Anticoagulation Clinic Research Articles

Selective serotonin reuptake inhibitor use and risk of major bleeding during treatment with vitamin K antagonists: results of a cohort study.

Selective serotonin reuptake inhibitors (SSRIs) may increase the risk of major bleeding by decreasing platelet function or decreasing vitamin K antagonist (VKA) metabolism via cytochrome P450 (CYP) inhibition. To determine whether SSRIs are associated with major bleeding during VKA treatment and investigate the possible mechanisms. In this cohort study, information on SSRI use and bleeding complications was obtained from patient records of VKA initiators between 2006 and 2018 from two anticoagulation clinics. Conditional logistic regression and time-dependent Cox regression were used to estimate the effect of SSRIs on a high INR (≥ 5) within 2 months after SSRI initiation and on major bleeding during the entire period of SSRI use, respectively. SSRI use was stratified for (non-)CYP2C9 inhibitors. 58,918 patients were included, of whom 1504 were SSRI users. SSRI initiation versus non-use was associated with a 2.41-fold (95% confidence interval [CI] 2.01-2.89) increased risk for a high INR, which was 3.14-fold (95%CI 1.33-7.43) among CYP2C9 inhibiting SSRI users. The adjusted hazard ratio of major bleeding was 1.22 (95%CI 0.99-1.50) in all SSRI users and 1.31 (95%CI 0.62-2.72) in CYP2C9 inhibiting SSRI users compared to non-users. SSRI use is associated with an increased risk of high INR and might be associated with major bleeding. The risk of a high INR was slightly more elevated for CYP2C9 inhibiting SSRI users, suggesting there might be a pharmacokinetic interaction (by CYP2C9 inhibition) next to a pharmacodynamic effect of SSRIs on platelet activation.

Anticoagulation control in Malaysia: Reports of time in therapeutic range, bleeding, and thromboembolic complications

The risk of thromboembolic events must be balanced against the risk of bleeding while using warfarin as an anticoagulant. Time in therapeutic range (TTR) is an important assessment for evaluating the quality of anticoagulation treatment because it has been proven to be associated with fewer bleeding and thromboembolic events. In Malaysia, the pharmacist-managed anticoagulant Medication Therapy Adherence Clinic (AC-MTAC) service is used for follow-up and dosage control of warfarin. This is the first report of TTR, bleeding, and thromboembolic events in the year 2020.

Use of SAMe-TT2R2 in a racially diverse anticoagulation clinic: prediction of optimal anticoagulation.

The SAMe-TT2R2 score predicts optimal long-term oral Vitamin K Antagonist (VKA) anticoagulation for homogenous Caucasian and homogenous Asian populations for non-valvular atrial fibrillation but at different score thresholds. The score that predicts optimal VKA anticoagulation in significantly diverse populations for multiple indications for systemic anticoagulation has not been reported. We determined whether optimal VKA anticoagulation is predicted by SAMe-TT2R2 score in a diverse inner-city population for non-valvular atrial fibrillation (NVAF), unprovoked venous and pulmonary thromboembolic disease (VTE), mechanical prosthetic heart valves and all other indications. All patients on long term VKA's that attended an inner-city anticoagulation clinic between February 2016 and October 2017 were included in this study. Eligible patients were grouped according to oral anticoagulation indication: (1) NVAF, (2) VTE, (3) prosthetic valves and (4) other indications. Each patient's SAMe-TT2R2 score and percent time of INR in the therapeutic range (TTR) was calculated with optimal international normalized ratio (INR) control defined as TTR ≥ 65%. The correlation between SAMe-TT2R2 score and TTR was determined by logistic regression for each oral anticoagulant indication. Receiver operating characteristic curves were then used to identify the best cutoff for prediction of ≥ 65% TTR. Of 316 patients meeting study criteria, 54% were non-Caucasian and there was a significant negative correlation between the SAMe-TT2R2 score and TTR (coefficient - 0.35, P < 0.0001) for all patients. A SAMe-TT2R2 score < 4 was identified as the best threshold for predicting optimal TTR (Youden's J-statistics = 0.238) with accuracy and positive likelihood ratio of 63.4% and 1.73, respectively. The SAMe-TT2R2 score predicts optimal VKA anticoagulation for systemic anticoagulation for multiple indications in a diverse urban population at a higher score than the original report for non-valvular atrial fibrillation of a cohort where < 10% non-Caucasians.

