Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table.

Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care.

An image fusion tool for echo-guided left ventricular lead placement in cardiac resynchronization therapy: Performance and workflow integration analysis.

BACKGROUND: The response rate to cardiac resynchronization therapy (CRT) may be improved if echocardiographic-derived parameters are used to guide the left ventricular (LV) lead deployment. Tools to visually integrate deformation imaging and fluoroscopy to take advantage of the combined information are lacking. METHODS: An image fusion tool for echo-guided LV lead placement in CRT was developed. A personalized average 3D cardiac model aided visualization of patient-specific LV function in fluoroscopy. A set of coronary venography-derived landmarks facilitated registration of the 3D model with fluoroscopy into a single multimodality image. The fusion was both performed and analyzed retrospectively in 30 cases. Baseline time-to-peak values from echocardiography speckle-tracking radial strain traces were color-coded onto the fused LV. LV segments with suspected scar tissue were excluded by cardiac magnetic resonance imaging. The postoperative augmented image was used to investigate: (a) registration accuracy and (b) agreement between LV pacing lead location, echo-defined target segments, and CRT response. RESULTS: Registration time (264 ± 25 seconds) and accuracy (4.3 ± 2.3 mm) were found clinically acceptable. A good agreement between pacing location and echo-suggested segments was found in 20 (out of 21) CRT responders. Perioperative integration of the proposed workflow was successfully tested in 2 patients. No additional radiation, compared with the existing workflow, was required. CONCLUSIONS: The fusion tool facilitates understanding of the spatial relationship between the coronary veins and the LV function and may help targeted LV lead delivery.

Temperature monitoring by channel data delays: Feasibility based on estimated delays magnitude for cardiac ablation.

Ultrasound thermometry is based on measuring tissue temperature by its impact on ultrasound wave propagation. This study focuses on the use of transducer array channel data (not beamformed) and examines how a layer of increased velocity (heat induced) affects the travel-times of the ultrasound backscatter signal. Based on geometric considerations, a new equation was derived for the change in time delay as a function of temperature change. The resulting expression provides insight into the key factors that link change in temperature to change in travel time. It shows that velocity enters in combination with heating geometry: complementary information is needed to compute velocity from the changes in travel time. Using the bio-heat equation as a second source of information in the derived expressions, the feasibility of monitoring the temperature increase during cardiac ablation therapy using channel data was investigated. For an intra-cardiac (ICE) probe, using this "time delay error approach" would not be feasible, while for a trans-esophageal array transducer (TEE) transducer it might be feasible.

A non-parametric permutation method for assessing agreement for distance matrix observations.

Distance matrix data are occurring ever more frequently in medical research, particularly in fields such as genetics, DNA research, and image analysis. We propose a non-parametric permutation method for assessing agreement when the data under study are distance matrices. We apply agglomerative hierarchical clustering and accompanying dendrograms to visualize the internal structure of the matrix observations. The accompanying test is based on random permutations of the elements within individual matrix observations and the corresponding matrix mean of these permutations. We compare the within-matrix element sum of squares (WMESS) for the observed mean against the WMESS for the permutation means. The methodology is exemplified using simulations and real data from magnetic resonance imaging.

A motion constrained cross-wire phantom for tracked 2D ultrasound calibration.

PURPOSE: Ultrasound-guided 3D interventions require calibration to relate real-time 2D images with the position and orientation of the ultrasound probe. Capturing several images of a single fixed point from different viewpoints is a simple and commonly used approach, but it is cumbersome and tedious. A new phantom for calibration was designed, built and tested to simplify this process. METHODS: A mechanical phantom that restricts the motion of the ultrasound probe was designed such that the ultrasound image always captures a designated fixed point. Software was implemented which computes calibration parameters. Although the software provides no scientific novelty, it is required to demonstrate the proof of concept and to assess the accuracy and precision of the calibration phantom. The software also illustrates how the phantom enables the fixed point to be located automatically, both in tracker device coordinates and in image pixel coordinates. RESULTS: The phantom was used to capture several hundred images of a single fixed point in less than 1 min, with different probe positions and orientations around the fixed point and with the single fixed point located in different parts of the ultrasound image. It would not be feasible to capture the same number of images by manual alignment of the probe with the fixed point. CONCLUSION: Images for single fixed point calibration can be captured easily and quickly with a new calibration phantom. Since a larger number of images can be used to compute the required parameters, the calibration robustness is increased.

