The Development of a Nationwide, Multicenter Electronic Database for Spinal Instrumentation Surgery in Japan: Japanese Spinal Instrumentation Society Database (JSIS-DB)

(1) Background: Despite the number of complicated and expensive spine surgery procedures maintained by the national health insurance system in Japan, until now there has been no large-scale multicenter clinical database for this field to understand and improve healthcare expenditure and treatment outcomes. The purpose of this report is to announce the establishment and methodology of a nationwide registry system for spinal instrumentation surgeries by the Japanese Spinal Instrumentation Society (JSIS), and to report the progress over the first 1.5 years of this database’s operation. (2) Methods: The JSIS recently produced an online database with an electronic server. The collected information included patient background, surgery information, and early complications of primary and revision cases. Analysis included data from February 2018, when registration began, to August 2019. (3) Results: As of August 2019, 73 facilities have completed the required paperwork to start, and 55 facilities have registered cases. Of the total 5456 registered cases, 4852 were valid and 2511 were completed. (4) Conclusions: JSIS-DB, the nationwide web-based registry system for spinal instrumentation surgery in Japan, was launched for the purpose of research, healthcare policy regulation, and improved patient care, and its methodology and progress in the first 1.5 years are reported in this study.

Analysis of Risk Factors for Postoperative Complications in Non-Small Cell Lung Cancer: Comparison With The Japanese National Clinical Database Risk Calculator

Background: Although the risk calculator of the National Clinical Database (RC-NCD) has been widely used to predict the occurrence of mortality and major morbidity in Japan, it has not been demonstrated whether a correlation between the calculated RC-NCD risk score and the actual occurrence of mortality and severe morbidity exists.Methods: The clinical data of 739 patients who underwent pulmonary resection for non-small cell lung cancer were collected, and the risk factors for postoperative morbidity were analyzed to verify the validity of the RC-NCD.Results: The coexistence of asthma (p=0.02), smoking status (p=0.04), forced expiratory volume % in one second (p=0.02), pulmonary lobe (p<0.01), and type of operative procedure (p<0.01) were significant risk factors for postoperative morbidity in the present study, and the body mass index (BMI) (p<0.01) and type of operative procedure (p<0.01) were significant risk factors for severe postoperative morbidity. Furthermore, in patients received lobectomy, coexistence of asthma (p=0.01) and pulmonary lobe (p<0.01) were identified as significant risk factors for postoperative morbidity. Meanwhile, male sex (p=0.01), high BMI (p<0.01), low vital capacity (p=0.04), and pulmonary lobe (p=0.03) were identified as significant risk factors for severe postoperative morbidity.Conclusions: Given that the pulmonary lobe was a significant risk factor for postoperative morbidity in patients received pulmonary resection and for severe postoperative morbidity in patients received lobectomy, the RC-NCD for postoperative morbidity needs to be modified according to high-risk lobes.Trial registration: The Institutional Review Board of Kanazawa Medical University approved the protocol of this retrospective study (approval number: I392), and written informed consent was obtained from all patients.

The impact of COVID-19 on surgical procedures in Japan: analysis of data from the National Clinical Database

Background and purpose The spread of COVID-19 has restricted the delivery of standard medical care to surgical patients dramatically. Surgical triage is performed by considering the type of disease, its severity, the urgency for surgery, and the condition of the patient, in addition to the scale of infectious outbreaks in the region. The purpose of this study was to evaluate the impact of the COVID-19 pandemic on the number of surgical procedures performed and whether the effects were more prominent during certain periods of widespread infection and in the affected regions. Methods We selected 20 of the most common procedures from each surgical field and compared the weekly numbers of each operation performed in 2020 with the respective numbers in 2018 and 2019, as recorded in the National Clinical Database (NCD). The surgical status during the COVID-19 pandemic as well as the relationship between surgical volume and the degree of regional infection were analyzed extensively. Results The rate of decline in surgery was at most 10–15%. Although the numbers of most oncological and cardiovascular procedures decreased in 2020, there was no significant change in the numbers of pancreaticoduodenectomy and aortic replacement procedures performed in the same period. Conclusion The numbers of most surgical procedures decreased in 2020 as a result of the COVID-19 pandemic; however, the precise impact of surgical triage on decrease in detection of disease warrants further investigation.

