Rivaroxaban in atrial fibrillation cardioversion: an update

Currently, atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with a prevalence of about 2-3% in the general population, representing a powerful risk factor for stroke and systemic thromboembolism and increased mortality and morbidity. Restoration of sinus rhythm is an important treatment option in AF and has a high success rate, but there is the need for an effective anticoagulation strategy to reduce the risk of embolic events. Anticoagulation with vitamin K antagonists is often associated with failure to achieving effective international normalized ratio. In this setting, recent data have led to extended approval for rivaroxaban in clinical practice, because it is effective and safe in patients with AF undergoing cardioversion, avoiding additional health costs and related time loss, while improving patient satisfaction. The present report provides an overview of the main randomized controlled trial and the main real-life studies, documenting the use of rivaroxaban in patients with non-valvular AF who underwent the cardioversion procedure. Considering that novel non-vitamin K antagonist oral anticoagulants in left atrial appendage thrombi resolution is still unknown in the real-world practice, the main findings on the use of rivaroxaban in this setting are also discussed

Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and cancer a meta-analysis

Background: Direct oral anticoagulants (DOACs) are recommended as first-line anticoagulants in patients with atrial fibrillation (AF). However, in patients with cancer and AF the efficacy and safety of DOACs are not well established. Objective: We performed a meta-analysis comparing available data regarding the efficacy and safety of DOACs vs vitamin K antagonists (VKAs) in cancer patients with non-valvular AF. Methods: An online search of Pubmed and EMBASE libraries (from inception to May, 1 2020) was performed, in addition to manual screening. Nine studies were considered eligible for the meta-analysis involving 46,424 DOACs users and 182,797 VKA users. Results: The use of DOACs was associated with reduced risks of systemic embolism or any stroke (RR 0.65; 95% CI 0.52–0.81; p 0.001), ischemic stroke (RR 0.84; 95% CI 0.74–0.95; p 0.007) and hemorrhagic stroke (RR 0.61; 95% CI 0.52–0.71; p 0.00001) as compared to VKA group. DOAC use was associated with significantly reduced risks of major bleeding (RR 0.68; 95% CI 0.50–0.92; p 0.01) and intracranial or gastrointestinal bleeding (RR 0.64; 95% CI 0.47–0.88; p 0.006). Compared to VKA, DOACs provided a non-statistically significant risk reduction of the outcomes major bleeding or non-major clinically relevant bleeding (RR 0.94; 95% CI 0.78–1.13; p 0.50) and any bleeding (RR 0.91; 95% CI 0.78–1.06; p 0.24). Conclusions: In comparison to VKA, DOACs were associated with a significant reduction of the rates of thromboembolic events and major bleeding complications in patients with AF and cancer. Further studies are needed to confirm our results

Rivaroxaban in atrial fibrillation cardioversion: an update

Carlo Lavalle, Martina Straito, Annalisa Caroli, Agostino Piro, Giuseppe Giunta, Marco Valerio Mariani, Francesco FedeleDepartment of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, “Sapienza” University of Rome, Policlinico Umberto I, Rome, ItalyAbstract: Currently, atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with a prevalence of about 2–3% in the general population, representing a powerful risk factor for stroke and systemic thromboembolism and increased mortality and morbidity. Restoration of sinus rhythm is an important treatment option in AF and has a high success rate, but there is the need for an effective anticoagulation strategy to reduce the risk of embolic events. Anticoagulation with vitamin K antagonists is often associated with failure to achieving effective international normalized ratio. In this setting, recent data have led to extended approval for rivaroxaban in clinical practice, because it is effective and safe in patients with AF undergoing cardioversion, avoiding additional health costs and related time loss, while improving patient satisfaction. The present report provides an overview of the main randomized controlled trial and the main real-life studies, documenting the use of rivaroxaban in patients with non-valvular AF who underwent the cardioversion procedure. Considering that novel non-vitamin K antagonist oral anticoagulants in left atrial appendage thrombi resolution is still unknown in the real-world practice, the main findings on the use of rivaroxaban in this setting are also discussed.Keywords: atrial fibrillation, cardioversion, novel oral anticoagulants, rivaroxaban, thrombu

Left atrial appendage exclusion in atrial fibrillation radiofrequency ablation during mitral valve surgery: a single-center experience

