Time in target range of systolic blood pressure and clinical outcomes in atrial fibrillation patients: results of the COOL-AF registry.

We aimed to investigate the relationship between time in target range of systolic blood pressure (SBP-TTr) and clinical outcomes in patients with atrial fibrillation (AF). We analyzed the results from multicenter AF registry in Thailand. Blood pressure was recorded at baseline and at every 6 monthly follow-up visit. SBP-TTr were calculated using the Rosendaal method, based on a target SBP 120-140 mmHg. The outcomes were death, ischemic stroke/systemic embolism (SSE), major bleeding, and heart failure. A total of 3355 patients were studied (mean age 67.8 years; 41.9% female). Average follow-up time was 32.1 ± 8.3 months. SBP-TTr was classified into 3 groups according to the tertiles. The incidence rates of all-cause death, SSE, major bleeding, and heart failure were 3.90 (3.51-4.34), 1.52 (1.27-1.80), 2.2 (1.90-2.53), and 2.83 (2.49-3.21) per 100 person-years, respectively. Patients in the 3rd tertile of SBP-TTr had lower rates of death, major bleeding and heart failure with adjusted hazard ratios 0.62 (0.48-0.80), p < 0.001, 0.64 (0.44-0.92), p = 0.016, and 0.61 (0.44-0.84), p = 0.003, respectively, compared to 1st SBP-TTr tertile. In conclusion, high SBP-TTr was associated with better clinical outcomes compared to other groups with lower SBP-TTr. This underscores the importance of good blood pressure control in AF patients.

Predicting Heart Failure in Patients with Atrial Fibrillation: A Report from the Prospective COOL-AF Registry.

BACKGROUND: This study aimed to determine risk factors and incidence rate and develop a predictive risk model for heart failure for Asian patients with atrial fibrillation (AF). METHODS: This is a prospective multicenter registry of patients with non-valvular AF in Thailand conducted between 2014 and 2017. The primary outcome was the occurrence of an HF event. A predictive model was developed using a multivariable Cox-proportional model. The predictive model was assessed using C-index, D-statistics, Calibration plot, Brier test, and survival analysis. RESULTS: There were a total of 3402 patients (average age 67.4 years, 58.2% male) with mean follow-up duration of 25.7 ± 10.6 months. Heart failure occurred in 218 patients during follow-up, representing an incidence rate of 3.03 (2.64-3.46) per 100 person-years. There were ten HF clinical factors in the model. The predictive model developed from these factors had a C-index and D-statistic of 0.756 (95% CI: 0.737-0.775) and 1.503 (95% CI: 1.372-1.634), respectively. The calibration plots showed a good agreement between the predicted and observed model with the calibration slope of 0.838. The internal validation was confirmed using the bootstrap method. The Brier score indicated that the model had a good prediction for HF. CONCLUSIONS: We provide a validated clinical HF predictive model for patients with AF, with good prediction and discrimination values.

Influence of gender on the clinical outcomes of Asian non-valvular atrial fibrillation patients: insights from the prospective multicentre COOL-AF registry.

