Median CHA2DS2-VASc Research Articles

Comparison between R2CHA2DS2-VASc Score and CHA2DS2-VASc Score to Predict Acute Stent Thrombosis in Patients with After Primary Percutaneous Coronary Intervention

Aim: Acute stent thrombosis (AST) is an important complication resulting from sudden vascular occlusion after stent implantation, especially in patients with ST-segment elevation myocardial infarction (STEMI). It occurs in about 1% of the patients after primary percutaneous coronary intervention. The CHA2DS2-VASc score is easily applied in daily practice and the components of this score are similar to common risk factors of the AST. Chronic renal disease has a hypercoagulable state and this condition is associated with an increased risk of AST in STEMI. Since the CHA2DS2-VASc score is insufficient to assess the risk of AST in patients with renal dysfunction, we aimed to investigate the prognostic significance of the modified score, R2CHA2DS2-VASc score in patients with AST.Methods:This cross-sectional study retrospectively included 56 patients withAST and 1493 patients without AST after STEMI. The CHA2DS2-VASc and R2CHA2DS2-VASc scores were compared between the two groups.Results:The median CHA2DS2-VASc and R2CHA2DS2-VASc scores were significantly higher in the AST group (P <0.001, P <0.001, respectively). The R2CHA2DS2-VASc score ≥2 was used as a predictor of the AST with a sensitivity of 65% and specificity of 89%.Conclusions: The R2CHA2DS2-VASc score is a simple, cheap, and easily accessible score that can predict AST.

Risk of stroke and other thromboembolic complications after interruption of DOAC therapy compared with warfarin therapy in patients with atrial fibrillation: a retrospective cohort analysis

Direct oral anticoagulants (DOACs) have become the treatment of choice in thromboembolism prophylaxis for non-valvular atrial fibrillation, surpassing warfarin. While interruption of DOAC therapy for various reasons is a common...

Rivaroxaban in patients with atrial fibrillation: from research to real practice (based on REGistry of Long-term AnTithrombotic TherApy-2 (REGATA))

Introduction. Despite the large evidence base for the use of rivaroxaban, cohort studies are interesting because shows the possibility of anticoagulant therapy in patients with high thromboembolic and bleeding risk and a burden of comorbidity in practice.Aim: to evaluate the efficacy and safety of rivaroxaban therapy in patients with atrial fibrillation in prospective REGATTA registry.Materials and methods. This study is a fragment of a single-center prospective REGATA registry (Registry of Long-term Antithrombotic Therapy (NCT043447187), conducted on the basis of the National Research Center of Cardiology of the Ministry of Health of the Russian Federation. 152 patients with high thromboembolic risk (median CHA2DS2-VASc = 4) received rivaroxaban therapy (median follow-up 1.5 years). The efficacy endpoint was the sum of cardiovascular complications (including cardiovascular death, ischemic stroke, and acute coronary syndrome). The safety endpoint bleedinds BARC types 2-5.Results. The frequency of cardiovascular events (combining cardiovascular death, ischemic stroke and acute coronary syndrome) was 5.8/100 patient-years. The use of a “reduced” dose of rivaroxaban was an independent predictor of the development of fatal cardiovascular complications. The rate of major bleeding was 3.7/100 patient-years, and the rate of clinical relevant bleedings was 19.4 /100 patientyears. The predictors of major/ clinical relevant bleedings were chronic kidney disease with a decrease in creatinine clearance of less than 50 ml/min and the anamneses of major/ clinical relevant bleedings.Conclusion. The main requirement for improving the safety of anticoagulants is follow up, focused in all changes in the cardiovascular and somatic status of the patient during treatment.

Comparative study of cardiac magnetic resonance imaging and transesophageal echocardiography in detection of left atrial and left atrial appendage thrombi

