Asystole on loop recorder in patients with unexplained syncope and negative tilt testing: age distribution and clinical predictors.

BACKGROUND: Approximately 50% of patients with unexplained syncope and negative head-up tilt test (HUTT) who have an electrocardiogram (ECG) documentation of spontaneous syncope during implantable loop recorder (ILR) show an asystolic pause at the time of the event. OBJECTIVE: The aim of the study was to evaluate the age distribution and clinical predictors of asystolic syncope detected by ILR in patients with unexplained syncope and negative HUTT. METHODS: This research employed a retrospective, single-center study of consecutive patients. The ILR-documented spontaneous syncope was classified according to the International Study on Syncope of Uncertain Etiology (ISSUE) classification. RESULTS: Among 113 patients (54.0 ± 19.6 years; 46% male), 49 had an ECG-documented recurrence of syncope during the observation period and 28 of these later (24.8%, corresponding to 57.1% of the patients with a diagnostic event) had a diagnosis of asystolic syncope at ILR: type 1A was present in 24 (85.7%), type 1B in 1 (3.6%), and type 1C in 3 (10.7%) patients. The age distribution of asystolic syncope was bimodal, with a peak at age < 19 years and a second peak at the age of 60-79 years. At Cox multivariable analysis, syncope without prodromes (OR 3.7; p = 0.0008) and use of beta blockers (OR 3.2; p = 0.002) were independently associated to ILR-detected asystole. CONCLUSIONS: In patients with unexplained syncope and negative HUTT, the age distribution of asystolic syncope detected by ILR is bimodal, suggesting a different mechanism responsible for asystole in both younger and older patients. The absence of prodromes and the use of beta blockers are independent predictors of ILR-detected asystole.

Short-duration head-up tilt test potentiated with sublingual nitroglycerin in suspected vasovagal syncope: the fast Italian protocol.

BACKGROUND: The traditional nitroglycerin (NTG) head-up tilt test (HUTT) is time-consuming and the test duration is a barrier to widespread utilization in clinical practice. It was hypothesized that a short-duration protocol is not inferior to the traditional protocol regarding the positivity rate and has a similar distribution of hemodynamic response. METHODS AND RESULTS: Patients undergoing HUTT were randomized 1:1 to a 10 min passive phase plus a 10 min 0.3 mg NTG if the passive phase was negative (Fast) or to a 20 min passive phase plus a 15 min 0.3 mg NTG if the passive phase was negative (Traditional). A sample size of 277 patients for each group achieved 80% power to detect an expected difference of 0% with a non-inferiority margin of -10% using a one-sided t-test and assuming a significant level alpha of 0.025. A total of 554 consecutive patients (mean age 46.6 ± 19.3 years, 47.6% males) undergoing HUTT for suspected vasovagal syncope were randomly assigned to the Fast (n = 277) or Traditional (n = 277) protocol. A positive response was defined as the induction of syncope in presence of hypotension/bradycardia, and was observed in 167 (60.3%) patients with Fast and in 162 (58.5%) patients with the Traditional protocol. There was a trend of lesser vasodepressor response (14.8% Fast vs. 20.6% Traditional) which was significant during the passive phase (P = 0.01). CONCLUSION: The diagnostic value of the Fast HUTT protocol is similar to that of the Traditional protocol and therefore the Fast protocol can be used instead of the Traditional protocol.

Dual Pathway Inhibition with Rivaroxaban and Aspirin Reduces Inflammatory Biomarkers in Atherosclerosis.

