Sensors integration in additive DMLS metal parts

The fabrication of metal parts by laser-based additive manufacturing (AM) processes is providing many applications in the medical field. The layer-by-layer growth of the component provided by powder micromelting allows, at least in theory, the incorporation of discrete sensors and wires inside the metal material. However, several process-related issues make this operation very challenging. This paper introduces the incorporation of thermal and inertial sensors inside 17-4PH steel specimens fabricated by DMLS (direct metal laser sintering) process (PCT/IB2019/053581, 02/05/2018). In the final configuration, the sensors are totally encased into the continuous metal parts with complete protection against contamination and tampering

Modelling distribution and fate of coralligenous habitat in the Northern Adriatic Sea under a severe climate change scenario

Due to their well-acknowledged capability in predicting habitat distributions, Habitat Suitability Models (HSMs) are particularly useful for investigating ecological patterns variations under climate change scenarios. The shallow coastal regions of the Northern Adriatic Sea, a sub-basin of the Mediterranean Sea, are studded with coralligenous outcrops recognized as important biodiversity hotspots exposed to the effects of climate change. In this research, we investigate the distributions of the Northern Adriatic Sea coralligenous habitats characterized by diverse species assemblages differently influenced by environmental factors, and provide a projection of how these might be impacted by climate change. Two models (Random Forest and MaxEnt), populated with occurrence data gathered from previous publications, environmental parameters’ from online databases (CMEMS, Bio-Oracle), and a set of dedicated ocean model simulations, are applied in recent past conditions and under a future severe climate change scenario (RCP 8.5). The model performance metrics confirm the ability of both approaches for predicting habitat distribution and their relationship with environmental conditions. The results show that salinity, temperature, and nitrate concentration are generally the most relevant variables in affecting the coralligenous outcrops distribution. The environmental variations projected under climate change conditions are expected to favour the spreading of opportunistic organisms, more tolerant to stressful conditions, at the expense of more vulnerable species. This will result in a shift in the distribution of these habitats, with a consequent potential loss of biodiversity in the Northern Adriatic Sea

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Multimodality imaging for atrial fibrosis detection in the era of precision medicine

In recent years, atrial fibrillation (AF) has increasingly become a focus of attention because it represents the most encountered arrhythmia in clinical practice and a major cause of morbidity and mortality. Issues underlying AF have long been debated; nevertheless, electrical, contractile, and structural remodeling is demonstrated to be the pivotal contributor to arrhythmic substrate. Fibrosis is a hallmark of arrhythmogenic structural remodeling, resulting from an accumulation of fibrillar collagen deposits, as a reparative process to replace degenerating myocardium with concomitant reactive fibrosis, which causes interstitial expansion. Although the precise role of fibrosis in AF initiation and maintenance remains to be fully elucidated, a better definition of its extent and distribution may assist in designing individually tailored ablation approaches and improving procedure outcomes by targeting the fibrotic substrates with an organized strategy employing imaging resources. A deep comprehension of the mechanisms underlying atrial fibrosis could be crucial to setting up improved strategies for preventing AF-promoting structural remodeling. Imaging modalities such as echocardiography, cardiac computed tomography, and cardiac magnetic resonance, combined sometimes with invasive electroanatomical mapping, could provide valuable information for the optimal patients’ management if their use is not limited to cardiac anatomy study but extended to characterize abnormal left atrial substrate. Although pulmonary vein isolation is usually efficacious in treating paroxysmal AF, it is not sufficient for many patients with nonparoxysmal arrhythmias, particularly those with longstanding persistent AF. Noninvasive imaging techniques play a pivotal role in the planning of arrhythmic substrates ablation and show a strong correlation with electro-anatomic mapping, whose novel multipolar mapping catheters allow nowadays a more precise comprehension of atrial substrate. This review aims to explore the impact of the various imaging modalities for the detection of atrial fibrosis and their role in the management of AF

Effectiveness of European Regulation on Euxyl K400 Sensitization in Northeastern Italy From 1996 to 2012 and Occupation

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Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study

Background Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical map (EAM) data may lead to increased procedure efficacy, efficiency, and safety. Methods VOYAGE is a prospective, randomized, multicenter controlled open label study designed to compare in terms of efficacy, efficiency, and safety a CMR aided/guided workflow to standard EAM-guided ventricular tachycardia (VT) ablation. Patients with an ICD or with ICD implantation expected within 1 month, with scar related VT, suitable for CMR and multidetector computed tomography (MDCT) will be randomized to a CMR-guided or CMR-aided approach, whereas subjects unsuitable for imaging or with image quality deemed not sufficient for postprocessing will be allocated to standard of care ablation. Primary endpoint is defined as VT recurrences (sustained or requiring appropriate ICD intervention) during 12 months follow-up, excluding the first month of blanking period. Secondary endpoints will include procedural efficiency, safety, impact on quality of life and comparison between CMR-guided and CMR-aided approaches. Patients will be evaluated at 1, 6 and 12 months. Discussion The clinical impact of real time CMR-guided/aided ablation approaches has not been thoroughly assessed yet. This study aims at defining whether such workflow results in more effective, efficient, and safer procedures. If proven to be of benefit, results from this study could be applied in large scale interventional practice. Trial registrationClinicalTrials.gov, NCT04694079, registered on January 1, 2021

Clinical impact of high-density mapping on the acute and long term outcome of atypical atrial flutter ablations

Purpose We evaluated the clinical impact of the high-density (HD) mapping compared with the standard low-density (LD) ablation catheter mapping technique in the treatment of AFLs. Methods We retrospectively evaluated short and long outcomes of patients approached with an HD and a LD electro-anatomical strategy for atypical AFLs. Results Eighty-seven patients were included. Patients were almost male (60%), relatively old (65 +/- 8 years), with a moderate CHA2DS2Vasc score (2.3 +/- 1.3), a preserved ejection fraction (58 +/- 6), and moderate atrial dilatation (44 +/- 7 mm). Baseline clinical characteristics were comparable between groups (p = NS). Among AFLs, 10 (11%) were located in the right and 78 (89%) in the left atrium, including 22 (28%) roof dependent and 37 (47%) mitral dependent (p = NS). Sinus rhythm restoration during ablation was more frequently observed in the HD group (79% vs 56%, p = 0.037), without differences in mapping time, procedural time, and radiological dose (p = NS). Overall AFL/AT/AF recurrence rate at 1, 2, and 3 years was lower in the HD group (14% vs 37% p = 0.02, 14% vs 48% p = 0.002 and 14% vs 50% p &lt; 0.001, respectively) with a time-dependent trend only in the LD group (37% vs 48% vs 50% at 1, 2, and 3 years respectively, p = 0.059). HD mapping (OR 0.17; 95% CI 0.04-0.66) and younger age (OR 1.09; 95% CI 1.01-1.19) resulted independent predictors of overall arrhythmias at follow-up. Conclusions Short- and long-term outcomes of atypical AFL ablation were better in the case of HD mapping, which resulted independent predictor of arrhythmia recurrences