Abstract 11900: Should Venous Thromboembolism Patients Treated With DOACs Be Dose Adjusted Like Patients With Atrial Fibrillation: Lessons From Apixaban

Introduction: In contrast to atrial fibrillation (AF), dose adjustment of apixaban and other DOACs is not recommended for pts with DVT or PE (VTE). Median DOAC levels were lower in VTE trials (e.g. apixaban 5-mg BID, AF 171 and 103 ng/mL vs. DVT 132 and 63 ng/mL, peak and trough, respectively), the result of a younger, lower weight population with better kidney function. Thus, VTE patients who meet or approach the apixaban dose reduction criteria may have levels far in excess of what’s needed to prevent recurrence. Hypothesis: Apixaban over exposure occurs in VTE pts at risk for elevated apixaban levels. Methods: Patients ≥ 75 yrs of age who had clinical markers that identified them as being at high risk for over exposure, including: 1) apixaban AF dose risk reduction criteria (age ≥ 80, creatinine ≥ 1.5, and wt ≤ 60-kg) and 2) approaching but not meeting dose reduction criteria (e.g. creatine 1.4, weight 65-kg) had a DOAC level measured at their anticoagulation clinic appointment. Levels were determined using liquid chromatography-mass spectrometry. Clinical decisions were made based on the “expected” apixaban levels. Results: Apixaban levels were obtained in 15 male pts. All 10 pts who were initially treated with apixaban 5-mg (2 of whom met the AF dose reduction criteria) had supratherapeutic apixaban levels on 5-mg BID. Of the 5 pts treated initially with apixaban 2.5-mg BID, 3 had adequate apixaban levels, while the other 2 had trough levels that were on the lower side. All 3 pts who met the AF dose reduction criteria (1 treated initially with 2.5-mg) had an adequate apixaban level on 2.5-mg BID. Conclusions: Apixaban treated VTE pts who meet or approach the AF dose reduction criteria are candidates for apixaban dose reduction, especially in light of the fact that peak and trough levels for VTE pts in general are lower than pts with AF.

Outcomes in patients undergoing periprocedural interruption of warfarin or direct oral anticoagulants

BackgroundDifferences in clinical outcomes following a temporary interruption of warfarin or a direct oral anticoagulant (DOAC) for a surgical procedure are not well described. Differences in patient characteristics from practice‐based cohorts have not typically been accounted for in prior analyses. AimTo describe risk‐adjusted differences in postoperative outcomes following an interruption of warfarin vs DOACs. MethodsPatients receiving care at six anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative were included if they had at least one oral anticoagulant interruption for a procedure. Inverse probability of treatment weighting (IPTW) was used to balance baseline differences between the warfarin cohort and DOAC cohort. Bleeding and thromboembolic events within 30 days following the procedure were compared between the IPTW cohorts using the Poisson distribution test. ResultsA total of 525 DOAC patients were matched with 1323 warfarin patients, of which 923 were nonbridged warfarin patients and 400 were bridged warfarin patients. The occurrence of postoperative minor bleeding (10.8% vs. 4.7%, p < .001), major bleeding (2.9% vs. 1.1%, p = .01) and clinically relevant nonmajor bleeding (CRNMB) (6.5% vs. 3.0%, p = .002) was greater in the DOAC cohort compared with the nonbridged warfarin cohort. The rates of postoperative bleeding outcomes were similar between the DOAC and the bridged warfarin cohorts. ConclusionPerioperative interruption of DOACs, compared with warfarin without bridging, is associated with a higher incidence of 30‐day minor bleeds, major bleeds, and CRNMBs. Further research investigating the perioperative outcomes of these two classes of anticoagulants is warranted.

185 CURRENT CHALLENGES IN MANAGING MULTIMORBID OLDER PATIENTS WITH ATRIAL FIBRILLATION – A PAN-EUROPEAN PERSPECTIVE

Abstract Background Atrial Fibrillation (AF) is the most common cardiac arrhythmia and associated with a substantial burden to patients and health systems globally and its prevalence is increasing as the population ages. Methods An online survey was distributed as part of a Horizon 2020 project (EHRA-PATHS) with the aim of evaluating how AF multimorbidity is currently addressed by clinicians, to characterize the treatment structure and to assess current interdisciplinary management of multimorbid AF. The survey included 21 questions and free-text option for comments on detection, assessment and management of AF-related comorbidities. Results A total of 451 responses were received with 339 responses eligible for inclusion with the highest response rate from United Kingdom, Spain and Ireland (n=149, 44%). From all responses, 221 were male (66%), 300 (91.5%) were physicians and 196 (57.8%) were working in academic university teaching hospitals. Half of the respondents managed between 20 to 50 patients per month with multimorbid AF. The survey revealed varying rates of specialist services and referral to these services such as diabetes and heart failure across Europe. Academic university teaching hospitals offered greater numbers of specialist services compared to non-teaching hospitals (e.g. anticoagulation clinic 92 (47%) vs 50 (35%), p&amp;lt;0.03). 67% (n=227) of respondents reported that approximately 40% of patients with multimorbid AF need onwards referral to other specialist clinicians. Barriers to referring to specialist services for AF comorbidities were identified and included lack of integrated care model (n=174, 51%), organisational or institutional issues (n=145, 43%) and issues with patient adherence (n=126, 37%). Respondents identified areas where patient outcomes could be improved: better access to patient lifestyle modifications; improved organisation flexibility to enable innovation; greater access to evidence-based guidelines; and better interdisciplinary collaboration. Conclusion The survey demonstrated the need for systematic, integrated management of AF-related comorbidities in older people and the results will inform the next stage of the EHRA-PATHS project.

