to as CTA arterial disease at two spots (1,2) (Computed Tomography Angiography). It is most commonly used as a pre-operative imaging tool, but has also proven to be an excellent tool in performing interventional procedures because of its good spatial resolution, especially in bone tissue (Gangi1997). CT-fluoroscopy enables real-time guidance in interventions and makes straight-forward and more complex procedures possible (Laufer 2001, Seibel 1997). The main drawback of CT-guidance is, as in X-ray fluoroscopy, the inherent radiation to which the operator and the patient are exposed. Magnetic Resonance Imaging: Magnetic resonance imaging (MRI) is a well-known tool for non-invasive diagnosis based on the nuclear magnetization of (usually) hydrogen atoms. With the advent of novel fast imaging technologies and open magnets, MRA (Magnetic Resonance Angiography) is also becoming an imaging tool for guiding

http://www.radiologyinfo.org/en/info.cfm?pg=angiocath

FP7-ICT-2009-4

248782 SCATh

vascular interventional procedures (Saborowski2007). The main advantage of MRI over fluoroscopy is the elimination of ionizing radiation exposure. Moreover, MRI yields excellent soft tissue contrast and has the ability to visualize lesions in high resolution. On the other hand, there are multiple technical challenges in guidance interventions under MRI, the most important being the need for MRI-compatible instruments that do not distort the image quality or induce local heating. Moreover, there are patients with absolute contraindications to MRI, such as patients with an implanted cardiac pacemaker or defibrillator, central nervous system aneurysm clips etc. (Buecker2006, Jacquier2007). b. Alternative techniques for catheter guidance: The three classical imaging techniques above have the common disadvantage of being bulky and sometimes even requiring adaptations to the buildings architecture, which is why other techniques are being explored for catheter tracking. Several other commercial technologies are currently available for tracking surgical instruments, which can also be applied (stand-alone or in combination) to the tracking of catheters: For visualization of the Figure 7. MRI of a normal aorta (with catheter, the tracking data is typically registered with pre-operative contrast medium) images. Acoustical tracking, based on ultrasound (Stoll2005), is a cheap, non-invasive and easy-to-use technique that provides 2D images, which are however of poor quality. Inertial tracking (e.g. Intersense Inertiacube2+, USA) uses accelerometers and gyrosensors to provide 3D position information. However, the sensors are prone to a non-negligible amount of drift, which is why inertial tracking should be combined with other modalities. Electrical tracking (LocaLisa, Medtronic and Ensite NavX, St. JudeTM) is based on the tracking of electrodes mounted on the catheter tip and provides the relative 3D position of the tracked instrument in an uncalibrated volume.

Electromagnetic tracking (e.g. AuroraTM NDI, Flock of BirdsTM, AscensionTM) can reach a good level of accuracy (Aurora NDI position accuracy RMS=0.9 mm and Ascension microBird accuracy RMS=1.4mm), in an acceptable volume (average working volume 0,125 m3). The main problem with EM systems used in a clinical setting is that they introduce ferromagnetic metals or conductive material into the imaging system, which can reduce the accuracy of imaging systems considerably (Hummel 2005). Research is ongoing to describe protocols and techniques to assess and improve the accuracy of such systems (Risholm 2007, Nafis 2006, Frantz 2003, Kindratenko). c. Scanning of the catheter environment: The process of imaging the local environment surrounding the catheter is provided by a number of scanning technologies: Systems that incorporate an ultrasound imaging transducer within the catheter tip have made intravascular ultrasound (IVUS) applications practical for human subjects. In the case of the VOLCANOTM system and Ultra ICE TM catheter, the scanning takes place in radial direction, perpendicular to the axis of the catheter (Onorato 2007). Another approach is taken by the AcuNavTM system whereby a longitudinal image plane is scanned that contains the axis of the catheter (Ren 2002). The AcuNavTM system is already integrated with the CartoTM navigation system (Biosense). For peripheral and intracardiac applications the probe can be larger than the one used in 10

FP7-ICT-2009-4

248782 SCATh

coronary arteries for which resolution will be significantly reduced. The larger sized probes may however limit their use in smaller patients and their disposal after each single use incurs high cost. Alternatively, an external US probe applied to the patient surface can be used for real-time 3D visualization of the catheter and its environment (Hung 2007). Such a probe has been successfully applied for catheter guidance (McKendrick 2005). Unlike transesophageal echocardiography, which involves endotracheal intubation, transthoracic echocardiography does not require the patient to be under general anaesthesia. Most optical techniques require temporary blood replacement with an optically clear liquid. However, recently the use of an infrared (IR) camera is proposed to overcome this requirement (Honda 2008). Blood becomes sufficiently transparent in the near IR region around 1.7 m as well as around 2.2 m. The visibility in blood is about 6-10 mm at a wavelength of 2.1m. Angiocam develops and sells a system based on this principle for vision through blood. Their technology is currently being integrated into an intra-cardiac catheter in order to give a real-time view of the inside of the beating heart and the major blood vessels. Intravascular optical coherence tomography (OCT) can achieve a resolution of 10-20 m which is about 10 times better than IVUS (Kubo 2007) with the trade-off being poorer penetration through blood and tissue. It is capable of resolving microstructure of atherosclerotic plaque and intracoronary thrombus. The delay-scanning interferometry approach of OCT is improved by varying the frequency of emitted light over a set range, an approach termed optical frequency domain imaging (OFDI) which can realise higher detection sensitivity and hence faster imaging speeds (Yun 2006). Intravascular MRI (IV MRI), e.g. from TopSpin Medical, overcomes the difficulty of imaging deeper coronary arteries using traditional MRI scanners by use of miniature IV MRI probe fitted over a guidewire. Aortic imaging resolution of 156m in-plane was achieved in animal studies (Worthley 2003) and a resolution of 312m in-plane was achieved in human studies with SNR far superior to that achievable using external antenna (Larose 2005). IV MRI devices that also incorporate the magnetic field and RF generation functions dont require an external MRI scanner for normal operation. Local static magnetic field gradients are generated at the site of measurement however instead of imaging the actual morphology, a simplified spatial representation of the lipid-rich component or the arterial walls is provided as a colour-coded diagram for each sector. A depth range of 250m can be achieved when assessing lipid-content or arterial plaques (Wilensky 2007).

Advances with respect to the state-of-the-art A major objective of SCATh is to reduce and eventually omit the need for classical (harmful or bulky) imaging technology during catheterization procedures. This will be achieved by a novel methodology based on SLAM (simultaneous localisation and mapping). The input for the SLAM-approach will be one or a combination of the alternative tracking systems described above together with one of the above scanning techniques. Algorithms for real-time processing of the scanning data will be developed.

FP7-ICT-2009-4

11

248782 SCATh

d.

Force Sensing:

Despite the common understanding that force information is of great use to improve the controllability of catheter procedures (Yokoyama 2008), catheter force sensing is still a very young technology. E.g. force information can be useful for controlling the cardiac radiofrequency ablation process and to avoid applying too much force to the heart wall, which can lead to perforation (Endosense 2008a). One can distinguish between two categories of sensors. Proximal TM force sensors are sensor systems that are mounted at the proximal Figure 8. Endosense Touch catheter side of the catheter (near the handle). They estimate the force applied on the tip of the catheter by measuring the force at the insertion point (Jayender 2008). However, this approach is highly sensitive to friction little sensitive to forces perpendicular to the tip axis. Recently, distal force sensors have been developed to overcome these limitations and to allow precise tri-axial measurement of the force vector. Such miniature force sensors require careful fabrication and are integrated into a particular type of catheter. Endosense has developed an open irrigated, radiofrequency ablation catheter equipped with a tri-axial force sensor positioned at the distal tip (figure 3). This catheter can measure the contact force between the heart wall and the catheter tip. This information can be used to increase safety and effectiveness of radiofrequency catheter ablation procedures (case study 4) for the treatment of supraventricular arrhythmias. Advances with respect to the state-of-the-art The interaction force in combination with tracking/scanning information will be used to construct a reliable morphologic map of the atrium prior to RF ablation. For damage prevention, a layer of supervisory control will be implemented in order to restrict interaction forces, which will significantly improve safety during navigation. SCATh will investigate how the force measurements can be used to provide haptic feedback taking into account the highly nonlinear aspects of the catheter system.

B.1.2.2

Geometrical modelling of aorta and atrium

No interventional catheter procedure takes place before the patient undergoes a preprocedural scan through means of MRI or CT. The interventionalist will analyse the patient-specific scan in order to plan the interventional procedure and she/he will typically rely on the preprocedural data during the procedure. To reduce the mental workload, the obtained patient data can be pre-processed by a computer program and a set of geometrical models can be computed automatically. Generation of these models requires segmentation and model reconstruction. This paragraph gives a non-exhaustive overview of the current state-of-the-art in processing techniques employed to derive geometrical models of the cardiovascular system, more specifically the aorta and the atrium. a. Aorta segmentation: Segmentation of the arterial lumen is a mature research field. It has been extensively investigated and computer tomography angiography (CTA) is the gold standard imaging modality for the preoperative sizing of endograft diameters. FP7-ICT-2009-4 12

248782 SCATh

One of the main applications of the analysis of aortic anatomy is the diagnosis and planning of the positioning of endovascular grafts for abdominal aortic aneurysm treatment (Subasic 2005), one of our clinical target applications (see WP1). The other main application field is the diagnosis of aortic dissections, which can be accurately diagnosed in both CTA and 3D contrast material-enhanced MRI (Liu2007). Nevertheless, the accuracy of the static imaging (CTA) of a dynamic process is uncertain. The aortic configuration and diameter may change during the cardiac cycle, and dynamic MRA demonstrated that pulsatile aortic distension is not equal in all axes, but rather occurs as an asymmetrical expansion and contraction (vanHerwaarden 2006). A recent, more detailed study revealed that aortic pulsatile distention in young healthy volunteers is asymmetric, with up to 41% radius change in the descending aorta (vanPrehn 2009). For treatment planning of aortic dissection the reliable identification of the true and false lumen is crucial. However, a fully automatic computer aided diagnosis system capable of displaying the different lumens in a user-friendly manner is still not available. Contributions have been done towards the identification of the true and false lumens (Kovacs 2006, Lee 2008). Some works specifically address the segmentation of the endovascular grafts for the follow-up of the patient (deBruijne 2003). This is needed to detect and prevent complications such as the process of aneurysm shrinkage, ongoing aneurysmal disease, and damage or fatigue of graft material. b. Atrium segmentation: Segmentation of the blood pool in the atrium to model the heart chamber is dealt with in most commercial navigation systems, such as EnSite NavX (St. Jude), Carto (Biosense Webster), LocaLisa (Medtronic). The main clinical need for atrium segmentation is the better guidance of interventional cardiac electrophysiology (EP) procedures. Electroanatomical mapping (EAM) for deriving 3-D structural information during these procedures has been demonstrated to improve the efficacy of catheter ablation (Pappone 2001). EAM has been further enhanced by the use of segmented surface models representing the left atrium and pulmonary veins (LAPV) imaged with volumetric techniques (MR/CT). Algorithms for LAPV segmentation have been presented for CT (Nollo 2004, vonBerg 2005), CTA (John 2005) and MRA (John 2005, Karim 2008). The pre-procedural anatomy derived from these models can be quite different from that at the time of intervention. Recently, a method for intra-procedural LAPV imaging has been developed based on contrast-enhanced 3D rotational X-ray angiography (3D RA) (Thiagalingam 2008). And rapid and automated methods for the extraction of the LAPV geometry for catheter guidance have been proposed (Meyer 2008). Advances with respect to the state-of-the-art SCATh will focus on making the segmentation methods more robust and accurate in the varying image conditions also taking into account the dynamic model variations due to the beating of the heart. The feasibility of segmentation of multiple wall layers (media and adventitia) in CT and MR images will be investigated in SCATh. SCATh will produce a relevant set of geometrical parameters that parameterize the physical space of the lumen as well as algorithms for the calculation of these parameters. The parameterized geometrical model will serve as an input for the intra-operative navigation tools. Automatic detection of aortic wall and atrial wall weaknesses will be developed in SCATh in 13

FP7-ICT-2009-4

248782 SCATh

order to detect high-risk regions (e.g. aneurysms).

B.1.2.3

Mechanical modelling of the cardiovascular system

Mechanical modelling of biological soft tissue is an active research topic throughout the world, an important applications being surgical simulation with reliable deformation and haptic feedback. Mechanical models can be subdivided into heuristic models, continuummechanical models and hybrid models, the latter being a combination of the first two. Heuristic models are most commonly used in current commercial surgical simulators and have the advantage of relatively fast computation but lack realism (Meier 2005). Therefore, more realistic continuum-mechanics based models (using finite element and sometimes on boundary element methods) are entering the scene. Continuum mechanics-based Finite Element Modelling (FEM) of the cardiovascular system has progressed dramatically in the last ten years. Figure 9. Model of the major A lot of effort is put to the definition of constitutive models components of a healthy elastic that capture the complex nonlinear behaviour of cardiovascular tissue artery (Holzapfel 2000) and soft tissue in general (Famaey 2008). The current state-of-the-art includes, but is not limited to a layer separated, fibre-reinforced constitutive model for the arterial wall with experimentally determined material properties (Holzapfel 2000; Holzapfel 2002; Sommer 2005, Holzapfel 2005a Holzapfel 2008). The artery is treated as a twolayer fibre-reinforced thick-walled tube, the two layers representing the media and the adventitia. These are the main (solid) mechanically relevant components in healthy arteries. Thus, a third layer (the intima) is disregarded because it has a negligible effect on the mechanical response. The mechanical contribution of the collagen fibres may also include a measure of fibre dispersion (which has been demonstrated experimentally) (Holzapfel 2005a, Holzapfel 2005b, Gasser06). An important factor for model realism is patient specificity. The state-of-the-art allows image-based, patient-specific model geometries which provide clinically relevant information (Holzapfel 2002). One important lacking feature so far, is the availability of reliable patient-specific constitutive model parameters. Mechanical modelling allows the calculation of local tissue stresses and deformations due to instrument manipulations in a procedure. These stress and deformation levels can be related to a certain level of tissue damage. Kiousis et al. (Kiousis IP) has developed a numerical and computational framework to quantify soft tissue damage based on FEM. Advances with respect to the state-of-the-art To enhance patient-specificity, SCATh will perform extensive uniaxial and biaxial soft tissue experiments, to correlate patient factors (e.g. age, gender, pathology,) with material behaviour. This will result in a material property factor indexed database of human mechanical properties to facilitate accurate and clinically relevant FEM. Post-operative analysis of the position- and force-data recorded during surgical procedures, will be used to continuously update and improve this database. To enhance procedural safety, SCATh will make advances with respect to damage prevention through mechanical modelling. Damage indices will be calibrated and validated based on a 14

FP7-ICT-2009-4

248782 SCATh

synergistic experimental and computational approach. SCATh will investigate how pre-operative calculations (using a patient-specific mechanical model) on critical scenarios in the procedure can be used for online damage prevention.

B.1.2.4

Physiological sensing and models

There is an abundance of miniaturized sensors on the market that can be mounted on a catheter in order to measure local physiological parameters such as temperature, pressure, haemoglobin concentration, pCO2, pO2 and O2-saturation. The parameters have great potential to enlarge efficiency and safety of catheter procedures (Li 2008). Therefore, the development and integration of miniaturized sensors in catheters is an active research field (Tanase 2002, Haga 2004). Several studies in literature describe methods relying on physiological parameters and models to monitor the progress and outcome of a surgical intervention. In (Fullerton 2008) the venous O2-saturation is used as a beneficial aid in the early, or even late, diagnosis of cardiac tamponade. Cardiac tamponade is a clinical syndrome caused by the accumulation of fluid in the pericardial space. It is a medical emergency, which can occur during catheter RF ablation, i.e. during case study 4 (Hsu 2005, Oneill 2008). In (Denninghoff 2003) a link is demonstrated between retinal venous O2-saturation and cardiac output. Another example is the use of the lowest perioperative mean arterial pressure as a reliable index to assess spinal cord ischemia (Chiesa 2005). Advances with respect to the state-of-the-art Physiological parameters and models will be integrated systematically in the control of the SCATh platform, in order to improve the monitoring of the progress and outcome of the procedure. Some examples are given below: The pressure in the EndoClamp balloon (see case study 3) is typically estimated based on a pressure measurement at the proximal end of the catheter. Integrating a model of the aortic compliance (Guyton 2005) will increase the accuracy of the estimate. SCATh will investigate how O2-saturation can be used to monitor initial damage and prevent further damage caused by tamponade. Especially for case study 4, this will result in improved safety and prediction of the surgical outcome.

B.1.2.5

Real-time modelling

Folllowing the top-down approach described in the introduction, the geometrical model of the cardiovascular system is registered to the real-time tracking data. Several studies on the quantitative evaluation of a rigid registration approach are described in literature. In (Fhamy 2007) an accuracy of landmark registration of 5.6 +- 3.2 mm was reported, shifted to 9.2+- 2.1 when integrated with surface registration. In (Zhong 2007) the error between planned path of ablation and the real path of ablation is over 10 mm. In (Decarret 2007) the catheter positioning in 18 patients was subject to spatial errors in the order of 0.5-1 cm relative to intracardiac echo imaging. These studies suggest that the approach of

FP7-ICT-2009-4

15

248782 SCATh

rigid registration, applied in commercial products like the Carto System8 and the EnSite NavX9, result is inaccurate localization of catheter within its environment. Following the bottom-up approach, the scanning technology deployed at the catheter tip will be used to construct a model of the surrounding structures in real-time and use this information to augment the existing parameterized patient specific model. The main approach for this will be to use simultaneous localisation and mapping (SLAM) to recover the intravascular and intracardiac geometry while concurrently determining the catheters position within the anatomy. The SLAM concept has received significant interest from the autonomous robotics community as a method for recovering a sensors egomotion as it navigates through an unknown environment (Newman 2007). For SLAM input data is typically provided by laser range scanners, which infer rich geometric information within man made environments especially when the system is grounded (Nieto 2006). For airborne applications radar has been used (Langelaan 2005) and for on or in water applications both radar and sonar have been deployed (Benjamin 2006). Scanning methods more pertinent to SCATh have also been deployed in mobile robotics, for example ultrasound and more recently white-light cameras in visual SLAM systems (Niera 2008, Davison 2007). One of the fundamental assumptions in SLAM systems is that the environment is static and rigid. Recently, some approaches have been reported to deal with moving object within the rigid environment (Wangsiripitak 2009). For minimally invasive surgery (MIS) the feasibility of SLAM within a deformable environment has also been demonstrated by using a stereo-laparoscope (Mountney 2006). Advances with respect to the state-of-the-art With the top-down approach, the accuracy is expected to raise from 5 to 3mm by using a nonrigid registration approach. The use of SLAM in SCATh offers the unique opportunity to safely navigate through the patients anatomy without prolonged expose to X-Ray radiation. Dealing with a deformable environment, however, is a major technical challenge, which will be addressed by using a the pre-operatively generated geometric model. The scanning technologies available within a catheter system will also shape the SLAM approach developed for SCATh. In particular, feature selection and subsequent temporal matching will be investigated to accommodate tissue deformation and blood flow in the scanning field-of-view.