Abstract Funding Acknowledgements Type of funding sources: None. Background Left atrial (LA) thrombi are the most common intracardiac masses. Left atrial appendage (LAA) is the most common site for thrombus formation in patients with atrial fibrillation (AF), and in patients with valvular lesions. Transesophageal echocardiography (TEE) has been the conventional investigation for thrombus detection. However, because TEE is a semi-invasive technique; a completely non-invasive technique would be of great concern. Purpose The aim of this study is to evaluate the feasibility and diagnostic performance of cardiac magnetic resonance imaging (CMR), for the assessment of thrombi in the left atrium and left atrial appendage (LA/ LAA). Also whether CMR is comparable to TEE in identification and measurement of thrombus size. Methods We studied 43 patients who were diagnosed to have LA/LAA thrombus, or highly suspected thrombus by TEE. They underwent multisequence CMR for assessment of thrombus detection; within 7 days of TEE performance. Data collected from CMR study were statistically analyzed to evaluate for sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) and overall accuracy of detection of LA/LAA thrombus using TEE as the gold standard. Also agreement between both imaging techniques was assessed using kappa agreement coefficient. We conducted a questionnaire where 10 questions were asked to every patient in the study. It aimed to obtain an idea about patients’ opinion of both tests. Results During the study period of 13 months, 43 patients were assessed. Twenty one patients had AF and 22 patients were in sinus rhythm. The median CHA2DS2VASc score of AF patients was 2.52 ± 1.12, and 76.7% of patients were undergoing anticoagulation therapy. In all subjects, the LAA was readily visualized with CMR. When evaluating the diagnostic performance of CMR results revealed overall sensitivity, specificity, PPV, NPV and accuracy of 97.44%, 75%, 97.44%, 75% and 95.35% respectively. Results of questionnaire was statistically significant p value yielding good overall opinion for the sake of CMR. There was an additional role for CMR regarding tissue characterization; where CMR detected 3 cases, diagnosed by TEE as thrombus, 1 case revealed Libman-Sacks Endocarditis and 2 cases revealed fibroelastoma. This made a paradigm shift in patient management. Conclusion CMR is a noninvasive, feasible and comparable modality for thrombus detection in the LA and LAA and could be a reasonable, more comfortable alternative to TEE.

Sex Differences in Outcomes Following Left Atrial Appendage Closure

ObjectiveTo evaluate the effects of female sex on in-hospital outcomes and to provide estimates for sex-specific prediction models of adverse outcomes following left atrial appendage closure (LAAC). Patients and MethodsCohort-based observational study querying the National Inpatient Sample database between October 1, 2015, and December 31, 2017. Demographics, baseline characteristics, and comorbidities were assessed with the Charlson Comorbidity Index (CCI), Elixhauser Comorbidity Index score (ECS), and CHA2DS2-VASc score. The primary outcome was in-hospital major adverse events (MAEs) defined as the composite of bleeding, vascular, cardiac complications, post-procedural stroke, and acute kidney injury. The associations of the CCI, ECS, and CHA2DS2-VASc score with in-hospital MAE were examined using logistic regression models for women and men, respectively. ResultsA total of 3294 hospitalizations were identified, of which 1313 (40%) involved women and 1981 (60%) involved men. Women were older (76.3±7.7 vs 75.2±8.4 years, P<.001), had a higher CHA2DS2-VASc score (4.9±1.4 vs 3.9±1.4, P<.001) but showed lower CCI and ECS compared with men (2.1±1.9 vs 2.3±1.9, P=.01; and 9.3±5.9 vs 9.9±5.7, P=.002, respectively). The primary composite outcome occurred in 4.6% of patients and was higher in women compared with men (women 5.6% vs men 4.0%, P=.04), and this was mainly driven by the occurrence of cardiac complications (2.4% vs 1.2%, P=.01). In women, older age, higher median income, and higher CCI (adjusted odds ratio [aOR], 1.32; 95% confidence interval [CI], 1.21 to 1.44; P<.001), ECS (aOR, 1.04; 95% CI, 1.02 to 1.07; P=.002), and CHA2DS2-VASc score (aOR, 1.24; 95% CI, 1.10 to 1.39; P<.001) were associated with increased risk of in-hospital MAE. In men, non-White race/ethnicity, lower median income, and higher ECS (aOR, 1.06; 95% CI, 1.04 to 1.09; P<.001) were associated with increased risk of in-hospital MAE. ConclusionWomen had higher rates of in-hospital adverse events following LAAC than men did. Women with older age and higher median income, CCI, ECS, and CHA2DS2-VASc scores were associated with in-hospital adverse events, whereas men with non-White race/ethnicity, lower median income, and higher ECS were more likely to experience adverse events. Further research is warranted to identify sex-specific, racial/ethnic, and socioeconomic pathways during the patient selection process to minimize complications in patients undergoing LAAC.

Adesão à terapêutica com anticoagulantes diretos em doentes com fibrilhação auricular não valvular – uma análise de mundo real

