Discontinuation Of Oral Anticoagulation Research Articles

Best anticoagulation strategy with and without appendage occlusion for stroke-prophylaxis in postablation atrial fibrillation patients with cardiac amyloidosis.

Both atrial fibrillation (AF) and amyloidosis increase stroke risk. We evaluated the best anticoagulation strategy in AF patients with coexistent amyloidosis. Consecutive AF patients with concomitant amyloidosis were divided into two groups based on the postablation stroke-prophylaxis approach; group 1: left atrial appendage occlusion (LAAO) in eligible patients and group 2: oral anticoagulation (OAC). Group 1 patients were further divided into Gr. 1A: LAAO + half-does NOAC (HD-NOAC) for 6 months followed by aspirin 81 mg/day and Gr. 1B: LAAO + HD-NOAC. In group 1 patients, with complete occlusion at the 45-day transesophageal echocardiogram, patients were switched to aspirin, 81 mg/day at 6 months. In case of leak, or dense "smoke"in the left atrium (LA) or enlarged LA, they were placed on long-term half-dose (HD)NOAC. Group 2 patients remained on full-dose NOAC during the whole study period. A total of 92 patients were included in the analysis; group 1: 56 and group 2: 36. After the 45-day TEE, 31 patients from group 1 remained on baby-aspirin and 25 on HDNOAC. At 1-year follow-up, four stroke, oneTIA and six device-thrombus were reported in group 1A, compared to none in patients in group 1B (5/31 vs. 0/25, p = .03). No bleeding events were reported in group 1, whereas group 2 had five bleeding events (one subdural hematoma, one retinal hemorrhage, and fourGI bleedings). Additionally, one stroke was reported in group 2 that happened during brief discontinuation of OAC. In patients with coexistent AF and amyloidosis, half-dose NOAC following LAAO was observed to be the safest stroke-prophylaxis strategy.

Discontinuation of Oral Anticoagulants in Atrial Fibrillation Patients: Impact of Treatment Strategy and on Patients' Health Status.

The discontinuation of oral anticoagulants (OACs) remains as a significant concern in the management of atrial fibrillation (AF). The discontinuation rate may vary depending on management strategy, and physicians may also discontinue OACs due to concerns about patient satisfaction with their care. We aimed to assess the incidence of OAC discontinuation and its relationship to patients' health in an outpatient AF registry. From a multicenter registry for newly recognized AF patients (n = 3313), we extracted 1647 (49.7%) patients with OACs and a CHA2DS2-Vasc score of ≥2. Discontinuation was defined as sustained cessation of OACs within a 1-year follow-up. We examined predictors associated with discontinuation and its relations to health status defined by the AFEQT questionnaire. Of the 1647 patients, 385 (23.6%) discontinued OACs after 1 year, with discontinuation rates varying across treatment strategies (15.3% for catheter ablation, 4.9% for rhythm control with antiarrhythmic drugs, and 3.0% for rate control). Successful rhythm control was associated with discontinuation in the catheter ablation (OR 6.61, 95% CI 3.00-14.6, p < 0.001) and antiarrhythmic drugs (OR 6.47, 95% CI 2.62-15.9, p < 0.001) groups, whereas the incidence of bleeding events within 1 year was associated with discontinuation in the rate control group. One-year AFEQT scores did not significantly differ between patients who discontinued OACs and those who did not in each treatment strategy group. OAC discontinuation was common among AF patients with significant stroke risk but varied depending on the chosen treatment strategy. This study also found no significant association between OAC discontinuation and patients' health status.

Oral anticoagulant use and outcomes in Asian patients with atrial fibrillation in the GLORIA-AF Registry

Abstract Background Ethnic differences in the management and outcomes of patients with atrial fibrillation (AF) have been shown in previous studies, but available data is still limited, although urgently needed. Purpose to analyse oral anticoagulant (OAC) prescription, OAC discontinuation, and long-term risk of major outcomes in Asian patients with AF, using data from a global prospective cohort study. Methods Using data from the GLORIA-AF Registry Phase II and III, we analysed patients according to their self-reported ethnicity (Asian vs. Non-Asian), and according to Asian ethnic subgroup (i.e. Chinese, Japanese, Korean and other Asian). Odds of OAC prescription were analysed through multivariable logistic regression, while the risk of OAC discontinuation and adverse outcomes were analysed through multivariable Cox-regression model. Primary outcome of this analysis was defined as the composite of all-cause death and major adverse cardiovascular events (MACE). Results 34,421 AF patients were included (70.0±10.5 years, 45.1% females, 6,900 (20.0%) Asian). Compared to Non-Asian subjects, prescription of OAC and non-vitamin K antagonist oral anticoagulant (NOAC) was lower in Asian subjects (Odds Ratio [OR] and 95% Confidence Intervals (CI): 0.23 [0.22-0.25] and 0.66 [0.61-0.71], respectively; Figure 1), but higher in the Japanese subgroup. Asian ethnicity was also associated with OAC discontinuation (Hazard Ratio [HR] and [95%CI]: 1.79 [1.67-1.92]), and lower risk of the primary composite outcome (HR [95%CI]: 0.86 [0.76-0.96]; Figure 2). Among the secondary outcomes, Asian patients had also higher risk of thromboembolism and intracranial haemorrhage, and lower risk of major bleeding events. Conclusions In this large, contemporary cohort of patients with AF, Asian subjects received suboptimal management of thromboembolic risk, and showed a peculiar long-term risk of adverse outcomes. Integrated and appropriate treatment of these patients is crucial to improve their prognosis.Figure 1Figure 2

