Structured Rehabilitation for Patients with Atrial Fibrillation Based on an Integrated Care Approach: Protocol for a Prospective, Observational Cohort Study.

Background: Guideline-recommended integrated care based on the ABC (Atrial fibrillation Better Care) pathway for "general" patients with atrial fibrillation (AF) improves clinical outcomes, as demonstrated in our prior mobile Atrial Fibrillation Application (mAFA)-II cluster randomized trial. The present study aims to investigate whether mAFA III-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (eg, for patients receiving drug treatment only, AF ablation, or left atrial appendage occlusion [LAAO]) will improve guideline adherence and reduce the risk of adverse cardiovascular events. Methods and Analysis: In this prospective, observational mAFA III pilot cohort study, patients with AF aged ≥ 18 years will be enrolled using the mAFA III App for self-management. Assuming an annual rate of composite outcome of "ischaemic stroke or systemic embolism, all-cause death and cardiovascular hospitalization" of 29.3% for non-ABC pathway compliance compared with 20.8% for ABC pathway compliance, at least 1475 patients would be needed to detect the outcome of the A, B and C components of the ABC pathway, assuming a withdrawal rate of 20% in the first year. The primary endpoint is adherence to guidelines regarding the A, B and C components of the ABC pathway. Ancillary analyses will be performed to determine the impact of the ABC pathway using smart technologies on the outcomes among the "high-risk" population (eg, ≥75 years old, with multimorbidities, with polypharmacy) and the application of artificial intelligence machine-learning AF risk prediction management in assessing AF recurrence. The individualised anticoagulants with AF burden will be monitored by smart devices. Trial Registration Number: ISRCTN13724416.

Mobile health technology integrated care in atrial fibrillation patients with diabetes mellitus in China: A subgroup analysis of the mAFA-II cluster randomized clinical trial.

BACKGROUND: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) prospective randomized trial showed the efficacy of a mobile health (mHealth) implemented 'Atrial fibrillation Better Care' (ABC) pathway for the integrated care management of patients with atrial fibrillation (AF). In this ancillary analysis, we evaluated the effect of mAFA intervention according to the history of diabetes mellitus (DM). METHODS: The mAFA-II trial enrolled 3324 AF patients across 40 centres in China, between June 2018 and August 2019. In this analysis, we assessed the interaction between history of DM and the effect of mAFA intervention on the risk of the primary composite outcome of stroke, thromboembolism, all-cause death and rehospitalizations. Results were expressed as adjusted hazard ratio (aHR) and 95% confidence intervals (95%CI). The effect of mAFA intervention on exploratory secondary outcomes was also assessed. RESULTS: Overall, 747 (22.5%) patients had DM (mean age: 72.7 ± 12.3, 39.6% females; 381 allocated to mAFA intervention). mAFA intervention was associated with a significant risk reduction for the primary composite outcome both in patients with and without DM (aHR [95%CI]: .36 [.18-.73] and .37 [.23-.61], respectively, p for interaction = .941). A significant interaction was found only for the composite of recurrent AF, heart failure and acute coronary syndromes (pint =.025), with lower effect of mAFA intervention in patients with DM. CONCLUSIONS: A mHealth-technology implemented ABC pathway showed a consistent effect in reducing the risk of the primary composite outcome in AF patients with and without DM. TRIAL REGISTRATION: WHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR-OOC-17014138.

Mobile Health-Technology-Integrated Care for Atrial Fibrillation: A Win Ratio Analysis from the mAFA-II Randomized Clinical Trial.

