INTRODUCTION:The increasing complexity of decision-making in clinical practice and the financial pressure requires clinicians to develop some background about the economic consequences of their decisions and to become more and more managers of pre-defined budgets. The present work aims at describing a simple technology solution that could support prescription decisions and illustrates the results of a preliminary assessment of the tool in a sample of professionals. The solution has been developed to allow informed decision-making in the prescription of oral anti-diabetic drugs (OADs) in type II diabetes mellitus (T2DM) patients by supporting prescriptive appropriateness.METHODS:The tool developed is compatible with many kinds of hardware architectures and the most diffused web browsers. The system allows real-time reproduction of economic evaluation of the different therapeutic options for the management of T2DM patients. Assessment of “ease to use” and “usefulness” of the tool was performed in a convenience sample of clinicians and pharmacists through a specific questionnaire.RESULTS:The tool was developed to compare dipeptidyl-peptidase inhibitors (DPP4i) with sulfonylureas, as second line therapy, for T2DM patients. The tool has a user-friendly Graphical User Interface allowing users to quickly and easily select the therapeutic options to compare, choosing geographical context, perspective of analysis, and changing some model parameters. Feedbacks obtained from thirty-three different professionals were generally positive for the “ease to understand information offered”, “ease of introduction of the tool to support usual working activity”, “usefulness within the usual working activity”.CONCLUSIONS:The study showed that the introduction of the tool as a support for clinicians in optimizing their practice could satisfy unmet needs of professionals by supporting informed prescriptive appropriateness in the choice of OADs as it allows to consider diabetes drug related costs in a comprehensive way. The routinely use of the tool developed could become a solution helping clinicians in the management of several diseases.

Augmented Reality (AR) has already proven its worth in various applications in the medical domain. However, most of the solutions proposed were bound to specific hardware or software configurations, and/or their application was limited to specific cases, thus lacking in flexibility. In this paper, we present a software framework suitable for AR video see-through systems conceived for medical applications: our solution allows merging of real world images grabbed by one or more external cameras with computer-generated sceneries coregistered to the acquired images. The software framework is highly configurable and extensible thanks to the employment of two text configuration files that make it suitable for many typologies of potential applications. The proposed solution can be easily adapted to functioning with different tracking and AR visualization modalities. The versatility of the software for video see-through AR applications was already tested on various medical applications, in conjunction with head-mounted displays or with external spatial displays.

Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA).The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches.The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p < 0.001). The study showed no significant difference in total costs between OS and DMLS. Total costs of general surgery RAS were significantly higher than those of OS (p < 0.001), but not against DMLS general surgery. Indirect costs were significantly lower in RAS compared to both DMLS general surgery and OS gynecological surgery due to the shorter length of hospital stay of RAS approach (p < 0.001). Additionally, in all specialties compared to OS, patients treated by RAS experienced a quicker recovery and significantly less pain during the hospitalization and after discharge.The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

Background: Cardiovascular diseases are the first cause of death globally: an estimated 17.5 million people died in 2012. By combining the benefits of magnetic navigation and ultrasound (US) imaging, the authors proposed a robotic platform (i.e. the MicroVAST platform) for intravascular medical procedures.Methods: A 3D imaging US-based tracking algorithm is implemented for the navigation of a magnetic-dragged soft-tethered device. Tests were performed to evaluate the algorithm in terms of tracking error and precision of locomotion.Results: The 3D imaging US-based algorithm tracked the endovascular device with an error of 6.4 ± 2.8 pixels and a mean displacement between the endovascular device and the preoperative path of 13.6 ± 4.5 mm (computational time of 12.2 ± 1.5 ms and 30.7 ± 6.1 matched features).Conclusions: The MicroVAST platform includes innovative solutions for navigation allowing for an assisted magnetic locomotion of medical devices in the cardiovascular district by combining a 3D imaging US-based tracking algorithm with pre-operative data.

The ability to integrate three-dimensional (3D) models obtained from radiological volumetric images with maps of anatomical surfaces offers the possibility of greater accuracy in identifying structures of interest and any lesions present in patients.

