Correction of Warfarin Coagulopathy for Non-bleeding Patients in the Outpatient Setting at an Ambulatory Care Organization: Application of Vitamin K Guidance.

BACKGROUND: Warfarin is an effective anticoagulant but requires close International Normalized Ratio (INR) monitoring and may occasionally require correction of excessive anticoagulation. Current guidelines provide limited practical guidance on the administration of vitamin K for the management of supratherapeutic INR levels ≥ 5.0 in non-bleeding outpatients. OBJECTIVE: Based on expert consensus and guidelines, the Atrius Health Anticoagulation Management Services (AMS) has developed internal guidance for oral vitamin K use in highly selected populations. This study will describe the internal guidance for oral vitamin K use and present associated results and clinical outcomes. METHODS: Episodes with INR > 5.0 were included, with vitamin K considered for episodes with INR ≥ 6. Moreover, compelling indications and exclusions to select ideal patients for vitamin K intervention were also defined. RESULTS: Overall, episodes were managed conservatively; of the 246 collected episodes of excessive anticoagulation, in 18 episodes (7%), patients received vitamin K, and in 228 (93%) episodes, patients did not receive vitamin K. The mean index INR was 6.0 (range 5.0 - 10.5, SD 1.07), with nearly 57% of episodes achieving INR correction and 15% of episodes developing INR overcorrection. High thrombotic risk patients, regardless of hemorrhagic risk, were less likely to receive vitamin K. Three episodes (1.2%) resulted in bleeding complications. No thrombotic complications occurred during the 30-day follow-up of the index INR value ≥ 5.0. CONCLUSION: Our internal guidance is a novel, standardized approach that serves as a decision support tool for the management of warfarin-associated coagulopathy and vitamin K intervention using patient-specific characteristics and index INR values. This guidance may assist other anticoagulation management services with practical applications and require validation in a prospective clinical trial.

Perioperative management of venous recanalization in a patient with inherited antithrombin deficiency: case report.

Background: Inherited antithrombin (AT) deficiency (ATD) is a severe thrombophilia causing venous thromboembolism, which can be complicated by postthrombotic syndrome (PTS). Venous recanalization, used to treat PTS, often requires a temporary withdrawal of anticoagulant therapy. In ATD patients, there is a risk of insufficient perioperative anticoagulation due to altered heparin response. Key Clinical Question: There is no consensus on how to manage perioperative anticoagulation in ATD patients. Clinical Approach: Warfarin-unfractionated heparin transition could be a more reliable strategy than low-molecular-weight heparin transition because unfractionated heparin anti-Xa activity not only reflects heparin-bound AT but also AT's activity, which correlates strongly with therapeutic anticoagulation. Biological monitoring could thus decrease the number of plasma-derived AT supplementation. Conclusion: This study describes a successful perioperative management of anticoagulation for venous recanalization that could be suggested to type 1 ATD patients with PTS.

Assessment of Population-Based Approach to Direct Oral Anticoagulant Management.

Background: As preferences for oral anticoagulation shift from warfarin to direct oral anticoagulants (DOACs), a new care management model is needed. A population approach leveraging a DOAC Dashboard was implemented to track all patients on a DOAC followed by a physician at an academic medical center. The DOAC Dashboard is a real-time report within the electronic health record (EHR) that identifies patients who require evaluation for DOAC dose/therapy adjustment due to changing renal function, age, weight, indication, and/or significant drug-drug interaction (DDI). Objective: This study aims to describe the initial phase of DOAC Dashboard implementation, to evaluate the effectiveness of interventions, and to assess a multidisciplinary approach to management. Method: Retrospective descriptive study of the DOAC Dashboard from August 22, 2019, to January 20, 2022. Primary outcomes include total number of alerts addressed and interventions needed. Secondary outcome is the proportion of interventions implemented by the prescribing clinician. Result: A total of 10 912 patients were identified by the DOAC Dashboard at baseline. A total of 5038 alerts were identified, with 668 critical alerts, 3337 possible critical alerts, and 1033 other alerts. Pharmacists addressed 1796 alerts during the study period (762 critical alerts and 1034 possible critical). Critical alerts included 62 significant DDI, 379 inappropriate dosing, and 321 others. Of the critical alerts, intervention was needed in 291 cases (38%), with 255 (88%) of proposed interventions implemented. Critical alerts and possible critical alerts not requiring intervention were resolved by data entry. Conclusion: The DOAC Dashboard provides an efficient method of identifying patients on DOACs that require dose adjustments or therapeutic modifications.