Left ventricular thrombus in patients with heart failure with improved ejection fraction

Abstract Background This study sought to: (1) determine the prevalence of LV thrombus at baseline and at the time of recovered ejection fraction (EF) in patients with heart failure with improved ejection fraction (HF-imp EF), (2) examine clinical and echocardiographic factors associated with the presence of LV thrombus, and (3) determine the prevalence of thromboembolic events when LVEF was improved and oral anticoagulant (OAC) was discontinued. Methods and results Patients with nonischemic HF-imp EF defined as a baseline LVEF of ≤ 40%, a ≥ 10% increase from baseline LVEF, and a second measurement (6 months apart) of LVEF of &amp;gt; 40% were consecutively enrolled in advanced HF clinic in a tertiary center. Patients with recent myocarditis, recent coronary revascularization, active chemotherapy, hypertrophic cardiomyopathy, cardiac amyloidosis, and tachycardia induced cardiomyopathy were excluded. A total of 104 consecutive patients (age 51 ± 15 years; 66% were male) with HF-imp EF were included. Of these, 14 patients (14%) had LV thrombus at baseline. Baseline LVEDD, LVEF, and LV global longitudinal strain (GLS) were 61 ± 10 mm, 23 ± 15%, and -5.9 ± 3.3%, respectively. Younger age, absence of atrial fibrillation, receiving oral diuretics, lower LVEF, reduced LV GLS, and reduced RV free wall (FW) GLS were significantly associated with LV thrombus at baseline (p &amp;lt; 0.05 for all) (Table 1). All patients (100%) with LV thrombus at baseline received oral anticoagulants (OAC). At the median follow-up of 27 months, 14 (100%) had complete resolution of LV thrombus when LVEF &amp;gt; 40%. Of 14 patients, 11 (79%) who were in sinus rhythm discontinued OAC. After a median further follow-up of 27.4 months following OAC discontinuation, there was no thromboembolic event or all-cause mortality in these patients. One of 11 patients developed worsening LVEF and recurrent LV thrombus at 25 months after LVEF improvement (&amp;gt; 40%). Conclusions Approximately 1 in 6 patients with HF-imp EF had LV thrombus at baseline. LV thrombus formation was associated with more impaired LV and RV systolic function and myocardial deformation implicating more thromboembolic milieu. Complete resolution of LV thrombus occurred in all patients who were on OAC therapy at the time of imp-EF. Discontinuation of OAC when LVEF &amp;gt; 40% was safe. However, recurrent thrombus formation can occur when LV systolic function was deteriorated. Annual or bi-annual echocardiographic follow-up may be essential in these patients.

It can be safe to discontinue oral anticoagulants after successful atrial fibrillation ablation: A systematic review and meta-analysis of cohort studies.

Current guidelines recommended that oral anticoagulants (OACs) should last for a minimum first 2 months after atrial fibrillation (AF) ablation and the long-term decision of anticoagulation after AF ablation should be based on the individual patient's risk of stroke rather than the rhythm status. There is controversy about the safety of discontinuing OACs in patients with atrial fibrillation after the blanking period due to the divergences between consensus recommendations and clinical practice. Electronic bibliographic sources (PubMed, Embase, and Web of Science) were searched until August 2023 to identify cohort studies about the safety of discontinuing OACs in patients with AF after the blanking period. The primary outcome was thromboembolism (TE). The secondary outcome was major bleeding events (MBEs). Two authors extracted articles independently using predefined data fields. The pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated based on a random-effects model. A total of 16 studies (11 prospective cohorts and 5 retrospective cohorts) enrolling 23,942 patients (14,382 OFF-OAC and 9560 ON-OAC) were included in our analysis. No significant difference emerged in the risk of TE between OFF-OAC and ON-OAC patients following AF ablation after the banking period (OR = 0.66; 95%CI, 0.43-1.01). Similar results emerged in the patients with a high risk of TE after stratification by the risk level of TE (OR = 0.72; 95%CI, 0.25-2.08). A significant reduction in incidences of major bleeding was found in the OFF-OAC patients compared with the ON-OAC patients (OR = 0.23; 95%CI, 0.12-0.42). Subgroup analyses for TE found a reduction of incidences in the subgroups who switched to antiplatelet drugs and with a follow-up duration <3 years. Subgroup analyses for MBEs found a significant reduction of incidences in all subgroups. Our study suggests it can be safe to discontinue OACs after successful AF ablation. Discontinuation of OACs may reduce the risk of MBEs while not increasing the risk of TE.

Implications of Clinical Risk Phenotypes on the Management and Natural History of Atrial Fibrillation: A Report From the GLORIA-AF.

