Novel system for real-time integration of 3-D echocardiography and fluoroscopy for image-guided cardiac interventions: Preclinical validation and clinical feasibility evaluation

© 2015 IEEE. Real-time imaging is required to guide minimally invasive catheter-based cardiac interventions. While transesophageal echocardiography allows for high-quality visualization of cardiac anatomy, X-ray fluoroscopy provides excellent visualization of devices. We have developed a novel image fusion system that allows real-time integration of 3-D echocardiography and the X-ray fluoroscopy. The system was validated in the following two stages: 1) preclinical to determine function and validate accuracy; and 2) in the clinical setting to assess clinical workflow feasibility and determine overall system accuracy. In the preclinical phase, the system was assessed using both phantom and porcine experimental studies. Median 2-D projection errors of 4.5 and 3.3 mm were found for the phantom and porcine studies, respectively. The clinical phase focused on extending the use of the system to interventions in patients undergoing either atrial fibrillation catheter ablation (CA) or transcatheter aortic valve implantation (TAVI). Eleven patients were studied with nine in the CA group and two in the TAVI group. Successful real-time view synchronization was achieved in all cases with a calculated median distance error of 2.2 mm in the CA group and 3.4 mm in the TAVI group. A standard clinical workflow was established using the image fusion system. These pilot data confirm the technical feasibility of accurate real-time echo-fluoroscopic image overlay in clinical practice, which may be a useful adjunct for real-time guidance during interventional cardiac procedures

Development of a Surgical Assistance System for Guiding Transcatheter Aortic Valve Implantation

Development of image-guided interventional systems is growing up rapidly in the recent years. These new systems become an essential part of the modern minimally invasive surgical procedures, especially for the cardiac surgery. Transcatheter aortic valve implantation (TAVI) is a recently developed surgical technique to treat severe aortic valve stenosis in elderly and high-risk patients. The placement of stented aortic valve prosthesis is crucial and typically performed under live 2D fluoroscopy guidance. To assist the placement of the prosthesis during the surgical procedure, a new fluoroscopy-based TAVI assistance system has been developed. The developed assistance system integrates a 3D geometrical aortic mesh model and anatomical valve landmarks with live 2D fluoroscopic images. The 3D aortic mesh model and landmarks are reconstructed from interventional angiographic and fluoroscopic C-arm CT system, and a target area of valve implantation is automatically estimated using these aortic mesh models. Based on template-based tracking approach, the overlay of visualized 3D aortic mesh model, landmarks and target area of implantation onto fluoroscopic images is updated by approximating the aortic root motion from a pigtail catheter motion without contrast agent. A rigid intensity-based registration method is also used to track continuously the aortic root motion in the presence of contrast agent. Moreover, the aortic valve prosthesis is tracked in fluoroscopic images to guide the surgeon to perform the appropriate placement of prosthesis into the estimated target area of implantation. An interactive graphical user interface for the surgeon is developed to initialize the system algorithms, control the visualization view of the guidance results, and correct manually overlay errors if needed. Retrospective experiments were carried out on several patient datasets from the clinical routine of the TAVI in a hybrid operating room. The maximum displacement errors were small for both the dynamic overlay of aortic mesh models and tracking the prosthesis, and within the clinically accepted ranges. High success rates of the developed assistance system were obtained for all tested patient datasets. The results show that the developed surgical assistance system provides a helpful tool for the surgeon by automatically defining the desired placement position of the prosthesis during the surgical procedure of the TAVI.Die Entwicklung bildgeführter interventioneller Systeme wächst rasant in den letzten Jahren. Diese neuen Systeme werden zunehmend ein wesentlicher Bestandteil der technischen Ausstattung bei modernen minimal-invasiven chirurgischen Eingriffen. Diese Entwicklung gilt besonders für die Herzchirurgie. Transkatheter Aortenklappen-Implantation (TAKI) ist eine neue entwickelte Operationstechnik zur Behandlung der schweren Aortenklappen-Stenose bei alten und Hochrisiko-Patienten. Die Platzierung der Aortenklappenprothese ist entscheidend und wird in der Regel unter live-2D-fluoroskopischen Bildgebung durchgeführt. Zur Unterstützung der Platzierung der Prothese während des chirurgischen Eingriffs wurde in dieser Arbeit ein neues Fluoroskopie-basiertes TAKI Assistenzsystem entwickelt. Das entwickelte Assistenzsystem überlagert eine 3D-Geometrie des Aorten-Netzmodells und anatomischen Landmarken auf live-2D-fluoroskopische Bilder. Das 3D-Aorten-Netzmodell und die Landmarken werden auf Basis der interventionellen Angiographie und Fluoroskopie mittels eines C-Arm-CT-Systems rekonstruiert. Unter Verwendung dieser Aorten-Netzmodelle wird das Zielgebiet der Klappen-Implantation automatisch geschätzt. Mit Hilfe eines auf Template Matching basierenden Tracking-Ansatzes wird die Überlagerung des visualisierten 3D-Aorten-Netzmodells, der berechneten Landmarken und der Zielbereich der Implantation auf fluoroskopischen Bildern korrekt überlagert. Eine kompensation der Aortenwurzelbewegung erfolgt durch Bewegungsverfolgung eines Pigtail-Katheters in Bildsequenzen ohne Kontrastmittel. Eine starrere Intensitätsbasierte Registrierungsmethode wurde verwendet, um kontinuierlich die Aortenwurzelbewegung in Bildsequenzen mit Kontrastmittelgabe zu detektieren. Die Aortenklappenprothese wird in die fluoroskopischen Bilder eingeblendet und dient dem Chirurg als Leitfaden für die richtige Platzierung der realen Prothese. Eine interaktive Benutzerschnittstelle für den Chirurg wurde zur Initialisierung der Systemsalgorithmen, zur Steuerung der Visualisierung und für manuelle Korrektur eventueller Überlagerungsfehler entwickelt. Retrospektive Experimente wurden an mehreren Patienten-Datensätze aus der klinischen Routine der TAKI in einem Hybrid-OP durchgeführt. Hohe Erfolgsraten des entwickelten Assistenzsystems wurden für alle getesteten Patienten-Datensätze erzielt. Die Ergebnisse zeigen, dass das entwickelte chirurgische Assistenzsystem ein hilfreiches Werkzeug für den Chirurg bei der Platzierung Position der Prothese während des chirurgischen Eingriffs der TAKI bietet