Application of eHealth Tools in Anticoagulation Management After Cardiac Valve Replacement: Scoping Review Coupled With Bibliometric Analysis.

BACKGROUND: Anticoagulation management can effectively prevent complications in patients undergoing cardiac valve replacement (CVR). The emergence of eHealth tools provides new prospects for the management of long-term anticoagulants. However, there is no comprehensive summary of the application of eHealth tools in anticoagulation management after CVR. OBJECTIVE: Our objective is to clarify the current state, trends, benefits, and challenges of using eHealth tools in the anticoagulation management of patients after CVR and provide future directions and recommendations for development in this field. METHODS: This scoping review follows the 5-step framework developed by Arksey and O'Malley. We searched 5 databases such as PubMed, MEDLINE, Web of Science, CINAHL, and Embase using keywords such as "eHealth," "anticoagulation," and "valve replacement." We included papers on the practical application of eHealth tools and excluded papers describing the underlying mechanisms for developing eHealth tools. The search time ranged from the database inception to March 1, 2023. The study findings were reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). Additionally, VOSviewer (version 1.6.18) was used to construct visualization maps of countries, institutions, authors, and keywords to investigate the internal relations of included literature and to explore research hotspots and frontiers. RESULTS: This study included 25 studies that fulfilled the criteria. There were 27,050 participants in total, with the sample size of the included studies ranging from 49 to 13,219. The eHealth tools mainly include computer-based support systems, electronic health records, telemedicine platforms, and mobile apps. Compared to traditional anticoagulation management, eHealth tools can improve time in therapeutic range and life satisfaction. However, there is no significant impact observed in terms of economic benefits and anticoagulation-related complications. Bibliometric analysis suggests the potential for increased collaboration and opportunities among countries and academic institutions. Italy had the widest cooperative relationships. Machine learning and artificial intelligence are the popular research directions in anticoagulation management. CONCLUSIONS: eHealth tools exhibit promise for clinical applications in anticoagulation management after CVR, with the potential to enhance postoperative rehabilitation. Further high-quality research is needed to explore the economic benefits of eHealth tools in long-term anticoagulant therapy and the potential to reduce the occurrence of adverse events.

