scholarly journals Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening—mHealth Screening to Prevent Strokes (mSToPS)

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258276
Author(s):  
Steven R. Steinhubl ◽  
Jill Waalen ◽  
Anirudh Sanyal ◽  
Alison M. Edwards ◽  
Lauren M. Ariniello ◽  
...  

Background Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes. Methods mSToPS was a pragmatic, direct-to-participant trial that randomized individuals from a single US-wide health plan to either immediate or delayed screening using a continuous-recording ECG patch to be worn for two weeks and 2 occasions, ~3 months apart, to potentially detect undiagnosed AF. The 3-year outcomes component of the trial was designed to compare clinical outcomes in the combined cohort of 1718 individuals who underwent monitoring and 3371 matched observational controls. The prespecified primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction among individuals with a new AF diagnosis, which was hypothesized to be the same in the two cohorts but was not realized. Results Over the 3 years following the initiation of screening (mean follow-up 29 months), AF was newly diagnosed in 11.4% (n = 196) of screened participants versus 7.7% (n = 261) of observational controls (p<0.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. For all individuals whose AF was first diagnosed clinically, a clinical event was common in the 4 weeks surrounding that diagnosis: 6.6% experienced a stroke,10.2% were newly diagnosed with heart failure, 9.2% had a myocardial infarction, and 1.5% systemic emboli. Cumulatively, 42.9% were hospitalized. For those diagnosed via screening, none experienced a stroke, myocardial infarction or systemic emboli in the period surrounding their AF diagnosis, and only 1 person (2.3%) had a new diagnosis of heart failure. Incidence rate of the prespecified combined primary endpoint was 3.6 per 100 person-years among the actively monitored cohort and 4.5 per 100 person-years in the observational controls. Conclusions At 3 years, screening for AF was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort, although the influence of earlier diagnosis of AF via screening on this finding is unclear. These observational data, including the high event rate surrounding a new clinical diagnosis of AF, support the need for randomized trials to determine whether screening for AF will yield a meaningful protection from strokes and other clinical events. Trail registration The mHealth Screening To Prevent Strokes (mSToPS) Trial is registered on ClinicalTrials.gov with the identifier NCT02506244.

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J Dickow ◽  
H.K Van Houten ◽  
L.R Sangaralingham ◽  
P.A Friedman ◽  
D.L Packer ◽  
...  

Abstract Background The Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST-AFNET 4) demonstrated clinical benefit of early rhythm-control therapy in patients with recently diagnosed atrial fibrillation (AF) and concomitant cardiovascular conditions (CHA2DS2-VASc-Score ≥2) compared to the current practice of limited rhythm-control therapy to improve AF-related symptoms. Purpose To evaluate the generalizability of the EAST-AFNET 4 trial in routine practice, we assessed the proportion of patients who would have met trial eligibility and examined the association between early rhythm-control and clinical outcomes. Methods Using a large US administrative database, we identified 109,739 patients with newly diagnosed AF from July 28th, 2011 to December 30th, 2016, the enrollment period of the EAST-AFNET 4 trial. Eligibility for trial inclusion was assessed based on inclusion criteria. Eligible patients were classified as either receiving early rhythm-control, i.e AF ablation and/or any antiarrhythmic drug therapy, within the first year after AF diagnosis (N=27,106) or patients not receiving early rhythm-control (N=82,633). The date 12 months after the first AF diagnosis was defined as the index date and the start of the follow up period. Propensity score overlap weighting was used to balance patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare early rhythm-control with no early rhythm-control for the primary outcome of a composite end point of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction. Results Eligible for the trial were 72.9% (82,633/109,739) of all patients with newly diagnosed AF. Early rhythm-control therapy was associated with a reduction in the composite end point in the overall cohort of patients (hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.75–0.97; P=0.015) with largely consistent treatment effects between patients eligible or ineligible for the trial. The reduction of stroke risk associated with early rhythm-control therapy was found in the overall cohort (HR 0.66; 95% CI 0.47–0.93; P=0.017) and in the trial-eligible cohort (HR 0.67; 95% CI 0.45–0.98; P=0.041). Conclusion In a large health care data set, the majority of patients with newly diagnosed AF were eligible for the trial. Early rhythm-control therapy was associated with a 15% reduction in the composite end point of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction, with the greatest benefit in the reduction of stroke risk. The treatment effect was consistent between patients eligible or ineligible for the trial. Patients in routine practice had higher rates of adverse outcomes than the trial, but the relative risk reduction with early rhythm-control therapy was similar. These data demonstrate the potential of early rhythm-control therapy to reduce outcomes in patients with AF. FUNDunding Acknowledgement Type of funding sources: Foundation. Main funding source(s): German Heart Foundation (Mit Fördermitteln der Deutschen Herzstiftung e.V.)