Augmented Image-Guidance for Transcatheter Aortic Valve Implantation

The introduction of transcatheter aortic valve implantation (TAVI), an innovative stent-based technique for delivery of a bioprosthetic valve, has resulted in a paradigm shift in treatment options for elderly patients with aortic stenosis. While there have been major advancements in valve design and access routes, TAVI still relies largely on single-plane fluoroscopy for intraoperative navigation and guidance, which provides only gross imaging of anatomical structures. Inadequate imaging leading to suboptimal valve positioning contributes to many of the early complications experienced by TAVI patients, including valve embolism, coronary ostia obstruction, paravalvular leak, heart block, and secondary nephrotoxicity from contrast use. A potential method of providing improved image-guidance for TAVI is to combine the information derived from intra-operative fluoroscopy and TEE with pre-operative CT data. This would allow the 3D anatomy of the aortic root to be visualized along with real-time information about valve and prosthesis motion. The combined information can be visualized as a `merged\u27 image where the different imaging modalities are overlaid upon each other, or as an `augmented\u27 image, where the location of key target features identified on one image are displayed on a different imaging modality. This research develops image registration techniques to bring fluoroscopy, TEE, and CT models into a common coordinate frame with an image processing workflow that is compatible with the TAVI procedure. The techniques are designed to be fast enough to allow for real-time image fusion and visualization during the procedure, with an intra-procedural set-up requiring only a few minutes. TEE to fluoroscopy registration was achieved using a single-perspective TEE probe pose estimation technique. The alignment of CT and TEE images was achieved using custom-designed algorithms to extract aortic root contours from XPlane TEE images, and matching the shape of these contours to a CT-derived surface model. Registration accuracy was assessed on porcine and human images by identifying targets (such as guidewires or coronary ostia) on the different imaging modalities and measuring the correspondence of these targets after registration. The merged images demonstrated good visual alignment of aortic root structures, and quantitative assessment measured an accuracy of less than 1.5mm error for TEE-fluoroscopy registration and less than 6mm error for CT-TEE registration. These results suggest that the image processing techniques presented have potential for development into a clinical tool to guide TAVI. Such a tool could potentially reduce TAVI complications, reducing morbidity and mortality and allowing for a safer procedure

