Continuous Oral Anticoagulation Research Articles

Association between preprocedural thromboembolic and bleeding events under oral anticoagulation therapy and mid-term outcomes after percutaneous left atrial appendage closure.

Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC) with preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy. We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into three groups based on preprocedural thromboembolic or bleeding events under OAC therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45days after LAAC and dual-antiplatelet therapy from 45days to 6months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32-15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45-58.3; P = 0.036). Continuation of OAC for 12months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with the conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1year after LAAC.

Incidence and temporal evolution of delayed peridevice leak after left atrial appendage closure

BackgroundPeridevice leak (PDL) after left atrial appendage closure (LAAC) portends adverse outcomes. ObjectiveThe purpose of this study was to assess the incidence, predictors, clinical implications, and temporal evolution of PDL after LAAC. MethodsThis single-center retrospective study included all patients who underwent LAAC with Watchman FLX and had no PDL detected at the time of implantation. The primary end point was the incidence of new PDL at initial imaging. The composite secondary end point included continued oral anticoagulation after initial imaging, device-related thrombus, stroke or transient ischemic attack, major bleeding, and need for PDL closure at longest follow-up. Temporal evolution of PDL was assessed in patients with available surveillance imaging. ResultsOf the 355 patients who completed imaging at 47 days (interquartile range [IQR] 44–50 days), 139 (39%) had new PDL with a mean leak size of 3.2 ± 1.4 mm (median 3.0 mm; IQR 2.0–4.0 mm; range 1.0–9.0 mm). Multiple deployment attempts and larger device size were positive predictors of PDL, while increased contrast volume administration was a negative predictor of PDL. The composite secondary end point occurred in 42 (30%) patients with PDL and 33 (15%) patients without PDL (P < .001). Of the 139 patients with PDL, 43 (31%) had surveillance imaging where the leak size regressed from 3.7 ± 1.8 mm at 46 days (IQR 44–51 days) to 1.7 ± 2.0 mm at 189 days (IQR 158–285 days) (P < .001). The leak size regressed in 33 (77%), remained stable in 4 (9%), and progressed in 6 (14%) cases. ConclusionDespite design improvements, LAAC with Watchman FLX demonstrates a significant incidence of PDL with meaningful clinical implications. Regardless of initial size, most leaks regressed over time.

Oral anticoagulants or antiplatelet drugs after heart valve reconstructive surgery: modern guidelines for the practitioners

After heart valve surgery, anticoagulant therapy is usually recommended. The duration and necessity of combining oral anticoagulants with antiplatelet drugs depends on the type of manipulation performed, patient comorbidity and some other factors. Several randomized trials have shown that continued direct oral anticoagulation as monotherapy in some groups of patients requiring cardiac surgery is superior in efficacy and safety to treatment combining anticoagulant and antiplatelet drugs. The presented literature review reflects the management strategy of patients after heart valve operations.

The continuation of oral anticoagulation and antiplatelet therapy for dento-alveolar surgery: a service evaluation.

Background Patients taking oral anticoagulants (OACs) and oral antiplatelets (OAPs) have a risk of post-operative bleeding when dental extractions are required. Guidance exists to assist dental practitioners on how best to clinically manage these patients, but this is based upon low-quality evidence. The current service evaluation provides real world clinical data when these drugs are not discontinued for oral surgery procedures.Materials and methods All OACs and OAPs were continued and patients requiring dental extractions had local haemostatic measures (local anaesthesia with adrenaline, socket packing with haemostat and resorbable sutures). All patients were offered a follow-up via a telephone clinic service after surgery to assess any post-operative bleeding.Results A total of 439 patients underwent 513 surgical episodes, equating to 1,001 dental extractions. Overall, 412 (95.9%) patients reported no post-operative bleeding complications. A total of 18 (4.1%) patients reported post-operative bleeding requiring further intervention. All but two patients were managed with local haemostatic measures, and no patient required hospital admission. For the single novel OAC cohort of patients, 8/185 (4.3%) procedures had post-operative bleeding.Conclusion This current service evaluation highlights that the risk of significant or life-threatening bleeding following dental extraction when OACs or OAPs are continued remains rare.