Collaborative co-design of emerging multi-technologies for surgery.

The EU Research Training Network on Augmented Reality in Surgery (ARIS*ER) was established with two aims: (1) to develop next-generation novel image guidance (augmented reality based on medical images) and cross-linked robotic systems (automatic control loops guided by information sensed from the patient) and (2) to educate young researchers in the user-centred, multidisciplinary design of emerging technologies for minimally invasive surgery (MIS) and intervention radiology. Collaborations between engineers, Human Factors specialists, industrial designers and medical end users were foreseen, but actual methodologies had to be developed. Three applications were used as development vehicles and as demonstrators. The resulting teamwork and process of identifying requirements, finding solutions (in technology and workflow), and shifting between these to optimize and speed development towards quality of care were studied. The ARIS*ER approach solves current problems in collaborative teams, taking a systems approach, and manages the overview of requirements and solutions, which is too complex to manage centrally.

Endoclamp balloon visualization and automatic placement system.

OBJECTIVES: Aortic occlusion is one of the most important open discussions in minimally invasive cardiac surgery. Different techniques can be employed, and all have benefits and drawbacks. The objective of our work is to improve the safety of internal aortic occlusion with the Port Access technique, which employs an endoclamp balloon catheter. We propose a combined information and positioning system based on augmented reality technology and robotics in which the position of the balloon can be seen at all times and can be automatically controlled by a robotic actuator. METHODS: The system was designed by a multidisciplinary team of engineers, medical doctors, and human factor specialists in a human-centered design approach. We measure the balloon position in real time with a magnetic tracking system. This position is superimposed on a 3-dimensional scan of the patient's thorax, with the balloon in the artery shown at all times. The position measurement is also used to control the robotic catheter inserter that places and maintains the balloon position at a specified target. The system was evaluated in 2 user studies that compared it with other visual aids. RESULTS: The user tests have shown that the system effectively supports the surgeon in the placement task, with an increase in placement accuracy and a reduction in time compared with the current visualization technique. The users also rated the system as supporting them well. CONCLUSIONS: The clinical feasibility of the system was proved. The system provides better visualization and position control and can effectively increase the safety of the procedure. This system has the potential of making Port Access a more attractive technique.

Cognitive processes as integrative component for developing expert decision-making systems: a workflow centered framework.

The development of expert decision-making systems, which improve task performance and reduce errors within an intra-operative clinical workspace, is critically dependent on two main aspects: (a) Analyzing the clinical requirements and cognitive processes within the workflow and (b) providing an optimal context for accurate situation awareness through effective intra-operative information visualization. This paper presents a workflow centered framework and its theoretical underpinnings to design expert decision-making systems. The framework integrates knowledge of the clinical workflow based on the requirements within the clinical workspace. Furthermore, it builds upon and integrates the theory of situation awareness into system design to improve decision-making. As an application example, this framework has been used to design an intra-operative visualization system (IVS), which provides image guidance to the clinicians to perform minimally invasive procedure. An evaluative study, comparing the traditional ultrasound guided procedure with the new developed IVS, has been conducted with expert intervention radiologists and medical students. The results reveal significant evidence for improved decision-making when using the IVS. Therefore, it can be stated that this study demonstrates the benefits of integrating knowledge of cognitive processes into system development to support clinical decision-making and hence improvement of task performance and prevention of errors.

Haptic guided 3-D deformable image registration.