COVID-19 Infection and Outcomes at a Comprehensive Sickle Cell Center

Introduction: The Grady Comprehensive Sickle Cell (SC) center is the largest adult sickle cell center in the United States (US) and has the first 24/7 acute care unit for management of sickle cell vaso-occlusive events (VOE). In 2019, the center provided 3077 sickle cell outpatient visits and 3695 acute care visits. When the COVID-19 pandemic reached the US, the center had a precipitous drop in the number of both outpatient clinic and acute care visits as state regulations for lockdown were passed. This report follows all the COVID-19 cases at a single adult center for sickle cell disease in one year. Methods: The clinical database has been tracking COVID-19 cases reported. Out of a total of 1343 patients, 55 patients contracted COVID-19 and were tracked in the clinical database with IRB approval. Results: Of the 55 patients with COVID-19, 28 were female and 27 were male. By genotype, 64% of patients were SS, 31% were SC and 5% were Sβ+ thalassemia. 35% of patient were on hydroxyurea for disease modification with the majority of them being of the SS genotype and 31% had elevated fetal hemoglobin determined by a percentage fetal hemoglobin above 5% by hemoglobin electrophoresis. Chronic pain (defined as patients experiencing daily pain episodes for more than 4 days a week for the last 3 months) and calculation of daily morphine equivalents were reported in clinic follow-up and the narcotic database utilization. 47% of the patients had chronic pain and the median morphine equivalents was 90 mg daily (45-225mg). The rate of emergency department (ED) visits or hospitalizations for the sickle cell patients with COVID-19 was 80%. 49% of the SC patients' visits were related to VOE and 27% related to COVID-19 primarily. 20% of SC patients with COVID-19 were not seen in any emergency setting or required any hospitalization. The COVID-19 signs and symptoms experienced by the patients were as follows: 58% had pain as the main presenting symptom, followed by cough and fever (40%), dyspnea (31%), and pneumonia with chest x-ray evidence (25%). 2 patients developed acute respiratory distress syndrome (ARDS) and were intubated, and 2 patients died. 29% of the patients had lung findings on imaging and 16 of 55 patients required treatment with the use of Remdesivir in 9, dexamethasone in 8 and red cell products in 7 of the 16 patients. The 2 patients who died had both presented with COVID-19 infection in June and July 2020 respectively. One patient had presented in June 2020 with VOE and was found to have bilateral lung opacities but was asymptomatic and was discharged home to return few days later with clinical picture of multi-organ failure for which a red cell erythrocytapheresis was attempted. The second patient had presented in July 2020 with COVID-19 pneumonia and was treated with Remdesivir and convalescent plasma with development of multi-organ failure and ARDS. Discussion: Several reports were published regarding the rate of COVID-19 related mortality and morbidity in sickle cell disease. The Grady comprehensive sickle cell center experience differs in the fact that 16 out of 55 patients who had contracted COVID-19 required treatment and 2 of those 16 had died. In fact, the deaths occurred early in the course of the pandemic in June and July 2020 when 20 total cases were diagnosed (from March to Septemeber 2020). The remaining 35 cases registered zero deaths (October 2020 to March 2021) with the rate of complicated COVID-19 hospitalizations decreasing with better treatment available. In addition, the timeline for the COVID-19 cases reported fits the population timeline of 2 peaks respectively happening in the summer of 2020 and the Winter of 2021. During the initial peak, we have noted a decrease in the number of clinic and acute care visits respectively. This was anticipated given the statewide lockdown that was implemented. To circumvent that, the center adopted virtual visits to deliver healthcare needs. This measure has aided in protecting patients against COVID-19. Additionally, it is interesting that despite the second peak in the winter of 2021, there were no reported deaths among the patients who developed COVID-19. This finding can suggest that despite the concern for morbidity and mortality of sickle cell patients, their diligence and awareness to stay home during the pandemic has proven crucial in reducing morbidity and mortality and the option of virtual visits for healthcare delivery was key and should be utilized further in sickle cell care. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

NIMG-69. FREQUENCY OF TUMOR-RELATED VASCULATURE IN PRIMARY CNS LYMPHOMA ON ROUTINE MRI

Primary central nervous system lymphoma (PCNSL) is known to express angiogenic factors and can have spontaneous or biopsy-related hemorrhage. Radiographically, PCNSL is characterized by homogenous enhancement and diffusion restriction, as well as T2/FLAIR abnormalities. A higher frequency of tumor-related vessels has been reported in gliomas compared to brain metastases, but this has not been assessed in PCNSL. We used a clinical database of patients with PCNSL treated at the University of Washington and reviewed pretreatment MRIs for 48 patients treated between 2014-2021 for whom susceptibility sequences were available. Median age at diagnosis was 64 years (range 35-90 years). Patients were 27.1% male and 72.9% female. Each lesion was scored by at least two independent reviewers for the presence of a prominent vessel located either centrally or eccentrically, and for the presence of hemorrhage. Lesions that were scored differently by the two reviewers (n=26) were then scored by a third independent reviewer. In several cases the findings were felt to be indeterminate. Lesions were considered measurable if they were greater than 5 mm in two perpendicular planes, and a total of 93 measurable lesions were categorized. Prominent vessels were seen in 56/93 (60.2%) lesions, with 26/56 (46.4%) being central and 30/56 (55.4%) being eccentric. An additional 7/93 (7.5%) lesions were indeterminate. Hemorrhage was seen in 11/93 (11.8%) lesions. We conclude that prominent vessels can be seen in a majority of PCNSL lesions on standard MRI.

