INR Testing Research Articles

Supratherapeutic INR During Treatment With Nirmatrelvir/Ritonavir and Warfarin and Acute Illness With COVID-19: A Case Report

Background: Several studies have examined INR fluctuations using pharmacokinetic (PK) models or post-hoc INR values after completing nirmatrelvir/ritonavir, but further study of the effects of the drug interaction with warfarin during treatment is necessary. Case Summary: Nirmatrelvir/ritonavir is largely utilized in the outpatient setting so data regarding INR trends in hospitalized patients on warfarin is limited. However, many who receive nirmatrelvir/ritonavir outpatient experience difficulty with presenting to clinic for INR checks due to feeling acutely ill along with isolation precautions. We present the case of a patient receiving warfarin and utilizing home INR testing for monitoring. After diagnosis of coronavirus disease of 2019 (COVID-19), she was started on nirmatrelvir/ritonavir on day five after testing positive. Most recent INR prior to the start of therapy was 2.7 and had been stable on the same dose for months prior to infection. On day two of nirmatrelvir/ritonavir, her INR rose to 4.0 on home point of care INR testing. Despite reducing her dose of warfarin by 15%, her INR remained supratherapeutic the day after completing nirmatrelvir/ritonavir (4.0) and for several checks after. One month after completion of therapy, her INR returned to therapeutic levels. Practice Implications: While PK models and case series have hypothesized both potential increases or decreases in INR with the nirmatrelvir/ritonavir and warfarin interaction, COVID-19 infection itself can cause several pharmacodynamic changes which can increase INR, including decreased appetite and, in severe cases, organ dysfunction. This case provides real-world insight into the drug interaction between nirmatrelvir/ritonavir and the drug-disease state interaction between warfarin and COVID-19.

Outcomes of Warfarin Home INR Monitoring vs Office-Based Monitoring: a Retrospective Claims-Based Analysis

BackgroundHome INR testing (patient self-testing) is feasible and effective for warfarin patients but little is known about real-world differences in outcomes for patients using PST versus laboratory-based INR monitoring.ObjectiveTo compare the safety/efficacy of patient self-testing of real-world warfarin therapy versus office/lab-based monitoring of therapy.Design/Setting/Participants/ExposureA retrospective claims-based analysis of warfarin patients enrolled in the MarketScan® Commercial Claims and Encounters and Medicare databases between January 1, 2013, and March 30, 2020. Stratification was based on INR testing method: patient self-testing versus testing at physicians’ offices/local laboratory. The probability of adverse events in each cohort was determined after adjusting for demographic and baseline clinical characteristics using a repeated measures analysis.Main MeasuresRates of all adverse events: deep venous thrombosis, pulmonary embolism, bleeding, and stroke. A secondary outcome of interest was emergency department visits.Key ResultsA total of 37,837 patients were included in the analysis: 1592 patients in the patient self-testing group and 36,245 in the office-based therapy group. After adjusting for demographic and baseline clinical characteristics, patients in the office-based group had statistically significantly higher rates of all adverse events (incidence rate ratio [IRR]=2.07, 95% CI [1.82, 2.36]), and specific adverse events including thromboembolism (IRR=4.38, 95% CI [3.29, 5.84]), major bleed (IRR=1.45, 95% CI [1.28, 1.64]), and stroke (IRR=1.30, 95% CI [1.05, 1.61]) than patients in the patient self-testing group. Office-based patients also had a statistically significant higher rate of emergency department visits than patient self-testing patients (IRR = 1.65, 95% CI [1.47, 1.84]).Conclusions/RelevanceThis analysis of real-world claims data shows lower rates of stroke, thromboembolism, and major bleeding, as well as fewer emergency department visits, with patient self-testing compared to office-based/lab INR monitoring. Our finding that PST is safe and effective among current users suggests that more patients may benefit from its use.

Abstract 15632: Warfarin Dose Management Using Offline Deep Reinforcement Learning