Evaluation of a pharmacist-led drive-up anticoagulation clinic during the coronavirus 2019 pandemic

BackgroundThe University of Kentucky HealthCare Anticoagulation Clinic at the Gill Heart and Vascular Institute in Lexington, Kentucky, designed and implemented a drive-up clinic for warfarin management with the goal to minimize person-to-person exposure during the coronavirus disease 2019 (COVID-19) pandemic. ObjectiveThe purpose of this study was to evaluate the effect on warfarin management in a pharmacist-led anticoagulation service when transitioned from an in-person clinic to a drive-up clinic during the COVID-19 pandemic. MethodsThis is a retrospective observational cohort study of 68 patients seen in the University of Kentucky HealthCare Anticoagulation Clinic on warfarin therapy for any indication. Patients were included if they had scheduled visits at least 3 times in the period 6 months before, during, and after the initiation of the drive-up clinic. The primary outcome is the difference in time in therapeutic range (TTR) before and during the drive-up clinic. ResultsThe difference between the mean TTR in period 1 (69.1% ± 23.2%) and period 2 (69.6% ± 19.2%) was not statistically significant (P = 0.882). The mean TTR in period 3 (70.5% ± 20.8%) did not differ in statistical significance from either period 1 (P = 0.688) or period 2 (P = 0.746). Safety outcomes including reported bleeding events and emergency department visits or hospital admissions for bleeding or thrombotic events were consistently low across each period. ConclusionThe results of this study illustrate that a drive-up clinic for warfarin management may be a reasonable alternative approach to providing care for outpatient anticoagulant management and may support nontraditional clinic models for long-term management of anticoagulation and other chronic disease states.

Experiences, perspectives, and practice patterns of pulmonary embolism follow-up in Denmark. A mixed method study informing the development of A sTrucTurEd INtegrateD post PE care model

Abstract Background Practice patterns of follow-up after pulmonary embolism (PE) varies both within and between countries, and high-quality evidence to provide clinical guidance is lacking [1,2]. This study is part of the trial – A sTrucTurEd INtegrateD post Pulmonary Embolism care model (Attend-PE) aimed at developing and testing the effectiveness of a structured, integrated and patient-centered follow-up care model for patients with PE. Purpose To explore experiences, perspectives, and practice patterns of PE follow-up. Ultimately identifying and describing the opportunity space for a structured integrated post PE care model. Methods We performed a convergent mixed method study based on data from patient journey mapping including surveys, observations, and semi-structured patient interviews across all main hospitals treating PE in Denmark. An integrated mixed methods interpretation was conducted using joint displays. Results Main results are presented in joint displays in Figure 1 and 2. Observations and surveys were conducted at 18 hospitals including 12 in-depth patient-interviews. The structure of care varied greatly. Patients expressed a need for early follow up and specialist care but at 18% of the sites first follow-up visit was not until 3–6 months after PE and 24% of the sites only had in-person contact with patients when follow-up echocardiography was needed. At some sites it was also highlighted that not all patients were referred to the post PE follow-up. anticoagulation clinics. Further, transition of care to the general practitioner was identified as a particular challenge. All sites considered Non-vitamin K antagonist oral anticoagulants the preferred anticoagulant treatment with low-molecular-weight heparins/Vitamin K antagonists as second choice. The possible need for extended treatment and reduced dose favored Rivaroxaban and Apixaban. The decision on treatment duration was most often taken at the 3–6-month follow-up visit, and patients described the decision on extended treatment as positive and reassuring. Patient information (oral and written) varied greatly and was most often focused on anticoagulant treatment, while knowledge on PE in general, symptom management, and activity was scarce. Two sites offered structured group-based patient education, but unstructured patient education at the individual follow-up visits was most common. Help and guidance on managing post-PE symptoms and returning to everyday life was perceived essential by patients, as it affected them both physically and mentally. However, none of the sites routinely offered or referred patients to rehabilitation. Involvement of relatives was considered important but 33% of the hospital sites did not systematically encourage relatives to attend follow-up. Conclusion The considerable variation in structure of PE follow-up care demonstrated in this mixed method study highlights the need for a structured integrated post pulmonary embolism care model. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): The Danish Heart AssociationThe Novo Nordisk Foundation