Background Clinical risk factors are common among patients with atrial fibrillation (AF), but there are still limited data on their association with oral anticoagulant (OAC) treatment patterns and major outcomes. We aim to analyze the association between clinical risk phenotypes on AF treatment patterns and the risk of major outcomes. Methods and Results The GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation) phase 2 and 3 registries enrolled patients with a recent diagnosis of AF between 2011 and 2016. We defined 4 features of clinical risk among patients with CHA2DS2-VASc ≥2: elderly individuals (aged ≥80 years), chronic kidney disease (estimated glomerular filtration rate <45 mL/min), history of stroke, and history of bleeding. We analyzed the odds of receiving OAC and the risk of OAC discontinuation and adverse events at follow-up according to specific combinations and cumulative burden of these features. Primary outcome was the composite of all-cause death, thromboembolism, and major bleeding. Among 28 891 (mean±SD age, 70.1±10.5 years; 45.5% women) patients included, 10 797 (37.3%) had at least 1 clinical risk feature. OAC use was lower among patients in the elderly group (odds ratio [OR], 0.85 [95% CI, 0.75-0.96]), those with history of both stroke and bleeding (OR, 0.45 [95% CI, 0.35-0.56]), and those with multiple features (OR, 0.71 [95% CI, 0.62-0.82]). Increasing burden of clinical risk features was associated with OAC discontinuation, with highest magnitude in those with ≥3 features (hazard ratio [HR], 1.68 [95% CI, 1.31-2.15]). Groups with increasingly complex clinical risk phenotypes were associated with the occurrence of the primary composite outcome, with the highest figures observed for groups with a history of both stroke and bleeding (adjusted HR, 2.36 [95% CI, 1.83-3.04]) and multiple features (adjusted HR, 2.86 [95% CI, 2.52-3.25]). Conclusions In patients with AF, clinical risk phenotypes are multifaceted and heterogenous, and they are associated with differences in stroke prevention and worse prognosis.

Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry

Previous studies suggested potential ethnic differences in the management and outcomes of atrial fibrillation (AF). We aim to analyse oral anticoagulant (OAC) prescription, discontinuation, and risk of adverse outcomes in Asian patients with AF, using data from a global prospective cohort study. From the GLORIA-AF Registry Phase II-III (November 2011-December 2014 for Phase II, and January 2014-December 2016 for Phase III), we analysed patients according to their self-reported ethnicity (Asian vs. non-Asian), as well as according to Asian subgroups (Chinese, Japanese, Korean and other Asian). Logistic regression was used to analyse OAC prescription, while the risk of OAC discontinuation and adverse outcomes were analysed through Cox-regression model. Our primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACE). The original studies were registered with ClinicalTrials.gov, NCT01468701, NCT01671007, and NCT01937377. 34,421 patients were included (70.0±10.5 years, 45.1% females, 6900 (20.0%) Asian: 3829 (55.5%) Chinese, 814 (11.8%) Japanese, 1964 (28.5%) Korean and 293 (4.2%) other Asian). Most of the Asian patients were recruited in Asia (n=6701, 97.1%), while non-Asian patients were mainly recruited in Europe (n=15,449, 56.1%) and North America (n=8378, 30.4%). Compared to non-Asian individuals, prescription of OAC and non-vitamin K antagonist oral anticoagulant (NOAC) was lower in Asian patients (Odds Ratio [OR] and 95% Confidence Intervals (CI): 0.23 [0.22-0.25] and 0.66 [0.61-0.71], respectively), but higher in the Japanese subgroup. Asian ethnicity was also associated with higher risk of OAC discontinuation (Hazard Ratio [HR] and [95% CI]: 1.79 [1.67-1.92]), and lower risk of the primary composite outcome (HR [95% CI]: 0.86 [0.76-0.96]). Among the exploratory secondary outcomes, Asian ethnicity was associated with higher risks of thromboembolism and intracranial haemorrhage, and lower risk of major bleeding. Our results showed that Asian patients with AF showed suboptimal thromboembolic risk management and a specific risk profile of adverse outcomes; these differences may also reflect differences in country-specific factors. Ensuring integrated and appropriate treatment of these patients is crucial to improve their prognosis. The GLORIA-AF Registry was funded by Boehringer Ingelheim GmbH.

Effect of clinic-based single-lead electrocardiogram rhythm assessment on oral anticoagulation prescriptions in patients with previously diagnosed atrial fibrillation.

