Health guidance intervention mitigates the escalation of predicted comprehensive cardiovascular disease risk: Interrupted time series design.

INTRODUCTION: Metabolic syndrome increases the risk of cardiovascular events. Despite the Japanese healthcare system's efforts in early detection and intervention, particularly through Specific Health Checkup and Guidance programs, research on their effectiveness is limited. This study evaluated the impact of Specific Health Guidance on the predicted risk of atherosclerotic cardiovascular disease (ASCVD) in working-age Japanese individuals. METHODS: Employing an Interrupted Time Series (ITS) design, this study compared the trends in predicted ASCVD risk and each individual risk factor used for the prediction of ASCVD risk before and after intervention in individuals participating in the guidance. RESULTS: Analyses based on the ITS design indicated that participation in Specific Health Guidance programs, specifically the intensive level program, mitigates the increase trend of the predicted ASCVD risk. On the other hand, the impact on the trends of individual cardiovascular risk factors was minimal. CONCLUSIONS: The intensive level Specific Health Guidance appeared to reduce the increasing trend in ASCVD risk, emphasizing the importance of comprehensive risk assessment in evaluating health interventions. However, the results are limited owing to the specific demographics and short evaluation period. Further research is necessary to understand the long-term impacts and broader applicability.

Laparoscopic and open minor liver resection for hepatocellular carcinoma with clinically significant portal hypertension: a multicenter study using inverse probability weighting approach.

BACKGROUND: Liver resection offers substantial advantages over open liver resection (OLR) for patients with hepatocellular carcinoma (HCC) in terms of reduced intraoperative blood loss and morbidity. However, there is limited evidence comparing the indications and perioperative outcomes with the open versus laparoscopic approach for resection. This study aimed to compare postoperative outcomes between patients undergoing laparoscopic liver resection (LLR) and OLR for HCC with clinically significant portal hypertension (CSPH). METHODS: A total of 316 HCC patients with CSPH (the presence of gastroesophageal varices or platelet count < 100,000/ml and spleen diameter > 12 cm) undergoing minor liver resection at eight centers were included in this study. To adjust for confounding factors between the LLR and OLR groups, an inverse probability weighting method analysis was performed. RESULTS: Overall, 193 patients underwent LLR and 123 underwent OLR. After weighting, LLR was associated with a lower volume of intraoperative blood loss and the incidence of postoperative complications (including pulmonary complications, incisional surgical site infection, and paralytic ileus) compared to the OLR group. The 3-, 5-, and 7-year postoperative recurrence-free survival rates were 39%, 26%, and 22% in the LLR group and 49%, 18%, and 18% in the OLR group, respectively (p = 0.18). And, the 3-, 5-, and 7-year postoperative overall survival rates were 71%, 56%, and 44% in the LLR group and 76%, 51%, 44% in the OLR group, respectively (p = 0.87). CONCLUSIONS: LLR for HCC patients with CSPH is clinically advantageous by lowering the volume of intraoperative blood loss and incidence of postoperative complications, thereby offering feasible long-term survival.

Japanese Study of the Effects of AMG (α1-Microglobulin) Reduction Rates on Survival (JAMREDS): A Protocol of a Multicenter Prospective Observational Cohort Study.

INTRODUCTION: Recent advances in dialysis therapy have made it possible to remove middle molecules. Removal of small-middle molecules, such as ß2-microglobulin, can now be achieved with conventional hemodialysis (HD), and removal of large-middle molecules has become a target, particularly for α1-microglobulin (AMG, 33 kD). The AMG reduction rate has emerged as a target for improvement of various clinical symptoms, but the effects on prognosis have yet to be determined. The "Japanese study of the effects of AMG (α1-microglobulin) reduction rates on survival" (JAMREDS) was started in April 2020, with the goal of determining if the AMG reduction rate associates with the risk of mortality and cardiovascular disease (CVD) events. METHODS: JAMREDS is a prospective observational study in patients on HD to examine the effects of: (1) AMG reduction rate on survival outcome and CVD events; (2) dialysis treatment modalities (HD, intermittent infusion hemodiafiltration(iHDF), pre/post-dilution online HDF) on survival and CVD events (based on AMG reduction rates with treatment mode); and (3) AMG reduction rates on survival and CVD events in patients undergoing each therapy (iHDF, pre/post-dilution online HDF). The number of planned subjects was 4,000 in preplanning. Data are collected using RED-Cap, which is an EDC system. A total of 9,930 patients were enrolled at the beginning of the study at 59 registered facilities. The JAMREDS observation period will continue until the end of 2023, after which the data will be cleaned and confirmed before analysis. CONCLUSION: This study may provide new evidence for the relationship between the amount of removed large-middle molecules (such as AMG) and the mortality and CVD risk. Comparisons with convection volumes will also be of interest.