Antithrombotic potential of Lippia alba: A mechanistic approach

Ethnopharmacological relevanceLippia alba (Mill.) N.E.Br. ex Britton & P. Wilson is traditionally used in Brazil as an adjunct in the relief of mild anxiety, as an antispasmodic, and as an antidyspeptic. This medicinal species was included in the Phytotherapeutic Form of the Brazilian Pharmacopeia 2nd edition (2021) and has already been described as the most used medicinal plant in a study with patients from an Anticoagulation Clinic in Brazil. Meanwhile, no studies were found that support the safety of the use of L. alba in patients using anticoagulants, a drug with several safety limitations. Aim of the studyProvide scientific evidence to ensure the safety of the concomitant use of L. alba and warfarin and support the management of these patients by evaluating its in vitro anticoagulant effect and chemical composition. And, as a timely complementation, evaluate the potential of this medicinal species in the development of new antithrombotics. MethodsThe chemical profile of L. alba derivatives was analyzed by chromatographic methods such as Ultra-Performance Liquid Chromatography (UPLC) coupled with electrospray ionization mass spectrometry (ESI-MS), qualitative UPLC using Diode-Array Detection, and Thin Layer Chromatography. The anticoagulant activity was evaluated by the innovative Thrombin Generation Assay by Calibrated Automated Thrombogram method and using traditional coagulometric tests: prothrombin time, activated partial thromboplastin time, and plasma fibrinogen measurement. ResultsExtracts and fractions prolonged the coagulation time in all the tests and reduced thrombin formation in thrombin generation assay. Coagulation times with the addition of ethanloic extract (2.26 mg/mL) was 17.78s, 46.43s and 14.25s respectively in prothrombin time, activated partial thromboplastin time and fibrinogren plasma measurement. In thrombin generation test, this same extract showed ETP as 323 nM/min compared to control (815 nM/min) with high tissue factor and 582 nM/min compared to control (1147 nM/min) using low tissue factor. Presence of flavonoids, phenylpropanoids, and triterpenes were confirmed by chromatographic methods and 13 compounds were identified by UPLC-ESI-MS. Based on these results and on the scientific literature, it is possible to propose that phenylpropanoids and flavonoids are related to the anticoagulant activity observed. ConclusionThe results demonstrate the in vitro anticoagulant activity of L. alba, probably due to the activation of intrinsic and extrinsic pathways. It is concluded, then, that there is a potential for interaction, which needs to be further studied, between L. alba and warfarin. Also, this medicinal species shows a great potential for use in the development of new antithrombotics.

Warfarin anticoagulation management during the COVID-19 pandemic: The role of internet clinic and machine learning.

Background: Patients who received warfarin require constant monitoring by hospital staff. However, social distancing and stay-at-home orders, which were universally adopted strategies to avoid the spread of COVID-19, led to unprecedented challenges. This study aimed to optimize warfarin treatment during the COVID-19 pandemic by determining the role of the Internet clinic and developing a machine learning (ML) model to predict anticoagulation quality. Methods: This retrospective study enrolled patients who received warfarin treatment in the hospital anticoagulation clinic (HAC) and “Internet + Anticoagulation clinic” (IAC) of the Nanjing Drum Tower Hospital between January 2020 and September 2021. The primary outcome was the anticoagulation quality of patients, which was evaluated by both the time in therapeutic range (TTR) and international normalized ratio (INR) variability. Anticoagulation quality and incidence of adverse events were compared between HAC and IAC. Furthermore, five ML algorithms were used to develop the anticoagulation quality prediction model, and the SHAP method was introduced to rank the feature importance. Results: Totally, 241 patients were included, comprising 145 patients in the HAC group and 96 patients in the IAC group. In the HAC group and IAC group, 73.1 and 69.8% (p = 0.576) of patients achieved good anticoagulation quality, with the average TTR being 79.9 ± 20.0% and 80.6 ± 21.1%, respectively. There was no significant difference in the incidence of adverse events between the two groups. Evaluating the five ML models using the test set, the accuracy of the XGBoost model was 0.767, and the area under the receiver operating characteristic curve was 0.808, which showed the best performance. The results of the SHAP method revealed that age, education, hypertension, aspirin, and amiodarone were the top five important features associated with poor anticoagulation quality. Conclusion: The IAC contributed to a novel management method for patients who received warfarin during the COVID-19 pandemic, as effective as HAC and with a low risk of virus transmission. The XGBoost model could accurately select patients at a high risk of poor anticoagulation quality, who could benefit from active intervention.

