Optimal Dose of Edoxaban for Very Elderly Atrial Fibrillation Patients at High Risk of Bleeding: The LEDIOS Registry.

BACKGROUND AND OBJECTIVES: Optimal anticoagulation in very elderly patients is challenging due to the high risk of anticoagulant-induced bleeding. The aim of this study was to assess outcomes of on-label reduced-dose edoxaban (30 mg) in very elderly patients who had additional risk factors for bleeding. METHODS: This was a multi-center, prospective, non-interventional observational study to evaluate the efficacy and safety of on-label reduced-dose edoxaban in atrial fibrillation (AF) patients 80 years of age or older and who had more than 1 risk factor for bleeding. RESULTS: A total of 2448 patients (mean age 75.0±8.3 years, 801 [32.7%] males) was included in the present study, and 586 (23.9%) were 80 years of age or older with additional risk factors for bleeding. Major bleeding events occurred frequently among very elderly AF patients who had additional bleeding risk factors compared to other patients (unadjusted hazard ratio [HR], 2.16; 95% confidence interval [CI], 1.16-4.02); however, there were no significant differences in stroke incidence (HR, 1.86; 95% CI, 0.98-3.55). There were no significant differences for either factor after adjusting for age and sex (adjusted HR, 1.65; 95% CI, 0.75-3.62 for major bleeding; adjusted HR, 1.13; 95% CI, 0.51-2.50 for stroke). CONCLUSIONS: In very elderly AF patients with comorbidities associated with greater risk of bleeding, the incidence of major bleeding events was significantly increased. In addition, risk of stroke showed tendency to increase in same population. Effective anticoagulation therapy might be important in these high-risk population, and close observation of bleeding events might also be required. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03554837.

Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System.

BACKGROUND AND OBJECTIVES: Although a single-lead electrocardiogram (ECG) patch may provide advantages for detecting arrhythmias in outpatient settings owing to user convenience, its comparative effectiveness for real-time telemonitoring in inpatient settings remains unclear. We aimed to compare a novel telemonitoring system using a single-lead ECG patch with a conventional telemonitoring system in an inpatient setting. METHODS: This was a single-center, prospective cohort study. Patients admitted to the cardiology unit for arrhythmia treatment who required a wireless ECG telemonitoring system were enrolled. A single-lead ECG patch and conventional telemetry were applied simultaneously in hospitalized patients for over 24 hours for real-time telemonitoring. The basic ECG parameters, arrhythmia episodes, and signal loss or noise were compared between the 2 systems. RESULTS: Eighty participants (mean age 62±10 years, 76.3% male) were enrolled. The three most common indications for ECG telemonitoring were atrial fibrillation (66.3%), sick sinus syndrome (12.5%), and atrioventricular block (10.0%). The intra-class correlation coefficients for detecting the number of total beats, atrial and ventricular premature complexes, maximal, average, and minimal heart rates, and pauses were all over 0.9 with p values for reliability <0.001. Compared to a conventional system, a novel system demonstrated significantly lower signal noise (median 0.3% [0.1-1.6%] vs. 2.4% [1.4-3.7%], p<0.001) and fewer episodes of signal loss (median 22 [2-53] vs. 64 [22-112] episodes, p=0.002). CONCLUSIONS: The novel telemonitoring system using a single-lead ECG patch offers performance comparable to that of a conventional system while significantly reducing signal loss and noise. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0008176.

Clinical Outcomes of Intracardiac Echocardiography-Guided Contrast Agent-Free Cryoballoon Ablation in Atrial Fibrillation Patients With Renal Insufficiency.