This paper describes the development of the prototype of an Augmented Reality based tele-consultation platform settled with a wearable video see through Head Mounted Display (HMD) with the aim to provide specialist consult to low specialist remote area without the need to move the patient. The platform prototype has the donning advantage that gives the user an immersive experience, moreover the video see through HMD allows for intrinsic coherence of the scenes shared between the users (the mentor and the proctored clinician). The platform has been preliminarily evaluated from a technical point of view and two different scenarios were identified for future clinical testing: ambulatorial (gynecologic) and surgical (orthopaedic).

In the context of surgical navigation systems based on augmented reality (AR), the key challenge is to ensure the highest degree of realism in merging computer-generated elements with live views of the surgical scene. This paper presents an algorithm suited for wearable stereoscopic augmented reality video see-through systems for use in a clinical scenario. A video-based tracking solution is proposed that relies on stereo localization of three monochromatic markers rigidly constrained to the scene. A PnP-based optimization step is introduced to refine separately the pose of the two cameras. Video-based tracking methods using monochromatic markers are robust to non-controllable and/or inconsistent lighting conditions. The two-stage camera pose estimation algorithm provides sub-pixel registration accuracy. From a technological and an ergonomic standpoint, the proposed approach represents an effective solution to the implementation of wearable AR-based surgical navigation systems wherever rigid anatomies are involved.

Ultrasound (US) imaging offers advantages over other imaging modalities and has become the most widespread modality for many diagnostic and interventional procedures. However, traditional 2D US requires a long training period, especially to learn how to manipulate the probe. A hybrid interactive system based on mixed reality was designed, implemented and tested for hand–eye coordination training in diagnostic and interventional US.

Currently the learning model for ultrasound imaging diagnosis and intervention follows a traditional approach based on learning by doing but this model exposes the patient to the whole learning curve of the novice. In order to enable training in a safe environment without compromising patient's health we have developed and demonstrated face, content and construct validity of a hybrid simulator for ultrasound-guided biopsy. This hybrid simulator is able to provide a support to acquire skills in term of 3D perception and hand-eye coordination thanks to a mixed reality visualization that allows accurate and easy planning of probe position/orientation and needle trajectory to reach the target.

Health Technology Assessment of innovative biomedical devices still requires the effort to introduce dedicated Information Technology tools able to support the implementation of the evaluation process. The aim of the study was to systematize the collection, the management and the analysis of large volumes of multidimensional data in order to optimally conduct an HTA study of emerging technologies. We designed a relational database, subsequently we developed and implemented a centralized, web-based user-friendly data entry for Case Report Form (CRF) data collection. (i) The development of User Interface (UI), (ii) data anonymization, (iii) differentiate accesses, (iv) automated quality control checks for data entry, (v) appropriate system tables to make data entry uniform, and (vi) the possibility of creating final reports were addressed. In the data extraction phase, we used MySQL computer languages and combined PHP and HTML codes. Knowledge Discovery in Data process was implemented with different software and programming languages for automation of the data collection, extraction and analysis. The IT tools have been applied to the first multicenter prospective Italian study of HTA on the da Vinci surgical system, obtaining meaningful end points in terms of costs and clinical outcomes. The study involved the enrolment of 699 patients from the 8 Italian Teaching Hospitals in the period 2011-2014. Patients were enrolled and prospectively evaluated from the preoperative work-up till six months after the discharge. The IT tools developed allow researchers to more efficiently and effectively manage large volumes of various source of HTA data, enhancing data quality from storage to processing. The database design could be empowered and readjusted for other HTA studies in near future and the entire approach generalized. In the immature field of HTA of innovative biomedical devices, this example of application could promote the automation of the implementation process of HTA.

Magnetic guide of endovascular devices or magnetized therapeutic microparticles to the specific target in the arterial tree is increasingly studied, since it could improve treatment efficacy and reduce side effects. Most proposed systems use external permanent magnets attached to robotic manipulators or magnetic resonance imaging (MRI) systems to guide internal carriers to the region of treatment. We aim to simplify this type of procedures, avoiding or reducing the need of robotic arms and MRI systems in the surgical scenario. On account of this we investigated the use of a wearable stereoscopic video see-through augmented reality system to show the hidden vessel to the surgeon; in this way, the surgeon is able to freely move the external magnet, following the showed path, to lead the endovascular magnetic device towards the desired position. In this preliminary study, we investigated the feasibility of such an approach trying to guide a magnetic capsule inside a vascular mannequin. The high rate of success and the positive evaluation provided by the operators represent a good starting point for further developments of the system.

