Transcatheter Ablation of Atrial Fibrillation in Patients with Chronic Heart Failure

Atrial fibrillation (AF) is the most frequent of all cardiac arrhythmias and it is associated with an increased risk of stroke, systemic embolism and heart failure. Patients with AF have a twofold increased risk of death and fivefold increased risk of stroke compared with those without AF. In patients with heart failure (HF), AF ablation improves left ventricular (LV) function over short- and long-term follow-ups, especially compared with medical treatment. Furthermore, AF ablation in HF patients relates to a significant improvement in quality of life, functional class and exercise tolerance, possibly related to the improvement in LV function and hemodynamic status of the patients. Finally, data showed that restoration of sinus rhythm in this setting of patients reduced the incidence of stroke and death. In this review, we reported all the major data regarding atrial fibrillation therapy in patients with heart failure

Zero Fluoroscopy Arrhythmias Catheter Ablation: A Trend Toward More Frequent Practice in a High-Volume Center

BACKGROUND: Awareness of radiation exposure risks associated to interventional cardiology procedures is growing. The availability of new technologies in electrophysiology laboratories has reduced fluoroscopy usage during arrhythmias ablations. The aim of this study was to describe procedures with and without X-Rays and to assess feasibility, safety, and short-term efficacy of zero fluoroscopy intervention in a high-volume center oriented to keep exposure to ionizing radiation as low as reasonably achievable. METHODS: Cardiac catheter ablations performed in our hospital since January 2017 to June 2021. RESULTS: A total of 1,853 procedures were performed with 1,957 arrhythmias treated. Rate of fluoroless procedures was 15.4% (285 interventions) with an increasing trend from 8.5% in 2017 to 22.9% of first semester 2021. The most frequent arrhythmia treated was atrial fibrillation (646; 3.6% fluoroless) followed by atrioventricular nodal reentrant tachycardia (644; 16.9% fluoroless), atrial flutter (215; 8.8% fluoroless), ventricular tachycardia (178; 17.4% fluoroless), premature ventricular contraction (162; 48.1% fluoroless), and accessory pathways (112; 31.3% fluoroless). Although characteristics of patients and operative details were heterogeneous among treated arrhythmias, use of fluoroscopy did not influence procedure duration. Moreover, feasibility and efficacy were 100% in fluoroless ablations while the rate of major complications was very low and no different with or without fluoroscopy (0.45 vs. 0.35%). CONCLUSION: Limiting the use of X-Rays is necessary, especially when the available technologies allow a zero-use approach. A lower radiation exposure may be reached, reducing fluoroscopy usage whenever possible during cardiac ablation procedures with high safety, full feasibility, and efficacy

Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE

AIMS: To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI). METHODS AND RESULTS: This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7 days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12 months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of ≥1 PVs after adenosine/isoproterenol challenge was observed in 9.3% (30/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12 months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12 months. CONCLUSION: PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT03437733

Atrial Thrombosis Prevalence Before Cardioversion or Catheter Ablation of Atrial Fibrillation: An Updated Systematic Review and Meta-Analysis of Direct Oral Anticoagulants Versus Vitamin K Antagonists

: Left atrial or left atrial appendage thrombosis (LAT) is contraindicated for cardiac ablation (CA) or cardioversion (CV) of atrial fibrillation (AF). This study was aimed to compare the frequency of LAT detected by transesophageal echocardiography (TEE) before CA or CV in patients with AF treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). We searched PubMed, Scopus, Web of Science, and Cochran Library databases from inception through July 13, 2023 to select studies reporting data on LAT identification before CA or CV using TEE in patients with AF treated with DOACs or VKAs. Pooled odds ratios (ORs) with 95% confidence interval were calculated with a random-effects model. Studies retrieved were 50 (38 observational), 29 on CA, 15 on CV, and 6 on both procedures (17,096 patients on DOACs and 13,666 on VKAs). The overall prevalence of LAT was smaller in DOACs than in VKAs, with an OR of 0.66 (0.52 to 0.84), confirmed at sensitivity analysis and in most subgroups. This finding was consistent for the 3 most reported DOACs: the pooled OR for LAT was 0.68 (0.50 to 0.90) in apixaban, 0.67 (0.51 to 0.88) in dabigatran, 0.61 (0.43 to 0.89) in rivaroxaban, and 1.10 (0.74 to 1.64) in edoxaban (not significant). In conclusion, in this large meta-analysis in patients with AF, the prevalence of LAT by TEE evaluation performed before CV or CA appears lower in those treated with DOACs than in those on VKAs. Additional research may help in better understanding differences between these classes of anticoagulant drugs in the setting of protection against AF-related left atrial thrombotic formation