Decreased thymic output predicts progression of chronic kidney disease.

BACKGROUND: Chronic kidney disease (CKD) is age-related disease, and decreased renal function is associated with the premature aging of T cells and increased incidence of other age-related diseases. However, the relationship between T cell senescence and CKD progression remains unclear. Here, we investigated the relationship between T cell senescence, as indicated by decreased thymic output and increased proportion of highly differentiated CD28- T cells, and CKD progression. RESULTS: A total of 175 patients with non-dialysis-dependent CKD were enrolled in this study. Thymic output was assessed based on the CD45RA+CD31+CD4+ cell (recent thymic emigrant [RTE]) counts (RTEs) (/mm3) and the proportion of RTE among CD4+ T cells (RTE%). Highly differentiated T cells were assessed based on the proportion of CD28- cells among CD4+ T cells (CD28-/CD4+) and CD28- cells among CD8+ T cells (CD28-/CD8+). The primary outcome was estimated glomerular filtration rate (eGFR) decline of ≥40% or initiation of renal replacement therapy. The association between T cell senescence and renal outcomes was examined using Cox proportional hazards models and restricted cubic splines. The median age was 73 years, 33% were women, and the median eGFR was 26 mL/min/1.73 m2. The median RTEs, RTE%, CD28-/CD4+, and CD28-/CD8+ were 97.5/mm3, 16.2, 5.3, and 49.7%, respectively. After a median follow-up of 1.78 years, renal outcomes were observed in 71 patients. After adjusting for age, sex, eGFR, proteinuria, diabetes, and cytomegalovirus seropositivity, decreased RTEs, which corresponded to decreased thymic output, significantly and monotonically increased the risk of poor renal outcome (p = 0.04), and decreased RTE% and increased highly differentiated CD28-/CD4+ T cells also tended to monotonically increase the risk (p = 0.074 and p = 0.056, respectively), but not CD28-/CD8+ T cells. CONCLUSIONS: Decreased thymic output in CKD patients, as well as increased highly differentiated CD4+ T cells, predicted renal outcomes. Thus, the identification of patients prone to CKD progression using T cell senescence, particularly decreased RTE as a biomarker, may help to prevent progression to end-stage kidney disease.

Deep Learning-Based Time-to-Death Prediction Model for COVID-19 Patients Using Clinical Data and Chest Radiographs.

Accurate estimation of mortality and time to death at admission for COVID-19 patients is important and several deep learning models have been created for this task. However, there are currently no prognostic models which use end-to-end deep learning to predict time to event for admitted COVID-19 patients using chest radiographs and clinical data. We retrospectively implemented a new artificial intelligence model combining DeepSurv (a multiple-perceptron implementation of the Cox proportional hazards model) and a convolutional neural network (CNN) using 1356 COVID-19 inpatients. For comparison, we also prepared DeepSurv only with clinical data, DeepSurv only with images (CNNSurv), and Cox proportional hazards models. Clinical data and chest radiographs at admission were used to estimate patient outcome (death or discharge) and duration to the outcome. The Harrel's concordance index (c-index) of the DeepSurv with CNN model was 0.82 (0.75-0.88) and this was significantly higher than the DeepSurv only with clinical data model (c-index = 0.77 (0.69-0.84), p = 0.011), CNNSurv (c-index = 0.70 (0.63-0.79), p = 0.001), and the Cox proportional hazards model (c-index = 0.71 (0.63-0.79), p = 0.001). These results suggest that the time-to-event prognosis model became more accurate when chest radiographs and clinical data were used together.

