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Purpose To evaluate safety and diagnostic accuracy of gadoteridol vs. other macrocyclic gadolinium-based contrast agents (GBCAs) in a large cohort of consecutive and non-selected patients referred for CE-MRI of the CNS. Material and methods Between November 2017 and March 2018, we prospectively enrolled a consecutive cohort of patients referred for neuroradiological CE-MRI (1.5 T MRI). Image quality and adverse events were assessed. Diagnostic performance was determined for a subgroup of patients with truth standard findings available. Comparison was made between patients receiving gadoteridol and patients receiving other macrocyclic GBCAs. Inter-reader agreement (kappa) between two expert neuroradiologists was calculated for the diagnosis of malignancy. Results Overall, 460 patients (220 M/240F; mean age 54 ± 16 years) were enrolled of which 230 received gadoteridol (Group 1) and 230 either gadoteric acid or gadobutrol [n = 83 (36.1%) and n = 147 (63.9%), respectively; Group 2]. Image quality was rated as good or excellent in both groups. The sensitivity, specificity and diagnostic accuracy for determination of malignancy was 88.2%, 96.5% and 95.4%, respectively, for Group 1 and 93.7%, 97.4% and 96.9%, respectively, for Group 2, with no significant differences between groups (P > 0.75) for any determination. Inter-reader agreement for the identification of malignancy was excellent [K = 0.877 (95%CI: 0.758–0.995) and K = 0.818 (95%CI: 0.663–0.972) for groups 1 and 2, respectively; P = 0.0913]. Adverse events occurred in 5 of 460 (1.09%) patients overall, with no significant difference (P = 0.972) between groups. Conclusion Gadoteridol was safe and guaranteed good image quality without significant differences when compared to gadobutrol and gadoteric acid in a wide range of CNS pathologies.

Background Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

The ACC/TVT score is a specific predictive model of in-hospital mortality for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to test its predictive accuracy in comparison with standard surgical risk models (Logistic Euroscore, Euroscore II, and STS-PROM) in the population of TAVI patients included in the multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) registry. The study cohort included 3293 patients who underwent TAVI between 2008 and 2019. The 4 risk scores were calculated for all patients. For all scores, the capability to predict 30-day mortality was assessed by means of several analyses testing calibration and discrimination. The ACC/TVT score showed moderate discrimination, with a C-statistics for 30-day mortality of 0.63, not significantly different from the standard surgical risk models. The ACC/TVT score demonstrated, in contrast, better calibration compared with the other scores, as proved by a greater correspondence between estimated probabilities and the actual observations. However, when the ACC/TVT score was tested in the subgroup of patients treated in a more contemporary period (from 2016 on), it revealed a slight tendency to lose discrimination and to overestimate mortality risk. In conclusion, in comparison with the standard surgical risk models, the ACC/TVT score demonstrated better prediction accuracy for estimation of 30-day mortality in terms of calibration. Nevertheless, its predictive reliability remained suboptimal and tended to worsen in patients treated more recently.

The Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the risk analysis techniques proposed by the ISO 14971 Standard. This analysis allows to identify and assess the consequences of faults that affect each component of a complex system. The FMECA is a forward-type technique used for highlighting critical points and classifying them by priority. It also makes it possible to evaluate the extent of failures by means of numerical indices. It can be applied to a product or to a work process. In the latter case we talk about Process-FMECA. The application of the Process-FMECA to bioengineering is of particular interest because this procedure provides an analysis related to risk management during all the different phases of the medical device life cycle. However, practical applications of this method have revealed some shortcomings that can lead to inaccuracies and inconsistencies regarding the risk analysis and consequent risk prioritization. This paper presents an example of application of a Fuzzy Process-FMECA, an improved Process-FMECA based on fuzzy logic, to a small computerized tomography (CT) device prototype designed for studying the extremities of the human body. This prototype is a CT device that uses the Cone Beam CT (CBCT) technology. The Fuzzy Process-FMECA analysis has made it possible to produce a table of risks, that are quantified according to the specifications of the method. The analysis has shown that each phase or activity is fundamental to guarantee a correct functioning of the device. The methodology applied to this specific device can be paradigmatic for analyzing the process risks for any other medical device.

AIM To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR). METHODS We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs.

