Management Of Oral Anticoagulant Therapy Research Articles

Thromboembolic prevention in athletes: management of anticoagulation in sports players affected by atrial fibrillation.

Atrial fibrillation (AF) is a common cardiac arrhythmia that poses a significant risk of stroke and thromboembolic events. Anticoagulation therapy is essential for preventing stroke in patients with AF. An increasing number of people of all ages, including cardiac patients, approach physical activity as both a leisure-time exercise and a competitive sport. Therefore, patients at risk of AF are increasingly allowed to practice sports activities. Management of oral anticoagulant therapy (OAT) in these patients is extremely challenging because of the need to balance the risks and benefits of medications, considering both hemorrhagic (in case of trauma) and ischemic complications when the drugs are avoided. Official recommendations are limited for these patients and forbid sports that increase the risk of trauma and consequent bleeding in most cases. These recommendations are strongly influenced by the "traditional" management of OAT, which mainly involves coumarin derivatives. Non-vitamin K antagonist direct oral anticoagulants (DOACs), with their more favorable pharmacokinetic-pharmacodynamic profile than that of coumarin derivatives, may represent an opportunity to modify the approach to sports activity in patients with AF and indications for OAT. This study aimed to review the use of anticoagulants in athletes with AF, highlight their efficacy and safety, and provide practical considerations regarding their management.

Abstract 12981: Digital Health for the Management of Oral Anticoagulation Therapy: A Systematic Review and Meta-Analysis

Background: Direct oral anticoagulants (DOACs) have progressively replaced vitamin K antagonists (VKAs). However, in certain conditions, especially antiphospholipid syndrome, mechanical heart valves and rheumatic mitral stenosis, VKAs remain the only drugs with established safety and efficacy. In low-income contexts, they are frequently the preferred option due to the high costs of DOACs. Its management is often challenging, and different digital health strategies have been implemented to support it. Aims: To systematically review the evidence on the impact of digital health strategies to support anticoagulation management compared to usual care on thromboembolic and bleeding events. Methods: Randomized controlled trials were searched in 5 databases from inception to September 2021. Two independent reviewers performed study selection, data extraction, and quality assessment using the Cochrane risk of bias tool (RoB2). Total thromboembolic events, major bleeding, mortality, and time in therapeutic range were assessed. Results were pooled using random effect models. Results: In total, 25 randomized controlled trials were included (25,746 patients) and classified as moderate to high risk of bias. Telemedicine resulted in a trend of reduced risk of thromboembolic events (13 studies, relative risk [RR] 0.75, 95% CI 0.53-1.07; I2=42%), comparable rates of major bleeding (11 studies, RR 0.94, 95% CI 0.82-1.07; I2=0%) and mortality (12 studies, RR 0.96, 95% CI 0.78-1.20; I2=11%), and an improved time in therapeutic range (16 studies, mean difference 3.38, 95% CI 1.12-5.65; I2=90%). In the subgroup of multitasking intervention, telemedicine resulted in an important reduction of thromboembolic events (RR 0.20, 95% CI 0.08-0.48). Conclusions: Digital health strategies resulted in similar rates of major bleeding and mortality, a trend for fewer thromboembolic events and better anticoagulation quality compared to standard care. Given the potential benefits of digital health-based care, such as greater access to remote populations, these findings may encourage further implementation of these strategies for anticoagulation management, particularly as part of multifaceted interventions for integrated care of chronic diseases.

Telemedicine-Based Management of Oral Anticoagulation Therapy: Systematic Review and Meta-analysis.

Oral anticoagulation is the cornerstone treatment of several diseases. Its management is often challenging, and different telemedicine strategies have been implemented to support it. The aim of the study is to systematically review the evidence on the impact of telemedicine-based oral anticoagulation management compared to usual care on thromboembolic and bleeding events. Randomized controlled trials were searched in 5 databases from inception to September 2021. Two independent reviewers performed study selection and data extraction. Total thromboembolic events, major bleeding, mortality, and time in therapeutic range were assessed. Results were pooled using random effect models. In total, 25 randomized controlled trials were included (n=25,746 patients) and classified as moderate to high risk of bias by the Cochrane tool. Telemedicine resulted in lower rates of thromboembolic events, though not statistically significant (n=13 studies, relative risk [RR] 0.75, 95% CI 0.53-1.07; I2=42%), comparable rates of major bleeding (n=11 studies, RR 0.94, 95% CI 0.82-1.07; I2=0%) and mortality (n=12 studies, RR 0.96, 95% CI 0.78-1.20; I2=11%), and an improved time in therapeutic range (n=16 studies, mean difference 3.38, 95% CI 1.12-5.65; I2=90%). In the subgroup of the multitasking intervention, telemedicine resulted in an important reduction of thromboembolic events (RR 0.20, 95% CI 0.08-0.48). Telemedicine-based oral anticoagulation management resulted in similar rates of major bleeding and mortality, a trend for fewer thromboembolic events, and better anticoagulation quality compared to standard care. Given the potential benefits of telemedicine-based care, such as greater access to remote populations or people with ambulatory restrictions, these findings may encourage further implementation of eHealth strategies for anticoagulation management, particularly as part of multifaceted interventions for integrated care of chronic diseases. Meanwhile, researchers should develop higher-quality evidence focusing on hard clinical outcomes, cost-effectiveness, and quality of life. PROSPERO International Prospective Register of Systematic Reviews CRD42020159208; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=159208.