Introduction and objectivesDirect oral anticoagulants (DOACs) changed the landscape of atrial fibrillation (AF) treatment, but also brought new challenges in terms of accessibility and compliance. The purpose of this study was to assess adherence to DOACs, and predictors of adherence in a population of AF patients. MethodsSingle‐center retrospective study including all patients with non‐valvular AF treated with a DOAC and followed in outpatient general cardiology, whose first DOAC prescription was between 1 April 2016 to August 2018. The number of pharmacy refills from the day of first prescription to 31 August 2018 was counted (by means of an electronic prescription platform). Medication refill adherence (MRA) was calculated by dividing the total days of supply by the number of days under therapy. Non‐compliance was defined as MRA <90%. ResultsA total of 264 patients (120 men, mean age 74 [PLEASE INSERT SYMBOL] 12 years) met the inclusion criteria. The median CHA2DS2VASC score was 3 (interquartile range (IQR) 2‐5) and the median HAS‐BLED was 1 (IQR 1‐2). Rivaroxaban, apixaban, dabigatran and edoxaban were prescribed in 45%, 41%, 24% and 13% of patients, respectively. Throughout the study, 51 patients (19%) used at least two DOACs. Patients were under DOAC for a median period of 439 days (IQR 269‐638), during which the included population adhered to therapy 90% of the time (IQR 75‐100%). Half of the patients (51%) were classified as non‐compliant; therapy duration (adjusted odds ratio (OR) 1.06 per month, 95% confidence interval (CI) 1.03‐1.08, p<0.001), taking DOACs with b.i.d. (adjusted OR 1.73, 95%CI 1.08‐2.75, p=0.022), and higher medication copayments (adjusted OR 2.13, 95%CI 1.28‐3.45, p=0.003) were independent predictors of non‐compliance. ConclusionHalf of the patients (51%) were classified as non‐compliant (medication refill adherence < 90%). Therapy duration, DOACs with b.i.d. posology and higher medication copayments were independent predictors of non‐compliance, which might be targets to improve patient adherence.

Effectiveness and Safety of Rivaroxaban Vs. Warfarin in Patients with Nonvalvular Atrial Fibrillation and Moderate-to-Severe Chronic Kidney Disease

Background: Chronic kidney disease (CKD) is a potent risk factor for both ischemic stroke and major bleeding in patients with nonvalular atrial fibrillation (NVAF).Objective: To assess the effectiveness and safety of rivaroxaban vs. warfarin in NVAF patients with moderate-to-severe CKD treated in routine practice.Methods: Using US MarketScan claims data from 11/2011-3/2016, we identified oral anticoagulation (OAC) naïve NVAF patients with moderate-to-severe CKD and ≥12 months of continuous insurance coverage prior to the qualifying OAC dispensing. Rivaroxaban users (20 mg or 15 mg once daily) were 1:1 matched to warfarin users by applying propensity-scores that were calculated based on demographics, comorbidities, stroke and bleeding risk factors and concomitant medications. Balance between cohorts was evaluated by inspecting standardized differences for baseline covariates (differences >0.1 indicating imbalance). Patients were followed until an event, OAC discontinuation/switch (30 day permissible gap), insurance disenrollment or end of follow up. Rates of stroke/systemic embolism (SSE) and major bleeding (per the Cunningham algorithm) between cohorts were compared using Cox regression. A separate propensity-score matched analysis of reduced dose rivaroxaban vs. warfarin users was performed.Results: We assessed 777 rivaroxaban and 777 warfarin users with NVAF and moderate-to-severe CKD with a median (interquartile range) available follow up of 1.3 (0.6-2.2) years. All baseline covariates evaluated had a standardized difference <0.1. Median age was 76 (68-82) years and median CHA2DS2-VASc and HAS-BLED scores were 4 (3-5) and 3 (3-4). Rivaroxaban use was associated with nonsignificant relative hazard reductions in SSE and ischemic stroke vs. warfarin (Figure). No differences in major bleeding or hemorrhagic stroke were observed between cohorts. The reduced dose 15 mg rivaroxaban vs. warfarin user analysis yielded similar conclusions to the full cohort analysis.Conclusions: Results of this claims database analysis are generally consistent with those seen in the randomized ROCKET AF trial. Rivaroxaban's relative effectiveness and safety vs. warfarin appears to be maintained in NVAF patients with moderate-to-severe CKD treated in routine clinical practice. [Display omitted] DisclosuresColeman:Boehringer Ingelheim: Consultancy, Honoraria; Bayer AG: Consultancy, Honoraria, Research Funding; Janssen Pharmaceuticals: Consultancy, Honoraria, Research Funding. Turpie:Bayer HealthCare Pharmaceuticals: Consultancy; Janssen Research and Development: Consultancy, Honoraria. Kreutz:Bristol-Myers Squibb: Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Berlin-Chemie Menarini: Consultancy; Bayer AG: Consultancy, Honoraria; Lundbeck: Consultancy; Servier Laboratories: Consultancy.

First-line treatment of persistent and long-standing persistent atrial fibrillation with single-stage hybrid ablation: a 2-year follow-up study.

