Integrated Care for Atrial Fibrillation Management: The Role of the Pharmacist.

Within Europe and the Asia-Pacific, the Atrial Fibrillation Better Care (ABC) pathway is the gold standard integrated care strategy for atrial fibrillation management. Atrial fibrillation diagnosis should be confirmed and characterized (CC) prior to implementation of ABC pathway components: 1) "A"- Anticoagulation/Avoid stroke; 2) "B"- Better symptom management; and 3) "C"- Cardiovascular and other comorbidity optimization. Pharmacists have the potential to expedite integrated care for atrial fibrillation across the health care continuum: hospital, community pharmacy, and general practice. This review summarizes the available evidence base for pharmacist-led implementation of the "CC to ABC" model.

Integrated care for optimizing the management of stroke and associated heart disease: a position paper of the European Society of Cardiology Council on Stroke.

The management of patients with stroke is often multidisciplinary, involving various specialties and healthcare professionals. Given the common shared risk factors for stroke and cardiovascular disease, input may also be required from the cardiovascular teams, as well as patient caregivers and next-of-kin. Ultimately, the patient is central to all this, requiring a coordinated and uniform approach to the priorities of post-stroke management, which can be consistently implemented by different multidisciplinary healthcare professionals, as part of the patient 'journey' or 'patient pathway,' supported by appropriate education and tele-medicine approaches. All these aspects would ultimately aid delivery of care and improve patient (and caregiver) engagement and empowerment. Given the need to address the multidisciplinary approach to holistic or integrated care of patients with heart disease and stroke, the European Society of Cardiology Council on Stroke convened a Task Force, with the remit to propose a consensus on Integrated care management for optimizing the management of stroke and associated heart disease. The present position paper summarizes the available evidence and proposes consensus statements that may help to define evidence gaps and simple practical approaches to assist in everyday clinical practice. A post-stroke ABC pathway is proposed, as a more holistic approach to integrated stroke care, would include three pillars of management: A: Appropriate Antithrombotic therapy.B: Better functional and psychological status.C: Cardiovascular risk factors and Comorbidity optimization (including lifestyle changes).

Beyond the 2020 guidelines on atrial fibrillation of the European society of cardiology.

The most recent atrial fibrillation (AF) guidelines delivered by European Society of Cardiology (ESC) offer an updated approach to AF management, with the perspective of improved characterization of the arrhythmia, the cardiac substrate and the patients profile in terms of associated risk factors and comorbidities. Recommendations were based on careful scrutiny and assessment of all available evidence with the final aim to offer to practitioners a lower level of uncertainty in the complex process of decision making for patients with AF. The 2020 ESC guidelines on AF propose a paradigm shift in the clinical approach to AF patients, moving from a single-domain AF classification to comprehensive characterization of AF patients. Given the complex nature of AF, an integrated holistic management of AF patients is suggested by the guidelines for improving patients outcomes through the formal introduction of the CC (Confirm AF and Characterize AF) to ABC (Atrial fibrillation Better Care) pathway. In line with this concept, these new guidelines underline the importance of a more comprehensive management of AF patients which should not be limited to simply prescribe oral anticoagulation or decide between a rhythm or rate control strategy. Indeed, each step of the ABC pathway represents one of the pivotal pillars in the management of AF and only a holistic approach has the potential to improve patients' outcomes. In this review we will discuss the background that supports some of the new recommendations of 2020 ESC guidelines, with important implications for daily management of AF patients.

Optimization of atrial fibrillation care: management strategies and quality measures.

Atrial fibrillation (AF) is the most common cardiac arrhythmia and a leading cause of mortality and morbidity. Optimal management of AF is paramount to improve quality of life and reduce the impact on health and social care services. Owing to its strong associations with other cardiovascular and non-cardiovascular comorbidities, a holistic management approach to AF care is advocated but this is yet to be clearly defined by international clinical guidelines. This ambiguity has prompted us to review the available clinical evidence on different management strategies to optimize AF care in the context of performance and quality measures, which can be used to objectively assess standards of care.

Practice-derived data on non-vitamin K antagonist oral anticoagulant therapy to complement observations from randomized trials.