Wooden Toothpick and Pancreatitis

A 43-year-old woman was consulted in the anticoagulant clinic with a complaint of abdominal pain, with irradiation to the back. The pain started 2 weeks prior and worsened during breathing. She was afebrile, anicteric, and denied nausea, vomiting, or urinary complaints, but reported elimination of dark stools.

Assessment of an Intervention to Reduce Aspirin Prescribing for Patients Receiving Warfarin for Anticoagulation

For some patients receiving warfarin, adding aspirin (acetylsalicylic acid) increases bleeding risk with unclear treatment benefit. Reducing excess aspirin use could be associated with improved clinical outcomes. To assess changes in aspirin use, bleeding, and thrombosis event rates among patients treated with warfarin. This pre-post observational quality improvement study was conducted from January 1, 2010, to December 31, 2019, at a 6-center quality improvement collaborative in Michigan among 6738 adults taking warfarin for atrial fibrillation and/or venous thromboembolism without an apparent indication for concomitant aspirin. Statistical analysis was conducted from November 26, 2020, to June 14, 2021. Primary care professionals for patients taking aspirin were asked whether an ongoing combination aspirin and warfarin treatment was indicated. If not, then aspirin was discontinued with the approval of the managing clinician. Outcomes were assessed before and after intervention for the primary analysis and before and after 24 months before the intervention (when rates of aspirin use first began to decrease) for the secondary analysis. Outcomes included the rate of aspirin use, bleeding, and thrombotic outcomes. An interrupted time series analysis assessed cumulative monthly event rates over time. A total of 6738 patients treated with warfarin (3160 men [46.9%]; mean [SD] age, 62.8 [16.2] years) were followed up for a median of 6.7 months (IQR, 3.2-19.3 months). Aspirin use decreased slightly from a baseline mean use of 29.4% (95% CI, 28.9%-29.9%) to 27.1% (95% CI, 26.1%-28.0%) during the 24 months before the intervention (P < .001 for slope before and after 24 months before the intervention) with an accelerated decrease after the intervention (mean aspirin use, 15.7%; 95% CI, 14.8%-16.8%; P = .001 for slope before and after intervention). In the primary analysis, the intervention was associated with a significant decrease in major bleeding events per month (preintervention, 0.31%; 95% CI, 0.27%-0.34%; postintervention, 0.21%; 95% CI, 0.14%-0.28%; P = .03 for difference in slope before and after intervention). No change was observed in mean percentage of patients having a thrombotic event from before to after the intervention (0.21% vs 0.24%; P = .34 for difference in slope). In the secondary analysis, reducing aspirin use (starting 24 months before the intervention) was associated with decreases in mean percentage of patients having any bleeding event (2.3% vs 1.5%; P = .02 for change in slope before and after 24 months before the intervention), mean percentage of patients having a major bleeding event (0.31% vs 0.25%; P = .001 for change in slope before and after 24 months before the intervention), and mean percentage of patients with an emergency department visit for bleeding (0.99% vs 0.67%; P = .04 for change in slope before and after 24 months before the intervention), with no change in mean percentage of patients with a thrombotic event (0.20% vs 0.23%; P = .36 for change in slope before and after 24 months before the intervention). This quality improvement intervention was associated with an acceleration of a preexisting decrease in aspirin use among patients taking warfarin for atrial fibrillation and/or venous thromboembolism without a clear indication for aspirin therapy. Reductions in aspirin use were associated with reduced bleeding. This study suggests that an anticoagulation clinic-based aspirin deimplementation intervention can improve guideline-concordant aspirin use.

Rosendaal linear interpolation method appraising of time in therapeutic range in patients with 12-week follow-up interval after mechanical heart valve replacement.