Pregnancy outcomes in women with a mitral valve prosthesis: A systematic review and meta-analysis

ObjectivesTo evaluate the ongoing debate concerning the choice of valve prosthesis for women requiring mitral valve replacement (MVR) and who wish to conceive. Bioprostheses are associated with risk of early structural valve deterioration. Mechanical prostheses require lifelong anticoagulation and carry maternal and fetal risks. Also, the optimal anticoagulation regimen during pregnancy after MVR remains unclear. MethodsA systematic review and meta-analysis was conducted of studies reporting on pregnancy after MVR. Valve- and anticoagulation-related maternal and fetal risks during pregnancy and 30 days’ postpartum were analyzed. ResultsFifteen studies reporting 722 pregnancies were included. In total, 87.2% of pregnant women had a mechanical prosthesis and 12.5% a bioprosthesis. Maternal mortality risk was 1.33% (95% confidence interval [CI], 0.69-2.56), any hemorrhage risk 6.90% (95% CI, 3.70-12.88). Valve thrombosis risk was 4.71% (95% CI, 3.06-7.26) in patients with mechanical prostheses. 3.23% (95% CI, 1.34-7.75) of the patients with bioprostheses experienced early structural valve deterioration. Of these, the mortality was 40%. Pregnancy loss risk was 29.29% (95% CI, 19.74-43.47) with mechanical prostheses versus 13.50% (95% CI, 4.31-42.30) for bioprostheses. Switching to heparin during the first trimester demonstrated a bleeding risk of 7.78% (95% CI, 3.71-16.31) versus 4.08% (95% CI, 1.17-14.28) for women on oral anticoagulants throughout pregnancy and a valve thrombosis risk of 6.99% (95% CI, 2.08-23.51) versus 2.89% (95% CI, 1.40-5.94). Administration of anticoagulant dosages greater than 5 mg resulted in a risk of fetal adverse events of 74.24% (95% CI, 56.11-98.23) versus 8.85% (95% CI, 2.70-28.99) in ≤5 mg. ConclusionsA bioprosthesis seems the best option for women of childbearing age who are interested in future pregnancy after MVR. If mechanical valve replacement is preferred, the favorable anticoagulation regimen is continuous low-dose oral anticoagulants. Shared decision-making remains priority when choosing a prosthetic valve for young women.

PO-02-134 REAL WORLD CLINICAL MANAGEMENT AFTER SURGICAL LEFT ATRIAL APPENDAGE EXCISION

Surgical left atrial appendage (LAA) closure is an increasingly utilized approach to mitigate the risk of cardioembolic stroke in patients with atrial fibrillation (AF). Optimal stroke prevention management after surgical LAA management with respect to imaging and continuation of oral anticoagulation (OAC) is not well understood. To elucidate real world clinical management of patients undergoing surgical LAA management. Over a 7-year period at a single center, 458 participants carried a diagnosis of AF and underwent surgical exclusion of their LAA during concomitant cardiac surgery. Clinical follow-up, including transesophageal echocardiography (TEE) data and OAC use were catalogued via chart review. Success of LAA ligation was defined as maximal stump depth < 1.0 cm (with no distal leak) in all dimensions imaged. Of the 458 participants, 115 (25%) had a post-operative TEE (with average post-operative time of 36 weeks). Of these 115 patients, 95 were discharged from cardiac surgery on OAC and 83/115 (72%) had successful LAA closure by TEE criteria; 19/115 had inadequate closure and 13/115 did not have sufficient image quality to assess LAA closure. Among the 83 patients with TEE-verified successful LAA closure, 7 had stroke during follow-up; of these strokes 3/7 occurred within 4 weeks of cardiac surgery. Only 1/7 patients was not on OAC at the time of their stroke. (Table 1) Among the 83 patients with successful LAA closure, 70 had been discharged on OAC following cardiac surgery. Of these 47/70 subsequently had their OAC discontinued; 43/47 of those discontinuations occurred after the TEE. Most patients undergoing surgical LAA management do not receive follow-up TEE imaging. When TEE is performed, surgical excision of the LAA is shown to have a moderate success rate. Clinical management after surgical LAA management, with regard to LAA imaging and OAC continuation, is highly heterogeneous.

