Protocol for a randomized controlled trial of intensive blood pressure control on cardiovascular risk reduction in patients with atrial fibrillation: rationale and design of the CRAFT trial.

BACKGROUND: Co-morbid hypertension is strong predictor of adverse cardiovascular (CV) outcomes in patients with atrial fibrillation (AF) but the optimal target for blood pressure (BP) control in this patient population has not been clearly defined. METHOD: The Cardiovascular Risk reduction in patients with Atrial Fibrillation Trial (CRAFT) is an investigator-initiated and conducted, international, multicenter, open-label, parallel-group, blinded outcome assessed, randomized controlled trial of intensive BP control in patients with AF. The aim is to determine whether intensive BP control (target home systolic blood pressure [SBP] <120 mmHg) is superior to standard BP control (home SBP <135 mmHg) on the hierarchical composite outcome of time to CV death, number of stroke events, time to the first stroke, number of myocardial infarction (MI) events, time to the first MI, number of heart failure hospitalization (HFH) events, and time to the first HFH. A sample size of 1675 patients is estimated to provide 80% power to detect a win-ratio of 1.50 for intensive versus standard BP control on the primary composite outcome. Study visits are conducted at 1, 2, 3, and 6 months post-randomization, and every 6 months thereafter during the study. CONCLUSION: This clinical trial aims to provide reliable evidence of the effects of intensive BP control in patients with AF.

Incidence and predictors of hospitalization in patients with atrial fibrillation: results from the Chinese atrial fibrillation registry study.

BACKGROUND: Patients with atrial fibrillation (AF) underwent a high risk of hospitalization, which has not been paid much attention to in practice. Therefore, we aimed to assess the incidence, causes and predictors of hospitalization in AF patients. METHODS: From August 2011 to December 2017, a total number of 20,172 AF patients from the Chinese Atrial Fibrillation Registry (China-AF) Study were prospectively selected for this study. We described the incidence, causes of hospitalization by age groups and sex. The Fine-Gray competing risk model was employed to identify predictors of first all-cause and first cause-specific hospitalization. RESULTS: After a mean follow-up of 37.3 ± 20.4 months, 7,512 (37.2%) AF patients experienced one or more hospitalizations. The overall incidence of all-cause hospitalization was 24.0 per 100 patient-years. Patients aged < 65 years were predominantly hospitalized for AF (42.1% of the total hospitalizations); while patients aged 65-74 and ≥ 75 years were mainly hospitalized for non-cardiovascular diseases (43.6% and 49.3%, respectively). We found patients complicated with heart failure (HF)[hazard ratio (HR) 1.10, 95% confidence interval (CI) 1.02-1.18], established coronary artery disease (CAD) (HR 1.24, 95%CI 1.17-1.33), ischemic stroke/transient ischemic attack (TIA) (HR 1.22, 95%CI 1.15-1.30), diabetes (HR 1.14, 95%CI 1.08-1.20), chronic obstructive pulmonary disease (COPD) (HR 1.28, 95%CI 1.02-1.62), gastrointestinal disorder (HR 1.37, 95%CI 1.21-1.55), and renal dysfunction (HR 1.24, 95%CI 1.09-1.42) had higher risks of hospitalization. CONCLUSIONS: More than one-third of AF patients included in this study were hospitalized at least once during over 3-year follow-up. The main cause for hospitalization among the elderly patients (≥ 65 years) is non-cardiovascular diseases rather than AF. Multidisciplinary management of comorbidities should be advocated to reduce hospitalization in AF patients older than 65 years old. Clinical Registry http://www.chictr.org.cn/showproj.aspx?proj=5831 . Unique identifier: ChiCTR-OCH-13003729. The registration date is October 22, 2013.

Incidence and risk factors of post-operative cognitive decline after ablation for atrial fibrillation.

