Scores to predict major bleeding risk during oral anticoagulation therapy: a prospective validation study.

BACKGROUND: Clinical scores may help physicians to better assess the individual risk/benefit of oral anticoagulant therapy. We aimed to externally validate and compare the prognostic performance of 7 clinical prediction scores for major bleeding events during oral anticoagulation therapy. METHODS: We followed 515 adult patients taking oral anticoagulants to measure the first major bleeding event over a 12-month follow-up period. The performance of each score to predict the risk of major bleeding and the physician's subjective assessment of bleeding risk were compared with the C statistic. RESULTS: The cumulative incidence of a first major bleeding event during follow-up was 6.8% (35/515). According to the 7 scoring systems, the proportions of major bleeding ranged from 3.0% to 5.7% for low-risk, 6.7% to 9.9% for intermediate-risk, and 7.4% to 15.4% for high-risk patients. The overall predictive accuracy of the scores was poor, with the C statistic ranging from 0.54 to 0.61 and not significantly different from each other (P=.84). Only the Anticoagulation and Risk Factors in Atrial Fibrillation score performed slightly better than would be expected by chance (C statistic, 0.61; 95% confidence interval, 0.52-0.70). The performance of the scores was not statistically better than physicians' subjective risk assessments (C statistic, 0.55; P=.94). CONCLUSION: The performance of 7 clinical scoring systems in predicting major bleeding events in patients receiving oral anticoagulation therapy was poor and not better than physicians' subjective assessments.

Scores to predict major bleeding risk during oral anticoagulation therapy: a prospective validation study

Clinical scores may help physicians to better assess the individual risk/benefit of oral anticoagulant therapy. We aimed to externally validate and compare the prognostic performance of 7 clinical prediction scores for major bleeding events during oral anticoagulation therapy.

Risk of falls and major bleeds in patients on oral anticoagulation therapy

The risk of falls is the most commonly cited reason for not providing oral anticoagulation, although the risk of bleeding associated with falls on oral anticoagulants is still debated. We aimed to evaluate whether patients on oral anticoagulation with high falls risk have an increased risk of major bleeding.

The management of patients on oral anticoagulation undergoing coronary stent implantation: a survey among interventional cardiologists from eight European countries

To evaluate the current management, and adherence to recommendations, of patients on oral anticoagulation (OAC) undergoing coronary stent implantation (PCI-S).

Patient self-management of long-term oral anticoagulation in Switzerland

Indications for oral anticoagulation (OAC) have increased in recent years. OAC requires frequent monitoring of the prothrombin time to keep the intensity within the therapeutic range and to minimise the risk for complications. Patient self-management (PSM) has been found to improve the quality of OAC. The present study aimed to investigate the first 330 patients performing PSM in Switzerland. A questionnaire was sent to all patients who followed a teaching program for PSM of OAC between 1998 and 2003. Moreover, family physicians were contacted and/or discharge letters were obtained from the hospitals or the treating physicians. During the study period 13 patients died. Out of the 300 patients providing information 254 (85%) still perform PSM. At least one INR determination per two weeks was done by 74% of the patients and 25% performed at least one INR measurement every 15-30 days. The median time spent within the individual INR target range was 72%. No thromboembolic complications occurred, however, among the 13 patients who died, 1 had myocardial infarction and 6 died of heart failure. When counting these events as arterial thromboembolic complications the frequency was 0.6 (95% CI: 0.3-1.3) per 100 patient-years. The frequency of major bleeding was 0.6 (95% CI: 0.2-1.3) per 100 patient-years. We conclude from this study investigating a real-world patient collective that PSM is suitable and safe for the patients identified by their family physicians and successfully trained by our training centre.

Patient self-management of oral anticoagulation with vitamin k antagonists in everyday practice: efficacy and safety in a nationwide long-term prospective cohort study.

Patient self-management (PSM) of oral anticoagulation is under discussion, because evidence from real-life settings is missing. Using data from a nationwide, prospective cohort study in Switzerland, we assessed overall long-term efficacy and safety of PSM and examined subgroups. Data of 1140 patients (5818.9 patient-years) were analysed and no patient were lost to follow-up. Median follow-up was 4.3 years (range 0.2-12.8 years). Median age at the time of training was 54.2 years (range 18.2-85.2) and 34.6% were women. All-cause mortality was 1.4 per 100 patient-years (95% CI 1.1-1.7) with a higher rate in patients with atrial fibrillation (2.5; 1.6-3.7; p<0.001), patients>50 years of age (2.0; 1.6-2.6; p<0.001), and men (1.6; 1.2-2.1; p = 0.036). The rate of thromboembolic events was 0.4 (0.2-0.6) and independent from indications, sex and age. Major bleeding were observed in 1.1 (0.9-1.5) per 100 patient-years. Efficacy was comparable to standard care and new oral anticoagulants in a network meta-analysis. PSM of properly trained patients is effective and safe in a long-term real-life setting and robust across clinical subgroups. Adoption in various clinical settings, including those with limited access to medical care or rural areas is warranted.

