Approvato il ‘DORA’: Regolamento (UE) 2022/2554 del 14.12.2022 relativo alla resilienza operativa digitale per il settore finanziario e che modifica i regolamenti (CE) n. 1060/2009, (UE) n. 648/2012, (UE) n. 600/2014, (UE) n. 909/2014 e (UE) 2016/1011.

Il contributo analizza il recente Regolamento (UE) 2022/2554 del 14.12.2022 relativo alla resilienza operativa digitale per il settore finanziario, c.d. DORA

Il Decreto del Ministero dell’economia e delle finanze del 13 gennaio 2022 sull’iscrizione alla sezione speciale del registro dei cambiavalute da parte dei prestatori di servizi relativi all’utilizzo di valuta virtuale e di portafoglio digitale.

Il contributo analizza il decreto MEF del 13 gennaio 2022 sull’iscrizione alla sezione speciale del registro dei cambiavalut

La sentenza Cassazione Sez. 2 Penale n. 44378/2022 del 26.10.2022 sulla qualificazione della moneta virtuale e delle Initial Coin Offerings (a proposito di un sequestro penale preventivo di wallet contenente bitcoin e di una fattispecie di reato di abusivismo finanziario ai sensi dell’art. 166 co. 1 TUF)

La nota si interroga criticamente sulla qualificazione della moneta virtuale e delle Initial Coin Offerings alla luce della sentenza Cassazione Sez. 2 Penale n. 44378/2022 del 26 ottobre 2022

Gli ELI Principles on blockchain technology, Smart contracts and consumer protection

Il contributo si interroga criticamente sugli ELI Principles on Blockchain Technology, Smart Contracts and Consumer Protection del 8 settembre 2022

L’apertura della prima finestra temporale sulla sandbox regolamentare per i progetti fintech di cui al Decreto del MEF n. 100 del 30 aprile 2021

Il contributo analizza l’apertura della prima finestra temporale sulla sandbox regolamentare per i progetti fintech di cui al Decreto del MEF n. 100/2021 e ai connessi provvedimenti delle Autorità di vigilanz

Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study

Background: Adenosine-free coronary pressure wire metrics have been proposed to test the functional significance of coronary artery lesions, but it is unexplored whether their diagnostic performance might be altered in patients with diabetes. Methods: We performed a post-hoc analysis of the CONTRAST study, which prospectively enrolled an international cohort of patients undergoing routine fractional flow reserve (FFR) assessment for standard indications. Paired, repeated measurements of all physiology metrics (Pd/Pa, iFR, contrast-based FFR, and FFR) were made. A central core laboratory analyzed blinded pressure tracings in a standardized fashion. Results: Of 763 subjects enrolled at 12 international centers, 219 (29%) had diabetes. The two groups were wellbalanced for age, clinical presentation (stable or unstable), coronary vessel studied, volume and type of intracoronary contrast, and volume of intracoronary adenosine. A binary threshold of cFFR ≤ 0.83 produced an accuracy superior to both Pd/Pa and iFR when compared with FFR ≤ 0.80 in the absence of significant interaction with diabetes status; indeed, accuracy in subgroups of patients with or without diabetes was similar for cFFR (86.7 vs 85.4% respectively; p = 0.76), iFR (84.2 vs 80.0%, p = 0.29) and Pd/Pa (81.3 vs 78.9%, p = 0.55). There was no significant heterogeneity between patients with or without diabetes in terms of sensitivity and specificity of all metrics. The area under the receiver operating characteristic (ROC) curve was largest for cFFR compared with Pd/Pa and iFR which were equivalent (cFFR 0.961 and 0.928; Pd/Pa 0.916 and 0.870; iFR 0.911 and 0.861 in diabetic and non-diabetic patients respectively). Conclusions: cFFR provides superior diagnostic performance compared with Pd/Pa or iFR for predicting FFR irrespective of diabetes (clinicaltrials.gov identifier NCT02184117)

A clinical and health-economic evaluation of pulmonary vein encircling ablation compared with antiarrhythmic drug treatment in patients with persistent atrial fibrillation (Catheter Ablation for the Cure of Atrial Fibrillation-2 study)

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Physical activity measured by implanted devices predicts atrial arrhythmias and patient outcome: Results of IMPLANTED (Italian Multicentre Observational Registry on Patients With Implantable Devices Remotely Monitored)

Background--To determine whether daily physical activity (PA), as measured by implanted devices (through accelerometer sensor), was related to the risk of developing atrial arrhythmias during long-term follow-up in a population of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD). Methods and Results--The study population was divided into 2 equally sized groups (PA cutoff point: 3.5 h/d) according to their mean daily PA recorded by the device during the 30- to 60-day period post-ICD implantation. Propensity score matching was used to compare 2 equally sized cohorts with similar characteristics between lower and higher activity patients. The primary end point was time free from the first atrial high-rate episode (AHRE) of duration 656 minutes. Secondary end points were: first AHRE 656 hours, first AHRE 6548 hours, and a combined end point of death or HF hospitalization. Data from 770 patients (65\ub115 years; 66% men; left ventricular ejection fraction 35\ub112%) remotely monitored for a median of 25 months were analyzed. A PA =3.5 h/d was associated with a 38% relative reduction in the risk of AHRE 656 minutes (72-month cumulative survival: 75.0% versus 68.1%; log rank P=0.025), and with a reduction in the risk of AHRE 656 hours, AHRE 6548 hours, and the combined end point of death or HF hospitalization (all P < 0.05). Conclusions--In HF patients with ICD, a low level of daily PA was associated with a higher risk of atrial arrhythmias, regardless of the patients' baseline characteristics. In addition, a lower daily PA predicted death or HF hospitalization