PO-03-133 BOTH OVERUSE AND UNDERUSE OF ORAL ANTICOAGULATION POST-ATRIAL FIBRILLATION ABLATION IN A LARGE HEALTHCARE SYSTEM

Guidelines recommend that decisions regarding oral anticoagulation (OAC) post ablation for atrial fibrillation (AF) should be based solely on the patient’s stroke risk profile, regardless of the outcomes of the procedure. The adherence to this recommendation in clinical practice has not been examined. To provide real-world data about adherence to anticoagulation guidelines after AF ablation. We included patients undergoing AF ablation in one of 8 hospitals of Northwell Health between 2014 and 2022. We excluded patients without continuous OAC for at least 2 months post-ablation and without a complete 3- and 12-month follow-up. Adherence to OAC guidelines was defined as continuing OAC for males with CHA2DS2-VASc≥2 and females with CHA2DS2-VASc≥3 and discontinuing OAC for the rest. A subgroup analysis of patients based on their CHA2DS2-VASc scores (0, 1, 2, and ≥3) was performed. Exploratory clinical endpoints included AF recurrence, stroke/transient ischemic attack, bleeding events, and all-cause mortality. Out of 900 patients, 69 (7.7%) and 187 (20.1%) discontinued OAC at 3- and 12-months post-ablation, respectively (Figure 1). Among patients who discontinued OAC at 12 months, 91 (48.6%) met indication for OAC. In contrast, among those without OAC indication, 36 (54.5%) patients remained on OAC at 12 months. Patients who discontinued OAC were younger with mostly paroxysmal AF and fewer comorbidities; lending to lower CHA2DS2-VASc scores (all p< 0.001). Specifically, 64.7%, 46.6%, 22.3% and 10.6% of patients with CHA2DS2-VASc of 0, 1, 2, and ≥3 respectively, discontinued OAC at 12 months (Table 1). Among those who discontinued OAC, 6 (13.0%), 32 (18.5%), 48 (13.2%), and 106 (10.5%) had AF recurrence and 0 (0%), 1 (2.3%), 0 (0%), and 1 (2.2%) had a stroke in CHA2DS2-VASc 0, 1, 2, and ≥3 groups, respectively. The most common reasons for discontinuation were patient preference, contraindications, and physician-patient shared decision-making. OAC was discontinued in approximately 20% of all patients undergoing catheter ablation at 1 year. Of these, roughly half had an ongoing indication for OAC. On the other hand, approximately half of patients with very low thromboembolic risk remain on OAC despite no evidence of AF recurrence.Tabled 1Table 1CHA2DS2-VASc0 (n=34)1 (n=133)2 (n=215)≥3 (n=518)Anticoagulation off (%)64.746.622.310.6AF Recurrence (%)17.624.122.520.6Stroke/TIA (%)01.01.22.2All-cause death (%)00.80.92.7Any bleeding (%)00.80.91.3 Open table in a new tab

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC). We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective. Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days. In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results. Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.

Continuation of oral anticoagulation during transcatheter aortic valve implantation: time to change practice?

Continuation of oral anticoagulation during transcatheter aortic valve implantation: time to change practice?

The Cost of Breaking Even: a Perspective on the Net Clinical Impact of Adding Aspirin to Antithrombotic Therapies in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

Outcomes from randomized controlled trials (RCTs) inform the latest recommendations on percutaneous coronary intervention (PCI) management of a short period of oral anticoagulation (OAC), a P2Y12 receptor inhibitor, and aspirin for 1week or until hospital discharge in patients with atrial fibrillation (AF) undergoing PCI, and up to 4weeks in individuals considered to be at high-risk for ischemic events, followed by discontinuation of aspirin and continuation of OAC and a P2Y12 inhibitor for up to 12months. We examined and summarized the outcomes of bleeding and major adverse cardiac events (MACEs) from RCTs and meta-analyses, published between 2013 and 2022, comparing therapy with OAC and a P2Y12 inhibitor with and without aspirin in AF patients undergoing PCI with stenting. Data comparing dual therapy with OAC and a P2Y12 inhibitor alone to triple therapy with OAC, a P2Y12 inhibitor, and aspirin with respect to the risks of MACEs, including stent thrombosis within the first 30days, are underpowered and inconclusive. The addition of aspirin does not appear to be associated with a decreased risk of ischemic events, even in patients with high-risk CHA2DS2-VASc scores, but does significantly increase bleeding hazards. The increased safety of newer generation drug-eluting stents may have further minimized any theoretical anti-ischemic benefits of aspirin. The possible attenuation of the pleiotropic effects of concomitant cardiovascular medications by aspirin may also have been a contributing factor. The addition of aspirin to OAC and a P2Y12 inhibitor is likely associated with a net clinical harm in patients with AF who undergo PCI with stenting, even within the first 1-4weeks after PCI. Revisiting the guideline recommendations to administer aspirin in this timeframe may be warranted.