Case-control analysis of venous thromboembolism risk in non-alcoholic steatohepatitis diagnosed by transient elastography.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. Studies have shown a strong association between non-alcoholic steatohepatitis (NASH) cirrhosis and portal vein thrombosis. Specifically, there is paucity of data on the association of NASH and venous thromboembolism (VTE), with one such study predicting a 2.5-fold increased risk for VTE compared to other liver diseases in hospitalized patients. The mechanism is believed to be a hepatocellular injury, which causes a chronic inflammatory state leading to the unregulated activation of procoagulant factors. There has been no prior analysis of the degree of steatosis and fibrosis (measured using transient elastography, commonly known as FibroScan) in NASH and its association with VTE. AIM: To examine the association between the degree of hepatic steatosis and fibrosis, quantified by transient elastography, and the incidence of VTE in patients with NASH. METHODS: In our case-control study, we included patients with a documented diagnosis of NASH. We excluded patients with inherited thrombophilia, hemoglobinopathy, malignancy, alcohol use disorder, autoimmune hepatitis, and primary biliary cirrhosis. The collected data included age, demographics, tobacco use, recreational drug use, medical history, and vibration controlled transient elastography scores. VTE-specific data included the location, type of anticoagulant, need for hospital stay, and history of VTE recurrence. Steatosis was categorized as S0-S1 (mild) and S2-S3 (moderate to severe) based on the controlled attenuation parameter score. Fibrosis was classified based on the kilopascal score and graded as F0-F1 (Metavir stage), F2, F3, and F4 (cirrhosis). χ2 and Mann-Whitney U tests were used for the qualitative and quantitative variable analyses, respectively. Furthermore, we performed a logistic regression using VTE as the dependent variable. RESULTS: A total of 415 patients were analyzed, and 386 met the inclusion criteria. 51 and 335 patients were included in the VTE and non-VTE groups, respectively. Patients with VTE had a mean age of 60.63 years compared to 55.22 years in the non-VTE group (P < 0.014). Patients with VTE had a higher body mass index (31.14 kg/m² vs 29.30 kg/m²) and a higher prevalence of diabetes mellitus (29.4% vs 13.1%). The history of NASH was significantly higher in the VTE group (45.1% vs 30.4%, P < 0.037). Furthermore, moderate-to-severe steatosis was significantly higher in the VTE group (66.7% vs 47.2%, P < 0.009). Similarly, the F2-F4 fibrosis grade had a prevalence of 58.8% in the VTE group compared to 38.5% in the non-VTE group (P < 0.006). On logistic regression, using VTE as a dependent variable, diabetes mellitus had an odds ratio (OR) =1.702 (P < 0.015), and F2-F4 fibrosis grade had an OR = 1.5 (P < 0.033). CONCLUSION: Our analysis shows that NASH is an independent risk factor for VTE, especially deep vein thrombosis. There was a statistically significant association between the incidence of VTE, moderate-to-severe steatosis, and fibrosis. All hospitalized patients should be considered for medical thromboprophylaxis, particularly those with NASH.

Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless Pacemaker Implantation.

INTRODUCTION: Data on peri-operative management of direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations remain limited. This study aimed to evaluate a standardized DOAC management regime consisting of interruption of a single dose prior to implantation and reinitiation within 6-24 h; also, patient clinical characteristics associated with this approach were identified. METHOD: Consecutive patients undergoing standard TPS implantation procedures from two Swiss tertiary centers were included. DOAC peri-operative management included the standardized approach (Group 1A) or other approaches (Group 1B). RESULTS: Three hundred and ninety-two pts (mean age 81.4 ± 7.3 years, 66.3% male, left ventricular ejection fraction 55.5 ± 9.6%) underwent TPS implantation. Two hundred and eighty-two pts (71.9%) were under anticoagulation therapy; 192 pts were treated with DOAC; 90 pts were under vitamin-K antagonist. Patients treated with DOAC less often had structural heart disease, diabetes mellitus, and advanced renal failure. The rate of major peri-procedural complications did not differ between groups 1A (n = 115) and 1B (n = 77) (2.6% and 3.8%, p = 0.685). Compared to 1B, 1A patients were implanted with TPS for slow ventricular rate atrial fibrillation (AF) (p = 0.002), in a better overall clinical status, and implanted electively (<0.001). CONCLUSIONS: Standardized peri-procedural DOAC management was more often implemented for elective TPS procedures and did not seem to increase bleeding or thromboembolic adverse events.

Long term follow-up of a multicentre cohort of COVID-19 patients with pulmonary embolism: Anticoagulation management and outcomes.