The differential outcomes across the age spectrum of transcatheter aortic valve implantation (TAVI) recipients are still debated. Aim of the study was to evaluate the clinical outcomes of oldest-old patients undergoing TAVI in the large "Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea (RISPEVA)" registry. A total of 3,507 patients were stratified according to age: 1,381 were ≥85 years, 2,126 were85 years. Primary endpoints were death at 30-days and complete follow-up (FU) (medium 368 days). Cerebrovascular events, myocardial infarction, bleedings, vascular complications at 30-days and complete FU were considered. In the unadjusted analysis, 30-days mortality in the oldest-old group was higher than in younger patients (4.2% vs 2.4%; p = 0.007); this difference kept true also at complete FU (19.6% vs 15.9%; p = 0.014). After propensity score (PS) matching, the oldest-old population showed a higher mortality solely at 30-days (4.7% vs 2.4%; p = 0.016), while the survival at complete FU was similar to that of younger patients (20.1% vs 18.0%; p = 0.286). The incidence of non-fatal outcomes resulted comparable between the 2 groups, also after propensity score matching. At the multivariate logistic regression analysis procedural major or disabling bleedings, cerebrovascular events, cardiogenic shock resulted predictors of 30-days death in the oldest-old cohort. In conclusion, patients ≥85 years can safely undergo TAVI being not more exposed to procedural complications than those85 years; nevertheless they showed worse 30-days mortality, probably driven by reduced tolerance to complications. Passed the critical periprocedural phase, patients ≥85 years had a similar survival to those85 years with comparable risk profile.

Network functions virtualization (NFV) attributes to the substitute of network functions on dedicated appliances such as load balancers and routers with the use of virtualized instances running as software. Any enterprise can easily implement a wide array of network functions using NFV while maximizing efficiencies and introducing new revenue-generating services that are significantly faster and easier than ever before. NFV is a key enabler of the coming 5G infrastructure, supporting the virtualization of various appliances in the network. The scope of this document is to provide a comprehensive overview of the development of NFV-based services, media services in particular, and their specific requirements that are addressed in existing service development kits (SDKs). By supplying an overview of available tools, the development workflow of an example use case on immersive media is demonstrated with an SDK that provides a set of open source tools facilitating the development of media applications.

Objectives The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR). Background Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality. Methods Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019. Results Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in “valve-in-valve” procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia Conclusions In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI.

A cutting-edge method to assess the status of photoreceptors is represented by chromatic pupillometry, which consists in stimulating the eyes of the patients with light of different wavelengths and intensities. The signals of the dynamics of the pupil after the optical stimulations can be approximated by a 2nd-order linear model. Fitting parameters are established by a weighted least-squares algorithm, in order to achieve the correct estimate of the shape of the pupillometric data. Results presented in this work indicate that our model is able to capture the dynamics of pupillometric signals.

The use of chromatic pupil responses may be a novel way to diagnose and monitor diseases affecting either the outer or inner retina. Here we developed a model-based approximation of the dynamics of pupillary diameter after an optical stimulation; we assume the response of the pupil is approximated as the output of a 2nd-order linear model. Model parameters are identified by using a least-squares fitting procedure, thus obtaining an optimal estimate of the activation time and of the shape of the pupil response to the stimulation. Results indicate the model adequately represents the curve shape; despite the presence of artifacts, that hinder the fitting procedure, a significant difference in the time constants of the model of controls and of patients is present.

Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clini​caltr​ials.gov ; Unique identifier: NCT02713932.

Inherited retinal diseases cause severe visual deficits in children. They are classified in outer and inner retina diseases, and often cause blindness in childhood. The diagnosis for this type of illness is challenging, given the wide range of clinical and genetic causes (with over 200 causative genes). It is routinely based on a complex pattern of clinical tests, including invasive ones, not always appropriate for infants or young children. A different approach is thus needed, that exploits Chromatic Pupillometry, a technique increasingly used to assess outer and inner retina functions. This paper presents a novel Clinical Decision Support System (CDSS), based on Machine Learning using Chromatic Pupillometry in order to support diagnosis of Inherited retinal diseases in pediatric subjects. An approach that combines hardware and software is proposed: a dedicated medical equipment (pupillometer) is used with a purposely designed custom machine learning decision support system. Two distinct Support Vector Machines (SVMs), one for each eye, classify the features extracted from the pupillometric data. The designed CDSS has been used for diagnosis of Retinitis Pigmentosa in pediatric subjects. The results, obtained by combining the two SVMs in an ensemble model, show satisfactory performance of the system, that achieved 0.846 accuracy, 0.937 sensitivity and 0.786 specificity. This is the first study that applies machine learning to pupillometric data in order to diagnose a genetic disease in pediatric age.

COVID-19 pandemic is plaguing the world and representing the most significant stress test for many national healthcare systems and services, since their foundation. The supply-chain disruption and the unprecedented request for intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions for the prevention, treatment and management of this disease which is involving a large amount of people. Every day, new Do-It-Yourself (DIY) solutions regarding personal protective equipment and medical devices populate social media feeds. Many companies (e.g., automotive or textile) are converting their traditional production to manufacture the most needed equipment (e.g., respirators, face shields, ventilators etc.). In this chaotic scenario, policy makers, international and national standards bodies, along with the World Health Organization (WHO) and scientific societies are making a joint effort to increase global awareness and knowledge about the importance of respecting the relevant requirements to guarantee appropriate quality and safety for patients and healthcare workers. Nonetheless, ordinary procedures for testing and certification are currently questioned and empowered with fast-track pathways in order to speed-up the deployment of new solutions for COVID-19. This paper shares critical reflections on the current regulatory framework for the certification of personal protective equipment. We hope that these reflections may help readers in navigating the framework of regulations, norms and international standards relevant for key personal protective equipment, sharing a subset of tests that should be deemed essential even in a period of crisis.

