Chronic Anticoagulation Research Articles

Abstract 15009: Hospital Readmission Among Anticoagulated Nonagenarians With Atrial Fibrillation: A Nationwide Cohort Sample

Background: The prevalence of atrial fibrillation (AF) increases with age, reaching 10% among those above the age of 80. The safety and efficacy of using anticoagulation (AC) to prevent stroke among nonagenarians are not well understood, due underrepresentation of this cohort in landmark clinical trials of oral anticoagulants. We sought to explore readmission rates for all-cause, gastrointestinal bleeding, and acute cerebrovascular events for nonagenarians on AC for AF compared to patients younger than 90. Methods: By using the Nationwide Readmission Database (NRD) from 2010-2015 and ICD-9-CM codes, we identified patients hospitalized with diagnoses of AF and chronic AC, and excluded patients under age 18, those who died during the index admission, and those with pulmonary embolism, deep vein thrombosis or a prosthetic valve. Patients hospitalized in December for each calendar year were excluded to allow 30-day follow-up for all patients since the database resets annually. Chi-Square test was used to compare readmission rates between the two groups and a linear test was used to analyze the trend for AC use across years. Results: Our criteria identified a total of 1,456,114 patients, of whom 132,476 (9.0%) were ≥ 90 years old. Use of AC for AF among nonagenarians increased over the years of the study from 12.3% in 2010 to 22.7% in 2015 (p<0.001). Thirty-day readmission rates in nonagenarians vs. those < 90 were: all-cause - 16.9% vs. 17.2% (p=0.03), gastrointestinal bleeding - 0.5% vs. 0.4% (p<0.001), and acute cerebrovascular events - 0.8% vs. 0.5% (p<0.001). Conclusion: Although the differences were small, nonagenarians treated with AC for AF had a lower 30-day all-cause readmission rate but higher gastrointestinal bleeding and acute cerebrovascular event re-hospitalization rates. Further investigations are warranted to explore the benefit vs. risk of using AC in this vulnerable population of patients.

Effectiveness and safety of same day discharge after left atrial appendage closure under moderate conscious sedation.

Left atrial appendage occlusion (LAAO) using Watchman device has become a world-wide, well-established therapeutic alternative to chronic systemic oral anticoagulation in patient who are at high-risk of bleeding with paroxysmal (PAF) or chronic atrial fibrillation (Afib). Currently, LAAO procedures are performed under general anesthesia (GA) and patients stay overnight post procedure in the United States. We aimed to present the effectiveness and safety of same day discharge following LAAO under moderate conscious sedation (MCS) in patients without procedural complications. A total of 112 patients between August 2019 and May 2020 with elevated CHA2 DS2 VASc (median score of 3) underwent transesophageal echocardiography (TEE)-guided LAAO with FDA approved Watchman (Boston Scientific, MN) under MCS and discharged home on the same day 6 hr following their post procedural transthoracic echocardiogram (TTE) evaluations. All patients had next day TTE and follow up at the cardiology clinic. We prospectively evaluated clinical and procedural outcomes using medical records of these patients. Among all the patients, the mean age was 83.5 ± 8.5 years, 45 (40%) were women. Procedural duration, device implant time and fluoroscopic times were 45 ± 8.6, 14.5 ± 7.8 and 10.2 ± 1.2 min, respectively. The median required dosage of propofol was 105 ± 2.8 mg. No complications arose from MCS. There was no need for conversion to GA in any of the patients during the procedure. All patients were able to be discharged 6 hr following their TTE evaluation post procedure. There were no procedural complications. Same day discharge following LAAO closure seems to be safe and effective in patients without procedural complications. LAAO can also be performed safely and effectively under moderate conscious sedation. Applying moderate conscious sedation may simplify the LAAO procedure, reduce procedural time, procedural costs and hospital stay while increasing overall patient satisfaction.