Development and trialling of a behavioural intervention for patients with atrial fibrillation initiating oral anticoagulation:the 'treat' study

Purpose: Atrial fibrillation (AF) is the most common heart arrhythmia and is associated with an increased risk of stroke. Stroke risk is commonly treated with oral anticoagulation (OAC) with a narrow therapeutic range (INR 2.0 to 3.0); which is poorly controlled in practice. Barriers to adherence include poor knowledge, and inaccurate perceptions surrounding illness and medications. Trial registration: ISRCTN93952605. Systematic review: Seven trials of educational, self-monitoring and decision aid interventions were included in a systematic review. Pooled analysis suggested education OR, 95% CI 7.89 (5.54-10.24) and self monitoring OR (95% CI) 5.47(2.55-8.39) significantly improve TTR; whereas decision aids are no more effective in reducing decision conflict than usual care, OR (95% CI) -0.10 (-0.17 to -0.02). Intervention development: The intervention was theoretically-driven (utilising the common sense and beliefs about medication models) and developed with expert patient feedback. Described using behavioural change techniques, the one-off group session included an educational booklet, ‘expert-patient’ focussed DVD, and worksheet. Methods: Ninety seven warfarin-naïve AF patients were randomised to receive the intervention (n=43), or usual care (n=54). The primary endpoint was time within therapeutic range (TTR), secondary endpoints included knowledge, quality of life (AF-QoL-18), beliefs about medication (BMQ), illness perceptions (IPQ-B), and anxiety and depression (HADS). Results: Intervention group had significantly higher TTR than usual care (78.5% vs. 66.7%; p=0.01). Knowledge changed significantly across time (F (3, 47) = 6.4; p<0.01), but not between groups (F (1, 47) = 3.3; p = 0.07). At six months knowledge predicted TTR (r=0.245; p=0.04). Illness concern negatively correlated with TTR (r= - 0.199; p=0.05). General Harm scores at one month predicted TTR (F (1, 72) = 4.08; p=0.048). There were significant differences in emotional representations (F (3, 49) = 3.3 (3, 49); p= 0.03), anxiety (F (3, 46) = 25.2; p<0.01) and depression (F (3, 46) = 37.7; p<0.01) across time. Conclusion: A theory-driven educational intervention can improve TTR in AF patients and potentially reduce the risk of adverse clinical outcomes. Improving education provision for AF patients is essential to ensure efficacious treatment.

Psychological influence of the media on patients commencing oral anticoagulation in atrial fibrillation:a qualitative analysis

Background: Oral anticoagulation (OAC) reduces stroke risk in patients with atrial fibrillation (AF); however it is still underutilized and sometimes refused by patients. Two inter-related studies were undertaken to understand the experiences and what influences this un- derutilisation of warfarin treatment in AF patients. These studies explored physician and patient experiences of AF and OAC treatment. The paper focuses on specific sub-themes from the study that explored patients’ experiences will be discussed. Aim: The study in question aimed to explore the experiences which influence patients’ decisions to accept, decline or discontinue OAC. Methods: Semi-structured individual interviews with patients were con- ducted. Three sub-groups of patients (n = 11) diagnosed with AF were interviewed; those who accepted, refused, and who discontinued war- farin. Interpretative phenomenological analysis (IPA) was used to examine the data. IPA is a qualitative method that focuses on how participants make sense of an experiences phenomenon Results: Three over-arching themes comprised patients’ experiences: (i)the initial consultation, (ii) life after the consultation, and (iii) patients’reflections. In the last theme, patients reflected on their perceptions ofaspirin and warfarin. Aspirin was perceived as a natural wonder-drugwhile warfarin was perceived as a dangerous drug usually given to peo-ple at the end of their life. Interestingly they perceive both drugs as‘old’. However, for aspirin it had a positive association, old meaningtried and tested. While for warfarin, old meant ‘has been around fortoo long’.Conclusion: Media had an important role in how patients’ perceptionsof these two drugs were influenced. Literature shows that framingtechniques, i.e. using certain words or phrases such as ‘rat poison’, areprocesses adopted by media to alter medical knowledge into lay per-son’s language. Patients in turn form negative cognitive schemas,between the word ‘poison’ and warfarin, leading to the negative per-ception of warfarin which could influence non-adherence to treatment.This qualitative research highlighted the potential influences of themedia on AF patient perceptions commencing OAC treatment. Theassociation between media stimuli and patient perceptions on OACshould be further explored. The influential power of lay-media couldalso be instrumental in disseminating appropriate educational materialto the public

Oral Anticoagulation in the Elderly: New Oral Anticoagulants-Innovative Solution for an Old Problem?