BACKGROUND: Catheter ablation is widely used in atrial fibrillation (AF) management. In this study, we are aimed to investigate the incidence of postprocedural cognitive decline in a larger population undergoing AF ablation under local anesthesia, and to evaluate the associated risk factors. METHODS: This study included 287 patients with normal cognitive functions, with 190 ablated AF patients (study group) and 97 AF patients who are awaiting ablation (practice group). We assessed the neuropsychological function of each patient for twice (study group: 24 h prior to ablation and 48 h post ablation; practice group: on the day of inclusion and 72 h later but before ablation). The reliable change index was used to analyze the neuropsychological testing scores and to identify postoperative cognitive dysfunction (POCD) at 48 h post procedure. Patients in the study group accepting a 6-month follow up were given an extra cognitive assessment. RESULTS: Among the ablated AF patients, 13.7% (26/190) had POCD at 48 h after the ablation procedure. Multivariable analysis revealed that, a minimum intraoperative activated clotting time (ACT) < 300 s (OR 3.82, 95% CI 1.48-9.96, P = 0.006) and not taking oral anticoagulants within one month prior to ablation(OR 10.35, 95% CI 3.54-30.27, P < 0.001) were significantly related to POCD at 48 h post-ablation. In 172 patients of the study group accepting a 6-month follow up, there were 23 patients with POCD at 48 h post-ablation and 149 patients without POCD. The global cognitive scores were decreased in 48 h post-operation tests (0 ± 1 vs - 0.15 ± 1.10, P < 0.001) and improved significantly at 6 months post-operation (0 ± 1 vs 0.43 ± 0.92, P < 0.001). In the 23 patients with POCD at 48 h after the procedure, global cognitive performance at 6 months was not significantly different compared with that at baseline (- 0.05 ± 1.25 vs - 0.19 ± 1.33, P = 0.32), while 13 of them had higher scores than baseline level. CONCLUSIONS: Incident of POCD after ablation procedures is high in the short term. Inadequate periprocedural anticoagulation are possible risk factors. However, most POCD are reversible at 6 months, and a general improvement was observed in cognitive function at 6 months after ablation.

Physical activity and atrial tachyarrhythmia recurrence in atrial fibrillation patients after catheter ablation.

BACKGROUND: The association between physical activity (PA) and atrial tachyarrhythmia (AT) recurrence after ablation for atrial fibrillation (AF) remains unclear. METHODS: We consecutively enrolled 496 patients treated with AF ablation therapy in Beijing Anzhen Hospital. After excluding six patients with valvular heart disease, seven patients with congenital heart disease, 33 patients lost to follow-up, and 14 patients who did not provide PA level during follow-ups, 436 patients had their PA level assessed by the International Physical Activity Questionnaire-Short Form before ablation and each time of follow-up. The association between PA level (measured at the time closest to AT recurrence, or the end of 12-month follow-up if no AT recurrence), as well as active PA during follow-up, and postablation AT recurrence was tested by multivariate logistic regression. RESULTS: Of the enrolled patients, 134 (30.7%) patients experienced AT recurrence in the first 12 months postablation. Compared to patients with low PA, patients with moderate or high PA had a lower risk of AT recurrence (odds ratio [OR] = .44; 95% confidence interval [CI], .25-.80; P = .01 for patients with moderate PA; and OR = .43 [95% CI, .21-.85], P = .02 for patients with high PA). Compared to patients without active PA, patients with active PA had a lower risk of AT recurrence (OR = .44 [95% CI, .27-.70], P < .01). CONCLUSIONS: Moderate and high PA are associated with a lower risk of AT recurrence after AF ablation. Active PA during follow-up is also associated with a significantly lower risk of AT recurrence in the postablation AF population.

Tongue Manifestation in Patients with Osteonecrosis of the Femoral Head: A Cross-sectional Study.

OBJECTIVE: Although tongue manifestation is a vital component of Traditional Chinese Medicine (TCM), relevant research on patients with osteonecrosis of the femoral head (ONFH) is still lacking. This study will explore the characteristic tongue manifestation of ONFH patients to inform future research and clinical practice. METHODS: This is a cross-sectional study. All ONFH patients meeting criteria and their clinical data were collected from the online China osteonecrosis of the femoral head database (CONFHD) since it was created. Organized tongue manifestations of eligible patients through the tongue manifestation acquisition instrument, including tongue shape, tongue color, tongue coating thickness, tongue coating color and tongue coating moisture. We used descriptive analysis for the general information while systematic clustering analysis for the better summary of tongue characteristics. RESULTS: A total of 375 ONFH patients were included with an average age of 46.3 years. Most patients appeared with enlarged tongue body (54.4%), and the proportions of pale and red tongue (62.4%) were higher than others. Tongue coating were mainly showed as thick (64.5%), white (57.6%) and moist (79.7%). Comparison of tongue shape between different causes of ONFH had a significant statistically difference (P = 0.000). Tongue manifestations could be cluster analyzed into three categories which were matched into four TCM syndromes. CONCLUSIONS: The tongue manifestation of ONFH patients has a significant change both in tongue body and coating, and different features may be related to the ONFH pathology. This study provides new and valuable tongue informations for a preliminary screening of ONFH patients.

Prevalence and factors associated with depressive and anxiety symptoms in a Chinese population with and without cardiovascular diseases.

