Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation.

BACKGROUND: In the Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban 20 mg was the on-label dose, and the dose-reduction criterion for rivaroxaban was a creatinine clearance of < 50 mL/min. Some Asian countries are using reduced doses label according to the J-ROCKET AF trial. The aim of this study was to assess the safety and efficacy of a high-dose rivaroxaban regimen (HDRR, 20/15 mg) and low-dose rivaroxaban regimen (LDRR, 15/10 mg) among elderly East Asian patients with atrial fibrillation (AF) in real-world practice. METHODS: This study was a multicenter, prospective, non-interventional observational study designed to evaluate the efficacy and safety of rivaroxaban in AF patients > 65 years of age with or without renal impairment. RESULTS: A total of 1,093 patients (mean age, 72.8 ± 5.8 years; 686 [62.9%] men) were included in the analysis, with 493 patients allocated to the HDRR group and 598 patients allocated to the LDRR group. A total of 765 patients received 15 mg of rivaroxaban (203 in the HDRR group and 562 in the LDRR group). There were no significant differences in the incidence rates of major bleeding (adjusted hazard ratio [HR], 0.64; 95% confidential interval [CI], 0.21-1.93), stroke (adjusted HR, 3.21; 95% CI, 0.54-19.03), and composite outcomes (adjusted HR, 1.13; 95% CI, 0.47-2.69) between the HDRR and LDRR groups. CONCLUSION: This study revealed the safety and effectiveness of either dose regimen of rivaroxaban in an Asian population for stroke prevention of AF. Considerable numbers of patients are receiving LDRR therapy in real-world practice in Asia. Both regimens were safe and effective for these patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04096547.

Additional anteromedial staple fixation prevents changes in the posterior tibial slope in retrotuberosity bi-planar open-wedge high tibial osteotomy.

PURPOSE: To compare the changes in posterior tibial slope (PTS) between retrotuberosity biplane open-wedge high tibial osteotomies (RT-OWHTOs) with and without additional anteromedial staple fixation. METHODS: Seventy-nine and 77 cases of RT-OWHTOs without (Group N) and with (Group S) additional staple fixation, respectively, were retrospectively reviewed. All procedures were performed using a locking spacer plate. Demographics and preoperative knee condition were similar between the groups. Clinically, the Western Ontario and McMaster Universities Arthritis Index and range of motion were evaluated preoperatively and 2 years postoperatively. Radiographically, the mechanical axis (MA), medial proximal tibial angle (MPTA), and PTS were evaluated preoperatively and within 2 years postoperatively. Hinge fractures were investigated using computed tomography at 2 weeks postoperatively. PTS loss was defined as the difference between the corresponding values at 2 weeks and 2 years postoperatively. The incidence of PTS failure (PTS loss ≥ ± 3°) was also investigated. RESULTS: The clinical results were not significantly different between groups N and S preoperatively and 2 years postoperatively. There were no significant differences in the MA, MPTA, and PTS between the groups preoperatively and 2 weeks postoperatively; changes in these variables did not differ significantly between the groups. The incidence of hinge fractures, all of which were categorized as Takeuchi type 1, did not differ significantly. PTS loss within 2 years postoperatively was significantly greater in group N than in group S (1.0° vs. 0.1°; p < 0.01). The incidence of the PTS failure was 16.5% (13/79) and 2.6% (2/77) in groups N and S, respectively (p < 0.01). CONCLUSION: Additional anteromedial staple fixation could prevent changes in the PTS in RT-OWHTO. It is a simple method for preventing an increase in the PTS after RT-OWHTO. LEVEL OF EVIDENCE: III.

Neutrophil-to-Lymphocyte Ratio at Emergency Room Predicts Mechanical Complications of ST-segment Elevation Myocardial Infarction.