Direct oral anticoagulants emerge as the most innovative and promising drug toward preventing and treating cardiovascular disease, raising great interest among the scientific community. Numerous studies and meta-analysis generated much data clarifying clinicians' doubts; however, uncertainties remain regarding their use in particular groups such as patients with prosthetic valves, in valvular atrial fibrillation (defined as atrial fibrillation related to mitral rheumatic heart disease or prosthetic heart valves), among the elderly, in paraneoplastic thromboembolism, in pulmonary embolism with hemodynamic compromise, and scarcity of specific antidotes. This review article intends to condense the vast scientific production addressing new oral anticoagulants by focusing on their advantages and disadvantages when used on the elderly.

Oral anticoagulation in atrial fibrillation, the patients and physicians experiences of the consultation:a qualitative study

Background: Oral anticoagulation (OAC) reduces stroke risk in patients with atrial fibrillation (AF), however it is still underutilized and sometimes refused by patients. This project was divided in two inter-related studies. Study 1 explored the experiences that influence prescription of OAC by physicians. Study 2 explored the experiences which influence patients' decisions to accept, decline or discontinue OAC. Methods: Semi-structured individual interviews were conducted in both studies. In Study 1four sub-groups of physicians (n = 16) experienced with OAC in AF were interviewed: consultant cardiologists, consultant general physicians, general practitioners and cardiology registrars. In Study 2 three sub-groups of patients (n = 11) diagnosed with AF were interviewed; those who accepted, refused, and who discontinued warfarin. Results: Study 1: Two over-arching themes emerged from doctors' experiences: (1) communicating information and (2) challenges with OAC prescription for AF. Physicians still adopt a paternalistic approach to decision-making. They should instead motivate patients to take part in treatment discussions and choices should reflect the patient's needs and concerns. Physician education should focus more on communication skills, individualised care and time-management as these are critical for patient adherence. Continuous OAC education for AF should adopt a multi-disciplinary approach. Further, interpreters should also be educated on medical communication skills. Study 2: Three over-arching themes comprised patients' experiences: (1) the initial consultation, (2) life after the consultation, and (3) patients' reflections. Patient education during the initial consultation was critical in increasing patient's knowledge of OAC. On-going patient education is imperative to maintain adherence. Patients valued physicians' concern for their needs during decision-making. Patients who had experience of stroke were more receptive to education aimed towards stroke risk reduction rather than bleeding risk. Patients' perceptions of warfarin are also influenced by the media. Comment: Qualitative research is crucial in exploring barriers to treatment as it provides an excellent insight into patients' experiences of healthcare. A patient-centred approach should be adopted and incorporated into physicians' education. Education and patient involvement in the decision-making process is essential to promote treatment acceptance and long-term adherence

Oral anticoagulation in octogenarians with atrial fibrillation

Vitamin K antagonists (VKAs) are still largely employed, even in nonvalvular atrial fibrillation (AF). Our aim was to study the clinical profile of octogenarians treated with oral anticoagulation and to study the effect of age on the quality of VKAs anticoagulation. Data are from a prospective national registry in an adult Spanish population of nonvalvular AF. We included 1637 patients who had been receiving VKAs for at least 6 months before enrolment. Mean age was 73.8 ± 9.4 years. Patients aged > 80 years (N = 429) had a high risk profile with higher risk of stroke and bleeding than younger patients; CHA2DS2-VASc (Cardiac failure, Hypertension, Age > 74, Diabetes, Stroke, Vascular disease, Age 65–74 years, and Sex category) 4.5 ± 1.3 vs. 3.5 ± 1.6, p < 0.001, HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (> 64 years), Drugs/alcohol concomitantly) 2.4 ± 0.9 vs. 1.9 ± 1.1, p < 0.001. Creatinine clearance was lower in octogenarians than in younger patients (54.3 ± 16.1 ml/min vs. 69.5 ± 23.7 ml/min, p < 0.001) and severe renal disease with creatinine clearance < 30 ml/min was more frequent in octogenarians (5.2% vs. 2.2%, p < 0.001). In patients treated with VKAs (N = 1637), the international normalized ratio values of the 6 months previous to enrollment were similar in all age quartiles, as was the time in the therapeutic range. In this large registry octogenarians with nonvalvular AF had high risk of stroke and bleeding and frequent renal disease. VKAs anticoagulation quality was similar in octogenarians and in younger patients.