B.1.2.6

Visualisation of interventional procedures

The aim of visualisation technology is to provide an intuitive representation of the catheter location within its environment. Fluoroscopy, providing a real-time visualization has been the gold standard for years, although its application was restricted as radiation exposure has to be minimized. Therefore, a major step in catheter procedures has been the development of nonfluoroscopic 3D navigation and mapping systems (Thornton 2007, Oral 2008). On the market, there are several systems such as the Carto System and the EnSite NavX, providing good 3D visualization of the catheter in the pre-operatively

8 9

www.biosensewebster.com/products/navigation/cartormt.aspx www.sjmprofessional.com/EN-US/ProductLibrary/Pages/EnSite-NavX-Navigation-Technology.aspx

FP7-ICT-2009-4

16

248782 SCATh

acquired geometric model, which facilitates the accuracy and efficacy of catheter procedures (Wong 2004). EnSite NavX e.g. provides different visual representations throughout the workflow of the operation. Figure 10 shows the registration of the catheter space to the preoperative segmented anatomy of the heart.

Figure 10. Registration of the catheter with the preoperative segmented anatomy of the heart (EnSite NavX system)

In the framework of the Marie Curie Actions project ARISER, KUL and IVS worked together on the realtime visualization of the catheter in the aorta. A simplified 3D model of the catheter was registered with the patient's anatomy and visualized through two 2D views and one customizable 3D view of the whole scene. Figure 11 shows the visualisation system, indicating the key concepts and tools. This visualisation platform is based on Studierstube (Schmalstieg 2002), an open source framework for developing augmented reality applications that uses the 3D modelling library Coin10 and opentracker (Reitmayr 2001). Advances with respect to the State-of-the-art As the efficacy of catheter procedure strongly depends on the visualization of the procedure, this project puts a considerable amount of effort in the design of the graphical user interface (GUI). However, the objective is not to go beyond the state-of-the-art. In this project, a GUI architecture will be defined, allowing to visualize in a well-organized way the relevant information of the sensing modalities and models developed models.

10

www.coin3d.org

FP7-ICT-2009-4

17

248782 SCATh

Figure 11. Catheter visualisation platform developed in ARISER

B.1.2.7

Automation or semi-automation for catheterization

Inspired by the success of the Da Vinci surgical system11 for laparoscopy and motivated by attempts to reduce X-ray exposure for both patient and surgeon, robotic tools for catheterization have recently appeared on the market. Both the electromechanical Sensei Robotic Catheter System12 (Hansen Medical Inc.) (figure 12) and the magnetic navigation system Niobe13 (Stereotaxis Inc.) allow navigation of conventional catheters from a distance. Initial experience with these systems shows the feasibility of a teleoperation approach (Saliba 2008a and Pappone 2005). However, these products lack a full integration of the control with the available knowledge. As research on the use of robotic tools for catheterization started only recently, there is no consensus yet on which is the most suitable control approach: autonomous control, teleoperation control, shared control or a combination of one of these (Romano 2007). The dynamic behaviour of the catheter, while navigating the catheter in a constrained environment, is highly nonlinear and is affected by the frictional forces acting along the length of the catheter, the flexibility of the catheter, the insertion force and the shape and size of the catheter and the environment (Jayender 2008a). Navigating the catheter is therefore a real challenge, which can be addressed by an autonomous control based on real-time tracking of the catheter in the environment (Villagran 2007 and Jayender 2008b) or by teleoperation control, which is closely related to teleoperation control of nonholonomic systems, such as wheeled mobile robots, i.e. when the input degrees of freedom (DOF) are not kinematically similar to the motion DOF (Mut 2002). While doing teleoperation control, the catheter can be under position control or rate control (Romano 2007). Both navigation approaches, i.e. autonomous and teleoperation, depend on the use of a robot to steer the catheter from outside the body of the patient. An overview of robots for catheter steering is presented in (Da 2008 and Saliba 2008b).

11 12 13

www.intuitivesurgical.com/products/davinci_surgicalsystem www.hansenmedical.com/products/sensei.aspx eu.stereotaxis.com/products-technology/magnetic-navigation

FP7-ICT-2009-4

18

248782 SCATh

Figure 12. The Sensei Robotic Catheter system of Hansen Medical for catheter control via a teleoperation approach

Several studies mention the lack of perception of the interaction force as an important drawback of the Sensei Robotic Catheter System (Da 2008 and Kanagaratnam 2008). Accurate control of the interaction force is useful during catheter ablation (see scenario 2 in WP1) and it can help to avoid damage or perforation of cardiac and vascular structures (Kanagaratnam 2008, Marcelli 2008 and Da 2008). Next to local force control at the catheter tip (Jayender 2008c), haptic feedback is often proposed to restore the kinesthetic perception of the surgeon. So far, only very little research is done on bilateral control teleoperation control of a catheter, although the interest in training simulators for catheterization with haptic feedback demonstrates the importance of haptic feedback (Gobbetti 2000, Barnes 2005, Ma 2007). Next to autonomous and teleoperation control, shared control has been proposed in order to enhance safety for the patient (Bertocchi 2006). In this work, not only the position of the instruments is controlled, but also the physiological pressure in the explored space, as even small variations in pressure can have serious consequences. In the framework of the Marie Curie Actions project ARISER, an autonomous control approach for positioning the endoclamp balloon (see case study 3) was developed by K.U.Leuven and IVS. A purposebuilt robot is used to steer the catheter. The control is based on a successful integration of tracking data, sensor input, pre-operative images and online registration (Furtado 2008). Advances with respect to the state-of-the-art SCATh will investigate the feasibility of autonomous control of the catheter by making use of the location of the catheter with respect to its environment. Integrating knowledge on the catheters environment, through the SLAM-approach will result in more accurate and reliable positioning. As several previous works mention the lack of haptic feedback, bilateral teleoperation control of the catheter will be investigated. The haptic feedback will be based on force and position measurement and the real-time model of the environment. Both autonomous control and bilateral teleoperation control will be extended with a layer of supervisory control. In order to guarantee safe navigation and manipulation the interaction forces, physiological parameters and the occurrence of critical scenarios are continuously monitored through a shared control approach. Next to position and orientation of the catheter, SCATh will investigate how other things can be controlled. The balloon inflation e.g. (see case study 3) will be controlled based on a physiological model of the aortas compliance.

FP7-ICT-2009-4

19

248782 SCATh

B.1.3
B.1.3.1

S/T methodology and associated work plan

Overall strategy

The framework for ICT-enhanced catheterization is explained by the figure below, detailing the interaction between the different work packages of the project.

Figure 13. Block diagram of the SCATh project

A series of techniques to acquire accurate and relevant real-time information will be investigated (WP2). Techniques to derive geometrical (WP3) and mechanical models (WP4) for the endovascular system will be refined, and methods will be derived to allow for the incorporation of real-time data in these models (WP5). This will include the development of SLAM-based algorithms for catheterization. A powerful user interface (WP6) will be designed that allows a) intuitive interpretation of the real-time multiscale model and b) intuitive control of the diagnostic or interventional catheter through the use of advanced control algorithms (WP7). The new concepts for tracking, sensing, modelling and manipulation of the surgical environment will be integrated in a common platform with existing technological state of the art (WP8) in close cooperation with clinical experts both in design and evaluation phase (WP1). Training scenarios can easily be implemented by emulating real-time sensor data and making use of previously obtained patient models.

FP7-ICT-2009-4

20

248782 SCATh

B.1.3.2

Timing of the different WP's

Time Plan of Work: GANTT chart

FP7-ICT-2009-4

21

248782 SCATh

Table 2. Project GANTT chart

FP7-ICT-2009-4

22

248782 SCATh

Interdependency of tasks: PERT diagram

Figure 14. SCATh PERT diagram. Milestones and deliverables are delivered at the end of the indicated month.

FP7-ICT-2009-4

23

248782 SCATh

B.2 B.2.1

Implementation
Management structure and procedures
Organisational structure

B.2.1.1

All planning and control of the project, as well as the overall responsibility, lies with the coordinating partner (K.U.Leuven). This entails the following duties: to monitor that all partners comply with their obligations under the EC Grant Agreement and the Consortium Agreement; to receive the financial contribution from the EC and to distribute it in accordance with the EC Grant Agreement and the Consortium Agreement; to keep the records and financial accounts of the Community financial contribution and to inform the Commission of its distribution thereof; to be the intermediary for efficient and correct communication between the partners and the Commission on the progress of the project; administration, preparation of minutes and provision of the chairperson of the Project Management Board, and follow-up of its decisions; reviewing the reports to the Commission to verify consistency with the project tasks before transmitting them to the Commission.

To support the project coordination, the management structure is composed by two different entities: The Project Management Board (PMB) The Technical Management Board (TMB) The project will also be supported by an External Advisory Board. Further details for the management structure will be fixed in a Consortium Agreement (CA) to be finalised before the grant agreement is signed. Project Management Board (PMB)

Figure 15. Constitution of the Project Management Board FP7-ICT-2009-4 24

248782 SCATh

The Project management board (Fig. 15, Tab.7) is composed by the project coordinator (or his representative) and by the person in charge of each partner (or his/her representative). The decision making procedures and voting follows the rules described in the Consortium Agreement. The main objective of this board is the overall coordination of the project. The PMB is the ultimate decision making body of the project. It is chaired by the Project Manager and will contain representatives from every project partner. The PMB will meet regularly during the course of the project to review progress and discuss any issues which might have come up regarding the coordination as well as the interaction between the partners. These meetings should take place at least every twelve months. The responsibilities of the PMB include the following: High-level progress monitoring of the project activities, with final validation of the related deliverables and milestones, and of the exploitation and dissemination of project results; Follow-up of different other issues: financial, administrative, reporting, planning, consortium and cooperation between partners, etc; Intellectual property management; Decision making on any needed modifications of the general project approach and project restructuring if necessary; Amendments to the consortium agreement. Deciding on conflicts of interest. Liaison with the European Commission in ensured through regular communication by the Project coordinator and, where necessary, invitation of the Project officer to PMB meetings. Technical Management Board (TMB) The TMB (Fig.16) is the driving force for all the RTD activities; it is composed by three different entities: The Work Package Leaders (WPL) (Table 10) The Ethical Task Force (EthTF) (Table 9) The Exploitation Task Force (ExTF) (Table 8)

Figure 16 Technical Management Board

The Work Package Leaders (WPL) have the responsibility of assuring that milestones and deliverables, related to the led WP, are delivered respecting the deadlines defined in the Grant Agreement. The WPL FP7-ICT-2009-4 25

248782 SCATh

will also assure the deliverables quality by evaluating them against the means of verification described in the Deliverable list. As much as possible external reviewers will be solicited to present feedback on delivered results. The meetings of the TMB will follow the projects necessities; at least every six months an exhaustive report of progress will be made by all the TMB members, this reporting will be either oral, during meeting be it physical or by teleconferencing, or written. The main purpose of the Ethical Task Force (EthTF) is to guarantee medical and ethical integrity during execution of all experiments. Among their duties there will be: evaluation of the state of progress of the project to decide if it is medically authorized to perform a certain experiment; providing advice on the content and protocol of the experiments; acquiring approval of the content and protocol of the planned experiments by an external ethical committee; steering the project towards clinically realistic solutions. An essential part of the TMB is the Exploitation Task Force (ExTF). The main objective of this task force is to steer the project towards scientifically and economically valuable results. The main duties of this task force are: supervising the dissemination and exploitation; solving possible intellectual property issues; devising plans for the exploitation of projects outcomes. Depending on the issues at hand an appropriate voting procedure will be agreed upon by the relevant partners. The people that represent the partners in the PMB are shown in Table 3. Partner K.U.Leuven UPM ZHAW IVS ICL TUG EndoS AngioC Person in charge Jos Vander Sloten Enrique Gomez Thomas Jrmann Ole Jakob Ellle Guang-Zhong Yang Gerhard A. Holzapfel Giovanni Leo Ingo Krisch
Table 3. Members of the PMB

The people forming the ExTF are listed in Table 4. Partner ZHAW K.U.Leuven EndoS AngioC FP7-ICT-2009-4 Person in charge Thomas Jrmann Mauro Sette Giovanni Leo Ingo Krisch
Table 4. People forming the ExTF

26

248782 SCATh

The people forming the EthTF are shown in Table 5. Partner IVS K.U.Leuven Person in charge Eric Fosse Paul Herijgers
Table 5. People forming the EthTF

The work package leaders are listed in Table 10. Work Work Package Leader Person in charge Package WP9 K.U.Leuven Mauro Sette WP1 IVS Ole Jakob Elle WP2 IVS Ole Jakob Elle WP3 UPM Enrique Gomez, Borja Rodriguez Vila WP4 TUG David Pierce WP5 ICL Danail Stoyanov WP6 UPM Patricia Sanchez, Maria Elena Hernando WP7 K.U.Leuven Emmanuel Vander Poorten WP8 ZHAW Thomas Jrmann
Table 6 Work Package Leaders

External Advisory Board (EAB) To increase the quality of the research results stemming from the assembled conducted research, this project will make use of an external advisory board that is not bounded by the tight constraints, nor is involved in the decision process. At all times, partners can invite members of the EAB to discuss progress and problems or to receive a critical review on the current evolution by a third party who is not involved in the decision process. An initial set of potential members of the EAB will be presented by the PMB in the negotiation phase of the contract (at this instant eSaturnus14, experts in visualisation of medical procedures, and Mentice AB15, with unique expertise in catheter procedure simulation, have already given their consent to join the EAB). During these contract negotiations every partner will have the right to veto any member of the EAB. If conflict of interest arises during the run of the project, vetoing external advisors must go through the PMB. Only after a full consensus is reached, in favour of a decision to keep the external advisor, the latter can keep belonging to the EAB. After the negotiation phase it is only possible to introduce new EAB members after receiving of a full consensus at a partner meeting of the PMB. A limited budget is foreseen as travel cost to pay expenses of EAB members that participate to official meetings of the consortium and bring in their expertise and knowledge. Requests for expenses should be directed at the PMB. The PMB will decide over the need to sign a confidentiality agreement by the members of the EAB and the partners of the consortium. Members that would like to invite people from the EAB to an official

14 15

newton.esaturnus.com www.mentice.com

FP7-ICT-2009-4

27

248782 SCATh

project meeting should formulate their request towards the PMB (project coordinator) with reasonable time in advance. The latter is responsible to report this request to all partners. Upon objection by any single partner, the invitation of members of the EAB will be redrawn.

B.2.1.2

Management Procedures

Decision making Throughout the project the goals and interests of all partners need to be respected and therefore a consensus in decision-making between all parties is desirable. The PMB is responsible for solving any issues between partners with respect to this decision-making process. Issues will be resolved by voting, where each project partner has one vote. The Project Managers vote is decisive in case of equality. When necessary, temporary working groups on specific issues important to the project progress can be set up, with clearly defined objective and identified decision power. The responsibilities are divided as follows: operational decisions are dealt with by WP Leaders. everyday management is handled by Task Leaders, who report to the relevant WP Leader. administrative issues are taken care of by the Project Manager. Communication flow To enhance information flow between partners the co-ordinating partner will create a mailing list for the overall project and for each work package. A proper document numbering and registration system will be established. An FTP server will be used to host shared documents and developments among partners. Additionally a shared workspace system such as BSCW will be installed in order to allow easy collaboration. Contributions to the biyearly project report are required by each partner and it will be compiled by the Coordinating Partner and delivered to the EC. This report will contain: progress report planning for the next period disseminations at meetings/conferences/events administrative or contractual issues The Coordinating partner will produce the financial reports on an annual basis, according to usual EC guidelines. IP management a. LRD

The Technology Transfer Department at K.U.Leuven R&D offers active support with respect to all aspects related to intellectual property and the protection and commercialisation thereof via a staff consisting of 4 technology transfer officers, two of whom have been involved extensively in technology transfer aspects related to stem cells, and one IPR officer. Support is offered with respect to: Providing information on Intellectual Property Rights (IPR); Assessing the feasibility, patentability and market potential of an invention; Determining a protection strategy; Drafting and filing a patent application (in close interaction with an external patent attorney); Follow-up of patent procedures & costs; Negotiating and drafting Non-Disclosure Agreements (NDA), Material Transfer Agreements (MTA) and Consortium Agreements; Negotiating and drafting of license agreements; and finding industrial partners. Representatives from K.U.Leuven R&D will monitor the dissemination of results, the management of knowledge, and the exploitation of the results. They will set-up follow-up activities when the project FP7-ICT-2009-4 28

248782 SCATh

reaches its end. The exploitation manager will report to the Steering Committee and the Project Coordinator and will work in close collaboration with the tech transfer officers of the partners. b. Management of foreground

The Exploitation and IPR manager will make a detailed plan to manage the foreground and the use of the results. A Consortium Agreement, based on the EU model provided, will be drafted and send to the participants and their respective institutions for their approval. This agreement will be signed by all partners before the signature of the Grant Agreement. Access Rights will be granted in accordance with and subject to the EC Contract. The consortium agreement will form the legal basis for the relationship and responsibilities between the partners for the duration of the work. It will facilitate the resolution of problems if these should occur between partners. The IPR team at K.U.Leuven R&D, in close collaboration with the technology transfer offices of the partners, will conduct technology transfer activities that will provide the project the ability to exploit the results in Europe. Communication between partners will be first on a credentials (confidential) basis, allowing evaluation of the potential of new technologies/products for eventual patent filing or any other means of IPR protection. Patent applications will be made for relevant innovative procedures/products and the costs will be shared according to percentage ownership that shall be subject to negotiation on a pro rata basis. The consortium policy will be to patent all innovative results which could be exploited without preventing publication and rapid circulation of information between the partners. Partners shall declare to the coordinator their intention to submit a patent application. A special task has been defined to define how the project results can be used in follow-up activities. Some of the results will not be ready for direct commercialization and need a follow-up project; other results may be ready for commercialization after the end of this project. Partners shall ensure adequate protection of IPR created in the project: 1. Inventorship will be determined on a case by case basis, taking into account the role and contribution of each partner in the conception and/or reduction to practice of such invention. 2. Any partner shall be entitled to take any action to protect results created solely by it during the project, which could be used for industrial or commercial exploitation. 3. If an invention results from the contribution of several partners, this invention will be co-owned by the said partners and they shall agree on a case-by-case basis on the best manner of protecting such joint invention. A co-ownership agreement will be established between all involved partners in order to define arrangement between them and the sharing of property among co-owners. The consortium agreement will cover the following issues, among others: the Partners obligations, the organization of the project, the costs, budget and payments, the consortium resources, the IPR provisions, the liabilities of the Partners, ethical issues, provisions related to changes in the consortium, provisions related to coming into force of the project, confidentiality clauses, force majeure, notices, language, severability, applicable law and provisions on solving disputes, lists of affiliates, bank details and a list of excluded pre-existing know-how. This consortium agreement will be based on the EU model available. Risk avoidance Each partner is responsible to report to the TMB any risks that might jeopardize any objectives or the schedule of the project. If possible appropriate solutions should be suggested. The TMB will analyse each report and propose/take relevant measures. In case of dispute, it is the responsibility of the project coordinator to ensure the voting procedure is properly used. Any affected partner has the right to FP7-ICT-2009-4 29

248782 SCATh

appeal to the PMB if they are not agreeing on the vote in the TMB. Detailed risks and contingencies related to the project are covered in the work package descriptions. The EthTF will assert the maturity of systems and algorithms before any in vivo experiments will be permitted. The EthTF formulates the conditions under which experiments approved by the EthTF can take place. After each experimental session, a brief, but accurate report must be handed16 to the EthTF, giving the EthTF the opportunity to judge whether continuation of the experiments is opportune. This protocol has the single goal to increase the ratio (clinical relevant outcome) / (number of in vivo experiments).