BACKGROUND: The neutrophil-to-lymphocyte ratio (NLR) has been proven to be a reliable inflammatory marker. A recent study reported that elevated NLR is associated with adverse cardiovascular events in patients with ST-segment elevation myocardial infarction (STEMI). We investigated whether NLR at emergency room (ER) is associated with mechanical complications of STEMI undergoing primary percutaneous coronary intervention (PCI). METHODS: A total of 744 patients with STEMI who underwent successful primary PCI from 2009 to 2018 were enrolled in this study. Total and differential leukocyte counts were measured at ER. The NLR was calculated as the ratio of neutrophil count to lymphocyte count. Patients were divided into tertiles according to NLR. Mechanical complications of STEMI were defined by STEMI combined with sudden cardiac arrest, stent thrombosis, pericardial effusion, post myocardial infarction (MI) pericarditis, and post MI ventricular septal rupture, free-wall rupture, left ventricular thrombus, and acute mitral regurgitation during hospitalization. RESULTS: Patients in the high NLR group (> 4.90) had higher risk of mechanical complications of STEMI (P = 0.001) compared with those in the low and intermediate groups (13% vs. 13% vs. 23%). On multivariable analysis, NLR remained an independent predictor for mechanical complications of STEMI (RR = 1.947, 95% CI = 1.136-3.339, P = 0.015) along with symptom-to balloon time (P = 0.002) and left ventricular dysfunction (P < 0.001). CONCLUSION: NLR at ER is an independent predictor of mechanical complications of STEMI undergoing primary PCI. STEMI patients with high NLR are at increased risk for complications during hospitalization, therefore, needs more intensive treatment after PCI.

Mechanical and Pharmacological Revascularization Strategies for Prevention of Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction: Analysis from Index of Microcirculatory Resistance Registry Data.

OBJECTIVES: We aimed to identify mechanical and pharmacological revascularization strategies correlated with the index of microcirculatory resistance (IMR) in ST-elevation myocardial infarction (STEMI) patients. BACKGROUND: Microvascular dysfunction (MVD) after STEMI is correlated with infarct size and poor long-term prognosis, and the IMR is a useful analytical method for the quantitative assessment of MVD. However, therapeutic strategies that can reliably reduce MVD remain uncertain. METHODS: Patients with STEMI who underwent primary percutaneous coronary intervention (PCI) were enrolled. The IMR was measured with a pressure sensor/thermistor-tipped guidewire immediately after primary PCI. High IMR was defined as values ≥66th percentile of IMR in enrolled patients (IMR > 30.9 IU). RESULTS: A total of 160 STEMI patients were analyzed (high IMR = 54 patients). Clinical factors for Killip class (P=0.006), delayed hospitalization from symptom onset (P=0.004), peak troponin-I level (P=0.042), and multivessel disease (P=0.003) were associated with high IMR. Achieving final thrombolysis in myocardial infarction myocardial perfusion grade 3 tended to be associated with low IMR (P=0.119), whereas the presence of distal embolization was significantly associated with high IMR (P=0.034). In terms of therapeutic strategies that involved adjusting clinical and angiographic factors associated with IMR, preloading of third-generation P2Y12 inhibitors correlated with reducing IMR value (ß = -10.30, P < 0.001). Mechanical therapeutic strategies including stent diameter/length, preballoon dilatation, direct stenting, and thrombectomy were not associated with low IMR value (all P > 0.05), and postballoon dilatation was associated with high IMR (ß = 8.30, P=0.020). CONCLUSIONS: In our study, mechanical strategies were suboptimal in achieving myocardial salvage. Preloading of third-generation P2Y12 inhibitors revealed decreased IMR value, indicative of MVD prevention.