OBJECTIVE: To determine the effect of gender on clinical outcomes of Asian non-valvular atrial fibrillation patients. DESIGN: This is a cohort study. SETTING: 27 university and regional hospitals in Thailand. PARTICIPANTS: Patients with non-valvular atrial fibrillation. PRIMARY AND SECONDARY OUTCOMES MEASURES: The clinical outcomes were ischaemic stroke/transient ischaemic attack (TIA), major bleeding, intracerebral haemorrhage (ICH), heart failure and death. Follow-up data were recorded every 6 months until 3 years. Differences in clinical outcomes between males and females were determined. Multivariate analysis was performed to assess the effect of gender on clinical outcomes. Survival analysis and log-rank test were performed to determine the time-dependent effect of clinical outcomes, and the difference between males and females. Effect of oral anticoagulant (OAC) on outcomes and net clinical benefit of OAC was assessed. The analysis was performed both for the whole dataset and propensity score matching with multiple imputation. RESULTS: A total of 3402 patients (mean age: 67.4±11.3 years; 58.2% male) were included. Average follow-up duration 25.7±10.6 months (7192.6 persons-year). Rate of ischaemic stroke/TIA, major bleeding, ICH, heart failure and death were 1.43 (1.17-1.74), 2.11 (1.79-2.48), 0.70 (0.52-0.92), 3.03 (2.64-3.46) and 3.77 (3.33-4.25) per 100 person-years. Females had increased risk for ischaemic stroke/TIA and heart failure and males had increased risk for major bleeding and ICH. Ischaemic stroke/TIA risk in females and major bleeding and ICH risk in males remained even after correction for age, comorbid conditions and anticoagulation treatment. OAC reduced the risk of ischaemic stroke/TIA in males and females, and markedly increased the risk of major bleeding and ICH in males. CONCLUSIONS: Females had a higher risk of ischaemic stroke/TIA and heart failure, and a lower risk of major bleeding and ICH compared with males. OAC reduced risk of ischaemic stroke/TIA in females, and markedly increased risk of major bleeding and ICH in males.

Optimal INR level in elderly and non-elderly patients with atrial fibrillation receiving warfarin: a report from the COOL-AF nationwide registry in Thailand.

BACKGROUND: Asian population are at increased risk of bleeding during the warfarin treatment, so the recommended optimal international normalized ratio (INR) level may be lower in Asians than in Westerners. The aim of this prospective multicenter study was to determine the optimal INR level in Thai patients with non-valvular atrial fibrillation (NVAF). METHODS: Patients with NVAF who were on warfarin for stroke prevention were recruited from 27 hospitals in the nationwide COOL-AF registry in Thailand. We collected demographic data, medical history, risk factors for stroke and bleeding, concomitant disease, electrocardiogram and laboratory data including INR and antithrombotic medications. Outcome measurements included ischemic stroke/transient ischemic attack (TIA) and major bleeding. Optimal INR level was assessed by the calculation of incidence density for six INR ranges (< 1.5, 1.5-1.99, 2-2.49, 2.5-2.99, 3-3.49, and ≥ 3.5). RESULTS: A total of 2, 232 patients were included. The mean age of patients was 68.5 ± 10.6 years. The mean follow-up duration was 25.7 ± 10.6 months. There were 63 ischemic stroke/TIA and 112 major bleeding events. The lowest prevalence of ischemic stroke/TIA and major bleeding events occurred within the INR range of 2.0-2.99 for patients < 70 years and 1.5-2.99 for patients ≥ 70 years. CONCLUSIONS: The INR range associated with the lowest risk of ischemic stroke/TIA and bleeding in the Thai population was 2.0-2.99 for patients < 70 years and 1.5-2.99 for patients ≥ 70 years. The rates of major bleeding and ischemic stroke/TIA were both higher than the rates reported in Western population.

Low Body Weight Increases the Risk of Ischemic Stroke and Major Bleeding in Atrial Fibrillation: The COOL-AF Registry.

We aimed to determine if low body weight (LBW) status (<50 kg) is independently associated with increased risk of ischemic stroke and bleeding in Thai patients with non-valvular atrial fibrillation (NVAF). (1) Background: It has been unclear whether LBW influence clinical outcome of patients with NVAF. (2) Methods: This prospective multicenter cohort study included patients enrolled in the COOL-AF Registry. The following data were collected: demographic data, medical history, risk factors and comorbid conditions, laboratory and investigation data, and medications. Follow-up data were collected every 6 months. Clinical events during follow-up were confirmed by the adjudication committee. (3) Results: A total of 3367 patients were enrolled. The mean age was 67.2 ± 11.2 years. LBW was present in 338 patients (11.3%). Anticoagulant and antiplatelet was prescribed in 75.3% and 26.2% of patients, respectively. Ischemic stroke, major bleeding, intracerebral hemorrhage (ICH), and death occurred during follow-up in 2.9%, 4.4%, 1.4%, and 7.7% of patients, respectively, during 25.7 months follow-up. LBW was an independent predictor of ischemic stroke, major bleeding, ICH, and death, with a hazard ratio of 2.40, 1.79, 2.37, and 2.65, respectively. (4) Conclusions: LBW was independently associated with increased risk of adverse outcomes in Thai patients with NVAF. This should be carefully considered when balancing the risks and benefits of stroke prevention among patients with different body weights.