BACKGROUND AND AIMS: Pulmonary embolism (PE) is a frequent complication in COVID19 hospitalized patients. Inflammatory storm and endothelial dysfunction due to the virus seem to be the two major risk factors for PE. Consequently, PE related to COVID19 could be consider as triggered by a transient inflammatory acute phase and treated for no longer than 3 months. However, few data are available on management of anticoagulation and risk of venous thromboembolic (VTE) recurrences in these patients and guidelines are still undefined. Aim of the present study is to evaluate the long-term follow-up of a cohort of covid-19 patients with PE. METHODS: We conducted a retrospective multicenter study in four Italian hospitals between March 1st, 2020, and May 31st, 2021 in patients who experienced a PE during hospitalization for a COVID-19 pneumonia, excluding patients who died during hospitalization. Baseline characteristics were collected and patients were grouped according to duration of anticoagulant treatment (< 3 months or > 3 months). The primary outcome was incidence of VTE recurrence while secondary outcome was the composite of deaths, major hemorrhages and VTE recurrence during follow-up. RESULTS: 106 patients with PE were discharged, of these 95 (89.6 %) had follow up longer than 3 months (seven patients were lost to follow up and four died within three months). The median follow-up was 13 months (IQR 1-19). Overall, 23 % of subjects (22/95) were treated for 3 months or less and 76.8 % (73/95) received anticoagulation for >3 months. Of patients in the short treatment group, 4.5 % died, compared with 5.5 % of those in the longer treatment group (p = NS); no difference was shown in risk of VTE recurrence (0 % vs 4.1 %, p = NS), major bleeding (4.5 % vs 4.1 %, p = NS) or in composite outcome (9.1 % vs 11 %, p = NS). No difference was found between the two treatment groups for composite outcome using the Kaplan-Meier analysis (Log Rank Test p = 0.387). CONCLUSION: In our retrospective multi-center cohort, prolongation of duration of anticoagulation seems not to affect risk of VTE recurrences, deaths and bleeding after a PE related to COVID-19.

The Impact of Clinical Pharmacy Services on Direct Oral Anticoagulant Medication Selection and Dosing in the Ambulatory Care Setting.

Background: Off-label dosing of direct oral anticoagulants (DOACs) is both common and associated with adverse patient outcomes. Evidence describing best practices to support optimal direct oral anticoagulant (DOAC) dosing is limited. Objective: To describe the impact of clinical pharmacist intervention on DOAC prescribing. Methods: This retrospective study was a descriptive analysis conducted within an integrated healthcare system with a centralized, pharmacist-led Anticoagulation Management Service (AMS). Patients prescribed a DOAC between January 1, 2020 and December 31, 2020 were included. Pharmacy dispensing reports were generated for pharmacist review and anticoagulant drug therapy changes were recommended to physicians where appropriate. The primary objective was to describe the number and type of recommendations made. Secondary objectives were to determine the provider acceptance rate based on the intervention type and on clinical vs formulary recommendations. Results: Clinical pharmacists made 147 recommendations for 2331 unique patients included in the analysis. Twenty-three recommendations (16%) were to decrease the dose, 46 (31%) were to increase the dose, 14 (10%) were to change the medication due to clinical scenario, 62 (42%) were to change the medication due to cost, and 2 (1%) were another issue. One hundred twenty-three (84%) recommendations were accepted. The provider acceptance rate was similar for clinical and formulary recommendations (85% and 82% respectively). Conclusion: Implementation of report-driven clinical pharmacist intervention led to an improvement in appropriate DOAC medication selection and dosing.

A scoping review of direct oral anticoagulant ambulatory management practices.

Models of care for managing direct oral anticoagulant (DOAC) therapy are evolving. Little is known of what services are provided by anticoagulation managements services (AMS) for DOACs, or what necessitates comprehensive DOAC management and what differentiates it from usual care. The purpose of this scoping review was to describe services, management, or monitoring of DOACs distinct from prescriber-managed or usual care of DOACs. This scoping review reported followed the 2018 Preferred Reporting Items for Systematic Review and Meta-Analyses extension for scoping reviews (PRISMA-ScR). We searched PubMed, CINAHL, and EMBASE from inception to November 2020 to identify articles of interest. No language restriction was applied. Articles were included if they provided a description of DOAC management services, and described longitudinal anticoagulation follow-up that occurred in ambulatory care, community, or outpatient-related settings. Data was extracted from a total of 23 articles. The specific types of DOAC management interventions provided varied across the included studies. Nearly all studies described some form of DOAC therapy appropriateness assessment. Other common interventions included assessments of DOAC therapy compliance, adverse event triage and management, assessment of DOAC dosing appropriateness, periprocedural management of DOAC therapy, educational interventions, and renal function monitoring. A variety of DOAC management interventions were identified, but additional studies are needed to help health systems decide whether specific interventions performed by dedicated services are preferred over the usual care provided by clinicians prescribing DOAC therapy.