Introduction: Warfarin is a commonly prescribed anticoagulant for treating atrial fibrillation, mechanical valves, and venous thromboembolism. Warfarin dose management remains challenging due to dosing variability between patients and warfarin’s narrow therapeutic window. Time in therapeutic range (TTR) is critical to warfarin’s safety and efficacy, but TTR typically remains low (40-50%) in community practices. Specialized anticoagulation clinics and protocolized approaches can increase TTR but have great administrative burdens and health care costs. Aim: To develop standardized optimal warfarin dose decision support using a machine learning model based on time series anticoagulation data and patient demographic characteristics Methods: The dataset included 12,497 warfarin patients monitored in the anticoagulation tracker of electronic medical records across the Mayo Clinic Enterprise. The dataset contained time series anticoagulation data (warfarin dose, INR, INR target range) and patient demographic characteristics. We implemented an offline deep reinforcement learning model (DRL) to predict the cumulative warfarin dose for the days until the next INR test based on a patient’s historical anticoagulation data. Prior approaches utilized traditional supervised learning methods such as regression or Long Short Term Memory (LSTM) neural networks to approximate a function mimicking the behavior of the training data. On the other hand, DRL learned an optimal dosing policy through continuous interaction and feedback from the training data. The key advantage of DRL is the model can learn to behave differently (and potentially better) for suboptimal clinical states in the data such as overdosing or underdosing. To evaluate the DRL model we compared the predicted warfarin doses with the physician-prescribed doses Results: DRL model’s prediction accuracy was 96.96%, outperforming our implementation of a baseline LSTM model with a prediction accuracy of 70.58%. Further evaluation of the DRL model indicated that the model correctly adjusted the warfarin dose at time steps when patients had out-of-range INRs. Conclusions: Offline deep reinforcement learning demonstrates potential in supporting warfarin dose management to maximize TTR.

DOES THE TIMING OF WARFARIN INGESTION AFFECT THE TIME IN THERAPEUTIC RANGE IN PATIENTS WITH METALLIC PROSTHETIC VALVE?

Aim: Warfarin , a vitamin K antagonist, is the only approved oral agent to provide anticoagulation in patients with metallic prosthetic valves. Since effectively initiating and maintaining anticoagulation is challenging due to various factors , those patients undergo frequent periodic INR testing. The aim of this study was to investigate the effect of the timing of warfarin ingestion on the stability of anticoagulation.
 Materials and Methods: A total of 60 patients with metallic prosthetic valves were included in the study. First, all the patients were informed to take warfarin between 19:30 and 20:00 during the first month, then to take warfarin between 09:30 and 10:00 during the second month. All the patients underwent INR monitoring once every 15 days during the follow-up period. The time in therapeutic range (TTR) values for the first month and second month ( referred to as ‘first TTR’ and ‘second TTR’, respectively) were calculated separately using the Rosendaal method. 
 Results: The mean age ( ± SD) of the patients was 59.6 ± 9.6 years and 36.7% (n=22) were male. There was no significant difference between the first TTR and second TTR values of the patients (66.23 ± 40.7% vs 64.12 ± 41.13%, p=0.783). The mean INR value in the first month was found to be significantly lower than in the second month (2.73 ± 0.53 vs 3.06 ± 0.47, p=0.001). 
 Conclusion:.The study results showed that the timing of warfarin ingestion did not affect the stability of anticoagulation although taking the warfarin in the morning provided higher INR values.

#3662 FREQUENCY OF INR TESTING IN HEMODIALYSIS PATIENTS ON VITAMIN K ANTAGONISTS: A RETROSPECTIVE STUDY

Abstract Background and Aims Despite the rising of direct oral anticoagulant agents’ use in the general population, vitamin K antagonists (VKA) are still used in hemodialysis (HD) French patients with atrial fibrillation. These HD patients on VKA have also poor levels of time in therapeutic range. It is recommended generally to follow patients with monthly INR, however there is lack of such evidence in HD. This study aims to analyze the frequency of INR testing needed in HD patients. Method This is a retrospective study of all patients treated with VKA in three French dialysis units between 1st January and 31st December 2022. Patients are followed with weekly INR. Variables collected included over twelve months the number of INR tests, their percentage within target, above target and below target, and number of VKA dose adjustment. Bleedings, transfusions, thrombotic events and antibiotic use were recorded. Linear regression analysis evaluated factors associated with number of VKA dose adjustment per year. This study was conducted in concordance with the Declaration of Helsinki 1975. Results Out of 160 HD patients, 45 (28.1%) were on VKA for paroxysmal or chronic atrial fibrillation. Their characteristics are summarized in Table 1. A total of 2609 INR tests were performed over a year with a mean of 57.9±18.6 per patient. The median number of VKA dose adjustment per year was 11 (8, 13). A significant correlation was found between the number of antibiotics and number of VKA dose adjustment (Spearman Rho = 0.360, p = 0.015). In univariate regression analysis, factors associated with higher numbers of dose adjustment were diabetes, sevelamer and blood flow (Table 2). Bleeding was not significantly different between those with high versus low VKA dose adjustment. Conclusion In this study, 22% of tests led to VKA dose adjustment. Patients with diabetes, on sevelamer, treated with antibiotics and with lower serum albumin needed frequent INR testing more than once monthly. These results could be helpful in contexts with limited resources.