Anticoagulant and Antiplatelet Use Not Associated with Improvement in Severe Outcomes in COVID-19 Patients

Introduction:SARS-CoV-2 coronavirus (COVID-19) associated coagulopathy leads to higher morbidity and mortality. It is unclear if anticoagulants or antiplatelets in patients with COVID-19 influences disease severity. We report outcomes of COVID-19 patients prescribed anticoagulants or antiplatelets for preexisting conditions within Kaiser Permanente Northern California (KPNC), a large integrated health system serving 4.4 million members.Methods:This retrospective cohort study included KPNC adult members (≥18 years) with positive COVID-19 testing between February 25,2020, and May 8,2020. Patients were stratified based on electronic medical records indicating a filled prescription or actively taking antiplatelets or anticoagulants within 90 days prior to COVID-19 diagnosis.Primary outcomes included emergency department (ED) visit, inpatient hospitalization, intensive care unit (ICU) stay, venous thromboembolism (VTE), mechanical ventilation, and mortality between date of COVID-19 diagnosis and the first of either 45 days after diagnosis or 6/9/2020. Any severe outcome was defined as any of inpatient hospitalization, mechanical ventilation, or mortality. Logistic regression was used to calculate odds ratios and 95% confidence intervals (CI) for the association of anticoagulants or antiplatelets with primary outcomes, adjusting for sociodemographic and clinical characteristics. Models were adjusted for week of diagnosis given changing testing and treatment guidelines over time.The Research Determination Committee for KPNC has determined the project does not meet the regulatory definition of research involving human subjects per 45 CFR 46.102(d).Results:Of 2,972 patients with confirmed positive COVID-19, 167(6%) were on antiplatelets, 69(2%) were on anticoagulants, and 7(<1%) on both. Most patients on anticoagulants or antiplatelets were older (77% aged >60 years), non-white (53%), overweight or obese (69%), and had >3 comorbidities (62%).After adjusting for sociodemographic and clinical characteristics, chronic anticoagulants or antiplatelets use was not associated with a lower risk of any primary outcome, including VTE, ED visit, ICU stay or severe outcome (OR 1.03, CI 0.74-1.45). Older patients had an increased risk of all outcomes except VTE, with the highest risk of severe outcomes in those > 80 years compared to 18-29 years (OR 13.62, CI 7.69-24.11). Male patients and Asian or Hispanic patients (compared to white patients) also had increased risk of severe outcomes. A higher mortality risk was noted in patients with underlying obesity (OR 2.28, CI 1.31-3.95) and hypertension (OR 2.03, CI 1.30-3.19), but not with diabetes (OR 1.43, CI 0.89-2.28). (Table 1)Conclusions:This analysis using a socio-demographically diverse cohort of COVID-19 positive patients demonstrated that patients on chronic anticoagulants or antiplatelets did not have lower risk for inpatient hospitalization, invasive ventilator, or death. There was a significantly higher risk of severe outcomes in those with older age, Asian or Hispanic ethnicity, male gender, obesity, hypertension and diabetes.Infection with COVID-19 can lead to a severe systemic inflammatory response, vascular endothelial dysfunction and hemostatic derangements, predisposing to microvascular and macrovascular thrombi and significant morbidity. Efforts to mitigate the disease severity have generated discussions regarding empiric use of anticoagulants and antiplatelets in COVID-19 patients. We did not find a difference in the risk of hospitalizations, mechanical ventilation or death for patients on chronic anticoagulants or antiplatelets. Our findings argue against the empiric use of these agents at COVID-19 diagnosis until prospective studies powered to evaluate thrombosis risk and clinical outcomes with value to patients and health care systems are completed.The major strength of this study included the availability of all outcomes data for inpatients and outpatients with COVID19. Limitations include possible missed data from undiagnosed COVID-19 patients due to evolving COVID-19 testing and variance in inpatient treatments which may influence outcomes. Despite this, our findings do not suggest a clinical benefit of chronic anticoagulants or antiplatelets in mitigating disease severity in COVID-19 patientsDisclosuresNo relevant conflicts of interest to declare.

Association of Anticoagulant Use with COVID-19 Diagnosis

BackgroundThe Coronavirus Disease 2019 (COVID-19) pandemic has challenged anticoagulation providers with providing optimal care while minimizing exposure risk, specifically in the management of patients on chronic warfarin. Here we provide data regarding our experience with managing patients on chronic anticoagulants, including warfarin, within Kaiser Permanente Northern California (KPNC), a large integrated healthcare delivery system serving more than 4 million patients.AimTo identify whether being on anticoagulation or antiplatelet agents correlates with an increased risk of contracting COVID-19.MethodsWe identified patients within KPNC electronic medical records on either warfarin, direct oral anticoagulation (DOAC) and/or antiplatelet agents between February 25 and July 3, 2020, as well as a randomly identified control group of patients not taking anticoagulation or antiplatelet. We looked for a correlation between taking anticoagulation and antiplatelets with the risk of testing positive for COVID-19.Results/ConclusionsAmong 188,438 patients on chronic anticoagulants or antiplatelets and 188,438 controls, 1,029 patients tested positive for COVID-19 during the study period. Being on chronic anticoagulants or antiplatelets was not associated with increased risk for a positive test. Patients on warfarin (N=30,242) also had no increased risk of developing COVID-19 compared to patients not on anticoagulation or antiplatelet therapy (odds ratio 0.87, 95% confidence interval 0.64-1.17). The time in the therapeutic range (TTR) of patients on warfarin during the COVID-19 pandemic remained near 72%, consistent with prior TTR, demonstrating persistent efficacy of anticoagulation despite measures to reduce COVID-19 transmission. Our data demonstrates the safety of continuing chronic warfarin in patients during the COVID-19 pandemic.DisclosuresNo relevant conflicts of interest to declare.

Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &amp;lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&amp;lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None

Randomized clinical trial comparing a rivaroxaban-based with an antiplatelet-based strategy for cerebral embolization after TAVR (EARTH TAVR)-a magnetic resonance imaging substudy of the GALILEO trial

Abstract Background Cerebral embolization in patients after Transcatheter Aortic Valve Replacement (TAVR) represents a serious complication, that was related to impaired bioprosthetic leaflet motion and new-onset atrial fibrillation (AFib). Purpose Hereafter we present the first randomized study comparing the effect of an anticoagulation plus antiplatelet with a dual antiplatelet antithrombotic treatment in patients after TAVR on cerebral embolizations as assessed by serial cerebral magnetic resonance imaging (MRI). Methods The Evaluation of Cerebral Thrombembolism After TAVR (EARTH - TAVR) study was conducted as an investigator initiated substudy of the multicenter, randomized, GALILEO study. After successful TAVR, patients without indication for chronic anticoagulation were randomly assigned to rivaroxaban 10mg plus acetylsalicylic acid 75–100mg once-daily or clopidogrel 75mg plus acetylsalicylic acid 75–100mg once-daily. Cerebral MRI scans were performed pre-TAVR as a baseline, post-TAVR (within 24–48 hours after TAVR) and 90 days after TAVR. The MRI protocol included diffusion-weighted (DWI) and fluid-attenuated inversion recovery (FLAIR) imaging. Cerebral embolic lesions were evaluated by an independent cerebral MRI core lab. The primary outcome measure of this study was the occurrence and extent of cerebral embolizations as measured by total volume of new ischaemic cerebral lesions. Results 36 patients were enrolled in the EARTH and the GALILEO study. The DWI MRI scans revealed an increase of cerebral lesions and volume post-TAVR by a median of 4.75 (95% NBCI 2.1–8.9) and 0.26cm3 (95% NBCI 0.11–0.59). On FLAIR imaging, lesion number and volume increased by a median of 3 (95% NBCI 1.5–6) and 0.1 cm3 (95% NBCI 0.04–0.31). At the 90 days MRI scan, there was no statistically significant change in cerebral lesions, if compared to the post-TAVR scan, irrespective of the treatment arm. Conclusion Thromboembolic events occur largely in the periinterventional phase post TAVR. Thereafter, the risk for additional cerebral embolization is low. An additional rivaroxaban therapy beyond antiplatelet inhibition did not impact on cerebral thromboembolism. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer Pharmaceuticals

Comparing anticoagulation therapy alone versus anticoagulation plus single antiplatelet drug therapy after transcatheter aortic valve implantation in patients with an indication for anticoagulation: a systematic review and meta-analysis.

This meta-analysis compared the efficacy and safety of oral anticoagulation (OAC) therapy alone versus OAC plus single antiplatelet therapy (SAPT) in patients with an indication for chronic OAC (mostly due to atrial fibrillation) after transcatheter aortic valve implantation (TAVI). A systematic literature search was performed in the PubMed, Embase, and Cochrane Library databases to identify relevant studies. Data was extracted from the eligible studies and outcomes expressed as relative risks (RRs) with 95% confidence intervals (CIs). Five studies comprising 1344 patients with an indication for chronic OAC and undergoing TAVI were included. Of the 1344 patients, 480 patients received OAC therapy alone and 864 patients received OAC plus SAPT. There were no significant differences between OAC alone versus OAC plus SAPT in all-cause mortality (RR = 1.05, 95% CI 0.84-1.30, p = 0.69) and ischemic stroke (RR = 0.95, 95% CI 0.95-1.61, p = 0.86). However, OAC alone was associated with significantly lower risks of all bleeding events (RR = 0.62, 95% CI 0.49-0.69, p < 0.0001) and major and/ life-threatening bleeding events (RR = 0.57, 95% CI 0.42-0.76, p = 0.0002) compared to OAC plus SAPT. In patients with an indication for chronic anticoagulation, post-TAVI antithrombotic therapy with OAC alone compared to OAC plus SAPT may be not significantly different in reducing all-cause mortality and ischemic stroke, but has an important benefit in a significantly lower risk of all bleeding and major and/life-threatening bleeding events.