BACKGROUND AND OBJECTIVES: Previous studies have reported an association between impaired renal function and poor outcomes after radiofrequency catheter ablation in patients with atrial fibrillation (AF). However, outcomes of cryoballoon ablation (CBA) in patients with renal insufficiency are not fully elucidated. This study aimed to compare outcomes of CBA in AF patients with chronic kidney disease (CKD) versus those without CKD and to assess changes in renal function over 12 months following CBA. METHODS: A total of 839 patients (65.1% with non-paroxysmal AF [PAF]) who underwent de novo CBA were prospectively enrolled. We divided patients into two groups based on creatinine clearance rate (CCr) and performed intracardiac echocardiography (ICE)-guided contrast agent-free CBA. RESULTS: In comparison with patients without CKD (CCr >50, n=722), those with CKD (CCr ≤50, n=117) were older and predominantly female, had a lower body mass index, and showed a higher prevalence of heart failure and hypertension. Mean CHA2DS2-VAS score was significantly higher in CKD group than in non-CKD group. Procedure-related complications were not significantly different between two groups. During a mean follow-up period of 25.4±11.9 months, clinical recurrence occurred in 182 patients (21.7%) and not significantly different between two groups. In multivariate analysis, non-PAF and left atrial size were independent predictors of AF recurrence. CCr levels significantly improved over 12 months after CBA in CKD group. CONCLUSIONS: ICE-guided contrast-agent-free CBA showed comparable long-term clinical outcomes without increasing procedure-related complications and improvement of renal function over 12 months following CBA in AF patients with CKD.

Improvement of road safety management systems of local governments in Korea after evaluating related indicators.

This study analyzes what has changed in the road safety management systems (RSMS) of local governments after evaluating the related indicators continuously from 2015 to 2019. It has evaluated 24 indicators in four areas of RSMS such as institutional management, intervention, intermediate outcome, and the final outcome, according to Han and Lee (2020). It seems that continuous evaluation of indicators of RSMSs in local governments for five years has helped to improve road safety performance in local governments. The result shows that the average overall scores have increased from 77.92 to 83.89, a 7.7% increase. This improvement should have resulted from the competition between local governments, which do not want to be at the bottom in the score comparison. The most remarkable increase has been identified in the areas of institutional management and intervention. They have increased by 13.3% and 16.0%, respectively. In terms of types of local governments, it has been found that the increase in overall scores is higher in provinces which include most rural areas than in metropolitans. However, it has been found that the improvement of institutional management and interventions are not directly associated with the increase of the intermediate and final outcomes, at least during the five years. Further studies examining the relationship between the four areas of RSMS are needed.

Safety and efficacy of intracardiac echocardiography-guided zero-fluoroscopic cryoballoon ablation for atrial fibrillation: a prospective randomized controlled trial.

AIMS: The development of intracardiac echocardiography (ICE) has enabled fluoroless atrial fibrillation (AF) ablation using three-dimensional electroanatomical mapping systems. However, fluoroless cryoballoon ablation (CBA) remains challenging, mainly because of the lack of a visual mapping system. Hence, this study aimed to investigate the safety and efficacy of fluoroless CBA for AF under ICE guidance. METHODS AND RESULTS: Patients (n = 100) who underwent CBA for paroxysmal AF were randomly assigned to zero-fluoroscopic (Zero-X) and conventional groups. Intracardiac echocardiography was used to guide the transseptal puncture and catheter and balloon manipulation in all enrolled patients. The patients were prospectively followed for 12 months after CBA. The mean age was 60.4 years, and the left atrial (LA) size was 39.4 mm. Pulmonary vein isolation (PVI) was achieved in all patients. In the Zero-X group, fluoroscopy was used in only one patient because of unstable phrenic nerve capture during right-sided PVI. The procedure time and LA indwelling time in the Zero-X group were not statistically different compared with that in the conventional group. Fluoroscopic time (9.0 vs. 0.008 min) and radiation exposure (29.4 vs. 0.02 mGy) were significantly shorter in the Zero-X group than in the conventional group (P < 0.001). The complication rate did not differ between the two groups. During a mean follow-up of 663.3 ± 172.3 days, the recurrence rate was similar (16.0 vs. 18.0%; P = 0.841) between the groups. Multivariate analysis revealed that LA size was the only independent predictor of clinical recurrence. CONCLUSION: Intracardiac echocardiography-guided fluoroless CBA for AF was a feasible strategy without compromising acute and long-term success or complication rates.

Safety of a single bolus administration of heparin without the measurement of activated clotting time during cryoballoon ablation: a prospective randomized controlled trial.