Mining of a Clinical Database: The Interpretation of Intense Serial Procalcitonin in the Prediction for Bloodstream Infection

Background: Procalcitonin (PCT) is a promising biomarker for predicting infection. Bloodstream infection (BSI) is usually a deteriorating stage of sepsis. The purpose of this study was to explore the predictive value of intense serial PCT assays for BSI in the intensive care unit (ICU).Methods: This study was a retrospective study based on a clinical database. We analyzed the data of critically ill patients from February 2016 to May 2020. The patients who received PCT assays and blood cultures (BCs) were classified into four groups according to the BCs: (i) BC negative, (ii) bacteria positive, (iii) fungi-positive, and (iv) combined-positive, and the patients with bacteremia were further subdivided into Gram+ and Gram– bacteremia.Results: The database included 11,219 patients. There were 3,593 patients who met the criteria for the analysis. The PCT concentration differed significantly across BC groups (p &lt; 0.0001). The fluctuation of PCT significantly increased in the BC positive groups (p &lt; 0.0001). According to the receiver operating characteristic (ROC), the optimum cutoff of the fluctuation of PCT was around 8 ng/ml for predicting BSI.Conclusion: Our study indicated that the fluctuation of PCT could be an indicator for screening BSI, but less accurate for Gram-positive infections. With a fluctuation of PCT less than 8 ng/ml, BSI should not be a rational cause for sepsis exacerbating.

Administration of antenatal corticosteroids for singleton preterm birth in China, 2017 to 2018

Background The administration of antenatal corticosteroids (ACS) to women who are at risk of preterm birth has been proven to reduce not only the mortality, but also the major morbidities of the preterm infants. The rate of ACS and the risk factors associated with ACS use in Chinese population is unclear. This study aimed to investigate the rate of ACS use and the associated perinatal factors in the tertiary maternal centers of China. Methods Data for this retrospective observational study came from a clinical database of preterm infants established by REIN-EPIQ trial. All infants born at <34 weeks of gestation and admitted to 18 tertiary maternal centers in China from 2017 to 2018 were enrolled. Any dose of dexamethasone was given prior to preterm delivery was recorded and the associated perinatal factors were analyzed. Results The rate of ACS exposure in this population was 71.2% (range 20.2% – 92%) and the ACS use in these 18 maternal centers varied from 20.2–92.0% in this period. ACS exposure was higher among women with preeclampsia, caesarean section delivery, antibiotic treatment and who delivered infants with lower gestational age and small for gestational age. ACS use was highest in the 28-31 weeks gestational age group, and lowest in the under 26 weeks of gestational age group (x2=65.478, P < 0.001). ACS exposure was associated with lower odds of bronchopulmonary dysplasia or death (OR, 0.778; 95% CI 0.661 to 0.916) and invasive respiration requirement (OR, 0.668; 95% CI 0.585 to 0.762) in this population. Conclusion The ACS exposure was variable among maternity hospitals and quality improvement of ACS administration is warranted.

Inotrope Use and Intensive Care Unit Mortality in Patients With Cardiogenic Shock: An Analysis of a Large Electronic Intensive Care Unit Database

Purpose: To determine whether inotrope administration is associated with increased all-cause mortality in cardiogenic shock (CS) patients and to identify inotropes superior for improving mortality.Methods: This retrospective cohort study analyzed data retrieved from the Philips Electronic ICU (eICU) database, a clinical database of 200,859 patients from over 208 hospitals located throughout the United States. The database was searched for patients admitted with CS to the intensive care unit (ICU) between 2014 and 2015. We evaluated 34,381 CS patients. They were classified into the inotrope and non-inotrope groups based on whether inotropes were administered during hospitalization. The primary endpoint was all-cause hospital mortality.Findings: In total, 15,021 (43.69%) patients received inotropes during hospitalization. The in-hospital mortality rate was significantly higher in the inotrope group than in the non-inotrope group (2,999 [24.03%] vs. 1,547 [12.40%], adjusted hazard ratio: 2.24; 95% confidence interval [CI]: 2.09–2.39; p &lt; 0.0001). After propensity score matching according to the cardiac index, 359 patients were included in each group. The risk of ICU (OR 5.65, 95% CI, 3.17–10.08, p &lt; 0.001) and hospital (OR 2.63, 95% CI: 1.75–3.95, p &lt; 0.001) mortality in the inotrope group was significantly higher. In the inotrope group, the administration of norepinephrine ≤0.1 μg/kg/min and dopamine ≤15 μg/kg/min did not increase the risk of hospital mortality, and milrinone administration was associated with a lower mortality risk (odds ratio: 0.559, 95% CI: 0.430–0.727, p &lt; 0.001). Meanwhile, the administration of &gt;0.1 μg/kg/min dobutamine, epinephrine, and norepinephrine and dopamine &gt;15 μg/kg/min was associated with a higher risk of hospital mortality.Conclusions: Inotropes should be used cautiously because they may be associated with a higher risk of mortality in CS patients. Low-dose norepinephrine and milrinone may associated with lower risk of hospital mortality in these patients, and supportive therapies should be considered when high-dose inotropes are administered.