Management of oral anticoagulant therapy after intracranial hemorrhage in patients with atrial fibrillation.

Intracranial hemorrhage (ICH) is considered a potentially severe complication of oral anticoagulants (OACs) and antiplatelet therapy (APT). Patients with atrial fibrillation (AF) who survived ICH present both an increased ischemic and bleeding risk. Due to its lethality, initiating or reinitiating OACs in ICH survivors with AF is challenging. Since ICH recurrence may be life-threatening, patients who experience an ICH are often not treated with OACs, and thus remain at a higher risk of thromboembolic events. It is worthy of mention that subjects with a recent ICH and AF have been scarcely enrolled in randomized controlled trials (RCTs) on ischemic stroke risk management in AF. Nevertheless, in observational studies, stroke incidence and mortality of patients with AF who survived ICH had been shown to be significantly reduced among those treated with OACs. However, the risk of hemorrhagic events, including recurrent ICH, was not necessarily increased, especially in patients with post-traumatic ICH. The optimal timing of anticoagulation initiation or restarting after an ICH in AF patients is also largely debated. Finally, the left atrial appendage occlusion option should be evaluated in AF patients with a very high risk of recurrent ICH. Overall, an interdisciplinary unit consisting of cardiologists, neurologists, neuroradiologists, neurosurgeons, patients, and their families should be involved in management decisions. According to available evidence, this review outlines the most appropriate anticoagulation strategies after an ICH that should be adopted to treat this neglected subset of patients.

Nursing self-efficacy for oral anticoagulant therapy management: Development and initial validation of a theory-grounded scale

AimThis study aimed to develop and validate a nursing self-efficacy scale for OAC management (SE-OAM). BackgroundOral anticoagulant therapy (OAC) requires specific nursing competencies. Given that self-efficacy acts as a proxy assessment of nursing competence, its measurement is pivotal for addressing educational programs to enhance nursing competence in managing OAC. Thus far, the measurement of self-efficacy in OAC is undermined by the unavailability of valid and reliable tools. MethodsA multi-method and multi-phase design was adopted: Phase one was a methodological study encompassing developmental tasks for generating items. Phase two comprised the validation process for determining the content validity, construct and concurrent validity, and internal consistency through two cross-sectional data collections. ResultsIn total, 190 nurses were enrolled for determining the psychometric structure of the SE-OAM through an exploratory approach, and 345 nurses were subsequently enrolled to corroborate its most plausible factor structure derived from the exploratory analysis. The SE-OAM showed evidence of face and content validity, adequate construct, concurrent validity, good internal consistency, and stability. The final version of the scale encompassed 21 items kept by five domains: clinical management, care management, education, clinical monitoring, and care monitoring. ConclusionsThe SE-OAM showed evidence of initial validity and reliability, fulfilling a current gap in the availability of tools for measuring nursing self-efficacy in managing OAC. SE-OAM could be strategic for performing research to improve the quality of OAC management by enhancing nursing self-efficacy.

Antithrombotic treatments in patients with SARS-CoV-2 infection: from current evidence to reasonable recommendations - A position paper from the Italian Working Group on Atherosclerosis, Thrombosis and Vascular Biology

Given the high prevalence of preexisting cardiovascular diseases and the increased incidence of adverse cardiovascular events in patients hospitalized for SARS-CoV-2 infection, the identification of optimal antithrombotic approaches in terms of risk/benefit ratio and outcome improvement appears crucial in this setting. In the present position paper we collected current evidence from the literature to provide practical recommendations on the management of antithrombotic therapies (antiplatelet and anticoagulant) in various clinical contexts prevalent during the SARS-CoV-2 outbreak: in-home management of oral anticoagulant therapy; interactions between drugs used in the SARS-CoV-2 infection and antithrombotic agents; in-hospital management of antithrombotic therapies; diagnosis, risk stratification and treatment of in-hospital thrombotic complications.