B.2.2

Beneficiaries

The SCATh partners combine the necessary complementary skills and expertise needed to address this challenging multidisciplinary project. Several of the partners have previously worked together in a Marie-Curie Training Network17. All partners share the common interest to build up a framework for safe and effective medical assistance through incorporation of patient-specific model-based knowledge in preoperative planning or training and intra-operative assistance. In the following part, every partner will be described separately. Beneficiary 1 Katholieke Universiteit Leuven (K.U.LEUVEN)
At the department of Mechanical Engineering, the Division of Production engineering, Machine Design and Automation (PMA) and the Division of Biomechanics and Engineering design (BMGO) joined forces in 2001 and created the Robot-Assisted Surgery-group. This fruitful cooperation has resulted in innovative projects on visual servoing, force- and tactile sensing, teleoperation control and soft tissue modelling, benefiting from the very complementary knowledge of both divisions. PMA has pioneered robotics research in Europe since the mid-1970s, covering virtually all aspects of sensor-based robotics, from the high-level task specification down to low-level sensor-based control. In the last decade, PMA shifted its attention towards human-robot interaction. BMGO, a very multi-disciplinary division, is having a strong expertise in both numerical and experimental analyses of human structure and function. Research topics cover the broad spectrum from cells to tissues and from organs to the entire body and its interaction with the environment. In 2007, the creation of the Leuven Medical Technology Centre (L.M.T.C.), an intergroup collaborative centre linking research groups within the University Hospital and the K.U.Leuven, strongly facilitated cooperation between engineers and clinical experts. The RAS-group has now access to an animal lab, the anatomy lab and patient-data. Key Researchers: Prof. Jos Vander Sloten, full professor in biomedical engineering, is chair of the L.M.T.C. His research interests are computer applications in musculoskeletal biomechanics and computer integrated surgery. In the European Alliance for Medical and Biological Engineering and Science (EAMBES) he served as president-elect (2005) and president (2006). Prof. Paul Herijgers MD, full professor at the Department of Cardiac Surgery is an expert in minimally invasive access procedures, reconstructive aortic and mitral surgery. Since more than a decade, he is cooperating efficiently with engineers of the Department of Mechanical Engineering. Prof. Hendrik Van Brussel, full professor in mechatronics and automation was a pioneer in robotics research in Europe and an active promoter of the mechatronics. He is recently elected as Foreign Associate of the United States National Academy. Prof. Dominiek Reynaerts, full professor in micro- and precision engineering, is mainly conducting research in micro-robotics and micromechanical systems. He is currently chairman of the Department of Mechanical Engineering. Other key scientists are Mauro Sette who worked on catheter control and Nele Famaey whose

16 17

The report can be handed in paper form, but electronic versions sent by email are preferred. ARIS*ER

FP7-ICT-2009-4

30

248782 SCATh

expertise is in mechanical modelling of soft tissue. Dr. Emmanuel Vander Poorten and Bert Willaert are experts in the design and control of haptic interfaces for teleoperation and virtual reality.
Table 7 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.1 0.05 1 0.1 0.1 0.1 1 0.19

K.U.Leuven Jos. Vander Sloten Paul Herijgers Mauro Sette E. Vander Poorten Bert Willaert Nele Famaey PhD PostDoc

Total MM 95

Total FTE/year needed 2.64

Total FTE/year attributed 2.64

Main tasks within SCATh K.U.LEUVEN is the co-ordinator of this project and will take the role of management (WP9), chairing the PMB. As co-ordinator, K.U.LEUVEN will be a member of the TMB. Research activities undertaken by K.U.LEUVEN are the clinical support and validation (WP1), sensing (WP2), mechanical modelling (WP4), real-time modelling (WP5), user-interface (WP6) and catheter control (WP7). In work packages WP6 and WP7, K.U.LEUVEN takes up the role of work package leader. Most relevant Publications Famaey N, Vander Sloten J, Soft tissue modelling for applications in virtual surgery and surgical robotics, Comput Methods Biomech Biomed Engin. (2008); 11: 351-366. J. Peirs, D. Reynaerts, H. Van Brussel, P. Herijgers et al. A micro-optical force sensor for force feedback during minimally invasive robotic surgery, Sensors and Actuators A (2004); 115: 447455. Willaert, B., Vander Poorten, E., Reynaerts, D. and Van Brussel, H. A pragmatic method for stable stiffness reflection in telesurgery. Proceedings of the 6th international conference on Haptics: Perception, Devices and Scenarios. Madrid, Spain (2008); 73 - 82 Flameng W., Herijgers P. and Bogaerts K. Recurrence of mitral valve regurgitation after mitral valve repair in degenerative valve disease. Circulation (2003); 107: 1609-1613. US Provisional Patent Appl. No. 61/059,149 Automatic Endoclamp balloon positioning system

FP7-ICT-2009-4

31

248782 SCATh

Beneficiary 2 UPM profile

Universidad Politcnica de Madrid (Technical University of Madrid, www.upm.es) (UPM) is the oldest and largest of the Spanish Technical Universities. It has more than 200 Research Units and several Research Institutes and Technological Centres. The contribution of the university to knowledge creation through its scientific publications is also significant. The annual average figures are 1,200 journal papers, 2,000 conference communications and 200 Ph.D. theses. The Biomedical Engineering and Telemedicine Centre (GBT) (www.gbt.tfo.upm.es) is a leading centre for education, research and technological development focused on bioengineering; mostly concerned with the application of information and communication technologies to biomedicine. GBT is the largest biomedical engineering and telemedicine research centre in Spain and maintains beneficial partnership with public and private sectors in its research and technological development areas. During the last fifteen years, GBT has published more than 350 scientific publications and participated in 55 European projects funded by several EU Research Programmes (AIM, RACE, TIDE, BRITE, Telematics Applications, ACTS, ESPRIT and IST). Some of the last relevant IST projects in which GBT has participated with a leadership role in the last years are: "M2DM- IST-1999-10315- 2000 - 2003); INCA- IST-2001-37632 - 2003 2005; "CHARTQLAM-2001-00535, 2002 2004; "SIMILAR- FP6-507609 , 2003-2007, CLEAR- CIP-ICT-224985, 2008-2011. Key researchers Prof. Enrique J. Gmez-Aguilera, full professor Bioengineering and Telemedicine at the Telecommunication Faculty of Universidad Politcnica de Madrid and director of the Master degree MSc on Telemedicine and Bioengineering. Secretary General of Sociedad Espaola de Ingeniera Biomdica-SEIB. In the European Alliance for Medical and Biological Engineering and Science (EAMBES) he served as treasurer (2008). Prof. Francisco del Pozo, full professor of Bioengineering and Telemedicine at the Telecommunication Faculty of Universidad Politcnica de Madrid. President of the Spanish Society of Telemedicine (SET). Director of the International Telemedicine Journal. Director of the Centre for Biomedical Technologies. Dr. M. Elena Hernando PhD, Associate Professor of Biomedical Engineering and Telemedicine at the Telecommunication Faculty of the Universidad Politcnica de Madrid. Other key researchers are Dr. Pablo Lamata PhD, an experienced researcher in the field of medical imaging, simulation and augmented reality in surgery, Borja Rodriguez-Vila MSc, who is doing his PhD on image processing for adaptive radiotherapy on prostate cancer, and Patricia Snchez-Gonzlez MSc, whose expertise is on interactive systems and video analysis for MIS training and navigation and has also been involved in the development on virtual reality laparoscopic simulators.

Table 8 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries
Involvement: Time dedicated Project duration 0.2 0.1 0.1 0.84 0.3 0.1

UPM E. J. Gmez-Aguilera F.Del Pozo M. Elena hernando B. Rodriguez-Villa P. Sanchez-Gonzalez P. Lamata

Total MM 59

Total FTE/year needed 1.64

Total FTE/year attributed 1.64

FP7-ICT-2009-4

32

248782 SCATh

Main tasks within SCATh UPM will provide its general expertise in medical imaging and medical image processing coordinating the development of the patient specific geometrical model (WP3). In the WP5 will provide expertise on medical image registration and fusion. Finally in WP6 will contribute to the design and evaluation of the SCATh graphical user interface. Most relevant Publications P. Snchez-Gonzlez, F. Gay, A.M. Cano, EJ. Gmez, "Segmentation and 3D reconstruction approaches for the design of laparoscopic augmented reality environments", Lecture Notes in Computer Science, pp.127-134, 2008. A.M. Cano, P. Snchez-Gonzlez, F.M. Snchez-Margallo, I. Oropesa, F.del Pozo, E.J. Gmez ,"Videoendoscopic image analysis for 3D reconstruction of the surgical scene", Proceeding of 4th European Conference of the Int. Federation for Medical and Biomedical Engineering (ECIFMBE 2008), vol.22, pp. 923-926, Antwerp (Belgium), 978-3-540-89207-6, November, 2008. B.Rodriguez-Vila, F.Gaya, F. del Pozo, F.Garcia-Vicente, E.J.Gomez,"A new geometrical method for 3D evaluation of non-rigid registration methods for radiotherapy in prostate cancer", Proceedings of Computer Assisted Radiology and Surgery (CARS 2008), vol.3 suppl.1, Barcelona(Spain), June, 2008 B.Rodriguez-Vila, J.Petterson, M.Borga, F.Garca-Vicente, E.J.Gomez Aguilera, Hanss Knutsson, "3D Deformable Registration for Monitoring Radiotherapy Treatment in Prostate Cancer", Scandinavian Conference on Image Analysis, ISBN: 978-3-540-73039-2, June, 2007.

FP7-ICT-2009-4

33

248782 SCATh

Beneficiary 3 - The Interventional Centre (IVS), Rikshospitalet, Oslo University Hospital.

Oslo University hospital HF was established 1st of January 2009 and comprises the former hospitals Aker, Ullevl and Rikshospitalet. The merged hospital has 20.000 employees, and serves local hospital services to citizens of Oslo and Follo, and highly specialised services at a national level. Rikshospitalet University Hospital is the largest medical and medical technology research institution in Norway. The Rikshospitalet merged with the Radiumhospitalet (The Norwegian Cancer Hospital) in 2006. According to the 2005 statistics, which constitute only the activities at the Rikshospitalet, the Rikshospitalet had 565 beds, 304 143 patients, 4012 employees (518 doctors), and a turn over of NOK 5 billion. It had 103 professors, published 691 scientific papers, and graduated 52 PhD fellows. It filed 7 patents, 44 registered patent pending applications, 4 license agreements and 2 spin-offs. The Interventional Centre is a unequally cross-disciplinary organised hospital research department. The department has pioneered many image-guided therapy techniques and is developing novel technologies for computer-aided surgery. The clinical research department has three experimental operation rooms, all equipped for cutting edge image-guided therapies. One room as an interventional MRI scanner, another room is a combined cath-lab and surgical suite, the third room is specialized for endoscopic procedures and robot aided surgery. The department represents a paradigm shift in the way hospitals are organized. Multi-disciplinary teams are put together to improve patient care, and image-guided technology is the common neutral ground that allows turf battles to be put aside. The Interventional Centre has a cross-disciplinary staff of 25 employees where about 40% of the staff has a technological including 5 professors and one associate professor. The centre has developed several new clinical methods and treated more than 6000 patients and performed more than 400 animal experiments. Fourteen PhD's have defended their thesis and more than 250 scientific papers are published based on research performed at The Interventional Centre. Five spin-off companies have been established in the areas of biosensors (Alertis Medical AS and Cardiacs), medical devices (Ostomicure), OR light system (LightOR) and surgical simulators (Simsurgery AS). The centre has 20 patents and patents pending. The research work at the centre has been focused on the following three areas; MR, X-ray, ultrasound, videoguided interventions and surgery; Robotics and simulators; and Biosensors, data processing, and wireless body area networks. The research covers image processing, visualization and navigation developing technological solutions which support minimally invasive procedures. As the title of the group indicates, the research focus is divided into three areas. Image processing methods are key elements in any software system which supports minimally invasive procedures. In particular, we are focused on developing real-time image-segmentation and registration methods where segmentation methods finds important anatomical structures such as tumours and vessel structures in images, while registration methods enables fusion of images. Visualization and navigation is required to present the medical images to the surgeon intra-operatively. We are developing visualization systems which use advanced techniques such as augmented reality and volume rendering for this purpose. To enhance the accuracy and safety in minimally invasive techniques advanced methods for cross-linking robotic systems with processed medical images are developed. This is to make no-go zones near critical structures and enable haptic feedback to semi-autonomous robotic systems. In addition to several projects funded by the Research Council of Norway and the Nordic Innovation Centre, IVS has coordinated the EU funded project called ARISER- Augmented Reality in surgery, and participate in several other EU funded projects. Key Researchers Directly involved researchers: Ole Jakob Elle PhD, is Head of Technology at The Interventional Centre He has a PhD from 2004 in Robotic Surgery from NTNU. Frederic Courivaud PhD, is a MR physicist and a senior researcher at The Interventional Centre. He has a PhD in robotic surgery from 2004, and did his master at NTNU in Trondheim, Norway

FP7-ICT-2009-4

34

248782 SCATh

in 1990. Jacob Bergsland MD, is a board certified cardiothoracic surgeon from US and Norway, and is heading the research group "Image guided cardiac surgery and intervention" at The Interventional Centre. He has submittet his PhD thesis "Safe introduction of new techniques in coronary surgery". Per Kristian Hol, PhD, is Radiologist and did his PhD in 2007 in how to integrate coronary angiography into the cardiac operating room. Supporting researchers: Edvard Nrum MSc, is doing his PhD at The Interventional Centre on haptic feedback and contact force estimation for robot assisted minimally invasive surgery. Petter Risholm MSc, is doing his PhD at The Interventional Centre on non-rigid image registration methods for medical applications. Professor Atle Bjrnerud PhD, (Advanced MR Neuro-imaging) is leading the AMRNI group and is further involved in many MR-projects where the main focus is on MR sequence optimization and data handling. Professor Erik Fosse, MD, is Head of The Interventional Centre and Thoracic Surgeon. Bjrn Edwin, PhD, is a laparoscopic surgeon and did his PhD in 2005 in developing advanced laparoscopic procedures at The Interventional Centre.

Table 9 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.15 0.1 0.15 0.1 1

IVS Ole Jakob Elle Frederic Courevaud Jacob Bergsland Per Kristian Hol PhD

Total MM 54

Total FTE/year needed 1.5

Total FTE/year attributed 1.5

Main tasks within SCATh IVS will provide his expertise in Interventional surgery giving a contribution in the WP1, will provide also the environment for experimentation. In the WP2 will provide fundamental expertise with electromagnetic tracking and registration. Finally in WP3 the contribution will be focused on image processing. Most relevant Publications Risholm P, Sauter A, Bosse G, Elle OJ, Samset E. "Registration free MRI-US fusion for identification of infraclavicular parts of plexus brachialis", 20th International Congress on Computer Assisted Radiology and Surgery, Osaka, Japan, June 28 - July 1 2006, Int J CARS Vol 1 Suppl 1 pp. 57-59 MorvanT, Reimers M, Samset E. 2008: High Performance GPU-based Proximity Queries using Distance Fields. In: Computer Graphics Forum, 27(8), pp. 2040-2052, 2008. Risholm P, Narum E, Elle OJ, Samset E: "An inexpensive and portable system for improving electromagnetic tracking accuracy", CARS 2007, Berlin

FP7-ICT-2009-4

35

248782 SCATh

Beneficiary 4 ZHAW: Zurich University of Applied Sciences, Institute of Mechatronic Systems IMS
Located in the greater area Zurich, Switzerland, the Institute of Mechatronic Systems IMS is a research and development centre of the ZHAW Zurich University of Applied Sciences. The Institute is integrated at the ZHAW into the School of Engineering SoE, a department with expertise in Technology, Computer Science and Natural Science. The SoE defines its role as link between basic research, as e.g. performed at the ETH in Zurich, and industry. The IMS is responsible for an innovative, professional, systematic and accurate realisation of projects for industrial partners or in partnership with the industry. IMS has been involved in many national and international research projects, e.g. in the EU project for Adaptive Robots for Flexible Manufacturing Systems (ARFLEX) of the FP6 for plant automation based on distributed systems (PABADIS) of FP5. The main expertise of the IMS is situated in the implementation and integration of mechatronic systems and human-machine interfaces. In robotics, the IMS is one of the leading institutions of the Swiss Applied Sciences landscape and also well embedded in international Networks of Excellence as e.g. the European robotics Network EURON. IMS has designed and implemented various highly sophisticated medical applications, robots for micro assembly, autonomous mobile operation and large scale purposes. Recently, in a consortium consisting of research institutions of the ETH and ZHAW the development of a Laparoscopic Surgery Simulator was completed successfully. IMS received the prestigious Swiss Technology Award in 2002. Most recently IMS established as one of the driving forces in the Swiss national Technology Platform ManuFuture, which is directly derived from its European pendant ManuFuture-EU driven by the European commission and industry.