AimsThis study evaluates the efficacy and safety of first-line single-stage hybrid ablation of (long-standing) persistent atrial fibrillation (AF), over a follow-up period of 2 years, and provides additional information on arrhythmia recurrences and electrophysiological findings at repeat ablation.Methods and resultsThis is a prospective cohort study that included 49 patients (65% persistent AF; 35% long-standing persistent AF) who underwent hybrid ablation as first-line ablation treatment (no previous endocardial ablation). Patients were relatively young (57.0 ± 8.5 years) and predominantly male (89.8%). Median CHA2DS2-VASc score was 1.0 (0.5; 2.0) and mean left atrium volume index was 43.7 ± 10.9 mL/m2. Efficacy was assessed by 12-lead electrocardiography and 72-h Holter monitoring after 3, 6, 12, and 24 months. Recurrence was defined as AF/atrial flutter (AFL)/tachycardia (AT) recorded by electrocardiography or Holter monitoring lasting >30 s during 2-year follow-up. At 2-year follow-up, single and multiple procedure success rates were 67% and 82%, respectively. Two (4%) patients experienced a major complication (bleeding) requiring intervention following hybrid ablation. Among the 16 (33%) patients who experienced an AF/AFL/AT recurrence, 13 (81%) were ATs/AFLs and only 3 (19%) were AF. Repeat ablation was performed in 10 (20%) patients and resulted in sinus rhythm in 7 (70%) at 2-year follow-up.ConclusionFirst-line single-stage hybrid AF ablation is an effective treatment strategy for patients with persistent and long-standing persistent AF with an acceptable rate of major complications. Recurrences are predominantly AFL/AT that can be successfully ablated percutaneously. Hybrid ablation seems a feasible approach for first-line ablation of (long-standing) persistent AF.

Left atrial appendage occlusion in the UK: prospective registry and data linkage to Hospital Episode Statistics.

AimsNon-valvular atrial fibrillation (AF) greatly increases the risk of ischaemic stroke. For people with contraindications to oral anticoagulation, left atrial appendage occlusion (LAAO) provides a non-pharmacological management alternative. The aim of this study was to measure the procedural safety and longer-term effectiveness of LAAO for AF in a UK setting.Methods and resultsThis was a prospective, single-armed registry of patients with AF for whom anticoagulation was unsuitable. Registry data were collected between October 2014 and April 2018 and linked to routine data sources for follow-up. Data from 583 LAAO procedures were entered into the registry, of which 537 (from 525 patients) were eligible for inclusion (median CHA2DS2-VASc score 4). A closure device was successfully implanted in 93.4% of cases, with a procedural success rate (device implanted without major complication) of 88.9%. Five patients (1.0%) died in hospital. During follow-up [median 729 (Q1:Q3, 523:913) days] 45 patients experienced neurological events; 33 of which were ischaemic. The ischaemic neurological event rate was 3.3 (1.6–5.0)% at 1 year (n = 387) and 7.0 (4.3–9.6)% at 2 years (n = 196). There were significant improvements in overall patient health (via Visual Analogue Scale) measured at 6 weeks and 6 months, but no significant improvements observed in patient utility over time.ConclusionThe findings of our study suggest that LAAO is not without procedural risk, but that this risk may be justified in high-risk patients with AF who cannot take an anticoagulant. Moreover, the data do not provide support for more widespread use of LAAO as the complication rate was relatively high and would be difficult to justify in many patients with AF who tolerate anticoagulation.

Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease

Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown. To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up. The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion. Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders. Incident AF lasting more than 30 seconds through 12 months. Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain). Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance. ClinicalTrials.gov Identifier: NCT02700945.

Head-to-head comparison of proprietary PPG and single-lead ECG algorithms for atrial fibrillation detection