Anticoagulation is fundamental in the management of patients with atrial fibrillation (AF). The study aims to provide a comparative review of the major phase III randomized clinical trials (RCTs) and real-world data (RWD) from reliable, high-grade Phase IV studies that assess the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) vs. vitamin K antagonists (VKAs). Observational studies based on nationwide or health insurance database records on the use of NOACs vs. VKAs in patients with AF were included. We performed a comparison of the efficacy and safety characteristics associated with NOACs vs. VKAs in RCTs and RWD. Although RCTs provide strong support for evidence-based practice, RWD may be used to reflect the broader picture of various clinical settings, provide supplementary insight and fulfil knowledge gaps. Both study types confirmed the safety and efficacy of NOACs in preventing stroke and thromboembolism in patients with AF. In comparison to VKAs, NOACs were associated with reduced risk of ischaemic events and lower rates of adverse events such as major bleeding or intracranial haemorrhage. Administration of NOACs might be associated with increased risk of dose-related gastrointestinal bleeding and myocardial ischaemic events, especially in the early treatment period after switching from VKAs. Special care should be taken in challenging clinical situations like severe renal or hepatic impairment when the treatment regimen needs to be considered individually. Randomized clinical trial and RWD studies are complementary and present comparable findings, affirming that NOACs are safe and effective for anticoagulation of patients with AF in daily clinical practice.

Comprehensive Management With the ABC (Atrial Fibrillation Better Care) Pathway in Clinically Complex Patients With Atrial Fibrillation: A Post Hoc Ancillary Analysis From the AFFIRM Trial.

Background For patients with atrial fibrillation, a comprehensive care approach based on the Atrial fibrillation Better Care (ABC) pathway can reduce the occurrence of adverse outcomes. The aim of this paper was to investigate if an approach based on the ABC pathway is associated with a reduced risk of adverse events in "clinically complex" atrial fibrillation patients, including those with multiple comorbidities, polypharmacy, and prior hospitalizations. Methods and Results We performed a post hoc analysis of the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial. The principal outcome was the composite of all-cause hospitalization and all-cause death. An integrated care approach (ABC group) was used in 3.8% of the multimorbidity group, 4.0% of the polypharmacy group, and 4.8%, of the hospitalized groups. In all "clinically complex" groups, the cumulative risk of the composite outcome was significantly lower in patients managed consistent with the ABC pathway versus non-ABC pathway-adherent (all P<0.05). Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups. Secondary analyses showed that the higher number of ABC criteria fulfilled the larger associated reduction in relative risk, even for secondary outcomes considered. Conclusions Use of an ABC consistent pathway is associated with fewer major adverse events in patients with atrial fibrillation who have multiple comorbidities, use of polypharmacy, and prior hospitalization.

Regular Bleeding Risk Assessment Associated with Reduction in Bleeding Outcomes: The mAFA-II Randomized Trial.

BACKGROUND: The mobile atrial fibrillation application (mAFA-II) randomized trial reported that a holistic management strategy supported by mobile health reduced atrial fibrillation-related adverse outcomes. The present study aimed to assess whether regular reassessment of bleeding risk using the Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratio, Elderly, Drugs or alcohol (HAS-BLED) score would improve bleeding outcomes and oral anticoagulant (OAC) uptake. METHODS: Bleeding risk (HAS-BLED score) was monitored prospectively using mAFA, and calculated as 30 days, days 31-60, days 61-180, and days 181-365. Clinical events and OAC changes in relation to the dynamic monitoring were analyzed. RESULTS: We studied 1793 patients with atrial fibrillation (mean, standard deviation, age 64 years, 24 years, 32.5% female). Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED ≥3 decreased (11.8% vs 8.5%, P = .008), with changes in use of concomitant nonsteroidal antiinflammatory drugs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED ≥3 (P < .05). Among 1077 (60%) patients who had 4 bleeding risk assessments, incident bleeding events decreased significantly from days 1-30 to days 181-365 (1.2% to 0.2%, respectively, P < .001). Total OAC usage increased from 63.4% to 70.2% (Ptrend < .001). Compared with atrial fibrillation patients receiving usual care (n = 1136), bleeding events were significantly lower in atrial fibrillation patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%, P = .004). OAC use decreased significantly by 25% among AF patients receiving usual care, when comparing baseline to 12 months (P < .001). CONCLUSION: Dynamic risk monitoring using the HAS-BLED score, together with holistic App-based management using mAFA-II reduced bleeding events, addressed modifiable bleeding risks, and increased uptake of OACs.