Maskless 2-Dimensional Digital Subtraction Angiography Generation Model for Abdominal Vasculature using Deep Learning.

PURPOSE: To develop a deep learning (DL) model to generate synthetic, 2-dimensional subtraction angiograms free of artifacts from native abdominal angiograms. MATERIALS AND METHODS: In this retrospective study, 2-dimensional digital subtraction angiography (2D-DSA) images and native angiograms were consecutively collected from July 2019 to March 2020. Images were divided into motion-free (training, validation, and motion-free test datasets) and motion-artifact (motion-artifact test dataset) sets. A total of 3,185, 393, 383, and 345 images from 87 patients (mean age, 71 years ± 10; 64 men and 23 women) were included in the training, validation, motion-free, and motion-artifact test datasets, respectively. Native angiograms and 2D-DSA image pairs were used to train and validate an image-to-image translation model to generate synthetic DL-based subtraction angiography (DLSA) images. DLSA images were quantitatively evaluated by the peak signal-to-noise ratio (PSNR) and structural similarity (SSIM) using the motion-free dataset and were qualitatively evaluated via visual assessments by radiologists with a numerical rating scale using the motion-artifact dataset. RESULTS: The DLSA images showed a mean PSNR (± standard deviation) of 43.05 dB ± 3.65 and mean SSIM of 0.98 ± 0.01, indicating high agreement with the original 2D-DSA images in the motion-free dataset. Qualitative visual evaluation by radiologists of the motion-artifact dataset showed that DLSA images contained fewer motion artifacts than 2D-DSA images. Additionally, DLSA images scored similar to or higher than 2D-DSA images for vascular visualization and clinical usefulness. CONCLUSIONS: The developed DL model generated synthetic, motion-free subtraction images from abdominal angiograms with similar imaging characteristics to 2D-DSA images.

Early Atrial Tachyarrhythmia Recurrence Predicts Late Atrial Tachyarrhythmia Recurrence After the Cryo-Maze Procedure　- An Observational Study.

BACKGROUND: It is unknown whether early atrial tachyarrhythmia (ATA) recurrence occurring within 3 months after the Maze procedure predicts late ATA recurrence.Methods and Results: This study involved 610 patients who underwent the modified Cryo-Maze procedure in conjunction with other cardiac surgery. The primary outcomes were late ATA recurrence, defined as occurring ≥3 months after surgery. The effects of early ATA recurrence on late ATA recurrence were analyzed using a Cox proportional hazards model. The following 11 covariates were considered explanatory variables: early ATA recurrence, age, sex, body surface area, preoperative duration of atrial fibrillation, preoperative left atrial diameter, and concomitant surgery (mitral valve replacement, mitral valve repair, aortic valve replacement, tricuspid annuloplasty, and left atrial appendage closure). Statistical analyses were performed with a 2-sided 5% significance level. Early ATA recurrence occurred in 174 patients (28.5%). Late ATA recurrence occurred in 167 patients (27.5%), with 595 events identified in these patients. The Cox proportional hazards model showed that early ATA recurrence was an independent predictor of late ATA recurrence (hazard ratio, 4.14; 95% confidence interval, 3.00-5.70; P<0.001)Conclusions: Early ATA recurrence was an independent predictor of late ATA recurrence among patients undergoing the modified Cryo-Maze procedure. The blanking period might not be applied to patients undergoing the modified Cryo-Maze procedure.

Laparoscopic liver resection reduces postoperative infection in patients with hepatocellular carcinoma: a propensity score-based analysis.