Fibrinogen level among children with liver cirrhosis

IntroductionThe liver has a major role in the production of coagulation factors, and cirrhotic patients have a series of coagulopathy disorders. The present study aimed to measure plasma fibrinogen levels in children with hepatic cirrhosis.MethodPatients younger than 18 years old after diagnosis of liver cirrhosis by biopsy were enrolled in the study. Laboratory data including hemoglobin, PT, PTT, INR, and liver function tests were recorded. Fibrinogen levels were measured using the Clauss method. PELD score for children less than 12 years and MELD Na for children over 12 years were used to measure the severity of the liver disease.ResultsFifty children with cirrhosis were studied. The mean fibrinogen level in the “PELD < 15” group was significantly higher than the other group (P < 0.001). There was no significant relationship between bleeding and fibrinogen levels. There was no significant relationship between PELD and bleeding in subjects (P = 0.87). The results of the study showed neither of these two factors (fibrinogen level and PELD) can play a predictive role in causing hemorrhage in patients.ConclusionOur study has shown that fibrinogen level is significantly associated with severity of liver cirrhosis and decreases with more severe disease (PELD levels), but platelet and fibrinogen cannot predict the severity of bleeding in these patients.

Abstract TP77: Point Of Care Inr And R-tpa Decision Making In Acute Ischemic Stroke

Introduction: IV r-tPA is the standard of care treatment in acute ischemic stroke presenting within 4.5 hours of last known well. Exclusion criteria for administering IV r-tPA include conditions that predispose to bleeding, including an INR of ≥ 1.7 . Point of care (POC) INR testing is significantly faster than laboratory derived INR results and can expedite IV r-tPA administration. However, POC INR testing is less accurate than laboratory-based testing with an acceptable variance range of +/- 0.4, which may lead to improper r-tPA exclusion or inclusion. Objectives: We demonstrate the utility of a protocolized approach to POC INR testing in acute ischemic stroke, in which known or suspected warfarin use requires a lab INR result to determine if r-tPA is contraindicated when POC INR is between 1.3-2.1. This approach prevents IV r-tPA from being inappropriately administered or withheld. Methods: We stratified a subset of real world paired POC and laboratory INR results (n=892) for stroke code patients at our institution from January 1st through July 4 th , 2022 by known or suspected warfarin status and calculated a positive predictive value for POC INR &gt; 1.7. Results: Fifty-four of 892 paired POC and laboratory INR results represented patients with known or suspected warfarin use. Twenty-five (46%) had a POC INR within 1.3-2.1 warranting a lab INR verification prior to safe administration of r-tPA. Thirteen of which had a POC INR &lt; 1.7 but a lab INR of ≥ 1.7. In 5.25% of cases where the POC INR &gt; 1.7 the laboratory INR was &lt; 1.7. The positive predictive value for POC INR &gt;= 1.7 among patients with known or suspected warfarin status is 88.2%. Conclusions: POC INR testing rapidly screens for coagulopathy in IV tPA eligible stroke patients, but due to inherent inaccuracy may inadvertently rule patients in or out for IV r-tPA treatment. Our institution has instituted a policy of requiring laboratory verified INR results when the POC INR is within +/- 0.4 of the laboratory based INR tPA cutoff. In our 892 patient sample, this policy would prevent 13 patients from inadvertently receiving IV tPA due to an inaccurate POC INR. Up to five percent of patients excluded from r-tPA based on POC INR may in-fact be treatment candidates.

Anticoagulation Control and Major Adverse Clinical Events in Patients with Operated Valvular Heart Disease with and without Atrial Fibrillation Receiving Vitamin K Antagonists.

Good quality anticoagulation among patients with operated valvular heart disease is needed to reduce ischaemic and thromboembolic complications. There is limited evidence regarding factors that affect anticoagulation control in patients implanted with mechanical or tissue prosthetic valve(s). To examine the quality of and factors that affect anticoagulation control, major adverse clinical events and all-cause death in operated valvular heart disease patients with and without atrial fibrillation who are receiving a vitamin K antagonist. Quality of anticoagulation were retrospectively assessed among 456 operated valvular heart disease patients [164 (36%) with AF and 290 (64%) without AF] via time in therapeutic range (TTR) (Rosendaal method) and percentage of INRs in range (PINRR) over a median of 6.2 (3.3-8.5) years. VHD was defined by the presence of a mechanical or tissue prosthetic valve at the mitral, aortic, or both sites. Mean age 51 (14.7), 64.5% men. Most (96.1%) had a mechanical prosthesis and 64% had aortic valve replacement. Overall, mean TTR was 58.5% (14.6) and PINRR was 50.1% (13.8). Operated valvular heart disease patients with AF had significantly lower mean TTR and PINRR (TTR: 55.7% (14.2) vs. 60.1% (14.6); p = 0.002, respectively, PINRR: 47.4% (13.5) vs. 51.6% (13.7); p = 0.002, respectively), and a lower proportion of TTR ≥ 70%, despite a similar number of INR tests compared to those without AF. Predictors of TTR < 70% were female sex, AF and anaemia/bleeding history. Significantly higher proportions of operated valvular heart disease patients with AF died (20.7% vs. 5.8%; p < 0.001), but ≥1 MACE rates were similar between the two groups. Operated valvular heart disease patients with AF at baseline have poorer anticoagulation control compared to those without AF. The presence of concomitant AF, anaemia/bleeding history and female sex independently predicted poor TTR. Stringent INR monitoring is needed to improve anticoagulation control and prevent major adverse clinical events in patients with operated valvular heart disease.