Is implantable cardioverter defibrillator surgery in patients with an implanted left ventricular assist device safe under uninterrupted oral anticoagulation?

Implantable cardioverter-defibrillator (ICD) surgery in patients with implanted left ventricular assist devices (LVAD) is associated with an increased risk of bleeding complications because of the need to ensure that these patients are adequately anticoagulated. Our study aimed to evaluate the safety of our new strategy of uninterrupted oral anticoagulation compared to heparin-bridging during the surgical interval. Between January 2009 and January 2020, 116 patients with LVAD underwent ICD surgery. Since January 2015, 60 patients were operated under continued sufficient oral anticoagulation with a vitamin k antagonist (VKA group). Fifty-six patients underwent a heparin-bridging regimen (heparin group). Demographics, perioperative data, complications, and mortality were analyzed. Bleeding complications attributable to the surgical intervention occurred more often (19.6% vs. 10.0%, p=0.142) and at a higher rate of re-exploratory surgery (14.3% vs. 5.0%, p=0.088) in the heparin group without reaching statistical significance. Moreover, the heparin group patients' postoperative total length of stay was 10days longer (17.8±23.8days vs. 8.3±9.5days, p=0.007). There were no procedure-related deaths, no thromboembolic events, and no LVAD-related thrombosis. Our strategy of uninterrupted oral anticoagulation is safe and results in a reduction by more than half the number of days in hospital without an increase in adverse events.

MRI-Detected Brain Lesions and Cognitive Function in Patients With Atrial Fibrillation Undergoing Left Atrial Catheter Ablation in the Randomized AXAFA-AFNET 5 Trial.

We aimed to assess the prevalence of ischemic brain lesions detected by magnetic resonance imaging and their association with cognitive function 3 months after first-time ablation using continuous oral anticoagulation in patients with paroxysmal atrial fibrillation (AF). We performed a prespecified analysis of the AXAFA-AFNET 5 trial (Anticoagulation Using the Direct Factor Xa Inhibitor Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy), which randomized 674 patients with AF 1:1 to uninterrupted apixaban or vitamin K antagonist therapy before first-time ablation. Brain magnetic resonance imaging using fluid-attenuated inversion recovery and high-resolution diffusion-weighted imaging was obtained within 3 to 48 hours after AF ablation in all eligible patients enrolled in 25 study centers in Europe and the United States. Patients underwent cognitive assessment 3 to 6 weeks before ablation and 3 months after ablation using the Montreal Cognitive Assessment (MoCA). In 84 (26.1%) of 321 patients with analyzable magnetic resonance imaging, high-resolution diffusion-weighted imaging detected at least 1 acute brain lesion, including 44 (27.2%) patients treated with apixaban and 40 (24.8%) patients treated with vitamin K antagonist (P=0.675). Median MoCA score was similar in patients with or without acute brain lesions at 3 months after ablation (28 [interquartile range (IQR), 26-29] versus 28 [IQR, 26-29]; P=0.948). Cerebral chronic white matter damage (defined as Wahlund score ≥4 points) detected by fluid-attenuated inversion recovery was present in 130 (40.5%) patients and associated with lower median MoCA scores before ablation (27 [IQR, 24-28] versus 27 [IQR, 25-29]; P=0.026) and 3 months after ablation (27 [IQR, 25-29] versus 28 [IQR, 26-29]; P=0.011). This association was no longer significant when adjusted for age and sex. Age was associated with lower MoCA scores before ablation (relative risk, 1.02 per 10 years [95% CI, 1.01-1.03]) and 3 months after ablation (relative risk, 1.02 per 10 years [95% CI, 1.01-1.03]). Chronic white matter damage as well as acute ischemic lesions detected by brain magnetic resonance imaging were found frequently after first-time ablation for paroxysmal AF using uninterrupted oral anticoagulation. Acute ischemic brain lesions detected by high-resolution diffusion-weighted imaging were not associated with cognitive function at 3 months after ablation. Lower MoCA scores before and after ablation were associated only with older age, highlighting the safety of AF ablation on uninterrupted oral anticoagulation. URL: https://www. gov; Unique identifier: NCT02227550.