BACKGROUND: Single-shot ablation has emerged as an effective technique for index atrial fibrillation (AF) ablation, with an advantage of short procedure time. Although recent guidelines recommend peri-procedural uninterrupted oral anticoagulants (OACs), the intra-procedural anticoagulation strategy remains uncertain under non-vitamin K OACs (NOACs). We investigated procedural safety of a single bolus administration of heparin without activated clotting time (ACT) measurement during cryoballoon ablation (CBA). METHODS: Two hundred patients (64.2 ± 10.0 years, 70% with non-paroxysmal AF) who underwent CBA with uninterrupted NOACs were randomly assigned to No-ACT group and ACT group. A bolus of heparin (100 U/kg) was routinely administered immediately after transseptal puncture. In the ACT group, an additional injection of heparin (30 U/kg) was administered if ACT at 30 min after the initial bolus was < 300 s. RESULTS: There were no differences in baseline characteristics including CHA2DS2-VASc score between the two groups. The left atrium indwelling and procedure times were 60.4 ± 13.1 min and 78.9 ± 13.9 min, respectively, and not significantly different between the two groups. The mean ACT was 335.2 ± 59.9 s in the ACT group. Any bleeding rate was 3.2% in all patients and there was no statistically significant difference in bleeding complications between the two groups. In the ACT group, groin hematoma, laryngopharyngeal bleeding, and hemoptysis occurred in 3, 1, and 1 patient, respectively. Cardiac tamponade occurred in 1 patient in the No-ACT group. No thromboembolic events occurred during the 30-day follow-up after CBA. CONCLUSIONS: Single bolus administration of heparin without ACT measurement is a feasible anticoagulation strategy for CBA in patients with uninterrupted NOAC intake.

A Multi-Center, Prospective Observational Study to Investigate the Safety, Compliance, and Efficacy of Omethyl QTlet Soft Capsule.

Omega-3 fatty acids have been shown to be effective in lowering triglyceride (TG) levels; however, tolerability issues arise due to the large size of the pills. The purpose of this study was to examine the safety, compliance, and efficacy of Omethyl QTlet soft capsules (OQCs). This multi-center, prospective, observational study evaluated the safety, compliance, and efficacy of OQCs. Patients with hypertriglyceridemia with a history of omega-3 fatty acid intake were enrolled in this study and were prescribed OQCs (2 g−4 g/day) for eight weeks. All adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) were recorded for safety evaluation. Adherence to treatment was assessed using questionnaires, and efficacy was assessed by changes in lipid and lipoprotein levels after eight weeks from baseline. The convenience of taking medication was analyzed for 580 patients, and the efficacy test was performed for 563 patients. The AE and ADR rates were 8.2% and 5.7%, respectively. There were only two SAEs. Of the patients, 55.8% responded that the OQC improved medication convenience, and mean changes in TG, total cholesterol, LDL-C, and non-HDL-C from baseline to eight weeks were −37.88 mg/dL, −11.56 mg/dL, −5.55 mg/dL, and −10.87 mg/dL, respectively (p-values < 0.001). In patients who had previously taken omega-3 fatty acids, OQCs showed safety and efficacy in lowering TG, and it was confirmed that compliance with medicine also improved compared to omega-3 fatty acids.

Therapeutic Response Monitoring with 89Zr-DFO-Pertuzumab in HER2-Positive and Trastuzumab-Resistant Breast Cancer Models.

Immuno-positron emission tomography (PET) has great potential to evaluate the target expression level and therapeutic response for targeted cancer therapy. Immuno-PET imaging with pertuzumab, due to specific recognition in different binding sites of HER2, could be useful for the determination of the therapeutic efficacy of HER2-targeted therapy, trastuzumab, and heat shock protein 90 (HSP90) inhibitor, in HER2-expressing breast cancer. The aim of this study is to evaluate the feasibility of monitoring therapeutic response with 89Zr-DFO-pertuzumab for the treatment of HER2-targeted therapeutics, trastuzumab, or the HSP90 inhibitor 17-DMAG, in trastuzumab-resistant JIMT-1 breast cancer models. We prepared an immuno-PET imaging agent using desferoxamine (DFO)-pertuzumab labeled with 89Zr and performed the biodistribution and PET imaging in breast cancer xenograft models for monitoring therapeutic response to HER2-targeted therapy. 89Zr-DFO-pertuzumab was successfully prepared and showed specific binding to HER2 in vitro and clearly visualized HER2 expressing JIMT-1 tumors. 89Zr-DFO-pertuzumab had prominent tumor uptake in HER2 expressing JIMT-1 tumors. JIMT-1 tumors showed trastuzumab-resistant and HSP90 inhibitor sensitive characterization. In immuno-PET imaging, isotype antibody-treated JIMT-1 tumors had similar uptake in trastuzumab-treated JIMT-1 tumors, but 17-DMAG-treated JIMT-1 tumors showed greatly reduced uptake compared to vehicle-treated tumors. Additionally, HER2 downregulation evaluated by immuno-PET imaging was verified by western blot analysis and immunofluorescence staining which resulted in a significant reduction in the tumor's HER2 level in 17-DMAG-treated JIMT-1 tumors. 89Zr-DFO-pertuzumab immuno-PET may be clinically translated to select pertinent patients for HER2-targeted therapy and to monitor the therapeutic response in HER2-positive cancer patients under various HER2-targeted therapeutics treatments.