Chronic therapeutic anticoagulation is associated with decreased thrombotic complications in SARS‐CoV‐2 infection

BackgroundThrombotic disease complicates severe SARS‐CoV‐2 infection and is associated with increased morbidity and mortality. Various anticoagulation strategies have been evaluated in hospitalized patients to prevent complications. The impact of chronic anticoagulation before SARS‐CoV‐2 infection on the risk for subsequent thrombosis has not been systematically studied. MethodsThis was a retrospective single‐center study. All patients with positive SARS‐CoV‐2 PCR testing from March 13, 2020, through May 6, 2020, at the University of Rochester Medical Center were identified. We included all patients receiving therapeutic anticoagulation for at least 1 month before COVID diagnosis. We documented the rate of thrombotic complications, type of anticoagulation, bleeding complications, and mortality. ResultsA total of 107 SARS‐CoV2‐infected patients were chronically anticoagulated before SARS‐CoV‐2 testing with a median age of 78. Of those, 42 required hospital admission, with 17 requiring intensive care. No patients, inpatient or outpatient, were diagnosed with a new symptomatic thrombotic complication. Three patients had minor bleeding in the hospital. Thirteen (12%) patients died (69% male). ConclusionOur uncontrolled findings suggest that chronic anticoagulation at the time of infection may protect against thrombotic complications and decrease disease severity.

A CASE OF PULMONARY VEIN THROMBOSIS WITH EXTENSION INTO THE LEFT ATRIUM

SESSION TITLE: Medical Student/Resident Signs and Symptoms of Chest Disease Posters SESSION TYPE: Med Student/Res Case Rep Postr PRESENTED ON: October 18-21, 2020 INTRODUCTION: Pulmonary vein thrombosis (PVT) is a rare and often misdiagnosed condition due to nonspecific symptoms at presentation. PVT is most commonly associated with lung malignancy, recent major pulmonary surgery, or atrial fibrillation. Symptoms generally include cough, dyspnea, nonspecific chest pain, and hemoptysis, similar to pulmonary embolism. Delay in diagnosis can be lethal. CASE PRESENTATION: A 76-year-old female with hyperthyroidism, history of DVT in 2018 previously on rivaroxaban, venous insufficiency and hypertension presented with cough, congestion, and progressive fatigue for 3 days. She was increasingly dyspneic at rest and with activity the day prior to admission. She required supplemental oxygenation with 2 L/minute via nasal cannula on evaluation at our emergency center. She additionally tested positive for influenza A and B. She denied chest pain, palpitations, or orthopnea, but did have associated worsening right lower extremity edema. Bilateral lower extremity venous duplex showed evidence of an acute thrombus in the right common femoral, superficial femoral, deep femoral, and popliteal veins; the left leg had no thromboses. Given evidence of acute DVT and acute hypoxemic respiratory failure on presentation, a CT PE protocol was done, noting a thrombus in the left lower pulmonary vein that extended into the left atrium (figures 1-3), with chronic occlusion of the left lower lobe pulmonary arteries as well as enlarged pulmonary arteries. She was initially treated with a heparin drip from 1/23/2020 to 1/27/2020, then she was transitioned to oral anticoagulation with rivaroxaban 20 mg PO daily. She maintained resting oxygen saturations on room air for three days prior to discharge on 1/28/2020 and her respiratory symptoms improved significantly. She had no evidence of underlying malignancy at the time. She has followed up twice with her primary care physician, remains on oral anticoagulation, and has had no respiratory complaints since discharge. Pending outpatient hypercoagulable workup and repeat chest imaging, which was recommended in 6 months. DISCUSSION: PVT is a rare yet life threatening condition if undiagnosed. It can lead to pulmonary hypertension, cor pulmonale, TIA or stroke, and even pulmonary infarction or gangrene. Though there is no present gold standard for diagnosis of PVT, CT pulmonary angiography led to the diagnosis in this case. CONCLUSIONS: Chronic anticoagulation is the mainstay of therapy for PVT. Though some cases may be idiopathic, it is prudent to investigate further for hypercoagulable states, including malignancy. Reference #1: Chaaya, G., & Vishnubhotla, P. (2017). Pulmonary Vein Thrombosis: A Recent Systematic Review. Cureus, 9(1), e993. https://doi.org/10.7759/cureus.993 Reference #2: Rana, M. A., Tilbury, N., & Kumar, Y. (2016). Idiopathic pulmonary vein thrombus extending into left atrium: a case report and review of the literature. Hindawi Publishing Corporation: Case Reports in Medicine, 2016, (article ID 3528393), 1-3. https://www.hindawi.com/journals/crim/2016/3528393/ Reference #3: Sahay, S., & Lodato, R. (2013). Pulmonary vein thrombosis: a rare entity. CHEST Journal, 144 (4_MeetingAbstracts). https://journal.chestnet.org/article/S0012-3692(16)42762-5/fulltext DISCLOSURES: No relevant relationships by Kendall Creed, source=Web Response No relevant relationships by Peter Khalil, source=Web Response No relevant relationships by Victor Test, source=Web Response No relevant relationships by Alexandra Wichmann, source=Web Response