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chan Soon Park ◽  
Eue-Keun Choi ◽  
Bongseong Kim ◽  
Kyung-Do Han ◽  
So-Ryoung Lee ◽  
...  

Abstract NTM infection demonstrates an increasing incidence and prevalence. We studied the impact of NTM in cardiovascular events. Using the Korean nationwide database, we included newly diagnosed 1,730 NTM patients between 2005 and 2008 and followed up for new-onset atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF), ischemic stroke (IS), and death. Covariates-matched non-NTM subjects (1:5, n = 8,650) were selected and analyzed. Also, NTM infection was classified into indolent or progressive NTM for risk stratification. During 4.16 ± 1.15 years of the follow-up period, AF, MI, HF, IS, and death were newly diagnosed in 87, 125, 121, 162, and 468 patients. In multivariate analysis, NTM group showed an increased risk of AF (hazard ratio [HR] 2.307, 95% confidence interval [CI] 1.560–3.412) and all-cause death (HR 1.751, 95% CI 1.412–2.172) compared to non-NTM subjects, whereas no significant difference in MI (HR 0.868, 95% CI 0.461–1.634), HF (HR 1.259, 95% CI 0.896–2.016), and IS (HR 1.429, 95% CI 0.981–2.080). After stratification, 1,730 NTM patients were stratified into 1,375 (79.5%) indolent NTM group and 355 (20.5%) progressive NTM group. Progressive NTM showed an increased risk of AF and mortality than indolent NTM group. Screening for AF and IS prevention would be appropriate in these high-risk patients.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
H Ogawa ◽  
M Esato ◽  
K Minami ◽  
S Ikeda ◽  
K Doi ◽  
...  