Mobile Health Technology to Improve Care for Patients With Atrial Fibrillation.

BACKGROUND: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines, and lack of consideration of patients' preferences, thus highlighting the need for a more holistic and integrated approach to AF management. OBJECTIVE: The objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care. METHODS: This is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk. RESULTS: There were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of 'ischemic stroke/systemic thromboembolism, death, and rehospitalization' were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05). CONCLUSIONS: An integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138).

Mobile Health (mHealth) technology for improved screening, patient involvement and optimising integrated care in atrial fibrillation: The mAFA (mAF-App) II randomised trial.

BACKGROUND: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines and lack of consideration of patient's preferences, thus highlighting the need for a holistic and integrated approach to AF management. This study aims to determine whether a mHealth technology-supported AF integrated management strategy will reduce AF-related adverse events. METHODS/DESIGN: The mAFA II trial is a prospective, cluster randomised controlled trial. The 40 sites will be randomised to mAFA-integrated care intervention or usual care arms. Prior to randomisation, study sites will be paired to be matched in size and the proportion of study eligible patients. All AF patients aged over 18 years old with CHA2 DS2 -VASc score ≥ 2 will be enrolled. Assuming a composite adverse event rate of 10% pre-intervention, reduced to 5% after intervention, we aim to recruit 3660 patients assuming a 10% loss to follow-up. The primary study endpoint is a composite of stroke/thromboembolism, all-cause death and rehospitalisation. Ancillary analyses would determine patient-related outcome measures, health economics and cost effectiveness, as well as an embedded qualitative study. DISCUSSION: The mAFA II trial will provide evidence for an integrated care approach to holistic AF care, supported by mobile health technology to improve screening, patient involvement and optimisation of management.

Stroke Prevention, Evaluation of Bleeding Risk, and Anticoagulant Treatment Management in Atrial Fibrillation Contemporary International Guidelines.

In recent years the management of atrial fibrillation patients has progressively and substantially changed because of the introduction of new treatments and the availability of new data regarding the epidemiology and clinical management of these patients. In the past 2 years alone, there have been 7 new guidelines or guideline updates that have been published, which have introduced new recommendations and significantly revised previously published ones. Two updates for Canadian guidelines were published in 2016 and 2018, whereas guidelines from the European Society of Cardiology in 2016, Asia Pacific Heart Rhythm Society were published in 2017, National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand, American College of Chest Physicians, and Korean Heart Rhythm Society have been published in 2018. In this narrative review we provide a comparison of these contemporary international guidelines, with particular attention on the evaluation of thromboembolic and bleeding risks and management of oral anticoagulant therapy. From the analysis of contemporary guidelines on the management of atrial fibrillation, a general agreement is evident about the baseline evaluation of thromboembolic and bleeding risk, as well as a preference for the use of non-vitamin K antagonist oral anticoagulants. Also, regarding the concomitant use of oral anticoagulant and antiplatelet drugs in patients with acute coronary syndromes, undergoing elective percutaneous coronary intervention, catheter ablation, and cardioversion procedures, all of the guidelines agree on the general principles and are supported by evidence. More data are still needed to better substantiate recommendations for specific atrial fibrillation subpopulations. The need for an integrated approach and holistic management is highlighted in the more recently published guidelines.

Improved Outcomes by Integrated Care of Anticoagulated Patients with Atrial Fibrillation Using the Simple ABC (Atrial Fibrillation Better Care) Pathway.

BACKGROUND: Integrated care for the clinical management of atrial fibrillation patients is advocated as a holistic way to improve outcomes; the simple Atrial fibrillation Better Care (ABC) pathway has been proposed. The ABC pathway streamlines care as follows: 'A' Avoid stroke; 'B' Better symptom management; 'C' Cardiovascular and Comorbidity optimization. METHODS: We performed a post hoc analysis of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) trial. An 'integrated care' approach was defined according to the ABC pathway. Patients fulfilling all criteria were categorized as the 'ABC' group; those not fulfilling all criteria were the 'non-ABC' group. Trial-adjudicated all-cause death, composite outcome of stroke/major bleeding/cardiovascular death, and first hospitalization were the main study outcomes. RESULTS: Among the 4060 patients in the original cohort, 3169 (78%) had available data to compare integrated care (ABC; n = 222; 7%) vs non-ABC (n = 2947; 93%) management. Over a median follow-up of 3.7 (interquartile range, 2.8-4.6) years, atrial fibrillation patients managed with integrated care (ABC group) had lower rates for all study outcomes (all P < .001) compared with the non-ABC group. A Cox multivariable regression analysis showed that atrial fibrillation patients managed in the ABC group had a significantly lower risk of all-cause death (hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.17-0.75), composite outcome (HR, 0.35; 95% CI, 0.18-0.68), and first hospitalization (HR, 0.65; 95% CI, 0.53-0.80). CONCLUSIONS: The simple ABC pathway allows the streamlining of integrated care for atrial fibrillation patients in a holistic manner and is associated with a lower risk of adverse outcomes (including mortality, stroke/major bleeding/cardiovascular death, and hospitalization).