ABSTRACT: Dual pathway inhibition (DPI) with low-dose rivaroxaban and aspirin in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) reduces the occurrence of cardiovascular (CV) events; however, the underlying mechanisms explaining these latter CV benefits are not clearly understood. Our explorative observational study aimed to evaluate the effect of dual pathway inhibition on plasma inflammation and coagulation markers among real-world patients with CAD and/or PAD. We prospectively included all consecutive patients with an established diagnosis of CAD and/or PAD treated with aspirin 100 mg once daily (OD) and rivaroxaban 2.5 mg twice daily (TD). Clinical evaluation and laboratory analyses, including hemoglobin, renal function (creatinine, urea, and cystatin-C), coagulation markers (INR and aPTT), inflammation markers (IL-6, CRP, lipoprotein-associated phospholipase A2, and copeptin), and growth differentiation factor-15 (GDF-15), were conducted at baseline, before starting treatment, and at 4 and 24 weeks after study drug administration. Fifty-four consecutive patients (mean age 66 ± 7 years; male 83%) who completed the 6-month follow-up were included. At 24-week follow-up, a statistically significant reduction in IL-6 serum levels [4.6 (3.5-6.5) vs. 3.4 (2.4-4.3) pg/mL ; P = 0.0001] and fibrinogen [336 (290-390) vs. 310 (275-364) mg/dL; P = 0.04] was shown; moreover, a significant increase in GDF-15 serum level [1309 (974-1961) vs. 1538 (1286-2913) pg/mL; P = 0.002] was observed. Hemoglobin, renal function, and cardiovascular homeostasis biomarkers remain stable over the time. The anti-Xa activity at both [0.005 (0-0.02) vs. 0.2 (0.1-0.34); P < 0.0001) significantly increased. The dual pathway inhibitions with low-dose rivaroxaban and aspirin in patients with CAD and/or PAD were associated with the reduction of inflammation biomarkers.

Remote monitoring of implantable cardiac monitors in patients with unexplained syncope: Predictors of false-positive alert episodes.

BACKGROUND: Remote monitoring is recommended for patients with implantable cardiac monitors (ICMs), but compared to other cardiac implantable devices, ICMs are less accurate and transmit a higher number of alerts. OBJECTIVE: The aim of this study was to investigate the predictors of false-positive (FP) arrhythmic alerts in patients with unexplained syncope who were implanted with ICM and followed by an automatic remote monitoring system. METHODS: We retrospectively evaluated all consecutive patients who received a long-sensing vector ICM for unexplained syncope between January 2019 to September 2021 at our Syncope Unit. The primary endpoint was the incidence of the first FP episode. The secondary endpoints included assessing the incidence of FP episodes for all types of algorhythms and indentifying the reasons for the misdetection of these episodes. RESULTS: Among 105 patients (44.8% males, median age 51 years), 51 (48.6%) transmitted at least one FP alert during a median follow-up of 301 days. The presence of pre-ventricular complexes (PVCs) on the resting electrocardiogram was the only clinical characteristic associated with an increased risk of FP alerts (adjusted Hazard ratio [HR] 5.76 [2.66-12.4], p = 0.010). The other significant device-related variables were a low-frequency filter at 0.05 Hz versus the default 0.5 Hz (adjusted HR 3.82 [1.38-10.5], p = 0.010) and the R-wave amplitude (adjusted HR 0.35 [0.13-0.99], p = 0.049). CONCLUSION: Patients who have PVCs are at higher risk of inappropriate ICM activations. To reduce the occurrence of FP alerts, it may be beneficial to target a large R-wave amplitude during device insertion and avoid programming a low-frequency filter at 0.05 Hz.

Gender Differences in Atrial Fibrillation: From the Thromboembolic Risk to the Anticoagulant Treatment Response.

Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with an increased thromboembolic risk. The impact of the female sex as an independent risk factor for thromboembolic events in AF is still debated. Background and Objectives: The aim of this review is to evaluate the gender-related differences in cardioembolic risk and response to anticoagulants among AF patients. Materials and Methods: The PubMed database is used to review the reports about gender differences and thromboembolic risk in atrial fibrillation. Results: Non-vitamin K oral anticoagulants (NOACs) represent the gold standard for thromboembolic risk prevention in patients with non-valvular atrial fibrillation (NVAF). Despite a similar rate of stroke and systemic embolism (SE) among men and women in NOACs or vitamin K antagonists (VKAs) treatment, the use of NOACs in AF women is associated with a lower risk of intracranial bleeding, major bleeding, and all-cause mortality than in men. Conclusions: The female sex can be defined as a stroke risk modifier rather than a stroke risk factor since it mainly increases the thromboembolic risk in the presence of other risk factors. Further studies about the efficacy and safety profile of NOACs according to sex are needed to support clinicians in performing the most appropriate and tailored anticoagulant therapy, either in male or female AF patients.

