Simulated Prosthesis Overlay for Patient-Specific Planning of Transcatheter Aortic Valve Implantation Procedures.

OBJECTIVE: We tested the hypothesis that simulated three-dimensional prosthesis overlay procedure planning may support valve selection in transcatheter aortic valve implantation (TAVI) procedures. METHODS: Preoperative multidimensional computed tomography (MDCT) data sets from 81 consecutive TAVI patients were included in the study. A planning tool was developed, which semiautomatically creates a three-dimensional model of the aortic root from these data. Three-dimensional templates of the commonly used TAVI implants are spatially registered with the patient data and presented as graphic overlay. Fourteen physicians used the tool to perform retrospective planning of TAVI procedures. Results of prosthesis sizing were compared with the prosthesis size used in the actually performed procedure, and the patients were accordingly divided into three groups: those with equal size (concordance with retrospective planning), oversizing (retrospective planning of a smaller prosthesis), and undersizing (retrospective planning of a larger prosthesis). RESULTS: In the oversizing group, 85% of the patients had new pacemaker implantation. In the undersizing group, in 66%, at least mild paravalvular leakage was observed (greater than grade 1 in one third of the cases). In 46% of the patients in the equal-size group, neither of these complications was observed. CONCLUSIONS: Three-dimensional prosthesis overlay in MDCT-derived patient data for patient-specific planning of TAVI procedures is feasible. It may improve valve selection compared with two-dimensional MDCT planning and thus yield better outcomes.

Image-based mechanical analysis of stent deformation: concept and exemplary implementation for aortic valve stents.

An approach for extracting the radial force load on an implanted stent from medical images is proposed. To exemplify the approach, a system is presented which computes a radial force estimation from computer tomography images acquired from patients who underwent transcatheter aortic valve implantation (TAVI). The deformed shape of the implanted valve prosthesis' Nitinol frame is extracted from the images. A set of displacement vectors is computed that parameterizes the observed deformation. An iterative relaxation algorithm is employed to adapt the information extracted from the images to a finite-element model of the stent, and the radial components of the interaction forces between the stent and the tissue are extracted. For the evaluation of the method, tests were run using the clinical data from 21 patients. Stent modeling and extraction of the radial forces were successful in 18 cases. Synthetic test cases were generated, in addition, for assessing the sensitivity to the measurement errors. In a sensitivity analysis, the geometric error of the stent reconstruction was below 0.3 mm, which is below the image resolution. The distribution of the radial forces was qualitatively and quantitatively reasonable. An uncertainty remains in the quantitative evaluation of the radial forces due to the uncertainty in defining a radial direction on the deformed stent. With our approach, the mechanical situation of TAVI stents after the implantation can be studied in vivo, which may help to understand the mechanisms that lead to the complications and improve stent design.

Safety and feasibility of novel technology fusing echocardiography and fluoroscopy images during MitraClip interventions.

AIMS: The EchoNavigator (EN) software (Philips Healthcare, Best, The Netherlands) enables real-time fusion of echocardiography and fluoroscopy by co-registration of the echocardiography probe on the x-ray image. We aimed to evaluate the feasibility and safety of this novel software during MitraClip procedures. METHODS AND RESULTS: Twenty-one patients were treated with the support of EchoNavigator software (EN+ patients). The primary (safety) endpoint was the total radiation dose. Secondary endpoints were fluoroscopy and total procedure time. The measurements were compared to those of 21 patients treated immediately before the installation of EchoNavigator (EN- patients). More MitraClips (45 vs. 36) were implanted in the EN+ group, mirroring more complex interventions in this group. In EN+ patients, radiation dose (Gy/cm2) was similar compared to EN- patients (146.5±123.6 vs.146.8±134.1, p=0.9). Total procedure time (minutes) was similar in the EN+ group compared to EN- patients (136.2±50.2 vs. 125.7±51.2, p=0.5). The main benefit of the EchoNavigator is the automated real-time fusion of echocardiography and fluoroscopy, leading to easier catheter manipulation. CONCLUSIONS: The use of EchoNavigator software was feasible and safe in all study patients. Further studies are necessary to confirm the benefits of using this software.

Stent Maps--Comparative Visualization for the Prediction of Adverse Events of Transcatheter Aortic Valve Implantations.