Towards Image-Guided Pediatric Atrial Septal Defect Repair

Congenital heart disease occurs in 107.6 out of 10,000 live births, with Atrial Septal Defects (ASD) accounting for 10\% of these conditions. Historically, ASDs were treated with open heart surgery using cardiopulmonary bypass, allowing a patch to be sewn over the defect. In 1976, King et al. demonstrated use of a transcatheter occlusion procedure, thus reducing the invasiveness of ASD repair. Localization during these catheter based procedures traditionally has relied on bi-plane fluoroscopy; more recently trans-esophageal echocardiography (TEE) and intra-cardiac echocardiography (ICE) have been used to navigate these procedures. Although there is a high success rate using the transcatheter occlusion procedure, fluoroscopy poses radiation dose risk to both patient and clinician. The impact of this dose to the patients is important as many of those undergoing this procedure are children, who have an increased risk associated with radiation exposure. Their longer life expectancy than adults provides a larger window of opportunity for expressing the damaging effects of ionizing radiation. In addition, epidemiologic studies of exposed populations have demonstrated that children are considerably more sensitive to the carcinogenic effects radiation. Image-guided surgery (IGS) uses pre-operative and intra-operative images to guide surgery or an interventional procedure. Central to every IGS system is a software application capable of processing and displaying patient images, registration between multiple coordinate systems, and interfacing with a tool tracking system. We have developed a novel image-guided surgery framework called Kit for Navigation by Image Focused Exploration (KNIFE). This software system serves as the core technology by which a system for reduction of radiation exposure to pediatric patients was developed. The bulk of the initial work in this research endevaour was the development of KNIFE which itself went through countless iterations before arriving at its current state as per the feature requirements established. Secondly, since this work involved the use of captured medical images and their use in an IGS software suite, a brief analysis of the physics behind the images was conducted. Through this aspect of the work, intrinsic parameters (principal point and focal point) of the fluoroscope were quantified using a 3D grid calibration phantom. A second grid phantom was traversed through the fluoroscopic imaging volume of II and flat panel based systems at 2 cm intervals building a scatter field of the volume to demonstrate pincushion and \u27S\u27 distortion in the images. Effects of projection distortion on the images was assessed by measuring the fiducial registration error (FRE) of each point used in two different registration techniques, where both methods utilized ordinary procrustes analysis but the second used a projection matrix built from the fluoroscopes calculated intrinsic parameters. A case study was performed to test whether the projection registration outperforms the rigid transform only. Using the knowledge generated were able to successfully design and complete mock clinical procedures using cardiac phantom models. These mock trials at the beginning of this work used a single point to represent catheter location but this was eventually replaced with a full shape model that offered numerous advantages. At the conclusion of this work a novel protocol for conducting IG ASD procedures was developed. Future work would involve the construction of novel EM tracked tools, phantom models for other vascular diseases and finally clinical integration and use

Dynamic Image Processing for Guidance of Off-pump Beating Heart Mitral Valve Repair

Compared to conventional open heart procedures, minimally invasive off-pump beating heart mitral valve repair aims to deliver equivalent treatment for mitral regurgitation with reduced trauma and side effects. However, minimally invasive approaches are often limited by the lack of a direct view to surgical targets and/or tools, a challenge that is compounded by potential movement of the target during the cardiac cycle. For this reason, sophisticated image guidance systems are required in achieving procedural efficiency and therapeutic success. The development of such guidance systems is associated with many challenges. For example, the system should be able to provide high quality visualization of both cardiac anatomy and motion, as well as augmenting it with virtual models of tracked tools and targets. It should have the capability of integrating pre-operative images to the intra-operative scenario through registration techniques. The computation speed must be sufficiently fast to capture the rapid cardiac motion. Meanwhile, the system should be cost effective and easily integrated into standard clinical workflow. This thesis develops image processing techniques to address these challenges, aiming to achieve a safe and efficient guidance system for off-pump beating heart mitral valve repair. These techniques can be divided into two categories, using 3D and 2D image data respectively. When 3D images are accessible, a rapid multi-modal registration approach is proposed to link the pre-operative CT images to the intra-operative ultrasound images. The ultrasound images are used to display the real time cardiac motion, enhanced by CT data serving as high quality 3D context with annotated features. I also developed a method to generate synthetic dynamic CT images, aiming to replace real dynamic CT data in such a guidance system to reduce the radiation dose applied to the patients. When only 2D images are available, an approach is developed to track the feature of interest, i.e. the mitral annulus, based on bi-plane ultrasound images and a magnetic tracking system. The concept of modern GPU-based parallel computing is employed in most of these approaches to accelerate the computation in order to capture the rapid cardiac motion with desired accuracy. Validation experiments were performed on phantom, animal and human data. The overall accuracy of registration and feature tracking with respect to the mitral annulus was about 2-3mm with computation time of 60-400ms per frame, sufficient for one update per cardiac cycle. It was also demonstrated in the results that the synthetic CT images can provide very similar anatomical representations and registration accuracy compared to that of the real dynamic CT images. These results suggest that the approaches developed in the thesis have good potential for a safer and more effective guidance system for off-pump beating heart mitral valve repair