Implementation of point-of-care INR testing to improve effectiveness of anticoagulation clinic

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Oral Vitamin K antagonist (VKA) is still widely used for anticoagulation. Anticoagulation clinics are set up to monitor patients’ INR and adjust their VKA doses accordingly. Anticoagulation clinic in our centre introduced point-of-care (POC) INR testing in June 2021 to improve the effectiveness of the clinic. Purpose This audit was done to evaluate the effectiveness of anticoagulation since the introduction of the POC INR test into the clinic workflow. Methods This was a retrospective, cross-sectional, cohort audit study. The study period was from 1st June 2021 to 31st July 2022. List of patients who attended the clinic from 1st – 31st January 2022 was taken from the clinic log and their electronic medical records were reviewed for the study period. Only patients who have been established on VKA for at least 3 months were included in the audit. The data collected included their basic demographics, indication for VKA, any complications / death during the study period and if their VKA had been stopped and why and serial INRs from the POC INR test during the study period. The time in therapeutic range (TTR) is calculated by Rosendaal method and all the results analysed on Microsoft Excel. The audit standard for safe and effective anticoagulation was a TTR ≥ 70%. Results were compared to an audit done previously for the centre’s anticoagulation clinic done in 2020. Results 207 patients were included in this audit. Male patients accounted for 53.6% of the study population. Their ages ranged from 22 years to 102 years with a median age of 67 years. Majority of the patients were on VKA as stroke prevention for their atrial fibrillation (AF) (79.7%), followed by metallic valve replacement (13%). The median TTR for patients with AF had improved from 40.8% in 2020 to 51.05% in 2020-21 study period and this difference is significant (p = 0.017). Patients getting effective anticoagulation also improved from 23.26% in 2020 to 26.79% during this audit period. 13% of the study population developed complications on VKA in which 2.9% of patients developed gastrointestinal bleed and 1% developed intracranial haemorrhage. There were 4 fatalities, none were from gastrointestinal bleeding, intracranial haemorrhage or stroke. 10% of patients had their VKA changed to a novel oral anticoagulant (NOAC) as they were identified to have poor TTR during clinic review. Conclusions The introduction of POC INR test has proven to make significant improvement in patient’s median TTR for patients with AF. However, more efforts need to be made to further improve effectiveness of anticoagulation in our patients such as converting them to a NOAC if eligible or more thorough counselling and more frequent INR checks.

Pharmacogenetics of warfarin and healthcare costs - Real-world data analysis.

Variants in CYP2C9 and VKORC1 genes have been associated with individuals' sensitivity to warfarin. The aim of this study was to investigate the differences of healthcare costs of genetically normal and genetically sensitive warfarin responder groups. This was a retrospective study linking genotype data from three Finnish biobanks (THL Biobank, Auria Biobank, Helsinki Biobank) with healthcare encounter data of the Finnish Institute of Health and Welfare (THL), drug dispensation data from the Social Insurance Institution of Finland (Kela) and laboratory data from Finnish hospital districts and municipalities. We compared the normal and sensitive warfarin responder groups in terms of healthcare costs related to bleeding and thromboembolic events, INR tests and medication purchases. We found a trend towards increased bleeding-related hospital costs in the sensitive warfarin responder group (881 patients) when compared with the normal responders (1627 patients) with a per patient difference of 150.9€/year (95% CI: -55.1, 414.6€/year, p=0.087). INR test costs were higher in the sensitive responder group with a difference of 7.2€/year (95% CI: -1.5, 16.4€/year, p=0.047). Medication costs were significantly lower in the sensitive responder group with a difference of -14.4€/year (95% CI: -15.8, -12.9€/year, p < 0.001). The difference in the costs of bleeding-related hospitalization between genetically sensitive and normal warfarin responders may justify genotype-guided warfarin dosing. Further studies with larger sample sizes would be needed to verify the result.