Transcatheter aortic valve implantation (TAVI) is a minimally-invasive method for the treatment of aortic valve stenosis in patients with high surgical risk. Despite the success of TAVI, side effects such as paravalvular leakages can occur postoperatively. The goal of this project is to quantitatively analyze the co-occurrence of this complication and several potential risk factors such as stent shape after implantation, implantation height, amount and distribution of calcifications, and contact forces between stent and surrounding structure. In this paper, we present a two-dimensional visualization (stent maps), which allows (1) to comprehensively display all these aspects from CT data and mechanical simulation results and (2) to compare different datasets to identify patterns that are typical for adverse effects. The area of a stent map represents the surface area of the implanted stent - virtually straightened and uncoiled. Several properties of interest, like radial forces or stent compression, are displayed in this stent map in a heatmap-like fashion. Important anatomical landmarks and calcifications are plotted to show their spatial relation to the stent and possible correlations with the color-coded parameters. To provide comparability, the maps of different patient datasets are spatially adjusted according to a corresponding anatomical landmark. Also, stent maps summarizing the characteristics of different populations (e.g. with or without side effects) can be generated. Up to this point several interesting patterns have been observed with our technique, which remained hidden when examining the raw CT data or 3D visualizations of the same data. One example are obvious radial force maxima between the right and non-coronary valve leaflet occurring mainly in cases without leakages. These observations confirm the usefulness of our approach and give starting points for new hypotheses and further analyses. Because of its reduced dimensionality, the stent map data is an appropriate input for statistical group evaluation and machine learning methods.

Simulation of transcatheter aortic valve implantation under consideration of leaflet calcification.

Transcatheter aortic valve implantation (TAVI) is a minimally invasive off-pump procedure to replace diseased aortic heart valves. Known complications include paravalvular leaks, atrioventricular blocks, coronary obstruction and annular rupture. Careful procedure planning including appropriate stent selection and sizing are crucial. Few patient-specific geometric parameters, like annular diameters, annular perimeter and measurement of the distance to the coronary ostia, are currently used within this process. Biomechanical simulation allows the consideration of extracted anatomy and material parameters for the intervention, which may improve planning and execution phases. We present a simulation workflow using a fully segmented aortic root anatomy, which was extracted from pre-operative CT-scan data and apply individual material models and parameters to predict the procedure outcome. Our results indicate the high relevance of calcification location and size for intervention planning, which are not sufficiently considered at this time. Our analysis can further provide guidance for accurate, patient-specific device positioning and future adaptations to stent design.

Implantation of personalized, biocompatible mitral annuloplasty rings: feasibility study in an animal model.

OBJECTIVES: Implantation of an annuloplasty ring is an essential component of a durable mitral valve repair. Currently available off-the-shelf rings still do not cover all the variations in mitral annulus anatomy and pathology from subject to subject. Computed tomography (CT) and echo imaging allow for 3-D segmentation of the mitral valve and mitral annulus. The concept of tailored annuloplasty rings has been proposed although, to date, no surgically applicable implementation of patient-specific annuloplasty rings has been seen. The objective of this trial was to prove the concept of surgical implantation of a model-guided, personalized mitral annuloplasty ring, manufactured based on individual CT-scan models. METHODS: ECG-gated CT angiography was performed in six healthy pigs under general anaesthesia. Based on the individual shape of the mitral annulus in systole, a customized solid ring with integrated suturing holes was designed and manufactured from a biocompatible titanium alloy by a rapid process using laser melting. The ring was implanted three days later and valve function was assessed by intraoperative echocardiography. The macroscopic annulus-annuloplasty match was assessed after heart explantation. RESULTS: CT angiography provided good enough image quality in all animals to allow for segmentation of the mitral annulus. The individually tailored mitral rings were manufactured and successfully implanted in all pigs. In 50%, a perfect matching of the implanted ring and the mitral annulus was achieved. In one animal, a slight deviation of the ring shape from the circumference was seen postoperatively. The rings implanted in the first two animals were significantly oversized but the deviation did not affect valve competence. CONCLUSIONS: CT image quality and accuracy of the dimensions of the mitral annulus were sufficient for digital modelling and rapid manufacturing of mitral rings. Implantation of individually tailored annuloplasty rings is feasible.

DICOM for implantations--overview and application.