S0596 Is Early Inpatient Endoscopy Necessary for Anticoagulant-Associated Gastrointestinal Bleeding?

INTRODUCTION: Patients on systemic anticoagulation are at increased risk for gastrointestinal bleeding (GIB). In those that present with GIB, resuscitation and support remain the standard of care. Guidelines also recommend endoscopy within 24 hours for diagnostic and therapeutic purposes. Unfortunately, lack of resources and/or gastroenterologists in small, community centers limit the ability to perform timely endoscopy. Conservative management is used in this setting with delayed or outpatient endoscopy, specifically in those who respond to medical therapy. There is minimal data on the outcomes of patients managed in this fashion. We look to compare presentation and outcomes of patients on anticoagulation who present with non-variceal upper GIB in a small community hospital. METHODS: We conducted a retrospective review of 115 patients with non-variceal upper GIB who underwent medical therapy (MT) alone vs inpatient endoscopy with MT. Outcomes included red blood cell (RBC) transfusions, re-admission for GIB, and 30-day all-cause mortality. Sub-group analysis was also performed based on endoscopy timeline and anticoagulant type. RESULTS: The MT group was comprised of 54 patients while 61 patients underwent inpatient esophagogastroduodenoscopy (EGD). There were no difference in age, gender, baseline laboratory values, or co-morbidities between both groups. Patient in the MT group required less RBC transfusions compared to EGD group (1.4 vs 2.5 average units, P = 0.004). There was no significant difference in the re-admission for GIB and overall mortality. There were 3 deaths, one in the endoscopy group (<24 hours) and 2 in the MT group (P = 0.60). Most patients were on warfarin (n = 47) and there were no differences in re-admission for GIB or mortality based on anticoagulant type. CONCLUSION: We aimed to evaluate outcomes in patients on chronic anticoagulation with non-variceal UGIB at a small, community medical center where urgent endoscopy cannot always be performed. In this retrospective study, we found that patients receiving MT only required significantly fewer blood transfusions than those undergoing endoscopy with no difference in recurrent GIB or mortality. Our study suggests that in a small, community center, conservative management could be employed safely if urgent endoscopy is not available. Nevertheless, a randomized, large study is needed to substantiate this claim.Table 1.: Demographic data comparing endoscopy group with Medical Therapy only groupFigure 1.: Average number of packed red blood cell transfusions was greater with endoscopy.Table 2

Dabigatran, the oral anticoagulant of choice at discharge in patients with non-valvular atrial fibrillation and COVID-19 infection: the ANIBAL protocol.

Atrial fibrillation is a frequent complication among patients with severe coronavirus disease-2019 (COVID-19) infection. Both direct and indirect mechanisms through COVID-19 have been described to explain this relationship. COVID-19 infection increases the risk of developing both arterial and venous thrombotic complications through systemic coagulation activation, leading to increased mortality. Chronic oral anticoagulation is essential to reduce the thromboembolic risk among AF patients. Switching to low-molecular-weight heparin has been recommended during hospitalization for COVID-19 infection. Of note, at discharge, the prescription of direct oral anticoagulants may offer some advantages over vitamin K antagonists. However, oral anticoagulants should only be prescribed after the consideration of drug–drug interactions with antiviral therapies as well as of the risk of hepatotoxicity, which is common among individuals with severe COVID-19 pneumonia. Not all anticoagulants have the same risk of hepatotoxicity; dabigatran has shown a good efficacy and safety profile and could have a lower risk of hepatotoxicity. Furthermore, its metabolism by cytochrome P450 is absent and it has a specific reversal agent. Therefore, dabigatran may be considered as a first-line choice for oral anticoagulation at discharge after COVID-19 infection. In this review, the available information on the antithrombotic management of AF patients at discharge after COVID-19 infection is updated. In addition, a practical algorithm, considering renal and liver function, which facilitates the anticoagulation choice at discharge is presented.