Virtual and Augmented Reality Techniques for Minimally Invasive Cardiac Interventions: Concept, Design, Evaluation and Pre-clinical Implementation

While less invasive techniques have been employed for some procedures, most intracardiac interventions are still performed under cardiopulmonary bypass, on the drained, arrested heart. The progress toward off-pump intracardiac interventions has been hampered by the lack of adequate visualization inside the beating heart. This thesis describes the development, assessment, and pre-clinical implementation of a mixed reality environment that integrates pre-operative imaging and modeling with surgical tracking technologies and real-time ultrasound imaging. The intra-operative echo images are augmented with pre-operative representations of the cardiac anatomy and virtual models of the delivery instruments tracked in real time using magnetic tracking technologies. As a result, the otherwise context-less images can now be interpreted within the anatomical context provided by the anatomical models. The virtual models assist the user with the tool-to-target navigation, while real-time ultrasound ensures accurate positioning of the tool on target, providing the surgeon with sufficient information to ``see\u27\u27 and manipulate instruments in absence of direct vision. Several pre-clinical acute evaluation studies have been conducted in vivo on swine models to assess the feasibility of the proposed environment in a clinical context. Following direct access inside the beating heart using the UCI, the proposed mixed reality environment was used to provide the necessary visualization and navigation to position a prosthetic mitral valve on the the native annulus, or to place a repair patch on a created septal defect in vivo in porcine models. Following further development and seamless integration into the clinical workflow, we hope that the proposed mixed reality guidance environment may become a significant milestone toward enabling minimally invasive therapy on the beating heart

Fusion of interventional ultrasound & X-ray

In einer immer älter werdenden Bevölkerung wird die Behandlung von strukturellen Herzkrankheiten zunehmend wichtiger. Verbesserte medizinische Bildgebung und die Einführung neuer Kathetertechnologien führten dazu, dass immer mehr herkömmliche chirurgische Eingriffe am offenen Herzen durch minimal invasive Methoden abgelöst werden. Diese modernen Interventionen müssen durch verschiedenste Bildgebungsverfahren navigiert werden. Hierzu werden hauptsächlich Röntgenfluoroskopie und transösophageale Echokardiografie (TEE) eingesetzt. Röntgen bietet eine gute Visualisierung der eingeführten Katheter, was essentiell für eine gute Navigation ist. TEE hingegen bietet die Möglichkeit der Weichteilgewebedarstellung und kann damit vor allem zur Darstellung von anatomischen Strukturen, wie z.B. Herzklappen, genutzt werden. Beide Modalitäten erzeugen Bilder in Echtzeit und werden für die erfolgreiche Durchführung minimal invasiver Herzchirurgie zwingend benötigt. Üblicherweise sind beide Systeme eigenständig und nicht miteinander verbunden. Es ist anzunehmen, dass eine Bildfusion beider Welten einen großen Vorteil für die behandelnden Operateure erzeugen kann, vor allem eine verbesserte Kommunikation im Behandlungsteam. Ebenso können sich aus der Anwendung heraus neue chirurgische Worfklows ergeben. Eine direkte Fusion beider Systeme scheint nicht möglich, da die Bilddaten eine zu unterschiedliche Charakteristik aufweisen. Daher kommt in dieser Arbeit eine indirekte Registriermethode zum Einsatz. Die TEE-Sonde ist während der Intervention ständig im Fluoroskopiebild sichtbar. Dadurch wird es möglich, die Sonde im Röntgenbild zu registrieren und daraus die 3D Position abzuleiten. Der Zusammenhang zwischen Ultraschallbild und Ultraschallsonde wird durch eine Kalibrierung bestimmt. In dieser Arbeit wurde die Methode der 2D-3D Registrierung gewählt, um die TEE Sonde auf 2D Röntgenbildern zu erkennen. Es werden verschiedene Beiträge präsentiert, welche einen herkömmlichen 2D-3D Registrieralgorithmus verbessern. Nicht nur im Bereich der Ultraschall-Röntgen-Fusion, sondern auch im Hinblick auf allgemeine Registrierprobleme. Eine eingeführte Methode ist die der planaren Parameter. Diese verbessert die Robustheit und die Registriergeschwindigkeit, vor allem während der Registrierung eines Objekts aus zwei nicht-orthogonalen Richtungen. Ein weiterer Ansatz ist der Austausch der herkömmlichen Erzeugung von sogenannten digital reconstructed radiographs. Diese sind zwar ein integraler Bestandteil einer 2D-3D Registrierung aber gleichzeitig sehr zeitaufwendig zu berechnen. Es führt zu einem erheblichen Geschwindigkeitsgewinn die herkömmliche Methode durch schnelles Rendering von Dreiecksnetzen zu ersetzen. Ebenso wird gezeigt, dass eine Kombination von schnellen lernbasierten Detektionsalgorithmen und 2D-3D Registrierung die Genauigkeit und die Registrierreichweite verbessert. Zum Abschluss werden die ersten Ergebnisse eines klinischen Prototypen präsentiert, welcher die zuvor genannten Methoden verwendet.Today, in an elderly community, the treatment of structural heart disease will become more and more important. Constant improvements of medical imaging technologies and the introduction of new catheter devices caused the trend to replace conventional open heart surgery by minimal invasive interventions. These advanced interventions need to be guided by different medical imaging modalities. The two main imaging systems here are X-ray fluoroscopy and Transesophageal  Echocardiography (TEE). While X-ray provides a good visualization of inserted catheters, which is essential for catheter navigation, TEE can display soft tissues, especially anatomical structures like heart valves. Both modalities provide real-time imaging and are necessary to lead minimal invasive heart surgery to success. Usually, the two systems are detached and not connected. It is conceivable that a fusion of both worlds can create a strong benefit for the physicians. It can lead to a better communication within the clinical team and can probably enable new surgical workflows. Because of the completely different characteristics of the image data, a direct fusion seems to be impossible. Therefore, an indirect registration of Ultrasound and X-ray images is used. The TEE probe is usually visible in the X-ray image during the described minimal-invasive interventions. Thereby, it becomes possible to register the TEE probe in the fluoroscopic images and to establish its 3D position. The relationship of the Ultrasound image to the Ultrasound probe is known by calibration. To register the TEE probe on 2D X-ray images, a 2D-3D registration approach is chosen in this thesis. Several contributions are presented, which are improving the common 2D-3D registration algorithm for the task of Ultrasound and X-ray fusion, but also for general 2D-3D registration problems. One presented approach is the introduction of planar parameters that increase robustness and speed during the registration of an object on two non-orthogonal views. Another approach is to replace the conventional generation of digital reconstructedradiographs, which is an integral part of 2D-3D registration but also a performance bottleneck, with fast triangular mesh rendering. This will result in a significant performance speed-up. It is also shown that a combination of fast learning-based detection algorithms with 2D-3D registration will increase the accuracy and the capture range, instead of employing them solely to the  registration/detection of a TEE probe. Finally, a first clinical prototype is presented which employs the presented approaches and first clinical results are shown