Non-vitamin K antagonist oral anticoagulants and sport.

Physical activity is worldwide recommended for its benefits on cardiovascular system. There is an increasing number of people of all ages that approach sport activity both as leisure time physical activity and as competitive sport. It is always more frequent the request even from older subjects and cardiac patients to be allowed to practice physical activity. Some problems could arise when these subjects present or develop pathologic conditions that require specific pharmacological treatment, in particular an anticoagulation therapy. This review focalizes on the management of oral anticoagulant therapy (OAT) in patients practicing sport activity, especially due to atrial fibrillation and deep vein thrombosis, which represent two highly prevalent conditions, particularly with increasing age. Official recommendations in this field may appear limiting for patients, forbidding in the majority of cases sports at risk of trauma and consequent bleeding. These recommendations still resent the heritage of the "traditional" management of OAT, mainly represented by vitamin-K antagonists (VKAs). The non-vitamin K antagonist oral anticoagulants, with their more favorable pharmacokinetic-pharmacodynamic profile compare to VKAs, may now represent an opportunity to modify the approach to sport activity in patients with an indication to OAT. This review of the literature deals with possible strategies to overcome the present limitations for OAT subjects willing to pursue a healthy lifestyle, that include sport activity, minimizing at the same time their risk of bleeding.

Specialized Management of Oral Anticoagulation Therapy Improves Outcome in Patients with Chronic Renal Insufficiency.

Oral anticoagulation (OAC) is effective at preventing and treating thromboses and thromboembolism in patients with normal renal function. We aimed to research the impact of severe renal failure (RF) on patient outcome and to determine the potential benefit of caring for these patients in a specialized coagulation service (CS). A total of 1516 usual medical care patients and 756 CS-managed patients of the thrombEVAL multicenter (21 centers), prospective, cohort study (NCT01809015) were analyzed in a 3-year follow-up. Patients with RF (serum creatinine >3 mg/dL, no renal replacement therapy) were compared to patients without RF in usual care and a CS. The fluctuations in the international normalized ratios were significantly lower in CS-managed patients, and regardless of treatment in usual care or a CS, the time in therapeutic range was significantly lower in RF patients. Cox regression-adjusted hazard ratios for long-term outcome (1.5, 95% CI: 1.22–1.83, p < 0.001), death (1.62, CI: 1.27–2.08, p < 0.001), and hospitalization (1.21, CI: 1.02–1.44, p = 0.032) were significantly higher in RF patients in usual care. Furthermore, there was a trend of more bleeding events in RF patients. CS-treated patients had significantly lower adjusted hazard ratios for death (0.24, CI: 0.14–0.39, p < 0.001), hospitalizations (0.41, CI: 0.34–0.5, p < 0.001), clinically relevant bleeding (0.29, CI: 0.18–0.47, p < 0.001), and major bleeding (0.33, CI: 0.18–0.59, p < 0.001). Thus, patients who required oral anticoagulation therapy benefitted significantly from being managed in a specialized coagulation service, regardless of their renal function.

Evaluation of a program of pharmaceutical counseling for French patients on oral anticoagulant therapy.

Background Oral anticoagulants are widely used for treatment and prevention of thromboembolic diseases. We set up a pharmaceutical counseling program for both direct oral anticoagulant and vitamin K antagonist drugs in our hospital in 2015. Objective Evaluate patient satisfaction and the evolution of their knowledge throughout the pharmaceutical counseling program on anticoagulants and identify knowledge variability factors. Setting Cardiology Inpatient Unit from the University Antoine Béclère Hospital, France. Methods Evaluation was based on data collection of patients surveyed between 2015 and 2018. Inpatients in the cardiology department on oral anticoagulants were eligible.The learning process was designed to enhance patient knowledge and understanding based on 10 cognitive or self-management skills, relating to the optimization of oral anticoagulant therapy management. It consisted in 2 face-to-face interviews during hospitalization and 2 additional phone interviews one and six months after discharge.The median patient score was evaluated at each step of the process as well as the mean score for each item from the global population. A sub-analysis was run on the less well-acquired skills in order to identify risk factors for limited knowledge. The association between those factors and the level of knowledge (score ≥ 7 or < 7) was assessed using Chi square test followed by multivariate analysis. Main outcome measure Patient knowledge of anticoagulation therapy depending on specific factors. Results Of the 880 patients eligible for pharmaceutical counseling, 319 entered the process and 102 completed it.Median knowledge scores were 8/10 and 9/10 after the first and the final interviews respectively with a significant improvement (p = 0.0003).The least well-acquired items at each step were surveillance and under-dosing management. The sub-analysis showed the use of vitamin K antagonist to be linked to an enhanced understanding related to treatment surveillance (p = 0.029). Patients suffering from atrial fibrillation were found to have a worse understanding of under-dosing management (p = 0.013). Finally, patients evaluated the process as helpful and suitable for their conditions. Conclusion Pharmaceutical counseling is appropriate for patients, improving and maintaining knowledge of oral anticoagulants. Our evaluation highlights the need to focus on patient-specific profiles to reach a satisfactory level of knowledge.