Health care professionals’ perceptions about atrial fibrillation care in the Brazilian public primary care system: a mixed-methods study

BackgroundAtrial fibrillation (AF) negatively impacts health systems worldwide. We aimed to capture perceptions of and barriers and facilitators for AF care in Brazilian primary care units (PCUs) from the perspective of healthcare professionals (HCPs).MethodsThis mixed-methods, cross-sectional study utilised an exploratory sequential design, beginning with the quantitative data collection (up to 18 closed questions) immediately followed by a semi-structured interview. HCPs were recruited from 11 PCUs in the Sao Paulo region and included managers, physicians, pharmacists, nurses and community health agents. Descriptive statistics were used to present findings from the quantitative questionnaire and inductive analysis was used to identify themes from the qualitative data.ResultsOne hundred seven HCPs were interviewed between September 2019 and May 2020. Three main themes were identified that encapsulated barriers and facilitators to AF care: access to care (appointments, equipment/tests and medication), HCP and patient roles (HCP/patient relationship and patient adherence) and the role of the organisation/system (infrastructure, training and protocols/guidelines). Findings from the qualitative analysis reinforced the quantitative findings, including a lack of AF-specific training for HCPs, protocols/guidelines on AF management, INR tests in the PCUs, patient knowledge of AF management and novel oral anticoagulants (NOACs) as key barriers to optimal AF care.ConclusionsDevelopment and implementation of AF-specific training for PCU HCPs are needed in Brazil, along with evidence-based protocols and guidelines, educational programmes for patients, better access to INR tests for patients taking warfarin and availability of NOACs.

Comparison of Point-of-Care PT-INR by Hand-Held Device with Conventional PT-INR Testing in Anti-phospholipid Antibody Syndrome Patients on Oral Anticoagulation.

Evidence on agreement of point-of-care (POC) INR testing with laboratory testing in APS patients on oral anticoagulation (OAC), is scarce. This study assessed agreement of paired PT INR testing by a POC device vs. conventional platform-based laboratory test, in APS patients on OAC using a pre-determined definition of agreement. Simultaneous paired PT INR estimation in 92 APS patients was carried out, during October 2020-September 2021. POC INR was performed on capillary blood (pin prick) using the qLabs® PT-INR hand-held device, while laboratory INR estimation was performed using citrated blood (venepuncture) on STA-R Max Analyzer® using STA-NeoPTimal thromboplastin reagent®. Concordance was defined no greater than ± 30% (as per international standards ISO 17593:2007 guidelines) for each paired INR estimation. Agreement between the two was defined as ≥ 90% of paired INR measurements being concordant. 211 paired estimations were performed, within which 190 (90%) were concordant. Good correlation was seen between the 2 methods of INR estimation on Bland Altman plot analysis with an Intra-class correlation coefficient (95% CI) of 0.91(0.882, 0.932). Lab INR range > 4 (P = 0.001) was a significant predictor of higher variability between both methods of INR estimation. Lupus anti-coagulant, other anti-phospholipid antibodies (APL) or triple APL positivity did not result in any statistically significant variation in paired measurements. This study demonstrated good correlation between POC INR measurement and Lab INR estimation and agreement was ascertained between the 2 methods in APS patients on OAC.

The Occurrence of Thrombosis during Intensive Chemotherapy Treatment for Acute Myeloid Leukemia Patients Does Not Impact on Long-Term Survival