The paper presents the main outcomes and future development of the INCEPTION project, “Inclusive Cultural Heritage in Europe through 3D semantic modelling”, funded by the European Commission under the Horizon 2020 Work Programme Europe in a changing world – inclusive, innovative and reflective Societies (Call Reflective-7-2014, Advanced 3D modelling for accessing and understanding European cultural assets) and completed in May 2019. In particular, the key-targeted project achievement will be presented: a specific cloud-based platform conceived to accomplish the main objectives of accessing, understanding and strengthening European Cultural Heritage by means of enriched 3D models. The need for digital data interpretation, in addition to documentation, guided the overall process of the cross-disciplinary work methodology, based on new methods and tools for 3D surveying and H-BIM modelling, new approaches and methodologies for Cultural Heritage 3D data inclusive access and exploitation by means of the Platform.

The increasing application of digital technologies to cultural heritage (CH) is wide and well documented, including a variety of tools such as digital archives, online guides, HBIM repositories. Several vocabularies and ontologies were designed to order heritage data and make CH more accessible and exploitable. However, these tools have often focused on a particular dimension of CH producing high value in separate sectors (e.g. access to conservation of historic buildings, data valorisation for restoration of heritage assets) but lacking ways for adapting or replicating the model to urban complex systems. Moreover, many studies and tools show large effort in cataloguing and archiving, but less in providing tools for designing and managing. The ROCK platform, developed within the Horizon 2020 (H2020) funded project ROCK (GA 730280), addresses the need for a management and intervention-oriented interoperable tool, aimed at storing, visualizing, elaborating and linking data on cultural heritage. The use of already existing ontologies was not sufficient for developing a tool to deal with the complexity of urban systems and heterogeneous data sources. Instead, a participative methodology was set in place for the development of a context-based semantic framework to define the needs and requirements of heritage-led regeneration actions.

Chromatic Pupillometry represents a novel approach for the assessment of Inherited Retinal Diseases. A multi-centric pilot study with a sample of 40 paediatric patients has been designed, involving physicians and engineers. In this paper, the Electronic Medical Record, named ORAO and specifically developed to collect ophthalmologic and pupillometric data, is presented. The platform is a cloud- based application, with a RESTful and three-tier architecture. These features make it available via web for the ophthalmologists involved in the project and working in two different University centres. The platform has been designed by the whole team and developed by the Department of Information Engineering of the University of Florence. The interfaces of the medical record have been evaluated in term of Usability, according to standards. An Heuristic Evaluation has been performed in the first stage of the design of the platform and the main severe usability issues have been addressed. The outcome of the project is a customized software solution. Moreover, the physicians have an excellent attitude toward the use of ORAO and they perceive it as a useful tool to gather the data they collect with the aim of evaluating the overall progression of the pilot study.

Chromatic pupillometry represents a pioneering approach to the evaluation of inherited ocular diseases in childhood and a pilot study has been designed to evaluate its clinical utility. The physicians involved in the project belong to two different University centres: the data they gather must be collected in an electronic medical record reachable via web. Therefore, a specified medical record has been designed. It has been realized as a .NET application with RESTful architecture. The user-interfaces have been built with the aim to reduce the risk of error and with particular attention to usability, according to standards. Each web page of the medical record has been made as user-friendly as possible. Thanks to these characteristics, the physicians have a good attitude toward the use of the electronic medical record as a way to improve the progression of the pilot study.

BACKGROUND Bioresorbable scaffolds (BRS) have been introduced to overcome the limitations of drug-eluting stents and the ABSORB (Everolimus-eluting BRS, Abbott Vascular, Santa Clara, CA) was the most extensively tested. Nevertheless, major RCTs reported higher rates of target lesion failures and BRS thrombosis at 3 years follow-up, bringing to the withdrawing of the device from the market. It has been suggested that a better lesions selection and an optimized implantation technique could mitigate the displayed adverse results. METHODS Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 4 years. Endpoint of interest was the target lesion failure (TLF), a composite outcome including cardiac death, target vessel myocardial infarction and target lesion revascularization. RESULTS A total of 62 patients with a mean age of 55±8.5 years were analysed of which 70.9% presented with an acute coronary syndrome and 59.6% with myocardial infarction. A total of 100 lesions were treated and 51.6% were complex (B2/C). Predilatation was performed in all the case, post-dilatation in 74.1%. All the target vessel reference diameter (RVD) were > 2.5 mm (average RVD 3.2 ± 0.24 mm). At 4 years, the rate for TLF was 6.9%. Subgroups analysis did not show significative differences among groups although consistently higher event rates were found for RVD < 2.5 mm (12.6 vs 6.4% p 0.5), BRS overlapping (11.8 vs 5% p 0.2) and Ticagrelor instead of Clopidogrel on top of Cardioaspirin (9.1 vs 3% p 0.2). CONCLUSIONS This small-sized real-world registry displays lower rates of clinical events during long-term follow-up in respect to previous studies. The avoidance of implantation in small vessels, inclusion of acute myocardial infarction and extensive performance of BRS post-dilatation could explain the observed better results. Long term outcomes of the ongoing ABSORB IV trial are needed to confirm this data.