Physicians' Opinion on Health Care in Oral Anticoagulation

The introduction of direct oral anticoagulants (DOAC) in addition to the established Vitamin K antagonist (VKA) has increased the complexity of antithrombotic therapy leading to numerous treatment options. Studies of the medical evaluation of the current treatment situation by health care providers, which are of great importance for the development of treatment strategies in addition to studies on pharmacovigilance, are limited in the literature. 11 700 physicians (Rhineland-Palatinate, Germany) were contacted to participate in the web-based survey on health care with oral anticoagulation (OAC). After detailed quality control, the study was analysed in synopsis with routine care data of VKA patients of the thrombEVAL study programme (N = 2.011). In total, 512 physicians (mean age: 48.0 ± 9.6 years; 74.0 % male) participated in the study. In general, quality of OAC therapy was rated as "average/satisfactory" (2.9 ± 0.9). Comparison of physicians' perception with data from routine care highlighted marked differences regarding time in therapeutic range (+ 6.4 % [95 %-CI 2.7 %; 9.5 %]), duration of control intervals (- 35.0 % [28.0 %; 41.4 %]) and rate of OAC-related complications (+ 61.8 [37.8 %; 83.3 %], which differed additionally and statistically-significant between physician groups. The willingness to use DOAC was approximately 50 % lower ingeneral physicians as compared to specialists (36.6 % [25.4 %; 47.8 %] vs. 72.4 % [66.0 %; 78.9 %]; p < 0.0001). Regarding management of OAC therapy, 73.8 % [69.7 %; 77.9 %] advocated the establishment of a service hotline and 67.3 % [62,9 %; 71.6 %] a specialized coagulation service. The present survey among physicians reveals a need for optimization of OAC therapy in daily practice. Specialized care models might facilitate optimized OAC therapy with both VKAs and DOACs.

E‐Health‐based management of patients receiving oral anticoagulation therapy: results from the observational thrombEVAL study

Background Management of oral anticoagulation (OAC) therapy is essential to minimize adverse events in patients receiving vitamin K-antagonists (VKAs). Data on the effect of e-health-based anticoagulation management systems on the clinical outcome of OAC patients are limited. Objectives To compare the clinical outcome of OAC patients managed by an e-health-based coagulation service (CS) with that of patients receiving regular medical care (RMC). Methods The prospective multicenter cohort study thrombEVAL (NCT01809015) comprised 1558 individuals receiving RMC and 760 individuals managed by a CS. Independent study monitoring and adjudication of endpoints by an independent review panel were implemented. Results The primary study endpoint (composite of thromboembolism, clinically relevant bleeding and death) occurred in 15.7 per 100 patient-years (py) with RMC and in 7.0 per 100 py with the CS (rate ratio [RR], 2.3; 95% confidence interval [CI], 1.7-3.1). Rates for major and clinically relevant bleeding were higher with RMC than with the CS: 6.8 vs. 2.6 and 10.1 vs. 3.6 per 100 py, respectively. Thromboembolic events showed an RR of 1.5 (95% CI, 0.8-2.6) comparing RMC with the CS. Hospitalization (RR, 2.6; 95% CI, 2.3-3.0) and all-cause mortality (RR, 4.6; 95% CI, 2.8-7.7) were markedly more frequent with RMC. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, treatment characteristics and sociodemographic status, hazard ratios (HR) for the primary endpoint (HR, 2.2; 95% CI, 1.5-3.4), clinically relevant bleeding (HR, 3.1; 95% CI, 1.7-5.5), hospitalization (HR, 2.2; 95% CI, 1.8-2.8) and all-cause mortality (HR, 5.6; 95% CI, 2.9-11.0) favored CS treatment. Conclusions In this study, e-health-based management of OAC therapy was associated with a lower frequency of OAC-specific and non-specific adverse events.

Management of Oral Anticoagulation Therapy After Gastrointestinal Bleeding: Whether to, When to, and How to Restart an Anticoagulation Therapy.