Impact of gender on heart failure presentation in non-obstructive hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease that represents a broad spectrum of morphologic features and clinical presentations. However, little is known about the impact of gender differences in heart failure (HF) development in non-obstructive HCM. We assessed clinical and echocardiographic parameters according to gender in patients with non-obstructive HCM and evaluated the impact of gender on HF presentation and cardiovascular (CV) outcomes in this population. We investigated 202 consecutive patients with non-obstructive HCM. Clinical parameters and conventional echocardiographic measurements including tissue Doppler measurements were evaluated and compared according to gender. Additionally, left ventricular (LV) deformation was assessed with global longitudinal strain (GLS) utilizing 2D speckle tracking software. Of the 202 patients (age = 63 ± 14 years, male: female = 141: 61), 51 patients (24.8%) presented with HF and female patients had HF more frequently (52.5% vs. 12.8%, P < 0.001). Females were older, had a higher prevalence of atrial fibrillation, had increased left atrial volume (LAV), and a higher ratio of early diastolic mitral inflow to early annular velocity (E/e') than males (70 ± 12 years vs. 59 ± 14 years, P < 0.001 for age; 51.4 ± 19.3 mL/m2 vs. 40.0 [Formula: see text] 13.4 mL/m2, P < 0.001 for indexed LAV; 17.2 [Formula: see text] 6.0 vs. 13.0 [Formula: see text] 4.3, P < 0.001 for E/e'). While LV maximal thickness and LV ejection fraction were comparable between men and women, GLS was decreased significantly in female patients (- 13.5 [Formula: see text] 3.4% vs. - 15.6 [Formula: see text] 4.0%, P = 0.001 for GLS). Even after adjusting for clinical factors, female was independently associated with HF presentation (Odd ratio 5.19, 95% CI 2.24-12.03, P < 0.001). During a median follow-up duration 34.0 months, 20 patients (9.9%) had HF hospitalization or CV death. In a multivariable analysis, female gender was associated with higher risk of the composite of HF hospitalization or CV death and HF hospitalization alone than male (Adjusted hazard ratio [HR] = 3.31, 95% CI 1.17-9.35, P = 0.024 for primary composite outcome of HF hospitalization or CV death; adjusted HR = 4.78, 95% CI 1.53-14.96, P = 0.007 for HF hospitalization). In patients with non-obstructive HCM, female patients presented with HF more frequently and showed a higher risk of CV events than male patients. LA volume, E/e' and LV mechanics were different between the genders, suggesting that these might contribute to greater susceptibility to HF in women with HCM.

Ivabradine-Induced Torsade de Pointes in Patients with Heart Failure Reduced Ejection Fraction.

Ivabradine is a selective inhibitor of the sinoatrial node "funny" current, prolonging the slow diastolic depolarization. As it has the ability to block the heart rate selectively, it is more effective at a faster heart rate. It is recommended for the treatment of heart failure reduced ejection fraction in the presence of beta-blocker therapy for the further reduction of the heart rate. However, previous reports have shown the association of Torsade de pointes (TdP) with concurrent use of ivabradine and drugs resulting in QT prolongation or blockage of the metabolic breakdown of ivabradine. In this article, we report two cases of patients with heart failure reduced ejection fraction who developed TdP after ivabradine use. Our report highlights the need to exercise caution with the administration of ivabradine in the presence of a reduced repolarization reserve, such as QT prolongation or metabolic insufficiency.

Prognostic Impact of Left Atrial Minimal Volume on Clinical Outcome in Patients with Non-Obstructive Hypertrophic Cardiomyopathy.

Maximal left atrial volume (LAVmax) has been suggested to be an important indicator of left ventricular (LV) diastolic function and a prognosticator in patients with hypertrophic cardiomyopathy (HCM). However, LAVmax can be influenced by LV longitudinal systolic function, which causes systolic descent of the mitral plane. We investigated the prognostic role of LAVmin in patients with HCM and tested if LAVmin is better than LAVmax in predicting clinical outcome in these patients. A total of 167 consecutive patients with HCM were enrolled (age = 64.7 ± 13.5 years, male: female = 120:47). Clinical parameters and conventional echocardiographic measurement including tissue Doppler measurement were evaluated. Left atrial maximal and minimal volumes were measured just before mitral valve opening and at mitral valve closure respectively using the biplane disk method. The relationship between LAVmin and the clinical outcome of hospitalization for heart failure (HF), stroke or all-cause mortality was evaluated. During a median follow-up of 25.0 ± 17.8 months, the primary end point of HF hospitalization, stroke or death occurred in 35 patients (21%). Indexed LAVmin was predictive of HF, stroke or death after adjustment for age, diabetes, hypertension, atrial fibrillation, LV ejection fraction, and E/e'in a multivariate analysis (P = 0.001). The model including indexed LAVmin was superior to the model including indexed LAVmax in predicting a worse outcome in patients with HCM (P = 0.02). In conclusion, LAVmin was independently associated with increased risk of HF, stroke, or mortality in patients with HCM and was superior to LAVmax in predicting clinical outcome in this population.