Key Researchers: Hans Wernher van de Venn is professor of mechatronics at the ZHAW and heads the IMS since April 2006. Since the FP4 he is involved as researcher, work package and project leader in international R&D projects funded by the European Commission, amongst others in the ESPRIT and BRITE-EURAM programme. In Switzerland, he worked on several research projects in the area of Mechatronics, Robotics and Manufacturing. In close cooperation with a leading Swiss watch manufacturer he initiated the European 6th FP Integrated Project Evolvable Ultra-Precision Assembly Systems (EUPASS). Prof. van de Venn is significantly involved in the European Technology Platform ManuFuture and member of the Swiss ManuFuture steering committee (ManuFuture-CH). Thomas Jrmann is senior scientist at the IMS and lecturer in biomedical engineering at the ZHAW and the ETH Zurich. He received his master and Ph.D. degree in physics and biomedical engineering at the ETH Zurich. During his Ph.D. at the institute for biomedical engineering (ETH Zurich) and the institute of neuroradiology (University Hospital Zurich) he developed an MRI-based system to reconstruct human brain nerve fibres in-vivo and non-invasively. Dr. Jrmann is experienced in leading medical development projects in academic as well as commercial institutions. He has written more than 20 peer review publications and published two book chapters. Richard A. Hppi graduated at the University of Applied Science Zurich (HSZ-T) in electrical engineering (1989) and received an executive MBA from the ZHAW, Winterthur in 2006. Since August 2001, he is applied by the IMS as senior research engineer. He is experienced in robotic controller design and robotic system integration. He is the project leader in several national research projects.
Table 10 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.05 0.33 0.05 0.9

ZHAW H. W. van de Venn Thomas Jrmann R. A. Hppi Scient. Employee

Total MM 48

Total FTE/year needed 1.33

Total FTE/year attributed 1.33

Most relevant Publications and Patents

FP7-ICT-2009-4

36

248782 SCATh

Jaermann, Th.; van de Venn, H.W., Bypass-Operationen mit semiautomatischem Nhinstrument: Die Kerbe die Leben rettet. Technica, 2009 Mar; (3): 48-49. Kus E; Grninger, R; Hppi R, Integration of Intelligent Sensors for Sensor-guided Motions in Industrial Robot Applications. IEEE International Conference on Automation and Logistics (ICAL 2008). Qingdao, 2008. Van de Venn H. W.; Zwicker, S.; Dolder, S., Entwicklung eines semi-automatischen Nhtools fr die Herzchirurgie. Proceeding of International Forum Mechatronics, ifm, 2007, ISBN: 978-3-033-01192-2. Th. Jaermann, N. De Zanche, P. Staempfli, K. P. Pruessmann, P. Boesiger, S.S. Kollias, Preliminary Experience with the Visualization of Intracortical Fibers Using Focused High-Resolution DTI (MRI), AJNR Am J Neuroradiol. 2008 Jan;29(1):146-50. Epub 2007 Oct 18. Chirurgisches Instrument zum Umstlpen eines Hohlorgans, Europische Patentanmeldung 05405023.2. Helixnadel zum Vernhen von Gewebe, Schweizerisches Patentgesuch 02093/04. Vorrichtung zur Stabilisierung der Herzoberflche whrend eines chirurgischen Eingriffs, Internationale Patentanmeldung PCT/CH 2005/000353.

FP7-ICT-2009-4

37

248782 SCATh

Beneficiary 5 -- Imperial College London (ICL)

Imperial College of Science, Technology and Medicine is an independent constituent part of the University of London. Rated as the world's ninth best university in the 2006 Times Higher Education Supplement University Rankings, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts students and staff of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and management. Imperials research in surgical robotics has an established track record particularly in SLAM, perceptual docking and dynamic active constraints. The ICL team has extensive experience in real-time 3D tissue deformation recovery for robotic assisted minimally invasive surgery (Stoyanov 2004) and performing SLAM in MIS (Mountney 2006). Other areas of expertise in the team include medical imaging including imaging of blood flow (Kilner 2000), augmented reality in robotic surgery (Lerotic 2007) and smart instruments (Noonan 2008). Key Researchers: Prof. Guang-Zhong Yang received Ph.D. in Computer Science from ICL and has served as a senior and then principal scientist of the Cardiovascular Magnetic Resonance Unit of the Royal Brompton Hospital prior to assuming his current full-time academic post. He is Director and Founder of the Royal Society/Wolfson Medical Image Computing Laboratory at Imperial and Chairman of the Imperial College Imaging Sciences Centre (ISC). He is holder of the Royal Society Research Merit Award in Medical Image Computing and has published over 200 original research articles including over 100 peer reviewed academic journal papers. His main research focus is on medical imaging, sensing and robotics. Dr. Danail Stoyanov received the Ph.D. degree in Medical Image Computing from Imperial College London for his work on soft-tissue 3D depth and motion recovery in robotic surgery. Currently, he is a researcher jointly at the Department of Biosurgery and Surgical Technology and at the Institute of Biomedical Engineering, Imperial College London. His main research interests are in computer vision, medical imaging and medical robotics. Dr. Adrian J. Chung received the Ph.D. degree from Imperial College London in 1999. He currently works as a research associate in the Surgical Technology division of the Medical Faculty at Imperial College. His primary research interests are surgical robotic guidance and navigation, augmented reality, patient specific tissue modelling, and compensating for deformation in medical imaging.

Table 11 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.026 0.05 0.95 0.414

ICL Prof. Guang-Zhong Yang Dr. Dan Stoyanov PostDoc PostDoc

Total MM 52

Total FTE/year needed 1.44

Total FTE/year attributed 1.44

Main tasks within SCATh ICL will coordinate the development of the SCATh real-time navigation and fusion system (WP5) with particular attention to new methods of modelling the endovascular system from real-time sensing while tracking the catheter by using SLAM. In addition, ICL will participate in the investigation of different sensing technologies and their application within SCATh. Most relevant publications

FP7-ICT-2009-4

38

248782 SCATh

P.J. Kilner, G.-Z. Yang, R.H. Mohiaddin, D.N. Firmin, M. Yacoub, Asymmetric redirection of flow through the heart Nature, Apr 2000, vol. 13, pp. 759-61. P. Mountney, D. Stoyanov, A. Davison, G.-Z. Yang, Simultaneous Stereoscope Localization and Soft-Tissue Mapping for Minimal Invasive Surgery MICCAI . vol. 1, 2006, pp. 347-354. D. Stoyanov, A. Darzi and G.-Z. Yang, A Practical Approach Towards Accurate Dense 3D Depth Recovery for Robotic Laparoscopic Surgery Computer Aided Surgery,vol.10, no.4, pp.199-208, 2005. M. Lerotic, A. J. Chung, G. P. Mylonas and G.-Z. Yang, pq-space Based Non-Photorealistic Rendering for Augmented Reality MICCAI, vol. 2, 2007, pp. 102-109. D. Noonan D, G. Mylonas, A. Darzi, G.-Z. Yang, Gaze Contingent Articulated Robot Control for Robot Assisted Minimally Invasive Surgery IEEE/RSJ International Conference on Intelligent Robots and Systems, 2008, pp. 11861191.

FP7-ICT-2009-4

39

248782 SCATh

Beneficiary 6 -- Institut fr Biomechanik, TU Graz (TUG)

The Institute of Biomechanics at Graz University of Technology was established in 2007 and is part of the Centre of Biomedical Engineering. Research of the Institute includes experimental and computational biomechanics and mechanobiology with an emphasis on topics in soft biological tissues: the cardiovascular system including blood vessels in health and disease, therapeutic interventions such as balloon angioplasty and stent implantation, magnetic resonance imaging and medical image processing. Core competencies include: nonlinear continuum mechanics, constitutive modelling of solids at finite strains, growth and remodelling, nonlinear finite element methods, fracture and material failure. The laboratory is equipped to measure mechanical responses of soft biological tissues that occur during (non)-physiological loading. Specific to WP4, the Institute has particular knowledge to model (physically and mathematically) the biomechanics of healthy arterial walls and atherosclerotic lesions on the basis of high-resolution magnetic resonance imaging. Key Researchers: Prof. Gerhard A. Holzapfel is Professor of Biomechanics at the Institute of Biomechanics, TUG, since 2007, and at the Royal Institute of Technology (KTH- Sweden), since 2004. After his PhD in Mechanical Engineering at TUG he received an Erwin-Schrdinger Scholarship for foreign countries to be a Visiting Scholar at Stanford University (1993-95). He achieved his Habilitation at TU Vienna in 1996 and received the START-Award in 1997, which is the most prestigious research award in Austria for young scientists. In the following years (1998-2004) he was the Head of the research group on "Computational Biomechanics" at TUG. Professor Holzapfel has authored a graduate textbook entitled "Nonlinear Solid Mechanics. A Continuum Approach for Engineering" (John Wiley & Sons), and co-edited four books. He has contributed chapters to 12 other books, and published 75 peer reviewed journal articles. He is the co-founder and co-editor of the international journal "Biomechanics and Modelling in Mechanobiology" (Springer-Verlag, Heidelberg). Dr. David M. Pierce is Universittsassistent (Assist. Professor) at the Institute of Biomechanics, TUG, since 2007. He earned a Ph.D. degree in applied mechanics at Stanford University, and additionally a Ph.D.-Minor in Applied Mathematics. His research involves computational mechanics, finite element methods, solid mechanics, constitutive modelling of solids, applied mathematics, nonlinear continuum (damage) mechanics, failure analysis, development of analysis/design tools and related computer programming/software. Currently he is focused on constitutive modelling and mechanical analysis of soft biological tissues, primarily human articular cartilage and arterial walls. The variety of research and work has generated numerous journal publications and two US patents.

Table 12 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.1 0.15 1.28

TUG Prof. G. A. Holzapfel Dr. D.M. Pierce PhD/PostDoc

Total MM 55

Total FTE/year needed 1.53

Total FTE/year attributed 1.53

Main tasks within SCATh TUG will coordinate the development of a patient-specific, image-based framework for finite element simulation of the endovascular system (WP4) with particular attention to: experimental testing of human tissue samples for determining accurate mechanical properties, generating a database of surgical tool geometries for efficient modelling, developing a rupture index for stenting, calibrating/validating the simulation results, and interacting with surgeons/staff to investigate clinical applications.

FP7-ICT-2009-4

40

248782 SCATh

Most relevant publications D.E. Kiousis, T.C. Gasser and G.A. Holzapfel: Smooth contact strategies with emphasis on the modeling of balloon angioplasty with stenting. Int. J. for Num. Meth. in Eng., 75 (2008) 826-855. G. Sommer, T.C. Gasser, P. Regitnig, M. Auer and G.A. Holzapfel: Dissection properties of the human aortic media: an experimental study. ASME J. Biomech. Eng., 130 (2008) 021007-1-021007-12. G.A. Holzapfel and T.C. Gasser: Computational stress-deformation analysis of arterial walls including high-pressure response. International Journal of Cardiology, 116 (2007) 78-85. G.A. Holzapfel, G. Sommer, et. al.: Determination of the layer-specific mechanical properties of human coronary arteries with non-atherosclerotic intimal thickening, and related constitutive modeling. Am. J. Physio. - Heart Circ. Phys., 289 (2005) 2048-2058. G.A. Holzapfel, M. Stadler and C.A.J. Schulze-Bauer: A layer-specific 3D model for the finite element simulation of balloon angioplasty using MR imaging and mechanical testing. Annals of Biomedical Engineering, 30 (2002) 753-767.

FP7-ICT-2009-4

41

248782 SCATh

Beneficiary 7 - Endosense: Company Overview

Endosense is a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias. The company has pioneered the use of contact force measurement in catheter ablation, with the development of its proprietary Touch+ sensor technology and its flagship product, the TactiCath. It is the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Endosense was founded in Geneva in 2003 by accomplished interventional cardiologist Dr. Vitali Verin and seasoned engineer Giovanni Leo to deliver breakthrough advances to the catheter ablation treatment of cardiac arrhythmias. Key People: Giovanni Leo co-founded Endosense in 2003 to develop novel technology for the catheter ablation treatment of cardiac arrhythmias. Leo brings to Endosense significant management and engineering experience in the fields of brachytherapy and particle accelerator control systems. Prior to Endosense, Leo was the director of the Geneva offices for Acrostak Corp., a Boston-Scientific-funded medical device company that developed the only European system for vascular brachytherapy. He was also co-founder of Isotopes and Metals Ltd., an emerging medical device company focused on technology for prostate and gynecological brachytherapy. Isotopes and Metals products are now sold by Philips Medical Systems. Leo previously held a software quality manager position at LeCroy Corp. as well as a CERN fellowship in the Accelerator Technology, Industrial Controls Group. Leo earned a degree in management engineering from Politecnico of Milano, Italy, following his education at the European School of Varese, Italy. Hendrik Lambert is a clinical engineering professional with deep experience in cardiac and vascular medical devices. Prior to Endosense, he spent eight years at Guidant Corporation, where he was most recently responsible for the companys Institute for Therapy Advancement. Under his tenure, the Institute became the first privately sponsored training center to organize courses as part of continuing medical education (CME) accreditation. Lambert also held various roles of increasing responsibility at Guidant, including manager of field clinical engineers and European clinical and research manager. Lambert previously held numerous clinical engineering positions with InControl, an emerging medical device company focused on the treatment of atrial fibrillation. Lambert earned masters degrees in electronic engineering and biomedical engineering as well as a Ph.D. in biomedical engineering from the University of Ghent, Belgium.
Table 13 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.15 0.15 0.14

EndoS G.Leo H.Lambert N. Aeby

Total MM 16

Total FTE/year needed 0.44

Total FTE/year attributed 0.44

Main tasks within SCATh: Endosense is going to make available their expertise and product around the intravascular force sensing (WP2) and participating in the multimodal data fusion in the WP5, coupling their force sensor with mapping techniques. Most relevant Publications Katsuaki Yokoyama et al Novel Contact Force Sensor Incorporated in Irrigated Radiofrequency Ablation Catheter Predicts Lesion Size and Incidence of Steam Pop and Thrombus Circulation : Arrhythmia and Electrophysiology 2008, 10.1161/CIRCEP.108.807925.

FP7-ICT-2009-4

42

248782 SCATh

Dipen C. Shah et al., Catheter Tip Force Required to Mechanically Perforate the Cardiac Free Wall ,Heart Rhythm Society, May 2008, San Francisco, USA, Abstract 6127, PO1-68, Abstract 6099, PO1-67, Abstract 6317, PO5-26, Abstract 4543, PO1-57, Abstract 4570, PO5-41, Aravinda Thiagalingam et al. The Relationship between Impedance Change and Catheter Contact Force During Radiofrequency Ablation: Evaluation in a Porcine Ex Vivo Cardiac Model Using a Novel Force-Sensing Irrigated Tip Ablation Catheter. American Heart Association, November 2007, Chicago, USA -Circulation. 116(2):487, Abstract 2239, Dipen C. Shah et al. Evaluation of a New Catheter Sensor for Real-Time Measurement of Tissue Contact, Heart Rhythm Society, May 2006, Boston, USA -Vol. 3, Issue 5 (Supplement), S75-S76, AB36-6.

FP7-ICT-2009-4

43

248782 SCATh

Beneficiary 8 - Angiocam IVS GmbH, Duisburg, Germany: Company Overview

Angiocam develops and sells a high resolution technology for vision through blood. This technology will be integrated into an intra-cardiac catheter in order to give a real-time inside view of the beating heart and the major blood vessels. This unique system can be used for minimally invasive cardiac surgery and for diagnoses of the cardiovascular system. The underlying technology of the new system is protected by a world wide patent. Any system available on the market today that visualizes the cardio system real-time is either limited by the necessity to eliminate the blood stream from the area of interest (video endoscopy) or by the problems caused by radiation, low resolution or size of the system in an operating room (X-ray, MRI, CT). The company is a spin-off from Fraunhofer Institut fr Mikroelektronische Schaltungen und Systeme (Duisburg, Germany), it started business in September 2008. For the proof of concept, a demonstrator of the system was built. According to the road map for the next 12 months, Angiocam will miniaturize the components, so that the entire system can be fitted into the tip of a catheter. Cardiologists are impressed by the quality and the resolution of the images produced by the demonstrator. The development of the prototype and the clinical study is financed by venture capital. The clinical validation study will take place at the Westdeutsche Herzzentrum Essen, directed by Prof. Dr. H. Jakob. Team: The Management of Angiocam consists of two people: Dr. Ingo Krisch (Founder and CEO) received his PhD in Plasma Physics and has a master degree in Medical Physics. He worked for 7 years for the IMS as leading project manager, responsible for the Angiocam project and for the epiretinal implant project EPIRET that won the prestigious Fraunhofer Award. Dipl. Kfm. Arnd Vossieg (CFO) holds a master degree in Business Administration. He has more than 15 years experience in finance of technology companies. Previously he founded B100 GmbH, a renewable energy start up. Dipl. Ing. Matthias Nawrocki, has a diploma degree in Computer Science. To date, he was responsible within the Angiocam project team for the system design and digital image processing. The Supervisory Board of Angiocam will consist of Prof. Dr. H. Jakob, Medical Director of the Westdeutsche Herzzentrum Essen at the University Hospital Duisburg-Essen, Prof. Dr. A. Grabmaier, Managing Director of the IMS in Duisburg and Prof. B.J. Hosticka, Ph.D., Chair for Mikroelectronic Systems at the University Duisburg-Essen.
Table 14 Distribution of work in FTE among the personnel

N.B. This list could be subject to changes according to the needs of the project and relevant timing constraints of the beneficiaries.
Involvement: Time dedicated Project duration 0.22 0.2 0.02

AngioC I.Krish A.Vossieg A.Yoganathan

Total MM 16

Total FTE/year needed 0.44

Total FTE/year attributed 0.44

Main tasks within SCATH Research activities undertaken by Angiocam are the clinical the sensing (WP2), real-time modelling (WP5), and system integration (WP8).