Air entrapment as a cause of early inappropriate shocks after subcutaneous defibrillator implant: A case series.

Inappropriate shock (IAS) is the most frequent device-related complication among patients with subcutaneous implantable cardioverter-defibrillator (S-ICD). Air entrapment (AE) has been described as an underdiagnosed cause of early postimplant IAS. We report 6 consecutive cases of early IAS after S-ICD implant, in whom the electrogram analysis (EGM) and/or chest radiography (CXR) were consistent with AE.

Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) study: the predictive role of programmed ventricular stimulation.

AIMS: Myotonic dystrophy type 1 (DM1) predisposes to the development of life-threatening arrhythmias and sudden cardiac death. Our study aimed to evaluate the prognostic value of programmed ventricular stimulation (PVS) in DM1 patients with conduction system disease. METHODS AND RESULTS: Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) is a double-arm non-randomized interventional prospective study. Myotonic dystrophy type 1 patients with permanent cardiac pacing indication were eligible for the inclusion. The study population underwent to pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation according to the inducibility of ventricular tachyarrhythmias at PVS. Primary endpoint of the study was a composite of appropriate ICD therapy and cardiac arrhythmic death. The secondary study endpoint was all-cause mortality. Seventy-two adult-onset DM1 patients (51 ± 12 years; 39 male) were enrolled in the study. A ventricular tachyarrhythmia was induced in 25 patients (34.7%) at PVS (PVS+) who underwent dual chambers ICD implantation. The remaining 47 patients (65.3%) without inducible ventricular tachyarrhythmia (PVS-) were treated with dual-chamber PM. During an average observation period of 44.7 ± 10.2 months, nine patients (12.5%) met the primary endpoint, four in the ICD group (16%) and five (10.6%) in the PM group. Thirteen patients died (18.5%), 2 in the ICD group (8%) and 11 in PM group (23.4%). The Kaplan-Meier analysis did not show a significantly different risk of both primary and secondary endpoint event rates between the two groups. CONCLUSIONS: The inducibility of ventricular tachyarrhythmias has shown a limited value in the arrhythmic risk stratification among DM1 patients.

Inappropriate shocks due to air entrapment in patients with subcutaneous implantable cardioverter-defibrillator: A meta-summary of case reports.

BACKGROUND: Air entrapment has been recently described as a cause of inappropriate shock (IAS) among patients who underwent subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Data about this complication are lacking in the literature. METHODS: In this meta-summary 14 case reports describing IAS due to air entrapment were included. Patients' characteristics, S-ICD implant technique and air entrapment properties were collected. RESULTS: All patients experienced IAS within 4 days following S-ICD implant. The subcutaneous air was demonstrated by chest x-ray in 11 cases (73.3%). The sensing vector was reprogrammed in 11 cases (73.3%), and ICD was switched off in 2 cases (1.3%). CONCLUSIONS: IAS due to air entrapment is an early complication of S-ICD implant. No association was observed between the implant technique and air retention. Diagnosis is confirmed by chest x-ray and device interrogation. Management includes switching off the device or, preferably, changing the sensing vector.

Optimized radiofrequency lesions through local impedance guidance for effective CTI ablation in right atrial flutter.