BACKGROUND: This study is aimed to compare the occurrence of postoperative infections between patients with hepatocellular carcinoma (HCC) undergoing laparoscopic liver resection (LLR) and those undergoing open liver resection (OLR). METHODS: This study included 446 patients who underwent initial curative liver resection for HCC 5 cm or less in size without macroscopic vascular invasion. To adjust for confounding factors between the LLR and OLR groups, propensity score matching and inverse probability weighting (IPW) analysis were performed. The incidence rates of postoperative infection, including incisional surgical site infection (SSI), organ/space SSI, and remote infection (RI), were compared between the two groups. RESULTS: An imbalance in several confounding variables, including period of surgery, extent of liver resection, difficult location, proximity to a major vessel, tumor size ≥ 3 cm, and multiple tumors, was observed between the two groups in the original cohort. After matching and weighting, the imbalance between the two groups significantly decreased. Compared with OLR, LLR was associated with a lower volume of intraoperative blood loss (140 vs. 350 mL, P < 0.001 in the matched cohort; 120 vs. 320 mL, P < 0.001 in the weighted cohort) and reduced risk of postoperative infection (2.0% vs. 12%, P = 0.015 in the matched cohort; 2.9% vs. 14%, P = 0.005 in the weighted cohort). Of the types of postoperative infections, organ/space SSI and RI were less frequently observed in the LLR group than in the OLR group in the matched cohort (1.0% vs. 6.0%, P = 0.091 for organ/space SSI; 0% vs. 6.0%, P < 0.001 for RI) and in the weighted cohort (1.2% vs. 7.8%, P < 0.001 for organ/space SSI; 0.3% vs. 5.1%, P = 0.009 for RI). CONCLUSIONS: Compared with OLR, LLR for HCC might reduce postoperative infections, including organ/space SSI and RI.

Ivermectin administration is associated with lower gastrointestinal complications and greater ventilator-free days in ventilated patients with COVID-19: A propensity score analysis.

INTRODUCTION: COVID-19 patients have been reported to have digestive symptoms with poor outcome. Ivermectin, an antiparasitic drug, has been used in COVID-19 patients. The objective of this study was to evaluate whether ivermectin has effects on gastrointestinal complications and ventilator-free days in ventilated patients with COVID-19. METHODS: COVID-19 patients who were mechanically ventilated in the ICU were included in this study. The ventilated patients who received ivermectin within 3 days after admission were assigned to the Ivermectin group, and the others were assigned to the Control group. Patients in the Ivermectin group received ivermectin 200 µg/kg via nasal tube. The incidence of gastrointestinal complications and ventilator-free days within 4 weeks from admission were evaluated as clinical outcomes using a propensity score with the inverse probability weighting method. RESULTS: We included 88 patients in this study, of whom 39 patients were classified into the Ivermectin group, and 49 patients were classified into the Control group. The hazard ratio for gastrointestinal complications in the Ivermectin group as compared with the Control group was 0.221 (95% confidence interval [CI], 0.057 to 0.855; p = 0.029) in a Cox proportional-hazard regression model. The odds ratio for ventilator-free days as compared with the Control group was 1.920 (95% CI, 1.076 to 3.425; p = 0.027) in a proportional odds logistic regression model. CONCLUSIONS: Ivermectin improved gastrointestinal complications and the number of ventilator-free days in severe COVID-19 patients undergoing mechanical ventilation. Prevention of gastrointestinal symptoms by SARS-Cov-2 might be associated with COVID-19 outcome.

Deep Learning-based Angiogram Generation Model for Cerebral Angiography without Misregistration Artifacts.

Background Digital subtraction angiography (DSA) generates an image by subtracting a mask image from a dynamic angiogram. However, patient movement-caused misregistration artifacts can result in unclear DSA images that interrupt procedures. Purpose To train and to validate a deep learning (DL)-based model to produce DSA-like cerebral angiograms directly from dynamic angiograms and then quantitatively and visually evaluate these angiograms for clinical usefulness. Materials and Methods A retrospective model development and validation study was conducted on dynamic and DSA image pairs consecutively collected from January 2019 through April 2019. Angiograms showing misregistration were first separated per patient by two radiologists and sorted into the misregistration test data set. Nonmisregistration angiograms were divided into development and external test data sets at a ratio of 8:1 per patient. The development data set was divided into training and validation data sets at ratio of 3:1 per patient. The DL model was created by using the training data set, tuned with the validation data set, and then evaluated quantitatively with the external test data set and visually with the misregistration test data set. Quantitative evaluations used the peak signal-to-noise ratio (PSNR) and the structural similarity (SSIM) with mixed liner models. Visual evaluation was conducted by using a numerical rating scale. Results The training, validation, nonmisregistration test, and misregistration test data sets included 10 751, 2784, 1346, and 711 paired images collected from 40 patients (mean age, 62 years ± 11 [standard deviation]; 33 women). In the quantitative evaluation, DL-generated angiograms showed a mean PSNR value of 40.2 dB ± 4.05 and a mean SSIM value of 0.97 ± 0.02, indicating high coincidence with the paired DSA images. In the visual evaluation, the median ratings of the DL-generated angiograms were similar to or better than those of the original DSA images for all 24 sequences. Conclusion The deep learning-based model provided clinically useful cerebral angiograms free from clinically significant artifacts directly from dynamic angiograms. Published under a CC BY 4.0 license. Supplemental material is available for this article.