FP7-ICT-2009-4

44

248782 SCATh

B.2.3

Consortium as a whole
Table 15. Competence areas and beneficiary complementarities in the Work Packages

Competence Area
Medical expertise in Cardiovascular disease treatment System Validation and Clinical Experiments Tool tracking in surgical environment Endovascular Scanning Image Acquisition and Processing Intra-operative Sensing technologies

WP1
IVS, KUL IVS, KUL

WP2

WP3

WP4

WP5

WP6

WP7

WP8

ZHAW IVS, UPM, KUL ICL, AngioC IVS, UPM EndoSense, ZHAW, KUL

ICL, AngioC IVS, UPM EndoSense, ZHAW, KUL, AngioC TUGraz, KUL KUL UPM, ICL ICL, KUL ICL, UPM, ZHAW, KUL UPM, KUL UPM, KUL K.U.Leuven, ICL, ZHAW ZHAW, Endosense, KUL

IVS, KUL

Mechanical Modelling of biological tissues Physiological modelling Multimodal Registration Endovascular SLAM Real Time data fusion Human Interface Design Real time robotic process control Software architecture design System Integration

ZHAW, KUL

FP7-ICT-2009-4

45

248782 SCATh

In order to create a breakthrough in developing innovative and effective methodologies for diagnosis, prevention and treatment of cardiovascular diseases, a multidisciplinary approach is the only solution. Integrating excellence in multiple key competences is therefore necessary. Since no EU country alone hosts enough knowledge to successfully compete on world-level, SCATh selected only the most competent European research institutes and the most ambitious and dynamic enterprises. The SCATh consortium now features: 1. A selection of five top universities with a wide and solid background on the basic SCATh research themes, willing to push the limits of the actual state of the art for the themes touched by SCATh. Beneficiary 1 Katholieke Universiteit Leuven (KUL): As project coordinator, KUL will have an active participation in many work packages of the project (WP2, WP4, WP5, WP6, WP7, and WP8) contributing to many tasks. KUL participates in the SCATh project with a wide field of expertise: at the department of Mechanical Engineering, the Division of Production engineering, Machine Design and Automation (PMA) and the Division of Biomechanics and Engineering design (BMGO) joined forces in the Robot-Assisted Surgery-group (RAS group). The RAS group deals with various aspects of medical technology: visual servoing, force- and tactile sensing, teleoperation control and soft tissue modelling. The RAS group is actively part of the Leuven Medical Technology Centre (L.M.T.C.), an intergroup collaborative centre linking research groups within the University Hospital and the K.U.Leuven, strongly facilitating cooperation between engineers and clinical experts. In this framework, expertise and advice will come from the University Hospital especially in WP1. Moreover the KUL can count on the expertise acquired during the ARISER project (a Research Training Network founded under the FP6), where unique techniques for augmented reality in surgery were developed. Beneficiary 2 - Universidad Politcnica de Madrid (UPM): UPM is an expert in medical imaging and medical image processing, specifically in automatic nonrigid registration, segmentation, organ reconstruction and rendering. The main task of UPM will be to provide the patient-specific geometrical information (WP3) and, through parameterization, integrate it into the real-time multiscale model (WP5). Also UPM can count on the expertise acquired during the ARISER project. Beneficiary 3 - Interventional Centre, Oslo University Hospital (IVS): The Interventional Centre is a research and development centre for image guided and minimally invasive therapy at the Rikshospitalet University Hospital in Oslo, Norway and at the Faculty of Medicine of the University of Oslo. In the centre, advanced imaging equipment is integrated in an operation room environment. Moreover, IVS can rely on a strong staff composed by engineers and surgeons with a strong experience in robotic, visualization, navigation and modelling techniques applied to interventional surgery. This unique formulation of technical and medical expertise will be involved in the WP1, WP2, and WP3. Also IVS can count on the expertise acquired during the ARISER project. Beneficiary 5 - Imperial College London (ICL): The ICL team has extensive experience in real-time 3D tissue deformation recovery for robotic assisted minimally invasive surgery (Stoyanov 2004) and performing SLAM in MIS (Mountney 2006). Other areas of expertise in the team include medical imaging including imaging of blood flow (Kilner 2000), augmented reality in robotic surgery (Lerotic 2007) and smart instruments (Noonan 2008). The contribution given by ICL in WP5 is absolutely indispensable for the project, moreover it is the FP7-ICT-2009-4 46

248782 SCATh

only centre applying SLAM algorithms to intravascular procedure, pushing the limits of the current state of art in navigation technologies. Beneficiary 6 - Institut fr Biomechanik, TU Graz (TUG): This institute combines experimental and computational biomechanics with mechanobiology, with an emphasis on topics related to the cardiovascular system, including blood vessels in health and disease, therapeutic interventions such as balloon angioplasty and stent implantation, magnetic resonance imaging and medical image processing. Core competencies include: nonlinear continuum mechanics, constitutive modelling of solids at finite strains, growth and remodelling, nonlinear finite element methods, fracture and material failure. The contribution to WP4 will lead to new techniques for the modelling and quantification of intra-operative risks and the generation of safety margins. 2. An institution ready to bridge the gap between medical and technological research, between clinical practice and industries, taking care of the preindustrial phase and pushing the research outcomes towards the most fruitful exploitation. Beneficiary 4 Zurich University of Applied Sciences, Institute of Mechatronic Systems (ZHAW: IMS is a research and development centre of ZHAW with unique expertise in the implementation and integration of mechatronic systems with human-machine interfaces. It has been involved in many national and international research projects, the EU project for Adaptive Robots for Flexible Manufacturing Systems (ARFLEX) of the FP6 for plant automation based on distributed systems (PABADIS) of FP5. In robotics, IMS is one of the leading institutions of the Swiss Applied Sciences landscape and also well embedded in international Networks of Excellence as the European robotics Network EURON. IMS has designed and implemented various highly sophisticated medical applications, robots for micro assembly, autonomous mobile operation and large scale purposes. In WP8, IMS will highlight the SCATh results in an efficient demonstrator. 3. A set of Small and Medium Enterprises (SME), with the aim of providing frontier technologies and ready to bring the project results to an industrial phase. Beneficiary 7 - Endosense. Endosense is a medical technology company was founded in Geneva in 2003 by accomplished interventional cardiologist Dr. Vitali Verin and seasoned engineer Giovanni Leo to deliver breakthrough advances to the catheter ablation treatment of cardiac arrhythmias. The company has pioneered the use of contact force measurement in catheter ablation, with the development of its proprietary Touch+ sensor technology and its flagship product, the TactiCath. Endosense will actively contribute in the SCATh project in WP2, bringing the expertise on force sensing, and in WP5 and WP8, collaborating in fusing tracking and force information for the cardiac ablation map creation. Beneficiary 8 - AngioCam. Angiocam develops and sells a unique high resolution technology for vision through blood. In fact, Angiocam provides the only optical system in the world capable of giving optical visualization through blood applicable to flexible catheters. This technology will be integrated into an intracardiac catheter in order to give a real-time inside view of the beating heart and the major blood vessels. This system can be used for minimally invasive cardiac surgery and for diagnoses of the cardiovascular system. In the SCATh project this system will be used in WP2, WP5 and WP8. FP7-ICT-2009-4 47

248782 SCATh

B.2.3.1

Involvement of industry and/or end-users

Involvement of industry SCATh consortium integrates a consistent number of SME with a high level of R&D, this companies are the most prone to give spaces to new ideas and integrate new concepts in the already existing products. SME are integrated in the project in different levels: o Fully integrated into the project with the aim of being completely involved in the research activities (AngioCam and Endosense). o In the advisory board with a constant and collaborative connection with SCATh giving support when needed and being ready of integrating research outcome in their products (eSaturnus and Mentice). o As end user of the project outcomes, both because the project integrate and expand the possible application of their products (AcuNav, SIEMENS) or because it gives direct solutions to technical problems limiting the spreading of their products with the safe requirements asked by the European directives (Endoclamp, EDWARDS and Perceval S, SORIN). AngioCam IVS SME, Duisburg, Germany www.angiocam.de Role in SCATh: Partner Products involved in SCATh: Infrared Vision system eSaturnus SME, Leuven, Belgium newton.esaturnus.com Role in SCATh: Advisory Board Products involved in SCATh: Nebula (Visualization system) Sorin, Saluggia, Italy www.sorinbiomedica.com Role in SCATh: End user Products involved in SCATh: Perceval S (Sutureless aortic valve) Edwards Cardiovations, Irvine, CA United States Role in SCATh: End user Products involved in SCATh: Endoclamp (Endoaortic clamping system) Endosense SME, Geneva, Switzerland www.endosense.com Role in SCATh: Partner Products involved in SCATh: Tacticat (Catheter with force sensor) Mentice SME, Gothenburg, Sweden http://www.mentice.com/ Role in SCATh: Advisory Board Products involved in SCATh: Mentice VIST (Simulator for Interventional procedures) Siemens, Munich, Germany Siemens Acuson, Malvern, PA United States www.acuson.com Role in SCATh: End user Products involved in SCATh: AcuNav (Catheter based Ultrasound) Biosense Webster, Waterloo, Belgium Role in SCATh: End user Products involved in SCATh: Carto System (Cardiac Navigation System)

Table 16. Description of involved industries.

Involvement of end-users The end-users are at the same time a) the medical instrumentation industry, who could benefit from the intellectual property created through this project and integrate this into a new line of products and b) the medical experts, more specifically interventionalists. In a broad sense also the social healthcare systems and patients suffering from cardiovascular diseases could be considered end-users. However they are not directly involved in this project. The medical instrument industry is involved in this project as described in paragraph 0. The medical experts are represented by the medical partners: IVS and K.U.Leuven. FP7-ICT-2009-4 48

248782 SCATh

B.2.3.2

Sub-contracting

A budget of 9000 has been allocated in the management section for subcontracting of audit certificates.

B.2.3.3

Third Parties Resources to be committed by the consortium

Description Estimated contribution (euro) 18 000 10 000 10 000 30 000 20 000 40 000 20 000 150 000 12 000 53 000 14 000 14 000 30 000 3 000 20 000 15 000 23 000 80 000

No third parties are foreseen during the project.

B.2.4
Partner

Table 17 Resources complementing the EC contribution

1 KUL

2 UPM 3 IVS

4 ZHAW

5 ICL 6 TUG

20 CT scans (700 euro -200 euro*) + 20 MRI scans (500 euro -100 euro*) (*For each scan, a minimum contribution from the budget is needed) Prototypes for catheter manipulation Force and pressure sensor systems Real-time control systems (NI PXI, D-Space) Facilities at the Centre for Experimental Surgery BOSE LM1 test bench Phantom haptic interface SARIX micro EDM machine Software licenses (Matlab, Labview, FEM software) Software licenses for visualization and modelling development. Laboratory facility for testing. Phillips 3T MR will be used in at least 5 experimental sessions. Siement Artis Zeego, robotic angiographic system will be used in at least 5 experimental sessions ARTrack optical tracking for whole room tracking of personnel and rigid instruments NDI Aurora magnetic tracking for instrument or flexible catheter tracking Robin Medical magnetic field tracking for intra-operative MR tracking of instruments ComputerMotion Zeus telemanipulator system Sensable Technologies: 2 Phantom Premium 1.5 and 3 Phantom Omnis devices for 3DOF haptic feedback The ZHAW provides different robotic labs (including equipment) as well as CAE/CAD facilities and expertise for SCATh system design, construction and integration. Optotrak, Polaris and Aurora Tracking systems ALOKA Prosound Ultrasound Experimental laboratory (81 m2 Biomechanic Labor) including: A uniaxial testing setup An extension-inflation testing setup

350 000 250 000

FP7-ICT-2009-4

49

248782 SCATh

7 EndoS 8 AngioC

A biaxial tensile testing setup, and A Zeiss Axio Scope.A1 Polarized Light Microscope. High-tech equipment for the production of catheters. Contribution of expert personnel Apparatus based on infrared light with high blood penetration.

63 000 48 000 150 000

Total Contribution from regular funding of the partners:

Table 18 Detailed Project Budget
1 K.U. Leuven 2 UPM 3 IVS 4 ZHAW 5 ICL 6 TUG

1 423 000

7 EndoS

8 AngioC

Budget Research and Development Personmonths Personnel Cost Subcontracts Others: travel consumables equipment Total Others Overhead Total FUNDING Management Personmonths Personnel Cost Subcontracts (CFS/Audit) Others: travel consumables equipment Total Others Overhead Total FUNDING

Consortium

372 2'049'285

82 434'248

58 271'306

54 342'000

47 257'000

51 274'299

54 249'798 20'000 23'000 12'000 55'000 182'879 487'677 365'758

15 100'500

15 121'440

137'000 213'500 79'000 429'500 1'348'295 3'827'081 2'870'311

23'000 45'000 20'000 88'000 313'349 835'597 626'698

15'000 20'000

15'000 20'000

15'000 20'000 5'000

17'000 22'000 12'000 51'000 195'180 520'479 390'359

15'000 33'500 20'000 68'500 33'800 202'800 152'100

17'000 30'000 10'000 57'000 35'688 214'128 160'596

35'000 181'694 488'000 366'000

35'000 226'200 603'200 452'400

40'000 178'200 475'200 356'400

20 133'298 9'000 17'700

13 88'686 2'000 4'400

1 5'474 1'000 1'900

1 7'000 1'000 1'900

1 7'000 1'000 1'900

1 5'055 1'000 1'900

1 5'761 1'000 1'900

1 6'700 1'000 1'900

1 8'096 1'000 1'900

17'700 83'161 243'159 243'159

4'400 55'852 150'938 150'938

1'900 3'666 12'040 12'040

1'900 5'340 15'240 15'240

1'900 5'340 15'240 15'240

1'900 4'173 12'128 12'128

1'900 4'597 13'258 13'258

1'900 1'720 11'320 11'320

1'900 1'999 12'995 12'995

Grand Total Funding

4'070'239 3'113'469

986'534 777'635 25%

500'040 378'040 12% 312'900 187'140

618'440 467'640 15% 386'900 231'540

490'440 371'640 12% 306'900 183'540

532'607 402'488 13% 333'255 199'353

500'934 379'015 12% 313'459 187'475

214'120 163'420 5% 178600 35'520

227'123 173'591 6% 189'436 37'687

Direct costs Indirect cost model

2'638'784 1'431'456

617'334 369'200

FP7-ICT-2009-4

50

248782 SCATh

Table 19 Overview project budget (euro) TOTAL Personmonths Personnel Cost Subcontracts Total Others Overhead Total FUNDING RTD 372 2'049'285 429'500 1'348'295 3'827'081 2'870'311 DEMO Other Management activities 20 133'298 9'000 17'700 83'161 243'159 243'159 Total 392 2'182'584 9'000 447'200 1'431'456 4'070'239 3'113'469

FP7-ICT-2009-4

51

248782 SCATh

B.3 B.3.1

Impact Summary - Project contribution to impacts listed in the work programme

The contribution of the SCATh project to the expected impact of the objective ICT-2009.5.2 ICT for Patient Safety is summarized in Error! Reference source not found.. Links towards the paragraphs containing a more detailed description of the specific impacts can also be found in this table. Expected Impact
Improved patient safety in surgery through advanced ICT application for training, preoperative planning, and computer-aided surgical intervention. Improved patient safety in surgery through advanced ICT application for training, preoperative planning, and computer-aided surgical intervention. Improved patient safety in surgery through advanced ICT application for training, preoperative planning, and computer-aided surgical intervention. Improved patient safety in surgery through advanced ICT application for training, preoperative planning, and computer-aided surgical intervention. Improved patient safety in surgery through advanced ICT application for training, preoperative planning, and computer-aided surgical intervention. Industrial and Economical impact Industrial and Economical impact Industrial and Economical impact Scientific and Technological Impact

Project Contribution
- Expanded possibilities for treatment. - Increase of the amount of eligible patients for endovascular treatment.

Detailed in
0

- Drastic reduction of the absorbed radioactive dose for the patient and the interventionalist. - Implementation of safety margins on the catheter tools. - Possibility to reproduce all pre-operative and intra-operatively recorded multi-modal data in a training modality to provide realistic information for training. - Pre-operative size and final position identification for prosthetic and catheter devices. - Pre-operative identification of safety margins for delicate anatomical structures. - Mitigation of the surgeons mental load through partial automatization and more intuitive control over the procedure -Shared control: both the surgeon and an intelligent monitoring system are in charge Competitiveness of Europe Cost- effectiveness SME Leading Innovation

02a I

02a II

02a III

02a IV

02b 02b 02b 3.1.1.c

Table 20: SCATh impact summary table

FP7-ICT-2009-4

52

248782 SCATh

Targeted medical field: cardiovascular diseases

Cardiovascular disease (CVD) is the class of medical diseases that affect the heart and surrounding blood vessels. CVD can take on many forms, such as stenosis, aortic aneurysms, valvular heart disease, rheumatic heart disease and stroke. In February 2008, the yearly European Cardiovascular Disease statistics reported that CVD caused over 4.3 million deaths in Europe, and over 2.0 million deaths in the European Union (EU), 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 of productivity loss and 42 billion in informal care. This will only become worse in the near future as the incidence of CVD pathologies has increased exponentially in the last years. This can be attributed to both external risk factors and the ageing of the population. It has been forecast that the prevalence of aortic stenosis, one of the most frequent CVD, will rise up to 4.6 million in 2030 in the US alone. This is almost the double of the current amount (Figure 17) (Vahanian 2008). The incidence of thoracic aortic aneurysms (TAAs) and acute dissections is estimated to be as high as 10 cases per 100.000 people per year, giving a potential number of 48.000 cases per year in Europe. The number of actual diagnosed cases is only 16,000 per year but this number is increasing rapidly due to improved imaging technology and better screening protocols (Medtech 2009).

Figure 17. Prevalence of Aortic Stenosis: forecast for 2030.