To evaluate current clinical evidence for management of oral anticoagulation therapy after gastrointestinal bleeding (GIB) with an emphasis on whether to, when to, and how to resume an anticoagulation therapy. Relevant articles from MEDLINE, Cochrane Library, and EMBASE databases were identified from 1946 through May 20, 2017, using the keywords: gastrointestinal hemorrhage or gastrointestinal bleeding and antithrombotic therapy or anticoagulation therapy or warfarin or dabigatran or rivaroxaban or apixaban or edoxaban. All English-language studies assessing management of oral anticoagulation therapy after GIB were evaluated. A total of 9 studies were identified. Four retrospective cohort studies showed that resuming anticoagulation therapy was associated with significantly lower rate of thromboembolism (TE) in the general population. Meta-analyses and prospective cohort studies also supported this finding. Two retrospective cohort studies indicated an increase in GIB when anticoagulation reinitiation occurred in less than 7 days without a decrease in TE. Resuming therapy between 7 and 15 days did not demonstrate a significant increase in GIB or TE. A large retrospective study showed that apixaban was associated with the significantly lowest risk of GIB compared with both rivaroxaban and dabigatran. Anticoagulation therapy resumption is recommended, with resumption being considered between 7 and 14 days following GIB regardless of the therapy chosen. Data for warfarin management after GIB should be applied with caution to direct oral anticoagulants (DOACs) because of the quicker onset and experimental nature of reversal agents. Apixaban may be a preferred option when restarting a DOAC therapy.

Managing periprocedural anticoagulation therapy in patients undergoing device implantation: survey in Germany, Austria and Switzerland.

Objective The management of patients who undergo cardiac implantable electronic device (CIED) surgery and receive concomitant oral anticoagulation therapy (OAT) is an important clinical topic, as physicians must balance the thromboembolic and bleeding risk when deciding on the perioperative anticoagulation medication. The object of the survey was to analyse the management of perioperative OAT with vitamin K antagonists or novel oral anticoagulant agents (NOACs) and time, type and dose of possibly heparin bridging in consideration of OAT indication during CIED implantation in Austria, Germany and Switzerland.Methods and results We performed a web-based survey across CIED implanting centres in Germany, Austria and Switzerland to collect data regarding the management of the perioperative anticoagulation therapy. In total, the survey was completed by 252 centres. In total, 65.2% of the Austrian, 46.0% of the German and 13.3% of the Swiss centres stop vitamin K antagonists before CIED implantation and bridge w...

Prevalencia de la anticoagulación oral y calidad de su seguimiento en el ámbito de la atención primaria: estudio de la Red Centinela Sanitaria de la Comunitat Valenciana

ObjectiveTo estimate the prevalence of patients with oral anticoagulant therapy (OAT) in the Region of Valencia and to evaluate the quality of management of OAT with vitaminK antagonists (VKA) carried out in primary healthcare. DesignObservational cross-sectional study conducted through the Health Sentinel Network of the Region of Valencia, which includes a survey and the retrospective analysis of OAT monitoring. SettingPrimary healthcare, Region of Valencia, Spain. SubjectsAll patients aged 18years or older on OAT who consulted during the year 2014. The population covered by the 59 doctors of the Health Sentinel Network constitutes 2.2% of the adult population of the Region of Valencia, and it is representative of it. Key measurementsDemographic, socioeconomic and health data as well as information concerning OAT. Quality of OAT management with VKA was assessed by means of the percentage of time in therapeutic range (TTR), computed using the Rosendaal method. ResultsA total of 1,144 patients were recorded (mean age 74.5±11 years; 49.7% women). Prevalence of OAT in the Region of Valencia is 1.3 cases per 100 population. The characteristic profile of these patients is an old person, with several comorbidities and a low level of education, who lives accompanied. Atrial fibrillation is the most common indication. 82.8% of patients on OAT with VKA were monitored in primary healthcare. The average TTR was 65.0%, and 53.9% of patients had a TTR ≥65%. Among inadequately controlled patients, 74.4% were perceived as well-controlled by their primary care doctor. ConclusionsPrevalence of OAT is high, and it is expected to increase. The degree of control achieved meets the generally accepted quality standard (mean TTR ≥65%), and it is comparable to that observed in other national and international studies. However, there is wide scope for improvement. It is crucial to optimize the management of this therapy in the most effective and cost-effective way. Among other measures, access of physicians to their patients’ clinical information should be improved.