Artificial intelligence-supported lung cancer detection by multi-institutional readers with multi-vendor chest radiographs: a retrospective clinical validation study.

BACKGROUND: We investigated the performance improvement of physicians with varying levels of chest radiology experience when using a commercially available artificial intelligence (AI)-based computer-assisted detection (CAD) software to detect lung cancer nodules on chest radiographs from multiple vendors. METHODS: Chest radiographs and their corresponding chest CT were retrospectively collected from one institution between July 2017 and June 2018. Two author radiologists annotated pathologically proven lung cancer nodules on the chest radiographs while referencing CT. Eighteen readers (nine general physicians and nine radiologists) from nine institutions interpreted the chest radiographs. The readers interpreted the radiographs alone and then reinterpreted them referencing the CAD output. Suspected nodules were enclosed with a bounding box. These bounding boxes were judged correct if there was significant overlap with the ground truth, specifically, if the intersection over union was 0.3 or higher. The sensitivity, specificity, accuracy, PPV, and NPV of the readers' assessments were calculated. RESULTS: In total, 312 chest radiographs were collected as a test dataset, including 59 malignant images (59 nodules of lung cancer) and 253 normal images. The model provided a modest boost to the reader's sensitivity, particularly helping general physicians. The performance of general physicians was improved from 0.47 to 0.60 for sensitivity, from 0.96 to 0.97 for specificity, from 0.87 to 0.90 for accuracy, from 0.75 to 0.82 for PPV, and from 0.89 to 0.91 for NPV while the performance of radiologists was improved from 0.51 to 0.60 for sensitivity, from 0.96 to 0.96 for specificity, from 0.87 to 0.90 for accuracy, from 0.76 to 0.80 for PPV, and from 0.89 to 0.91 for NPV. The overall increase in the ratios of sensitivity, specificity, accuracy, PPV, and NPV were 1.22 (1.14-1.30), 1.00 (1.00-1.01), 1.03 (1.02-1.04), 1.07 (1.03-1.11), and 1.02 (1.01-1.03) by using the CAD, respectively. CONCLUSION: The AI-based CAD was able to improve the ability of physicians to detect nodules of lung cancer in chest radiographs. The use of a CAD model can indicate regions physicians may have overlooked during their initial assessment.

Impact of stroke history on the presence of cerebral microbleeds in hemodialysis patients.

INTRODUCTION: Cerebral microbleeds (CMBs) are detected on gradient-echo T2*-weighted magnetic resonance imaging (MRI). Clinically, CMBs are often detected after stroke, including in cases of intracerebral hemorrhage and ischemic cerebrovascular disease. Hemodialysis (HD) patients are widely known to have a high incidence of stroke, and HD patients without stroke history have been reported to have a high prevalence of CMBs. In this study, we investigated whether history of stroke affects the prevalence of CMBs in HD patients. METHODS: A cross-sectional study was performed in 241 HD patients who underwent brain T2*-weighted MRI. We compared the prevalence of CMBs between the patients with and without a history of stroke. Moreover, the relationship between history of stroke and presence of CMBs was examined by multivariate logistic regression analysis. RESULTS: Among these patients, 22 (9.1%) had a history of stroke. CMBs were detected in 70 patients (29.0%). The prevalence of CMBs was significantly higher in patients with a history of stroke compared to those without this history (54.5 vs. 26.5%, p = 0.012). In the multivariable analysis adjusted for background characteristics, history of stroke was a significant and independent factor related to CMBs (OR: 3.24, 95%CI: 1.18-8.89, p = 0.02). DISCUSSION/CONCLUSIONS: As has been reported for non-dialysis patients, our results showed a high prevalence of CMBs in HD patients with a history of stroke, and indicated that a history of stroke is significantly and independently associated with CMBs in HD patients.