Even in good hands, treatment of CVD through open surgery has been associated with serious complications, especially in those patients who are not physically fit enough for open surgery. As endovascular surgery has the potentially to replace open surgery, this project focuses on increasing the performance of endovascular procedures. A well-established endovascular approach can double the amount of eligible patients compared to open surgery as well as expand the possibilities for treatment. The predicted increase in CVD patients consequently has a strong effect on the market size. In particular the market of transcutaneous heart valve prostheses has been forecast to grow 12 times in the next 6 years (Figure 10). Also the market of devices for aneurysms and aortic dissection repair has grown exponentially in the past years and most likely, this trend will remain for the next decade (Figure 11).

FP7-ICT-2009-4

53

248782 SCATh

Figure 18. Market forecast for transcatheter valve technologies

Figure 19. Trend in the endovascular thoracic aneurysm and dissection repair market.

In order to provide an efficient health support and to maintain high standards for quality and safety of the provided services, a strong and aggressive investment in this research field is necessary. Research should also be directed to reduce the workload of the medical staff and tackle the cost of prolonged hospitalization and expensive equipment. Also, the development of effective methodologies for diagnosis, prevention and treatment requires excellence in multiple research domains. Expertise in these multiple research domains is currently spread over various EU member states. In order to create a high quality platform for endovascular treatment of CVD, it is mandatory to combine this expertise. No EU member state alone seems to be able to develop a platform competitive enough, given the present distribution of expertise. SCATh is a multidisciplinary project bringing together leading RTD institutions across Europe with experience in medical imaging, tracking and navigation techniques, mechanical modelling, robotics and control. Awareness creation and dissemination of obtained results will also largely profit from the projects European perspective, since a project undertaken at European level will receive significant more attention in the member states than any national initiative. Each consortium partner in turn will monitor the progress in their own research areas world-wide in order to ensure that SCATh remains at the edge of technological development and research.

FP7-ICT-2009-4

54

248782 SCATh

Addressing the Work Programme Objectives

Social Impact: ICT for patient safety Improved patient safety in surgery through advanced ICT application for training, pre-operative planning, and computer-aided surgical intervention. I. Reduction of the risks related to the patient and surgeon exposure to ionizing radiations. Currently, interventional procedures depend most often on visualization through either X-ray fluoroscopy or computed tomography (CT). This imaging technique is based on the different level of xray absorbance of tissues and results in a non-natural harmful exposure of both the patient and the surgeon to ionizing radiation. This radiation is a threat for the patients safety, especially for those in need for repeated interventions. But is also a problem for the surgeon performing the procedure, as they also receive a non-negligible dose of radiation. Measurements on the radiation dose delivered to both patient and surgeon were reported in a recent publication by Tsapaki (Tsapaki 2008): the median skin dose delivered to the patients during interventional procedures of percutaneous coronary angioplasty was estimated to be on average 799 mGy (320-1660 mGy) and in RF ablation 160 mGy (35-1920 mGy). This is close to the value of 2Gy which causes skin erythema. The median local dose to the surgeons arm, hand and foot were 12.6 Sv, 27 Sv and 13 Sv respectively. Note that the lifetime risk of fatal cancer resulting from irradiation is estimated by the International Commission on Radiological Protection (ICRP) to be about 0.05 per Sv (Gy).

The International Commission on Radiological Protection (ICRP) states that any maximum cumulative doses absorbed exceeding 1 Gy (for fluoroscopy-guided procedures that may be repeated) or 3 Gy (for any procedure) should be recorded in the patient's clinical file. The SCATh platform relies on modelbased navigation and has as such the potential to drastically reduce the need for intra-operative fluoroscopic imaging. The goal is to restrict the radiation dose below 1Gy, which can directly improve the patients safety. Furthermore, methods for autonomous and teleoperated catheter navigation and manipulation will be implemented, which can eliminate the radiation exposure for the interventionalist completely. II. Better training for surgeons The SCATh platform will allow the creation of a database containing both pre-operative data, such as the geometrical model and the mechanical model, and intra-operative data such as interaction forces with tissue, the catheters path, the progress along this path and sensor signals describing the biomechanical processes. Each time a procedure is done the database can be extended. This database with preoperative and intra-operative data, combined with the developed graphical user interface is an ideal starting point for improving training of interventionalists. This will allow (young) interventionalists to develop a better understanding of the endovascular procedures and to develop a better technique which is less prone to errors and complications.

FP7-ICT-2009-4

55

248782 SCATh

III. Reducing the surgical risks with a better surgical planning In a pre-operative phase the SCATh platform will become an indispensable means for planning of the surgical intervention. The SCATh platform will offer new ways to optimize both the selection of tools and the strategy of the intervention. The placement of a stent graft and the treatment of a stenotic aortic valve e.g. are two procedures that can benefit largely from a better planning. During the positioning of the stent graft occurrence of major paraplegia was found to have an incidence of as high as 32% in type I and type II TAAs (Bafort 2002). The problem is that the stent graft covers the entry of the intercostal arteries causing spinal cords ischemia. During treatment of a stenotic aortic valve the risk of tamponade (fluid accumulation in the pericardium) was estimated to be 2.9% due to the absence of accurate knowledge of the patients anatomy. (Iung 2003) The SCATh platform offers the surgeon a detailed patient-specific quantitative overview of the overall anatomy. Moreover, the SCATh platform offers a tool for prediction of delicate structures and allows for pre-operative calculation of the outcome in terms of arterial damage for the planned actions. All of this will improve the selection of the size of implantable devices and the localization of a safe landing point. Also, damage will be less likely to occur as delicate structures are pin-pointed during the planning. IV. Full support to the surgeon during the surgical intervention SCATh aims to give a better insight and control on the ongoing procedure by fusing pre-operative models with intra-operative reality. The pre-operative model will be enriched with online acquired information coming from different sensors. This will facilitate significantly the challenging task of navigating the catheter through the vascular system to the right place, while being less dependent on harmful imaging modalities like fluoroscopy. An intuitive User Interface will continuously provide relevant information to the surgeon allowing him to take better and faster decisions. This can be either through visualization, audio cues or haptic feedback. The SCATh plaform will also provide the necessary technological tools to enable partial automation of some procedures. Several subtasks belonging to surgical procedures can be automated safely. The result of this process is a mitigation of the mental load to which the surgeon is subject, reducing the risks of errors and allowing him to conduct safer and more systematic and delicate procedures. E.g. with the positioning system for the endoclamp balloon, the position of the balloon can be autonomously controlled, avoiding migration of the balloon. Consequences of migration of the balloon are among others brain ischemia or blowing of the balloon itself with consequent massive blood loss. Therefore, avoiding this migration means a clear improvement of patients safety.

FP7-ICT-2009-4

56

248782 SCATh

To summarize, 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

Apart from these general targets, a set of specific contributions to improve patient safety in the selected endovascular procedures are detailed in Table 21.

Procedure Stent graft placement

Risk Blood vessel or aneurisms rupture Wrong size of implantable devices selected Incorrect positioning Renal Failure Damage to surrounding tissue Paravalvular leak and Coronary ostia obstruction Tamponade

How the risk will be reduced Definition of stress threshold by means of mechanical modelling (rupture index) Preoperative study based on patient-specific geometrical model Accurate navigation with based on a patientspecific geometrical model Reduced need for contrast dye Pre-operatively calculated damage indexes Correct position assessment based on geometrical model and SLAM Introduction of force sensing and haptic feedback + Monitoring of physiological parameters Monitoring ablated region based on geometric and force sensor information Accurate navigation with based on a patientspecific geometrical model Autonomously controlled

Sutureless aortic valves placement

Cardiac radiofrequency ablation

Aortic endoclamp balloon

Wrong assessment of ablation zone Wrong positioning and/or migration Surgical focus not on the main procedure

Table 21. Expected risk reduction related the procedures listed in WP1:

FP7-ICT-2009-4

57

248782 SCATh

Industrial and economical Impact. V. Competitiveness of Europe Currently, the U.S. is clearly ahead of Europe in research and development of medical technology. Figure 22 shows the current difference in the market of medical devices in the U.S. and Europe. Also in the field of endovascular procedure, the U.S. is a step a head of Europe. For example, the only two commercially available systems for remote catheter navigation are exploited by two U.S. companies (Hansen Medical Inc. and Stereotaxis Inc.). The main cause for this situation is rather a lack in coordination of research efforts and fragmented investments than a lack of knowledge. The outcome of the SCATh project, consisting of partners with very Figure 20. Medical device complementary knowledge, will be a general framework for endovascular market, 2008 procedure. This framework will at the least be competitive to research efforts all over the world, and contributes to decreasing the gap between the U.S. and the EU and contributes to the implementation of article 157 of the treaty establishing the EU. VI. Cost-effectiveness A classical analysis starts from the evaluation of the costs associated with a given program with respect to either the effectiveness (as measured by some suitable clinical proxies), or the benefits (in terms of utility, whatsoever specified) for society, derived by the utilization of such innovations. Great care is needed in the definition of these concepts. As an example, costs involved could be either the direct costs (i.e. for the acquisition and usage of the technology, as well as those derived by side effects), or could be extended to include also the indirect costs, associated with loss of work, home care and patients poor quality of life. Note that more than 20% of the total cost of health care in the EU can be attributed to productivity loss. The SCATh project works towards lowering the total cost associated with health care. Introducing high level technology in surgical procedures will result in a reduction of complications and an improvement of the procedures outcome. As such, this increases the costs associated with the procedure itself, but in the long run, this will significantly reduce the costs associated with productivity loss and patient recovery. VII. SME Leading Innovation A critical contribution to medical device innovation is given by small firms. Start-up firms have been disproportionately responsible for the innovation and early development of truly novel devices, including angioplasty catheters, artificial joints, cardiac support devices, diagnostic ultrasound, diagnostic test kits, and vascular grafts. In contrast, larger firms are more likely to pursue nextgeneration or incremental improvements, for example, by refining or building on current product lines of familiar markets (The Lewin Group, 1999). This SCATh project will support two emerging SME, i.e. Endosense and Angiocam by providing a larger framework for their innovative products.

FP7-ICT-2009-4

58

248782 SCATh

VIII. Producing Useful Solutions The technologies developed in the SCATh project will have an important industrial value. SCATh projects management has a medical, technical and general board. The medical board has the important role of steering the research towards useful application. Too often the technicians provide the clinicians with solutions hardly applicable. The SCATh researchs activities will be supervised by a medical board composed by engineers and medical doctors, in order to solve concrete and consistent problems of the clinical practice. In addition to this, experiments will be used to steer possible reiteration of technological developments. On the other hand, a strong contribution from the industrial partners is expected for optimizing the feasibility of the solutions exploitation, from the start of the project. This follows the recommendations of section 8.3 about medical devices competitiveness and impact on public expenditure of a study for the Directorate entrpise of the European commission (July 2005).

B.3.2

Dissemination and/or exploitation of project results, and management of intellectual property

Dissemination
In order to generate a maximal impact, SCATh will actively disseminate the project results trough different dissemination channels, depending on the target group. SCATh will disseminate scientific and technological results not only to academia and industry, but also to health professionals, surgeons, interested stakeholders and the broader public. As such the project results can contribute to an increased awareness, education, and interest in technology-based evolution in healthcare systems. In the following, the target groups are introduced and dissemination actions explained for each target group, having different interests and different level of knowledge: - The consortium - Scientific experts - User groups (Technical and Medical) - Interested stakeholders and broader public. The consortium As good communication within the consortium is mandatory for a successful project, a considerable amount of effort will be put in the exchange of ideas and results within the consortium: - The annual project report and work package reports will be reviewed by the appointed Project Management board and distributed to all the partners via email-groups and free download from a web server. - Workshops and seminars will be organized, where the results of every partner can be presented and discussed. It is planned to have at least one session to be organized by each partner. Other experts from outside the consortium will be invited to participate, taking into account the regulations from the IP management. - Two Schools will be organized at month 13 and 25, which will have sessions open to the wide scientific community and sessions restricted to the only Consortiums members.

FP7-ICT-2009-4

59

248782 SCATh

Scientific experts In order to publish project results and follow ongoing evolution in the field, conferences on clinical research, medical devices, biomedical engineering and robotic technology will attended: - Int. Conf. on Medical Image Computing and Computer Assisted Intervention (MICCAI) - Int. Congress on Computer Assisted Radiology and Surgery (CARS) - IEEE/RSJ Int. Conf. on Intelligent Robots and Systems (IROS) - Int. Conf. on Computational Biomechanics and Biology (ICCBB) - Congress of the European Society of Biomechanics (ESB) - European Society of Cardiovascular Surgery Annual Congress (ESCSAC) Besides attending conferences, research results will be published in national and international journals, SCATh expects to have at least two articles every year starting from year 2. Journals that qualify for publishing are: - Biomechanics and Modeling in Mechanobiology - IEEE Transactions on Biomedical Engineering - IEEE Transactions on Haptics - Cardiovascular and Interventional Radiology - Journal of Interventional Cardiac Electrophysiology - Int. Journal of Medical Robotics and Computer Assisted Surgery - Annals of Biomedical Engineering (Springer Science + Business Media) - Biomechanics and Modeling in Mechanobiology (Springer Berlin/Heidelberg) - Computer Methods in Biomechanics and Biomedical Engineering (Taylor & Francis) - Journal of Biomechanical Engineering (ASME) - Journal of Biomechanics (Elsevier) - Medical Image Analysis (Elsevier) - Medical Engineering & Physics (Elsevier) Moreover, clustering Meetings organized by the EC will be attended User Groups The envisioned user groups for SCATH consist of the medical world, which will make use of the new technology, and the industrial world, who will be interested in the new technology in order to commercialize it. Both worlds are to be reached through a coordinated approach, as interests from both are mandatory for a successful launching of the technology on the market. Ideas for convincing dissemination to the medical and technical world are: - Medical and industrial partners in the consortium, - An important industrial partner in the advisory board, - Lab visits with demonstrations for interested companies, - Experimental testing of the new technology by medical partners, - Publication of results in magazines addressed to the medical and industrial world. - The projects results will be disseminated to the final user groups including health professionals and surgeons. Preferred way is inviting both user groups to the projects events (Workshop and Summer School). - The project will have a representative in some of the most famous meeting of the medical device market in Europe: MEDICA at Dsseldorf, Germany. FP7-ICT-2009-4 60

248782 SCATh

Stakeholders and broader public General goal: Informing stakeholders and interested citizens about the possibilities of new technologies for healthcare systems, in order to justify and motivate investments in this domain. This will be achieved through the following actions: A project website will be created as soon as the project starts. It will contain all necessary information and documents to promote the project and its outcome Open house events at least once during the project Publishing project results via newspapers and/or television. The K.U.Leuven has its own PR department having strong connection to different national and international media. Publishing of popular science articles in adequate magazines. The research results will be incorporated into educational material, i.e. meaningful examples at various student levels. A press release will be sent to a selected group of media. Workshop and Summer School During the SCATh project are foreseen two events, a workshop and a summer school. The main difference between those two events will be the discussed themes, one more monographic the second more wide in contents, but modalities and scopes of those events are the identical. The first aim is to dedicate time for the team working within the consortium, allowing the interaction of partners working on not strictly correlated fields. There will be organized presentations on the projects evolution and discussion session trying to identify means of integrating the research conducted within the project. It is expected that such event will enhance the level of awareness, among the partners, on project direction, and will be encouraged horizontal and international collaboration among the researchers. The second aim of those events is to compare the achievements and research lines of the project with the wider scientific community. Therefore the invitation to the events will be extended to the wide scientific community and general public. During presentation and discussion session open to the wide audience will be presented the projects research lines.

B.3.2.1

Management of knowledge and intellectual property

A separate work package is foreseen that aside from management of the project as a whole is meant to ensure proper valorisation of the project. Since the deliverables of this project are in different fields, the management of the exploitation will be very important and will take into account the following points: The Consortium Agreement will settle issues related to prior art, delineation of the project and partnership between all the universities and enterprises. A confidentiality agreement for execution of the project will be signed by all partners and the members of the external advisory board (EAB). New Knowledge will lead to new patents to be filed, through the aid of the respective Tech Transfer Offices of the Universities or Companies. Following matters could be considered: Pre-operative image free navigation through vascular system (SLAM for endovascular system); Method for adaptive parameterized anatomical modelling; Novel soft registration methods for vasculatory; Teleoperation operation for catheter guidance; 61

FP7-ICT-2009-4

248782 SCATh

Real-time multiscale model fusion for catheter guidance Automatic balloon positioning and repositioning Software for operation planning taking tissue damage / stress into account Catheter surrounding scanning for local navigation and mapping Pre-operative wall thickness segmentation .

The pre-existing IP of all partners will be further expanded A Scientific Monitor / Assistant will aid the Coordinator and the Steering Committee building contacts with industrial partners. Job description of the Assistant will include preparation of formal presentations of research results and technologies by the Coordinator, technical follow up of ongoing research contracts, help with transport of animals, implementation of biosafety regulations etc. The Assistant will be in contact with the TTOs and work package leaders of all Universities. The Assistant will also establish the SCATh website, take care of updates (PDF files of publications), provide examples of deliverables and results in the public domain, and provide information for lay public. The Deliverables defined as restricted will be considered for industrial exploitation, thus restriction becomes necessary. If they will be judged not interesting for industry, they will be released as publication

A consortium agreement will be drafted, which will be signed by all partners. This agreement will form the legal basis for the relationship and responsibilities between the partners for the duration of the work. It will facilitate the resolution of problems if these should occur between partners. This Consortium agreement will stipulate among other things that the ownership of IP on results obtained in the project will remain with the partner who developed the results and that, in the case results have been jointly developed between multiple parties, the IP will be jointly-owned. The IPR team at K.U.Leuven R&D, in close collaboration with the tech transfer offices of the partners, will conduct technology transfer activities that will provide the project the ability to exploit the results in Europe. The coordinator will emphasize that the participants protect their results which have potential industrial applicability. Every six months, the project results will be checked for exploitation potential. Patent application activities will be performed by and in the name of the respective partners institutions. If inventions result from collaboration between more participants, co-ownership agreements will be established.