An Uncommon Severe Case of Pulmonary Hypertension - From Genetic Testing to Benefits of Home Anticoagulation Monitoring

AbstractA 62 year-old caucasian male was admitted in our pulmonary hypertension expert center with initial diagnosis of pulmonary veno-occlusive disease for validation and specific treatment approach. Routine examinations revealed no apparent cause of pulmonary hypertension. Patient was referred for a thorax contrast enhanced multi-slice computed tomography which revealed extensive bilateral thrombi in pulmonary lower lobe arteries, pleading for chronic post embolic lesions. A right heart catheterization and pulmonary angiography confirmed the diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH). Following the local regulations, the patient underwent thrombophilia screening including molecular genetic testing, with positive findings for heterozygous for VCORK1 -1639G&gt;A gene single nucleotide polymorphism, PAI-1 4G/5G and factor II G20210A gene. With heterozygous genetic profile of 3 mutations he has a genetic predisposition for developing a thrombophilic disease which could be involved in the etiology of CTEPH. Familial screening was extended to descendants; the unique son was tested with positive results for the same three genes. Supportive pulmonary hypertension drug therapy was initiated together with patient self-monitoring management of oral anticoagulation therapy. For optimal control of targeted anticoagulation due to a very high risk of thrombotic state the patient used a point-of-care device (CoaguChek®XS System, Roche Diagnostics) for coagulation self-monitoring.

Managing periprocedural anticoagulation therapy in patients undergoing device implantation: survey in Germany, Austria and Switzerland

Objective The management of patients who undergo cardiac implantable electronic device (CIED) surgery and receive concomitant oral anticoagulation therapy (OAT) is an important clinical topic, as physicians must balance the thromboembolic and bleeding risk when deciding on the perioperative anticoagulation medication. The object of the survey was to analyse the management of perioperative OAT with vitamin K antagonists or novel oral anticoagulant agents (NOACs) and time, type and dose of possibly heparin bridging in consideration of OAT indication during CIED implantation in Austria, Germany and Switzerland.Methods and results We performed a web-based survey across CIED implanting centres in Germany, Austria and Switzerland to collect data regarding the management of the perioperative anticoagulation therapy. In total, the survey was completed by 252 centres. In total, 65.2% of the Austrian, 46.0% of the German and 13.3% of the Swiss centres stop vitamin K antagonists before CIED implantation and bridge with heparin, targeted to a therapeutic level, in most cases. NOACs were stopped before CIED implantation in most centres (95.8% of the Austrian, 89.5% of the German and 87.5% of the Swiss centres) surveyed without heparin bridging.Conclusions Previous meta-analyses showed that heparin bridging in patients undergoing CIED implantation increases the risk of bleeding complications compared to continuation of vitamin K antagonist treatment but data from our survey shows that interruption of vitamin K antagonist treatment and bridging with heparin remains a commonly employed strategy. Data regarding CIED implantation with uninterrupted NOACs are limited; thus, most centres surveyed stop NOACs before CIED implantation without heparin bridging.

Technology-assisted self-testing and management of oral anticoagulation therapy: a qualitative patient-focused study.

Oral anticoagulation therapy requires regular blood testing to ensure therapeutic levels are maintained and excessive bleeding/clotting is avoided. Technology-assisted self-testing and management is seen as one of the key areas in which quality of care can be improved whilst reducing costs. Nevertheless, levels of patient engagement in self-testing and management remain low. To date, little research emphasis has been placed on understanding the patients' perspectives for low engagement. The typical approach adopted by healthcare providers is to provide patient education programmes, with the expectation that individual patients will change their behaviour and adopt new self-care strategies. However, if levels of patient engagement are to be increased, healthcare providers must also develop a better understanding of how their clinical service provision is perceived by patients and make adaptations. To explore patient views, needs and expectations of an anticoagulation service and the self-testing and management services provided. Interviews were conducted with 17 patients who currently engage in international normalised ratio (INR) self-testing and management. Thematic coding and analysis were carried out on the interview transcripts. Four high-level themes emerged from interviews: (i) role of clinic, (ii) motivations for self-testing, (iii) managing INR and (iv) trust. The clinic was seen as adding value in terms of specifying testing frequency, dosage profiles and calibrating equipment. Prompt communication from clinic to patient was also valued, although more personalised/real-time communication would help avoid feelings of isolation. Patients felt more in control as self-tester/managers and often took decisions about treatment adjustments themselves. However, some also manipulated their own test results to avoid 'unnecessary' interventions. More personalised/real-time communication, pragmatic and collaborative patient-clinician partnerships and recognition of expert patient knowledge and expertise are needed if increased levels of engagement with self-testing and management service provision is to be realised.

Effective and Safe Management of Oral Anticoagulation Therapy in Patients Who Use the Internet-Accessed Telecontrol Tool SintromacWeb.