Impact of area strain by 3D speckle tracking on clinical outcome in patients after acute myocardial infarction.

BACKGROUND: Three-dimensional (3D) speckle tracking echocardiography (STE) has been developed to overcome the limitations of two-dimensional (2D) STE and has been applied in the several clinical settings. However, no data exist about the prognostic value of 3DSTE-based strain on clinical outcome after myocardial infarction (MI). This study was designed to investigate the prognostic value of area strain (AS) by 3D speckle tracking in predicting clinical outcome after acute MI. METHODS: We assessed 96 patients (62±14 years, 72% male) with acute MI and who had undergone a coronary angiography. Clinical parameters and conventional echocardiographic measurements including the left atrial (LA) size and tissue Doppler measurements were evaluated. The global left ventricular (LV) AS was measured using 3D speckle tracking software. The relationship between the AS and clinical outcome of death or hospitalization for heart failure (HF) was assessed. RESULTS: During a median follow-up of 33±10 months, primary endpoint of death or HF occurred in 12 patients (12.5%). AS was predictive of death or HF after adjustment for age, gender, peak CK-MB, LA volume, LV end-systolic volume, LV mass, the ratio of early mitral inflow velocity to early mitral annular velocity, and LV ejection fraction in a multivariate Cox model (HR 1.23, 95% CI 1.02-1.47, P=.03). In addition, AS added incremental value in predicting death or heart failure on a model based on clinical and standard echocardiographic measures (P=.008). CONCLUSION: AS is independently associated with increased risk of death or HF after acute MI, suggesting that it can be a useful prognostic parameter in the patients following MI.

The development and evaluation of a program for leg-strengthening exercises and balance assessment using Kinect.

[Purpose] In this study, a program was developed for leg-strengthening exercises and balance assessment using Microsoft Kinect. [Subjects and Methods] The program consists of three leg-strengthening exercises (knee flexion, hip flexion, and hip extension) and the one-leg standing test (OLST). The program recognizes the correct exercise posture by comparison with the range of motion of the hip and knee joints and provides a number of correct action examples to improve training. The program measures the duration of the OLST and presents this as the balance-age. The accuracy of the program was analyzed using the data of five male adults. [Results] In terms of the motion recognition accuracy, the sensitivity and specificity were 95.3% and 100%, respectively. For the balance assessment, the time measured using the existing method with a stopwatch had an absolute error of 0.37 sec. [Conclusion] The developed program can be used to enable users to conduct leg-strengthening exercises and balance assessments at home.

Comparison of joint kinematics and pedaling force in the young and the elderly.

[Purpose] Proper pedaling posture can improve muscle strength and cardiopulmonary function. To investigate proper pedaling posture for the elderly, this study compared the pedaling efficiency of the elderly with that of the young by using an index of effectiveness (IE) and kinematic results. [Subjects and Methods] Eight adults in their twenties and eight in their seventies participated in 3-min, 40 rpm cycle pedaling tests, with the same load and cadence. The joint angle, range of motion (ROM), and IE were compared by measuring 3-dimensional motion and 3-axis pedal-reaction force during 4 pedaling phases (Phase 1: 330-30°, Phase 2: 30-150°, Phase 3: 150-210°, and Phase 4: 210-330°). [Results] The knee and ankle ROM, maximum knee extension, and maximum ankle dorsiflexion in the elderly were significantly decreased compared with those in the young. Moreover, there were significant differences in IE for the total phase, Phase 1, and Phase 4 between the elderly and young. IE of the young was greater than that of the elderly, except in Phase 3. [Conclusion] Joint movement in the elderly during pedaling was limited. This study provides information that will facilitate the proposal of an efficient pedaling method for the elderly.

