First Ex Vivo Animal Study of a Biological Heart Valve Prosthesis Sensorized with Intravalvular Impedance

IntraValvular Impedance (IVI) sensing is an innovative concept for monitoring heart valve prostheses after implant. We recently demonstrated IVI sensing feasible in vitro for biological heart valves (BHVs). In this study, for the first time, we investigate ex vivo the IVI sensing applied to a BHV when it is surrounded by biological tissue, similar to a real implant condition. A commercial model of BHV was sensorized with three miniaturized electrodes embedded in the commissures of the valve leaflets and connected to an external impedance measurement unit. To perform ex vivo animal tests, the sensorized BHV was implanted in the aortic position of an explanted porcine heart, which was connected to a cardiac BioSimulator platform. The IVI signal was recorded in different dynamic cardiac conditions reproduced with the BioSimulator, varying the cardiac cycle rate and the stroke volume. For each condition, the maximum percent variation in the IVI signal was evaluated and compared. The IVI signal was also processed to calculate its first derivative (dIVI/dt), which should reflect the rate of the valve leaflets opening/closing. The results demonstrated that the IVI signal is well detectable when the sensorized BHV is surrounded by biological tissue, maintaining the similar increasing/decreasing trend that was found during in vitro experiments. The signal can also be informative on the rate of valve opening/closing, as indicated by the changes in dIVI/dt in different dynamic cardiac conditions

Augmented reality for orthopedic and maxillofacial oncological surgery: a systematic review focusing on both clinical and technical aspects

This systematic review offers an overview on clinical and technical aspects of augmented reality (AR) applications in orthopedic and maxillofacial oncological surgery. The review also provides a summary of the included articles with objectives and major findings for both specialties. The search was conducted on PubMed/Medline and Scopus databases and returned on 31 May 2023. All articles of the last 10 years found by keywords augmented reality, mixed reality, maxillofacial oncology and orthopedic oncology were considered in this study. For orthopedic oncology, a total of 93 articles were found and only 9 articles were selected following the defined inclusion criteria. These articles were subclassified further based on study type, AR display type, registration/tracking modality and involved anatomical region. Similarly, out of 958 articles on maxillofacial oncology, 27 articles were selected for this review and categorized further in the same manner. The main outcomes reported for both specialties are related to registration error (i.e., how the virtual objects displayed in AR appear in the wrong position relative to the real environment) and surgical accuracy (i.e., resection error) obtained under AR navigation. However, meta-analysis on these outcomes was not possible due to data heterogenicity. Despite having certain limitations related to the still immature technology, we believe that AR is a viable tool to be used in oncological surgeries of orthopedic and maxillofacial field, especially if it is integrated with an external navigation system to improve accuracy. It is emphasized further to conduct more research and pre-clinical testing before the wide adoption of AR in clinical settings

Development of a CO2 sensor for extracorporeal life support applications

Measurement of carbon dioxide (CO2) in medical applications is a well-established method for monitoring patient’s pulmonary function in a noninvasive way widely used in emergency, intensive care, and during anesthesia. Even in extracorporeal-life support applications, such as Extracorporeal Carbon Dioxide Removal (ECCO2R), Extracorporeal Membrane Oxygenation (ECMO), and cardiopulmonary by-pass (CPB), measurement of the CO2 concentration in the membrane oxygenator exhaust gas is proven to be useful to evaluate the treatment progress as well as the performance of the membrane oxygenator. In this paper, we present a new optical sensor specifically designed for the measurement of CO2 concentration in oxygenator exhaust gas. Further, the developed sensor allows measurement of the gas flow applied to the membrane oxygenator as well as the estimation of the CO2 removal rate. A heating module is implemented within the sensor to avoid water vapor condensation. Effects of temperature on the sensor optical elements of the sensors are disclosed, as well as a method to avoid signal–temperature dependency. The newly developed sensor has been tested and compared against a reference device routinely used in clinical practice in both laboratory and in vivo conditions. Results show that sensor accuracy fulfills the requirements of the ISO standard, and that is suitable for clinical applications

An Update of Eyeglasses-Supported Nasal–Facial Prosthetic Rehabilitation of Cancer Patients with Post-Surgical Complications: A Case Report