PURPOSE: We present a system which supports deformable image registration guided by a haptic device. METHODS: The haptic device is tied to a block matching method where a set of uniformly distributed control points determine the block positions. Each control point constitutes a particle in a mass spring grid which limits the space of allowed movements to elastic movements. Control points are manipulated by the haptic device, and the negative gradient of the similarity metric over the corresponding block is rendered as a force on the haptic device guiding the user to a minimum of the optimization landscape. Fast update of forces was achieved by exploiting the GPU for computations of the similarity metric and for interpolation of the deformation field. RESULTS: We show that haptic guided registration facilitates faster and improved registration compared to using a purely visual alignment in a user study on synthetic images. We also demonstrate feasibility of applying the system on medical images through a comparison with an automatic block matching algorithm. A radiologist performing registration with the haptic registration system posted faster registration times and better registration results than the automatic block matching algorithm when using identical grid and block sizes. CONCLUSIONS: Possible applications of the system are refinement of registration results from automatic registration methods and construction of initial state used in automatic deformable registration methods.

Evaluation of bivariate correlation ratio similarity metric for rigid registration of US/MR images of the liver.

OBJECTIVE: Radio frequency ablation (RFA) can be used to treat liver cancer minimally invasively by depositing energy from the RF probe placed in the center of the tumor. The procedure relies on pre-operative imaging (typically MRI or CT) for the interventional planning and ultrasound (US) for intra-operative guidance during needle insertion. Visual presentation of co-registered pre- and intra-operative images would help to improve the navigation during the needle positioning phase. METHODS: In the present study, we compared six registration methods using different similarity metrics: two versions of the correlation ratio, bivariate correlation ratio, and conventional normalized mutual information and correlation coefficient. The accuracy, robustness and speed were assessed by computing rigid registrations between eight pairs of the MR and freehand 3D US datasets. RESULTS: The correlation ratio computed on the MR-gradient-norm and US images outperformed other similarity metrics in terms of robustness (40-82%) and demonstrated average accuracy (0.32 degrees , 0.69 mm) which is clinically acceptable for the RFA of liver cancer. CONCLUSIONS: We observed that the performance of all similarity metrics is largely dependent on the quality of the US images, sufficient field of view of the reconstructed 3D US and absence of motion artifacts.

Collision detection and untangling for surgical robotic manipulators.

BACKGROUND: Robotic-assisted minimally invasive surgery provides several advantages over traditional surgery; however, it also has several drawbacks, such as possible collisions between the robotic arms and a limited field of view. METHODS: A generic method for tracking the configuration of a surgical manipulator in real time is presented. It is coupled with a collision detection and dynamic simulation algorithm, allowing the operator to detect collisions between robotic arms before they happen and presenting the best possible untangling direction to get out of collisions. RESULTS: Our algorithm successfully tracks the configuration of the Zeus surgical system and accurately detects possible collisions in real time. A pilot study on our system proved its efficiency in reducing the duration and severity of collisions, at the price of longer completion times. CONCLUSION: Our system helps alleviate the collision problem by reducing the time in collision.

A novel method for registration of US/MR of the liver based on the analysis of US dynamics.

Radiofrequency ablation of liver cancer is a minimally invasive alternative to open surgery. Typically, the preoperative planning is done on an MR (or CT) scan, while the intervention relies on ultrasound (US) guidance. Registration of intra-operative US and preoperative MR (or CT) would assist navigation and increase the confidence of RFA needle positioning. In this paper we present a novel method for registration of US and MR images of the liver. Hepatic vessels are extracted from 2D US by an algorithm that models US dynamics. It generates 2D probability maps representing hepatic vessels which are then combined into probability volumes. A multi-resolution registration framework performs registration of the pre-processed MR with two 3D vessel probability images. The accuracy, robustness and speed of the method were assessed by registering eight US/MR datasets. High robustness (86%) and reasonable accuracy (1.98 degrees, 4.10 mm), acceptable for the RFA clinical application, suggest that the method has a good potential for intra-operative use.