Anticoagulation management in elderly patients with proximal femur fractures - overview of current concepts.

Objectives: Proximal femur fractures (PFF) are common injuries in elderly patients and can have considerable effects on their quality of life, morbidity, and mortality. Due to pre-existing comorbidities, the prevalence of anticoagulated patients is increasing. The right timing for surgery and perioperative anticoagulation treatment remains controversial. Content: This overview aims to summarize current practices in the pre- and postoperative anticoagulation management and the recommended time to surgery in elderly patients with PFF. Summary and Outlook: Time to surgery for anticoagulated patients is often prolonged due to worries about serious perioperative bleeding and higher transfusion demands. But the delay of surgical PFF treatment increases the risk for perioperative complications like pulmonary embolism, pneumonia, deep vein thrombosis and urinary tract infections. Early surgery can be achieved with a consistent and interdisciplinary perioperative anticoagulation management. Antiplatelets do not have to be discontinued and surgery should be performed early without delay. For patients taking vitamin K antagonists (VKA) an INR less than 1.5 is recommended prior to surgery, which can be achieved by pausing VKA intake or by administering vitamin K, prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). For the treatment with direct oral anticoagulants (DOAC) a plasma drug level of under 50 pg/mL is considered safe for surgery. If the plasma level can not be determined, a gap of 24 h between the last DOAC dose and surgery is recommended. The systemic administration of tranexamic acid can reduce overall blood loss and transfusion rates in anticoagulated patients with PFF. Surgical treatment of PFF should be performed within 24 h, as delayed surgery increases the risk for perioperative complications. This also applies to anticoagulated patients, when clinically appropriate. International and interdisciplinary guidelines are necessary to ensure early and appropriate treatment of anticoagulated elderly patients with PFF.

Rivaroxaban in heart failure patients with left ventricular thrombus: A retrospective study.

Background: The role of rivaroxaban in patients with heart failure (HF) combined with left ventricular (LV) thrombus remains unknown in current guideline-directed anticoagulant therapy. The aim of this study was to investigate the impact on clinical outcomes of rivaroxaban compared to vitamin K antagonists (VKAs) in patients with HF combined with LV thrombus. Methods: We retrospectively extracted clinical, echocardiographic and follow-up data of HF patients (all classifications) admitted at China-Japan Union Hospital of Jilin University from January 2017 to June 2021. A total of 198 patients with HF were identified with LV thrombus by echocardiography, 78 of them were managed with VKAs, 109 with rivaroxaban. Results: The median follow-up was 17.0 months (interquartile range: 6.0-24.0 months). High rates of major cardiovascular adverse events (MACEs) were observed in both the rivaroxaban and VKAs groups (49.5% vs. 57.7%). However, rivaroxaban versus VKAs observed a decrease in MACEs (adjusted HR:0.636; 95%CI:0.418-0.970; p = 0.035) and systemic embolism (4.6% vs. 12.8%; adjusted HR:0.318; 95%CI:0.108-0.933; p = 0.037; Gray's test p = 0.041) but was not found to have a benefit with regard to LV thrombus resolution (59.6% vs. 70.6%; adjusted HR: 1.303; 95% CI:0.898-1.890; p = 0.163; Gray's test p = 0.073). Additionally, there was no significant between-group difference in the rate of International Society on Thrombosis and Hemostasis (ISTH) bleeding events. Conclusion: Our data found that in populations with HF combined with LV thrombus, the overall prognosis in both the rivaroxaban and VKAs groups was catastrophic. Although rivaroxaban improved the prognosis to some extent, a considerable need remains for new treatments to improve their clinical course.

Hemostasis in neonatal ECMO.