BACKGROUND: Although radiofrequency (RF) catheter ablation of cavo-tricuspid isthmus (CTI) is an established treatment for typical right atrial flutter (RAFL), it remains to be established whether local tissue impedance (LI) is able to predict effective CTI ablation and what LI drop values during ablation should be used to judge a lesion as effective. We aimed to investigate the ability of LI to predict ablation efficacy in patients with RAFL. METHODS: RF delivery was guided by the DirectSense™ algorithm. Successful single RF application was defined according to a defragmentation of atrial potentials (DAP), reduction of voltage (RedV) by at least 80% or changes on unipolar electrogram (UPC). The ablation endpoint was the creation of bidirectional conduction block (BDB) across the isthmus. RESULTS: 392 point-by-point RF applications were analyzed in 48 consecutive RAFL patients. The mean baseline LI was 105.4 ± 12Ω prior to ablation and 92.0 ± 11Ω after ablation (p < 0.0001). According to validation criteria, absolute drops in impedance were larger at successful ablation sites than at ineffective ablation sites (DAP: 17.8 ± 6Ω vs. 8.7 ± 4Ω; RedV: 17.2 ± 6Ω vs. 7.8 ± 5Ω; UPC: 19.6 ± 6Ω vs. 10.1 ± 5Ω, all p < 0.0001). LI drop values significantly increased according to the number of criteria satisfied (ranging from 7.5Ω to 19.9). BDB was obtained in all cases. No procedure-related adverse events were reported. CONCLUSIONS: A LI-guided approach to CTI ablation was safe and effective in treating RAFL. The magnitude of LI drop was associated with effective lesion formation and BDB and could be used as a marker of ablation efficacy. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Cardioinhibitory syncope with asystole during nitroglycerin potentiated head up tilt test: prevalence and clinical predictors.

AIMS: The aim of our study was to evaluate the prevalence and clinical predictors of cardioinhibitory (CI) responses with asystole at the nitroglycerin (NTG)-potentiated head-up tilt test (HUTT) in patients with a history of syncope admitted to a tertiary referral syncope unit. METHODS: We retrospectively evaluated all consecutive patients who underwent NTG-potentiated HUTT for suspected reflex syncope at our institution from March 1 2017 to May 1 2020. The prevalence of HUTT-induced CI syncope was assessed. Univariate and multivariate analyses were performed to test the association of asystolic response to HUTT with a set of clinical covariates. RESULTS: We enrolled 1285 patients (45 ± 19.1 years; 49.6% male); 368 (28.6%) showed HUTT-induced CI response with asystole. A multivariate analysis revealed that the following factors were independently associated with HUTT-induced CI syncope: male sex (OR 1.48; ConInt 1.14-1.92; P = 0.003), smoking (OR 2.22; ConInt 1.56-3.115; P < 0.001), traumatic syncope (OR: 2.81; ConInt 1.79-4.42; P < 0.001), situational syncope (OR 0.45; ConInt 0.27-0.73; P = 0.002), and the use of diuretics (OR 9.94; ConInt 3.83-25.76; P < 0.001). CONCLUSIONS: The cardioinhibitory syncope with asystole induced by NTG-potentiated HUTT is more frequent than previously reported. The male gender, smoking habit, history of traumatic syncope, and use of diuretics were independent predictors of HUTT-induced CI responses. Conversely, the history of situational syncope seems to reduce this probability.

Direct Oral Anticoagulants Plasma Levels Measurement: Clinical Usefulness from Trials and Real-World Data.

Measurement of direct oral anticoagulants (DOACs) activity is not routinely necessary. Indeed, evaluation of DOACs plasmatic concentration is discouraged for the majority of patients, due to the lack of outcome data supporting this approach. Nevertheless, DOAC measurements may be useful in emergency situations such as serious bleeding events, need for urgent invasive procedures, and acute ischemic stroke or in managing anticoagulation in "special populations" not adequately studied in clinical trials, for example the very elderly or those at the extremes of body weight. The aim of this review is to describe and summarize the methods for DOACs activity evaluation and the settings in which their plasma level measurement may be indicated, analyzing indications from scientific societies and evidence from clinical trials, as well as real world data on the usefulness of DOACs plasma levels "monitoring."

Direct Current Cardioversion in Atrial Fibrillation Patients on Edoxaban Therapy Versus Vitamin K Antagonists: a Real-world Propensity Score-Matched Study.