Despite benefits of oral anticoagulation (OAC), many individuals with diagnosed atrial fibrillation (AF) do not receive OAC. The purpose of this study was to assess whether cardiac rhythm assessment for AF impacted use of OAC in patients with previously diagnosed AF. VITAL-AF was a cluster randomized controlled trial conducted in 16 primary care practices assessing the efficacy of AF rhythm assessment with single-lead electrocardiogram in routine care. Patients 65 years and older were offered rhythm assessment at visits. In this secondary analysis, we evaluated rhythm assessment uptake and compared initiation and discontinuation of OAC in patients with previously diagnosed AF from intervention and control arms over 1 year. The study included 4593 patients with previously diagnosed AF (2250 intervention; 2343 control). In the intervention arm, 2022 (89.9%) completed rhythm assessment (median 2 visits with rhythm assessment) and 40.1% had ≥1 "Possible AF" result. Initiation of OAC was similar in the intervention (17.7%) and control (19.1%) arms but was influenced by the rhythm assessment result: higher with a "Possible AF" (26.1%; adjusted odds ratio [aOR] 1.62; 95% confidence interval [CI] 1.04-2.51), and lower with a "Normal" result (9.9%; aOR 0.45; 95% CI 0.29-0.71) compared to control. OAC discontinuation was similar in the intervention (6.3%) and control (7.2%) arms, with lower discontinuation with a "Possible AF" result (3.8%; aOR 0.51; 95% CI 0.32-0.81). Including patients with previously diagnosed AF in a point-of-care rhythm assessment strategy did not increase overall OAC use compared to the control arm. However, the rhythm assessment result influenced both initiation and discontinuation of OAC.

Optimal length of oral anticoagulant treatment for maximum benefit within 5 years after discontinuation of oral anticoagulants in patients with acute pulmonary embolism who require secondary thromboprophylaxis

BackgroundExtended oral anticoagulant (OA) use is recommended in patients with acute pulmonary embolism (PE) who require secondary thromboprophylaxis. Nevertheless, the optimal length of OA use for the maximum long-term benefit...

Incidental left atrial appendage isolation after catheter ablation of persistent atrial fibrillation: Mechanisms and long-term risk of thromboembolism.

Incidental left atrial appendage (LAA) isolation may occur during radiofrequency ablation of persistent atrial fibrillation (AF). The study aims to describe the mechanisms and long-term thromboembolic risk related to incidental LAA isolation. Patients who experienced incidental LAA isolation after AF ablation were included. Culprit sites where ablation resulted in LAA isolation were identified. Thromboembolic risk despite oral anticoagulation (OAC) was compared to that in a propensity-matched control group without LAA isolation. Forty-one patients with LAA isolation, and 82 matched patients without LAA isolation were included. The patient age, ejection fraction, LA diameter, and CHA2 DS2 -VASc score were 64 ± 11 years, 55 ± 12%, 45.0 ± 7 mm and 2.62 ± 1.5, respectively. Culprit sites included the LAA base, mitral isthmus, inferior LA, Bachmann's bundle, coronary sinus, and Marshall vein. After 4.2 ± 3.6 years follow-up, thromboembolism occurred in 7 of 41 patients (17%) with LAA isolation versus 3 of 82 patients (4%) without isolation (log rank p < .009, HR 5.14, 95% CI [1.32-19.94], p = .02). Patients with and without thromboembolism had similar CHA2 DS2 -VASc scores (2.65 ± 1.3 vs. 2.71 ± 0.76, p = .89). Thromboembolism occurred during noncompliance with or temporary discontinuation of OAC in four of the sevenpatients. Incidental LAA isolation may occur during ablation of atrial arrhythmias in the vicinity of, or even at sites remote from the appendage. Patients with incidental LAA isolation had higher rates of thromboembolism compared to patients without isolation. Since thromboembolism may occur despite prescription for OAC, the risks of LAA isolation must be weighed against clinical benefit and appendage occlusion devices should be considered in vulnerable patients.

Abstract 15031: Anticoagulation Status and Risk of Stroke Following Leak-Closure Procedure for Residual Leak After Occlusion of the Left Atrial Appendage in Patients With Atrial Fibrillation

Introduction: Studies have shown a correlation between leaks following left atrial appendage occlusion procedure and thromboembolic (TE) events. Hypothesis: We investigated the benefits of leak-closure in terms of safe discontinuation of oral anticoagulation (OAC) and minimization of the stroke-risk. Methods: Consecutive patients undergoing leak-closure procedure at our institution were included in the analysis. Procedures included closure with endovascular coils or Amplatzer plug or by using radiofrequency ablation (RFA). Persistence of the leak was verified by multiplane transesophageal echocardiogram (TEE) using color Doppler. Follow-up TEE were performed 60 ± 15 days post-procedure to evaluate LAA closure and patients were kept on OAC until then. After confirmation of closure, they were transitioned to ASA 81 mg/day. All patients were monitored quarterly for thromboembolic (TE) events. Results: A total of 139 post-Watchman patients undergoing leak-closure were included in the analysis (RFA: 10, Amplatzer plug: 5, coil-closure: 124). Pre-coil closure TE events were reported in 7 (5%) subjects. Moderate (3-4 mm) and severe (≥5 mm) leak were detected in 118 (85%) and 21 (15%) patients respectively. After the leak-closure procedure, complete sealing of the leak was confirmed at the follow-up TEE in 138 (99.2%) patients. Figure 1 shows significant reduction in TE events following the leak-closure procedure (p=0.031). During the 2-year follow-up period, six deaths were reported due to unrelated causes. Of the remaining 133 subjects, two patients were on DAPT because of history of coronary artery disease, two with prior stroke were on half-dose OAC and the remaining 129 (95.8%) were on ASA 81 mg/day. No TE events were reported in patients that transitioned to ASA. Conclusions: In this series, successful percutaneous leak-closure not only minimized the risk of stroke but also enabled the majority of patients to discontinue OAC without any TE events.