Abstract Funding Acknowledgements Type of funding sources: None. Background Population based screening for atrial fibrillation (AF) has been suggested to reduce stroke. Photoplethysmography (PPG) deriving smartphone apps and single-lead electrocardiography (ECG) tools are attractive devices for screening due to their low cost, convenience, and accessibility. Automated algorithm analysis can serve as pre-screening or remote monitoring for AF, while confirmation on an ECG trace &amp;gt;30s is required to establish the diagnosis. This work directly compares the performance of proprietary algorithms on PPG vs single-lead ECG for the detection of AF. Purpose To evaluate and compare the diagnostic performance of a PPG-deriving smartphone app and a single-lead ECG-deriving handheld device for AF detection. Methods Patients were recruited from the cardiology ward. After obtaining written informed consent, demographic and medical information were collected. Patients were instructed to perform one measurement using a pulse-deriving smartphone app and one via a single-lead ECG handheld device. A 12-lead electrocardiogram (ECG) was collected and interpreted by a cardiologist as gold standard. Patients with atrial flutter were excluded, with additional exclusions for insufficient quality measurements and unsuccessful measurements resulting due to technical errors. Unclassified single-lead ECG measurements were handled as test-negative. Sensitivity, specificity and accuracy were calculated with respect to the reference diagnosis. McNemar’s analysis was performed to compare the sensitivity and specificity of the proprietary PPG and single-lead ECG AF detection algorithms. Results The median age in the study population (n = 300) was 70 years (interquartile range: 51-78), 56.3% were men, and the median CHA2DS2-VASc was 3 (interquartile range: 1-4) with an AF-prevalence of 32.3%. PPG signal and single‑lead ECG quality was sufficient in 272/300 (91.0%) and 278/298 (93.3%) participants, respectively. After excluding atrial flutter patients (n = 25) and insufficient quality measurements, the sensitivity and specificity were 97.6% (95% CI 93.8 to 99.3) and 94.1% (95% CI 86.8 to 98.1) for the PPG signal versus 95.7% (95% CI 91.4 to 98.3) and 91.1% (95% CI 83.2 to 96.1) for the single‑lead ECG signal, respectively. Results demonstrated a 96.4% (95% CI 93.2 to 98.3) accuracy for PPG and 94.1% (95% CI 90.4 to 96.6) for single-lead ECG. No significant differences in sensitivity (P = 0.453) or specificity (P = 0.219) between the proprietary PPG and single-lead ECG algorithms were found. Conclusion This study demonstrated equivalent diagnostic performance of PPG and single-lead ECG proprietary AF detection algorithms in smartphone apps.

Mitral regurgitation attenuates thrombotic risk in nonrheumatic atrial fibrillation: a new CHA2DS2-VASc score risk modifier?

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction: Atrial fibrillation (AF) carries a thrombotic risk related to left atrial blood stasis. Many risk scores, such as the CHA2DS2-VASc score, have been developed to guide physicians in initiating anticoagulant therapy. However, the risk prediction with these models is modest at best (C-statistic = 0.6). The presence of mitral regurgitation (MR) has been shown to reduce thrombotic risk in patients with rheumatic AF. In nonrheumatic AF, direct evidence of a lower thrombotic risk in patients with MR is still controversial. Purpose The current study assessed the effect of MR on thrombotic risk in nonrheumatic AF patients. Methods The prevalence of atrial thrombosis, defined as the presence of left atrial appendage thrombus (LAAT) and/or left atrial spontaneous echo contrast (LASEC) grade &amp;gt;2, was determined in 686 consecutive nonrheumatic AF patients without (adequate) anticoagulation scheduled for transoesophageal echocardiography before electrical cardioversion and was related to the severity of MR adjusted for the CHA2DS2-VASc score. The independent predictors of atrial thrombosis were assessed by stepwise multiple logistic regression analysis. Results A total of 103 (15%) patients had severe MR, 210 (31%) had moderate MR, and 373 (54%) had no-mild MR; the median CHA2DS2-VASc score was 3.0 (IQR 2.0-4.0). Atrial thrombosis (LAAT and/or LASEC grade &amp;gt;2) was observed in 118 patients (17%). The prevalence of atrial thrombosis decreased with increasing MR severity: 19.9% versus 15.2% versus 11.6% for no-mild, moderate, and severe MR, respectively (p for trend = 0.03) (Figure 1). Patients with moderate and severe MR had a lower risk of atrial thrombosis than patients with no-mild MR, with adjusted odds ratios (ORs) of 0.51 (95% CI 0.31-0.84) and 0.24 (95% CI 0.11-0.49), respectively. The other independent predictors of atrial thrombosis were: the CHA2DS2-VASc score with an adjusted OR of 1.25 (95% CI 1.10-1.42), poor left ventricular ejection fraction (LVEF, &amp;lt;40%) with an adjusted OR of 4.08 (95% CI 2.56-6.50), and large left atrial volume index (LAVI, &amp;gt;37 ml/m²) with an adjusted OR of 1.90 (95% CI 1.19-3.03) (Figure 1, upper right corner). The C-statistic of the regression model increased significantly (p = 0.0003) from 0.62 to 0.75 by adding MR grade, LVEF, and LAVI to the univariate CHA2DS2-VASc score model. The protective effect of MR was present across all levels of the CHA2DS2-VASc score and the presence of moderate-severe MR in patients with an intermediate CHA2DS2-VASc score (2-3) lowered the atrial thrombotic risk to the level of patients with a low CHA2DS2-VASc score (0-1). Conclusion Our data show that the presence of MR attenuated the atrial thrombotic risk by more than 50% in patients with nonrheumatic AF, independent of the CHA2DS2-VASc risk score. Moderate to severe MR can therefore be considered a new risk modifier of the CHA2DS2-VASc score, which might help refine the indication of anticoagulants in AF patients. Abstract Figure 1. Thrombotic risk per MR grade.

