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

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

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

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

REAL-TIME 4D ULTRASOUND RECONSTRUCTION FOR IMAGE-GUIDED INTRACARDIAC INTERVENTIONS

Image-guided therapy addresses the lack of direct vision associated with minimally- invasive interventions performed on the beating heart, but requires effective intraoperative imaging. Gated 4D ultrasound reconstruction using a tracked 2D probe generates a time-series of 3D images representing the beating heart over the cardiac cycle. These images have a relatively high spatial resolution and wide field of view, and ultrasound is easily integrated into the intraoperative environment. This thesis presents a real-time 4D ultrasound reconstruction system incorporated within an augmented reality environment for surgical guidance, whose incremental visualization reduces common acquisition errors. The resulting 4D ultrasound datasets are intended for visualization or registration to preoperative images. A human factors experiment demonstrates the advantages of real-time ultrasound reconstruction, and accuracy assessments performed both with a dynamic phantom and intraoperatively reveal RMS localization errors of 2.5-2.7 mm, and 0.8 mm, respectively. Finally, clinical applicability is demonstrated by both porcine and patient imaging

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