Abstract Background Patients with atrial fibrillation (AF) occasionally require pacemaker implantation. Meanwhile, patients with implanted pacemaker are occasionally found to have subclinical AF and develop clinical AF. However, little is known about the clinical outcomes of AF patients with implanted pacemaker. Purpose We aimed to investigate the clinical outcomes in AF patients undergoing previous pacemaker therapy. Methods The Fushimi AF Registry is a community-based prospective survey of the AF patients in a city of Japan. Follow-up data including prescription status were available for 4,447 patients. After exclusion of patients with implantable cardioverter defibrillator and cardiac resynchronization therapy, we investigated 293 AF patients with pacemaker implantation at baseline. We performed propensity score-matching analysis to assess the impact of pacemaker therapy in AF patients. Results Of a total cohort, patients with pacemaker were more often female (51.2% vs. 39.7%; p&lt;0.01) and older (78.0 vs. 73.3 years of age; p&lt;0.01). Patients with pacemaker were more likely to have pre-existing heart failure (33.1% vs. 26.6%; p&lt;0.01), valvular heart disease (22.9% vs. 16.8%; p&lt;0.01), chronic kidney disease (48.8% vs. 34.7%; p&lt;0.01), and history of performing direct current cardioversion (7.2% vs. 3.1%; p&lt;0.01), compared with patients without pacemaker. Mean CHA2DS2-VASc score was higher in patients with pacemaker (3.80 vs. 3.34; p&lt;0.01). Patients with pacemaker were more often prescribed oral anticoagulants (62.1% vs. 55.2%; p=0.02), verapamil (13.3% vs. 9.4%; p=0.03), and loop diuretics (30.7% vs. 21.8%; p&lt;0.01). Using propensity score-matching, 291 patients with pacemaker and 291 without pacemaker were matched and baseline characteristics were comparable. The median follow-up period was 1,819 days. All-cause death occurred in 91 patients with pacemaker (6.0 /100 person-years) and 79 patients without pacemaker (5.9 /100 person-years), with a hazard ratio (HR) for patients with pacemaker of 1.01 (95% confidence interval [CI], 0.75 to 1.37; p=0.93). Furthermore, HR of cardiac death for patients with pacemaker was 1.00 (95% CI, 0.23 to 4.32; p=0.99), that of stroke or systemic embolism was 0.69 (95% CI, 0.44 to 1.07; p=0.10) and that of hospitalization for heart failure was 0.94 (95% CI, 0.65 to 1.37; p=0.76). Conclusion We identified that patients undergoing previous pacemaker therapy were not associated with the incidence of various adverse clinical events in Japanese AF patients. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boehringer Ingelheim, Bayer Healthcare, Pfizer, Bristol-Myers Squibb, Astellas Pharma, AstraZeneca, Daiichi Sankyo, Novartis Pharma, MSD, Sanofi-Aventis, Takeda Pharmaceutical, and the Practical Research Project for Life-Style related Diseases including Cardiovascular Diseases and Diabetes Mellitus from Japan Agency for Medical Research and Development.


Author(s):  
Yuki Obayashi ◽  
Hiroki Shiomi ◽  
Takeshi Morimoto ◽  
Yodo Tamaki ◽  
Moriaki Inoko ◽  
...  

Background It remains controversial whether long‐term clinical impact of newly diagnosed atrial fibrillation (AF) in the acute phase of acute myocardial infarction (AMI) is different from that of prior AF diagnosed before the onset of AMI. Methods and Results The current study population from the CREDO‐Kyoto AMI (Coronary Revascularization Demonstrating Outcome Study in Kyoto Acute Myocardial Infarction) Registry Wave‐2 consisted of 6228 patients with AMI who underwent percutaneous coronary intervention. The baseline characteristics and long‐term clinical outcomes were compared according to AF status (newly diagnosed AF: N=489 [7.9%], prior AF: N=589 [9.5%], and no AF: N=5150 [82.7%]). Median follow‐up duration was 5.5 years. Patients with newly diagnosed AF and prior AF had similar baseline characteristics with higher risk profile than those with no AF including older age and more comorbidities. The cumulative 5‐year incidence of all‐cause death was higher in newly diagnosed AF and prior AF than no AF (38.8%, 40.7%, and 18.7%, P <0.001). The adjusted hazard ratios (HRs) for mortality of newly diagnosed AF and prior AF relative to no AF remained significant with similar magnitude (HR, 1.31; 95% CI, 1.12–1.54; P <0.001, and HR, 1.32; 95% CI, 1.14–1.52; P <0.001, respectively). The cumulative 5‐year incidence of stroke decreased in the order of newly diagnosed AF, prior AF and no AF (15.5%, 12.9%, and 6.3%, respectively, P <0.001). The higher adjusted HRs of both newly diagnosed AF and prior AF relative to no AF were significant for stroke, with a greater risk of newly diagnosed AF than that of prior AF (HR, 2.05; 95% CI, 1.56–2.69; P <0.001, and HR, 1.33; 95% CI, 1.00–1.78; P =0.048, respectively). The higher stroke risk of newly diagnosed AF compared with prior AF was largely driven by the greater risk within 30 days. The higher adjusted HRs of newly diagnosed AF and prior AF relative to no AF were significant for heart failure hospitalization (HR, 1.73; 95% CI, 1.35–2.22; P <0.001, and HR, 2.23; 95% CI, 1.82–2.74; P <0.001, respectively) and major bleeding (HR, 1.46; 95% CI, 1.23–1.73; P <0.001, and HR, 1.36; 95% CI, 1.15–1.60; P <0.001, respectively). Conclusions Newly diagnosed AF in AMI had risks for mortality, heart failure hospitalization, and major bleeding higher than no AF, and comparable to prior AF. The risk of newly diagnosed AF for stroke might be higher than that of prior AF.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Joung ◽  
P.S Yang ◽  
J.H Sung ◽  
E Jang ◽  
H.T Yu ◽  
...  