Pulsed Field Ablation to Treat Atrial Fibrillation: A Review of the Literature

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and catheter ablation, which can be used in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary vein isolation (PVI) remains the cornerstone of any ablation procedure. A major limitation of current catheter ablation procedures is important to recognize because even when the PVI is performed in highly experienced centers, PVI reconnection was documented in about 20% of patients. Therefore, better technology is needed to improve ablation lesions. One of the novelties in recent years is pulsed filed ablation (PFA), a non-thermal energy that uses trains of high-voltage, very-short-duration pulses to kill the cells. The mechanism of action of this energy consists of creating pores in the myocardiocyte cell membrane in a highly selective and tissue-specific way; this leads to death of the target cells reducing the risk of damage to surrounding non-cardiac tissues. In particular during the animal studies, PVI and atrial lines were performed effectively without PV stenosis. Using PFA directly on coronary arteries, there was no luminal narrowing, there has been no evidence of incidental phrenic nerve injury, and finally, PFA has been shown not to injure esophageal tissue when directly applied to the esophagus or indirectly through ablation in the left atrium. The aim of this review is to report all published animal and clinical studies regarding this new technology to treat paroxysmal and persistent AF

Smart Factory Security: A Case Study on a Modular Smart Manufacturing System

Abstract Smart manufacturing systems are an attractive target for cyber attacks, because they embed valuable data and critical equipment. Despite the market is driving towards integrated and interconnected factories, current smart manufacturing systems are still designed under the assumption that they will stay isolated from the corporate network and the outside world. This choice may result in an internal architecture with insufficient network and system compartmentalization. As a result, once an attacker has gained access, they have full control of the entire production plant because of the lack of network segmentation. With the goal of raising cybersecurity awareness, in this paper we describe a practical case study showing attack scenarios that we have validated on a real modular smart manufacturing system, and suggest practical security counter measures. The testbed smart manufacturing system is part of the Industry 4.0 research laboratory hosted by Politecnico di Milano, and comprises seven assembly stations, each with their programmable logic controllers and human-computer interfaces, as well as an industrial robotic arm that performs pick-and-place tasks. On this testbed we show two indirect attacks to gain initial access, even under the best-case scenario of a system not directly connected to any public network. We conclude by showing two post-exploitation scenarios that an adversary can use to cause physical impact on the production, or keep persistent access to the plant. We are unaware of a similar security analysis performed within the premises of a research facility, following a scientific methodology, so we believe that this work can represent a good first step to inspire follow up research on the many verticals that we touch

Linee guida AIAC all’impianto di pacemaker, dispositivi per la resincronizzazione cardiaca, defibrillatori automatici e loop recorder - update 2011