A Real-Time Detection Device for the Rapid Quantification of Skin Casual Sebum Using the Oil Red O Staining Method.

The human skin sebum suggests that it (along with other epidermal surface lipids) plays a role in skin barrier formation, the moderation of cutaneous inflammation, and antimicrobial defense. Various methods have been developed for collecting and measuring skin sebum. We tested methods of detection using "color intensity", by staining the skin casual sebum. This process was conducted in three steps; first, the selection of materials for sebum collection; second, staining the collected sebum; third, the development of a device that can measure the level of stained sebum. A plastic film was used to effectively collect sebum that increased with the replacement time of the sebum. In addition, the collected sebum was stained with Oil Red O (ORO) and checked with RGB; as a result, the R2 value was higher than 0.9. It was also confirmed that the correlation value was higher than 0.9 in the comparison result with Sebumeter®, which is a common standard technology. Finally, it was confirmed that the R2 value was higher than 0.9 in the detection value using the sensor. In conclusion, we have proven the proof of concept (PoC) for this method, and we would like to introduce an effective sebum measurement method that differs from the existing method.

A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus.

This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The co-primary end points were patch pump usage time for one attachment and number of serious adverse events related to the patch pump. The secondary end points were total amount of insulin injected per patch and changes in glycemic parameters including continuous glucose monitoring data compared to those at study entry. The median usage time per patch was 84.00 hours (interquartile range, 64.50 to 92.50). Serious adverse events did not occur during the trial. Four weeks later, time in range 70 to 180 mg/dL was significantly improved (70.71%±17.14 % vs. 82.96%±9.14%, P=0.01). The times spent below range (<54 mg/dL) and above range (>180 mg/dL) also improved (All P<0.05). Four-week treatment with a tubeless patch pump was safe and led to clinical improvement in glycemic control.

Does merged three-dimensional mapping improve contact force and long-term procedure outcome in atrial fibrillation ablation? (MICRO-AF study): a prospective randomized controlled study.

Integration of electroanatomical map (EAM) with preacquired three-dimensional (3D) cardiac images provides detailed appreciation of the complex anatomy of the left atrium (LA) and pulmonary vein (PV). High-density (HD) multi-electrode mapping catheters have enabled creating more accurate EAM reflecting real-time volume-rendered LA-PV geometry during atrial fibrillation (AF) ablation. However, no study has compared the outcomes of AF ablation using HD-EAM versus 3D-merged map. We aimed to investigate the procedural and clinical outcomes of AF ablation with HD-EAM (HD-EAM group) versus 3D-merged map (Merge group). One hundred patients (59.5 ± 11.5 years, 53% with paroxysmal AF [PAF]) were randomly assigned (1:1) to HD-EAM or Merged group. HD multi-electrode mapping and contact force (CF)-sensing catheters were used to create virtual LA-PV chamber and to perform wide antral circumferential ablation (WACA), respectively. The two groups showed no significant differences in baseline characteristics and procedural data including ablation time, fluoroscopy time, LA voltage, and CF. PV isolation with a single WACA line was achieved in 21 (42%) and 27 (54%) patients in the Merge and HD-EAM groups, respectively (P = NS). CF was significantly lower in lesions with gap than lesions without gap after a single WACA (7.3 ± 7.3 g vs. 16.0 ± 8.3, respectively, P < 0.001). During the 12-month follow-up, no significant difference in AF recurrence was observed between two groups, irrespective of AF type. In multivariate analysis, non-PAF was an independent risk factor for AF recurrence. Integration of 3D cardiac imaging did not improve procedural and clinical outcomes. HD-EAM provides an accurate real-time LA geometry.

Bosworth-type fibular entrapment fracture of the ankle without dislocation: a rare case report and a review of the literature.