Time in Therapeutic Range for Bivalirudin Among Pediatric Ventricular Assist Device Recipients.

Given the adverse event rates involving bleeding and thrombosis among children on ventricular assist devices (VADs), anticoagulant management has become a focal point for quality improvement and innovation. There may be advantages to using direct thrombin inhibitors, such as bivalirudin, though this has not been fully explored. As the percent time in therapeutic range (%TTR) for anticoagulants is classically associated with improved clinical outcomes, we evaluated the %TTR for bivalirudin among pediatric VAD recipients. Using a modification of the Rosendaal method, %TTR was calculated using activated partial thromboplastin time measurements for 11 VAD recipients in the early postoperative period (postoperative days 0-14) and for the duration of VAD support. In the initial 2 weeks after VAD implant, mean %TTR was 68.7 (±13.0). During the entire support course, the mean %TTR improved to 79.6 (±11.0). There was an era effect with improving %TTR in the latter half of the study period. We report very good %TTR for bivalirudin both in the first 2 weeks post implant and this improved over the duration of support. Because %TTR reflects the degree of safety and efficacy in chronic anticoagulation, this relatively high %TTR among a diverse, often critically ill cohort suggests that bivalirudin may be a promising agent. Although this study was underpowered to comprehensively evaluate adverse events on bivalirudin, this represents an important next step for larger scale study.

Evaluation of a pharmacist-led shared decision-making in atrial fibrillation and patients' satisfaction-a before and after pilot study.

Chronic complex diseases like atrial fibrillation have potential long-term economical and personal consequences. Shared decision-making principles may promote therapeutic compliance, satisfaction and outcomes. Pharmacists, as patient-advocates, play a key role in guiding them through complex clinical decisions about their chronic disease management and anticoagulation choices. To evaluate the impact of pharmacist-led shared decision making on patients' satisfaction and appropriateness of their anticoagulation therapy in newly diagnosed atrial fibrillation patients. A prospective 2-phase before and after single-centre study was conducted in an Australian hospital. Phase 1 provided usual care, and patients' satisfaction and appropriateness of their anticoagulation therapy were evaluated. Phase-2 assessed the impact on satisfaction and appropriateness of anticoagulant therapy following pharmacist-led interventions of shared decision making to promote patients' involvement. Patients with pharmacist-led shared decision making reported higher degree of appropriateness of anticoagulation therapy and satisfaction (36% vs 92%, P < 0.001; 25% vs 68, P < 0.001), respectively. Additionally, patients who had a pharmacist input during their hospital stay received guideline-recommended anticoagulant therapy and reported satisfaction with their management was also higher in stage 2 (21% vs 65%, p < 0.001). The study highlights pharmacist-led shared decision making in atrial fibrillation that contributes to patient satisfaction and appropriateness of therapy.

Riociguat in the Treatment of Chronic Thromboembolic Pulmonary Hypertension: An Evidence-Based Review of Its Place in Therapy.

Chronic thromboembolic pulmonary hypertension (CTEPH) is classified as group-4 pulmonary hypertension caused by organized thrombi in pulmonary arteries and vasculopathy in nonoccluded areas leading to right heart failure and death. In addition to chronic anticoagulation therapy, each patient with CTEPH should receive treatment assessment starting with evaluation for pulmonary endarterectomy (PEA), which is the guideline recommended treatment. There is increasing experience with balloon pulmonary angioplasty (BPA) for inoperable patients; this option, like PEA, is reserved for specialized centers with expertise in this treatment method. Inoperable patients are candidates for targeted drug therapy. Riociguat remains the only approved medical therapy for CTEPH patients deemed inoperable or with persistent pulmonary hypertension after PEA. The role of riociguat therapy preoperatively or in tandem with BPA is currently under investigation. The purpose of this review is to evaluate the safety and efficacy of riociguat in the treatment of CTEPH.

Discussion

Discussion

Non-vitamin K oral anticoagulants in hypertrophic cardiomyopathy patients undergoing catheter ablation of atrial fibrillation.