Fast catheter segmentation and tracking based on x-ray fluoroscopic and echocardiographic modalities for catheter-based cardiac minimally invasive interventions

X-ray fluoroscopy and echocardiography imaging (ultrasound, US) are two imaging modalities that are widely used in cardiac catheterization. For these modalities, a fast, accurate and stable algorithm for the detection and tracking of catheters is required to allow clinicians to observe the catheter location in real-time. Currently X-ray fluoroscopy is routinely used as the standard modality in catheter ablation interventions. However, it lacks the ability to visualize soft tissue and uses harmful radiation. US does not have these limitations but often contains acoustic artifacts and has a small field of view. These make the detection and tracking of the catheter in US very challenging. The first contribution in this thesis is a framework which combines Kalman filter and discrete optimization for multiple catheter segmentation and tracking in X-ray images. Kalman filter is used to identify the whole catheter from a single point detected on the catheter in the first frame of a sequence of x-ray images. An energy-based formulation is developed that can be used to track the catheters in the following frames. We also propose a discrete optimization for minimizing the energy function in each frame of the X-ray image sequence. Our approach is robust to tangential motion of the catheter and combines the tubular and salient feature measurements into a single robust and efficient framework. The second contribution is an algorithm for catheter extraction in 3D ultrasound images based on (a) the registration between the X-ray and ultrasound images and (b) the segmentation of the catheter in X-ray images. The search space for the catheter extraction in the ultrasound images is constrained to lie on or close to a curved surface in the ultrasound volume. The curved surface corresponds to the back-projection of the extracted catheter from the X-ray image to the ultrasound volume. Blob-like features are detected in the US images and organized in a graphical model. The extracted catheter is modelled as the optimal path in this graphical model. Both contributions allow the use of ultrasound imaging for the improved visualization of soft tissue. However, X-ray imaging is still required for each ultrasound frame and the amount of X-ray exposure has not been reduced. The final contribution in this thesis is a system that can track the catheter in ultrasound volumes automatically without the need for X-ray imaging during the tracking. Instead X-ray imaging is only required for the system initialization and for recovery from tracking failures. This allows a significant reduction in the amount of X-ray exposure for patient and clinicians.Open Acces