A study on balance assessment according to the levels of difficulty in postural control.

[Purpose] This study aimed to determine appropriate measures for assessing balance ability according to difficulty level during standing tasks. [Subjects and Methods] The subjects were 56 old (>65 years) and 30 young (20-30 years) adults. By using the Berg balance scale, the subjects were divided into three groups: 29 healthy older (Berg score≥52), 27 impaired older (Berg score≥40), and 30 healthy young (Berg score≥55). One inertial measurement unit sensor was attached at the waist, and the subjects performed standing tasks (1 min/task) with six difficulty levels: eyes open and eyes closed on firm ground, one foam, and two foams. Thirty-nine (24 time-domain, 15 frequency-domain) measures were calculated by using acceleration data. The slope of each derived measure was calculated through the least-squares method. [Results] Five (95% ellipse sway area, root mean squares [anterior-posterior and resultant directions], and mean distance [anterior-posterior and resultant directions] in time domain) of the 39 measures showed significant differences among the groups under specific standing conditions. The slopes of derived measures showed significant differences among the groups and significant correlations with the Berg scores. [Conclusion] The slope according to the difficulty level can be used to assess and discriminate standing balance ability.

Fall- and BBS-related differences in muscle strength and postural balance of the elderly.

[Purpose] The purpose of this study was to compare the differences in muscle strength and postural balance between fallers and non-fallers. We also compared the difference between normal and impaired balance groups using the same subjects and the same variables. [Subjects and Methods] Seventy-one healthy elderly females (age: 75.1 ± 75 years; weight: 57.3 ± 57 kg; height: 150.1 ± 15 cm) who had high levels of physical activity participated [25 fallers (FG) vs. 46 non-fallers (NG); and 52 healthy balance group (HBG) and 19 impaired balance group (IBG) subjects]. To compare the groups, the muscle strengths of 9 muscle groups, and 20 variables of the instrumented standing balance assessment (2 area variables, 9 time-domain variables, and 9 frequency-domain variables) were assessed. [Results] The FG and NG could only be categorized based on the frequency-domain variables of the instrumented standing balance assessment. On the other hand, there were significant differences between HBG and IBG in height, 6 muscle strength, and 2 time-domain variables of the instrumented standing balance assessment. [Conclusion] These results suggest that muscle strength and standing balance are reflected in physical balance ability (i.e., BBS); however they are in sufficient for determining the actual occurrence of falls.

Relationship between J Waves and Vagal Activity in Patients Who Do Not Have Structural Heart Disease.

BACKGROUND: J waves are associated with increased vagal activity in patients with idiopathic ventricular fibrillation in several studies to date. However, the relationship between J waves and autonomic nervous activity in patients without structural heart disease remains under investigation. We investigated whether the presence of a J wave on the surface electrocardiogram (ECG) was related to increased vagal activity in patients without structural heart disease. METHODS: This retrospective study included 684 patients without structural heart disease who had undergone Holter ECG and surface ECG monitoring. Based on the presence of J waves on the surface ECG, patients were divided into two groups: those with J waves (group 1) and those without J waves (group 2). We compared heart rate variability (HRV), reflecting autonomic nervous activity, using 24-h Holter ECG between the groups. RESULTS: J waves were present in 92 (13.4%) patients. Heart rate (HR) in group 1 was significantly lesser than that in group 2 (P = 0.031). The ratio of low-frequency (LF) components to high-frequency (HF) components (LF/HF) in group 1 was significantly lower than that in group 2 (P = 0.001). The square root of the mean squared differences of successive NN intervals in group 1 was also significantly higher than that in group 2 (P = 0.047). In a multivariate regression analysis, male sex, HR, and LF/HF ratio remained independent determinants for the presence of J waves (P = 0.039, P = 0.036, and P < 0.001, respectively). CONCLUSION: In patients without structural heart disease, the presence of a J wave was associated with a slow HR, male sex, and increased vagal activity, independently.