PURPOSE: The purpose of the present study was to compare the long-term effectiveness and safety of newly initiated anticoagulation with edoxaban (EDO) versus uninterrupted vitamin K antagonist (VKA) therapy in patients with atrial fibrillation (AF) scheduled for transesophageal echocardiogram (TEE)-guided direct electrical current cardioversion (DCC). METHODS: A propensity score-matched cohort observational study was performed comparing the safety and effectiveness of edoxaban versus well-controlled VKA therapy among a cohort of consecutive non-valvular AF patients scheduled for DCC. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). FINDINGS: A total of 130 AF patients receiving edoxaban 60-mg (EDO) treatment were compared with the same number of VKA recipients. The cumulative incidence of major bleedings was 1.54% in the EDO group and 3.08% in the VKA group (P = 0.4). The cumulative incidence of thromboembolic events was 1.54% in the EDO group and 2.31% in the VKA group (P = 0.9). A non-significant trend in improved adherence was observed between the EDO and VKA groups with a total anticoagulant therapy discontinuation rate of 4.62% (6/130) vs 6.15% (8/130), respectively (P = 0.06). IMPLICATIONS: Our study provides the evidence of a safe and effective use of edoxaban in this clinical setting, justified by no significant difference in major bleedings and thromboembolic events between edoxaban and well-controlled VKA treatments.

Clinical Performance of Nonvitamin K Antagonist Oral Anticoagulants in Real-World Obese Patients with Atrial Fibrillation.

The prevalence of both atrial fibrillation (AF) and obesity has steadily increased. Nonvitamin K antagonist oral anticoagulants (NOACs) have been shown to be more effective and safer than vitamin K antagonists (VKAs) for long-term stroke prevention in patients with nonvalvular AF. There are still limited data in the literature regarding performance of NOACs in obese patients with AF in the "real world." The aim of our study was to compare the safety and effectiveness of NOACs versus well-controlled VKA therapy in obese AF patients in a "real-world" setting. Here, we have considered patients with AF and obesity (body mass index [BMI] > 30 kg/m2) on NOAC or VKA therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MBs) and thromboembolic events (composite of ischemic stroke, transient ischemic attack, and systemic embolism) was respectively considered primary safety and effectiveness outcomes. We identified 1,047 AF patients with obesity who received NOAC (n = 272) or VKA (n = 775) treatment. After propensity score matching analysis, 248 NOAC and 496 VKA recipients with similar clinical characteristics, including BMI (34.8 ± 3.4 in NOAC vs. 35.1 ± 3.8 in the VKA group; p = 0.50), were evaluated. The mean follow-up was 39 ± 7 months. The incidence rate of thromboembolic events was 1.10 per 100 person-years (0.67 in NOAC vs. 1.28 in the VKA group; hazard ratio [HR]: 0.52; 95% confidence interval [CI]: 0.22-1.22; p = 0.19). The incidence rate of MB was 1.9 per 100 person-years (1.1 in NOAC vs. 2.28 in the VKA group; HR: 0.46; 95% CI: 0.24-0.88; p = 0.04). The incidence rate of intracranial hemorrhage was 0.4 per 100 person-years (0.27 in NOAC vs. 0.47 in the VKA group; HR: 0.57; 95% CI: 0.12-2.73; p = 0.48). A positive net clinical benefit (NCB) of NOACs over VKAs was found (+0.91). Presence of anemia (HR: 1.75; p = 0.003) and concomitant use of antiplatelet drugs (HR: 2.41; p = 0.001) were found to be independent predictors of MB; moreover, age (HR: 1.65; p = 0.003) was an independent predictor of thromboembolic events. Our data support the hypothesis of safe and effective use of NOACs in patients with AF and obesity, justified by a statistically significant lower incidence of MB and a favorable NCB over VKAs.

Prevalence of Left Ventricular Systolic Dysfunction in Myotonic Dystrophy Type 1: A Systematic Review.