SAMe-TT2R2 score for prediction of suboptimal time in therapeutic range in a Thai population with atrial fibrillation.

INTRODUCTION: International normalised ratio (INR) control is an important factor in patients with non-valvular atrial fibrillation (NVAF) being treated with warfarin. INR control was previously reported to be poorer among Asians compared to Westerners. We aimed to validate the SAMe-TT2R2 score for prediction of suboptimal INR control (defined as time in therapeutic range [TTR] < 65% in the Thai population) and to investigate TTR among Thai NVAF patients being treated with warfarin. METHODS: INR data from patients enrolled in a multicentre NVAF registry was analysed. Clinical and laboratory data was prospectively collected. TTR was calculated using the Rosendaal method. Baseline data was compared between patients with and without suboptimal INR control. Univariate and multivariate analyses were performed to identify variables independently associated with suboptimal INR control. RESULTS: A total of 1,669 patients from 22 centres located across Thailand were included. The average age was 69.1 ± 10.7 years, and 921 (55.2%) were male. The mean TTR was 50.5% ± 27.5%; 1,125 (67.4%) had TTR < 65%. Univariate analysis showed hypertension, diabetes mellitus, heart failure, renal disease and SAMe-TT2R2 score to be significantly different between patients with and without optimal TTR. The SAMe-TT2R2 score was the only factor that remained statistically significant in multivariate analysis. The C-statistic for the SAMe-TT2R2 score in the prediction of suboptimal TTR was 0.54. CONCLUSION: SAMe-TT2R2 score was the only independent predictor of suboptimal TTR in NVAF patients being treated with warfarin. However, due to the low C-statistic, the score may have limited discriminative power.

Risk profiles and pattern of antithrombotic use in patients with non-valvular atrial fibrillation in Thailand: a multicenter study.

BACKGROUND: Anticoagulation therapy is a standard treatment for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) that have risk factors for stroke. However, anticoagulant increases the risk of bleeding, especially in Asians. We aimed to investigate the risk profiles and pattern of antithrombotic use in patients with NVAF in Thailand, and to study the reasons for not using warfarin in this patient population. METHODS: A nationwide multicenter registry of patients with NVAF was created that included data from 24 hospitals located across Thailand. Demographic data, atrial fibrillation-related data, comorbid conditions, use of antithrombotic drugs, and reasons for not using warfarin were collected. Data were recorded in a case record form and then transferred into a web-based system. RESULTS: A total of 3218 patients were included. Average age was 67.3 ± 11.3 years, and 58.2% were male. Average CHADS2, CHA2DS2-VASc, and HAS-BLED score was 1.8 ± 1.3, 3.0 ± 1.7, and 1.5 ± 1.0, respectively. Antiplatelet was used in 26.5% of patients, whereas anticoagulant was used in 75.3%. The main reasons for not using warfarin in those with CHA2DS2-VASc ≥2 included already taking antiplatelet (26.6%), patient preference (23.1%), and using non-vitamin K antagonist oral anticoagulants (NOACs) (22.7%). Anticoagulant was used in 32.3% of CHA2DS2-VASc 0, 56.8% of CHA2DS2-VASc 1, and 81.6% of CHA2DS2-VASc ≥2. The use of NOACs increased from 1.9% in 2014 to 25.6% in 2017. CONCLUSIONS: Anticoagulation therapy was prescribed in 75.3% of patients with NVAF. Among those receiving anticoagulant, 90.9% used warfarin and 9.1% used NOACs. The use of NOACs increased over time.

A Comparison of Accuracy of Planar and Evolution SPECT/CT Bone Imaging in Differentiating Benign from Metastatic Bone Lesions.