Effects of low light on the stability of the head and pelvis of the healthy elderly.

[Purpose] The purpose of this study was to evaluate the changes in body stability of the elderly while walking on even surface ground under low light. [Subjects] Ten young males and ten elderly males participated in this experiment. [Methods] Each subject walked along a 7 m walkway five times at their preferred walking speed under normal (>300 lux, NORM) and low light conditions (<5 lux, LOW). To compare the changes in body stability, the root mean square of acceleration (RMSacc) at the head and pelvis was used. [Results] The results show that the body stability of young adults showed a similar RMSacc in all directions at the head and pelvis between the normal and low light walking conditions. In contrast, the RMSacc in all directions at the head and pelvis during low light walking by elderly adults was significantly greater than that of normal light walking. [Conclusion] It was confirmed that, despite walking on even ground, low light condition affects the body stability of the elderly. To clearly evaluate the effect of low light with aging on gait pattern, further study will be necessary to perform additional experiments under various environmental conditions to investigate walking speed, multi-tasking, stairs, and uneven walkway performance.

The relationship between J wave on the surface electrocardiography and ventricular fibrillation during acute myocardial infarction.

We investigated whether the presence of J wave on the surface electrocardiography (sECG) could be a potential risk factor for ventricular fibrillation (VF) during acute myocardial infarction (AMI). We performed a retrospective study of 317 patients diagnosed with AMI in a single center from 2009 to 2012. Among the enrolled 296 patients, 22 (13.5%) patients were selected as a VF group. The J wave on the sECG was defined as a J point elevation manifested through QRS notching or slurring at least 1 mm above the baseline in at least two leads. We found that the incidence of J wave on the sECG was significantly higher in the VF group. We also confirmed that several conventional risk factors of VF were significantly related to VF during AMI; time delays from the onset of chest pain, blood concentrations of creatine phosphokinase and incidence of ST-segment elevation. Multiple logistic regression analysis demonstrated that the presence of J wave and the presence of a ST-segment elevation were independent predictors of VF during AMI. This study demonstrated that the presence of J wave on the sECG is significantly related to VF during AMI.

Artificial intelligence-enhanced electrocardiography for early assessment of coronavirus disease 2019 severity.

Despite challenges in severity scoring systems, artificial intelligence-enhanced electrocardiography (AI-ECG) could assist in early coronavirus disease 2019 (COVID-19) severity prediction. Between March 2020 and June 2022, we enrolled 1453 COVID-19 patients (mean age: 59.7 ± 20.1 years; 54.2% male) who underwent ECGs at our emergency department before severity classification. The AI-ECG algorithm was evaluated for severity assessment during admission, compared to the Early Warning Scores (EWSs) using the area under the curve (AUC) of the receiver operating characteristic curve, precision, recall, and F1 score. During the internal and external validation, the AI algorithm demonstrated reasonable outcomes in predicting COVID-19 severity with AUCs of 0.735 (95% CI: 0.662-0.807) and 0.734 (95% CI: 0.688-0.781). Combined with EWSs, it showed reliable performance with an AUC of 0.833 (95% CI: 0.830-0.835), precision of 0.764 (95% CI: 0.757-0.771), recall of 0.747 (95% CI: 0.741-0.753), and F1 score of 0.747 (95% CI: 0.741-0.753). In Cox proportional hazards models, the AI-ECG revealed a significantly higher hazard ratio (HR, 2.019; 95% CI: 1.156-3.525, p = 0.014) for mortality, even after adjusting for relevant parameters. Therefore, application of AI-ECG has the potential to assist in early COVID-19 severity prediction, leading to improved patient management.