This article presents a Computer Aided Facility Management informative system which can output Key Performance Indicators and quantitative parameters about the analysed healthcare facility. The designed system is a self-sufficient application able to manage and analyse digital plans of hospital buildings with no need of third-party plugins or licenses. The system maps hospital’s inner organisation, destinations of use and environmental comforts giving quantitative, qualitative and graphical reports. The core database is linked to other existing hospital databases, so that the system can act as a central control cockpit. Outputs can be used by top-management and decisional staff as a decision-support tool in order to improve hospital’s structure and organisation and to reduce the major workflow risks. Furthermore, many plug-ins and modules have been developed through the years which can be easily linked to the main application thanks to its REST architecture, and which contribute to a complete analysis and management of the healthcare facilities.

The identification and classification of the risks associated with the use of electromedical equipment is a critical part of its design, requiring the application of precise methods to analyse such risks. The result of this analysis leads to the preparation of documents assessing all possible risks associated with the manufacture of electromedical devices, from design to production and final use, including installation and maintenance activities, and after-sales surveillance. This process translates into a guarantee of device reliability. The more that is done to make the device design safe, the greater its reliability will be and the lower the frequency of failures. Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the many risk analysis techniques proposed by the ISO 14971 standard. This method makes it possible to identify and evaluate the consequences of the failure of each component in a complex system and to quantify the extent of each failure using numerical indices. This paper describes the application of this methodology to a small Computer Tomography (CT) prototype device designed to investigate the extremities of the human body. This prototype uses Cone Beam CT (CBCT) technology, employing a divergent, cone shaped X-ray beam rather than the classic fan-shaped beam. A special bed is used in conjunction with the CT scanner to support the patient. This bed is not merely an added accessory but is part of a complex system.

The use of left ventricular assist devices (LVADs) as a bridge-to-transplant or destination therapy in patients with end-stage heart failure has been increased during the last years. However, a pot...

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. Background: Data on pacemaker insertion complicating TAVR in women are scarce. Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85–7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30–0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9–16] days in PPI vs. 9 [7–14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adjHR 0.95, 95% CI 0.60–1.52, p = 0.84 and adjHR 1.22, 95% CI 0.83–1.79, p = 0.31, respectively). Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Funding Acknowledgements Type of funding sources: None. Background Ventricular arrhythmias in athletes represent an important issue in sport eligibility as they may be a marker of a concealed cardiomyopathy, potentially at risk of sudden cardiac death during sport activity. Purpose to assess the utility of cardiac magnetic resonance (CMR) to identify cardiac abnormalities in athletes with documented frequent premature ventricular beats (PVB) or complex ventricular arrhythmias (VA) undergoing competitive sport eligibility screening. Methods We enrolled 65 athletes with documented ventricular arrhythmias as follows: 1) frequent PVB at 24-hour ambulatory ECG monitoring (>100 PVB/24h); 2) polymorphic PVB; 3) repetitive PVB (couplets, triplets, or nonsustained ventricular tachicardia). All athletes were studied with rest ECG, exercise stress testing, 24-hour ambulatory ECG monitoring, transthoracic echocardiography and contrast-enhanced CMR. Results Sixty-five athletes (56 males, 9 females, age 30 ± 15years) underwent CMR with gadolinium contrast. In 55 patients (84.6%) CMR was normal, in 10 patients (15.4%) the following abnormalities were reported at CMR: four patients with isolated late gadolinium enhancement (LGE) of whom 3 patients with subepicardial LGE in the inferolateral wall and 1 patient with intramyocardial basal inferior LGE; 1 patient with hypertrophic cardiomyopathy with septal LGE; 1 patient with left ventricular non compaction; 3 patients with right ventricular abnormalities (a 13-year-old patient with dilated right ventricle and LGE located at the superior interventricular insertion point, 1 patient with a dilated and hypokinetic right ventricle, 1 patient with a focal right ventricular aneurysm). Transthoracic echocardiography was normal in 7/10 (70%) athletes with CMR abnormalities. Conclusion In athletes with frequent or complex ventricular arrhythmias cardiac magnetic resonance identifies cardiac abnormalities in a significant proportion of subjects and it may offer a diagnostic incremental value.