Extracorporeal membrane oxygenation (ECMO) is a life-saving support for cardio-respiratory function. Over the last 50 years, the extracorporeal field has faced huge technological progress. However, despite the improvements in technique and materials, coagulation problems are still the main contributor to morbidity and mortality of ECMO patients. Indeed, the incidence and survival rates of the main hemorrhagic and thrombotic complications in neonatal respiratory ECMO are relevant. The main culprit is related to the intrinsic nature of ECMO: the contact phase activation. The exposure of the human blood to the non-endothelial surface triggers a systemic inflammatory response syndrome, which chronically activates the thrombin generation and ultimately leads to coagulative derangements. Pre-existing illness-related hemostatic dysfunction and the peculiarity of the neonatal clotting balance further complicate the picture. Systemic anticoagulation is the management's mainstay, aiming to prevent thrombosis within the circuit and bleeding complications in the patient. Although other agents (i.e., direct thrombin inhibitors) have been recently introduced, unfractionated heparin (UFH) is the standard of care worldwide. Currently, there are multiple tests exploring ECMO-induced coagulopathy. A combination of the parameters mentioned above and the evaluation of the patient's underlying clinical context should be used to provide a goal-directed antithrombotic strategy. However, the ideal algorithm for monitoring anticoagulation is currently unknown, resulting in a large inter-institutional diagnostic variability. In this review, we face the features of the available monitoring tests and approaches, mainly focusing on the role of point-of-care (POC) viscoelastic assays in neonatal ECMO. Current gaps in knowledge and areas that warrant further study will also be addressed.

Challenging clinical scenarios for therapeutic anticoagulation: A practical approach.

Therapeutic anticoagulation remains a fundamental backbone in the treatment and prevention of venous thromboembolism. However, while modern therapies are increasingly safe, anticoagulation is not without risks, particularly in those at high risk for or with recent bleeding. When weighing concurrent risks and benefits in each challenging clinical scenario, an individualized assessment of the risk and acuity of bleeding should be balanced by the indication for anticoagulation. Addressing modifiable risk factors and routine re-evaluation of any changes in this balance is critical. This review outlines available data and current guidelines for the management of anticoagulation in high-risk populations, including those with thrombocytopenia, elderly and high-fall risk, inherited bleeding disorders, and in acute coronary syndrome. We also examine management after clinically significant bleeding episodes, including intracranial hemorrhage, gastrointestinal bleeding, hemoptysis, retroperitoneal bleeding, hematuria, and abnormal uterine bleeding. The aim is to provide a comprehensive review of available literature to guide clinicians in providing optimal, safe, and individualized care for patients in these challenging scenarios.

Adherence to Antithrombotic Therapy for Patients Attending a Multidisciplinary Thrombosis Service in Canada - A Cross-Sectional Survey.

Background: Poor medication adherence puts patients who require antithrombotic therapy at greater risk of complications. We started a multidisciplinary Adult Outpatient Thrombosis Service in 2017 in a Canadian health authority and were interested in the level of medication adherence in the population attending. AimS: The aim of this study is to assess adherence to antithrombotic medications for patients attending a multidisciplinary Thrombosis Service. Methods: We conducted a cross-sectional survey of outpatients seen at the Thrombosis Service between 2017 and 2019 using the 12-item validated Adherence to Refills and Medications Scale (ARMS) to assess adherence to antithrombotic (anticoagulants and antiplatelet) therapy. Linear regression analysis examined the factors associated with adherence to antithrombotic therapy. Results: Of 1058 eligible patients, 53.2% responded to the survey. Seventeen were excluded from the analysis for missing more than 6 responses to the 12 items on the ARMS. About 55% (n = 297) were on direct oral anticoagulants (DOACs), 19% (n = 102) on warfarin, 5.0% (n = 27) on low molecular weight heparin, 3.3% (n = 18) on antiplatelet therapy and 18% (n = 96) were no longer on antithrombotic therapy. Nearly half (47%, n = 253) had taken antithrombotic therapy for 1-5 years while 28% (n = 150) and 25% (n = 137) had taken antithrombotic treatments for <1 and >5 years, respectively. Most patients (87%, n = 475) were ≥50 years and half (51%, n = 277) were male. The mean adherence score was 13.9 (SD±2.2) and 88% (n = 481) of participants were adherent to antithrombotic treatment (ARMS = 12-16). Multivariable linear regression showed that patients with post-graduate education had 0.4% lower adherence to antithrombotic therapy as compared with elementary education (ß = 0.0039, p = 0.048). Patients with prior antithrombotic agent use >5 years had 0.5% lower adherence to antithrombotic treatment compared to patients with <1 year (ß = 0.0047, p = 0.0244). Conclusion: Self-reported adherence to antithrombotic therapy was high (88%) within a multidisciplinary Thrombosis Service. Patients with advanced education and prolong duration of antithrombotic therapy were more likely to have lower self-reported adherence to antithrombotic treatment.