BackgroundDespite the existing evidence that highlights the benefits of oral anticoagulation therapy (OAT) self-testing and self-management by patients in comparison with conventional control, significant progress is still needed in the implementation of computer-based, Internet-assisted systems for OAT within health care centers. The telecontrol tool “SintromacWeb” is a previously validated system for OAT management at home, which is currently operative and accessed by patients through a hospital Web portal.ObjectiveThe intent of the study was to assess the effectiveness and safety of OAT management in patients using the SintromacWeb telecontrol system in reference to control in patients using the conventional system (management at the hematology department), in terms of time in therapeutic range (TTR) of International Normalized Ratio (INR).MethodsIn this observational prospective study, patients were identified by their physician and divided in two groups according to the OAT management system that they were already using (conventional control or telecontrol with SintromacWeb). For 6 months, patients were required to visit the hematology department every time their physician considered it necessary according to usual clinical practice. Sociodemographic and clinical variables for the study were collected at first visit (baseline) and at those visits closest to 2, 4, and 6 months after first visit.ResultsA total of 173 patients were evaluated, 87 with conventional control and 86 with telecontrol. Follow-up time was a median of 6.3 (range 5.2-8.1) months. The average time of OAT treatment prior to enrollment was 9.2 (SD 6.4) years. Patients in the telecontrol group tested their INR a median of 21 (range 4-22) days versus a median of 35 (range 14-45) days in patients in the conventional control group (P<.001). TTR in the telecontrol group was 107 (SD 37) days versus 94 (SD 37) days in the conventional control group (an increase of 12.6%; P=.02). In all visits, the percentage of TTR was higher in the telecontrol group (at the third visit: 59% vs 48%; P=.01). Higher TTR (positive coefficient) was associated with patients under OAT telecontrol (P=.03). Under-anticoagulation (INR<1.5) and over-anticoagulation (INR>5) were observed in 34 (19.7%, 34/173) and 38 (22.0%, 38/173) patients, respectively (no differences between treatment groups). Seven thrombotic and/or bleeding events were serious, 12 were non-serious, and most of them (5 and 10, respectively) occurred in the conventional control group.ConclusionsIn clinical practice, OAT management with the Internet-based tool SintromacWeb is effective and safe for those patients who are eligible for OAT telecontrol.

Four-Factor Prothrombin Complex Concentrate (4F-PCC) Is Superior to Three-Factor Prothombin Comlex Concentrates (3F-PCC) for Reversal of Coumarin Anticoagulation