A health technology assessment (HTA) is commonly defined as a multidisciplinary approach used to evaluate medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. To help inform HTA recommendations, the surveillance of social media platforms can provide important insights to the clinical community and to decision makers on the effectiveness and safety of the use of health technologies on a patient. A scoping review of the published literature was performed to gain some insight on the accuracy and automation of sentiment analysis (SA) used to assess public opinion on the use of health technologies. A literature search of major databases was conducted. The main search concepts were SA, social media, and patient perspective. Among the 1,776 unique citations identified, 12 studies that described the use of SA methods to evaluate public opinion on or experiences with the use of health technologies as posted on social media platforms were included. The SA methods used were either lexicon-or machine learning-based. Two studies focused on medical devices, three examined HPV vaccination, and the remaining studies targeted drug therapies. Due to the limitations and inherent differences among SA tools, the outcomes of these applications should be considered exploratory. The results of our study can initiate discussions on how the automation of algorithms to interpret public opinion of health technologies should be further developed to optimize the use of data available on social media.\ud

Objectives: To determine interobserver variability in axillary nodal contouring in breast cancer (BC) radiotherapy (RT) by comparing the clinical target volume of participating single centres (SC-CTV) with a gold-standard CTV (GS-CTV). Methods: The GS-CTV of three patients (P1, P2, P3) with increasing complexity was created in DICOM format from the median contour of axillary CTVs drawn by BC experts, validated using the simultaneous truth and performance-level estimation and peer-reviewed. GS-CTVs were compared with the correspondent SC-CTVs drawn by radiation oncologists, using validated metrics and a total score (TS) integrating all of them. Results: Eighteen RT centres participated in the study. Comparative analyses revealed that, on average, the SC-CTVs were smaller than GS-CTV for P1 and P2 (by −29.25% and −27.83%, respectively) and larger for P3 (by +12.53%). The mean Jaccard index was greater for P1 and P2 compared to P3, but the overlap extent value was around 0.50 or less. Regarding nodal levels, L4 showed the highest concordance with the GS. In the intra-patient comparison, L2 and L3 achieved lower TS than L4. Nodal levels showed discrepancy with GS, which was not statistically significant for P1, and negligible for P2, while P3 had the worst agreement. DICE similarity coefficient did not exceed the minimum threshold for agreement of 0.70 in all the measurements. Conclusions: Substantial differences were observed between SC- and GS-CTV, especially for P3 with altered arm setup. L2 and L3 were the most critical levels. The study highlighted these key points to address. Advances in knowledge The present study compares, by means of validated geometric indexes, manual segmentations of axillary lymph nodes in breast cancer from different observers and different institutions made on radiotherapy planning CT images. Assessing such variability is of paramount importance, as geometric uncertainties might lead to incorrect dosimetry and compromise oncological outcome.

Low-flow low-gradient aortic stenosis (LFLG AS) with reduced left ventricle ejection fraction (LVEF) is still a diagnostic and therapeutic challenge. The aim of this paper is to review the latest evidences about the assessment of the valvular disease, usually difficult because of the low-flow status, and the therapeutic options. Special emphasis is given to the available diagnostic tools for the characterization of LFLG AS without functional reserve at stress echocardiography and to the factors that clinicians should evaluate to choose between surgical aortic valve repair, transcatheter aortic valve implantation, or medical therapy.

Objective: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). Background: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. Methods: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. Results: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p =.002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p Conclusions: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

In this work, we combine Lithium Niobate on insulator with a silicon nitride layer to form strip-loaded waveguides that can take advantage of the strong nonlinear optical coefficients of lithium niobate and of the high refractive contrast and ease of processing of silicon nitride. We describe the design and fabrication of a Fabry-Perot cavity formed by Distributed Bragg Reflectors. We discuss the design trade-offs implicit in the realisation of such microcavities of this nature and demonstrate an experimental quality factor of 2300, which is to our knowledge, the highest experimentally reported result for such type of waveguide based Fabry-Perot cavity.

We demonstrate a novel form of induced transparency and associated slow light due to thermo-optic effect. The phenomenon provides group delay as high as 0.5 µs in a silicon photonic crystal cavity at room temperature.

Road Mapping (RM) is a variant of the commonly used Digital Subtraction Angiography (DSA). In this work we propose a Road Mapping algorithm in which the mask is extracted by means of vessels segmentation from DSA images. The algorithm extracts a two-dimensional map consisting of two values (black and white), to be superimposed on the live fluoroscopic image. A dedicated phantom has been created to develop the RM algorithm, simulating a circulatory system. A prototype algorithm is developed in Matlab R2018b in order to reach some preliminary results and compare different techniques. A Qt graphical interface is also developed for a fast and effective use of this new RDA approach to real veterinary fluoroscopies. Two workflows are presented, both succeeding in performing segmentation of the vessel. Their performances are compared and discussed.