Introduction A thrombotic event is seen in 10% of newly diagnosed acute myeloid leukemia (AML) patients and has been shown to be associated with disseminated intravascular coagulation (Libourel et al. Blood. 2016). As of yet, the association of developing thrombosis during intensive chemotherapy with AML risk models such as the Medical Research Council (MRC) cytogenetics-based assessment and the European LeukemiaNet (ELN) 2017 molecular based risk model has not been rigorously evaluated. In addition, there is a paucity of data pertaining to the long-term prognostic impact of thrombosis in AML patients. Aiming to investigate these prognostic facets of thrombosis in AML, we performed an analysis of patients with AML diagnosed with thrombosis during treatment with intensive chemotherapy. Methods For this analysis, we collected data on baseline clinical, laboratory, cytogenetic and molecular characteristics of patients with newly diagnosed AML who were treated with intensive chemotherapy and were diagnosed with venous thrombosis. These data were compared with intensively treated patients who did not experience thrombosis to assess for clinical parameters associated with a higher likelihood of developing thrombosis, and to determine whether overall survival was affected by thrombosis. Results The analyzed cohort consisted of 335 newly diagnosed AML patients diagnosed and treated between 2007 through 2021 at the Sheba Medical Center. Median patient age at diagnosis was 55 years. At the time of data analysis 162 patients were alive (48%). Two hundred and eighty-three patients were classified as de novo AML (85%) and the remainder were categorized as secondary disease (15%). Ninety patients harbored the FLT3-ITD mutation (28%) and 117 patients harbored NPM1 mutations (39%). Of evaluable patients, 7 were found to have biallelic CEBPA mutations (8%). In terms of MRC cytogenetic risk, 35 patients (11%) were classified as favorable risk, 219 (66%) patients as intermediate risk, 58 patients (17%) as adverse risk and 21 patients had technically insufficient cytogenetic studies. Using the ELN 2017 risk stratification model, 132 patients (40%) had favorable risk disease, 122 patients (36%) intermediate risk, and 80 patients (24%) adverse risk disease. Venous thrombosis was seen in 33 patients (9.9%) with 28 patients diagnosed with central catheter related thrombosis and 5 patients with lower extremity deep vein thrombosis. In 23 patients (70%) thrombosis occurred during the initial induction chemotherapy phase, in 5 patients (15%) during the first consolidation treatment phase, in 3 patients (9%) during the second consolidation treatment phase, and in 2 patients (6%) during admission for salvage chemotherapy. Following diagnosis of thrombosis, the central catheter was taken out in 9 patients (28%), and 3 patients (8.8%) experienced a recurrence of thrombosis. At the time of thrombosis diagnosis, 14 patients (42%) were found to have a concurrent blood stream bacterial infection. Nineteen patients (58%) were started on anticoagulation following the diagnosis of thrombosis. In univariate analysis, patient age, initial levels of white blood cells, hemoglobin, platelets, creatinine, uric acid, lactate dehydrogenase, INR, albumin, and liver function tests were not significantly different between patients who developed thrombosis and those who did not. Disease type (de novo versus secondary), FLT3-ITD and NPM1 mutational status, achievement of remission, and ELN 2017 risk category also not did not differ to a significant degree between groups. However, MRC intermediate risk group patients were significantly more likely to experience thrombosis compared to favorable risk and adverse risk patients (12.8% versus 5.7% and 1.7%, respectively; p=0.049). Overall survival was not significantly impacted by the diagnosis of thrombosis with an estimated median overall survival of 3.7 years seen in patients without thrombosis compared with 2.2 years in patients with thrombosis (p=0.47). Leukemia-free survival was also comparable between groups (2.4 years versus 1 year; p=0.15). Conclusion Venous thrombosis is seen mostly during the initial induction phase of AML patients receiving intensive therapy with a tight association with the MRC intermediate risk category, however long-term survival and leukemia related outcomes are not significantly impacted by the diagnosis of thrombosis.

Point of care testing to monitor INR control in patients with antiphospholipid syndrome.

Patients with antiphospholipid syndrome (APS) typically require lifelong warfarin anticoagulation following a thrombotic event due to a significant risk of recurrent thrombosis. Point of care testing (POCT) to monitor INR is discouraged in patients with APS as interactions between antiphospholipid antibodies and thromboplastin used for INR testing may influence results. Review of INR testing in 36 APS patients showed 87.2% of paired POCT and venous INRs (n = 94) having acceptable variation (≤0.5 difference), and high correlation (r = 0.9) excluding INRs ≥4.8. Six‐month TTR was comparable for APS patients using POCT (57.1% ± 24.8%) to those using venous INR monitoring (59.2% ± 23.2%) (p = 0.66). These results support POCT management of APS but requires further study.

Bleeding risk of intramuscular injection of COVID‐19 vaccines in adult patients with therapeutic anticoagulation

Bleeding risk of intramuscular injection of COVID‐19 vaccines in adult patients with therapeutic anticoagulation

Online KidClot education for patients and families initiating warfarin therapy: The eKITE study

Anticoagulation with Vitamin K antagonists (VKA) has always posed challenges in terms of monitoring requirements. These challenges were further exacerbated in the setting of the COVID-19 pandemic, with limited access to and/or avoidance of laboratory testing. The importance of utilizing point of care (POC) health technology for individualized patient management is salient. The foundation of effective home INR monitoring is establishing patient knowledge about their therapy and INR testing proficiency. The eKITE series was developed to support patients in establishing foundational knowledge required for VKA (warfarin) management and INR monitoring. The primary objectives were to evaluate eKITE, a patient-oriented innovative online education program for warfarin therapy, participant learning stress, and patient preference for online learning. This multi-center prospective study provided patients access to warfarin online education. Participants were required to complete written quizzes assessing warfarin knowledge of key concepts proficiency and identifying knowledge deficits. Patient preference, evaluating calm (lack of anxiety) while learning, and an INR on a home meter was completed. Participants performed INR tests at home and reported INRs by telephone. The analysis included 144 children and caregivers enrolled at five US and CDN sites. Most indications for anticoagulation were cardiac (congenital or acquired heart disease) with varied INR target ranges. Mean knowledge scores for warfarin and INR self-testing modules were 97%, with low anxiety with TTR of 84%. Patient preferred online learning. eKITE is an effective teaching modality for warfarin/home INR monitoring with safe INR testing and warfarin management that is appropriate for pediatrics and adults alike. PrologueThe whir in the hallways is deafening. Lights bright, alarms are ringing in a chorus of unsynchronized beeps and screeches. It has been more than a week since I have slept. Snuggled beside me is my precious child, whining and equally irritated with the asynchronous symphony, further compounded by anxiety, procedures, and pain. The sun has broken.The staff smiles are welcoming and incessant, as one after one, they approach hurried, urgent, assiduous, their need to coach me for our upcoming departure to the warmth of home. Each provides essential information that I will require to keep my child, my treasure, safe and healthy. Yet, my eyes are heavy, blurred, and my brain foggy, trapped in a dark heavy cloud. How am I to follow? Comprehend? and retain anything? As they instruct, my precious child yearns for loving arms, compassion and love, whining, crying in disquiet. Overwhelmed does not adequately describe my ineffable exhaustion. Amidst this, how am I to learn about warfarin? Such a challenging medication, with so much to know. Concentrate, I tell myself, focus; now is my only opportunity to learn. I must be alert. It seems to be nonsensical.