BACKGROUND: The Mobile Health (mHealth) Technology for Improved Screening and Optimized Integrated Care in atrial fibrillation (AF) (mAFA-II) cluster randomized trial assessed the efficacy of an integrated care approach in improving the prognosis of AF patients. In this study, we provide a reanalysis of the trial outcomes using the win ratio (WR) approach. METHODS: The mAFA-II trial allocated patients to receive a mHealth-technology implemented Atrial Fibrillation Better Care (ABC) pathway (mAFA intervention) or usual care. The primary outcome was the composite of all-cause death, ischemic stroke or systemic thromboembolism, and rehospitalization. The efficacy of the mAFA intervention was analyzed according to the WR method using the unmatched pairs approach, with the components of the primary outcome analyzed hierarchically as follows: (1) all-cause death; (2) ischemic stroke or thromboembolism; (3) rehospitalization. Results were reported as WR and 95% confidence intervals (CIs). In addition, we calculated win odds (WO) and 95% CI. RESULTS: A total of 3,324 patients were enrolled in the mAFA-II trial and included in this analysis (1,646 allocated to mAFA intervention and 1,678 to usual care). Among 2,761,988 unmatched pairs comparisons, the number of wins was higher in the mAFA intervention group, with a WR: 2.78 (95% CI: 1.85-4.17). WO confirmed the effect of mAFA intervention, although with a lower magnitude (WO: 1.06; 95% Cl: 1.04-1.08). CONCLUSION: In this posthoc WR analysis of the mAFA-II trial, a mHealth-technology-implemented integrated care approach was effective in reducing the risk of the primary composite outcome of all-cause death, ischemic stroke or thromboembolism, and rehospitalization, even when prioritizing fatal events.

Mobile health-technology integrated care in secondary prevention atrial fibrillation patients: a post-hoc analysis from the mAFA-II randomized clinical trial.

AF patients with history of thromboembolic events are at higher risk of thromboembolic recurrences, despite appropriate antithrombotic treatment. We aimed to evaluate the effect of mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway approach (mAFA intervention) in secondary prevention AF patients. The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster randomized trial enrolled adult AF patients across 40 centers in China. The main outcome was the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization. Using Inverse Probability of Treatment Weighting (IPTW), we evaluated the effect of the mAFA intervention in patients with and without prior history of thromboembolic events (i.e., ischemic stroke or thromboembolism). Among the 3324 patients enrolled in the trial, 496 (14.9%, mean age: 75.1 ± 11.4 years, 35.9% females) had a previous episode of thromboembolic event. No significant interaction was observed for the effect of mAFA intervention in patients with vs. without history of thromboembolic events [Hazard ratio, (HR): 0.38, 95% confidence interval (CI):0.18-0.80 vs. HR 0.55, 95% CI 0.17-1.76, p for interaction = 0.587); however, a trend towards lower efficacy of mAFA intervention among AF patients in secondary prevention was observed for secondary outcomes, with significant interaction for bleeding events (p = 0.034) and the composite of cardiovascular events (p = 0.015). A mHealth-technology-implemented ABC pathway provided generally consistent reduction of the risk of primary outcome in both primary and secondary prevention AF patients. Secondary prevention patients may require further specific approaches to improve clinical outcomes such as bleeding and cardiovascular events.Trial registration: WHO International Clinical Trials Registry Platform (ICTRP) Registration number ChiCTR-OOC-17014138.

Efficacy of mobile health-technology integrated care based on the 'Atrial fibrillation Better Care' (ABC) pathway in relation to sex: a report from the mAFA-II randomized clinical trial.

The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster-randomized trial showed that a mobile health (mHealth)-implemented 'Atrial fibrillation Better Care' (ABC) pathway approach reduced the risk of adverse events in atrial fibrillation (AF) patients. Whether this benefit can be applied to both males and females is unclear, especially given the suboptimal management and poorer cardiovascular outcomes in females with AF. In this post-hoc analysis, we performed a sex-stratified analysis of the mAFA-II trial. Between June 2018 and August 2019, adult AF patients were enrolled across 40 centers in China. The primary outcome was the composite of stroke, thromboembolism, all-cause death, and re-hospitalization. The effect of mAFA intervention according to sex was evaluated through adjusted Cox-regression models. Among the 3,324 patients enrolled in the trial, 2,062 (62.0%) patients were males (mean age: 67.5 ± 14.3 years; 1,021 allocated to mAFA intervention) and 1,262 (38.0%) were females (mean age: 70.2 ± 13.0; 625 allocated to mAFA intervention). A significant risk reduction of the primary composite outcome in patients allocated to mAFA intervention was observed in both males (adjusted hazard ratio [aHR] and 95% confidence interval [CI] 0.30 [0.17-0.52]) and females (aHR [95%CI] 0.50 [0.27-0.92]), without statistically significant interaction (p = 0.225). Sex-based interactions were observed for other secondary outcomes, including all-cause death (p = 0.026) and bleeding events (p = 0.032). A mHealth-technology implemented ABC pathway was similarly effective in reducing the risk of adverse clinical events both in male and female patients. Secondary outcomes showed greater benefits of mAFA intervention in men.