Background. Atrial fibrillation surgical radiofrequency ablation (AFSA) during mitral valve surgery (MVS) has almost completely superseded the Cox-Maze procedure for the treatment of atrial fibrillation. Methods. We retrospectively analyzed 100 patients who underwent MVS + AFSA in our institution from January 2008 to June 2017. We compared the effectiveness of AFSA in patients who underwent LAA exclusion to those who did not. Moreover, we analyzed the role of preoperative AF duration (≤ or >1 year) and medial-lateral left atrial dimensions (ML-LAD) (≤ or >6 cm). The efficacy endpoint was freedom from AF at discharge and at 2-year follow-up. The safety endpoints were need of a permanent pacemaker (PMK), surgical re-exploration, occurrence of stroke, and left circumflex artery or esophageal lesions. Results. Overall, the rate of AF freedom was 69% at discharge and 80% at 2-year follow-up. LAA exclusion did not influence AF freedom at 2-year follow-up, and 84.6% of patients who underwent LAA exclusion were in the sinus rythm (SR) at 2 year compared to 75% of those who did not receive LAA exclusion free from AF as well (p=0.230). AF duration ≤1 or >1 year did not influence sinus rhythm (SR) maintenance (85.7% vs. 75.8%; p=0.224), and in these two groups, LAA exclusion did not change the efficacy of AFSA. ML-LAD ≤ 6 cm was associated with better results in terms of SR maintenance. A statistically significant association between LAA exclusion and SR maintenance at 2-year follow-up (p=0.017) was found among patients with ML-LAD ≤ 6 cm. Complications included 7 cases of PMK implantation, 2 cases of surgical re-exploration, and 1 case of stroke. No circumflex artery or esophageal lesions occurred after surgical procedures. Conclusions. In our experience, AFSA during isolated MVS resulted in good outcomes in terms of SR maintenance and incidence of complications. AF duration ≤ 1 year did not influence results, while patients with ML-LAD ≤ 6 cm had significantly better results regarding SR at follow-up. In patients with ML-LAD ≤ 6 cm, LAA exclusion significantly increased the success rate of SR maintenance at 2-year follow-up

Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network.

Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile

The scar: the wind in the perfect storm—insights into the mysterious living tissue originating ventricular arrhythmias

Background: Arrhythmic death is very common among patients with structural heart disease, and it is estimated that in European countries, 1 per 1000 inhabitants yearly dies for sudden cardiac death (SCD), mainly as a result of ventricular arrhythmias (VA). The scar is the result of cardiac remodelling process that occurs in several cardiomyopathies, both ischemic and non-ischemic, and is considered the perfect substrate for re-entrant and non-re-entrant arrhythmias. Methods: Our aim was to review published evidence on the histological and electrophysiological properties of myocardial scar and to review the central role of cardiac magnetic resonance (CMR) in assessing ventricular arrhythmias substrate and its potential implication in risk stratification of SCD. Results: Scarring process affects both structural and electrical myocardial properties and paves the background for enhanced arrhythmogenicity. Non-uniform anisotropic conduction, gap junctions remodelling, source to sink mismatch and refractoriness dispersion are some of the underlining mechanisms contributing to arrhythmic potential of the scar. All these mechanisms lead to the initiation and maintenance of VA. CMR has a crucial role in the evaluation of patients suffering from VA, as it is considered the gold standard imaging test for scar characterization. Mounting evidences support the use of CMR not only for the definition of gross scar features, as size, localization and transmurality, but also for the identification of possible conducting channels suitable of discrete ablation. Moreover, several studies call out the CMR-based scar characterization as a stratification tool useful in selecting patients at risk of SCD and amenable to implantable cardioverter-defibrillator (ICD) implantation. Conclusions: Scar represents the substrate of ventricular arrhythmias. CMR, defining scar presence and its features, may be a useful tool for guiding ablation procedures and for identifying patients at risk of SCD amenable to ICD therapy

Management of cardiac implantable electronic device follow-up in COVID-19 pandemic: Lessons learned during Italian lockdown

Introduction: Remote monitoring (RM) has significantly transformed the standard of care for patients with cardiac electronic implantable devices. It provides easy access to valuable information, such as arrhythmic events, acute decompensation manifestations and device-related issues, without the need of in-person visits. Methods: Starting March 1st, 332 patients were introduced to an RM program during the Italian lockdown to limit the risk of in-hospital exposure to severe acute respiratory syndrome-coronavirus-2. Patients were categorized into two groups based on the modality of RM delivery (home [n = 229] vs. office [n = 103] delivered). The study aimed at assessing the efficacy of the new follow-up protocol, assessed as mean RM activation time (AT), and the need for technical support. In addition, patients' acceptance and anxiety status were quantified via the Home Monitoring Acceptance and Satisfaction Questionnaire and the Generalized Anxiety Disorder 7-item scale. Results: AT time was less than 48 h in 93% of patients and 7% of them required further technical support. Despite a higher number of trans-telephonic technical support in the home-delivered RM group, mean AT was similar between groups (1.33 \ub1 0.83 days in home-delivered vs 1.28 \ub1 0.81 days in office-delivered patients; p =.60). A total of 28 (2.5%) urgent/emergent in-person examinations were required. A high degree of patient satisfaction was reached in both groups whereas anxiety status was higher in the office-delivered group. Conclusions: The adoption of RM resulted in high patient satisfaction, regardless of the modality of modem delivery; nonetheless, in-office modem delivery was associated with a higher prevalence of anxiety symptoms