Cardiac involvement is recorded in about 80% of patients affected by myotonic dystrophy type 1 (DM1). The prevalence of cardiac conduction abnormalities and arrhythmias has been well described. Data regarding the prevalence of left ventricle systolic dysfunction (LVSD) and heart failure (HF) are still conflicting. The primary objective of this review was to assess the prevalence of LVSD and HF in DM1. The secondary aim was to examine the association of clinical features with LVSD and to detect predisposing and influencing prognosis factors. A systematic search was developed in MEDLINE, EMBASE, Cochrane Register of Controlled Trials, and Web of Science databases to identify original reports between January 1, 2009, and September 30, 2017, assessing the prevalence of LVSD and HF in populations with DM1. Retrospective and prospective cohort studies and case series describing the prevalence of LVSD, as evaluated by echocardiography, and HF in patients with DM1 were included. Case reports, simple reviews, commentaries and editorials were excluded. Seven studies were identified as eligible, of which 1 was a retrospective population-based cohort study, and 6 were retrospective single-center-based cohort studies. Echocardiographic data concerning LV function were available for 647 of the 876 patients with DM1 who were included in the analysis. The prevalence of LVSD in patients with DM1, defined as LVEF < 55%, was 13.8%, 4.5-fold higher than in general population. Patients with DM1 and LVSD were older, were more likely to be male, had longer baseline atrioventricular and intraventricular conduction-time durations, had higher incidences of atrial arrhythmias, and were more likely to have undergone device implantation. Also, symptomatic HF is more prevalent in patients with DM1 despite their limited levels of physical activity. Further studies are needed to evaluate the prevalence of LVSD and HF in patients with DM1 and to investigate electrocardiographic abnormalities and other clinical features associated with this condition.

Non-vitamin K vs vitamin K oral anticoagulants in patients aged > 80 year with atrial fibrillation and low body weight.

BACKGROUND: Octogenarian patients are at high risk of both ischaemic and bleeding events, and the low body weight is considered a risk factor for major bleeding in atrial fibrillation (AF) patients on anticoagulation therapy. The aim of our study was to compare the safety and effectiveness of NOACs versus well-controlled VKA therapy among patients aged > 80 year with AF and low body weight in real-life setting. METHODS: Data for this study were sourced from the multicenter prospectively maintained Atrial Fibrillation Research Database (NCT03760874). From this, we selected AF patients aged ≥ 80 years and weighted ≤ 60 kg who received NOACs or VKAs treatment (only those with a time in therapeutic range > 70%). 279 patients (136 in NOAC group and 143 in VKA group) were selected. RESULTS: A total of 71 patients (17 in NOAC vs 54 in VKA group) died during the follow-up. The incidence rate of all-cause mortality was 27.70 per 100 person-years (14.91 in NOAC vs 37.94 in VKA group, adjusted hazard ratio 0.43; 95% CI 0.25 to 0.975; P = .003). 22 patients (9 in NOAC vs 13 in VKA group, P = .6) had major bleeding events. Diabetes mellitus, COPD and age resulted positively associated with death, whereas NOACs, parossistic AF and weight negatively associated with mortality. CONCLUSIONS: Our real-world data might suggest the safe and efficacy use of NOACs in this setting of population, justified by a reduction in overall mortality over VKAs. Further studies are needed to confirm these data.

Atrial Fibrillation in COVID-19: From Epidemiological Association to Pharmacological Implications.

Coronavirus disease 2019 (COVID-19) outbreak is a public health emergency of international concerns because of a highly pathogenic human coronavirus (HCoV), actually named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite much emerging data about the epidemiological association between cardiovascular diseases and COVID-19, little is still known about atrial fibrillation and its optimal management in this clinical contest. The aim of our review is to describe the pharmacological interactions between cardiovascular drugs more commonly used in atrial fibrillation management and experimental COVID-19 therapies, based on EU and US summaries of product characteristics.

Update on Direct Oral Anticoagulants in Atrial Fibrillation Patients Undergoing Cardiac Interventional Procedures: From Clinical Trials to Real-World Evidence.