Bosworth fracture-dislocation of ankle is a rare and irreducible type of ankle injury, with a high incidence of complication. This type of fracture was defined originally as entrapment of the proximal fragment of the fibula behind the posterior tubercle of the distal tibia. Recently, many variants of this type of fracture dislocation have been reported, but all of those reports included the syndesmosis ligament injury of ankle. Here, we report a case of a particularly rare variant of Bosworth fracture-dislocation without syndesmosis ligament injury of ankle. A 48-year-old male presented with a Bosworth fracture dislocation with entrapment of proximal fragment behind the tibia. After temporary treatment in emergency department was applied, emergency open reduction and internal fixation with a plate and screws was performed due to irreducibility of the fracture fragment. The fractured lateral malleolus was entrapped behind the tibia and rupture of the interosseous ligament was found intraoperatively. The anterior inferior tibiofibular ligament, a part of syndesmosis ligament of ankle, was grossly intact and no abnormal findings was seen by fluoroscopy with external rotational stress. Moreover, the deltoid ligament was found to be normal in ultrasonography. There were no complications after surgery and the patient showed full functional recovery at 2 years follow up. These fractures will frequently be irreducible and should be considered for open reduction and internal fixation with the careful evaluation of injury mechanisms with syndesmotic stability.

A systematic review comparing the results of early vs delayed ligament surgeries in single anterior cruciate ligament and multiligament knee injuries.

PURPOSE: The purpose of this study was to compare clinical outcomes and incidence of concomitant injuries in patients undergoing early vs delayed surgical treatment of single anterior cruciate ligament (ACL) injury and multiligament knee injury (MLKI). METHODS: A literature search using PubMed, Embase, the Cochrane Library, the Cumulative Index to Nursing and Allied Health, and Scopus from their inception to April 30, 2020 was conducted. Studies with levels I to IV evidence reporting the incidence of meniscus or cartilage injury according to early vs delayed surgery in single ACL injuries and MLKIs were included. In the meta-analysis, data based on the number of meniscus and cartilage injuries were extracted and pooled. Lysholm and Tegner scores were analyzed using two-sample Z-tests to calculate the non-weighted mean difference (NMD). A meta-regression analysis was also performed to determine the effect of single ACL injury and MLKI/study design. RESULTS: Sixteen studies on single ACL injury and 14 studies on MLKI were included in this analysis. In the analysis, there were significant decreases in Lysholm score (NMD - 5.3 [95% confidence interval (CI) - 7.37 to - 3.23]) and Tegner score (NMD - 0.25 [95% CI - 0.45 to - 0.05]) and increases in risk of meniscus tear (odds ratio [OR] 1.73 [95% CI 1.1-2.73], p = 0.01) and cartilage injury (OR 2.48 [95% CI 1.46-4.2], p = 0.0007) in the delayed surgery group regardless of single ACL injury or MLKI. The result of the meta-regression analysis indicated that single ACL injury and MLKI/study design were not significant moderators of overall heterogeneity (p > 0.05). CONCLUSIONS: Our study suggests that delayed ACL surgery significantly resulted in a higher risk of meniscus tear and cartilage injury and decreased Lysholm and Tegner scores compared to early ACL surgery. The Lysholm scores in the delayed MLKI surgery group were significantly decreased, but the risks of meniscus tear and cartilage injury in the delayed MLKI surgery group remained unclear. LEVEL OF EVIDENCE: Level III, meta-analysis.

Efficacy of high-power and short-duration ablation in patients with atrial fibrillation: a prospective randomized controlled trial.

AIMS: The formation of radiofrequency lesions depends on the power and duration of ablation, and the contact force (CF). Although high power (HP) creates continuous and transmural lesions, most centres still use 25-30 W for 30-40 s for safety reasons. We evaluated the clinical efficacy and safety of a HP and short-duration (HPSD) strategy for atrial fibrillation (AF) ablation. METHODS AND RESULTS: One hundred and fifty patients [58.2 ± 10.0 years, 48% with paroxysmal AF (PAF)] scheduled for index AF ablation using a CF-sensing catheter were randomly assigned to three groups [30 W, 40 W, and 50 W at ablation sites of anterior, roof, and inferior segments of pulmonary vein (PV) antra and roof line between each upper PV]. In 25-30 W for ≤20 s was applied at posterior wall ablation site in all subjects. Compared with the 30 W and 40 W groups, procedure (P < 0.001) and ablation times (P < 0.001) were shorter and ablation number for PV isolation (P < 0.001) was smaller in the 50 W group. There were no significant differences in the CF and ablation index (AI) among the three groups. There were no significant differences in the procedure-related complication rates. During the 12-month follow-up, AF recurred in 24 (16%) patients with no significant difference among the groups (P = 0.769). In the multivariate analysis, non-PAF [hazard ratio (HR) 2.836, P = 0.045] and AI (HR 0.983, P = 0.001) were independent risk factors for AF recurrence. CONCLUSION: Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.