Objective: To compare sensitivity, specificity, accuracy and diagnostic confidence in the differentiation between benign and metastatic bone lesions on whole body planar bone scintigraphy and Evolution SPECT/CT. Material and Method: Eighty diagnosed or suspected cancer patients with indeterminate lesions on planar scintigraphy were recruited in the present prospective study. Additional whole body Evolution SPECT/CT was performed after whole body planar scintigraphy. All lesions on both imagings were categorized into 5 categories; definitely metastasis, probably metastasis, indeterminate, probably benign and definitely benign. The diagnosis of each lesion was confirmed by follow-up imaging, pathological findings or clinical follow-up for at least 6 months. Results: Detected lesions on planar scintigraphy and Evolution SPECT/CT imaging were 442 and 477 lesions, respectively.The sensitivity, specificity and accuracy of planar scintigraphy and Evolution SPECT/CT imaging in the diagnosis of metastatic lesions were 27% (95% CI: 13.8, 44.1), 63.2% (95% CI: 58.5, 67.7), 60%, and 97.3% (95% CI: 85.8, 99.9), 100% (95% CI: 96.4, 100) and 99.8%, respectively. Indeterminate lesions on planar scintigraphy were 34.2% (151 lesions from total 442 lesions, which 135 of these 151 indeterminate lesions or 89.4% were located in axial skeleton). Evolution SPECT/CT images were able to characterize all indeterminate lesions. Conclusion: Differentiation of benign and metastatic lesions by Evolution SPECT/CT images has superior diagnostic performance and diagnostic confidence over the planar scintigraphy. Thus, Evolution SPECT/CT images should be considered in characterization of indeterminate lesions on planar scintigraphy, especially in the axial skeleton.

A prospective randomized study of the efficacy and cost-effectiveness of high and low dose regimens of I-131 treatment in hyperthyroidism.

OBJECTIVE: To compare the efficacy and cost-effectiveness of high and low dose regimens of I-131 treatment in patients with hyperthyroidism. MATERIAL AND METHOD: One hundred fifty patients with proven hyperthyroidism were randomly allocated into the high (74 patients) and low (76 patients) dose regimen of I-131 treatment. Four patients of the high dose group and one patient of the low dose group were excluded because of lost follow-up. A gland-specific dosage was calculated on the estimated weight of thyroid gland and 24-hour I-131 uptake. The high and low I-131 dose regimens were 150 microCi/gm and 100 microCi/gm, respectively. The first mean radioiodine activity administered to the high and low dose group was 10.2 and 8 mCi, respectively. Repeated treatment was given to 25 patients of the high dose group and 40 patients of the low dose group. Clinical outcome and calculated costs for outpatient attendances, and laboratory tests together with initial and subsequent treatments were evaluated for one year after I-131 treatment. Elimination of hyperthyroidism that resulted in either euthyroidism or hypothyroidism was classified as therapeutic success. The cost effectiveness was also compared. RESULTS: At 6 months after treatment, 45 (64.3%) patients receiving high dose and 59 (78.7%) patients receiving low dose were hyperthyroidism. Clinical outcome at one year showed persistence of hyperthyroidism in 21 (30%) patients of the high dose regimen and 36 (48%) patients of the low dose regimen. At one year post treatment, it was demonstrated that the high dose regimen could eliminate hyperthyroidism in a significantly shorter time than the low dose regimen, i.e., 259.6 days and 305.5 days, respectively, p = 0.008). For the persistent hyperthyroid patients, the average total cost of treatment in the low dose group was significantly higher than that of the high dose group, i.e., 13,422.78 baht and 10,942.79 baht, respectively; p = 0.050). CONCLUSION: A high dose regimen of radioactive iodine treatment is more effective than the low dose regimen. The successful outcome of a high dose regimen occurred significantly earlier than that of the low dose regimen. For the persistent hyperthyroid patients, the average total cost in the low dose group was significantly higher than that of the high dose group.

Prospective, randomized comparison of castor oil and sodium phosphate preparation for barium enema.