Benefits and Risks Associated with Long-term Oral Anticoagulation after Successful Atrial Fibrillation Catheter Ablation: Systematic Review and Meta-analysis.

Oral anticoagulation (OAC) prevents thromboembolism yet greatly increases the risk of bleeding, inciting concern among clinicians. Current guidelines lack sufficient evidence supporting long-term OAC following successful atrial fibrillation catheter ablation (CA). A literature search was performed in PubMed, Google Scholar, Medline, and Scopus to seek out studies that compare continued and discontinued anticoagulation in post-ablation Atrial fibrillation (AF) patients. Funnel plots and Egger’s test examined potential bias. Via the random-effects model, summary odds ratios (OR) with 95% confidence intervals (CI) were calculated using RevMan (5.4) and STATA (17.0). Twenty studies, including 22 429 patients (13 505 off-OAC) were analyzed. Stratified CHA2DS2-VASc score ≥2 examining thromboembolic events (TE) favored OAC continuation (OR 1.86; 95% CI: 1.02-3.40; P = .04). Sensitivity analysis demonstrated this association was attenuated. The on-OAC arm had greater incidence of major bleeding (MB) (OR 0.16; 95% CI: 0.08-0.95; P < .00001), particularly intracranial hemorrhage (ICH) and gastrointestinal bleeding (GI); (OR 0.17; 95% CI: 0.08-0.36; P < .00001) and (OR 0.12; 95% CI: 0.04-0.32; P < .0001), respectively. Our findings support sustained anticoagulation in patients with a CHA2DS2-VASc score of ≥2. Due to reduced outcome robustness, physician discretion is still advised.

Abstract 11107: Comparison of Left Atrial Appendage Occlusion and Direct Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation in Russian Prospective Registry

Introduction: Left atrial appendage occlusion (LAAO) is non-inferior to warfarin and direct oral anticoagulants (DOAC) in thromboembolic prophylaxis in atrial fibrillation (AF). However, these antithrombotic strategies in patients with and without contraindications to anticoagulants were not assessed separately before. Hypothesis: LAAO is superior to oral anticoagulants (OAC) in net clinical benefit in patients without contraindications for its usage, and superior to no thromboembolic prophylaxis in patients with contraindications for OAC. Methods: A prospective registry included 379 patients with nonvalvular AF and high risk of thromboembolic events. Patients were assigned into cohorts with and without contraindications to continuous therapy with OAC. In the first cohort patients with LAA occlusion (n=45), on DOAC (n=99) and on warfarin (n=100) were compared. In the second cohort patients with LAAO (n=75) were compared with those who received no antithrombotic prophylaxis (n = 60). The primary composite endpoint was net clinical benefit (all-cause mortality, ischemic stroke/transient ischemic attack/systemic embolism and major bleeding) in 3 years. Results: Using log-rank analysis of Kaplan-Meier curves in the cohort of patients without contraindications to OAC LAAO was superior to warfarin, reaching statistical significance (p=0.048), with a trend towards superiority over DOAC (p=0.061) . In the cohort of patients with contraindications to continuous OAC use, LAAO, in terms of both overall efficacy and safety, was significantly superior to no prophylaxis of thromboembolic events (p=0.003). (Figure 1). Conclusions: LAA occlusion demonstrated superiority to warfarin and no prophylaxis of thromboembolic events in terms of net clinical benefit. There was a trend to superiority of LAAO over DOAC in patients with contraindications to OAC.