Anticoagulation Strategies in Pediatric Cardiopulmonary Bypass, Weight-Based vs. Concentration-Based Approaches.

Pediatric patients undergoing cardiopulmonary bypass (CPB) require adequate anticoagulation to combat hemostatic activation. Heparin is used to bind and catalyze antithrombin III (ATIII) that works to inhibit clot formation. To dose heparin, a weight-based (WB) or patient-specific concentration-based (PSCB) method can be used. The WB protocol calculates the dose based on the patients' weight and uses an activated clotting time (ACT) test to ensure anticoagulation. The ACT has limitations during CPB especially for pediatric patients who have immature hemostatic systems. The PSCB method predicts the patients' response to heparin by projecting a heparin dose-response (HDR) curve. Some investigators have found benefit to using the PSCB method but further investigation into how well the HDR predicts the heparin response is needed. A literature review was conducted for studies that looked at heparin management strategies in pediatric CPB patients between 1992 and 2020. Articles that focused on pediatric physiology, heparin management strategies, and anticoagulation were included. Articles older than 1990 were excluded. The literature review highlights that utilizing the PSCB approach more adequately anticoagulated patients. The WB protocol was found to have several flaws due to its reliance on the ACT, especially in infants. The results show that further investigation is needed to understand why there is benefit to using the PSCB approach. Observing the association between the HDR curve and subsequent heparin concentrations could determine how accurately it predicts the patients' response to heparin and why there is benefit to using this method.

Improvement in the Management of Oral Anticoagulation in Patients with Atrial Fibrillation in Primary Health Care.

(1) Background: Evaluation and improvement of the management of patients with atrial fibrillation in treatment with oral anticoagulants from primary health care. (2) Methods: prospective quasi-experimental study, conducted on 385 patients assisted with Atrial Fibrillation (AF) at the Las Fuentes Norte Health Center, before and after the implementation of actions to improve oral anticoagulants management from October 2015 to July 2017. (3) Results: The ACO-ZAR I study revealed that the population with AF presents a global prevalence of 1.7%, an indication of oral anticoagulants of 92.1%, undertreatment of 24%, suboptimal control of vitamin K antagonists of 43%, use of antiaggregant as primary prevention of 13.42%, and primary health care monitoring of 34%. The implementation of activities aimed at improving the management of oral anticoagulants in the ACO-ZAR II study achieves a reduction in undertreatment up to 16%, in the use of antiaggregant up to 9%, and in suboptimal control up to 30%, as well as an increase in control from primary health care up to 69.2% and of the penetrance of direct oral anticoagulants up to 28%. (4) Conclusions: In conclusion, the application of activities aimed at optimizing the management of oral anticoagulants in health center patients allowed the improvement of risk assessment and registration, undertreatment, use of antiaggregant, suboptimal control of vitamin K antagonists, control by primary health care center, and the penetrance of direct oral anticoagulants.

Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock: JACC Review Topic of the Week.