Intraoperative navigation of an optically tracked surgical robot.

This paper presents an adaptive control scheme for improving the performance of a surgical robot when it executes tasks autonomously. A commercial tracking system is used to correlate the robot with the preoperative plan as well as to correct the position of the robot when errors between the real and planned positions are detected. Due to the noisy signals provided by the tracking system, a Kalman filter is proposed to smooth the variations and to increase the stability of the system. The efficiency of the approach has been validated using rigid and flexible endoscopic tools, obtaining in both cases that the target points can be reached with an error less than 1mm. These results make the approach suitable for a range of abdominal procedures, such as autonomous repositioning of endoscopic tools or probes for percutaneous procedures.

Towards scarless surgery: an endoscopic ultrasound navigation system for transgastric access procedures.

OBJECTIVE: Scarless surgery is an innovative and promising technique that may herald a new era in surgical procedures. We have created a navigation system, named IRGUS, for endoscopic and transgastric access interventions and have validated it in in vivo pilot studies. Our hypothesis is that endoscopic ultrasound procedures will be performed more easily and efficiently if the operator is provided with approximately registered 3D and 2D processed CT images in real time that correspond to the probe position and ultrasound image. MATERIALS AND METHODS: The system provides augmented visual feedback and additional contextual information to assist the operator. It establishes correspondence between the real-time endoscopic ultrasound image and a preoperative CT volume registered using electromagnetic tracking of the endoscopic ultrasound probe position. Based on this positional information, the CT volume is reformatted in approximately the same coordinate frame as the ultrasound image and displayed to the operator. RESULTS: The system reduces the mental burden of probe navigation and enhances the operator's ability to interpret the ultrasound image. Using an initial rigid body registration, we measured the mis-registration error between the ultrasound image and the reformatted CT plane to be less than 5 mm, which is sufficient to enable the performance of novice users of endoscopic systems to approach that of expert users. CONCLUSIONS: Our analysis shows that real-time display of data using rigid registration is sufficiently accurate to assist surgeons in performing endoscopic abdominal procedures. By using preoperative data to provide context and support for image interpretation and real-time imaging for targeting, it appears probable that both preoperative and intraoperative data may be used to improve operator performance.

EUS with CT improves efficiency and structure identification over conventional EUS.

BACKGROUND: EUS is complicated because of the subtleties of US interpretation, small fields of observation, and uncertainty of probe position and orientation. OBJECTIVE: Improved EUS performance is sought by providing contextual information to support US probe positioning and identification of features in US images. Our aims were to demonstrate the feasibility of the image registered gastroscopic US (IRGUS) system in a porcine model and to compare the effectiveness and the efficiency of IRGUS with traditional EUS. DESIGN: Animal feasibility study. INTERVENTIONS: The IRGUS system uses preprocedure CT and miniature US probe trackers to create real-time synthetic displays of the position of the probe tip and a matched slice of CT data for comparison with the US image. Participants used EUS and IRGUS systems in a porcine model to evaluate the speed and accuracy of structure identification. MAIN OUTCOME MEASUREMENTS: The performance and utility of IRGUS were determined by the number of correctly identified structures in a timed trial, kinematic variables, and a structured survey. RESULTS: IRGUS was twice as effective as EUS in localizing and identifying individual structures. In timed trials, IRGUS users identified over 25% more structures than EUS users. Improvement in examination efficiency and accuracy of feature identification was statistically significant, and 90% of the users preferred IRGUS to EUS for these tasks. CONCLUSIONS: IRGUS appears feasible and may be superior to conventional EUS in efficiency and accuracy of probe positioning and in image interpretation. IRGUS has the potential to shorten the EUS learning curve and to broaden the adoption of EUS techniques by gastroenterologists.

Device connectivity for image-guided medical applications.