Purpose An anatomically realistic ultrasound liver phantom with tissue-specific distinct signal properties is needed for training of novices in diagnostic and interventional procedures. The main objective of this work was development and testing of a new durable liver ultrasound training phantom for use with a hybrid simulator. Methods A liver ultrasound phantom was fabricated in four main phases: materials selection, segmentation of CT images and realization of 3D models, vessel and lesion realization, and final assembly with silicone casting. Silicone was used as basic material due to its durability and stability over time. Several additives were analyzed and mixed with the polymer to reproduce the echogenicity of three simulated soft tissue types: parenchyma, lesions, and veins. Results Cysts and vessel trees appear anechoic in the B mode ultrasound images when realized with pure silicone. The liver parenchyma, hypoechoic, and hyperechoic lesions were realized with different concentrations of graphite and Vaseline oil to increase their relative echogenicity. These materials were successful for creation of an ultrasound liver phantom containing simulated blood vessels and lesions. Conclusion The phantom reproduces the human liver morphology and provides vessels and lesions ultrasound images with recognizable differences in echogenicity. The speed of sound in the simulated materials is inaccurate, but the problem can be overcome via software adjustment in a hybrid simulator.

Aim: We present a newly designed, localiser-free, head-mounted system featuring augmented reality as an aid to maxillofacial bone surgery, and assess the potential utility of the device by conducting a feasibility study and validation.Methods: Our head-mounted wearable system facilitating augmented surgery was developed as a stand-alone, video-based, see-through device in which the visual features were adapted to facilitate maxillofacial bone surgery. We implement a strategy designed to present augmented-reality information to the operating surgeon. LeFort1 osteotomy was chosen as the test procedure. The system is designed to exhibit virtual planning overlaying the details of a real patient. We implemented a method allowing performance of waferless, augmented-reality assisted bone repositioning. In vitro testing was conducted on a physical replica of a human skull, and the augmented reality system was used to perform LeFort1 maxillary repositioning. Surgical accuracy was measured with the aid of an optical navigation system that recorded the coordinates of three reference points (located in anterior, posterior right, and posterior left positions) on the repositioned maxilla. The outcomes were compared with those expected to be achievable in a three-dimensional environment. Data were derived using three levels of surgical planning, of increasing complexity, and for nine different operators with varying levels of surgical skill.Results: The mean error was 1.70 +/- 0.51 mm. The axial errors were 0.89 +/- 0.54 mm on the sagittal axis, 0.60 +/- 0.20 mm on the frontal axis, and 1.06 +/- 0.40 mm on the craniocaudal axis. The simplest plan was associated with a slightly lower mean error (1.58 +/- 0.37 mm) compared with the more complex plans (medium: 1.82 +/- 0.71 mm; difficult: 1.70 +/- 0.45 mm). The mean error for the anterior reference point was lower (1.33 +/- 0.58 mm) than those for both the posterior right (1.72 +/- 0.24 mm) and posterior left points (2.05 +/- 0.47 mm). No significant difference in terms of error was noticed among operators, despite variations in surgical experience. Feedback from surgeons was acceptable; all tests were completed within 15 min and the tool was considered to be both comfortable and usable in practice.Conclusion: We used a new localiser-free, head-mounted, wearable, stereoscopic, video see-through display to develop a useful strategy affording surgeons access to augmented reality information. Our device appears to be accurate when used to assist in waferless maxillary repositioning. Our results suggest that the method can potentially be extended for use with many surgical procedures on the facial skeleton. Further, our positive results suggest that it would be appropriate to proceed to in vivo testing to assess surgical accuracy under real clinical conditions. (C) 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Holmium Laser Enucleation of the Prostate (HoLEP) is an endoscopic transurethral surgical technique for Benign Prostatic Hyperplasia (BPH) treatment that carries significant benefits compared with the traditional Trans-Urethral Resection of the Prostate (TURP). In HoLEP procedure the portion of the prostate with hyperplasia (adenoma) is cut under endoscopic view. Only a few experts in the world perform HoLEP, since the adenoma borders are not clearly visible in the 2D endoscopic images and consequently the clinicians have difficulties to orientate the laser.Virtual reality navigators demonstrated their potentialities in many fields of surgery to show hidden structures to direct vision and to restore surgeon's orientation.3D trans-rectal ultrasound (US) probe allows acquiring volumetric information containing prostate and adenoma borders, which can be segmented and represented in a virtual environment. To coherently and real-time render the surgical instrument in respect to the patient anatomy, we can employ a tracking system. A crucial aspect of each navigation system regards the virtual scene ergonomics.We designed and implemented a pilot surgical navigation system to support the surgeons to accomplish the HoLEP, showing them the cutting plane and the outlines of adenoma and the prostatic capsule in respect of the surgical tool.Under supervision of an expert urologist we studied and tested the optimal way to realize an anthropomorphous US phantom. Furthermore our virtual reality surgical navigator provides various visualization modalities studied on the basis of clinical requirements.On the basis of our results it will be possible to perform in-vitro trails to evaluate the usability of our solution to precisely enucleate the adenoma along its borders.