BackgroundThe objective of this study was to evaluate the quality of anticoagulation by the time in therapeutic range (TTR) for patients with 12-week INR follow-up interval.Materials and methodsFrom January 2018 to December 2020, a selective group of patients who underwent mechanical valve replacement and followed up at our anticoagulation clinic for adjustment of warfarin dose were enrolled. The incidences of complications of anticoagulation therapy were reported by linearized rates. TTR was calculated by the Rosendaal linear interpolation method.ResultsTwo hundred and seventy-four patients were eligible for this study. The mean age of these patients was 52.8 ± 12.7 years, and 65.7% (180 cases) of them were females. The mean duration of warfarin therapy was 16.7 ± 28.1 months. A total of 1309 INR values were collected, representing 66789 patient days. In this study, the mean TTR was 63.7% ± 18.6%, weekly doses of warfarin were 20.6 ± 6.0 mg/weekly, and the mean monitoring interval for the patient was 53.6 ± 27.1 days. There were 153 cases in good TTR group (TTR ≥ 60%) and 121 cases in poor TTR group (TTR < 60%). The calculated mean TTR in both groups was 42.6% ± 22.1% and 74.8% ± 10.4%, respectively. Compared with the TTR ≥ 60% group, the TTR < 60% group exhibited a more prevalence of female gender (p = 0.001), atrial fibrillation (p < 0.001), NYHA ≥ III (p < 0.001), and lower preoperative left ventricular ejection fraction (LVEF, p = 0.032). In multivariate analysis, female gender (p = 0.023) and atrial fibrillation (p = 0.011) were associated with TTR < 60%. The incidence of major bleeding and thromboembolic events was 2.7% and 1.1% patient-years, respectively. There was one death which resulted from cerebral hemorrhage. The incidence of death was 0.5% patient-years. The difference in anticoagulation-related complications between the TTR < 60% group and the TTR ≥ 60% group was not statistically significant.ConclusionFor patients with stable international normalized ratio monitoring results who are follow-up at anticoagulation clinics, a 12-week monitoring interval has an acceptable quality of anticoagulation. The female gender and atrial fibrillation were associated with TTR < 60%.

Time in therapeutic range for virtual anticoagulation clinic versus in-person clinic during the COVID-19 pandemic: a crossover study.

COVID-19 infection affects the quality of the medical services globally. The pandemic required changes to medical services in several institutions. We established a virtual clinic for anticoagulation management during the pandemic using the Whatsapp application. Compare anticoagulation management quality in virtual versus in-person clinics. A retrospective crossover study SETTINGS: Specialized cardiac care center PATIENTS AND METHODS: The study included patients who presented to Prince Sultan Cardiac Center in Riyadh for anticoagulation management during the pandemic from March 2020 to January 2021. We compared time in therapeutic range (TTR) in the same patients during virtual and in-person clinics. All international normalized ratio (INR) measures during the virtual clinic visits and prior ten INR measures from the in-person clinic were recorded. Patients who had no prior follow-up in the in-person clinic were excluded. TTR calculated using the Rosendaal method. 192 patients RESULTS: The mean age was 58.6 (16.6) years and 116 (60.4%) were males. Patients were diagnosed with atrial fibrillation (n=101, 52.6%), mechanical mitral valve (n=88, 45.8%), mechanical aortic valve (n=79, 41%), left ventricular thrombus (n=5, 2.6%) and venous thromboembolism (n=8, 4.2%). Riyadh residents represented 56.7% of the study population (n=93). The median (IQR) percent TTR was 54.6 (27.3) in the in-person clinic versus 50.0 (33.3) (P=.07). Virtual clinic results were comparable to in-person clinics for anticoagulation management during the COVID-19 pandemic. Number of INR measures during the virtual clinic visits, retrospective nature and single-center experience. None.

The challenge of managing multimorbid atrial fibrillation: a pan-European European Heart Rhythm Association (EHRA) member survey of current management practices and clinical priorities.

As part of the EHRS-PATHS study examining comorbidities in atrial fibrillation (AF) across Europe, the aim was (i) to evaluate how multimorbidity is currently addressed by clinicians during AF treatment to characterize the treatment structure and (ii) to assess how the interdisciplinary management of multimorbid AF is currently conducted. An online survey was distributed among European Heart Rhythm Association (EHRA) members in Europe that included 21 questions and a free-text option for comments on detection, assessment, and management of AF-related comorbidities. A total of 451 responses were received with 339 responses eligible for inclusion. Of these, 221 were male (66%), 300 (91.5%) were physicians, and 196 (57.8%) were working in academic university teaching hospitals. Half of the respondents managed between 20 and 50 patients per month with multimorbid AF. Varying rates of specialist services and referral to these services were available at each location (e.g. heart failure and diabetes), with a greater number of specialist services available at academic university teaching hospitals compared with non-teaching hospitals [e.g. anticoagulation clinic 92 (47%) vs. 50 (35%), P < 0.03]. Barriers to referring to specialist services for AF comorbidities included lack of integrated care model (n = 174, 51%), organizational or institutional issues (n = 145, 43%), and issues with patient adherence (n = 126, 37%), highlighting the need for organizational restructuring and developing an integrated collaborative evidenced-based approach to multimorbid AF care. The survey and analyses of free-text comments demonstrated the need for systematic, integrated management of AF-related comorbidities, and these results will inform the next phases of the EHRA-PATHS study.