Evaluation of the device independent nature of a photoplethysmography-deriving smartphone app

Abstract Funding Acknowledgements Type of funding sources: None. Background Smartphone apps using photoplethysmography (PPG) technology enable digital heart rhythm monitoring through their built-in camera, without the need for additional, specific, or costly hardware. This may positively impact the availability and scalability of remote monitoring. However, the diversity of smartphone specifications on the consumer market may raise concerns regarding the robustness of AF detection algorithms between various devices. Purpose To study the device independency of AF detection performance by a PPG-based smartphone application. Methods Patients from the cardiology department were consecutively enrolled. Patients were handed 7 iOS models and 1 Android model and were asked to consecutively perform one PPG measurement per device. A 12-lead electrocardiogram (ECG) was collected during the same consultation and interpreted by a cardiologist as reference diagnosis. To allow an objective comparison across the devices, patients who failed to perform one successful measurement on each device were excluded. Additional exclusions were atrial flutter rhythms and insufficient quality results. Sensitivity, specificity and accuracy were calculated with respect to the reference diagnosis. McNemar’s analysis was used for the head-to-head comparison of the sensitivity and specificity of the proprietary algorithm on the different smartphone devices. Results A total of 150 patients participated in the study with a median CHA2DS2-VASc score of 3 (interquartile range: 1-5). The median age of the study population was 70 (interquartile range: 56-79) years. In total, 54.7% of the population was male and the AF-prevalence was 35.3%. After the exclusion of patients with atrial flutter (n = 14) and patients who did not successfully perform a PPG measurement on each device (n = 5), diagnostic-grade results of 131 patients were used to calculate the performance of the proprietary algorithm. The sensitivity and specificity of the AF detection algorithm ranged from 90.9% (95% CI 75.7-98.1) to 100.0% (95% CI 91.0-100) and 94.5% (95% CI 86.6-98.5) to 100.0% (95% CI 94.6-100), respectively. The overall accuracy across the devices ranged from 94.4% (95% CI 88.3-97.9) to 99.0% (95% CI 94.6-100). Head-to-head comparisons of the results did not reveal significant differences in sensitivity (P = 0.125-1.000) or specificity (P = 0.375-1.000) of the proprietary AF detection algorithm among the different devices. Conclusion This study demonstrated the device-independent nature of the PPG-deriving smartphone application with respect to 12-lead ECG diagnosis.

Prevalence and Resolution of Resistant Left Atrial Appendage Thrombus in Non-Valvular Atrial Fibrillation Patients Submitted to Percutaneous Interventions

Introduction: Left atrial appendage (LAA) thrombus in atrial tachyarrhythmias is one of the principal causes of stroke. Prevalence and strategies to thrombus resolution has recently been described in the era of the direct oral anticoagulants (DOAC). The aim of the study was to determine the prevalence and strategies to resolve previous LAA thrombus during regular oral antithrombotic therapy in preparation to perform atrial fibrillation (AF) ablation and/or LAA closure. Methods: Between January 2011 and December 2020 we prospectively followed 23 patients (5.39%) that showed LAA thrombus formation. Persistent AF occurred in 13 (56.52%), median age 72.39 years, 15 (65.22%) females, median CHA2DS2VASC of 4.13, HASBLED of 2.28, 17 (73.91%) with hypertension, (52.17%) with coronary disease, 9 (39.13%) had priors’ thromboembolic events, 7 (30.43%) with heart failure and Diabetes. Diagnosis was by transesophageal echocardiogram (TEE) in 20 (86.96%) and the rest by computed angiotomography. Rivaroxaban was used in 11 (47.83%), Dabigatran in 6 (26.09%), 5 (21.74%) with therapeutic range Warfarin and 1 (4.34%) with Apixaban. Main strategy of treatment was to change mechanism of action of antithrombotic medication in association to an antiplatelet drug, Clopidogrel 75mg a day, and perform a TEE at 90 days after. Results: Complete resolution of the LAA thrombus was achieved in 18 (78.26%) patients in first medical therapeutic change. Of the remaining a second approach with medical therapy adjustment with off-label dose prescription associated with Clopidogrel showed complete resolution in 3 (13.04%) totalizing a success rate of 91.30% for all patients (p value of 0.001 for treatment success). The failure of the antithrombotic plus antiplatelet therapy occurred in 2 (8.7%) patients, one with LAA sludge and other with a huge thrombus in all LAA and part of left atrium. Conclusion: Modification of the mechanism of action of direct oral anticoagulants in association with Clopidogrel demonstrates to be successful in a large number of patients with previous resistant left atrial thrombus with and secure since the low adverse event rates.