Relação da doença periodontal com a anticoagulação oral e os benefícios do tratamento periodontal em pacientes anticoagulados

Anticoagulantes orais são amplamente indicados para prevenção de eventos tromboembólicos. No entanto, nem sempre os pacientes atingem a faixa terapêutica recomendada. Os objetivos desse estudo foram avaliar a associação entre periodontite e níveis de anticoagulação (fase 1) e o efeito do tratamento periodontal nos níveis de anticoagulação (fase 2) em pacientes que faziam uso do anticoagulante oral varfarina. O exame clínico incluiu índice CPO-D, índice de placa, sangramento à sondagem, profundidade de bolsa e nível de inserção clínica. Coeficiente normalizado internacional (INR), níveis de albumina, proteína C-reativa (PCR) e fibrinogênio foram avaliados no dia zero e até 180 dias após tratamento periodontal. Na fase 1 do estudo foram examinados 62 pacientes (42 mulheres e 20 homens, com idade média de 50,8 9,2 anos). Observamos uma correlação negativa entre extensão e severidade da doença periodontal e índice de placa com valores de INR. Não houve associação entre diagnóstico periodontal e níveis de anticoagulação. Dentre os pacientes fora do alvo terapêutico, 87% apresentavam diagnóstico de periodontite, enquanto no grupo na faixa terapêutica apenas 56%. Participaram da fase 2 do estudo 26 pacientes com periodontite severa (15 mulheres e 11 homens, com idade média de 51,3 9,2 anos). O tratamento periodontal resultou em melhora significativa de todos os parâmetros periodontais e dos níveis de anticoagulação 30, 60 90 e 180 dias após conclusão da terapia periodontal. Não houve alteração significativa na dose semanal da varfarina. Foi observada redução significativa entre níveis séricos de albumina dos dia 90 e 180 após a terapia periodontal, quando comparado aos valores do dia 0 (p < 0,05). De acordo com o alvo terapêutico estabelecido, observamos que no dia 0 doze pacientes (46,15%) estavam fora dessa faixa. Esse percentual foi reduzido significativamente após tratamento periodontal, sendo 26,1% e 29,2% nos dias 60 e 90, respectivamente. Embora tenha ocorrido melhora nos níveis de anticoagulação, não houve alteração significativa nos níveis de PCR e fibrinogênio. Sendo assim, pacientes com periodontite severa podem apresentar dificuldade para atingir a faixa terapêutica e o tratamento periodontal pode resultar em benefícios na busca da anticoagulação plena. Novos estudos são necessários para avaliar se formas menos severas de doença periodontal também podem interferir com a varfarina.

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.

BACKGROUND: Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument - the Duke Anticoagulation Satisfaction Scale (DASS). METHODS: The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. RESULTS: 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78-0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. CONCLUSIONS: The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.

Atrial assist device, a new alternative to lifelong anticoagulation?

OBJECTIVE: Atrial fibrillation is a very common heart arrhythmia, associated with a five-fold increase in the risk of embolic strokes. Treatment strategies encompass palliative drugs or surgical procedures all of which can restore sinus rhythm. Unfortunately, atria often fail to recover their mechanical function and patients therefore require lifelong anticoagulation therapy. A motorless volume displacing device (Atripump) based on artificial muscle technology, positioned on the external surface of atrium could avoid the need of oral anticoagulation and its haemorrhagic complications. An animal study was conducted in order to assess the haemodynamic effects that such a pump could provide. METHODS: Atripump is a dome-shape siliconecoated nitinol actuator sewn on the external surface of the atrium. It is driven by a pacemaker-like control unit. Five non-anticoagulated sheep were selected for this experiment. The right atrium was surgically exposed, the device sutured and connected. Haemodynamic parameters and intracardiac ultrasound (ICUS) data were recorded in each animal and under three conditions; baseline; atrial fibrillation (AF); atripump assisted AF (aaAF). RESULTS: In two animals, after 20 min of AF, small thrombi appeared in the right atrial appendix and were washed out once the pump was turned on. Assistance also enhanced atrial ejection fraction. 31% baseline; 5% during AF; 20% under aaAF. Right atrial systolic surfaces (cm2) were; 5.2 +/- 0.3 baseline; 6.2 +/- 0.1 AF; 5.4 +/- 0.3 aaAF. CONCLUSION: This compact and reliable pump seems to restore the atrial "kick" and prevents embolic events. It could avoid long-term anticoagulation therapy and open new hopes in the care of end-stage heart failure.