Healthcare provider and patient perspectives on access to and management of atrial fibrillation in the Northern Province, Sri Lanka: a rapid evaluation of barriers and facilitators to care

BackgroundAtrial fibrillation (AF) is the most common cardiac arrhythmia that affects 60 million people worldwide. Limited evidence on AF management exists from low- and middle-income countries and none from Sri Lanka. We aimed to investigate the existing AF care pathway and patients’ perception on AF management to identify barriers and enablers for optimal AF care in Northern Province, Sri Lanka.MethodsA rapid evaluation was undertaken with use of qualitative methods. Local healthcare providers (HCPs) mapped the intended pathway of care for AF patients which was then explored and annotated through 12 iterative sessions with additional HCPs. Topics of inefficiencies identified from the finalised map were used to guide focus group discussions (FGDs) with AF patients. AF patients who were attending the anticoagulation clinic at the only tertiary hospital in Northern Province were recruited and invited to participate using purposive sampling. The topic guide was developed in collaboration with local clinicians and qualitative experts. FGDs were conducted in the native Tamil language and all sessions were recorded, transcribed verbatim and thematically analysed using a deductive approach.ResultsThe mapped pathway revealed inefficiencies in referral, diagnosis and ongoing management. These were explored through three FGDs conducted with 25 AF patients aged 25 to 70 years. Two key themes that contributed to and resulted in delays in accessing care and ongoing management were health seeking behaviours and atomistic healthcare structures. Four cross-cutting sub-themes identified were decision making, paternalistic approach to care, cost impacts and lifestyle impacts. These are discussed across 10 unique categories with consideration of the local context.ConclusionsStrengthening primary healthcare services, improving public health literacy regarding AF and building patient autonomy whilst understanding the importance of their daily life and family involvement may be advantageous in tackling the inefficiencies in the current AF care pathway in Sri Lanka.

Drug-related problem characterization and the solved status associated factor analysis in a pharmacist-managed anticoagulation clinic.

Drug-related problems (DRPs) in a pharmacist-managed anticoagulation clinic (AC) have not been extensively studied. We aimed to characterize the DRPs in a pharmacist-managed AC, identify the factors associated with the solved status of DRPs, and analyze the secondary outcomes, including the safety and efficacy of AC service. The patients receiving services at a pharmacist-managed AC in a medical center for the first time from March 2019 to August 2020 were reviewed retrospectively. The DRPs were retrieved from a self-developed Intelligent AC Service System and classified according to the Pharmaceutical Care Network Europe Foundation v9.0 classification system. Logistic regression models were performed to identify the potential factors associated with the solved status of DRPs. A total of 78 direct oral anticoagulant (DOAC) and 34 warfarin users were included. The major types of DRPs identified at the initial service were adverse drug events (ADEs) (68.4%) and untreated symptoms or indications (14.8%) in the DOAC group, and ADEs (51.6%) and suboptimal effect of drug treatment (38.7%) in the warfarin group. The rates of totally solved DRPs were 56.8% and 51.6% in the DOAC and warfarin groups, respectively. According to the multivariable analysis, receiving AC services 3 times or more in 180 days (OR 3.11, 95% CI 1.30–7.44) was associated with the totally solved status of DRPs in the DOAC group, but no relevant factor was identified in the warfarin group. The secondary outcomes showed that DOAC users demonstrated fewer thromboembolism events, major bleeding, and bleeding-related hospitalizations after AC services, whereas the warfarin users increased percentage time in therapeutic range (TTR% 55.0% vs. 74.6%, P = 0.006) after AC services. These findings may be utilized to develop DOAC and warfarin AC services.

Major bleedings in mechanical prosthetic heart valves patients on Vitamin K antagonist treatment. Data from the PLECTRUM Study