The integration of medical devices with software applications is crucial for image-guided medical applications. This work describes a general device interface that has been designed for high-frequency streaming of multi-modal events, thus providing maximum performance and flexibility for such applications. Several sample applications and performance tests are provided to demonstrate the usability of the concept.

Temperature mapping of thermal ablation using MRI.

MRI is a unique tool for minimally invasive thermal ablation in that it can provide both targeting, monitoring and control during the procedure. Monitoring is achieved by using MRI temperature mapping. In this review the relevant physics is explained as a background to the state-of-the-art methods for computing temperature maps as well as the more cutting edge methods. The review covers both methods to monitor heating and cooling of tissue and explains temperature mapping using Proton Resonance Frequency shift, T1 mapping, diffusion mapping, R2* mapping and thermal models.

Wireless continuous arterial blood pressure monitoring during surgery: a pilot study.

Patient monitoring devices supporting wireless transmission can facilitate transport and ambulation of patients in hospitals. To replace wired sensors with wireless sensors, the accuracy and resistance to interference of the wireless sensors have to be documented. We compared the performance of a wireless arterial blood pressure biomedical sensor prototype with standard wired sensors in a clinical setting. Four patients undergoing laparoscopic abdominal surgery were recruited for testing of the device. Lines to a wireless arterial blood pressure sensor and standard wired sensor were connected to the same arterial cannula inserted in the right radial artery. Data from both systems were logged for postprocedure statistical comparison. During the procedure, 13 other electric devices were used, either continuously or intermittently. A sample-by-sample comparison was performed for both wired and wireless data. Statistical tests showed mean difference of 0.71, standard deviation of 0.14, and confidence interval of -1.28 to 1.56), indicating no significant electromagnetic interference on invasive arterial blood pressure monitoring caused by biomedical devices used during surgery. The wireless pressure biomedical sensor with Bluetooth wireless transmission of signals did not interfere with biomedical devices used in the operating room or vice versa.

Towards scarless surgery: an endoscopic-ultrasound navigation system for transgastric access procedures.

Scarless surgery is a new and very promising technique that can mark a new era in surgical procedures. We have created and validated a navigation system for endoscopic and transgastric access interventions in in vivo pilot studies. The system provides augmented visual feedback and additional contextual information by establishing a correspondence between the real time endoscopic ultrasound image and a preoperative CT volume using rigid registration. The system enhances the operator's ability to interpret the ultrasound image reducing the mental burden used in probe placement. Our analysis shows that rigid registration is accurate enough to help physicians in endoscopic abdominal surgery where, by using preoperative data for context and real-time imaging for targeting, distortions that limit the use of only preoperative data can be overcome.

Early recognition of regional cardiac ischemia using a 3-axis accelerometer sensor.

Perioperative mortality in coronary artery bypass grafting is usually caused by reduced left ventricular function due to regional myocardial ischemia or infarction. Post-operative graft occlusion is a well-known problem in coronary surgery. A sensitive tool to detect graft occlusion and monitor myocardial function may give the opportunity to revise malfunctioning grafts before departure from the hospital. This paper describes how a new method can detect cardiac ischemia using a 3-axis piezoelectric accelerometer. In three anesthetized pigs, a 3-axis piezoelectric accelerometer was sutured on the lateral free wall of the left ventricle. The left anterior descending (LAD) was occluded for different time periods and the accelerometer data were sampled with a PC. Short-time Fourier transform was calculated based on the accelerometer time series. The results were visualized using a 2D color-coded time-frequency plot. In the area of occlusion, a change to stronger power of higher harmonics was observed. Consequently, a difference value between the instant frequency pattern and a reference frequency pattern showed a rise in absolute value during the occlusion period. The preliminary results indicate that early recognition of regional cardiac ischemia is possible by analyzing accelerometer data acquired from the three animal trials using the prototype 3-axis accelerometer sensor.