Bleeding and ischaemic events after first bleed in anticoagulated atrial fibrillation patients: risk and timing.

To determine the risk of subsequent adverse clinical outcomes in anticoagulated patients with atrial fibrillation (AF) who experienced a new bleeding event. Anticoagulated AF patients were followed in two prospective cohort studies. Information on incident bleeding was systematically collected during yearly follow-up visits and events were adjudicated as major bleeding or clinically relevant non-major bleeding (CRNMB) according to the International Society on Thrombosis and Haemostasis guidelines. The primary outcome was a composite of stroke, myocardial infarction (MI), or all-cause death. Time-updated multivariable Cox proportional-hazards models were used to compare outcomes in patients with and without incident bleeding. Median follow-up was 4.08 years [interquartile range (IQR): 2.93-5.98]. Of the 3277 patients included (mean age 72 years, 28.5% women), 646 (19.7%) developed a new bleeding, 297 (9.1%) a major bleeding and 418 (12.8%) a CRNMB. The incidence of the primary outcome was 7.08 and 4.04 per 100 patient-years in patients with and without any bleeding [adjusted hazard ratio (aHR): 1.36, 95% confidence interval (CI): 1.16-1.61; P < 0.001; median time between a new bleeding and a primary outcome 306 days (IQR: 23-832)]. Recurrent bleeding occurred in 126 patients [incidence, 8.65 per 100 patient-years (95% CI: 7.26-10.30)]. In patients with and without a major bleeding, the incidence of the primary outcome was 11.00 and 4.06 per 100 patient-years [aHR: 2.04, 95% CI: 1.69-2.46; P < 0.001; median time to a primary outcome 142 days (IQR: 9-518)], and 59 had recurrent bleeding [11.61 per 100 patient-years (95% CI: 8.99-14.98)]. The incidence of the primary outcome was 5.29 and 4.55 in patients with and without CRNMB [aHR: 0.94, 95% CI: 0.76-1.15; P = 0.53; median time to a composite outcome 505 days (IQR: 153-1079)], and 87 had recurrent bleeding [8.43 per 100 patient-years (95% CI: 6.83-10.40)]. Patients who had their oral anticoagulation (OAC) discontinued after their first bleeding episode had a higher incidence of the primary composite than those who continued OAC (63/89 vs. 159/557 patients; aHR: 4.46, 95% CI: 3.16-6.31; P < 0.001). In anticoagulated AF patients, major bleeding but not CRNMB was associated with a high risk of adverse outcomes, part of which may be explained by OAC discontinuation. Most events occurred late after the bleeding episode, emphasizing the importance of long-term follow-up in these patients.

Oral Anticoagulant Discontinuation and Its Predictors in Patients with Atrial Fibrillation.

Background: Oral anticoagulants (OACs) are important in reducing the risk of ischaemic stroke in people with atrial fibrillation (AF). Although patients need to take their OAC continuously, it has been suggested that discontinuation is common in clinical practice, and this could predispose patients to thrombotic complications. Aims: To investigate the rate of OAC discontinuation and its predictors in patients with AF, using national data from Australian general practices. Methods: We analysed data obtained from NPS MedicineWise’s MedicineInsight dataset. We included patients with a recorded diagnosis of AF who newly started an OAC between 1 January 2013 and 31 December 2017. Patients were considered persistent if an OAC was prescribed continuously without discontinuing more than 60 days gap in therapy. The follow-up period was 12 months post-initiation. Multivariable models were used for the analysis of predictors. Results: Of 16,075 patients included in the cohort, 47.3% were females, and the mean age was 74.6 (SD 10.2) years. The overall OAC discontinuation rate was 13.2% (confidence interval (CI) 12.6–13.7%) by 12 months post-initiation. The discontinuation rates for warfarin, apixaban, dabigatran and rivaroxaban were 18.3% (95% CI 17.2–19.5%), 10.1% (95% CI 9.2–11.0%), 10.9% (95% CI 9.4–12.5%) and 12.2% (95% CI 11.4–13.2%), respectively. Warfarin had a significantly higher risk of discontinuation compared to direct-acting OACs. Factors that are known to increase the risk of stroke (older age, diabetes, and hypertension) were associated with better persistence. Conclusions: A relatively high proportion of patients with AF continued OAC therapy by 12 months post-initiation. Positively, patients with the highest risk of stroke and lowest risk of bleeds seemed to have better persistence.