Integrating new approaches to atrial fibrillation management: the 6th AFNET/EHRA Consensus Conference.

There are major challenges ahead for clinicians treating patients with atrial fibrillation (AF). The population with AF is expected to expand considerably and yet, apart from anticoagulation, therapies used in AF have not been shown to consistently impact on mortality or reduce adverse cardiovascular events. New approaches to AF management, including the use of novel technologies and structured, integrated care, have the potential to enhance clinical phenotyping or result in better treatment selection and stratified therapy. Here, we report the outcomes of the 6th Consensus Conference of the Atrial Fibrillation Network (AFNET) and the European Heart Rhythm Association (EHRA), held at the European Society of Cardiology Heart House in Sophia Antipolis, France, 17-19 January 2017. Sixty-two global specialists in AF and 13 industry partners met to develop innovative solutions based on new approaches to screening and diagnosis, enhancing integration of AF care, developing clinical pathways for treating complex patients, improving stroke prevention strategies, and better patient selection for heart rate and rhythm control. Ultimately, these approaches can lead to better outcomes for patients with AF.

Non-vitamin K antagonist oral anticoagulants (NOACs) in patients with concomitant atrial fibrillation and heart failure: a systemic review and meta-analysis of randomized trials.

BACKGROUND: No pooled analysis has been undertaken to assess the efficacy and safety of the non-vitamin K antagonist oral anticoagulants (NOACs) compared with warfarin in the subgroup of patients with atrial fibrillation (AF) and heart failure (HF), including edoxaban data from recent randomized controlled trials (RCTs). METHODS: Comprehensive literature searches were conducted using the Cochrane Library, MEDLINE, and Scopus databases from inception to April 2015. Statistical analyses were performed using RevMan 5.3 software. RESULTS: Four RCTs were included: 19 122 of 32 512 AF patients with HF were allocated to a NOAC (13 384 receiving single-/high-dose NOAC regimens), and 13 390 to warfarin. Among AF patients with HF, single/high-dose NOACs significantly reduced the risk of stroke/systemic embolic (SE) events by 14% [odds ratio0.86, 95% confidence interval (CI) 0.76-0.98), and had a 24% lower risk of major bleeding(OR 0.76, 95% CI 0.67-0.86). For low-dose NOAC regimens, comparable efficacy to warfarin for stroke or SE events (OR 1.02, 95% CI 0.86-1.21) and a non-significant trend for lower major bleeding was observed. Regardless of high- or low-dose NOAC, the incidences of both major bleeding and stroke/SE in AF patients with HF were similar to those without HF. Atrial fibrillation patients with HF on NOACs had a 41% lower risk of intracranial haemorrhage compared with those without HF (OR 0.59, 95% CI 0.40-0.87). CONCLUSION: Among AF patients with HF, single-/high-dose NOAC regimens have a better efficacy and safety profile, but low-dose regimens had similar efficacy and safety to warfarin. NOACs were similarly effective or even safer (less intracranial haemorrhage) in AF patients with HF compared with those without HF.

Renal function and non-vitamin K oral anticoagulants in comparison with warfarin on safety and efficacy outcomes in atrial fibrillation patients: a systemic review and meta-regression analysis.