Artificial intelligence-estimated biological heart age using a 12-lead electrocardiogram predicts mortality and cardiovascular outcomes.

Background: There is a paucity of data on artificial intelligence-estimated biological electrocardiography (ECG) heart age (AI ECG-heart age) for predicting cardiovascular outcomes, distinct from the chronological age (CA). We developed a deep learning-based algorithm to estimate the AI ECG-heart age using standard 12-lead ECGs and evaluated whether it predicted mortality and cardiovascular outcomes. Methods: We trained and validated a deep neural network using the raw ECG digital data from 425,051 12-lead ECGs acquired between January 2006 and December 2021. The network performed a holdout test using a separate set of 97,058 ECGs. The deep neural network was trained to estimate the AI ECG-heart age [mean absolute error, 5.8 ± 3.9 years; R-squared, 0.7 (r = 0.84, p < 0.05)]. Findings: In the Cox proportional hazards models, after adjusting for relevant comorbidity factors, the patients with an AI ECG-heart age of 6 years older than the CA had higher all-cause mortality (hazard ratio (HR) 1.60 [1.42-1.79]) and more major adverse cardiovascular events (MACEs) [HR: 1.91 (1.66-2.21)], whereas those under 6 years had an inverse relationship (HR: 0.82 [0.75-0.91] for all-cause mortality; HR: 0.78 [0.68-0.89] for MACEs). Additionally, the analysis of ECG features showed notable alterations in the PR interval, QRS duration, QT interval and corrected QT Interval (QTc) as the AI ECG-heart age increased. Conclusion: Biological heart age estimated by AI had a significant impact on mortality and MACEs, suggesting that the AI ECG-heart age facilitates primary prevention and health care for cardiovascular outcomes.

Edoxaban treatment in atrial fibrillation in routine clinical care: One-year outcomes of the prospective observational ETNA-AF study in South Korean patients.

Background: The real-world outcomes of edoxaban treatment in patients with atrial fibrillation (AF) were analyzed in the ETNA-AF (Edoxaban Treatment in Routine Clinical Practice) study involving data from multiple regional registries. This report addresses effectiveness and safety of edoxaban in the Korean ETNA-AF population. Methods: One-year data from 1887 Korean ETNA-AF participants were analyzed according to edoxaban dose and patient age and compared with results of other ETNA-AF registries. Results: Approximately 70% of patients received the recommended doses of edoxaban (60 mg/30 mg); non-recommended 60 mg and 30 mg doses were prescribed to 9.6% and 19.8% of the patients, respectively. The proportions of reference age (<65 years), youngest-old (65-74 years) and middle-old/oldest-old (≥75 years) groups were 21.4%, 40.2%, and 38.4%, respectively. Incidence of major or clinically relevant nonmajor bleeding was similar within dose (0.57%-1.71%) and age subgroups (1.26%-1.63%). Incidence of net clinical outcome, a composite of stroke, systemic embolic event, major bleeding, and all-cause mortality, was also comparable among dose subgroups (1.14%-3.10%) and age subgroups (2.28%-2.78%). The percentage of Korean patients receiving non-recommended 30 mg (19.8%) was over twice that of the European population (8.4%). However, the clinical outcomes were generally similar among different populations included in the ETNA-AF study. Conclusions: The outcomes in the Korean ETNA-AF population are like those in the global ETNA-AF population, with overall low event rates of stroke, major bleeding and all-cause mortality across age and dose subgroups. Edoxaban can be used effectively and safely in specific populations of Korean AF patients, including the elderly.

Effectiveness of low-intensity atorvastatin 5 mg and ezetimibe 10 mg combination therapy compared with moderate-intensity atorvastatin 10 mg monotherapy: A randomized, double-blinded, multi-center, phase III study.