Reperfusion therapies and in-hospital outcomes for ST-elevation myocardial infarction in europe. the ACVC-EAPCI EORP STEMI registry of the european society of cardiology

Aims: The aim of this study was to determine the contemporary use of reperfusion therapy in the European Society of Cardiology (ESC) member and affiliated countries and adherence to ESC clinical practice guidelines in patients with ST-elevation myocardial infarction (STEMI). Methods and results: Prospective cohort (EURObservational Research Programme STEMI Registry) of hospitalized STEMI patients with symptom onset <24 h in 196 centres across 29 countries. A total of 11 462 patients were enrolled, for whom primary percutaneous coronary intervention (PCI) (total cohort frequency: 72.2%, country frequency range 0-100%), fibrinolysis (18.8%; 0-100%), and no reperfusion therapy (9.0%; 0-75%) were performed. Corresponding in-hospital mortality rates from any cause were 3.1%, 4.4%, and 14.1% and overall mortality was 4.4% (country range 2.5-5.9%). Achievement of quality indicators for reperfusion was reported for 92.7% (region range 84.8-97.5%) for the performance of reperfusion therapy of all patients with STEMI <12 h and 54.4% (region range 37.1-70.1%) for timely reperfusion. Conclusions: The use of reperfusion therapy for STEMI in the ESC member and affiliated countries was high. Primary PCI was the most frequently used treatment and associated total in-hospital mortality was below 5%. However, there was geographic variation in the use of primary PCI, which was associated with differences in in-hospital mortality

Reperfusion therapies and in-hospital outcomes for ST-elevation myocardial infarction in Europe: The ACVC-EAPCI EORP STEMI Registry of the European Society of Cardiology

Aims: The aim of this study was to determine the contemporary use of reperfusion therapy in the European Society of Cardiology (ESC) member and affiliated countries and adherence to ESC clinical practice guidelines in patients with ST-elevation myocardial infarction (STEMI). Methods and results: Prospective cohort (EURObservational Research Programme STEMI Registry) of hospitalized STEMI patients with symptom onset <24 h in 196 centres across 29 countries. A total of 11 462 patients were enrolled, for whom primary percutaneous coronary intervention (PCI) (total cohort frequency: 72.2%, country frequency range 0-100%), fibrinolysis (18.8%; 0-100%), and no reperfusion therapy (9.0%; 0-75%) were performed. Corresponding in-hospital mortality rates from any cause were 3.1%, 4.4%, and 14.1% and overall mortality was 4.4% (country range 2.5-5.9%). Achievement of quality indicators for reperfusion was reported for 92.7% (region range 84.8-97.5%) for the performance of reperfusion therapy of all patients with STEMI <12 h and 54.4% (region range 37.1-70.1%) for timely reperfusion. Conclusions: The use of reperfusion therapy for STEMI in the ESC member and affiliated countries was high. Primary PCI was the most frequently used treatment and associated total in-hospital mortality was below 5%. However, there was geographic variation in the use of primary PCI, which was associated with differences in in-hospital mortality

The ESC ACCA EAPCI EORP acute coronary syndrome ST-elevation myocardial infarction registry

Aims: The Acute Cardiac Care Association (ACCA)-European Association of Percutaneous Coronary Intervention (EAPCI) Registry on ST-elevation myocardial infarction (STEMI) of the EurObservational programme (EORP) of the European Society of Cardiology (ESC) registry aimed to determine the current state of the use of reperfusion therapy in ESC member and ESC affiliated countries and the adherence to ESC STEMI guidelines in patients with STEMI. Methods and results: Between 1 January 2015 and 31 March 2018, a total of 11 462 patients admitted with an initial diagnosis of STEMI according to the 2012 ESC STEMI guidelines were enrolled. Individual patient data were collected across 196 centres and 29 countries. Among the centres, there were 136 percutaneous coronary intervention centres and 91 with cardiac surgery on-site. The majority of centres (129/196) were part of a STEMI network. The main objective of this study was to describe the demographic, clinical, and angiographic characteristics of patients with STEMI. Other objectives include to assess management patterns and in particular the current use of reperfusion therapies and to evaluate how recommendations of most recent STEMI European guidelines regarding reperfusion therapies and adjunctive pharmacological and non-pharmacological treatments are adopted in clinical practice and how their application can impact on patients' outcomes. Patients will be followed for 1 year after admission. Conclusion: The ESC ACCA-EAPCI EORP ACS STEMI registry is an international registry of care and outcomes of patients hospitalized with STEMI. It will provide insights into the contemporary patient profile, management patterns, and 1-year outcome of patients with STEMI