Road safety performance across local governments: a data envelopment analysis approach.

Road safety performance varies among local municipalities since road safety involves multiple inputs (e.g. facilities and programs) and multiple outputs (e.g. crashes and casualties). A benchmark analysis between local governments is a useful platform to improve their road safety performances because the analysis can specify which other municipalities' processes should be consulted to improve their practices. This study employs the data envelopment analysis approach for benchmark analysis. The input-oriented variable returns to scale model is applied to Korea. The outputs are the numbers of crashes and fatalities, and two sets of indexed inputs comprising institutional managements and governmental interventions are visited. In particular, standardized data formatting between, and controllability by, local governments are highlighted as the required properties for inputs. The overall efficiency scores and the nature of returns to scale reveal the under-investments in road safety in Korea. Efficiency scores by each municipality are also provided. This examination shows the projected values of inputs and outputs as well as benchmarks for each municipality. A sensitivity analysis based on the leave-one-out method generates stable efficiency scores across local governments, which shows the robustness of the model. Finally, the incorporation of environmental variables and dynamic analysis is suggested for further studies.

Pulmonary function testing for the early detection of drug-induced lung disease: a systematic review in adults treated with drugs associated with pulmonary toxicity.

Pulmonary function tests (PFT) are sometimes monitored during treatment with known pulmonary toxic drugs to detect asymptomatic drug-induced interstitial lung disease (DILD). We conducted a systematic review to assess the accuracy of PFT, including the diffusing capacity for carbon monoxide (DLCO), for early detection of DILD in a range of drugs. Using a pre-specified, registered review protocol, OvidMEDLINE and EMBASE were searched from 1946 to February 2018. Two reviewers independently screened abstracts and reviewed full-text articles for inclusion. Included studies were assessed for risk of bias using adapted QUADAS-2 domains and primary outcome data were extracted and entered into RevMan5 to estimate sensitivity and specificity with 95% confidence intervals (CI). The search identified 4065 citations and included 42 studies. The most commonly studied drugs were bleomycin and amiodarone. Due to clinical heterogeneity between studies, a pooled analysis was not performed. Sensitivity of monitoring with DLCO varied between 0 and 100%, with the majority of studies finding a sensitivity of <80%. CI were wide for the majority of studies. Specificity was less than 90% in all studies. Risk of bias was high for the majority of studies for the quality domain of reference standard. The findings of this review do not support routine PFT for early detection of DILD. Due to methodological limitations, the relatively small number of participants and the low prevalence of DILD in the included studies, there remains significant uncertainty about the sensitivity of PFT to screen for DILD.

Design of Multi-Wavelength Optical Sensor Module for Depth-Dependent Photoplethysmography.

The multi-wavelength photoplethysmography sensors were introduced to measure depth-dependent blood volume based on that concept that the longer the light wavelength, the deeper the penetration depth near visible spectrum band. In this study, we propose an omnidirectional optical sensor module that can measure photoplethysmogram while using multiple wavelengths, and describe implementation detail. The developed sensor is manufactured by making a hole in a metal plate and mounting an LED therein, and it has four wavelength LEDs of blue (460 nm), green (530 nm), red (660 nm), and IR (940 nm), being arranged concentrically around a photodetector. Irradiation light intensity was measured by photoluminescent test, and photoplethymogram was measured with each wavelength simultaneously at a periphery of the human body such as fingertip, earlobe, toe, forehead, and wrist, in order to evaluate the developed sensor. As a result, the developed sensor module showed a linear increase of irradiating light intensity according to the number of LEDs increases, and pulsatile waveforms were observed at all four wavelengths in all measuring sites.

Development of a Multi-Array Pressure Sensor Module for Radial Artery Pulse Wave Measurement.