Assessing liver stiffness with conventional cut-off values overestimates liver fibrosis staging in patients who received the Fontan procedure.

AIM: Patients who undergo the Fontan procedure for complex congenital heart disease are prone to liver cirrhosis. Liver stiffness (LS) reflects liver fibrosis stage in patients with chronic viral hepatitis; however, its accuracy in predicting liver fibrosis stage in Fontan patients is controversial. We aimed to clarify the correlation between LS and liver fibrosis stage in Fontan patients. METHODS: Fifty-eight Fontan patients were prospectively measured for LS with transient elastography. We undertook liver biopsy, cardiac catheterization, and laboratory tests in 22 of these patients (median age, 14.7 years; range, 9.9-32.1 years) with LS > 11.0 kPa (median, 19.2 kPa; range, 12.2-39.8 kPa); these elevated LS values suggest liver cirrhosis. RESULTS: Histologically, all patients showed mild-to-severe portal and sinusoidal fibrosis but no cirrhosis. Statistically, LS did not predict histological liver fibrosis scores (p = 0.175). Liver stiffness was not correlated with central venous pressure (p = 0.456) or with the hepatic venous pressure gradient (HVPG; p = 0.062), although the p value for HVPG was only slightly above the threshold for significance. CONCLUSIONS: Fontan patients are prone to developing both portal and sinusoidal fibrosis. Liver stiffness could be influenced by HVPG, and using the conventional cut-off values for LS overestimates and overtreats liver fibrosis in these patients.

Impact of Advancing Age on the Status and Risk of Postoperative Infections After Liver Resection.

BACKGROUND: Despite the recently increasing number of elderly patients undergoing liver resection, the impact of advancing age on postoperative infections (PIs) incidence and risk remains unclear. This study aimed to investigate the impact of advancing age on PIs incidence and status. METHODS: This retrospective study included 744 patients undergoing liver resection without biliary reconstruction or combined resection of other organs. Multivariable analysis with a restricted cubic spline was used to evaluate the impact of advancing age on PIs and to determine its association with PIs risk in patients undergoing open and laparoscopic liver resection (OLR and LLR, respectively). RESULTS: Multivariable analysis demonstrated that advancing age was significantly associated with increased PIs risk (P = 0.017). The spline curve showed that the odds ratio for PIs sharply increased starting approximately at 65 years of age. Unadjusted restricted cubic splines assessing the subcategories of PIs demonstrated that advancing age was associated with increased risks of organ/space surgical site infection and sepsis (P = 0,064 and 0.048, respectively). Multivariable analysis revealed that LLR was associated with the lower PIs risk compared with OLR (P = 0.025), whereas the lower PIs risk with LLR was not significantly obscured by advancing age (P = 0.29). CONCLUSIONS: Advancing age was associated with increased risk of PIs, including organ/space surgical site infections and sepsis, after liver resection especially in patients aged ≥ 65 years.

Safety and Efficacy of Tandem Hemodialysis and Selective Plasma Exchange in Pretransplant Desensitization of ABO-Incompatible Kidney Transplantation.

INTRODUCTION: In patients requiring both hemodialysis (HD) and apheresis, the 2 treatments can be performed simultaneously. At our hospital, selective plasma exchange (SePE) is often performed along with HD for removal of isoagglutinins before ABO-incompatible (ABOi) kidney transplantation. The 2 treatments can be completed within the HD schedule, which allows the treatment time to be shortened. This approach is also less stressful for patients because fewer punctures are required. In this study, we investigated the safety and efficacy of tandem HD and SePE. METHODS: A total of 58 SePE sessions in 30 ABOi kidney transplant recipients were investigated. The SePE circuit was connected in parallel with the HD circuit, and tandem HD and SePE therapy was performed using filtration methods. The SePE sessions were divided into 2 groups: those with SePE monotherapy (group S, n = 20) and those with tandem therapy (group T, n = 38). Changes in transmembrane pressure (TMP), arterial pressure (AP), venous pressure (VP), and decrease in isoagglutinin titers over time were compared between the groups with adjustment for background data. RESULTS: The internal pressures (AP and VP) were higher in group T, and there were significant differences in changes of TMP and AP over time between groups T and S. Membrane exchange was required in 1 case in group T due to coagulation. There was a more significant decrease of immunoglobulin G isoagglutinin titers in group T compared to group S. No case had antibody-mediated rejection after transplantation. DISCUSSION/CONCLUSION: In HD/SePE tandem therapy, internal pressures were higher and TMP and AP tended to increase more compared to SePE monotherapy, but we were able to perform the 2 treatments without any functional problems. Tandem therapy was also effective in decreasing isoagglutinin titers, which suggests that this may be a beneficial treatment modality as apheresis before ABOi kidney transplantation.