FP7-ICT-2009-4

62

248782 SCATh

B.4 B.4.1

Ethical issues
Ethics related to experiments
YES Informed Consent
Does the proposal involve children? Does the proposal involve patients or persons not able to give consent? Does the proposal involve adult healthy volunteers? Does the proposal involve Human Genetic Material? Does the proposal involve Human biological samples? Does the proposal involve Human data collection? Research on Human embryo/foetus Does the proposal involve Human Embryos? Does the proposal involve Human Foetal Tissue / Cells? Does the proposal involve Human Embryonic Stem Cells? x x x x x x x x x 4.1.3 4.1.4-5 PG

Privacy
Does the proposal involve processing of genetic information or personal data (eg. health, sexual lifestyle, ethnicity, political opinion, religious or philosophical conviction) Does the proposal involve tracking the location or observation of people? x 4.1.4-5

Research on Animals
Does the proposal involve research on animals? Are those animals transgenic small laboratory animals? Are those animals transgenic farm animals? Are those animals cloning farm animals? Are those animals non-human primates? x 4.1.6-7 x x x x

Research Involving Developing Countries

Use of local resources (genetic, animal, plant etc) Benefit to local community (capacity building i.e. access to healthcare, education etc) x x

Dual Use
Research having potential military / terrorist application x

I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL

Table 22. Ethical Issues table

FP7-ICT-2009-4

63

248782 SCATh

The ethical task force (EthTF) will have the duty of properly assessing the medical needs, evaluating the effectiveness of the provided solutions and evaluating the needs of medical testing. The EthTF will also be the contact point for patients and test users of the prototype developed in this project. The EthTF will guarantee the respect for ethical issues involved in the project and will plan experimental sessions. All data and information obtained from test users will be subject to national and international data protection regulations as described below. The EthTF, when animal tests are needed, is responsible to ask the opinion of the national and local ethical committee in order to guarantee maximum respect of the local and European directives. The EthTF will have also the duty of selecting, among the medical staff, a user group that will test and evaluate the produced prototypes. The EthTF is responsible for the ethical issues relevant to medical research. The members of the Ethical Task Force will not be involved actively in medical research. In case their expertise will be needed for medical research, they will need to declare it and they will be replaced in the Ethical Task Force. IN addition to the ethical task Force, it should be noted that all procedures involving human subjects will be submitted to the relevant hospital ethics committee, whose requirements will be closely adhered to: K.U.Leuven: Commissie medische ethiek van de universitaire ziekenhuizen K.U.Leuven. Rikshospitalet IVS: Regional Committees for Medical and Health Research Ethics in Norway

B.4.2

Local ethics committees

The EthTF will address local ethics committees when needed and their opinion and authorisations will be delivered accordingly. An approval from the K.U.Leuven university hospital ethical committee has already been granted for testing human cardiovascular material that is excised during surgical operations (i.e. removed unhealthy tissue and surplus material from bypass operations). At the K.U.Leuven and IVS the procedure foresee an application for ethical approval 3 months before the experimental trial. This term will be respected and no trial will be started without the ethical committees approval.

B.4.3

Risk management

Risk analysis of the product will be performed according to ISO 14971:2007. The TMB has to address a commission for ethical issues on a case to case basis for approval of the analysis.

B.4.4

Use of Human Biological Samples

Tests on human biological samples will be performed under the approval of the local Ethical Committee. An approval from the K.U.Leuven university hospital ethical committee has already been granted for testing human cardiovascular material that is excised during surgical operations (i.e. removed unhealthy tissue and surplus material from bypass operations). This approval has been deposited in the national registry with the number: B32220071899 (appendix 5.2.). When human biological samples will be needed for testing, an informed consent will be required. At the moment there is not foreseen the use of material coming from bio bank. Eventually will be used data from previous experiments that are been collected and stored with the approval of the local ethical committees.

FP7-ICT-2009-4

64

248782 SCATh

B.4.5 Informed consent

Informed consent will be filled in case the evaluation of the prototype will involve volunteers in interviews and accessing personal data, in any case no clinical test on patients are foreseen within this project. Human subjects that will participate in any testing will be informed extensively about the project and written informed consent will be obtained. Information will be presented to enable persons to voluntarily decide whether or not to participate as a research subject. The procedures used in obtaining informed consent will be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation, explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits will be written in "lay language". The SCATh consortium will provide the participants with information on contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries.

B.4.6 Confidentiality concerning data storage

The ethical task force (EthTF) will have the duty of being responsible and put in place measures for the confidentiality preservation od sensitive data collected during the project. Only after written informed consent by the test users, personal data and data gathered during the experiments will be stored. The storage equipment will only be accessible to authorized personnel. The stored data will only be used during the course of the project and only by members of the consortium. All the data that will be used within the project have been stored after the signature of an informed consent by the patient. The project has also available a database with previously collected data that eventually will be used in the project, in the informed consent related to those data is clearly stated that the data were going to be stored and used in future experiments. The collected data will be stored in a secure password controlled server, protected by the hospital firewall and safety features. Dissemination of the data will be done in an anonymous way by eliminating names from the medical files: Patients data will be collected mainly in three forms: Medical images in DICOM format Data collected manually through interviews or collected from medical databases. Images from intraoperative scanning In the case of data in DICOM format, dedicated software for data anonymization will be used (e.g. tool dicomanon from the Matlab Image Processing Toolbox, the Mathworks or softwares like DICOM Anonymizer Pro from NeoLogica) In case of data collected manually, all the data defined as personal will be removed and substituted with progressive numeration. If intraoperative scanning images will be recorded, the patients name will not be recorded.

B.4.7

Subjects and insurance

The users will be selected in the population of healthy, volunteer, skilled users (e.g. cardiologists, cardiac surgeons, vascular surgeons,.). The prototypes will not be used in patients. FP7-ICT-2009-4 65

248782 SCATh

The selected subject will be covered by insurance from their employer; this is guaranteed by the fact that the selected subject will be in any case already part of research or clinical teams. The research and the solutions developed within SCATh may have additional implication once they will be deployed into routine clinical practice. However SCATh does not plan to address this during the project as it does not plan to deploy into routine clinical practice. However the project will closely monitor through the ethical task force any such implications and it will highlight the issue in the project results. A specific section will be added, if needed, in the context of deliverable D1.2 (Detailed report on selected Interventional procedures, approaches, expected outcome and validation procedures) or D1.3 (Detailed report on conducted in vitro and in vivo experiments). The project will closely observe the requirements of the EC Medical Devices Directive.

B.4.8 Animal Experimentations

All animal experiments will comply with the Amsterdam Protocol on Animal Protection and Welfare and the Directive 86/609/EEC on the Protection of Animals Used for Experimental and Other Scientific Purposes. The 3Rs strategy will be taken into account: Replacement, the SCATh project will make large use of phantom mimicking the human geometry in a first experimental phase. The phantoms will be used for the refinements of the algorithms and for the testing of the first solutions iterations. Virtual reality model will be as well used for the validation phase. Only when it will be really necessary animal models will be used for the experimental testing. The quantity of animals considered for the experimental phase will be decided on the basis of a Reduction strategy: Limiting to only those experiments considered as absolutely necessary Reduction of useless repetitions. This does not mean going against one of the fundamental principles of experimentation which requires the confirmation of original results by independent peers, but rather avoiding the repetition of previous studies conducted in another country, and seeking to meet national or Community legislative/regulatory requirements (Directive no. 86/609/EEC) in view of a marketing authorization. Sharing of animals in experiments between colleagues conducting research, either related but with different techniques or different but compatible. Drafting of an experimental protocol before any experiment, in the idea that a well-prepared study is highly likely to provide conclusive results and thus it will be unnecessary to verify through other tests on a new series of animals. Use of statistics in the drawing up of the experimental protocol for a preliminary estimation of the number of animals required for obtaining results that are statistically useable. Maximum exploitation of data obtained during an experiment. Use of homogeneous animals in terms of biological characters and, amongst other things, health status, so as to reduce the variability of individuals from each other as far as possible

FP7-ICT-2009-4

66

248782 SCATh

The design of the experimentation will consider Refinement alternatives focus on methods that alleviate or minimise pain, suffering and distress for the animals: Animals will undergo to controls on the care and accommodation and detailed guidelines will be drawn. Distress and unnecessary pain and suffering to the experimental animals will be avoided Not to use animals if alternatives are available Anesthesia will be used wherever possible and appropriate Advance notice will be given to the appropriate authority about the experiments or the persons conducting the experiments The people conducting the experiments and those caring for the animals will have appropriate training Establishments carrying out experiments and establishments breeding or supplying laboratory animals will be registered or approved by the appropriate authority A veterinarian or other competent person will advise on the well-being of laboratory animals Animals used will be specifically bred for use in experiments, with exceptions for the lesser-used species. Records will be kept of the animals used and this information will be collected and reported to the European commission at regular intervals 3Rs practical implementation: Replacement, in the development phase and first validation phase, phantom mimicking human arterial tree will be used, an example are the phantoms produces by Shelly Medical Technologies (www.simutec.com). Reduction, will be implemented the strategies developed by independent studies on 3Rs implementation. One example is the use of The strategic planning for research programmes an algorithm to optimize the experiments and thus reduce the animal number, this algorithm was refined by an independent association called Frame (www.frame.co.uk) Refinement, in practice the SCATh project is dealing with minimally invasive technologies, thus for the greater part of the experiments animals will be treated with minimally invasive procedures that intrinsically minimizes the pain for the animal. The researchers involved in the experiment will undergo to ethical courses on animal experiments. At the end of the experiment the animal will be terminated unless the non termination is well motivated. The researchers performing the animal experiments have acquired FELASA C status and are experienced in cardiovascular research in large animal models. This makes failure of the experiments less likely, and allows maximally reliable data acquisition.

FP7-ICT-2009-4

67

248782 SCATh

B.4.8.1 Experimental protocol

The following table reports the main decision that will be taken regarding the animal use in the experimental protocols. Species Pig or Sheep Number of animals used for each tested 6-8 modality Endpoints The animal will be maintained under anaesthesia for overall the experiment and at the end of the experiment terminated. Checked Alternatives Physical and virtual phantoms will be used when possible. Husbandry The animal will come from certified stabularies.
Table 23. Animal use

B.4.9 Relevant national and international regulations

The following national regulations are recognized to be relevant for the SCATh project: - Medical Devices Directive (Council Directive 93/42/EEC, 14.06.1993) regulating the procedure of clinical trials and the involvement of commissions for ethical issues. The details for and the necessity of involvement of commissions for ethical issues are organized by national regulations known to the consortium and will be observed by the researching project entities. Protection of personal data is regulated in the countries participating in user tests as follows: o AT: Datenschutzgesetz 2000 (DSG 2000), BGBl. I Nr. 165/1999 o BE: Wet tot bescherming van de persoonlijke levenssfeer ten opzicht van de ver-werking van persoonsgegevens (08/12/1992) Furthermore the codes of conduct of IEEE (relevant mainly for the hardware) and ACM (relevant mainly for the software) will be considered and observed.

The following EU regulations are recognized to be relevant for the SCATh project: - Directive 86/609/EEC - The scientific issues addressed by the proposed project conform with national and European legislation and regulations and comply with the Charter of Fundamental Rights (2000) in respect to the citizens dignity, freedom, equality, rights, and justice. - Universal Declaration on the Human Genome and Human Rights from 1999 - Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (Convention Nr. 108). - Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. - Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. FP7-ICT-2009-4 68

248782 SCATh

Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation laid down by law, regulation or administrative action relating to proprietary medicinal products. Helsinki Declaration in its latest version Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997.

B.4.10

Conflicts of Interests

SCAThs Project Management Board has the duty of avoiding circumstances or situation were an individual's primary responsibility of providing unbiased and impartial decisions, judgments, or opinions on the research results might be influenced by a secondary factor. At each Project Management Board meeting, the chair will request that all members disclose if they have any potential conflict of interest with items on the agenda. Those with a conflict of interest will not participate in the discussion or vote on the matter. It will usually be appropriate for the individual to leave the room during the discussion and the vote. The minutes will reflect the action taken. If involved in experimental sessions, each member will be requested to disclose if he/she has any potential conflict of interest with the experiments results. In case of conflict of interests that particular member will be excluded from the experiment execution and data analysis.

B.5

Gender issues

Prof. Jos Vander Sloten, coordinator of SCATh, is promotor of the "Female Engineer" project of the K.U.Leuven, which aims at the promotion of the engineering profession and the engineering education in a gender-neutral way. Also in SCATh an absolute equity between genders will be pursued. In addition, the classical gender issues will be carefully considered, such as encouraging female researchers to apply. It is taken for granted here that the subject of medical technology in general is particularly attractive for female students and researchers.

Appendix
References
C. Bafort, MD et al. "Predicting Spinal Cord Ischemia Before Endovascular Thoracoabdominal Aneurysm Repair: Monitoring Somatosensory Evoked Potentials J Endovasc Ther 2002; 9:289294. Barnes, S.Z.; Morr, D.R.; Oggero, E.; Pagnacco, G. and Berme, N., The realization of a haptic (force feedback) interface device for the purpose of angioplasty surgery simulation. Biomed Sci Instrum, 1997, 33, 19-24. M. Benjamin, J. Curcio, J. Leonard, and P. Newman, Navigation of unmanned marine vehicles in accordance with the rules of the road, in Proc 2006 IEEE Int Conf on Robotics and Automation, 2006. K.P. Berthold and B.G. Rhunck, Determining Optical Flow, Artificial Intelligence, 17 (198 I ) 18.5-203. FP7-ICT-2009-4 69

248782 SCATh

Bertocchi, U.; Ascari, L.; Stefanini, C.; Laschi, C. & Dario, P., Human-Robot Shared Control for RobotAssisted Endoscopy of the Spinal Cord, Proceedings of the Int. Conf. on Biomedical Robotics and Biomechatronics,2006, 543-48 M. Bock and F. K. Wacker, MR-guided intravascular interventions: Techniques and applications. J. Magn. Reson. Imaging, vol. 27(2), 2008, pp. 326-338. Buecker, A., Safety of MRI-guided vascular interventions, Minim Invasive Ther Allied Technol, 2006, 15, 65-70. Chiesa, R. et. al., Spinal cord ischemia after elective stent-graft repair of the thoracic aorta, Journal of Vascular Surgery,Volume 42, Issue 1, July 2005, Pages 11-17. Clijmans, T.; Mommaerts, M.; Gelaude, F.; Suetens, P. & Sloten, J. V., Skull reconstruction planning transfer to the operation room by thin metallic templates: clinical results., J Craniomaxillofac Surg, 2008, 36, 66-74. C. Cobelli, G. Nucci, S.D. Prato, A Physiological Simulation Model of the Glucose-Insulin System, Proceedings of the BMES/EMBS Conference, Antlanta, GA, 1999. Da, L.; Zhang, D. & Wang, T., Review Article: Overview of the vascular interventional robot The Int.l Journal of Medical Robotics and Computer Assisted Surgery, 2008, 4, 289 - 294 Davidson M.J., White J.K., Baim D.S., Percutaneous therapies for valvular heart disease, Cardiovascular pathology 15, 2006, pp. 123-129. A. J. Davison, I. D. Reid, N. D. Molton and O. Stasse, MonoSLAM: Real-Time Single Camera SLAM. IEEE Trans. Patt. Anal. Mach. Intell., 2007, vol. 29(6), pp. 10521067. Deccarett M, Segerson NM, Gunther J, et al. Blinded correlation study of three dimensional electroanatomical image integration and phased array intra-cardiac echocardiography for left atrial mapping. Europace 2007; 9:923M. de Bruijne, W.J. Niessen, J.B.A. Maintz, et al., Localization and segmentation of aortic endografts using marker detection, IEEE Transactions on Medical Imaging, 22(4):473-482, 2003. Endosense, Catheter Tip Force Required to Mechanically Perforate the Cardiac Free Wall, Heart Rhythm Society, May 2008, San Francisco, USA, Abstract 6127, PO1-68 Endosense, Novel Contact Force Sensor Incorporated in Irrigated Radiofrequency Ablation Catheter Predicts Lesion Size and Incidence of Steam Pop and Thrombus Circulation, Arrhythmia and Electrophysiology, 2008, 10.1161/CIRCEP.108.807925 Famaey N, Vander Sloten J, Soft tissue modelling for applications in virtual surgery and surgical robotics, Comput Methods Biomech Biomed Engin. (2008); 11: 351-366. T.S. Fhamy, H. Mlcochova, O.M. Wazni, et al., Intracardiac echo-guided image integration: optimizing strategies for registration. J Cardiovasc Electrophysiol. 2007; 18:276-82. D.A. Fullerton, et al., Mixed Venous Oxygen Saturation in the diagnosis of Cardiac Tamponade, J CARD SURG., 2008;23:163-181 H. Furtado, B. Gersak , E. Samset, M. Sette, N. Famaey, T. Studeli US Provisional Patent Appl. No. 61/059,149 Automatic Endoclamp balloon positioning system Gangi A, Dietemann JL, Gasser B, Mortazavi R, Brunner P, Mourou MY, Dosch JC, Durckel J, Marescaux J & Roy C (1997a) Interstitial laser photocoagulation of osteoid osteomas with use of CT guidance. Radiology 203(3): 843-8. FP7-ICT-2009-4 70

248782 SCATh

T. C. Gasser, R. W. Ogden, and G. A. Holzapfel, Hyperelastic modelling of arterial layers with distributed collagen fibre orientations. J. R. Soc. Interface, 3:1535, 2006. G. P. Gravlee, R. F. Davis, A. H. Stammers, R. M. Ungerleider, Cardiopulmonary bypass: principles and practices, Published by Lippincott Williams & Wilkins, 2007, Edition: 3. Grundfest, W. S.; Val-Mejias, J.; Monnet, E.; Knight, B. P.; Nazarian, S.; Berger, R. D.; Ferguson, T. B.; Roden, M. M.; Amundson, D.; Hanlin, J. & Blankenship, L., Real-time percutaneous optical imaging of anatomical structures in the heart through blood using a catheter-based infrared imaging system. Semin Thorac Cardiovasc Surg, 2007, 19, 336-341. Gobbetti, E.; Tuveri, M.; Zanetti, G. and Zorcolo, A., Catheter insertion simulation with co-registered direct volume rendering and haptic feedback. Stud Health Technol Inform, 2000, 70, 96-98 Haegeli, E. Kotschet, J. Byrne, D. C. Adam, P. G. Novak et al. Cardiac injury after percutaneous catheter ablation for atrial fibrillation Europace Advance Access (2008) Hall E. J., Brenner D. J., Cancer risks from diagnostic radiology, Br. J. Radiol., May 1, 2008; 81(965): 362 378. G.A. Holzapfel, T.C. Gasser and R.W. Ogden, A new constitutive framework for arterial wall mechanics and a comparative study of material models. Journal of Elasticity, 61 (2000) 1-48 (IF: 0.743). G.A. Holzapfel, M. Stadler and C.A.J. Schulze-Bauer, A layer-specific 3D model for the finite element simulation of balloon angioplasty using MR imaging and mechanical testing. Annals of Biomedical Engineering, 30 (2002) 753-767 (IF: 2.346). G.A. Holzapfel, G. Sommer, C.T. Gasser and P. Regitnig, Determination of the layer-specific mechanical properties of human coronary arteries with non-atherosclerotic intimal thickening, and related constitutive modeling. American J. Physiology - Heart Circulation Physiology, 289 (2005) H2048-2058 (IF: 3.973). G.A. Holzapfel, M. Stadler and T. C. Gasser, Changes in the Mechanical Environment of Stenotic Arteries During Interaction With Stents: Computational Assessment of Parametric Stent Designs. ASME Journal of Biomechanical Engineering, Vol. 127, Feb 2005, pp. 166-180. G.A. Holzapfel: Collagen in Arterial Walls: Biomechanical Aspects. In: P. Fratzl (ed.), Collagen. Structure and Mechanics, Chapter 11, Springer-Verlag, Heidelberg, (2008), 285-324. Y. Honda and P.J. Fitzgerald, Frontiers in Intravascular Imaging Technologies, Circulation 2008, Issue 117, Pages 2024-2037. J.B. Hummel, et. al., Design and application of an assessment protocol for electromagnetic tracking systems, Med. Phys. 32(7), July 2005. J. Hung et al., 3D Echocardiography: A Review of the Current Status and Future Directions, Journal of the American Society of Echocardiography, 2007, Volume 20, Number 3, Pages 213-233. International Commission on Radiological Protection Avoidance of radiation injuries from medical interventional procedures. ICRP Publication 85. Ann ICRP (2000) 30:7--67
L.M.