This study proposes a new structure for a pressure sensor module that can reduce errors caused by measurement position and direction in noninvasive radial artery pulse wave measurement, which is used for physiological monitoring. We have proposed a structure for a multi-array pressure sensor with a hexagonal arrangement and polydimethylsiloxane that easily fits to the structure of the radial artery, and evaluated the characteristics and pulse wave measurement of the developed sensor by finite element method simulation, a push-pull gauge test, and an actual pulse wave measurement experiment. The developed sensor has a measuring area of 17.6 × 17.6 mm2 and a modular structure with the analog front end embedded on the printed circuit board. The finite element method simulation shows that the developed sensor responds linearly to external pressure. According to the push-pull gauge test results for each channel, there were differences between the channels caused by the unit sensor characteristics and fabrication process. However, the correction formula can minimize the differences and ensure the linearity, and root-mean-squared error is 0.267 kPa in calibrated output. Although additional experiments and considerations on inter-individual differences are required, the results suggested that the proposed multiarray sensor could be used as a radial arterial pulse wave sensor.

Identification of Markers Associated With Development of Stroke in "Clinically Low-Risk" Atrial Fibrillation Patients.

Background Stroke and thromboembolic events may still occur in "clinically low-risk" atrial fibrillation (AF) patients as categorized by CHA2DS2-VASc score. Our aim was to assess the proportion of "clinically low-risk" patients using a nongender CHA2DS2-VASc (ie, CHA2DS2-VA) score of 0 to 1 among patients who experienced AF-associated stroke and to identify markers associated with stroke in "clinically low-risk" patients. Methods and Results We retrospectively recruited nonvalvular AF patients who experienced embolic stroke between 2013 and 2016 from 9 institutes in Korea. AF patients with CHA2DS2-VA score of 0 to 1 at the time of stroke were analyzed and compared with "clinically low-risk" AF patients without stroke. A total of 3033 subjects with AF-associated stroke were recruited. Of these, 583 patients (19.2%) had CHA2DS2-VA score of 0 to 1. On multivariate analysis, age (≥60 years), N-terminal pro B-type natriuretic peptide (≥300 pg/mL), creatinine clearance (<50 mL/min), and left atrial dimension (≥45 mm) were independently associated with stroke. With the combined application of these 4 factors (collectively, ABCD score) to the "clinically low-risk" patients, the c-index was 0.858 (95% CI 0.838-0.877; P<0.001). Conclusions The present study suggests a new insight into how additional use of markers can further refine stroke risk differentiation among AF patients initially classified as "clinically low-risk." Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03147911.

Association between epicardial adipose tissue and embolic stroke after catheter ablation of atrial fibrillation.

INTRODUCTION: Risk factors of embolic stroke (ES) after atrial fibrillation (AF) ablation have not been fully elucidated especially among the Asian subjects, particularly regarding epicardial adipose tissue (EAT) in cardiac imaging. We aimed to assess the incidence of ES during a long-term follow-up period after AF ablation and to identify the risk factors associated with postablation ES, specifically focusing on EAT. METHODS AND RESULTS: We enrolled patients who experienced postablation ES and control subjects from a consortium of AF ablation registries from three institutes in Korea. EAT was assessed using multislice computed tomography before AF ablation. A total of 3464 patients who underwent AF ablation were recruited and followed-up. During a follow-up of 47.2 ± 36.4 months, ES occurred in 47 patients (1.36%) with a CHA2 DS2 -VASc score of 1.48 ± 1.39 and the overall annual incidence of ES was 0.34%. Compared with the control group (n = 190), the ES group showed significantly higher prior thromboembolism (TE) and AF recurrence rates, larger left atrium size, lower creatinine clearance rate (CCr), and greater total and peri-atrial EAT volume. Multivariate regression analysis demonstrated larger peri-atrial EAT volume (hazards ratio, 1.065; 95% confidence interval, 1.005-1.128), in addition to a prior history of TE and lower CCr, was independently associated with postablation ES. When a cut-off value of peri-atrial EAT volume of ≥20.15 mL was applied, patients with smaller peri-atrial EAT volume showed significantly higher ES-free survival. CONCLUSION: Larger peri-atrial EAT volume, in addition to prior TE and lower CCr, was independently associated with postablation ES regardless of AF recurrence and CHA2 DS2 -VASc score. (ClinicalTrials.gov number, NCT03479073).