Risk Levels and Adverse Clinical Outcomes Among Patients With Nonvalvular Atrial Fibrillation Receiving Oral Anticoagulants

The CHA2DS2-VASc score (calculated as congestive heart failure, hypertension, age 75 years and older, diabetes, stroke or TIA, vascular disease, age 65 to 74 years, and sex category) is the standard for assessing risk of stroke and systemic embolism and includes age and thromboembolic history. To our knowledge, no studies have comprehensively evaluated safety and effectiveness outcomes among patients with nonvalvular atrial fibrillation receiving oral anticoagulants according to independent, categorical risk strata. To evaluate the incidence of key adverse outcomes among patients with nonvalvular atrial fibrillation receiving oral anticoagulants by CHA2DS2-VASc risk score range, thromboembolic event history, and age group. This cohort study was a retrospective claims data analysis using combined data sets from 5 large health claims databases. Eligible participants were adult patients with nonvalvular atrial fibrillation who initiated oral anticoagulants. Data were analyzed between January 2012 and June 2019. Initiation of oral anticoagulants. We observed clinical outcomes (including stroke or systemic embolism, major bleeding, and a composite outcome) on treatment through study end, censoring for discontinuation of oral anticoagulants, death, and insurance disenrollment. The population was stratified by CHA2DS2-VASc risk score; history of stroke, systemic embolism, or transient ischemic attack; and age groups. We calculated time to event, incidence rates, and cumulative incidence for outcomes. We identified 1 141 097 patients with nonvalvular atrial fibrillation; the mean (SD) age was 75.0 (10.5) years, 608 127 patients (53.3%) were men, and over 1 million were placed in the 2 highest risk categories (high risk 1, 327 766 participants; high risk 2, 688 449 participants). Deyo-Charlson Comorbidity Index scores ranged progressively alongside CHA2DS2-VASc risk score strata (mean [SD] scores: low risk, 0.4 [1.0]; high risk 2, 4.1 [2.9]). The crude incidence of stroke and systemic embolism generally progressed alongside risk score strata (low risk, 0.25 events per 100 person-years [95% CI, 0.18-0.34 events]; high risk 2, 3.43 events per 100 person-years [95% CI, 3.06-4.20 events]); patients at the second-highest risk strata with thromboembolic event history had higher stroke incidence vs patients at the highest risk score strata without event history (2.06 events per 100 person-years [95% CI, 2.00-3.12 events] vs 1.18 events per 100 person-years [95% CI, 1.14-1.30 events]). Major bleeding and composite incidence also increased progressively alongside risk score strata (major bleeding: low risk, 0.68 events per 100 person-years [95% CI, 0.56-0.82 events]; high risk 2, 6.29 events per 100 person-years [95% CI, 6.21-6.62 events]; composite incidence: 1.22 events per 100 person-years [95% CI, 1.06-1.41 events]; high risk 2, 10.67 events per 100 person-years [95% CI, 10.26-11.48 events]). The 12-month cumulative incidence proportions for stroke and systemic embolism, major bleeding, and composite outcomes progressed alongside risk score strata (stroke or systemic embolism, 0.30%-1.85%; major bleeding, 0.55%-5.55%; composite, 1.05%-8.23%). Age subgroup analysis followed similar trends. The observed incidence of stroke or systemic embolism and major bleeding events generally conformed to an expected increasing incidence by risk score, adding insight into the importance of specific risk score range, thromboembolic event history, and age group strata. These results can help inform clinical decision-making, research, and policy.

Transesophageal Echocardiography Following Left Atrial Appendage Electrical Isolation: Diagnostic Pitfalls and Clinical Implications.

Following left atrial appendage (LAA) electrical isolation, the decision on whether to continue oral anticoagulation after successful atrial fibrillation ablation is based on the study of its mechanical function on transesophageal echocardiography (TEE). In this cohort, LAA contraction is absent and the incorrect interpretation of emptying flow velocities can lead to unwanted clinical sequelae. One hundred and sixty consecutive TEE exams performed to evaluate the LAA mechanical function following its electrical isolation were reviewed by an experienced operator blinded to the original diagnosis of LAA dysfunction. The rate of diagnostic discrepancy in the assessment LAA dysfunction and its clinical implications were evaluated. Diagnostic discrepancy with misclassification of the LAA mechanical function occurred 36% (58/160) of TEE exams. In most cases (57/58), such discrepancy was observed in the setting of an incorrect original diagnosis of a normal LAA mechanical function despite absent/reduced or inconsistent LAA contraction. This main source of this wrong diagnosis was the wrong interpretation of passive LAA flows (34/57; 60%), followed by failure to identify dissociated firing (15/57; 26%). In rare cases (8/57; 14%), velocities of surrounding structures were interpreted as LAA flow due to misplacement of the pulsed-wave Doppler sample volume. Following LAA isolation, the proportion of patients who experienced a cerebrovascular event while off oral anticoagulation due to the misclassification of their LAA mechanical function was 70% (7/10 [95% CI, 40%-89%]). Underdiagnosis of LAA mechanical dysfunction is common in TEEs performed following LAA electrical isolation, and it is associated with an increased risk of cerebrovascular events owing to oral anticoagulation discontinuation despite absent/reduced LAA contraction. Careful review of the TEE exam by an operator with specific expertise in LAA imaging and familiar with the functional implications of LAA isolation is necessary before interrupting oral anticoagulation in this cohort.

Healthcare utilization and clinical outcomes after ablation of atrial fibrillation in patients with and without insertable cardiac monitoring.

