Evaluation of a Patient-Specific, Low-Cost, 3-Dimensional–Printed Transesophageal Echocardiography Human Heart Phantom

Simulation based education has been shown to increase the task-specific capability of medical trainees. Transesophageal echocardiography training greatly benefits from the use of simulators. They allow real time scanning of a beating heart and generation of ultrasound images side by side with anatomically accurate virtual model. These simulators are costly and have many limitations. 3D printing technologies have enabled the creation of bespoke phantoms capable of being used as task-trainers. This study aims to compare the ease of use and accuracy of a low-cost patient-specific, Computer-tomography based, 3D printed, echogenic TEE phantom compared to a commercially available echocardiography training mannequin. We hypothesized that a low-cost, 3D printed custom-made, cardiac phantom has comparable image quality, accuracy and usability as existing commercially available echocardiographic phantoms. After Institutional Ethic Research Board approval, we recruited ten American Board – Certified cardiac anesthesiologists and conducted a blinded comparative study divided into two stages. Stage one consisted of image assessment. A set of basic TEE views obtained from the 3D printed and commercial phantom were presented to the participants on a computer screen in random order. For each image, participants will be asked to identify the view, identify the quality of the image on a 1-5 Likert scale compared to the corresponding human view and guess with which phantom it was acquired (1 not at all realistic to patients view and 5 realistic to patients view). Stage two, participants will be asked to use the 3D printed and the commercially available phantom to obtain basic TEE views. In a maximum of 30 minutes. Each view was recorded and assessed for accuracy by two certified echocardiographers. Time needed to acquire each basic view and number of correct views was recorded. Overall usability of the phantoms was assessed through a questionnaire. For all continuous variables, we will calculate mean, median and standard deviation. We use Wilcoxon Signed-Rank test to assess significant differences in the rating of each phantom. All ten participants completed all part of the study. All participants could recognize all of the standard views. The average Likert scale was 3.2 for the 3D printed and 2.9 for the commercial Phantom with no significant difference. The average time to obtain views was 24.5 and 30 sec for the 3D printed and the commercial phantoms respectively statistically significantly in favor of the 3D printed phantom. The qualitative user assessment for ease to obtain the views, probe manipulation, image quality and overall experience were in great favor of the 3D printed phantom. Our Study suggest that the quality of TEE images obtained on the 3D printed phantom are not significantly different from those obtained on the commercial Phantom. The ease of use and time required to complete a basic TEE exam were in favor of the 3D Printed phantom.:Table of Content 1. Bibliographic Description 3 2. Introduction 4 2.1. Perioperative transesophageal echocardiography 4 2.2. Transesophageal echocardiography training 5 2.3. Transesophageal echocardiography simulation 6 2.4. 3D Heart Printing 13 2.5. 3D Segmentation 16 2.6. Development of the study phantom 17 2.7. Study Rationale 18 3. Publication 22 4. Summary 30 5. References 33 6. Appendices 37 6.1. Darstellung des eigenes Beitrags 38 6.2. Erklärung über die eigenständige Abfassung der Arbeit 39 6.3. Lebenslauf 40 6.4. Publikationen und Vorträge 44 6.5. Danksagung 61

Efficacy of a Mixed Methods Training Program for Transthoracic Echocardiography

Background and Review of Literature: Currently, there is a knowledge gap in CRNA education. As anesthesia providers, CRNAs are licensed to perform cardiac diagnostic imaging such as TTE during surgery, yet it is often missing from CRNA school curriculum. Other studies have shown that simulation is an effective way of teaching this crucial skill. Purpose: The project’s goal was to establish the efficacy of using a mixed model computerized and in-person simulation program for training CRNAs in the use of TTE during non-cardiac surgery. Methods: A training program was created that uses a computerized training session along with a hands-on simulation. This program focuses on ultrasound basics, landmark identification, and diagnosis of hypovolemia and ventricular dysfunction. A cohort of CRNA participants engaged in the training to study its efficacy. Implementation Plan/Procedure: A pretest and posttest that included an attitudes survey was given to the participants to evaluate increases in competency and comfort in performing TTE skills as a result of the training program. A skills checkoff was also completed to demonstrate competency. Implications/Conclusion: Data analysis suggests that the program was effective in increasing TTE knowledge and creating a base level of skill and competency in the use of TTE for all participants

The ultrasound use of simulators, current view, and perspectives: Requirements and technical aspects (WFUMB state of the art paper)

Simulation has been shown to improve clinical learning outcomes, speed up the learning process and improve learner confidence, whilst initially taking pressure off busy clinical lists. The World Federation for Ultrasound in Medicine and Biology (WFUMB) state of the art paper on the use of simulators in ultrasound education introduces ultrasound simulation, its advantages and challenges. It describes different simulator types, including low and high-fidelity simulators, the requirements and technical aspects of simulators, followed by the clinical applications of ultrasound simulation. The paper discusses the role of ultrasound simulation in ultrasound clinical training, referencing established literature. Requirements for successful ultrasound simulation acceptance into educational structures are explored. Despite being in its infancy, ultrasound simulation already offers a wide range of training opportunities and likely holds the key to a broader point of care ultrasound education for medical students, practicing doctors, and other health care professionals. Despite the drawbacks of simulation, there are also many advantages, which are expanding rapidly as the technology evolves

NOVEL STRATEGIES FOR THE MORPHOLOGICAL AND BIOMECHANICAL ANALYSIS OF THE CARDIAC VALVES BASED ON VOLUMETRIC CLINICAL IMAGES