Challenges of Anticoagulation Management Service and Need of Establishing Pharmacist-Led Anticoagulation Clinic in Tertiary Care Teaching Hospital, Ethiopia: A Qualitative Study.

PuposeTo explore the challenges of anticoagulation management (AMS) and assess the need for establishing a pharmacist-led anticoagulation clinic (PLAC) at Tikur Anbessa Specialized Hospital (TASH) in Addis Ababa, Ethiopia.MethodsWe conducted a qualitative study at TASH. Using a semistructured interview guide, we interviewed 15 physicians from different specialties, heads of pharmacy and laboratory departments. We also included 20 patients to explore their general perceptions, and experiences with and challenges of AMS; and the need to implement PLAC in the hospital.ResultsOnly three physicians responded that they had protocols for initiating and maintaining warfarin dosing. Having protocols for venous thromboembolism (VTE) risk assessment, VTE prophylaxis and treatment, bleeding risk assessment, and contraindication to anticoagulant therapy were reported by seven, six, four, and three participants, respectively. Lack of trained healthcare professionals and a separate AMS clinic, inconsistency in INR testing and anticoagulant availability, and longer appointment times were the biggest challenges of the existing AMS, according to 80% of respondents. Fourteen patient respondents indicated that their satisfaction with the AMS was affected by long wait times and inconsistent availability of anticoagulants and INR testing. The head of the laboratory stated that the facilities for INR testing are inadequate and affect the quality of AMS and customer satisfaction, and supplemented by the head of the pharmacy by adding irregularities of supplies and inadequate counseling on anticoagulants. Respondents suggested that there is a need to establish a PLAC with well-adopted standard operating procedures, qualified manpower, adequate training of assigned staff, and sustained supply of anticoagulants and INR testing.ConclusionThe hospital’s AMS is not optimal to provide adequate services during the study period. Based on these findings and recommendations, the supporting literature, and the experiences of other facilities, the PLAC was established in TASH.

Novel INR testing concept ensures continuum of care

A drive-through point-of-care international normalized ratio (INR) testing model in a rural community during the pandemic promoted patient engagement and achieved maintenance of INR time in therapeutic range (TTR) above the benchmark for anticoagulation management, according to recent data published in the January 2022 issue of the American Journal of Health-System Pharmacy. As Courtney Farrell, MD, explains, outpatient clinics started to close in March 2020 and patients were afraid to go to labs to get their INR tested. “We needed to develop a novel care model to ensure we maintained appropriate access to care for our patients,” said Farrell, who is medical director for the Centralized Anticoagulation Clinic for Dartmouth-Hitchcock Medical Center in Lebanon, NH, where the clinic model is based. “This drive-through INR testing option allowed our patients to feel safe getting their INR tested, helped maintain compliance with testing appointments, and the overall feedback was extremely positive, with patients loving this alternative testing option and wanting us to continue to offer this service.” Clinicians, including pharmacists, at the Centralized Anticoagulation Clinic at Dartmouth-Hitchcock Medical Center, which serves a rural population, noticed that the stay-at-home orders issued early on in the COVID-19 pandemic resulted in a decline in patient INR testing. Seeing the need to maintain routine INR testing, especially for those who were high-risk or were not maintained on a stable dose of warfarin, a drive-through point-of-care INR testing site opened within 5 days following issuance of the order. The service was available from April 1, 2020, to May 15, 2020, and clinicians saw patients 4 days a week, with a total of 15 patients coming through the testing site each day. Patients were offered a 5-minute slot for their testing appointment. The staff completed 168 drive-through patient appointments in April and 84 in May. The availability of this service allowed the clinic to maintain stability in patient care, and the outcomes were positive. The TTR was 68% to 70% prior to the pandemic, and in April 2020, it remained stable at 70%. The TTR dropped slightly in May to 68% but rebounded in June to 71%. When considering developing a novel testing model such as this, Farrell noted that leadership buy-in and support up-front is essential. The space and location to run such a clinic also needs to be well thought out. Farrell said their clinic parking lot got extremely busy, and this model may be challenging to implement if space is a limitation—as it might be in an urban area. The local weather is also a factor to consider, as CoaguChek monitors need to be operated in a temperature range of 59 °F to 90 °F. Since the outdoor temperature in New Hampshire during April was 40 °F, monitors were rotated and only outdoors for no more than 3 to 5 minutes at a time. A modified medical supply cart was also used to help protect equipment and supplies from the outdoor elements. Additionally, staff was needed to run the drive-through testing and to follow up with phone consultations later in the day to discuss any warfarin dosage modifications. Another consideration is billing, as clinicians may be losing billable office visits to the drive-through visits. However, the drive-through visits could be billed as a telephone visit. Pharmacists are not currently considered billable providers and there may be a loss of revenue depending on the staff in the anticoagulation clinic. “This model can be applied even more broadly in the future as it appeals to a broad set of patients because of its ease of use,” said Farrell. “A drive-through clinic model offers additional opportunities for access to care for patients who have mobility disabilities and for many who appreciate the convenience. We need to think beyond the confines of a traditional clinic model.”