BACKGROUND: Few data have reported the prevalence of depressive and anxiety symptoms in patients with cardiovascular disease (CVD) in China. Our study aimed to estimate the prevalence and related risk factors of these mental health symptoms. METHODS: A total of 47841 participants from seven regions of China were enrolled by a two-stage, stratified, community-based, clustering sampling strategy between 2014 and 2016. Data of sociodemographic status and medical history were collected through a standard questionnaire. The Center for Epidemiologic Studies Depression Scale and Zung's self-rating anxiety scale were used to screen depressive and anxiety symptoms. RESULTS: Among 47588 individuals who completed the self-report questionnaires, the weighted prevalence of depressive symptom was 2.9% and that of anxiety symptom was 1.5%. In females with heart failure (HF) and stroke, prevalence of either depressive and anxiety symptoms were 15.1% and 13.8%, respectively; while 9.4% and 8.4% for the male counterparts. Among patients with ≥ any 3 specific CVDs, the prevalence of having either depressive or anxiety symptoms were 13.1% and 6.8% for females and males, respectively. Younger age, female, unmarried, lower income, and disease history of atrial fibrillation, HF and stroke tend to link with higher risks of mental health symptoms. LIMITATIONS: Cross-sectional study. CONCLUSION: A high proportion of patients with CVD had depressive and anxiety symptoms. Screening for mental health symptoms is more important in higher-risk populations who are at younger age, being female, unmarried, with low income, and with diagnoses of atrial fibrillation, HF, and stroke.

Influence of passive smoking on the onset of Legg-Calvè-Perthes disease: a systematic review and meta-analysis.

The relationship between passive smoking and the onset of Legg-Calvè-Perthes disease is still controversial. Therefore, we conducted the study to systematically evaluate and analyze the relationship. A comprehensive search was conducted. Meta-analysis was performed with RevMan 5.3 software, with the odds ratio as the effect size. Eight English articles with a total of 1379 Legg-Calvè-Perthes disease patients were eventually included. Passive smoking type of family members smoking in indoor (odds ratio = 2.53), paternal smoking (odds ratio = 2.76), maternal smoking (odds ratio = 2.02), maternal smoking during pregnancy (odds ratio = 1.68), using stove indoor (odds ratio = 2.56) are statistically significant (P < 0.05). For the family members smoking indoor, region may be a confounding factor (European group I = 92%, odds ratio = 2.51; USA group I = 5%, odds ratio = 3.26; and Asian group I = 0%, odds ratio = 2.25). In addition, the type of maternal smoking (odds ratio = 0.80, for 1-10 per day; odds ratio = 2.73, for 10-20 per day; odds ratio = 2.78, for >20 per day) and the type of maternal smoking during pregnancy (odds ratio = 1.36, for 1-9 per day; odds ratio = 2.02, for ≥10 per day) may show a dose-effect relationship. Passive smoking is a risk factor for the onset of Legg-Calvè-Perthes disease, but the specific types of passive smoking (haze, etc.), dose, dose-effect relationship, regional confounding, pathological mechanisms, etc. also require clinicians and researchers to continue exploring.

Exploring the Risk Factors for the Misdiagnosis of Osteonecrosis of Femoral Head: A Case-Control Study.

OBJECTIVE: The purpose of the present study was to evaluate the present situation and risk factors for the misdiagnosis of osteonecrosis of femoral head (ONFH), providing the basis for accurate diagnosis of ONFH. METHODS: For this retrospective study, 1471 patients with ONFH were selected from the China Osteonecrosis of Femoral Head Database (CONFHD). These patients had been recruited between July 2016 and December 2018. According to whether or not they were misdiagnosed, the patients were divided into two groups, with 1168 cases (22-84 years old) included in the diagnosis group and 303 cases (21-80 years old) in the misdiagnosis group. Misdiagnosis was measured using the following criteria: (i) the patient had the same symptoms and signs, and the second diagnosis was not consistent with the initial diagnosis within 6 months; and (ii) the patient was admitted to a hospital participating in CONFHD and the previous diagnosis was inconsistent with the diagnosis given by the expert group. Comparisons of age, visual analogue scale for pain, and body mass index between the two groups were performed using a t-test. Gender, causes of ONFH, primary diseases requiring corticosteroids, methods of corticosteroid use, corticosteroid species, type of trauma, onset side of the disease, pain side, whether symptoms are hidden, and type of imaging examination at the initial visit were compared using the χ2 -test. Years of alcohol consumption, weekly alcohol consumption, and physician title at the initial visit were compared using a Mann-Whitney U-test. Furthermore, the statistically significant factors were evaluated using multiple regression analysis to investigate the risk factors of misdiagnosis. RESULTS: A total of 303 patients (20.6%) were misdiagnosed: 118 cases were misdiagnosed as lumbar disc herniation, 86 cases as hip synovitis, 48 cases as hip osteoarthritis, 32 cases as rheumatoid arthritis, 11 cases as piriformis syndrome, 5 cases as sciatica, and 3 cases as soft-tissue injury. Whether symptoms are hidden (P = 0.038, odds ratio [OR] = 1.546, 95% confidence interval [CI] = 1.025-2.332), physician title at the initial visit (P < 0.001, OR = 3.324, 95% CI = 1.850-5.972), X-ray examination (P < 0.001, OR = 4.742, 95% CI = 3.159-7.118), corticosteroids (P < 0.001, OR = 0.295, 95% CI = 0.163-0.534), alcohol (P < 0.001, OR = 0.305, 95% CI = 0.171-0.546), and magnetic resonance imaging (MRI) examination (P = 0.042, OR = 0.649, 95% CI = 0.427-0.985) were each found to be associated with misdiagnosis. CONCLUSION: Osteonecrosis of the femoral head is easily misdiagnosed as lumbar disc herniation, hip synovitis, hip osteoarthritis, and rheumatoid arthritis. Patient history of corticosteroid use or alcohol abuse and MRI examination at the initial diagnosis may be protective factors for misdiagnosis. Hidden symptoms, physician title at the initial visit (as attending doctor or resident doctor), and only X-ray examination at the initial diagnosis may be risk factors for misdiagnosis.