Due to its wide range of therapeutic indications approximately 2.5 million adults and children are currently receiving vitamin K antagonist (VKA) therapy in the US (Pengo et al., 2006). Bleeding is the major risk of anticoagulation, with an incidence of major hemorrhage in VKA-treated patients of 1.7-3.4% per year (Schulman et al., 2008). The 4-factor prothrombin complex concentrate (4F-PCC), which contains the human coagulation factors II, VII, IX and X together with the endogenous inhibitor proteins S and C, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by VKA (e.g. warfarin or coumarin) therapy in adult patients with acute major bleeding. In contrast, the 3-factor prothrombin complex concentrates (3F-PCC), which contain factors II, IX, X and only minimal amounts of factor VII, are only indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients. Nevertheless, the use of 3F-PCC for correcting hemostasis following warfarin overdose has been discussed (Imberti et al. 2011, Holland et al. 2009). However, the lack of factor VII in these 3F-PCC products has raised questions about efficacy in comparison to 4F-PCC (Sarode et al. 2012). To date, no studies have directly compared 3F-PCC vs. 4F-PCC regarding their efficacy for reversal of VKA anticoagulation.Therefore, this study was conducted as a head-to-head comparison of 4F-PCC and 3F-PCC for effective reversal of VKA (coumarin) induced anticoagulation using an established rat model of acute bleeding (Dickneite et al. 2007).Rats received an oral dose of 2.5 mg/kg phenprocoumon. At 15.75 hours post dosing, animals were treated with a single intravenous dose of saline, 4F-PCC (Beriplex® P/N, Kcentra®, CSL Behring) or 3F-PCC (Bebulin® VH and Profilnine® SD). Study endpoints included bleeding following tail clip, activated partial thromboplastin time (aPTT), and prothrombin time (PT). In addition, the plasma levels of vitamin K dependent coagulation factors were determined.Acute coumarin anticoagulation of rats induced a rise in median bleeding time by ≥2 fold from an average of 823 to 1800 seconds (max. observation period) compared to untreated animals. In parallel, PT and aPTT were prolonged from 8.9 to 29.9 seconds and 14.5 to 25.5 seconds, respectively. Treatment with 4F-PCC was able to fully and statistically significantly reverse bleeding, achieving average bleeding times of 676 seconds. In parallel, the elevation in PT was reversed to 15.1 seconds. In contrast, the 3F-PCCs were not or only partially able to reduce coumarin induced bleeding with average bleeding times of 1398 and 1708 seconds post treatment. This also correlated with inferior reductions in PT which achieved minimum levels of 23.8 and 29.5 seconds. There was no reduction in aPTT seen for any treatment option.In conclusion, this first direct comparison of 4F-PCC and 3F-PCCs for the reversal of VKA anticoagulation in a rat model of acute bleeding suggests that replenishment of all vitamin K-dependent coagulation factors including factor VII as achieved using a 4F-PCC may result in superior efficacy compared to the use of 3F-PCCs.ReferencesDickneite G: Prothrombin complex concentrate versus recombinant factor VIIa for reversal of coumarin anticoagulation.Thromb Res 119:643–651, 2007Holland L, Warkentin TE, Refaai M, et al. Suboptimal effect of three-factor prothrombin complex concentrate (Profilnine-SD) in correcting supratherapeutic INR due to warfarin overdose. Transfusion 2009;49:1171–7.Imberti D, Barillari G, Biasioli C, et al. Emergency reversal of anticoagulation with a three-factor prothrombin complex concentrate in patients with intracranial haemorrhage. Blood Transfus 2011;9:148–55.Pengo V, Pegoraro C, Cucchini U, IIiceto S. The management of oral anticoagulant therapy: the ISAM study. J Thromb Thrombolysis 2006;21:73-7Sarode R, Matevosyan K, Bhagat R, Rutherford C, Madden C, Beshay JE. Rapid warfarin reversal: a 3-factor prothrombin complex concentrate and recombinant factor VIIa cocktail for intracerebral hemorrhage.J Neurosurg 116:491–497, 2012Schulman S, Beyth RJ, Kearon C, Levine MN. Hemorrhagic complications of anticoagulant and thrombolytic treatment: american college of chest physicians evidence-based clinical practice guidelines (8th edition). Chest 2008;13:257S-98S DisclosuresHerzog:CSL Behring GmbH: Employment. Off Label Use: Non-clinical data on the use of 3F-PCC for reversal of VKA . Kaspereit:CSL Behring GmbH: Employment. Krege:CSL Behring GmbH: Employment. Niebl:CSL Behring GmbH: Employment. Schulte:CSL Behring GmbH: Employment. Dickneite:CSL Behring GmbH: Employment.

ATRIAL FIBRILLATION IN RURAL AND NORTHERN CANADA: A QUALITATIVE STUDY OF PRIMARY CARE PROVIDERS MANAGING ATRIAL FIBRILLATION AND ENACTING CLINICAL GUIDELINES

Approximately 350,000 people in Canada are known to have atrial fibrillation (AF)- a serious but often-undetected cardiac arrhythmia characterized by uncoordinated and erratic atrial activity. AF is the most common sustained arrhythmia and is associated with very high increases in death and disability, including a 500% increase in stroke risk. AF is rising at an unprecedented rate due to the compounding effects of three of our largest health challenges: the aging population, chronic disease and obesity. The burden of this growth on urban parts of Canada will be great, however, effects on rural Canada will be profound due to the rapidly aging population in Canada’s rural communities, increased incidence of chronic disease, poorest health outcomes, and more limited capacity of rural health systems. In rural communities, AF is predominantly managed outside the hospital with limited resources. However, the majority of clinical guidelines for AF assume that services are provided in large urban centres. Services for rural and northern Canada are, by comparison, very scarce, and further research in this area is urgently needed. To understand these challenges further, we undertook a qualitative study with primary care providers in rural and northern Alberta and British Columbia. Telephone interviews with a purposive sample of 18 primary care providers were undertaken to explore both the experiences of managing AF and enacting clinical guidelines in rural and northern settings. Analysis of the data revealed that healthcare providers saw AF as a manageable condition, but that challenges existed due to limited access to specialist services, the hurdles and obstacles of patient monitoring, high workloads, poor patient literacy, and a lack of integration between the healthcare agencies managing AF. Activities addressing stroke prevention were considered most burdensome, particularly in relation to communication around stroke risk and the initiation and management of oral anticoagulation therapy. Vulnerable patients, such as transient workers and those with poor compliance, created significant challenges and often required physicians to delineate clinical recommendations in light of complex socioeconomic factors. Throughout the research, a range of innovative approaches to health care delivery were identified, including the use of telemedicine, expanded provider roles, and integrated approaches to patient education. This research has identified significant challenges faced by rural primary care providers when managing AF and enacting clinical guidelines. Understanding these challenges is critical to developing health care services that are responsive to the needs of the high risk and underserved rural populations.