Patients with mechanical prosthetic heart valves (MHV) need vitamin K antagonist (VKA) treatment, due to the high thrombotic risk. The need to evaluate the bleeding risk of these patients is of great clinical relevance. This is an observational retrospective multicenter study among Centers affiliated to the Italian Federation of Anticoagulation Clinics on MHV patients, with the aim to evaluate the risk of major bleeding (MB) and associated risk factors. 2357 patients with MHV were included in the study, patients were followed for 24.081 pt-years; 246 patients had MB (rate 1.0 ×100 pt-yrs), 54 were intracranial hemorrhage (rate 0.22 ×100 pt-yrs). Patients with MB were significantly older, more affected by peripheral obstructive arterial disease (POAD) and atrial fibrillation (AF), and presented a history of previous MB, with respect to patients who did not bleed. Patients with MB showed a trend for lower time in therapeutic range (TTR), and a significant number of patients had a TTR in the lower quartile. Patients with MB had a higher mortality rate with respect to patients who did not bleed (p=0.001). The history of previous bleeding, the presence of POAD or of AF, and a TTR in the lowest quartile, were significantly associated with MB. MHV patients treated with VKAs followed by Anticoagulation Clinics, showed a low bleeding risk. Risk factors associated with major bleeding are older age, the presence of POAD or AF, the history of previous bleeding, and poor quality of anticoagulation. Patients who experienced MB during anticoagulation are at high risk of death.

Cost-Utility and Budget Impact Analysis of Implementing Anticoagulation Clinics and Point-of-Care Monitoring Devices in Anticoagulated Patients in Argentina.

BackgroundWorldwide, 1 % of the population receives anticoagulation therapy, with prevalence higher in older adults. Difficulties in the adequate management of these patients have led to the development of strategies focused on achieving therapeutic control and reducing adverse events with efficient use of resources.ObjectiveTo estimate the cost utility and budget impact on the Argentinean health system of implementation of anticoagulation clinics (ACs) (with and without use of point-of-care [POC] CoaguChek® devices [Roche Diagnostics International Ltd]) compared with the traditional laboratory method (non-AC settings) for the management of anticoagulated patients.MethodsFor the cost-utility analysis, a cohort-based state transition model was designed to compare costs and health outcomes of implementing ACs for outpatient management of anticoagulated patients. The budget impact analysis used an analytical model to estimate the differential costs of implementing an AC and the expected adverse events avoided, and the differential costs of an international normalized ratio (INR) determination using a POC device rather than a conventional laboratory.ResultsWe calculated the study outcomes for a cohort of 1000 patients. Considering a 5 % discount rate, the use of ACs generated 13.9 additional quality-adjusted life-years (0.014 per patient) and 12.5 additional life-years (0.013 per patient). Incremental cost-effectiveness ratios of AC implementation with and without the use of POC devices compared with the scenario without ACs were dominant in both cases. In the probabilistic sensitivity analysis, nearly all simulated results were cost effective (i.e., below the 1 or 3 gross domestic product per capita thresholds). Budget impact analysis results showed AC implementation generated savings from the first year of implementation, with savings of AR $265,325 by year 5. The addition of POC devices in the ACs also generated savings as early as the first year of implementation, with savings of AR $488,072 by year 5 (AR $488 per patient).ConclusionsAnticoagulation clinics are estimated to be cost effective and generate notable savings in the treatment of patients on long-term oral anticoagulant therapy when compared with non-AC settings. These savings are considerably higher when POC devices are added as part of the patient management, due to lower laboratory technician costs per INR determination.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-022-00352-4.

PHARMACOGENETIC TESTING AS AN ELEMENT OF PERSONALIZED MEDICINE IN REAL CLINICAL PRACTICE

Introduction . It has been proven that patients with thrombosis and with a high risk of systemic thromboembolic complications (TEС), including patients with non-valvular atrial fibrillation (AF) should receive effective and safe antithrombotic therapy [1–3]. A personalized approach to prolonged AVK therapy is associated with an improvement in hemostasiological markers of thrombinemia and clinical outcomes in patients with VTE and non-valvular AF [4–8]. Materials and methods . Prospective study was carried out on the basis of the anticoagulant clinic (AC) of the Department of hemostasis and atherothrombosis laboratory of the state budgetary health institution of the Arkhangelsk region “First city clinical hospital named after names E. E. Volosevich” (GBUZ AR FCCH). The object of the study is patients of the AVK registry who applied to the RCATT (n = 107) who underwent pharmacogenetic testing (CYP2C9, CYP4F2, VKORC1 genotype) with calculation of individual doses of warfarin and assessment of quality of life using validated questionnaires. The analysis of the effectiveness and safety of warfarin therapy was carried out. Results . It was found that complications of warfarin therapy developed regardless of the presence of the genotype (CYP2C9, CYP4F2, VKORC1) and the warfarin dosing algorithm under observation in AC. It has been shown that pharmacogenetic testing in patients with VTE and AF is an additional method under the condition of observation in AC. Conclusion . A personalized approach to prolonged VKA therapy using pharmacogenetic testing is appropriate for patients of the older age group, patients with a aggravated hemorrhagic history, frequent minor bleeding at target INR values and the presence of concomitant therapy with cytochrome P450 inhibitors.