BackgroundCompared with short-term electrocardiogram (ECG) monitors, insertable cardiac monitors (ICMs) have been shown to increase atrial fibrillation (AF) detection rates and the opportunity to treat recurrent AF in patients postablation.ObjectiveTo examine healthcare utilization and clinical outcomes following AF ablation, in patients with vs without ICM.MethodsRetrospective analysis pooling Optum Clinformatics and Medicare Fee-for-service 5% Sample claims databases. Patients with an AF ablation between January 1, 2011, and March 31, 2018 who received an ICM implant within 1 year pre-/postablation were propensity score matched 1:3 to patients without ICM. Outcomes included AF-related healthcare utilization, medication use, and occurrence of composite severe cardiovascular events (stroke / transient ischemic attack, major bleeds, systemic embolism, AF- or heart failure–related hospitalization, or death).ResultsA total of 1000 ICM patients and 2998 non-ICM patients were included. During mean follow-up of 33 ± 16 months postablation, ICM patients experienced significantly fewer severe cardiovascular events (1.09 ± 2.22 vs 1.37 ± 4.19, P = .008) and associated costs ($20,757 vs $29,106, P = .0005). ICM patients had a greater number of AF-related clinic visits (16.8 vs 11.6 visits, P < .0001) and were more likely to receive a repeat ablation (38.7% vs 32.4%, P = .0003). Total all-cause costs during follow-up were not statistically different. Discontinuation of oral anticoagulation was higher in ICM patients at 1 year (44% vs 31%, P < .0001) and 2 years (73% vs 64%, P = .0012).ConclusionA shift from acute, reactive care to routine outpatient management was observed in patients with long-term ECG monitoring. Results suggest closer patient management in patients with long-term monitoring after an AF ablation and an improvement in outcomes, at similar overall cost.

Temporal Changes and Clinical Implications of Delayed Peridevice LeakFollowing Left Atrial AppendageClosure.

The aim of this study was to assess temporal changes and clinical implications of peridevice leak (PDL) after left atrial appendage closure. Endocardial left atrial appendage closure devices are alternatives to long-term oral anticoagulation (OAC) for patients with atrial fibrillation. PDL >5mm may prohibit discontinuation of OAC. Patients included in the study had: 1) successful Watchman device implantation without immediate PDL; 2) new PDL identified at 45 to 90days using transesophageal echocardiography; 3) eligibility for OAC; and 4) 1 follow-up transesophageal echocardiographic study for PDL surveillance. Relevant clinical and imaging data were collected by chart review. The combined primary outcome included failure to stop OAC after 45 to 90days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure. Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90days was 3.2 ± 1.6mm. On the basis of a median PDL of 3mm, patients were separated into≤3mm (n=73) and >3mm (n=35) groups. In the≤3mm group, PDL regressed significantly (2.2 ± 0.8mm vs 1.6 ± 1.4mm; P=0.002) after 275 ± 125days. In the >3mm group, there was no significant change in PDL (4.9 ± 1.4mm vs 4.0 ± 3.0mm; P=0.12) after 208 ± 137days. The primary outcome occurred more frequently (69% vs 34%; P=0.002) in the >3mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size. New PDL detected by transesophageal echocardiography at 45 to 90days occurred in a significant percentage of patients and was associated with worse clinical outcomes. PDL≤3mm tended to regress over time.

Gender-specific differences in patients who underwent left atrial appendage closure.

Aim: We aimed to study gender-specific differences in patients who underwent left atrial appendage closure (LAAC). Materials & methods:A total of201 consecutive patients who underwent LAAC were enrolled. The EQ-5D-3L questionnaire was employed before and 3months post-LAAC to study the quality of life. Results: Women had a higher score for Anxiety/Depression before implantation. Three months after LAAC, both groups showed a significant improvement in mobility, self-careand usual activities. The female gender had a significant improvement in health state 3months after implantation than their male counterparts. Conclusion: Our data shows an improvement in mobility, self-care, usual activitiesand the overall health state in all patients after LAAC. This potential improvement, most likely caused by the discontinuation of oral anticoagulants, should be considered an indication for LAAC.

Abstract 12118: Patterns of Anticoagulation Use in Atrial Fibrillation and Active Cancer: Observations From Medicare