Association Between Sternotomy Versus Thoracotomy and the Prevalence and Severity of Chronic Postsurgical Pain After Mitral Valve Repair: An Observational Cohort Study.

OBJECTIVE: Investigate differences in the prevalence and severity of chronic postsurgical pain (CPSP) after cardiac surgery via thoracotomy versus sternotomy are not well-understood. DESIGN: An observational cohort study. SETTING: A tertiary care hospital. PARTICIPANTS: Four hundred twenty-eight patients (sternotomy: 192 patients, thoracotomy: 236 patients) who underwent mitral valve repair. INTERVENTIONS: A questionnaire about the severity of surgical wound pain evaluated with a numerical rating scale (NRS) was sent. NRS responses for current pain, peak pain in the last four weeks, and average pain in the last four weeks were evaluated. MEASUREMENTS AND MAIN RESULTS: The main outcomes were the severity of CPSP evaluated using NRS and the prevalence of CPSP. CPSP was defined as pain >0 that developed after a surgical procedure. During the median follow-up of 29 months, 79 patients complained of CPSP. (sternotomy: 15 patients, thoracotomy: 64 patients). Multivariate ordinal logistic regression showed that NRS responses for current pain (adjusted odds ratio [aOR], 3.17; 95% confidence interval [CI] 1.64-6.12; p = 0.001), peak pain in the last four weeks (aOR, 2.00; 95% CI 1.11-3.61; p = 0.021), and average pain in the last four weeks (aOR, 2.21; 95% CI 1.31-3.72; p = 0.003) were significantly higher in patients who underwent thoracotomy. Multivariate logistic regression showed that thoracotomy was an independent predictor of CPSP (aOR, 3.63; 95% CI 1.67-7.88; p = 0.001). CONCLUSIONS: The prevalence and severity of CPSP were higher among patients who underwent mitral valve repair via thoracotomy than sternotomy.

U-Shaped Association Between Intraoperative Net Fluid Balance and Risk of Postoperative Recurrent Atrial Tachyarrhythmia Among Patients Undergoing the Cryo-Maze Procedure: An Observational Study.

OBJECTIVE: The ability of perioperative fluid management to prevent postoperative recurrence of atrial tachyarrhythmia remains controversial. The aim of the present study was to assess if intraoperative net fluid balance was associated with atrial tachyarrhythmia recurrence after the Cryo-Maze procedure. DESIGN: An observational cohort study. SETTING: A tertiary care hospital from April 2007 to May 2019. PARTICIPANTS: Four hundred forty-four patients undergoing the Cryo-Maze procedure in conjunction with other cardiac surgeries. INTERVENTIONS: The Cryo-Maze procedure in conjunction with other cardiac surgeries. MEASUREMENTS AND MAIN RESULTS: The main outcome was early atrial tachyarrhythmia recurrence, consisting of atrial fibrillation, atrial flutter, or atrial tachycardia, within the first three months after surgery. Complete follow-up was achieved in 443 patients (99.8%), of them 127 (28.6%) developed early atrial tachyarrhythmia recurrence. The median intraoperative net fluid balance was 1,627 mL (interquartile range, -215 to 3,557 mL). Multivariate logistic regression showed that intraoperative net fluid balance (p = 0.001), preoperative AF duration (adjusted odds ratio, 1.40; 95% CI, 1.17-1.68; p < 0.001) and left atrial volume index (aOR, 1.61; 95% CI, 1.06-2.45; p = 0.025) were independent predictors of early atrial tachyarrhythmia recurrence. The adjusted log odds were lowest (-1.52) when net fluid balance was 1,557 mL. CONCLUSIONS: There is a significant U-shaped association between intraoperative net fluid balance and early atrial tachyarrhythmia recurrence among patients undergoing the Cryo-Maze procedure.