The asset management of an insurance company is more complex than traditional portfolio management due to the presence of obligations that the insurance company must fulfill toward the clients. These obligations, commonly referred to as liabilities, are payments whose magnitude and occurrence are a byproduct of insurance contracts with the clients, and of portfolio performances.

Transcatheter aortic valve implantation (TAVI) has become first-line treatment for severe aortic valve stenosis in patients with moderate, high or prohibitive surgical risk. However, access site complications may occur more frequently in extreme body mass index (BMI) categories. The aim of this study was to describe the features and outcomes of patients undergoing TAVI in a comprehensive Italian prospective clinical registry, focusing on BMI classes.A national prospective database was queried for baseline, procedural, and outcome details of patients undergoing TAVI according to established BMI categories: underweight (BMI18.5 kg/mA total of 3075 subjects were included, 64 (2.1%) were underweight, 1319 (42.9%) were normal weight, 1152 (37.4%) were overweight, and 540 (17.6%) were obese. Several baseline differences were evident, including gender, diabetes mellitus, renal function, chronic obstructive pulmonary disease, surgical scores, and left ventricular ejection fraction (LVEF) (all P0.05). Several procedural differences were also evident, including percutaneous approach, predilation, prosthesis type and size (all P0.05), with postprocedural aortic regurgitation2+ significantly more common in underweight patients (P0.05). Nonetheless, unadjusted analysis for one-month outcomes showed similar rates for fatal and non-fatal outcomes, including MAE (all P0.05), with the notable exception of permanent pacemaker implantation, which was more common in higher BMI classes (P=0.010) Unadjusted analysis for long-term events showed an increased rate of death in underweight patients (P=0.024). Multivariable adjusted analysis confirmed the increased risk of permanent pacemaker implantation in obese patients (P=0.015 when comparing obese vs. normal weight subjects), but disproved differences in long-term mortality and other outcomes (P0.05 for all comparisons).Irrespective of BMI class, TAVI is associated with favorable outcomes in surgical high-risk risk patients, with the notable exclusion of permanent pacemaker implantation, which is significantly more common in obese subjects.

Background Female subjects constitute half of all transcatheter aortic valve implantation (TAVI) candidates, but the association between important comorbidities such as diabetes mellitus (DM) and clinical outcomes after TAVI remains unclear in this group. Method WIN-TAVI is a real-world international registry of exclusively female subjects undergoing TAVI. The study population was stratified into those with (DM) and those without DM (NDM). Valve Academic Research Consortium (VARC)-2 efficacy (composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or worsening congestive heart failure, or valve-related dysfunction) was the primary endpoint for this analysis. Results Of the 1012 subjects included in this study, 264 (26.1%) had DM at baseline. DM patients were younger but had a higher burden of comorbidities. There were no differences in VARC-2 efficacy events between DM and NDM patients at 30 days or 1 year. Conversely, patients with DM had a lower risk of VARC-2 life threatening bleeding at 30 days and 1 year after TAVI compared to NDM patients, which remained significant even after multivariable adjustment (HR, 0.34, 95% CI, 0.12–0.99; p = .047). In the subgroup analysis, insulin-dependent DM was not associated with an increased risk of adverse outcomes. Conclusions Among female patients undergoing TAVI, more than one-fourth of the subjects presented with DM. At 1-year follow-up, DM was associated with lower bleeding complications and no increase in the risk of other adverse events, including mortality, after TAVI.

Blood vessels 3D rendering has numerous applications, ranging from diagnosis to pre-procedural and surgical approaches as it enriches vessels visualization for the clinician. In this paper, we propose a 3D blood vessels segmentation method designed for use with a cone beam computed tomography (CBCT). The algorithm constitutes a module in the development of an angio-CT visualization system, based on augmented or virtual reality as instruments supporting and improving medical decisions.

This paper performs a feasibility analysis to find the best-fitting solution in terms of quality/price ratio for designing and developing a Real-Time Location System for Indoor Positioning inside healthcare facilities. In particular, an overall comparison of all the available solutions is done, highlighting pros and cons of each technology (WiFi, RFID, WLAN, Ultra-Wide Band, Bluetooth Low Energy, ZigBee, magnetic fields, infrareds, ultrasounds, computer-vision and Pedestrian Data-Reckoning) for accuracy, price, coverage, infrastructure development and installation, and maintenance. A preliminary scope-review is also produced, which summarizes the obtained outcomes in similar studies. In the results section the proposed system is illustrated via flowcharts and block diagrams, both for off-site and on-site scenarios.

Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), is an ongoing global pandemic with high morbidity and mortality.1 Patients with preexist...

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients undergoing surgical aortic valve replacement, while its prognostic role in transcatheter aortic valve replacement ...