Mobile health-technology integrated care in atrial fibrillation patients with heart failure: A report from the mAFA-II randomized clinical trial.

BACKGROUND: To assess the effect of mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway-approach (mAFA intervention) in AF patients with Heart Failure (HF). METHODS: From the Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster randomized trial, we evaluated the effect of mAFA intervention on the risk of major outcomes in patients with HF using Inverse Probability of Treatment Weighting. Primary outcome was the composite outcome of stroke/thromboembolism, all-cause death, and rehospitalization. The effect of mAFA and the interaction with HF at baseline was assessed through Cox-regressions. RESULTS: Among the 3,324 patients originally enrolled in the trial, 714 (21.5%; mean age: 72.7±13.1 years; 39.9% females) had HF. The effect of mAFA intervention on the primary outcome was consistent in patients with and without HF (Hazard Ratio, (HR): 0.59, 95% Confidence Interval (CI): 0.29-1.22 vs. HR: 0.40, 95%CI: 0.21-0.76, p for interaction=0.438); similar findings were found for rehospitalisations and bleeding events. A trend towards lower efficacy of mAFA in HF patients was observed for all-cause death, while the risk of the composite outcome of 'recurrent AF, HF and acute coronary syndrome' was higher among AF-HF patients allocated to mAFA (p for interaction: <0.001). CONCLUSION: A mHealth-technology implemented ABC pathway provides consistent effects on the risks of primary outcome, rehospitalisation and bleeding, in AF patients both with and without HF. However, AF-HF patients may need tailored approaches to improve their overall prognosis, specifically to reduce the risk of recurrent AF, HF and acute coronary syndrome.

Mobile health technology integrated care in older atrial fibrillation patients: a subgroup analysis of the mAFA-II randomised clinical trial.

BACKGROUND: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) randomised trial demonstrated the efficacy of a mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway-approach (mAFA intervention) in reducing the risk of adverse events in patients with atrial fibrillation (AF). Whether these benefits also apply to older patients is unclear. In this ancillary analysis, we evaluated the effect of mAFA intervention among older AF patients. METHODS: The mAFA-II trial enrolled adult AF patients across 40 centres in China. For this analysis, we defined older patients as those aged ≥75 years. Primary outcome was the composite of ischemic stroke or thromboembolism, all-cause death and rehospitalisation. The effect of mAFA intervention was assessed through multivariable Cox-regression models. We also evaluated the interaction between age and effect of the mAFA intervention in the main trial population. RESULTS: In this analysis, we included 1,163 AF patients ≥75 years (mean age: 82.6 ± 5.3 years, 43.1% females); 520 were allocated to mAFA intervention, 643 to usual care. mAFA intervention was associated with a significant reduction of the primary composite outcome (adjusted hazard ratio [aHR]: 0.58, 95% confidence interval [CI]: 0.35-0.97) and rehospitalisations alone (aHR: 0.47, 95%CI: 0.24-0.91). Significant interaction between age and mAFA intervention effect was observed for both the composite outcome (P = 0.002) and rehospitalisation alone (P = 0.015), with the effect decreasing as age increased, particularly among patients ≥80 years old. CONCLUSIONS: A mHealth technology-implemented ABC pathway is effective in reducing adverse clinical outcomes in older AF patients. The benefits obtained with mAFA intervention were attenuated at extreme ages.

Effects of the Atrial Fibrillation Better Care Pathway on Outcomes Among Clinically Complex Chinese Patients With Atrial Fibrillation With Multimorbidity and Polypharmacy: A Report From the ChiOTEAF Registry.