Surgeons have to deal with many devices from different vendors within the operating room during surgery. Independent communication standards are necessary for the system integration of these devices. For implantations, three new extensions of the Digital Imaging and Communications in Medicine (DICOM) standard make use of a common communication standard that may optimise one of the surgeon's presently very time-consuming daily tasks. The paper provides a brief description of these DICOM Supplements and gives recommendations to their application in practice based on workflows that are proposed to be covered by the new standard extension. Two of the workflows are described in detail and separated into phases that are supported by the new data structures. Examples for the application of the standard within these phases give an impression of the potential usage. Even if the presented workflows are from different domains, we identified a generic core that may benefit from the surgical DICOM Supplements. In some steps of the workflows, the surgical DICOM Supplements are able to replace or optimise conventional methods. Standardisation can only be a means for integration and interoperability. Thus, it can be used as the basis for new applications and system architectures. The influence on current applications and communication processes is limited. Additionally, the supplements provide the basis for further applications, such as the support of surgical navigation systems. Given the support of all involved stakeholders, it is possible to provide a benefit for surgeons and patients.

Cubic Hermite Bezier spline based reconstruction of implanted aortic valve stents from CT images.

Mechanical forces and strain induced by transcatheter aortic valve implantation are usually named as origins for postoperative left ventricular arrhythmia associated with the technique. No quantitative data has been published so far to substantiate this common belief. As a first step towards quantitative analysis of the biomechanic situation at the aortic root after transapical aortic valve implantation, we present a spline-based method for reconstruction of the implanted stent from CT images and for locally measuring the deformation of the stent.

Applicability of DICOM structured reporting for the standardized exchange of implantation plans.

PURPOSE: Today's operating room is equipped with different devices supporting the surgeon. Due to the lack of common interfaces between devices, an integrated support of the surgical workflow is missing. In the field of implantation, a smooth exchange of preoperatively planned data between devices is of great interest. Additionally, the availability of standardized preoperative data would facilitate the documentation, especially with regard to Electronic Health Records. METHODS: To analyze whether DICOM Structured Reporting can be the basis for a standardized digital human- and machine-readable implantation plan, we derived all requirements for such a document. Therefore, we examined the conventional implantation plan and future applications of the digital plan. RESULTS: In this paper, we propose to use the mechanisms introduced by DICOM Structured Reporting as storage and communication infrastructure for implantation plans in the surgical domain. DICOM Structured Reporting complies with all requirements of our analysis. Additionally, we introduce a first draft of a standardized implantation plan structure. CONCLUSIONS: A standardized digital implantation plan based on the DICOM Structured Report has the potential to overcome current integration problems in the OR and to facilitate new applications.

Value of augmented reality-enhanced transesophageal echocardiography (TEE) for determining optimal annuloplasty ring size during mitral valve repair.

BACKGROUND: Mitral valve (MV) annuloplasty is an integral part of MV repair, but sizing under direct vision is occasionally challenging. Furthermore, traditional sizing is not possible for percutaneous MV repair techniques. This study compared augmented reality-enhanced three-dimensional (3D) transesophageal echocardiography (TEE) for determining MV annuloplasty size with conventional surgical sizing. METHODS: In patients undergoing elective MV repair, a 3D MV reconstruction was performed using TEE. Modified 4D valve assessment software was used to create 3D computer-aided design models of standard annuloplasty rings (28 to 36 mm), which were stored in a digital database. These virtual 3D annuloplasty ring templates were superimposed on the preoperative 3D TEE reconstructions of the MV, and results were compared with conventional sizing under direct vision. A post hoc validation of the 3D models was performed using the implanted rings as a control. The echocardiographer was blinded to the implanted ring size. RESULTS: The study included 50 patients. The correlation between the selected 3D annuloplasty ring template and the implanted annuloplasty ring size was 0.83. Thirty ring templates (60%) were the same size as the implanted annuloplasty ring, 19 templates (38%) differed by +/-2 mm in size, and 1 template differed by +4 mm. Postoperatively, the validation protocol revealed a correlation of 0.94 between the size of the ring templates and the implanted annuloplasty prostheses. CONCLUSIONS: Augmented reality-enhanced TEE for determining optimal annuloplasty ring size during MV repair correlates well with conventional surgical sizing and may facilitate future percutaneous MV repair techniques.

Steps towards open standards for medical virtual reality systems.

Very little medical virtual reality systems which are developed are applied in real surgical scenarios. One reason for this is that the system solutions resulting from research projects often address a single research question and are not embedded in an overall design. This paper presents a DICOM based approach on standardizing data structures, i.e. surface meshes, which are required for supporting surgical workflows by virtual reality applications.