Catheter ablation for atrial fibrillation is associated with reduced risk of mortality in the elderly: a prospective cohort study and propensity score analysis.

BACKGROUND: It is unclear whether catheter ablation (CA) for atrial fibrillation (AF) affects the long-term prognosis in the elderly. This study aims to evaluate the relationship between CA and long-term outcomes in elderly patients with AF. METHODS: Patients more than 75 years old with non-valvular AF were prospectively enrolled between August 2011 and December 2017 in the Chinese Atrial Fibrillation Registry Study. Participants who underwent CA at baseline were propensity score matched (1:1) with those who did not receive CA. The outcome events included all-cause mortality, cardiovascular mortality, stroke/transient ischemic attack (TIA), and cardiovascular hospitalization. RESULTS: Overall, this cohort included 571 ablated patients and 571 non-ablated patients with similar characteristics on 18 dimensions. During a mean follow-up of 39.75 ± 19.98 months (minimum six months), 24 patients died in the ablation group, compared with 60 deaths in the non-ablation group [hazard ratio (HR) = 0.49, 95% confidence interval (CI): 0.30-0.79, P = 0.0024]. Besides, 6 ablated and 29 non-ablated subjects died of cardiovascular disease (HR = 0.25, 95% CI: 0.11-0.61, P = 0.0022). A total of 27 ablated and 40 non-ablated patients suffered stroke/TIA (HR = 0.79, 95% CI: 0.48-1.28, P = 0.3431). In addition, 140 ablated and 194 non-ablated participants suffered cardiovascular hospitalization (HR = 0.84, 95% CI: 0.67-1.04, P = 0.1084). Subgroup analyses according to gender, type of AF, time since onset of AF, and anticoagulants exposure in initiation did not show significant heterogeneity. CONCLUSIONS: In elderly patients with AF, CA may be associated with a lower incidence of all-cause and cardiovascular mortality.

Effect of Mental Health Status on Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation.

BACKGROUND: Patients diagnosed with atrial fibrillation suffer more from anxiety and depression than the general population. This study sought to evaluate the association between mental health status and recurrence of atrial tachyarrhythmia (AT) after catheter ablation. METHODS: A total of 448 patients who underwent catheter ablation for atrial fibrillation were enrolled in this single-centre prospective cohort study. Mental Health Inventory-5 (MHI-5) was used to assess the mental health status at the end of the blanking period after ablation and lower scores indicated poorer mental health status. Patients with no early recurrence of AT during the blanking period were included for analyses. Multivariate logistic regression was used to examine the association between mental health status and risk of arrhythmia recurrence in the following 3 months. RESULTS: Among 335 patients without early recurrence during the blanking period, 36 patients (10.7%) experienced AT recurrence in the 3 months after the mental health status evaluation. Recurrence rates were 35.7%, 13.5%, 10.6%, and 4.6% in patients with an MHI-5 score of 0-52, 53-75, 76-85, and 86-100, respectively (overall P = 0.004). A significant association between low MHI-5 scores and AT recurrence was observed after multivariate adjustment (odds ratio: 8.81 [1.93-40.22], P = 0.005 for the MHI-5 score of 0-52 and 3.61 [1.05-12.35], P = 0.041 for the MHI-5 score of 53-75, compared with an MHI-5 score of 86-100). CONCLUSIONS: A poorer mental health status is associated with AT recurrence after catheter ablation. Intervention studies are warranted to evaluate the efficacy of counselling and psychological support after ablation in improving success rates in these patients.