Abstract Background It is unclear whether catheter ablation is beneficial in frail patients with AF. Purpose This study aimed to evaluate whether catheter ablation reduces death and other outcomes in real-world frail patients with atrial fibrillation (AF). Methods Out of 801,710 patients with AF in the Korean National Health Insurance Service database from 2006 to 2015, 1,411 frail patients underwent AF ablations. The Hospital Frailty Risk Score were calculated retrospectively. Inverse probability of treatment weighting (IPTW) was used to categorize ablation and non-ablation frail groups. Results After IPTW, the two cohorts had similar background characteristics. During a median follow-up of 4.7 years (interquartile range: 2.2–7.8), the risk of death in frail patients with ablations was reduced by 65% compared to frail patients without ablations (2.0 and 6.4 per 100 person-years, respectively; hazard ratio [HR] 0.35; 95% confidence interval [CI] 0.25–0.50; P&lt;0.001). Ablations were related with a lower incidence and risk of heart failure admission (1.8 and 3.1 per 100 person-years, respectively; HR 0.66, 95% CI 0.44–0.98; P=0.042) and acute myocardial infarction (0.2 and 0.6 per 100 person-years, respectively; HR 0.30, 95% CI 0.15–0.62; P=0.001). However, the risk of stroke did not change after ablation. Conclussion Ablation may be associated with lower incidences of death, heart failure, and acute myocardial infarction in real-world frail patients with AF, supporting the role of AF ablation in these patients. The effect of frailty risk on the outcome of ablation should be evaluated in further studies. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.H Lim ◽  
S.R Lee ◽  
E.K Choi ◽  
J.P Yun ◽  
H.J Ahn ◽  
...  

Abstract Introduction Regular exercise is known to decrease the risk of dementia. There is a paucity of information about the impact of the change of exercise habit on cardiovascular outcomes after a new diagnosis of atrial fibrillation (AF). We aimed to investigate whether regular exercise is associated with the risk of developing dementia in patients with AF. Methods Using the Korean National Health Insurance Service database, we enrolled patients with newly diagnosed AF who had undergone health screening between 2010 and 2016. The study population was divided into four groups based on the consistency of regular exercise before and after AF diagnosis: (1) persistent non-exerciser, (2) exercise starter, (3) exercise quitter, and (4) exercise maintainer. We investigated the association between exercise and the risk of dementia. Results A total of 126,555 patients were included (mean age 62.7 years, male 62.0%, and mean CHA2DS2-VASc Score 2.7). During a median follow-up duration of 3.0 years, 5,943 patients were newly diagnosed as dementia (1.57 per 100 person-years). Among patients with incident dementia, 4,410 patients had Alzheimer's dementia and 951 patients had vascular dementia (1.16 and 0.25 per 100 person-years, respectively). Persistent non-exerciser, exercise starter, quitter, and maintainer groups were 65.1%, 12.8%, 12.7%, and 9.4%, respectively. After multivariable adjustment, we found that exercise was associated with a lower risk of developing overall dementia. When compared to persistent non-exerciser, exercise starter and maintainer showed reduced risk of developing dementia (hazard ratio [HR] 0.80, 95% confidence interval [95% CI] 0.73–0.88 and HR 0.63, 95% CI 0.54–0.73, respectively, all p-value &lt;0.0001), but exercise quitter showed no significant risk reduction (HR 0.95, 95% CI 0.88–1.03, Figure). Alzheimer's dementia showed consistent results: a 20% lower risk with exercise starter, and a 37% lower risk with exercise maintainer. Change of exercise habit, however, did not affect the risk of vascular dementia (all, p-value &gt;0.05, Figure). Conclusions Regular exercise showed a lower risk of dementia in patients with new-onset AF. Starting exercise even after the diagnosis of AF was beneficial to patients who had little physical activity previously. These findings may support physicians to recommend that AF patients should start exercise or keep their physical activity to reduce the risk of dementia. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Xing ◽  
X Bai ◽  
J Li