FP7-ICT-2009-4

71

248782 SCATh

Iung et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease, European Heart Journal 2003 24, 12311243 Jacquier, A.; Higgins, C. B. & Saeed, M., MR imaging in assessing cardiovascular interventions and myocardial injury, Contrast Media Mol Imaging, 2007, 2, 1-15 Jayender, J.; Azizian, M. and Patel, R.V. Bilateral Telemanipulation of a Flexible Catheter in a Constrained Environment Proceedings of the IEEE Int. Conf. on Robotics and Automation, 2008, 649-654 Jayender, J.; Azizian, M. and Patel, R.V. Autonomous Image-Guided Robot-Assisted Active Catheter Insertion IEEE Transactions on Robotics, 2008, 24, 858-871 Jayender, J. and Patel, R. Wave variables based bilateral teleoperation of an active Proceedings of the Int. Conf. on Biomedical Robotics and Biomechatronics, 2008, 27-32

catheter

M. John, N. Rahn, Automatic left atrium segmentation by cutting the blood pool at narrowings, In: Duncan, J.S., Gerig, G. (eds.) MICCAI 2005. LNCS, vol. 3750, pp. 798805. Springer, Heidelberg (2005). Kanagaratnam, P.; Koa-Wing, M.; Wallace, D.; Goldenberg,A.; Peters, N. and Davies, D. Experience of robotic catheter ablation in humans using a novel remotely steerable catheter sheath. J. Interv Card Electrophysiol, 2008, 21, 19-26 R. Karim, R. Mohiaddin, D. Rueckert, Left atrium segmentation for atrial fibrillation ablation, Proc. SPIE Med. Imag., vol.6918 , pp. 69182U-69182U-8 (2008). P.J. Kilner, G.-Z. Yang, R.H. Mohiaddin, D.N. Firmin, M. Yacoub, Asymetric redirection of flow through the heart Nature, Apr 2000, vol. 13, pp. 759-61. D.E. Kiousis, T.C. Gasser and G.A. Holzapfel, Smooth contact strategies with emphasis on the modeling of balloon angioplasty with stenting. International Journal for Numerical Methods in Engineering, 75 (2008) 826-855 (IF: 1.612). D.E. Kiousis, S.F. Rubinigg, M. Auer and G.A. Holzapfel, A Methodology to Analyze Changes in Lipid Core and Calcification onto Fibrous Cap Vulnerability: The Human Atherosclerotic Carotid Bifurcation as an Illustratory Example. ASME Journal of Biomechanical Engineering, in press18. S. Knecht, I. Nault, M. Wright, P. Jas et al. Imaging in catheter ablation for atrial fibrillation: enhancing the clinician's view Europace 2008 10(Supplement 3):iii2-iii7 T. Kono, et al., Cardiac Rupture After Catheter Ablation Procedure, Ann Thorac Surg, 2005;80:3268. T. Kovacs, P. Cattin, H. Alkadhi, S. Wildermuth, and G. Szkely, Automatic Segmentation of the Aortic Dissection Membrane from 3D CTA Images, Medical Imaging and Augmented Reality (MIAR), 2006.

18

Available at: http://www.biomech.tugraz.at/publications under In Press. 72

FP7-ICT-2009-4

248782 SCATh

T. Kubo et al., Assessment of Culprit Lesion Morphology in Acute Myocardial Infarction: Ability of Optical Coherence Tomography Compared With Intravascular Ultrasound and Coronary Angioscopy, Journal of the American College of Cardiology,Volume 50, Issue 10, 4 September 2007, Pages 933-939. Lamata P., Jalote-Parmar A., Lamata F. and Declerck J. The Resection Map, a proposal for intraoperative hepatectomy guidance. International Journal of Computer Assisted Radiology and Surgery, (2008) 3(3-4), pp. 299306 J. Langelaan and S. Rock, Passive GPS-free navigation for small UAVs, in IEEE Aerospace Conference, 2005, pp. 19. E. Larose et al., Characterization of Human Atherosclerotic Plaques by Intravascular Magnetic Resonance Imaging, Circulation 2005, Issue 112, Pages 2324-2331. Laufer U, Kirchner J, Kickuth R, Adams S, Jendreck M & Liermann D (2001) A comparative study of CT fluoroscopy combined with fluoroscopy versus fluoroscopy alone for percutaneous transhepatic biliary drainage. Cardiovasc Intervent Radiol 24(4): 240-4. N. Lee, H. Tek, A. F. Laine, True-False Lumen Segmentation of Aortic Dissection using Multi-Scale Wavelet Analysis and Generative-Discriminative Model Matching, Proceedings of the SPIE, Medical Imaging, Vol. 6915, pp. 69152V-69152V-11, 2008 M. Lerotic, A. J. Chung, G. P. Mylonas and G.-Z. Yang, pq-space Based Non-Photorealistic Rendering for Augmented Reality MICCAI, vol. 2, 2007, pp. 102-109. The Lewin Group, 1999: Outlook for Medical Technology Innovation: Will Patients Get the Care They Need? The Health Industry Manufacturer Association. Ma, X. Latest Development of an Interventional Radiology Training Simulation System: NeuroCath, Digital Human Modeling 2007, 4561, 684-693 Marcelli, E.; Cercenelli, L. and Plicchi, G., A novel telerobotic system to remotely navigate standard electrophysiology catheters, Computers in Cardiology, 2008, 137-140 . R. McKendrick, C.Y. Owada, Real-time 3D echocardiography-guided transcatheter device closure of atrial septal defects, Catheterization and Cardiovascular Interventions, 2005, Volume 65, Issue 3, Pages 442-446. Medtech, Endovascular Thoracic Aortic Aneurysm Repair Device Market Technology Update & Market Forecast, Medtech Reports 2009. Meier U, Lopez O, Monserrat C, Juan MC, Alcaniz M. 2005. Real-time deformable models for surgery simulation: A survey. Comput Methods Program Biomed. 77(3):183197. C. Meyer, R. Manzke, J. Peters, O. Ecabert, R. Kneser, V.Y. Reddy, R.C. Chan, J. Weese, Automatic intraoperative generation of geometric left atrium/pulmonary vein models from rotational X-ray angiography, Proc. 11th MICCAI, LNCS, vol.5242(Pt 2):61-9 (2008). Mirabel M, Iung B, Baron G, et al., Eur Heart J, 2007;28(11): 135865. P. Mountney, D. Stoyanov, A. Davison, G.-Z. Yang, Simultaneous Stereoscope Localization and SoftTissue Mapping for Minimal Invasive Surgery International Conference on Medical Image Computing and Computer Assisted Interventions. vol. 1, 2006, pp. 347-354. FP7-ICT-2009-4 73

248782 SCATh

P. Mountney, D. Stoyanov, A. Davison, G.-Z. Yang, Simultaneous Stereoscope Localization and SoftTissue Mapping for Minimal Invasive Surgery, vol. 1, 2006, pp. 347-354 Mut, V.; Prostigo, J.; Slawinski, E. and Kuchen, B., Bilateral Teleoperation of mobile robots Robotica, 2002, 20, 213-212. J. Neira J, A. Davison A and J. J. Leonard JJ, Guest Editorial Special Issue on Visual SLAM. IEEE Trans. Robotics, vol. 24(5), 2008, pp. 929-931. P. Newman, Editorial for Journal of Field Robotics Special Issue on SLAM in the Field. Journal Field Robotics, vol. 24(1), 2007, pp. 1-2. J. Nieto, J. Guivant, and E. Nebot, DenseSLAM: Simultaneous localization and dense mapping, International Journal of Robotics Research, vol. 25(4), 2006, pp. 711-744 D. Nistr, Automatic dense reconstruction from uncalibrated video sequences. PhD Thesis, Royal Institute of Technology KTH, Stockholm, Sweden, ISBN 91-7283-053-0, March 2001. Nkomo VT, Gardin JM, Skelton TN, et al., Lancet, 2006;368(9540):100511. D. Noonan D, G. Mylonas, A. Darzi, G.-Z. Yang, Gaze Contingent Articulated Robot Control for Robot Assisted Minimally Invasive Surgery IEEE/RSJ International Conference on Intelligent Robots and Systems, 2008, pp. 1186-1191. G. Nollo, A. Cristoforetti, L. Faes, et al., Registration and fusion of segmented left atrium CT images with CARTO electrical maps for the ablative treatment of atrial fibrillation, Computers in Cardiology, 345 348 (2004). E. Onorato, F. Casilli, M. Zanchetta, Intracardiac echocardiography by Ultra ICE, Percutaneous Interventions for Congenital Heart Disease, CRC Press 2007, Pages 49-60. Pappone, C.; Vicedomini, G.; Manguso, F.; Gugliotta, F.; Mazzone, P. et al. Robotic magnetic navigation for atrial fibrillation ablation. J Am Coll Cardiol, 2006, 47, 1390-1400 C. Pappone, G. Oreto, S. Rosanio, et al., Atrial electroanatomic remodeling after circumferential radiofrequency pulmonary vein ablation: efficacy of an anatomic approach in a large cohort of patients with atrial fibrillation. Circulation, 104, 25392544 (2001). Parodi JC, Palmaz JC,Barone HD, Transfemoral intralumial graft implantation for abdominal aortic aneurysms, Annals of Vascular Surgery,1991, 5:491-499. Pfirrmann CW, Oberholzer PA, Zanetti M, Boos N, Trudell DJ, Resnick D & Hodler J (2001) Selective nerve root blocks for the treatment of sciatica: evaluation of injection site and effectiveness--a study with patients and cadavers. Radiology 221(3): 704-11. Reitmayr G. and Schmalstieg D. An Open software Architecture for Virtual Reality Interaction. Proc. of the ACM symposium on Virtual Reality software and technology. 2001; 4754. J.F. Ren, F.E. Marchlinski, D.J. Callans, H.C. Herrmann, Clinical use of AcuNav diagnostic ultrasound catheter imaging during left heart radiofrequency ablation and transcatheter closure procedures, Journal of the American Society of Echocardiography, 2002, Volume 15, Issue 10, Pages 1301-1308.

FP7-ICT-2009-4

74

248782 SCATh

K. S. Rhode, M. Sermesant, D. Brogan, S. Hegde, J. Hipwell, P. Lambiase, E. Rosenthal, C. Bucknall, S. A. Qureshi, J. S. Gill, R. Razavi, D. L. G. Hill, A system for real-time XMR guided cardiovascular intervention. IEEE Trans. Med. Imaging, vol. 24(11), 2005, pp. 1428-1440. Romano, J.; Webster, R. and Okamura, A. Teleoperation of Steerable Needles Proceedings of the IEEE Int. Conf. on Robotics and Automation 2007, 934-939 Saborowski O., Saeed M., An overview on the advances in cardiovascular interventional MR imaging, Magn. Reson. Mater. Phy, vol 20, pp. 117-127 (2007). Saliba, W.; Ernst, S.; Reddy, V. and Kuck, K., Remote Catheter Navigation Contemporary Cardiology: Atrial Fibrillation 2008, 385-396 Saliba, W.; Reddy, V.Y.; Wazni, O.; Cummings, J.E.; Natale, A. et al. Atrial fibrillation ablation using a robotic catheter remote control system J Am Coll Cardiol, 2008, 51, 2407-2411 Schmalstieg D., Fuhrmann A., Hesina G., Szalavri Z., En carnacao L. M., Gervaultz M., and Purgathofer W., The Studierstube Augmented Reality Project Teleoper. Virtual Environ. 2002; 11(1):3354. Seibel RM, Melzer A, Schmidt A & Plabetamann J (1997) Computed Tomography- and Magnetic Resonance Imaging: Guided Microtherapy. Semin Laparosc Surg 4(2): 61-73. G. Sommer, T.C. Gasser, P. Regitnig, M. Auer and G.A. Holzapfel, Dissection properties of the human aortic media: an experimental study. ASME Journal of Biomechanical Engineering, 130 (2008) 0210071-021007-12 (IF: 1.591). Stoll J., Passive markers for ultrasound tracking of surgical instruments, Int Conf Med Image Comput Comput Assist Interv. 2005;8(Pt 2):41-8. D. Stoyanov, A. Darzi and G.-Z. Yang, A Practical Approach Towards Accurate Dense 3D Depth Recovery for Robotic Laparoscopic Surgery Computer Aided Surgery,vol.10, no.4, pp.199-208, 2005. M. Subasic, S. Loncaric, E. Sorantin, Model-based quantitative AAA image analysis using a priori knowledge, Computer Methods and Programs in Biomedicine, 80(2):103-114, 2005. Shope TB. Radiation-induced skin injuries from fluoroscopy, Radiographics 1996;16:11959. A. Thiagalingam, R. Manzke, A. DAvila, et al., Intraprocedural volume imaging of the left atrium and pulmonary veins with rotational X-ray angiography: implications for catheter ablation of atrial fibrillation, J. Cardiovasc. Electrophysiol. 19, 293300 (2008). Tsapaki et al., Level of patient and operator dose in the largest cardiac centre in Greece, Radiat Prot Dosimetry,2008; 129: 71-73 A. Vahanian, O.R. Alfieri, N. Al-Attar, M.J. Antunes, J. Bax, B. Cormier, et al., Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg., 2008 Jul;34(1):1-8. FP7-ICT-2009-4 75

248782 SCATh

A. Vahanian, MD, Bichat University Hospital, Paris; from a presentation given at Edwards Lifesciences 2008 Investor Conference, December 2008. J.A. van Herwaarden, L.W. Bartels, B.E. Muhs, et al., Dynamic magnetic resonance angiography of the aneurysm neck: Conformational changes during the cardiac cycle with possible consequences for endograft sizing and future design. Journal of Vascular Surgery, 44(1):22-28, 2006. J. van Prehn, K.L. Vincken, S.M. Sprinkhuizen, M.A. Viergever MA, J.W. van Keulen, J.A. van Herwaarden, F.L. Moll; L.W. Bartels, Aortic pulsatile distention in young healthy volunteers is asymmetric: analysis with ECG-gated MRI, Eur J. Vasc Endovasc Surg. 37(2):168-74. 2009. Villagran, C.R.T.; Ikeda, S.; Fukuda, T.; Sekiyama, K.; Okada, Y.; Uchiyama, T. et al. Catheter insertion path reconstruction with autonomous system for endovascular surgery Proceedings of the IEEE Int. Symp. on Computational Intelligence in Robotics and Automation 2007, 398403 J. von Berg, C. Lorenz, Accurate left atrium segmentation in multislice CT images using a shape model, Proc. SPIE Med. Imag., vol. 5747, pp. 351360 (2005). T. Walther, M.W. Chu, F.W. Mohr, Transcatheter aortic valve implantation: time to expand?, Current opinion in cardiology, 2008 Mar;23(2):111-6. T. Walther, V. Falk, J. Kempfert, M.A. Borger, J. Fassl, M.W. Chu, et al., Transapical minimally invasive aortic valve implantation; the initial 50 patients, Eur J Cardiothorac Surg, 2008 Jun;33(6):983-8. S. Wangsiripitak S and D. W. Murray, Avoiding moving outliers in visual SLAM by tracking moving objects. (To be presented) Proc IEEE Int Conf on Robotics and Automation, Kobe, May 2009. R.L. Wilensky and J. Schneiderman, Intravascular MRI for the Evaluation of Lipid-Rich Vulnerable Plaques in Coronary and Peripheral Vessels, Vascular Disease Management, Volume 4 (2007), Issue 5. Worthley et al., A Novel Nonobstructive Intravascular MRI Coil: In Vivo Imaging of Experimental Atherosclerosis, Arteriosclerosis, Thrombosis, and Vascular Biology. 2003, Issue 23, Page 346. K. Yokoyama, Novel Contact Force Sensor Incorporated in Irrigated Radiofrequency Ablation Catheter Predicts Lesion Size and Incidence of Steam Pop and Thrombus, Circulation: Arrhythmia and Electrophysiology, (2008), 1:354-362 S.H. Yun et al., Comprehensive volumetric optical microscopy in vivo, Nature Medicine - 12, 2006, Pages 1429 1433. H. Zhong, J.M. Lacomis, D. Schwartzman, On the accuracy of CartoMerge for guiding posterior left atrial ablation in man. Heart Rhythm 2007; 4:595-602.

FP7-ICT-2009-4

76

248782 SCATh

Ethical committee approval for biological sample collection

FP7-ICT-2009-4

77

248782 SCATh

FP7-ICT-2009-4

78

248782 SCATh

FP7-ICT-2009-4

79

248782 SCATh

FP7-ICT-2009-4

80