Direct oral anticoagulants (DOACs) are considered a first-line therapy for long-term stroke prevention in patients with nonvalvular atrial fibrillation (AF) and high thromboembolic risk. The potential role of DOACs in cardiac interventional procedures is a pressing clinical question, considering the increasing number of procedures and the growing prevalence of patients in DOAC therapy. The aim of this review is to provide an update on available evidence about the clinical performance of DOACs in AF patients undergoing different interventional procedures (AF cardioversion and ablation, and percutaneous coronary and structural heart disease interventions) and to explore the possible role of DOACs as an alternative therapeutic strategy in cardiac interventional procedures among non-AF patients.

Clinical profile of direct oral anticoagulants versus vitamin K anticoagulants in octogenarians with atrial fibrillation: a multicentre propensity score matched real-world cohort study.

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice and its prevalence increases with age. Few data are available about the clinical performance of direct oral anticoagulant (DOACs) in patients aged ≥ 80 years with AF. The aim of our propensity score matched cohort study was to compare the safety and efficacy of DOACs versus well-controlled VKA therapy among octogenarians with AF in real life setting. Data for this study were sourced from the multicenter prospectively maintained Atrial Fibrillation Research Database (NCT03760874), which includes all AF patients followed by the participating centers, through outpatient visits every 3 to 6 months. The database was queried for AF patients aged ≥ 80 years who received DOACs or VKAs treatment. The primary effectiveness endpoint was the occurrence of thromboembolic events (a composite of stroke, transient ischemic attack, systemic embolism); the primary safety endpoint was the occurrence of major bleeding; the secondary endpoint was all-cause mortality. The database query identified 774 AF patients aged ≥ 80 years treated with VKAs and 279 with DOACs. Propensity score (2:1) matching selected 252 DOAC and 504 VKA recipients. The mean follow-up was 31.07 ± 14.09 months. The incidence rate of thromboembolic events was 13.79 per 1000 person-years [14.80 in DOAC vs 13.34 in VKA group, Hazard Ratio 1.10; 95% confidence interval (CI) 0.49 to 2.45; P = 0.823]. The incidence rate of intracranial hemorrhage (ICH) was 8.06 per 1000 person-years (3.25 in DOAC vs 10.23 in VKA group, HR 0.33; 95% CI 0.07 to 1.45; P = 0.600). Through these incidence rates, we found a positive net clinical benefit (NCB) of DOACs over VKAs, equal to + 9.01. The incidence rate of all-cause mortality was 105.05 per 1000 person-years (74.67 in DOAC vs 118.67 in VKA group, Hazard Ratio 0.65; 95% CI 0.47 to 0.90; P = 0.010). The concomitant use of antiinflammatory drugs (HR 7.90; P < 0.001) were found to be independent predictor of major bleeding. Moreover, age (HR 1.17; P < 0.002) and chronic kidney disease (HR 0.34; P = 0.019) were found to be independently associated with thromboembolic events. In our study no significant difference in terms of both thromboembolic and major bleeding events, but a significant lower incidence of all-cause mortality, was detected in AF patients aged ≥ 80 years treated with DOACs vs VKAs.

Edoxaban in elderly patient with morbid obesity and atrial fibrillation: the role of plasma levels evaluation for selecting the appropriate dose.

We present the case of a 80-year-old man with atrial fibrillation, morbid obesity (weight 123 kg, height 167 cm, BMI 44.1), high clearance of creatinine and pharmacological polytherapy, in which the serial determinations of edoxaban plasma levels help us to choose the appropriate dose.

Atrial Fibrillation and Malignancy: The Clinical Performance of Non-Vitamin K Oral Anticoagulants-A Systematic Review.

Atrial fibrillation (AF) is commonly diagnosed in the setting of active cancer. Because of an increased risk of either thromboembolic events or bleeding, the decision to initiate therapeutic anticoagulation in patients with active cancer can be challenging. Moreover, little is still known about the optimal anticoagulation therapy in the setting of AF and cancer, and no guidelines are as yet available. Considering that nonvitamin K antagonist oral anticoagulants (NOACs) are recommended as alternatives to vitamin K antagonists for stroke prevention in AF patients with CHA2DS2-VASc score ≥2, the authors performed a systematic review of the current literature to describe the efficacy and safety of NOACs in AF patients with malignancy.