OBJECTIVE: To compare castor oil and sodium phosphate preparation (Swiff) in patients' satisfaction, efficacy for colon cleanness, side effects, and prices. MATERIAL AND METHOD: One hundred patients referred for barium enema were randomized to receive castor oil (n = 50) and sodium phosphate preparation (n = 50). They graded their satisfaction using a 5-point scale (easy, acceptable, slightly difficult, extremely difficult, and unacceptable). The efficacy for colon cleanness was graded by two radiologists using a 5-point scale (excellent, easy for evaluation, acceptable, difficult for evaluation, and unacceptable). Side effects were evaluated by patients' vital signs, total number of bowel frequency, and 10 associated symptoms. RESULTS: Both preparations revealed no difference in patients' satisfaction (p = 0.882) and efficacy of colon cleanness (p = 0.130). Sodium phosphate preparation was more expensive (79 vs. 10 Baht) and caused higher number of bowel frequency (p < 0.001). CONCLUSION: With a cheaper price, castor oil was comparable with sodium phosphate preparation in patients' satisfaction and efficacy of colon cleanness.

Fractional thigh volume by three-dimensional ultrasonography for birth weight prediction.

OBJECTIVE: To determine the correlation between actual birthweight (BW) and fetal weight calculated from fractional thigh volume (ThiV). MATERIAL AND METHOD: The authors have conducted a prospective, cross-sectional study of normal Thai fetal thigh volume. There were 176 eligible pregnant women who met the criteria of singleton with no fetal anomaly were recruited into the present study. Prior to the present study, 3 operators had been trained and standardized for fractional ThiV measurement by an expert for the first 20 cases. To generate the fetal weight calculating formula, fetal ThiV data from the first 100 cases were employed Then, the authors' new prediction formula was compared and validated with the Hadlock's and the Tongsong formula in 56 normal late-third-trimester fetuses. All patients were assessed for 2D fetal biometry and 3D fractional ThiV within one week before delivery. RESULTS: A total of 176 fetuses underwent ultrasound at the gestational age of 38.5 +/- 2.1 weeks. The reproducibility of fractional ThiV measurement technique showned very good correlation in both inter- and intra-observer reliability as observed by the high intraclass correlation (0.971-0.994). By using the regression model, fractional ThiV presents a superior correlation to actual BW (r = 0.965). The fitting formula is characterized by predicted fetal BW (g) = 774.744 + 32.658 x fractional ThiV (ml). The presented new formula shows the smallest absolute percentage error (APE) for BW estimation when compared to that of Hadlock's and Tongsong's. CONCLUSION: Fetal 3D-fractional ThiV is consistent with actual BW The measurement of fractional ThiV can improve the accuracy of fetal weight prediction especially in some eventful conditions.

Derived 12-lead electrocardiogram in the assessment of ST-segment deviation and cardiac rhythm.

BACKGROUND: There are little data on the validation of 12-lead electrocardiogram (ECG) derived by the EASI lead system used for continuous monitoring in critical care settings. OBJECTIVE: The objectives of this study were to determine the accuracy of 12-lead ECG derived by the EASI lead system in the detection of ST-segment deviation and cardiac rhythm compared with the standard 12-lead ECG. METHODS: All patients admitted to the coronary care unit were studied. Kappa statistics was used to calculate the agreement between both ECG systems in the determination of cardiac rhythm and premature ventricular complex morphology. ST-segment analysis was performed in patients with acute coronary syndromes. Pearson correlation was used to correlate the ST-segment deviation between both techniques. The sensitivity and specificity of the determination of significant ST-segment deviation by the EASI lead system were calculated. RESULTS: There were a total of 282 patients enrolled in this study. There was a complete agreement in the interpretation of cardiac rhythm between the 2 methods (kappa = 1). Analysis of ST-segment deviation of 12-lead ECG also showed a significant correlation (correlation coefficient varied from 0.62 in lead I to 0.823 in lead aVF with a P value of <.001 in all leads) between the 2 methods with very high sensitivity and specificity in the detection of significant ST-segment elevation and depression. CONCLUSION: The 12-lead ECG derived by the EASI lead system is an accurate and reliable information for the assessment of ST-segment deviation and cardiac rhythm in critically ill patients.