OBJECTIVES A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.BACKGROUND Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.METHODS Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).RESULTS Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 +/- 10% for stentless ViV-TAVR vs. 6 +/- 9% for stented ViV-TAVR (and 8 +/- 10% for stentless ViV-TAVR vs. 3 +/- 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.CONCLUSIONS Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome. (C) 2019 by the American College of Cardiology Foundation.

Within the EU funded project INCEPTION – Inclusive Cultural Heritage in Europe through 3D semantic modelling, the key-targeted achievement is the development of a specific cloud based platform, in order to accomplish the main objectives of accessing, understanding and strengthening European Cultural Heritage by means of enriched 3D models. The whole INCEPTION project is based on the close connection between state-of-the-art architectural modeling technologies (BIM, Building Information Modeling) and the latest cutting-edge web technologies. The platform is grounded on semantic web technologies and makes extensive use of WebGL and RESTful APIs, in order to enrich heritage 3D models by using Semantic Web standards. The INCEPTION platform will be a space for interchange of information and for the dialogue among professionals, students, scholars, curators, non-expert users, etc. Furthermore, the Semantic Web structure interlinks the platform with external Cultural Heritage available linked data and makes it gradually enhanced by specific flexible data structures provided as project specific ontologies. The paper will describe solutions based on the match between BIM, Cloud and Semantic Web.

A preclinical insert for small animal simultaneous SPECT and MR imaging, in particular for imaging mouse brains, is presented. It consists of ten static magnetic resonance imaging (MRI)-compatible gamma cameras based on tiles of silicon photomultipliers readout by a multichannel ASIC and coupled to 5 cm $\boldsymbol \times $ 5 cm CsI(Tl) scintillators and to an MRI-compatible multipinhole collimator. Calibration and image reconstruction algorithm are illustrated. Mutual compatibility is demonstrated along with imaging performance that is comparable with other non-MR micro-SPECT systems: 0.9 mm tomographic spatial resolution across a transverse field of view of 15.6 mm, 12% energy resolution (at 140 keV), and 1105 cps/MBq sensitivity. Experimental results with phantoms (glass capillaries of 290 $ \mu \text{m}$ diameter and a mini Derenzo) are presented.

Controlling the optical response of a medium through suitably tuned coherent electromagnetic fields is highly relevant in a number of potential applications, from all-optical modulators to optical storage devices. In particular, electromagnetically induced transparency (EIT) is an established phenomenon in which destructive quantum interference creates a transparency window over a narrow spectral range around an absorption line, which, in turn, allows to slow and ultimately stop light due to the anomalous refractive index dispersion. Here we report on the observation of a new form of both induced transparency and amplification of a weak probe beam in a strongly driven silicon photonic crystal resonator at room temperature. The effect is based on the oscillating temperature field induced in a nonlinear optical cavity, and it reproduces many of the key features of EIT while being independent of either atomic or mechanical resonances. Such thermo-optically induced transparency will allow a versatile implementation of EIT-analogs in an integrated photonic platform, at almost arbitrary wavelength of interest, room temperature and in a practical, low cost, and scalable system., Thermo-optically induced transparency is a versatile implementation of EIT-analogs in an integrated photonic platform, at arbitrary wavelength of interest, room temperature and in a practical, low cost, and scalable system.

Aims Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. Methods and results A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2–12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02–1.13)], age [HR 1.21 (95% CI 1.01–1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11–1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis–patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31–14.39)], device malposition [SHR 3.75 (95% CI 1.36–10.35)], EBEV [SHR 3.34 (95% CI 1.26–8.85)], and age [SHR 0.59 (95% CI 0.44–0.78)]. Conclusions The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

To ensure high Quality of Experience (QoE) for end users, many media applications require significant quantities of computing and network resources, making their realization challenging in resource constrained environments. In this paper, we present the approach of the 5G-MEDIA project, providing an integrated programmable service platform for the development, design and operations of media applications in 5G networks, facilitating media service management across the service life cycle. The platform offers tools to service developers for efficient development, testing and continuous correction of services. One step further, it provides a service virtualization platform offering horizontal services, such as a Media Service Catalogue and accounting services, as well as optimization mechanisms to flexibly adapt service operations to dynamic conditions with efficient use of infrastructure resources. The paper outlines three use cases where the platform was tested and validated.

Patient safety has always been an important responsibility for Clinical Engineering Departments (CEDs), but the breadth of safety issues changed dramatically over the years, from electrical-focused safety and electromagnetic interference in the latter half of the 20th century to a concern with adverse events (AEs) and medical errors in the 21st century (Frize, 2017). Although this is a well-known fact, especially since the publication of the article: To Err is Human (Institute of Medicine (1985), patient safety in healthcare institutions has not improved despite the significant attention that has been focused on this topic in the past 20 years, advancements in healthcare technology, and the increasing cost of health care.