PURPOSE:Vessel lumen centerline extraction is important for intraoperative tracking of abdominal vessels and guidance of endovascular instruments. Three-dimensional ultrasound has gained increasing acceptance as a safe and convenient surgical image guidance modality. We aimed to optimize vascular centerline detection and tracking in 3D ultrasound.METHOD:To overcome the intrinsic limitation of low ultrasound image quality, an active contour method (snake) was used to track changes in vessel geometry. We tested two variants of a classic snake using the image gradient and gradient vector field (GVF) as external forces. We validated these methods in liver ultrasound images of 10 healthy volunteers, acquired at three breath-holding instances during the exhalation phase. We calculated the distances between the vessel centerlines as detected by algorithms and a gold standard consisting of manual annotations performed by an expert.RESULTS:Both methods (GVF and image gradient) can accurately estimate the actual centerlines with average Euclidean distances of 0.77 and 1.24 mm for GVF and gradient, respectively. Both methods can automatically follow vessel morphology and position changes.CONCLUSIONS:The proposed approach is feasible for liver vessel centerline extraction from 3D ultrasound images. The algorithm can follow the movement of the vessels during respiration; further improvements of hardware components are needed for a real-time implementation.

BACKGROUND:The da Vinci robotic surgical telemanipulator has been utilized in several surgical specialties for varied procedures, and the users' experiences have been widely published. To date, no detailed system technical analyses have been performed.METHODS:A detailed review was performed of all publications and patents about the technical aspects of the da Vinci robotic system.RESULTS:Published technical literature on the da Vinci system highlight strengths and weaknesses of the robot design. While the system facilitates complex surgical operations and has a low malfunction rate, the lack of haptic (especially tactile) feedback and collisions between the robotic arms remain the major limitations of the system. Accurate, preplanned positioning of access ports is essential.CONCLUSION:Knowledge of the technical aspects of the da Vinci robot is important for optimal use. We confirmed the excellent system functionality and ease of use for surgeons without an engineering background. Research and development of the surgical robot has been predominant in the literature. Future trends address robot miniaturization and intelligent control design.

BACKGROUND:Endovascular procedures are nowadays limited by difficulties arising from the use of 2D images and are associated with dangerous X-ray exposure and the injection of nephrotoxic contrast medium.METHODS:An electromagnetic navigator is proposed to guide endovascular procedures with reduced radiation dose and contrast medium injection. Five DOF electromagnetic sensors are calibrated and used to track in real time the positions and orientation of endovascular catheters and guidewires, while intraoperative 3D rotational angiography is used to acquire 3D models of patient anatomy. A preliminary prototype is developed to prove the feasibility of the system using an anthropomorphic phantom.RESULTS:The spatial accuracy of the system was evaluated during 70 targeting trials obtaining an overall accuracy of 1.2 ± 0.3 mm; system usability was positively evaluated by three surgeons.CONCLUSIONS:The strategy proposed to sensorize endovascular instruments paves the way for the development of surgical strategies with reduced radiation dose and contrast medium injection. Further in vitro, animal and clinical experiments are necessary for complete surgical validation.