Oral Anticoagulation Discontinuation Following Catheter Ablation of Typical Atrial Flutter

Catheter ablation (CA) of typical atrial flutter (AFL) is the preferred treatment for typical AFL due to its excellent long-term success rate. However, current guidelines recommend pursuing oral anticoagulation (OAC) based on established indices of stroke regardless of the perceived success of ablation. We conducted a retrospective study of all patients who underwent typical AFL ablation at our institute from 2011 to 2017. All patients continued OAC for at least six weeks post-CA and underwent 24-hour Holter monitoring. OAC was discontinued if there was no evidence of recurrence at six weeks. In patients with low left ventricular ejection fraction or prior atrial fibrillation episodes, OAC was continued for six months with repeat Holter monitoring at six months. A total of 106 patients were included in our analysis, with a mean age of 64 ± 14 years and 78.3% of whom were male. The mean CHA2DS2-VASc score was 3 ± 1 points. OAC was discontinued by six weeks in 17% and at one year in 55.7% of patients, respectively, but was continued indefinitely in 44.3%. Over a mean follow-up period of 28.6 ± 27.3 months, there was one ischemic stroke in the OAC discontinuation group and no ischemic events in the continued OAC group. There were a total of three major bleeding events, all in the OAC group. In patients undergoing successful AFL ablation, a strategy of OAC discontinuation with close rhythm monitoring appears feasible. The benefit of continued OAC in this cohort may be outweighed by an adverse risk of bleeding. Further studies examining rhythm-guided OAC can minimize unnecessary exposure to long-term anticoagulation.

Anticoagulation Therapy After Biologic Aortic Valve Replacement.

Objectives: Thromboembolism prophylaxis after biologic aortic valve replacement (BAVR) is recommended for 3 months postoperatively. We examined the continuation of oral anticoagulation (OAC) treatment and its effect on the long-term prognosis after BAVR.Methods: We used nation-wide register data from 4,079 individuals who underwent BAVR. We examined the association between warfarin and the non-vitamin K antagonist oral anticoagulant use with death, stroke and major bleeding in 2010 – 2016.Results: The risk of stroke was higher (HR 2.39, 95% CI 1.62 – 3.53, p < 0.001) and the risk of death was lower (HR 0.79, 95% CI 0.65 – 0.96, p = 0.016) in OAC-users compared to individuals without OAC. We observed no significant associations between OAC use and bleeding risk.Conclusion: OAC use after BAVR was associated with increased risk of stroke and decreased risk of death. These observational findings warrant validation in randomized controlled trials before any clinical conclusions can be drawn.

Prevalence of Left Atrial Thrombus in Anticoagulated Patients With Atrial Fibrillation

BackgroundThe prevalence of left atrial (LA) thrombus in patients with atrial fibrillation (AF) or atrial flutter (AFL) on guideline-directed anticoagulation is not well known, yet this may inform transesophageal echocardiogram (TEE) use before cardioversion or catheter ablation. ObjectivesThe purpose of this study was to quantify LA thrombus prevalence among patients with AF/AFL on guideline-directed anticoagulation and to identify high-risk subgroups. MethodsEMBASE, MEDLINE, and CENTRAL were systematically searched from inception to July 2020 for studies reporting on LA thrombus prevalence among patients with AF/AFL undergoing TEE following at least 3 weeks of continuous therapeutic oral anticoagulation with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs). Meta-analysis was performed using random effects models. ResultsThirty-five studies describing 14,653 patients were identified. The mean-weighted LA thrombus prevalence was 2.73% (95% confidence interval [CI]: 1.95% to 3.80%). LA thrombus prevalence was similar for VKA- and DOAC-treated patients (2.80%; 95% CI: 1.86% to 4.21% vs. 3.12%; 95% CI: 1.92% to 5.03%; p = 0.674). Patients with nonparoxysmal AF/AFL had a 4-fold higher LA thrombus prevalence compared with paroxysmal patients (4.81%; 95% CI: 3.35% to 6.86% vs. 1.03%; 95% CI: 0.52% to 2.03%; p < 0.001). LA thrombus prevalence was higher among patients undergoing cardioversion versus ablation (5.55%; 95% CI: 3.15% to 9.58% vs. 1.65%; 95% CI: 1.07% to 2.53%; p < 0.001). Patients with CHA2DS2-VASc scores ≥3 had a higher LA thrombus prevalence compared with patients with scores ≤2 (6.31%; 95% CI: 3.72% to 10.49% vs. 1.06%; 95% CI: 0.45% to 2.49%; p < 0.001). ConclusionsLA thrombus prevalence is high in subgroups of anticoagulated patients with AF/AFL, who may benefit from routine pre-procedural TEE use before cardioversion or catheter ablation.

Joint Latent Class Analysis of Oral Anticoagulation Use and Risk of Stroke or Systemic Thromboembolism in Patients with Atrial Fibrillation.