Dosing of Direct Oral Anticoagulants in Patients with Moderate Chronic Kidney Disease in US Clinical Practice: Results from the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF II).

Direct oral anticoagulants (DOACs) have partial renal clearance and generally require dosage adjustments based on renal function. While current US and European guidance recommends dose adjustments in patients with moderate chronic kidney disease (CKD), it is unclear how often this is done appropriately in routine clinical practice. We examined rates of appropriate and inappropriate dosing in patients with atrial fibrillation (AF) and moderate CKD, as determined by creatinine clearance (CrCl) of 30-50 mL/min calculated with the Cockcroft-Gault formula. Descriptive statistics were used to describe the rate of appropriate and inappropriate dosing as well as event rates. Among 1134 patients (8.5% of the overall ORBIT-AF II registry) with AF and CrCl 30-50 mL/min, the median age was 82 (25th, 75th percentile: 78, 86), 38% were male, and the median CHA2DS2VASC score was 4 (25th, 75th percentile: 4, 5). At baseline, more than one-third (34%) of patients with moderate CKD were inappropriately dosed with DOACs. When evaluating the specific prescribed doses in those with moderate CKD, 15% (N = 170/1134) were underdosed, 66% (743/1134) were appropriately dosed, and 20% (N = 221/1134) were overdosed. There were no significant differences in comorbid medical conditions between patients with moderate CKD who were appropriately and inappropriately dosed with a DOAC. In routine clinical practice, prescribing of DOACs in patients with AF with moderate CKD is often inconsistent with drug labeling, with up to one-third of patients being inappropriately dosed.

Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial

Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective. SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥18, newly-prescribed (≤90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone. The intervention consisted of combination of a medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling for severe nonadherence. The primary outcome was the proportion of days covered by rivaroxaban (PDC) at 6 months. There were 25 U.S. sites, all cardiology and electrophysiology outpatient practices, activated for a target sample size of 378, but the study was terminated by the sponsor prior to reaching target enrollment. There were 139 participants (age 65±9.6 years, 30% female, median CHA2DS2-VASc score 3 with IQR 2 to 4, mean total medication burden 7.7±4.4). DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence. Per protocol analyses had similar results. Because of the high overall PDC, the likelihood to answer the primary hypothesis was only 51% even if target enrollment were achieved. There were no study-related adverse events. The use of a centralized digital and human adherence intervention was feasible across multiple sites. Overall adherence was much higher than expected despite prescreening for at-risk individuals. SmartADHERE illustrates the challenges of trials of behavioral and technology interventions, where enrollment itself may lead to selection bias or treatment effects. Pragmatic study designs, such as cluster randomization or stepped-wedge implementation, should be considered to improve enrollment and generalizability.

Effect of Mitral Regurgitation on Thrombotic Risk in Patients With Nonrheumatic Atrial Fibrillation: A New CHA2DS2-VASc Score Risk Modifier?

The current study assessed the effect of mitral regurgitation (MR) on thrombotic risk in nonrheumatic atrial fibrillation (AF). AF carries a thrombotic risk related to left atrial blood stasis. The prevalence of atrial thrombosis, defined as the presence of left atrial appendage thrombus and/or left atrial spontaneous echo contrast grade >2, was determined in 686 consecutive nonrheumatic AF patients without (adequate) anticoagulation scheduled for transesophageal echocardiography before electrical cardioversion and was related to the severity of MR adjusted for the CHA2DS2-VASc score. A total of 103 (15%) patients had severe MR, 210 (31%) had moderate MR, and 373 (54%) had no-mild MR; the median CHA2DS2-VASc score was 3.0 (interquartile range 2.0 to 4.0). Atrial thrombosis was observed in 118 patients (17%). The prevalence of atrial thrombosis decreased with increasing MR severity: 19.9% versus 15.2% versus 11.6% for no-mild, moderate, and severe MR, respectively (p value for trend = 0.03). Patients with moderate and severe MR had a lower risk of atrial thrombosis than patients with no-mild MR, with adjusted odds ratios of 0.51 (95% confidence interval 0.31 to 0.84) and 0.24 (95% confidence interval 0.11 to 0.49), respectively. The protective effect of MR was present across all levels of the CHA2DS2-VASc risk score and the presence of moderate-severe MR in patients with an intermediate CHA2DS2-VASc score (2 to 3) lowered the atrial thrombotic risk to the level of patients with a low CHA2DS2-VASc score (0 to 1). In conclusion, our data show that the presence of MR attenuated the atrial thrombotic risk by more than 50% in patients with nonrheumatic AF.