Background Patients with atrial fibrillation commonly have complex clinical backgrounds of multimorbidity and polypharmacy. The Atrial Fibrillation Better Care (ABC) pathway has been developed to help deliver integrated and holistic care for patients with atrial fibrillation. In this ancillary analysis, we assessed the adherence to and the effectiveness of the ABC pathway at reducing adverse outcomes in Chinese patients with atrial fibrillation with a complex clinical background of multimorbidity or polypharmacy. Methods and Results The ChiOTEAF (Optimal Thromboprophylaxis in Elderly Chinese Patients With Atrial Fibrillation) registry is a prospective, multicenter, nationwide study conducted from October 2014 to December 2018. The primary outcomes of interest were the composite end point of all-cause death and thromboembolic events, as well as individual end points of all-cause death, thromboembolic events, and major bleeding. Multimorbidity was defined as the presence of ≥2 comorbidities, and polypharmacy was defined as the concomitant use of ≥5 medications. The eligible cohort included 4644 patients with multimorbidity, of whom 2610 (56.2%) had available data to assess the ABC pathway usage (mean age, 74.4±10.2; 42.8% women). Among patients with polypharmacy (n=2262; mean age, 74.6±10.1; 43.3% women), 1328 (58.7%) had available data to assess the use of the ABC pathway. Adherence to the ABC pathway was associated with a lower risk of the primary composite outcome among patients with multimorbidity (odds ratio, 0.48; 95% CI, 0.29-0.79) and in the polypharmacy group (odds ratio, 0.39; 95% CI, 0.19-0.78). Health-related quality of life was lower in the non-ABC-adherent group compared with the ABC-treated patients. Conclusions This nationwide real-world registry shows that adherence to the ABC pathway is associated with improved clinical outcomes and health-related quality of life in clinically complex Chinese patients with atrial fibrillation with multimorbidity or polypharmacy.

Adherence to the 'Atrial Fibrillation Better Care' Pathway in Patients with Atrial Fibrillation: Impact on Clinical Outcomes-A Systematic Review and Meta-Analysis of 285,000 Patients.

OBJECTIVE: The 'Atrial fibrillation Better Care' (ABC) pathway has been recently proposed as a holistic approach for the comprehensive management of patients with atrial fibrillation (AF). We performed a systematic review of current evidence for the use of the ABC pathway on clinical outcomes. METHODS AND RESULTS: We performed a systematic review and meta-analysis according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed and EMBASE were searched for studies reporting the prevalence of ABC-pathway-adherent management in AF patients, and its impact on clinical outcomes (all-cause death, cardiovascular death, stroke, and major bleeding). Meta-analysis of odds ratio (OR) was performed with random-effects models; subgroup analysis and meta-regression were performed to account for heterogeneity. Among the eight studies included, we found a pooled prevalence of ABC-adherent management of 21% (95% confidence interval, CI: 13-34%), with a high grade of heterogeneity, explained by the increasing adherence to each ABC criterion. Patients treated according to the ABC pathway showed a lower risk of all-cause death (OR: 0.42; 95% CI: 0.31-0.56), cardiovascular death (OR: 0.37; 95% CI: 0.23-0.58), stroke (OR: 0.55; 95% CI: 0.37-0.82) and major bleeding (OR: 0.69; 95% CI: 0.51-0.94), with moderate heterogeneity. Prevalence of comorbidities was moderators of heterogeneity for all-cause and cardiovascular death, while longer follow-up was associated with increased effectiveness for all outcomes. CONCLUSION: Adherence to the ABC pathway was suboptimal, being adopted in one in every five patients. Adherence to the ABC pathway was associated with a reduction in the risk of major adverse outcomes.

Quality indicators in the management of elderly Chinese patients with atrial fibrillation: a report from the Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry.

AIMS: To evaluate the quality measures and clinical performance indicators among elderly Chinese patients with atrial fibrillation (AF). The management of patients with AF requires a holistic, multidisciplinary approach. Quality indicators have been proposed to assess the quality of care in 'real-world' clinical practice when managing patients with AF. METHODS AND RESULTS: The Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry is a prospective, observational, large-scale multicentre registry conducted between October 2014 and December 2018 in China. Data were collected at the enrolment and during the follow-up visits by the local investigators. In the ChiOTEAF registry, 14 primary and 8 secondary indicators from six domains of care were assessed. Six thousand four hundred twenty patients who completed the 1-year follow-up were included in the analysis. Median age was 76 years, and the majority of patients was male (60.8%). Overall, 3246 patients (54.8%) were not treated with oral anticoagulants (OACs) appropriate to their risk of stroke; specifically, among those at highest risk of stroke, OACs were prescribed in only 43.3% patients (1258/2905). Among patients with permanent AF, 32 (3.6%) were prescribed antiarrhythmic drugs, and among those with paroxysmal AF, catheter ablation was performed in 20.7%. Patients were overburdened with multi-morbidities, including hypertension, diabetes mellitus, obesity, and sleep apnoea. During 1-year follow-up, 435 deaths (6.8%) and 89 thromboembolic events (1.4%) occurred. Patient-reported outcomes showed that 55% of patients had indicators of reduced quality of life. CONCLUSION: Assessment of quality indicators revealed the gaps in AF care among Chinese patients, highlighting the need for a more integrated or holistic approach to AF management.