This work was focused on the morphological and biomechanical analysis of the heart valves exploiting the volumetric data. Novel methods were implemented to perform cardiac valve structure and sub-structure segmentation by defining long axis planes evenly rotated around the long axis of the valve. These methods were exploited to successfully reconstruct the 3D geometry of the mitral, tricuspid and aortic valve structures. Firstly, the reconstructed models were used for the morphological analysis providing a detailed description of the geometry of the valve structures, also computing novel indexes that could improve the description of the valvular apparatus and help their clinical assessment. Additionally, the models obtained for the mitral valve complex were adopted for the development of a novel biomechanical approach to simulate the systolic closure of the valve, relying on highly-efficient mass-spring models thus obtaining a good trade-off between the accuracy and the computational cost of the numerical simulations. In specific: \u2022 First, an innovative and semi-automated method was implemented to generate the 3D model of the aortic valve and of its calcifications, to quantitively describe its 3D morphology and to compute the anatomical aortic valve area (AVA) based on multi-detector computed tomography images. The comparison of the obtained results vs. effective AVA measurements showed a good correlation. Additionally, these methods accounted for asymmetries or anatomical derangements, which would be difficult to correctly capture through either effective AVA or planimetric AVA. \u2022 Second, a tool to quantitively assess the geometry of the tricuspid valve during the cardiac cycle using multidetector CT was developed, in particular focusing on the 3D spatial relationship between the tricuspid annulus and the right coronary artery. The morphological analysis of the annulus and leaflets confirmed data reported in literature. The qualitative and quantitative analysis of the spatial relationship could standardize the analysis protocol and be pivotal in the procedure planning of the percutaneous device implantation that interact with the tricuspid annulus. \u2022 Third, we simulated the systolic closure of three patient specific mitral valve models, derived from CMR datasets, by means of the mass spring model approach. The comparison of the obtained results vs. finite element analyses (considered as the gold-standard) was performed tuning the parameters of the mass spring model, so to obtain the best trade-off between computational expense and accuracy of the results. A configuration mismatch between the two models lower than two times the in-plane resolution of starting imaging data was yielded using a mass spring model set-up that requires, on average, only ten minutes to simulate the valve closure. \u2022 Finally, in the last chapter, we performed a comprehensive analysis which aimed at exploring the morphological and mechanical changes induced by the myxomatous pathologies in the mitral valve tissue. The analysis of mitral valve thickness confirmed the data and patterns reported in literature, while the mechanical test accurately described the behavior of the pathological tissue. A preliminary implementation of this data into finite element simulations suggested that the use of more reliable patient-specific and pathology-specific characterization of the model could improve the realism and the accuracy of the biomechanical simulations

A transesophageal phased array transducer for ultrasonic imaging of the heart

In this thesis the development of a miniaturized phased array ultrasound transducer is described. The application of this transducer in the field of echocardiology is devoted to transesophageal cross-sectional scanning of the heart and its great vessels. The enormous increase in diagnostic applications of ultrasound over the last three decades is particularly due to the non-invasive character of this technique. Consequently the developments of transcutaneous scanning techniques have outnumbered all other possibilities, but researchers have continuously been investigating the alternatives of scanning organs from within the human body. In those patients in whom inhibiting factors preclude adequate diagnostic information to be obtained transcutaneously, alternative scanning techniques still may-provide vital information. For cardiac imaging two possibilities exist to enter the human body, invasively by means of a catheter or 'non-invasively' by means of an endoscope. In Chapter I, the introduction, our early experiences with a catheter-mounted scanning system are described. The limited possibilities of such a system combined with the inherent technological complications, as well as the invasive character of such a technique favoured the search for a different approach. The idea to advance in the catheter direction was never left but first the experience gained has been applied to transesophageal scanning with an endoscope-mounted transducer as described in this thesis

Towards Patient Specific Mitral Valve Modelling via Dynamic 3D Transesophageal Echocardiography

Mitral valve disease is a common pathologic problem occurring increasingly in an aging population, and many patients suffering from mitral valve disease require surgical intervention. Planning an interventional approach from diagnostic imaging alone remains a significant clinical challenge. Transesophageal echocardiography (TEE) is the primary imaging modality used diagnostically, it has limitations in image quality and field-of-view. Recently, developments have been made towards modelling patient-specific deformable mitral valves from TEE imaging, however, a major barrier to producing accurate valve models is the need to derive the leaflet geometry through segmentation of diagnostic TEE imaging. This work explores the development of volume compounding and automated image analysis to more accurately and quickly capture the relevant valve geometry needed to produce patient-specific mitral valve models. Volume compounding enables multiple ultrasound acquisitions from different orientations and locations to be aligned and blended to form a single volume with improved resolution and field-of-view. A series of overlapping transgastric views are acquired that are then registered together with the standard en-face image and are combined using a blending function. The resulting compounded ultrasound volumes allow the visualization of a wider range of anatomical features within the left heart, enhancing the capabilities of a standard TEE probe. In this thesis, I first describe a semi-automatic segmentation algorithm based on active contours designed to produce segmentations from end-diastole suitable for deriving 3D printable molds. Subsequently I describe the development of DeepMitral, a fully automatic segmentation pipeline which leverages deep learning to produce very accurate segmentations with a runtime of less than ten seconds. DeepMitral is the first reported method using convolutional neural networks (CNNs) on 3D TEE for mitral valve segmentations. The results demonstrate very accurate leaflet segmentations, and a reduction in the time and complexity to produce a patient-specific mitral valve replica. Finally, a real-time annulus tracking system using CNNs to predict the annulus coordinates in the spatial frequency domain was developed. This method facilitates the use of mitral annulus tracking in real-time guidance systems, and further simplifies mitral valve modelling through the automatic detection of the annulus, which is a key structure for valve quantification, and reproducing accurate leaflet dynamics

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