Heterogeneity of diabetes as a risk factor for major adverse cardiovascular events in anticoagulated patients with atrial fibrillation: an analysis of the ARISTOTLE trial

Whether diabetes without insulin therapy is an independent cardiovascular (CV) risk factor in atrial fibrillation (AF) has recently been questioned. We investigated the prognostic relevance of diabetes with or without insulin treatment in patients in the ARISTOTLE trial. Patients with AF and increased stroke risk randomized to apixaban vs. warfarin were classified according to diabetes status: no diabetes; diabetes on no diabetes medications; diabetes on non-insulin antidiabetic drugs only; or insulin-treated. The associations between such patient subgroups and stroke/systemic embolism (SE), myocardial infarction (MI), and CV death were examined by Cox proportional hazard regression, both unadjusted and adjusted for other prognostic variables. Patients with diabetes were younger and had a higher body mass index. Median CHA2DS2VASc score was 4.0 in patients with diabetes and 3.0 in patients without diabetes. We found no significant difference in stroke/SE incidence across patient subgroups. Compared with no diabetes, only insulin-treated diabetes was significantly associated with higher risk. When adjusted for clinical variables, compared with no diabetes, the hazard ratios (HRs) for MI (95% confidence intervals) were for diabetes on no medication: 1.15 (0.62-2.14); for diabetes on non-insulin antidiabetic drugs: 1.32 (0.90-1.94); for insulin-treated diabetes: 2.34 (1.43-3.82); interaction P = 0.008. HRs for CV death were for diabetes on no medication: 1.19 (0.86-166); for diabetes on non-insulin antidiabetic drugs: 1.12 (0.88-1.42); for insulin-treated diabetes 1.85 (1.36-2.53), interaction P = 0.001. In anticoagulated patients with AF, a higher risk of MI and CV death is largely confined to diabetes treated with insulin.

Rivaroxaban Experience at Tertiary Care Centre in Saudi Arabia:A Retrospective Observational Study

Background: Atrial fibrillation (AF) and Venous Thromboembolism (VTE) are significant causes of morbidity and mortality. Direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) with a propensity to cause less major bleeding. This study aimed to assess the safety and effectiveness of rivaroxaban in routine clinical practice in a large tertiary referral center in Saudi Arabia. Materials and Methods: In this study, patients who received rivaroxaban at a tertiary referral hospital were included in this study. All adverse events were recorded, including major bleeding, non-major bleeding events, symptomatic thromboembolic events (deep vein thrombosis, pulmonary embolism) and all-cause death. Results: A total of 509 patients were prescribed rivaroxaban during the study period. The most common indication for rivaroxaban was non-valvular AF (65.3%) and VTE (34.7%). The mean age was 60.4 ± 16.4 years, and 50.8% were female. The median CHA2DS2-Vasc score was 2.1 in patients on rivaroxaban for non-valvular AF. Bleeding occurred in 72 (14.1%) patients, of which 20 (3.9%) had major bleeds. Thrombosis events occurred in 13 (2.5%) patients in the overall cohort. Fourteen (2.7%) patients died during the study, including a case of fatal bleeding secondary to rivaroxaban. Conclusion: This study describes the use of rivaroxaban in a broad patient population in clinical practice in the Middle East. The overall bleeding and thrombosis rates in this study were comparable to those seen in major clinical trials.

Rivaroxaban Experience at Tertiary Care Centre in Saudi Arabia:A Retrospective Observational Study

Background: Atrial fibrillation (AF) and Venous Thromboembolism (VTE) are significant causes of morbidity and mortality. Direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) with a propensity to cause less major bleeding. This study aimed to assess the safety and effectiveness of rivaroxaban in routine clinical practice in a large tertiary referral center in Saudi Arabia. Methods and Materials: In this study, patients who received rivaroxaban at a tertiary referral hospital were included in this study. All adverse events were recorded, including major bleeding, non-major bleeding events, symptomatic thromboembolic events (deep vein thrombosis, pulmonary embolism) and all-cause death. Results: A total of 509 patients were prescribed rivaroxaban during the study period. The most common indication for rivaroxaban was non-valvular AF (65.3%) and VTE (34.7%). The mean age was 60.4 ± 16.4 years, and 50.8% were female. The median CHA2DS2-Vasc score was 2.1 in patients on rivaroxaban for non-valvular AF. Bleeding occurred in 72 (14.1%) patients, of which 20 (3.9%) had major bleeds. Thrombosis events occurred in 13 (2.5%) patients in the overall cohort. Fourteen (2.7%) patients died during the study, including a case of fatal bleeding secondary to rivaroxaban. Conclusion: This study describes the use of rivaroxaban in a broad patient population in clinical practice in the Middle East. The overall bleeding and thrombosis rates in this study were comparable to those seen in major clinical trials. [GMJ.2020;9:e1882] DOI:10.31661/gmj.v9i0.1882&#x0D;