This article aims to provide a thorough overview of the use of Artificial Intelligence (AI) techniques in studying the gut microbiota and its role in the diagnosis and treatment of some important diseases. The association between microbiota and diseases, together with its clinical relevance, is still difficult to interpret. The advances in AI techniques, such as Machine Learning (ML) and Deep Learning (DL), can help clinicians in processing and interpreting these massive data sets. Two research groups have been involved in this Scoping Review, working in two different areas of Europe: Florence and Sarajevo. The papers included in the review describe the use of ML or DL methods applied to the study of human gut microbiota. In total, 1109 papers were considered in this study. After elimination, a final set of 16 articles was considered in the scoping review. Different AI techniques were applied in the reviewed papers. Some papers applied ML, while others applied DL techniques. 11 papers evaluated just different ML algorithms (ranging from one to eight algorithms applied to one dataset). The remaining five papers examined both ML and DL algorithms. The most applied ML algorithm was Random Forest and it also exhibited the best performances.

Congestive Heart Failure (CHF) is a severe pathophysiological condition associated with high prevalence, high mortality rates, and sustained healthcare costs, therefore demanding efficient methods for its detection. Despite recent research has provided methods focused on advanced signal processing and machine learning, the potential of applying Convolutional Neural Network (CNN) approaches to the automatic detection of CHF has been largely overlooked thus far. This study addresses this important gap by presenting a CNN model that accurately identifies CHF on the basis of one raw electrocardiogram (ECG) heartbeat only, also juxtaposing existing methods typically grounded on Heart Rate Variability. We trained and tested the model on publicly available ECG datasets, comprising a total of 490,505 heartbeats, to achieve 100% CHF detection accuracy. Importantly, the model also identifies those heartbeat sequences and ECG’s morphological characteristics which are class-discriminative and thus prominent for CHF detection. Overall, our contribution substantially advances the current methodology for detecting CHF and caters to clinical practitioners’ needs by providing an accurate and fully transparent tool to support decisions concerning CHF detection.

The complexity of modern hospitals in terms of structural, technological and organizational requirements has been growing exponentially over the years. Hospitals must comply with a large number of requirements in order to fulfill their clinical and medical duties. Computer-Aided Facilities Management Systems have become essential tools to manage such a high level of complexity having a holistic approach. In this chapter, some real-world experiences are shown, by describing some custom tools used every day in the main hospitals in Tuscany.

We sought to analyze outcomes of women receiving balloon-expandable valves (BEV) or self-expanding valves (SEV) in contemporary transcatheter aortic valve implantation (TAVI). WIN TAVI (Women's INternational Transcatheter Aortic Valve Implantation) is the first all-female TAVI registry to study the safety and performance of TAVI in women. We compared women treated with BEV (n = 408, 46.9%) versus those treated with SEV (n = 461, 53.1%). The primary efficacy end point was the Valve Academic Research Consortium-2 (VARC-2) composite of 1-year all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction. Women receiving SEV had higher surgical risk scores, higher rate of previous stroke and pulmonary hypertension whereas women receiving BEV were more frequently denied surgical valve replacement due to frailty. BEV patients were less likely to require post-dilation and had significantly lower rates of residual aortic regurgitation grade ≥2 (9.8% vs 4.7%, p = 0.007). At 1 year, the crude incidence and adjusted risk of the primary VARC-2 efficacy end point was similar between groups (17.1% with SEV and 14.3% with BEV, p = 0.25; hazards ratio 1.09, 95% confidence interval 0.68 to 1.75). Conversely the crude rate and adjusted risk of new pacemaker implantation was higher with SEV than BEV (15% vs 8.6%, p = 0.001; hazards ratio 1.97, 95% confidence interval 1.13 to 3.43). A subanalysis on new generation valves showed no difference in the need for pacemaker implantation between the 2 devices (10.1% vs 8.0%, p = 0.56). In conclusion, in contemporary TAVI, SEV are used more frequently in women with greater co-morbidities. While there were no differences in unadjusted and adjusted risk of 1-year primary efficacy end point between the valve types, there was a greater need for permanent pacemakers after SEV implantation.

The Clinical Engineering Division of the International Federation for Medical and Biological Engineering (IFMBE/CED), chaired by Ernesto Iadanza in the period 2015–18, has done its part in advancing clinical engineering in Italy by having many contacts and participations in Italian events and conferences in the last years. To further confirm this, the third edition of the International Conference of Clinical Engineering and Health Technology Management (ICEHTMC, 2019, http://www.icehtmc.com ) will be held in Rome in October 2019, in combination with the Global Clinical Engineering Day (October 21). There is no doubt that today Italy is having a big impact on the worldwide clinical engineering, for example, also exporting at European Union level its coding system for medical devices. Very good signals arrive from academia, with more and more students choosing this path and with excellent figures in their placement after graduation. Nevertheless, there is still a lot to do—both on the legislative level and on the organizational level—before seeing a clinical engineer sitting at all the tables of healthcare top managers.