Oral anticoagulation (OAC) is recommended to reduce the risk of stroke or systemic thromboembolism (TE) in atrial fibrillation (AF). In this study, we applied novel joint latent class mixed models to identify heterogeneous patterns of trajectories of OAC use and determined how these trajectories are associated with risks of thromboembolic outcomes. We used 2013-2016 claims data from a 5% random sample of Medicare beneficiaries, obtained from the Centers for Medicare and Medicaid Services. Our study sample included 16,399 patients newly diagnosed with AF in 2014-2015 who were followed for 12 months after the first AF diagnosis and filled at least one OAC prescription in this time period. OAC use was defined as the number of days covered with OACs every 30-day interval after the first AF diagnosis. We used a joint latent class mixed model to simultaneously evaluate the longitudinal patterns of OAC use and time to stroke or TE, while adjusting for age, race, CHAD2S2-VASc score and HAS-BLED score. Five classes of OAC use patterns were identified: late users (17.8%); late initiators (12.5%); early discontinuers (18.6%); late discontinuers (15.4%); and continuous users (35.6%). Compared with continuous users, the risk of stroke or TE was higher for participants in the late initiators (hazard ratio [HR] 1.73, 95% confidence interval [CI] 1.49-2.01) and late discontinuers (HR 1.23, 95% CI 1.04-1.45) classes. Late initiators and late discontinuers had a higher risk of stroke or TE than continuous users. Early initiation and continuous OAC use is important in preventing stroke and TE among patients diagnosed with AF.

Continuation or discontinuation of oral anticoagulants after HAS-BLED scores increase in patients with atrial fibrillation

The bleeding risk profile of patients with atrial fibrillation (AF) may change over time, and the increment of HAS-BLED score is perceived to result in discontinuations of oral anticoagulants (OACs). To investigate the changes of HAS-BLED scores of AF patients initially with a low bleeding risk. The associations between continuation or discontinuation of OACs and clinical outcomes after patients' bleeding risk profile worsened (ie HAS-BLED increased) were studied. The present study used Taiwan nationwide health insurance research database. From year 2000 to 2015, a total of 24,990 AF patients aged ≥ 20years with a CHA2DS2-VASc score ≥ 1 (males) or ≥ 2 (females) having an HAS-BLED score of 0-2 who were treated with OACs were identified and followed up for changes of the HAS-BLED scores. Patients who did not refill OACs within 90days after their HAS-BLED scores increased to ≥ 3 were defined as discontinuations of OACs. The risks of clinical outcomes were compared between patients who continued or stopped OACs once their HAS-BLED scores increased to ≥ 3. Mean HAS-BLED score of study population increased from 1.54 to 3.33. At end of 1year, 5,229 (20.9%) patients had an increment of their HAS-BLED scores to ≥ 3, mainly due to newly diagnosed hypertension, stroke, bleeding, and concomitant drug therapies. Among 4777 patients who consistently had an HAS-BLED score ≥ 3, 1,062 (22.2%) stopped their use of OACs. Patients who kept on OACs (n = 3715; 77.8%) even after their HAS-BLED scores increased to ≥ 3 were associated with a lower risk of ischemic stroke (aHR 0.60, 95%CI 0.53-0.69), major bleeding (aHR 0.78, 95%CI 0.67-0.91), all-cause mortality (aHR 0.88, 95%CI 0.79-0.97), and any adverse events (aHR 0.75, 95%CI 0.68-0.82) adjusted for age, sex, heart failure, and HAS-BLED score. These results were consistent among the cohorts after propensity matching. For patients whose HAS-BLED scores increased to ≥ 3, the continuation of OACs was associated with better clinical outcomes. An increased HAS-BLED score in anticoagulated AF patients may not be the only reason to withhold OACs, but reminds physicians to correct modifiable bleeding risk factors and follow up patients more closely. Associations between Continuation or Discontinuation of Oral Anticoagulants and Risks of Clinical Outcomes after HAS-BLED Scores Increased AF atrial fibrillation; aHR adjusted hazard ratio; ICH intra-cranial hemorrhage; OACs oral anticoagulants.

Periprocedural management of anticoagulation therapy and in-hospital outcomes in patients with warfarin indication undergoing percutaneous coronary intervention. Data from the WAR-STENT registry

In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry. The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared. The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route. In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.