Featured Application: This case report aims to describe an update of the digital protocol for the fabrication of a facial prosthesis for those patients who cannot be rehabilitated with plastic surgery because of post-surgical complications after maxillofacial surgery. In detail, it describes the application of the digital protocol to a mid-facial defect. The innovation proposed is oriented to simplify the procedures and reduce the time and cost of the process, aiming to recover the quality of life of inoperable patients. This case report aims to describe novel steps in the digital design/manufacturing of facial prostheses for cancer patients with wide inoperable residual defects, with a focus on a case of a mid-facial defect. A facial scanner was used to make an impression of the post-surgical residual defect and to digitalize it. The daughter’s face scan was used for reconstructing the missing anatomy. Using 3D printing technologies, try-in prototypes were produced in silicone material. The substructure was laser melted. The final prosthesis was relined directly onto the patient’s defect. The prosthesis resulted in a very low weight and a high elasticity of the external margins. The laser-melted substructure ensured the necessary rigidity with minimum thickness

Pretreatment Tumor Volume and Tumor Sphericity as Prognostic Factors in Patients with Oral Cavity Squamous Cell Carcinoma: A Prospective Clinical Study in 95 Patients

The prognostic impact of tumor volume and tumor sphericity was analyzed in 95 patients affected by oral cancer. The pre-operative computed tomography (CT) scans were used to segment the tumor mass with threshold tools, obtaining the corresponding volume and sphericity. Events of recurrence and tumor-related death were detected for each patient. The mean follow-up time was 31 months. A p-value of 0.05 was adopted. Mean tumor volume resulted higher in patients with recurrence or tumor-related death at the Student's t-test (respectively, 19.8 cm(3) vs. 11.1 cm(3), p = 0.03; 23.3 cm(3) vs. 11.7 cm(3), p = 0.02). Mean tumor sphericity was higher in disease-free patients (0.65 vs. 0.59, p = 0.04). Recurrence-free survival and disease-specific survival were greater for patients with a tumor volume inferior to the cut-off values of 21.1 cm(3) (72 vs. 21 months, p < 0.01) and 22.4 cm(3) (85 vs. 32 months, p < 0.01). Recurrence-free survival and disease-specific survival were higher for patients with a tumor sphericity superior to the cut-off value of 0.57 (respectively, 49 vs. 33 months, p < 0.01; 56 vs. 51 months, p = 0.01). To conclude, tumor volume and sphericity, three-dimensional parameters, could add useful information for better stratification of prognosis in oral cancer

Augmented Reality to Assist in the Diagnosis of Temporomandibular Joint Alterations

Augmented Reality (AR) is an increasingly prominent technology with diverse applications across various surgical disciplines. This study aims to develop and assess the feasibility of a novel AR application intended to aid surgeons in the clinical assessment of temporomandibular joint (TMJ) alterations necessitating surgical intervention. The application employs a multi-modality tracking approach, combining both marker-less and marker-based tracking techniques to concurrently track the fixed portion of the joint and the movable mandible involved in TMJ. For the marker-based tracking both a planar marker with a binary QR-code pattern and a cuboid marker that contains a unique QR-code pattern on each face were tested and compared. The AR application was implemented for the HoloLens 2 head-mounted display and validated on a healthy volunteer performing the TMJ task, i.e. the opening and closing of the mouth. During the task, video recordings from the HoloLens cameras captured the horizontal and vertical excursions of the jaw movements (TMJ movements) using virtual markers anchored to the AR-displayed virtual anatomies. For validation, the video-recorded TMJ movements during AR viewing were compared with standard kinesiographic acquisitions. The findings demonstrated the consistency between the AR-derived trajectories and the kinesiography curves, especially when using the cubic Multi Target tracker to follow the moving mandible. Finally, the AR application was experienced on a patient and it was extremely useful for the surgeon to diagnose alterations in the normal kinematics of the TMJ. Future efforts should be addressed to minimize the bulkiness of the tracker and provide additional visual cues for surgeons

CathROB: A Highly Compact and Versatile Remote Catheter Navigation System

Several remote catheter navigation systems have been developed and are now commercially available. However, these systems typically require specialized catheters or equipment, as well as time-consuming operations for the system set-up. In this paper, we present CathROB, a highly compact and versatile robotic system for remote navigation of standard tip-steerable electrophysiology (EP) catheters. Key features of CathROB include an extremely compact design that minimizes encumbrance and time for system set-up in a standard cath lab, a force-sensing mechanism, an intuitive command interface, and functions for automatic catheter navigation and repositioning. We report in vitro and in vivo animal evaluation of CathROB. In vitro results showed good accuracy in remote catheter navigation and automatic repositioning (1.5\u2009\ub1\u20090.6\u2009mm for the left-side targets, 1.7\u2009\ub1\u20090.4\u2009mm for the right-side targets). Adequate tissue contact was achieved with remote navigation in vivo. There were no adverse events, including absence of cardiac perforation or cardiac damage, indicative of the safety profile of CathROB. Although further preclinical and clinical studies are required, the presented CathROB system seems to be a promising solution for an affordable and easy-to-use remote catheter navigation