Introduction: Use of oral anticoagulation (OAC) in patients with atrial fibrillation (AF) and cancer is challenging due to increased thrombotic and bleeding risks, and data on prescription patterns are lacking. Hypothesis: Underutilization of OAC among patients with AF and cancer is associated with cancer specific factors. Methods: This study examined OAC use and factors associated with discontinuation of OAC among Medicare patients with AF and a new diagnosis of cancer from 2011-2016. We described OAC use patterns prior to and after a diagnosis of cancer. Logistic regression was used to evaluate clinical variables associated with discontinuation of OAC at time of cancer diagnosis and cox proportional hazards model was used to evaluate variables associated with discontinuation after diagnosis. Results: Among 44,769 patients with established AF and newly diagnosed cancer, 30.2% (n=13,508) were taking OAC at the time of cancer diagnosis. A total of 15,228 patients (34%) had an OAC prescription fill after index cancer diagnosis. Warfarin was the most commonly used OAC, but direct oral anticoagulant use increased over the study period. A total of 29.5% of patients had their OAC discontinued at the time of cancer diagnosis. Patients with gastric (OR 2.75, CI 2.12-3.57), pancreatic (OR 2.71, CI 2.15-3.41), and colorectal (OR 1.97, CI 1.70-2.28) cancer were most likely to have their OAC discontinued at diagnosis (Figure). Bleeding (HR1.37, CI 1.28-1.48) and chemotherapy (HR 1.38, CI 1.06-1.80) were associated with subsequent discontinuation in those who remained on OAC after diagnosis. Conclusions: Nearly 2 in 3 patients with established AF were not treated with OAC after cancer diagnosis despite an elevated stroke risk. Significant heterogeneity in OAC use exists depending on cancer type, baseline comorbidities, and chemotherapy use. Studies are needed to characterize the thrombotic and bleeding risks in this population to establish management guidelines.

Identification of Patients with Unprovoked Venous Thromboembolism and a Low Risk of Recurrence Estimated By the Vienna Prediction Model: A Prospective Cohort Management Study

▪Introduction:Patients with unprovoked venous thromboembolism (VTE) have a high recurrence risk, and, according to guidelines, should receive extended oral anticoagulation (OAC). OAC prevents recurrence in most patients but may cause major bleeding. Patients with a low recurrence risk could therefore benefit from limited OAC duration. The Vienna prediction model (VPM) estimates the recurrence risk of patients with a first unprovoked deep vein thrombosis (DVT) of the leg and/or pulmonary embolism (PE) based on the patient's sex, site of index VTE and D-Dimer measured after stopping OAC (Eichinger et al., Circulation 2010). In a prospective cohort management study, we evaluated whether the VPM can identify patients with an unprovoked VTE at low recurrence risk.Methods: The study was performed between January 2013 and May 2021 at two tertiary Austrian hospitals. Patients >18 years with a first symptomatic DVT of the leg and/or symptomatic PE were eligible. The diagnosis of VTE was established by compression ultrasonography (CUS), spiral computed tomography, or lung scanning. We excluded patients with previous VTE, VTE provoked by a temporary risk factor including surgery, trauma, pregnancy, immobilisation, or female hormone intake, with cancer, OAC duration longer than 7 months or OAC for reasons other than VTE. OAC was discontinued 3 to 7 months after VTE diagnosis. D-Dimer was measured by a quantitative assay 3 weeks later and the probability of recurrence was estimated by the VPM. In patients with <180 risk points (corresponding to a predicted one-year recurrence risk of <4.4%), OAC was not resumed. CUS of both legs was performed at the time of discontinuation of OAC for reference baseline imaging in case of suspected recurrence. Patients were seen after 3, 12 and 24 months or at recurrence. Patients with a high recurrence risk (>180 VPM risk points) were excluded and their management was left to the discretion of their local practitioner. The main outcome measure was independently adjudicated recurrence of symptomatic DVT of the leg and/or symptomatic PE.The study was approved by the local ethics committees and all patients gave written informed consent.Statistical analysis:Baseline characteristics of patients were described by median and interquartile range (IQR) or by absolute frequency and percentage. The cumulative risk of recurrent VTE after discontinuation of OAC was estimated using the Kaplan-Meier method. Recurrence risk was also predicted with the VPM for each patient, and predictions were averaged over the study group.Results:Of 818 eligible patients, 520 (65%) had a risk score of <180 points and were classified as being at low risk of recurrence. They were included in the study and did not resume OAC. Their median age was 52 (42-65) years, and 289 (56%) were men. 226 (43%) patients had PE, 206 (40%) proximal and 88 (17%) distal DVT as index VTE. Median duration of anticoagulation was 3.9 (3.3-5.7) months, and the median time of follow-up was 23.9 (23.8, 23.9) months. Ten (1.9%) patients were lost to follow-up.52 patients (of which 30 were male) had non-fatal recurrent VTE (5.8 events per 100 patient-years, 95% CI 4.4-7.7). 28 (54%) patients had PE, 17 (33%) proximal and 7 (13%) distal DVT at recurrence.The cumulative risk of recurrence at one and two years was 5.2% (95% CI 3.2-7.2) and 11.2% (95% CI 8.3-14), respectively (Figure 1). The corresponding predicted recurrence risk for the study group was 4% and 7%, respectively.Conclusion: The VPM identifies patients with unprovoked VTE at low risk of recurrence. Applying the VPM refines risk stratification which could facilitate treatment decisions on the duration of OAC for patients and physicians. The model was well calibrated at one year. The apparent underestimation of the recurrence risk at two years could be countered by recalibration. [Display omitted] DisclosuresEichinger: Takeda: Speakers Bureau; Daiichi-Sankyo: Speakers Bureau; BMS: Speakers Bureau; Bayer: Speakers Bureau; Pfizer: Speakers Bureau; Boehringer-Ingelheim: Speakers Bureau; CSL Behring: Speakers Bureau.