PREFAZIONE L’aggiornamento delle linee guida deve essere considerato un compito istituzionale delle società medicoscientifiche; solo attraverso l’adeguamento delle linee guida, alla luce degli studi recenti, è possibile garantire al medico il migliore e attuale percorso diagnostico-terapeutico da offrire al singolo paziente. L’utilizzo delle linee guida nella pratica clinica, riflettendo queste ultime l’opinione di esperti nei vari settori, dovrebbe garantire un approccio condiviso per la diagnosi, il trattamento e la prevenzione di specifiche condizioni morbose. L’Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC) aggiorna, con il presente documento, le precedenti linee guida all’impianto dei dispositivi elettronici cardiaci pubblicate nel 2006. Nell’edizione 2011, è stata fatta una completa e aggiornata revisione del testo, della bibliografia e delle raccomandazioni. Una revisione della precedente edizione era necessaria per molte ragioni: ■ importanti studi hanno aumentato la nostra conoscenza della storia naturale di bradi- e tachiaritmie che possono essere trattate in maniera ottimale con impianto di dispositivi; ■ in questi ultimi anni c’è stato un cambiamento sostanziale della terapia dello scompenso cardiaco che oggi comprende sempre più spesso terapia farmacologica e dispositivi; ■ l’implementazione tecnologica viene sempre più in aiuto nella gestione delle comorbilità e nel follow-up del paziente aritmico o affetto da scompenso cardiaco. In particolare, nel campo della terapia di resincronizzazione cardiaca, trattamento elettrico dello scompenso cardiaco con risultati talora sorprendenti, sono state implementate le indicazioni facendo seguito ai risultati dei recenti trial internazionali. È stato aggiunto un nuovo capitolo, dedicato all’utilizzo dei loop recorder, cioè dei registratori Holter impiantabili. Questi dispositivi sono particolarmente utili nelle sincopi ad eziologia indeterminata e nei pazienti con palpitazioni difficilmente documentabili con Holter tradizionali. Nelle nuove linee guida gli esperti pongono l’accento anche sugli attuali sistemi di monitoraggio remoto al fine di ottimizzare le risorse, minimizzare i follow-up ambulatoriali e di migliorare la compliance e la qualità di vita dei pazienti. I sistemi di telemonitoraggio permettono di visualizzare in ogni momento i dati attuali e pregressi dei dispositivi impiantati, rendendo possibile una rilevazione precoce di eventi aritmici o anomalie incipienti del sistema di stimolazione o defibrillazione cardiaca. Le raccomandazioni aggiornate dal gruppo di lavoro incaricato dall’AIAC rappresentano un documento importante affinché il medico possa svolgere una corretta pratica clinica. Ma occorre sottolineare che il supporto scientifico e le disponibilità terapeutiche offerte dalla linee guida non devono forzarlo nella scelta immobilizzandolo all’interno di schemi precostituiti. Le indicazioni riportate devono essere un suggerimento della strada da percorrere da applicare sulla base della propria esperienza e nella specificità del singolo caso che il medico si trova ad affrontare. Le raccomandazioni sono state elaborate riferendosi a un paziente standard ma devono essere interpretate e applicate tenendo in considerazione l’unicità del paziente, della sua malattia, delle condizioni familiari, lavorative ed ambientali. Come nell’edizione precedente la “mission” che l’AIAC ha voluto dare alle proprie linee guida è quella di mettere al centro della scena il singolo paziente affidando al medico la decisione del programma diagnostico-terapeutico. La speranza che si accompagna a queste linee guida è che il medico ne tragga il massimo supporto scientifico riducendo al minimo la possibilità di incorrere in errore, senza costringerlo in schemi troppo rigidi. L’AIAC si impegnerà affinché, dopo l’attuale pubblicazione, le linee guida vengano diffuse in tutto il territorio nazionale attraverso il sito web dell’Associazione, versioni tascabili, versioni digitali scaricabili, attraverso meeting e supportando la loro pubblicazione anche su riviste nazionali che raggiungano oltre ai soci AIAC anche tutti i cardiologi e gli internisti del territorio nazionale. Infine, per poter chiudere il cerchio, e cioè per essere certi che l’implementazione delle linee guida derivanti dalla ricerca clinica abbiano una ricaduta sulla pratica clinica e quindi sulla salute dei pazienti, l’AIAC si pone l’obiettivo di utilizzare speciali strumenti, quali i suoi registri, per verificarne la loro reale applicazione