Patients with hypertrophic cardiomyopathy (HCM) and atrial fibrillation (AF) require chronic anticoagulation due to high thromboembolic risk. Evidence supporting the use of non-vitamin K oral anticoagulants (NOACs) in patients with HCM remains sparse, and there are no data regarding the use of NOACs in patients with HCM undergoing catheter ablation of AF. Observational nonrandomized study in four European centers. We aimed to investigate the safety and efficacy of NOACs compared with vitamin K antagonists (VKAs) in patients with HCM undergoing catheter ablation for AF. A total of 137 patients with HCM (mean age: 55.0 ± 13.4, 29.1% female) underwent 230 catheter ablations for AF (1.7 ± 1.0 per patient). A total of 55 patients (39.4%) underwent 70 procedures (30.4%) on NOAC, while the remaining were on VKA. Warfarin (97.6%) and rivaroxaban (56.4%) were the most frequently used agents in the respective groups. No procedure-related deaths were reported. We observed no significant difference in the rate of thromboembolism (VKA: 0.6%; NOAC: 0%; p = 1.0) or minor bleeding (VKA: 0.6%; NOAC: 1.4%; p = .54). There was a nonsignificant trend towards a lower incidence of major bleeding (VKA: 6.9%; NOAC: 1.4%; p = .09). These preliminary data suggest that NOACs are at least as safe and effective as VKAs in patients with HCM undergoing catheter ablation for AF.

Impact of bariatric surgery on oral anticoagulants pharmacology, and consequences for clinical practice: a narrative review.

The prevalence of obesity has been steadily increasing in recent years worldwide. At the same time bariatric surgery, the best therapeutic strategy to date in terms of sustainable weight loss and improvement of associated comorbidities has been also increasing. However, these surgeries, whether primarily restrictive or malabsorptive, raise questions about the pharmacology of oral drugs. Among widely used drugs, anticoagulants are the referent therapy to treat some cardiovascular diseases such as atrial fibrillation and venous thromboembolism. How bariatric surgery may impact pharmacological properties of oral anticoagulants, and more specifically, direct oral anticoagulants (DOACs) are difficult to anticipate. In this review, we describe available data concerning the potential impact of bariatric surgery on the pharmacology of oral anticoagulants. The vitamin K antagonists (VKAs) requirements for the same international normalized ratio target are reduced after bariatric surgery. Limited data available for dabigatran 150mg twice daily indicate a risk of insufficient efficacy in atrial fibrillation after gastric bypass due to probable impaired absorption. Data for rivaroxaban at the prophylactic dose of 10mg per day suggest no impact of bariatric surgery from 3days to 8months post-surgery. However, no conclusive data are available for other anticoagulants or the use of DOACs at therapeutic doses. To date, DOACs are not recommended in patients who have undergone bariatric surgery, because of limited available data. Pending new studies to confirm the predictable pharmacokinetics and safety of DOACs in this population, especially at therapeutic doses, VKAs remain the first option for chronic anticoagulation.

Effects of Preoperative Anticoagulation on Outcomes of Patients Undergoing Lower Extremity Bypass

The effects of oral anticoagulation on outcomes of bypass grafts have been studied with mixed results as to the usefulness these agents to improve graft patency. However, there is a paucity of data on the effects of chronic oral preoperative anticoagulation use on outcomes following lower extremity bypass (LEB). Therefore, we sought to compare perioperative and long-term outcomes of patients undergoing LEB on preoperative anticoagulation versus those are not on anticoagulation.

Guidance for anticoagulation management in venous thromboembolism during the coronavirus disease 2019 pandemic in Poland: an expert opinion of the Section on Pulmonary Circulation of the Polish Cardiac Society.

The coronavirus disease 2019 (COVID-19) pandemic affects anticoagulation not only in those infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) but also in most patients who require daily anticoagulant therapy and are facing substantial limitations in medical care these days. Concomitant venous thromboembolism (VTE), a potential cause of unexplained deaths, has frequently been reported in patients with COVID-19, but its management is still challenging due to the complexity between antithrombotic therapy and hematological alterations. In the era of COVID-19 pandemic, it is highly recommended for patients who require chronic anticoagulation to continue therapy to prevent thromboembolic events. To avoid regular and frequent blood tests and unnecessary exposure to SARS-CoV-2 during contacts with medical personnel, direct oral anticoagulants should be strongly preferred whenever possible. Current evidence is insufficient to recommend routine pharmacological antithrombotic prophylaxis in all hospitalized patients with COVID-19. In patients with COVID-19 who are suspected of VTE or in whom the diagnosis is confirmed, parenteral therapy with low-molecular-weight heparin should be initiated in the absence of contraindications. If heparin-induced thrombocytopenia is suspected, nonheparin anticoagulants should be used such as bivalirudin or fondaparinux. In case of confirmed acute pulmonary embolism, treatment should be guided by risk stratification as defined in the current guidelines.