2021 Focused Update Consensus Guidelines of the Asia Pacific Heart Rhythm Society on Stroke Prevention in Atrial Fibrillation: Executive Summary.

The consensus of the Asia Pacific Heart Rhythm Society (APHRS) on stroke prevention in atrial fibrillation (AF) has been published in 2017 which provided useful clinical guidance for cardiologists, neurologists, geriatricians, and general practitioners in the Asia-Pacific region. In these years, many important new data regarding stroke prevention in AF were reported. The practice guidelines subcommittee members comprehensively reviewed updated information on stroke prevention in AF, and summarized them in this 2021 focused update of the 2017 consensus guidelines of the APHRS on stroke prevention in AF. We highlighted and focused on several issues, including the importance of the AF Better Care pathway, the advantages of non-vitamin K antagonist oral anticoagulants (NOACs) for Asians, the considerations of use of NOACs for Asian AF patients with single one stroke risk factor beyond gender, the role of lifestyle factors on stroke risk, the use of oral anticoagulants during the "coronavirus disease 2019" pandemic, etc. We fully realize that there are gaps, unaddressed questions, and many areas of uncertainty and debate in the current knowledge of AF, and the physician's decision remains the most important factor in the management of AF.

The Effects of Implementing a Mobile Health-Technology Supported Pathway on Atrial Fibrillation-Related Adverse Events Among Patients With Multimorbidity: The mAFA-II Randomized Clinical Trial.

Importance: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in Atrial Fibrillation (mAFA-II) trial is a prospective cluster randomized trial that found a significant reduction in the composite clinical outcome of stroke or thromboembolism, all-cause death, and rehospitalization among patients with atrial fibrillation (AF) who used a mobile health (mHealth) technology that implemented the Atrial Fibrillation Better Care (ABC) pathway (ie, A, anticoagulation/avoid stroke; B, better symptom control; and C, cardiovascular disease and comorbidity management) compared with those receiving usual care. Multimorbidity (defined as ≥2 chronic long-term conditions) is common in older patients with AF, but the impact of integrated or holistic care (based on the ABC pathway) on clinical outcomes in this population is uncertain. Objective: To evaluate whether implementation of the integrated ABC pathway, supported by mHealth technology, would reduce AF-related adverse events in patients with multimorbidity. Design, Setting, and Participants: This prespecified ancillary analysis of data from the extended follow-up of the mAFA II trial was conducted between June 2018 and April 2021. Adult patients with AF were included in the analysis if they had at least 2 comorbidities. Participants were enrolled across 40 centers in China. Intervention: Integrated care supported by mHealth technology (mAFA intervention) vs usual care. Main Outcomes and Measures: The main outcome was the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization. Cox proportional hazard modeling was performed for adverse outcomes after adjusting for cluster effect and baseline risk factors. Results: Of 1890 patients, 833 (mean [SD] age, 72.0 [12.0] years; 278 [33.4%] women) with multimorbidity were allocated to the intervention group (ABC pathway), with a mean (SD) follow-up of 419 (257) days, and 1057 patients (mean [SD] age, 72.8 [13.0] years; 443 [41.9%] women) with multimorbidity were allocated to usual care, with a mean (SD) follow-up of 457 (154) days. Compared with usual care, the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization was significantly reduced in the intervention group (hazard ratio [HR], 0.37; 95% CI, 0.26-0.53; P < .001), as were rehospitalizations alone (HR, 0.42; 95% CI, 0.27-0.64; P < .001). For the C criterion of the ABC pathway, rates of acute coronary syndrome, heart failure, and uncontrolled blood pressure during follow-up were lower in the intervention group than the usual care group (27 patients [3.2%] vs 145 patients [13.7%]; HR, 0.29; 95% CI, 0.19-0.45; P < .001). Subgroup analyses by age, prior stroke, and sex demonstrated consistently lower HRs for the primary composite outcome and rehospitalization for patients with AF allocated to the intervention group compared with patients receiving usual care. Conclusions and Relevance: In this study, mHealth technology-based integrated care that facilitated the implementation of the ABC pathway reduced meaningful clinical adverse events in older patients with AF and multimorbidity vs usual care. Trial Registration: WHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR-OOC-17014138.