BACKGROUND: We compared the efficacy and safety of low-intensity atorvastatin and ezetimibe combination therapy with moderate-intensity atorvastatin monotherapy in patients requiring cholesterol-lowering therapy. METHODS: At 19 centers in Korea, 290 patients were randomized to 4 groups: atorvastatin 5 mg and ezetimibe 10 mg (A5E), ezetimibe 10 mg (E), atorvastatin 5 mg (A5), and atorvastatin 10 mg (A10). Clinical and laboratory examinations were performed at baseline, and at 4-week and 8-week follow-ups. The primary endpoint was percentage change from baseline in low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. Secondary endpoints included percentage changes from baseline in additional lipid parameters. RESULTS: Baseline characteristics were similar among the study groups. At the 8-week follow-up, percentage changes in LDL cholesterol levels were significantly greater in the A5E group (49.2%) than in the E (18.7%), A5 (27.9%), and A10 (36.4%) groups. Similar findings were observed regarding the percentage changes in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. Triglyceride levels were also significantly decreased in the A5E group than in the E group, whereas high-density lipoprotein levels substantially increased in the A5E group than in the E group. In patients with low- and intermediate-cardiovascular risk, 93.3% achieved the target LDL cholesterol levels in the A5E group, 40.0% in the E group, 66.7% in the A5 group, and 92.9% in the A10 group. In addition, 31.4% of patients in the A5E group, 8.1% in E, 9.7% in A5, and 7.3% in the A10 group reached the target levels of both LDL cholesterol < 70 mg/dL and reduction of LDL ≥ 50% from baseline. CONCLUSIONS: The addition of ezetimibe to low-intensity atorvastatin had a greater effect on lowering LDL cholesterol than moderate-intensity atorvastatin alone, offering an effective treatment option for cholesterol management, especially in patients with low and intermediate risks.

Artificial intelligence-enhanced 12-lead electrocardiography for identifying atrial fibrillation during sinus rhythm (AIAFib) trial: protocol for a multicenter retrospective study.

Introduction: Atrial fibrillation (AF) is the most common arrhythmia, contributing significantly to morbidity and mortality. In a previous study, we developed a deep neural network for predicting paroxysmal atrial fibrillation (PAF) during sinus rhythm (SR) using digital data from standard 12-lead electrocardiography (ECG). The primary aim of this study is to validate an existing artificial intelligence (AI)-enhanced ECG algorithm for predicting PAF in a multicenter tertiary hospital. The secondary objective is to investigate whether the AI-enhanced ECG is associated with AF-related clinical outcomes. Methods and analysis: We will conduct a retrospective cohort study of more than 50,000 12-lead ECGs from November 1, 2012, to December 31, 2021, at 10 Korean University Hospitals. Data will be collected from patient records, including baseline demographics, comorbidities, laboratory findings, echocardiographic findings, hospitalizations, and related procedural outcomes, such as AF ablation and mortality. De-identification of ECG data through data encryption and anonymization will be conducted and the data will be analyzed using the AI algorithm previously developed for AF prediction. An area under the receiver operating characteristic curve will be created to test and validate the datasets and assess the AI-enabled ECGs acquired during the sinus rhythm to determine whether AF is present. Kaplan-Meier survival functions will be used to estimate the time to hospitalization, AF-related procedure outcomes, and mortality, with log-rank tests to compare patients with low and high risk of AF by AI. Multivariate Cox proportional hazards regression will estimate the effect of AI-enhanced ECG multimorbidity on clinical outcomes after stratifying patients by AF probability by AI. Discussion: This study will advance PAF prediction based on AI-enhanced ECGs. This approach is a novel method for risk stratification and emphasizes shared decision-making for early detection and management of patients with newly diagnosed AF. The results may revolutionize PAF management and unveil the wider potential of AI in predicting and managing cardiovascular diseases. Ethics and dissemination: The study findings will be published in peer-reviewed publications and disseminated at national and international conferences and through social media. This study was approved by the institutional review boards of all participating university hospitals. Data extraction, storage, and management were approved by the data review committees of all institutions. Clinical Trial Registration: [cris.nih.go.kr], identifier (KCT0007881).