Review on Augmented Reality in Oral and Cranio-Maxillofacial Surgery: Toward 'Surgery-Specific' Head-Up Displays

In recent years, there has been an increasing interest towards the augmented reality as applied to the surgical field. We conducted a systematic review of literature classifying the augmented reality applications in oral and cranio-maxillofacial surgery (OCMS) in order to pave the way to future solutions that may ease the adoption of AR guidance in surgical practice. Publications containing the terms 'augmented reality' AND 'maxillofacial surgery', and the terms 'augmented reality' AND 'oral surgery' were searched in the PubMed database. Through the selected studies, we performed a preliminary breakdown according to general aspects, such as surgical subspecialty, year of publication and country of research; then, a more specific breakdown was provided according to technical features of AR-based devices, such as virtual data source, visualization processing mode, tracking mode, registration technique and AR display type. The systematic search identified 30 eligible publications. Most studies (14) were in orthognatic surgery, the minority (2) concerned traumatology, while 6 studies were in oncology and 8 in general OCMS. In 8 of 30 studies the AR systems were based on a head-mounted approach using smart glasses or headsets. In most of these cases (7), a video-see-through mode was implemented, while only 1 study described an optical-see-through mode. In the remaining 22 studies, the AR content was displayed on 2D displays (10), full-parallax 3D displays (6) and projectors (5). In 1 case the AR display type is not specified. AR applications are of increasing interest and adoption in oral and cranio-maxillofacial surgery, however, the quality of the AR experience represents the key requisite for a successful result. Widespread use of AR systems in the operating room may be encouraged by the availability of 'surgery-specific' head-mounted devices that should guarantee the accuracy required for surgical tasks and the optimal ergonomics

A novel non-invasive device for the assessment of central venous pressure in hospital, office and home

Background: Venous congestion can be quantified by central venous pressure (CVP) and its monitoring is crucial to understand and follow the hemodynamic status of patients with cardio-respiratory diseases. The standard technique for CVP measurement is invasive, requiring the insertion of a catheter into a jugular vein, with potential complications. On the other hand, the current non-invasive methods, mainly based on ultrasounds, remain operator-dependent and are unsuitable for use in the home environment. In this paper, we will introduce a novel, non-invasive device for the hospital, office and home assessment of CVP. Methods: After describing the measurement concept, we will report a preliminary experimental study enrolling 5 voluntary healthy subjects to evaluate the VenCoM measurements’ repeatability, and the system’s capability in measuring small elicited venous pressure variations (2 mmHg), as well as an induced venous hypertension within a pathological range (12÷20 mmHg). Results: The experimental measurements showed a repeatability of ±1mmHg. The VenCoM device was able to reliably detect the elicited venous pressure variations and the simulated congestive status. Discussion and Conclusion: The proposed non-invasive VenCoM device is able to provide a fast and repeatable CVP estimate, having a wide spectrum of potential clinical applications, including the monitoring of venous congestion in heart failure patients and in subjects with renal and hepatic dysfunction, as well as pulmonary hypertension (PH) that can be extended to pneumonia COVID-19 patients even after recovery. The device needs to be tested further on a large sample size of both healthy and pathological subjects, to systematically validate its reliability and impact in clinical setting

Volumetric Analysis of Aortic Changes after TEVAR Using Three-Dimensional Virtual Modeling

TEVAR (thoracic endovascular aortic repair) is the preferred approach for treating descending thoracic aortic aneurysm (DTAA). After the procedure, patients require lifelong CTA (computed tomography angiography) follow-up to monitor the aorta’s remodeling process and the possible development of associated complications. With CTA, the aorta is usually measured with maximum diameters taken at specific locations, and even in experienced centers, this type of evaluation is prone to inter-observer variability. We introduce a new volumetric analysis of aortic changes after TEVAR using three-dimensional (3D) anatomical models. We applied the volumetric analysis to 24 patients who underwent TEVAR for DTAA. For each patient, the descending thoracic aorta was evaluated using both the maximum diameter from CTA and the volume from 3D reconstructions, at discharge and 12 months after TEVAR. Both volume and diameter evaluations were then related to the development of TEVAR complications. The group with TEVAR-related complications showed a 10% volume increase in the descending aorta, while the group with no TEVAR-related complications only had a 1% increase. An increase of 40 mL in the descending aorta volume at 12 months seemed to be predictive of complications, with 94% specificity and 75% sensitivity. Volumetric analysis is a promising method for monitoring DTAA remodeling after TEVAR, and it may help in the early identification of high-risk patients who may benefit from a stricter follow-up, even if further evaluations on a larger sample size are required to confirm these preliminary results