OBJECTIVE: To investigate the relative effect of warfarin versus non-vitamin K oral anticoagulants (NOACs) in thrombotic and bleeding outcomes in subgroups of atrial fibrillation (AF) patients with varying degrees of renal dysfunction. METHODS: Systemic review and meta-regression analyses on NOACs versus warfarin, supplemented with indirect comparisons were conducted. The eligibility criteria for inclusion were randomised controlled trials comparing NOACs against warfarin for stroke prevention in AF patients. Outcomes of interest were stroke or systemic embolism (SE) and major bleeding. RESULTS: Five studies comprising 72,845 AF patients randomised to either a NOAC or warfarin were included in the meta-regression analysis. A shift in strata from no renal impairment to renal impairment resulted in a non-significant impact on bleeding and stroke/SE, indicating similar safety and efficacy, despite renal function status. Apixaban was associated with less major bleeding compared to dabigatran and rivaroxaban but not edoxaban in patients with moderate renal impairment. For efficacy outcomes, only dabigatran 150 mg was statistically significantly favoured compared to edoxaban 30 mg. For efficacy outcomes in mild renal impairment, both dabigatran 150 mg and rivaroxaban 10 mg (J-ROCKET) were statistically significantly favoured against edoxaban 30 mg. CONCLUSION: Non-vitamin K oral anticoagulants had similar efficacy and safety compared to warfarin across different levels of renal function. Indirect comparisons suggest that apixaban and edoxaban were associated with a better safety profile in patients with moderate renal impairment. However, caution is warranted when interpreting indirect comparisons of drugs investigated in different trials. Prescribers should fit the most appropriate NOAC to the AF patient characteristics (and vice versa) to individualise effective stroke prevention.

Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

BACKGROUND: The risk of stroke varies considerably across different groups of patients with atrial fibrillation (AF). Antithrombotic prophylaxis for stroke is associated with an increased risk of bleeding. We provide recommendations for antithrombotic treatment based on net clinical benefit for patients with AF at varying levels of stroke risk and in a number of common clinical scenarios. METHODS: We used the methods described in the Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines article of this supplement. RESULTS: For patients with nonrheumatic AF, including those with paroxysmal AF, who are (1) at low risk of stroke (eg, CHADS(2) [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack] score of 0), we suggest no therapy rather than antithrombotic therapy, and for patients choosing antithrombotic therapy, we suggest aspirin rather than oral anticoagulation or combination therapy with aspirin and clopidogrel; (2) at intermediate risk of stroke (eg, CHADS(2) score of 1), we recommend oral anticoagulation rather than no therapy, and we suggest oral anticoagulation rather than aspirin or combination therapy with aspirin and clopidogrel; and (3) at high risk of stroke (eg, CHADS(2) score of ≥ 2), we recommend oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel. Where we recommend or suggest in favor of oral anticoagulation, we suggest dabigatran 150 mg bid rather than adjusted-dose vitamin K antagonist therapy. CONCLUSIONS: Oral anticoagulation is the optimal choice of antithrombotic therapy for patients with AF at high risk of stroke (CHADS(2) score of ≥ 2). At lower levels of stroke risk, antithrombotic treatment decisions will require a more individualized approach.

Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study.

The concept of net clinical benefit has been used to quantify the balance between risk of ischaemic stroke (IS) and risk of intracranial haemorrhage (ICH) with the use oral anticoagulant therapy (OAC) in the setting of non-valvular atrial fibrillation (AF), and has shown that patients at highest risk of stroke and thromboembolism gain the greatest benefit from OAC with warfarin. There are no data for the new OACs, that is, dabigatran, rivaroxaban and apixaban, as yet. We calculated the net clinical benefit balancing IS against ICH using data from the Danish National Patient Registry on patients with non-valvular AF between 1997-2008, for dabigatran, rivaroxaban and apixaban on the basis of recent clinical trial outcome data for these new OACs. In patients with CHADS(2)=0 but at high bleeding risk, apixaban and dabigatran 110 mg bid had a positive net clinical benefit. At CHA(2)DS(2)-VASc=1, apixaban and both doses of dabigatran (110 mg and 150 mg bid) had a positive net clinical benefit. In patients with CHADS(2) score≥1 or CHA(2)DS(2)-VASc≥2, the three new OACs (dabigatran, rivaroxaban and apixaban) appear superior to warfarin for net clinical benefit, regardless of risk of bleeding. When risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit than warfarin. In the absence of head-to-head trials for these new OACs, our analysis may help inform decision making processes when all these new OACs become available to clinicians for stroke prevention in AF. Using 'real world' data, our modelling analysis has shown that when the risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit compared to warfarin.