Interest in the use of mechanical circulatory support for patients presenting with cardiogenic shock is growing rapidly. The Impella (Abiomed Inc), a microaxial, continuous-flow, short-term, ventricular assist device (VAD), requires meticulous postimplantation management. Because systemic anticoagulation is needed to prevent pump thrombosis, patients are exposed to increased bleeding risk, further aggravated by sepsis, thrombocytopenia, and high shear stress-induced acquired von Willebrand syndrome. The precarious balance between bleeding and thrombosis in percutaneous VAD-supported cardiogenic shock patients is often the main reason that patient outcomes are jeopardized, and there is a lack of data addressing optimal anticoagulation management strategies during percutaneous VAD support. Here, we present a parallel anti-Factor Xa/activated partial thromboplastin time-guided anticoagulation algorithm and discuss pitfalls of heparin monitoring in critically ill patients. This review will guide physicians toward a more standardized (anti)coagulation approach to tackle device-related morbidity and mortality in this critically ill patient group.

Retrospective review of secondary prevention strategies for gastrointestinal bleeding and associated clinical outcomes in left ventricular assist device patients.

BACKGROUND: Gastrointestinal bleeding (GIB) is one of the most common bleeding complications associated with left ventricular assist devices (LVAD). Currently, there is no strong evidence or clear guidance for which secondary GIB prophylaxis strategy should be implemented after the discontinuation of aspirin. METHODS: Our single-center study describes the outcomes of 26 LVAD patients who experienced a total of 49 GIB events: these individuals were either in Group-1 (lower INR target range) or Group-2 (lower INR target plus a hemostatic agent) as the secondary prophylaxis strategy. Each GIB event was considered an independent event. Outcomes assessed were bleeding reoccurrence rates, time to next GIB, acute GIB strategies, GIB-free days, thromboembolic events, survival, coagulation, and hematologic parameters. RESULTS: GIB reoccurrence rates were not statistically different: Group-1, 9 (40.9%), versus Group-2, 15 (55.6%); p = 0.308. Danazol was utilized 81.5% of the time as the designated hemostatic agent. Additionally, no significant differences were observed with all of our secondary outcome measures for bleeding, ischemic events, or survival. CONCLUSION: While our study was not powered to assess the clinical outcomes related to survival and thromboembolic events, no discernable increased risk for ischemic events including pump thrombosis were observed. Our data suggest that a lower INR target range plus danazol does not confer any additional benefit over a lower INR target range only approach. The results of this report are hypothesis-generating and additional studies are warranted to elucidate the optimal antithrombotic strategy and role of hemostatic agents in reducing the risk of recurrent GIB events.

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

Pupose: To 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. Methods: We 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. Results: Only 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. Conclusion: The 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.

A smartphone application for remote adjustment of warfarin dose: Development and usability study.

AIM: The aim of this article is (a) to design and develop a smartphone app called Alfalfa that can provide remote dose adjustment (b) to evaluate its usability. BACKGROUND: Patients taking warfarin need to spend substantial time, money, and energy frequently visiting the hospital in order to adjust its dose. Internet technology may be able to provide convenient dose adjustment services for these patients. METHODS: We thought and discussed repeatedly about how to ensure the safety and effectiveness of remote administration of warfarin, and finally designed and developed the Alfalfa app. In addition, patients and medical practitioners were invited to participate in a system usability scale (SUS) to assess the usability of Alfalfa. RESULTS: As of July 5, 2021, the number of Alfalfa accounts was 1736, including 1624 patients and 112 medical staff, and it provided a total of 12,968 remote dose adjustments. A total of 26 people participated in the questionnaire, including 15 patients and 11 medical staff. The results of SUS show that the usability score of patient terminal and medical terminal is 61.8 and 82.7, respectively. And age does not affect the usability of patient terminal. The usability of the Alfalfa app was rated similarly by younger and older adults (63.5 vs. 58.5, P = .535). CONCLUSIONS: This study proves that the Alfalfa app can be used for remote management of warfarin. The usability of medical terminal is acceptable to medical practitioners, while the usability of patient terminal needs further improvement. TRIAL REGISTRATION: ChiCTR1900021920.