Impact of background factors on outcomes of pharmacological therapy for chronic low back pain: A nationwide multicenter prospective study.

BACKGROUND: Chronic low back pain (CLBP) is a major cause of chronic pain with nociceptive, neuropathic or both pain components, and a leading cause of disability. The objectives of this study were to determine the impact of background factors including previous use of drugs on outcomes of pharmacological therapy for CLBP in a nationwide multicenter prospective study. METHODS: The subjects were 474 patients (male: 41.9%, median age: 73.0) with CLBP. Background factors that could influence outcomes after pharmacological treatment for 6 months were examined: age, gender, body mass index (BMI), duration of CLBP, osteoporosis, history of spinal surgery, history of malignant tumor, smoking habit, employment status (yes or no), exercise habit (frequency), number of live-in family members, having something to do for pleasure, Center for Epidemiologic Studies depression scale (CES-D) score, and medication at baseline. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) for LBP, JOA Back Pain Evaluation Questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire (RDQ), Short-form 8-item health survey (SF-8), and EQ-5D were used for evaluation at baseline and after 6 months. Multivariate linear regression models were used in statistical analysis. RESULTS: Drugs for neuropathic pain at baseline (p < 0.001), Tramacet® at baseline (p < 0.05), weak opioids at baseline (p < 0.05), older age (p < 0.001), long disease duration (p < 0.005), history of spinal surgery (p < 0.001), and smoking habit (p < 0.001) had significant negative effects on outcomes. Employment (p < 0.05), exercise habit (p < 0.05), and CED-D at baseline (p < 0.001) had positive effects on outcomes. CONCLUSIONS: This is the first study to identify significant prognostic factors for outcomes of pharmacological treatment of CLBP. The neuropathic pain component of CLBP at baseline is a major significant negative factor for most outcomes involving improved pain, activities of daily life, and quality of life. Treatment strategies developed with consideration of these factors may be advantageous for recovery from CLBP.

A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19.

Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 1:1 ratio to early or late favipiravir therapy (in the latter case, the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76 to 2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, times to defervescence were 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95% CI, 0.81 to 4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by reverse transcription-PCR (RT-PCR) by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred in any of the patients in either treatment group during the 28-day participation. (This study has been registered with the Japan Registry of Clinical Trials under number jRCTs041190120.).

Positive correlation between pancreatic volume and post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND AND AIM: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most common and serious adverse event associated with ERCP. Risk factors for PEP have been described in various reports. However, risk factors have not been quantified to date. The aim of this study was to investigate the risk factors for PEP by quantification of pancreatic volume using pre-ERCP images. METHODS: Overall, 800 patients were recruited from April 2012 to February 2015 for this study. There were 168 patients who satisfied the inclusion criteria. Measurement of pancreatic volume was achieved using the volume analyzer SYNAPSE VINCENT in all cases and was used to evaluate the risk factors for PEP. RESULTS: According to the criteria established by the consensus guidelines (Cotton classification), 17 patients (10.1%) were classified as having mild disease, 4 (2.4%) as having moderate disease, and 5 (3.0%) as having severe disease. Multivariate model analysis showed that a large pancreatic volume was a significant risk factor for PEP (odds ratio [OR] 1.10, 95% confidence interval [CI] 1.06-1.13; P < 0.001). In addition, the association between the pancreatic volume and the severity of PEP was positively correlated (the effect of volume [per 1 mL]; OR 1.09, 95% CI 1.07-1.12; P < 0.001, the effect of volume [per 10 mL]; OR 2.27, 95% CI 1.72-3.00; P < 0.001). A larger pancreatic volume was significantly associated with a higher incidence of PEP. CONCLUSIONS: A large pancreatic volume was identified as a risk factor for PEP. The results of this study suggest that pre-ERCP images might be useful for predicting PEP.