Genome-wide identification, characterization and expression profiles of the CCD gene family in Gossypium species.

Carotenoid cleavage dioxygenases (CCDs) are a group of enzymes that catalyze the selective oxidative cleavage steps from carotenoids to apocarotenoids, which are essential for the synthesis of biologically important molecules such as retinoids, and the phytohormones abscisic acid (ABA) and strigolactones. In addition, CCDs play important roles in plant biotic and abiotic stress responses. Till now, a comprehensive characterization of the CCD gene family in the economically important crop cotton (Gossypium spp.) is still missing. Here, we performed a genome-wide analysis and identified 33, 31, 16 and 15 CCD genes from two allotetraploid Gossypium species, G. hirsutum and G. barbadense, and two diploid Gossypium species, G. arboreum and G. raimondii, respectively. According to the phylogenetic tree analysis, cotton CCDs are classified as six subgroups including CCD1, CCD4, CCD7, CCD8, nine-cis-epoxycarotenoid dioxygenase (NCED) and zaxinone synthase (ZAS) sub-families. Evolutionary analysis shows that purifying selection dominated the evolution of these genes in G. hirsutum and G. barbadense. Predicted cis-acting elements in 2 kb promoters of CCDs in G. hirsutum are mainly involved in light, stress and hormone responses. The transcriptomic analysis of GhCCDs showed that different GhCCDs displayed diverse expression patterns and were ubiquitously expressed in most tissues; moreover, GhCCDs displayed specific inductions by different abiotic stresses. Quantitative reverse-transcriptional PCR (qRT-PCR) confirmed the induction of GhCCDs by heat stress, salinity, polyethylene glycol (PEG) and ABA application. In summary, the bioinformatics and expression analysis of CCD gene family provide evidence for the involvement in regulating abiotic stresses and useful information for in-depth studies of their biological functions in G. hirsutum. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13205-021-02805-9.

Mobile health technology-supported atrial fibrillation screening and integrated care: A report from the mAFA-II trial Long-term Extension Cohort.

BACKGROUND: In the mobile Atrial Fibrillation App (mAFA)-II trial, the use of mobile health (mHealth) technology, incorporating AF screening and integrated management strategy, was associated with improved short-term clinical outcomes. The aim of this study was to report adherence/persistence and long term (≥1 year) clinical outcomes of the mAFA-II trial, with mHealth-supported optimised stroke prevention, symptom control and comorbidity management. METHODS: We studied an adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention. In this cluster randomised trial, comparing mHeath intervention to usual care, the primary composite outcome was 'stroke/thromboembolism, all-cause death and rehospitalization'. RESULTS: The 1261 subjects (mean age 67.0 years, 38.0% female) who were followed up over one year (mean follow-up 687 (standard deviation, SD 191) days) in the intervention arm, had a lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization' (hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female). Of 842 patients using their smart devices for 'Better symptom management', 70.8% had good management adherence (monitoring time/follow-up since initial monitoring ≥ 70%), with the persistence of use of 91.7%. CONCLUSION: Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.

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.

Risk factors for new-onset atrial fibrillation: A focus on Asian populations.

The incidence of new-onset atrial fibrillation (NOAF) is increasing both in the Asian populations and Western countries. Several demographic and clinical risk factors were independently associated with NOAF, including ageing, male sex, obesity, obstructive sleep apnea syndrome, hypertension, coronary artery disease, renal dysfunction and heart failure. However, some differences in the incidence of NOAF, the prevalence of some risk factors and lifestyle or environmental conditions may exist between Asian and Western countries. Early recognition and holistic management of risk factors in an integrated manner may help reduce the burden of NOAF and its complications. While some risk scores have been developed to predict the risk of NOAF, thus far none are currently recommended or adequately validated to be used as a screening tool especially in the Asian population. The present semi-systematic review article aims to provide a comprehensive overview on the risk factors associated to NOAF, focusing on those explored in the Asian populations.