Abstract Background Whether discharge heart rate for hospitalized heart failure (HF) patients with coexisted atrial fibrillation (AF) is associated with long-term clinical outcomes and whether this association differs between patients with and without beta-blockers have not been well studied. Purpose We investigated the associations between discharge heart rate and clinical outcomes in hospitalized HF patients with coexisted AF, while stratified to beta-blockers at discharge. Methods The study cohort included 1631 HF patients hospitalized primarily with AF, which was from the China PEACE Prospective Heart Failure Study. Clinical outcome was 1-year combined all-cause mortality and HF hospitalization after discharge. We analyzed association between outcome and heart rate at discharge with restricted cubic spline and Cox proportional hazard ratios (HR). Results The median age was 68 (IQR: 60- 77) years, 41.9% were women, discharge heart rate was (median (IQR)) 75 (69- 84) beats per minute (bpm), and 60.2% received beta-blockers at discharge. According to the result of restricted cubic spline plot, the relationship between discharge heart rate and clinical outcome may be nonlinear (P&lt;0.01). Based on above result, these patients were divided into 3 groups: lowest &lt;65 bpm, middle 65–86 bpm and highest ≥87 bpm, clinical outcomes occurred in 128 (64.32%), 624 (53.42%) and 156 (59.32%) patients in the lowest, middle, and highest groups respectively. In the Cox proportional hazard analysis, the lowest and highest groups were associated with increased risks of clinical outcome compared with the middle group (HR: 1.289, 95% confidence interval (CI): 1.056 - 1.573, p=0.013; HR: 1.276, 95% CI: 1.06 - 1.537, p=0.01, respectively). And a significant interaction between discharge heart rate and beta-blocker use was observed (P&lt;0.001 for interaction). Stratified analysis showed the lowest group was associated with increased risks of clinical outcomes in patients with beta-blockers (HR: 1.584, 95% confidence interval (CI): 1.215–2.066, p=0.001). Conclusion There may be a U-curve relationship between discharge heart rate and clinical outcomes in hospitalized HF patients with coexisted AF. They may have the best clinical outcomes with heart rates of 65 - 86 bpm. And strict heart rate control (&lt;65 bpm) may be avoided for patients who discharge with beta-blockers. Figure 1 Funding Acknowledgement Type of funding source: Other. Main funding source(s): This work was supported by the National Key Research and Development Program (2017YFC1310803) from the Ministry of Science and Technology of China; the CAMS Innovation Fund for Medical Science (2017-I2M-B&R-02); the 111 Project from the Ministry of Education of China (B16005).


2021 ◽  
Vol 22 (8) ◽  
pp. 4110
Author(s):  
Gerhild Euler ◽  
Jens Kockskämper ◽  
Rainer Schulz ◽  
Mariana S. Parahuleva

Heart failure (HF) and atrial fibrillation (AF) are two major life-threatening diseases worldwide. Causes and mechanisms are incompletely understood, yet current therapies are unable to stop disease progression. In this review, we focus on the contribution of the transcriptional modulator, Jun dimerization protein 2 (JDP2), and on HF and AF development. In recent years, JDP2 has been identified as a potential prognostic marker for HF development after myocardial infarction. This close correlation to the disease development suggests that JDP2 may be involved in initiation and progression of HF as well as in cardiac dysfunction. Although no studies have been done in humans yet, studies on genetically modified mice impressively show involvement of JDP2 in HF and AF, making it an interesting therapeutic target.


Sign in / Sign up

Export Citation Format

Share Document