Effect of Ayurveda Management on Liver Cirrhosis with Ascites-A Retrospective Cohort Study

Liver cirrhosis with ascites is a challenging medical condition. Ayurveda Clinical experiences suggest of a favourable role but lacks evidence. In a Retrospective cohort study, hospital records of patients with liver cirrhosis and ascites diagnosed though medical ultrasonography, treated at in patient division, department of Kayachikitsa, Medical Research Facility of KLE Ayurveda Hospital Belagavi were screened. Records with Nityavirechana procedure, minimum of 7 days of admission, proper documentation and meeting the other inclusion and exclusion criteria were selected for the study. Assessment were abdominal girth measurements at umbilicus, Xiphisternum to umbilicus measurement, Umbilicus to pubic symphysis measurement, weight, clinical global impression (CGI) scales (Severity, improvement and efficacy index), hemoglobin, liver function tests, Prothrombin time, INR and renal function tests. Fifty five case records met the methodological criteria of the study. Patients were suffering from stage 3, decompensated cirrhosis and Child-Turcotte-Pugh Score was in class C. Analysis of 15 days of interventions was carried out. Assessments were carried out at base line, 7th, 9th, 11th and 15th day of treatment. Interventions included nitya virechana, oral medicaments, diet, salt and fluid restrictions. Ayurveda interventions resulted in significant improvement (p<0.001) at all time points in various parameters of abdominal measurements, weight, CGI scales, hemoglobin, liver function tests, prothrombin time, INR and renal function tests. Study showed complex Ayurveda interventions through nitya virechana, oral medications, diet, fluid and salt restrictions improve the clinical profile, liver function, renal function, prothrombin time, INR parameters in patients of ascites with decompensated cirrhosis and warrants further studies.

Warfarin Compliance after Mechanical AVR in the Pediatric Population: Case Series from a Developing Country

Background and Aim: Mechanical prosthetic heart valves exert a lifelong thromboembolic complication requiring continuous antithrombotic therapy. Vitamin K antagonist is the recommended therapy of choice along with meticulous INR monitoring to achieve and maintain an INR of 2.0 - 3.0. The study aimed to assess the compliance of anticoagulant therapy in pediatric patients after AVR and to highlight the challenges faced during follow-ups. Methods: A retrospective study was conducted at NICVD Hospital in Karachi, Pakistan for a time frame of 2 years from 2020-2021 where 7 patients were selected. Data were collected using hospital medical records and then validated through a phone call mediated structured questionnaire-based interview. Results: 2 out of 7 patients in the case series were compliant to regular follow-ups and had their INR in the desired range owing to their higher education status and access to INR clinic for regular follow-up in urban setting. Younger patients in the case series were non-compliant. 4 out of 7 patients who were on dual anti-coagulant regimens including warfarin and aspirin were either closer or within the range than compared to those on single drug regimen. Conclusion: Compliance was observed in patients who had favorable demographics and higher education. Multiple recent trials including PROACT and PROACT XA are underway to develop novel treatment options apart from warfarin after mechanical aortic valve replacement. Home-based INR testing kits provide easy access to regular testing in remote areas. Multi-center studies are required for in-depth analysis regarding reasons of non-compliance in pediatric population.