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

Abstract

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.

Atrial fibrillation: epidemiology, screening and digital health

“… 57 China RCT 833 (IC) 1057(UC) 72 ± 12 73 ± 13 33% 42% ≥12 months Death/ischemic stroke/systemic thromboembolism, rehospitalization (IC vs UC): HR, 0.37; 95% CI, 0.26–0.53 Rehospitalizations alone: HR 0.42; 95% CI 0.27–0.64 Stroke/thromboembolism alone: HR 0.17; 95% CI 0.05–0.51 MI/HF/uncontrolled BP: HR 0.29; 95% CI 0.19–0.45 Guo et al. 58 China RCT 2062 (men) 1262 (women) 68 ± 14 70 ± 13 0% 100% ≥12 months Death/ischemic stroke/systemic thromboembolism/rehospitalization (IC vs UC): HR 0.30, 95% CI 0.17–0.52 (men), HR 0.50, 95% CI 0.27–0.92 (women) Thromboembolism: NS Death: HR 0.32, 95% CI 0.12–0.87 (men) Rehospitalization: HR 0.29, 95% CI 0.15–0.57 (men), HR 0.31, 95% CI 0.14–0.68 (women) Bleeding): NS RAF/HF/MI: HR 0.32, 95% CI 0.18–0.56 (men) Luo et al. 59 China Cost benefit analysis NA NA NA 30 y Costs (IC vs UC): US $35,691 vs US $34,601 QALY gain: 7.2749 vs 7.2019 ICER below WTP: US $14,936 vs US $33,438 per QALY Guo et al.…”

“…This superior effect held true for patients with multimorbidity 57 and both in males and females. 58 In a hypothetical cohort within the mAFA-II trial, the base-case analysis indicated cost-effectiveness of applying mHealth-based integrated care for AF with cost-effective ratio of US $14,936 per quality-adjusted life years, which was below the willingness-to-pay (US $33,438 per quality-adjusted life years). 59 However, these findings should be interpreted cautiously due to the model-based approach, short follow-up, region-specific factors, and multiple cost inputs (including expert opinions).…”

“…A total of 33 publications were considered relevant. Of those, 14 publications reported on integrated e-health enhanced management of AF, 47 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 5 on remote AF management platforms, 65 , 66 , 67 , 68 , 69 3 publications on mHealth-based heart rate/rhythm monitoring, 70 , 71 , 72 6 publications on mHealth supported patient self-care and medication adherence tools 73 , 74 , 75 , 76 , 77 , 78 and 5 publications reported on clinical decision making support tools. 79 , 80 , 81 , 82 , 83 …”

Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review

“…In addition, further critical issues make the situation more serious, such as the rising aging population, the shortage of health personnel, increasing healthcare costs, and the lack of congruence between investment needs and financing strategies [ 4 , 5 ]. In the last two decades and, more importantly, during and after the COVID-19 emergency, technology has increasingly been used as an instrument to face these challenges [ 5 , 6 , 7 , 8 , 9 , 10 ], thanks to its potential to expand the physical boundaries of healthcare systems, introducing the possibility to offer healthcare services remotely [ 4 , 11 , 12 , 13 ].…”

Envisioning simple equitable and mobile-health solutions for complex and diverse needs of women and men with atrial fibrillation

“…In this context, we read with great interest the paper of Guo Y et al [ 3 ], a secondary analysis of the mAFA-II (Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF) trial aimed at exploring whether the effectiveness of mobile-Health implemented ABC intervention varies by patient’s biological sex. While a significant risk reduction of 1-year adverse events (i.e., stroke, thromboembolism, all-cause death, and rehospitalization) was evident in patients allocated to mAFA intervention regardless of sex; yet the sex-by-intervention interaction analysis unrevealed differences in terms of the occurrence of all-cause death and bleeding events.…”