SAT0194 LACK OF EFFICACY OF RIVAROXABAN IN THE TREATMENT OF ANTIPHOSPHOLIPID SYNDROME AND CLINICAL SIGNIFICANCE OF ANTIPHOSPHOLIPID ANTIBODIES

Background:Chronic anticoagulation with vitamin K antagonists (VKA) is the standard treatment to prevent thrombotic events in antiphospholipid syndrome (APS). But in recent years treatment schemes began to include rivaroxaban. Use of direct oral anticoagulants (DOAC) is an attractive and often preferred alternative to VKAs in other medical settings owing to greater ease of use, fewer food and drug interactions, and lower bleeding risks [1].However, according to last guidelines, rivaroxaban should not be used in patients with triple aPL positivity due to the high risk of recurrent events [2].Objectives:1.To determine the risk of recurrent thrombosis in single or double positive APS patients treated with rivaroxaban.2.Find out possible association between presence of particular antiphospholipid antibodies or high level of lupus anticoagulant (LA) and type of vascular events.Methods:33 patients with confirmed APS (25 female (75.8%), 8 male (24.2%), mean age 43.2±11.6 years) were included in the study. 17 (51.5%) of investigated patients had primary APS, in remaining 16 (48.5%) APS was included in the framework of SLE. 18 (54.5%) patients were treated with warfarin 2.5-7.5 mg/daily, 15 (45.5%) patients - with rivaroxaban 20mg/daily for a follow-up period of 12 months. The data is introduced as odds ratios (OR) with 95% confidence interval (CI). The results were considered significant when p &lt;0.05.Results:At baseline 21 (63.6%) patients had history of arterial thrombosis, 10 (30.3%) - venous thrombosis, 17 (51.5%) - pregnancy loss. According to results of serum immunology check, 29 (87.9%) patients were anticardiolipin antibody (ACA) positive, 9 (27.3%) - LA positive, 19 (57.6%) - anti-ß2-glycoprotein antibodies (anti-ß2-gp) positive; 20 (60.6%) patients were double positive (12 (36.4%) of them had positive ACA and anti-ß2-gp, 6 (18.2%) - ACA and LA, and 2 (6.1%) - anti-ß2-gp and LA), 4 (12.1%) patients were triple positive.No association between vascular event and/or pregnancy loss in patients with single positive ACA was found. We have found positive association between arterial thrombosis and single positive anti-ß2-gp (OR /CI 95%/ = 5.0 /2.08 – 23.06/, p&lt; 0.05), positive association between positive LA and venous thrombosis (OR /CI 95%/ = 10 /1.7-57.7/, p&lt; 0.05), strong positive association between positive LA and thromboembolism of pulmonary artery (OR /CI 95%/ = 46.0 /4.0-525.1/, p&lt; 0.001), negative association between positive LA and pregnancy loss (OR /CI 95%/ =0.06 /0.03 – 0.1/, p&lt; 0.01).Risk of thrombosis and/or pregnancy loss was not significantly increased in double positive patients, but triple positive patients had increased risk of venous thrombosis (OR /CI 95%/ =9.4 /3.2 – 105.8/, p&lt;0.04).Recurrent thrombosis was detected in 16 patients: 2 patients (12.5%) were on warfarin, 14 (87.5%) - on rivaroxaban (10 (71.4%) arterial thrombosis, 4 (28.6%) venous thrombosis).No association between warfarin 2.5-7.5 mg/daily and occurrence of recurrent thrombosis was detected. An association between use of warfarin and increased risk of bleeding was found, but the risk was not significant (OR /CI 95%/ = 7.0 /0.7 – 66/, p= 0.09). Rivaroxaban 20 mg/daily was associated with recurrent thrombosis not only for triple positive patients (p&lt; 0.02), but also in double positive patients (OR /CI 95%/ = 21.3 /1.8 – 251/, p&lt; 0.04).Conclusion:Rivaroxaban does not prevent recurrent thrombosis not only in triple positive patients, but also in single and double positive APS patients. Type of antiphospholipid antibodies can be predictive for the type of further vascular event.