Characteristics and outcomes of heart failure in Japan: A hospital-based administrative database analysis.

AIMS: Epidemiological and outcome studies on patients in Japan with heart failure (HF) categorized by left ventricular ejection fraction (LVEF) are currently limited. The aim of this non-interventional database study was to provide further information on these patients. METHODS AND RESULTS: Administrative claims data and electronic medical records from hospitals participating in the Voluntary Hospitals in Japan (VHJ) organization were used. Patients hospitalized with a primary diagnosis of HF between 1 April 2017 and 30 March 2020 were categorized by baseline LVEF on echocardiogram: HF with reduced EF (HFrEF, LVEF <40%); HF with preserved EF (HFpEF, LVEF ≥50%); and HF with mildly reduced EF (HFmrEF, 40% to <50% LVEF). Patients were evaluated for baseline characteristics, pre-admission diagnosis, prescription drugs, length of hospitalization, HF treatment cost, overall cost of hospitalization, and in-hospital prescription. An exploratory analysis compared post-hospitalization mortality and re-hospitalization rates. In total, 10 646 hospitalized patients from 17 VHJ hospitals were enrolled. Of these, 7212 were included in the analysis set and categorized into HFpEF (3183, 44.1%), HFmrEF (1280, 17.7%), and HFrEF (2749, 38.1%) groups based on baseline LVEF. Beta-blocker use increased during hospitalization, with a mean (95% confidence interval [CI]) of 23.3% (22.3-24.3) of patients receiving these agents before admission versus 69.4% (68.3-70.5) at discharge. Administration of diuretics, angiotensin converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers (ARBs) showed a similar trend. Differences in treatments were observed between HF categories at discharge, with a higher proportion (95% CI) of ACE inhibitor use in the HFrEF group (40.6% [38.7-42.4]) versus HFmrEF (27.5% [25.1-30.0]) and HFpEF (20.6% [19.2-22.1]) groups (P < 0.0001), and more ARB use in the HFmrEF and HFpEF groups (32.5% [29.9-35.1] and 31.2% [29.6-32.9], respectively) versus HFrEF (25.1% [23.5-26.8]; P < 0.0001). Mean (standard deviation [SD]) length of hospitalization was 22.2 (23.3) days, and the median (interquartile range) was 17 (11-25) days. Estimated average cost of HF treatment per patient during index hospitalization was 300 090 yen with HFrEF treatment costing the most. Average total healthcare expenditure during hospitalization was 1 225 650 yen per index hospitalization per patient, with HFrEF also the most expensive. During a mean (SD) observation period of 324 (304) days, ~21% of patients in each group required re-hospitalization for HF, and 625 patients (8.7%) died. CONCLUSIONS: The proportion of patients in each HF category was largely consistent with existing data. Discharge medications indicated high prescription of guideline-directed therapy. This study provides real-world data on patients with HF in Japan that can help inform future clinical decision-making.

Assessing national trends in indications for pediatric total thyroidectomy.

PURPOSE: The most common indications for total thyroidectomy (TT) in children are malignancy and thyrotoxicosis due to Graves' disease (GD). However, the incidence of patients with GD among patients undergoing TT is unknown. This study aims to examine trends in pediatric TT. MATERIALS AND METHODS: The US Agency for Health Research and Quality Healthcare Cost and Utilization Project (HCUP) Kids' Inpatient Database (KID) was queried to identify patients who underwent TT between 1997 and 2019. Weighted national estimates were obtained. Statistical analysis was completed using univariate logistic regression and one-sided Mann-Kendall Test. RESULTS: An estimated 4803 pediatric patients underwent TT within the study years. GD was the indication in 25 % of cases. Mann-Kendall testing showed a trend toward an increasing proportion of TT for GD without reaching statistical significance (z = 1.3609, S = 12, p = 0.0688). Statistically significant univariate associations were found among those who underwent thyroidectomy for GD compared to other indications, as they were more likely to be female (ß = 0.286, 95 % CI [0.058, 0.514], p = 0.014), Black, or Hispanic (ß = 1.392 [1.064, 1.721], p < 0.001; and ß = 0.562 [0.311, 0.814], p < 0.001, respectively). Additionally, they were less likely to have private insurance (ß = -0.308 [-1.076, -0.753], p = 0.002) and more likely to live in a ZIP code associated with a median household income below the 50th percentile (ß = 0.190 [0.012, 0.369], p = 0.036). The associations with the female sex, Black race, and Hispanic race persisted in multivariate analysis. CONCLUSION: GD appears to be an increasingly prevalent indication for TT. Patient characteristics differ from those who undergo TT for other diagnoses.

A DPC Database Study on the Safety of Atezolizumab/Bevacizumab/Carboplatin/Paclitaxel in Non-small Cell Lung Cancer in Japanese Patients.

INTRODUCTION: Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) combination therapy is a standard of care for advanced non-squamous non-small cell lung cancer (NSQ-NSCLC); however, the lack of safety data limits its clinical application in Japan. METHODS: This study compared the safety of ABCP with that of bevacizumab, carboplatin, and paclitaxel (BCP) combination for the treatment of advanced NSQ-NSCLC in Japanese patients by evaluating the clinical background and incidence of adverse events (AEs) based on data extracted from the Diagnosis Procedure Combination (DPC) database. Incidence rates and restricted mean survival times (RMSTs) for up to 1 year were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method. RESULTS: A search conducted using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes identified 350,987 patients, of whom 202 were included in the ABCP cohort and 232 in the BCP cohort. Among the 19 AEs, the incidence of skin disorder and febrile neutropenia (FN) was significantly higher in the ABCP cohort versus the BCP cohort. The adjusted incidence rate ratios were 2.65 [95% confidence interval (CI) 1.43-4.91] for skin disorder and 1.70 (95% CI 1.01-2.85) for FN. The adjusted RMST differences were - 64.2 days (95% CI - 93.0 to - 35.4 days) and - 46.0 days (95% CI - 73.5 to - 18.5 days) for skin disorder and FN, respectively. These results were comparable to those of other pivotal clinical trials. CONCLUSIONS: The findings of this DPC database study highlight the safety of ABCP in Japanese clinical practice, and this methodology may facilitate more efficient research in real-world settings. TRIAL REGISTRATION: UMIN Clinical Trials Registry ID UMIN000041507.

A DPC Database Study on the Safety of Atezolizumab/Carboplatin/Etoposide in Extensive-Disease Small Cell Lung Cancer in Japanese Patients.

INTRODUCTION: Atezolizumab, carboplatin, and etoposide (ACE) therapy is a standard of care for extensive-disease small cell lung cancer (SCLC); however, its safety data are scarce, limiting generalization to the Japanese population. METHODS: This study aimed to compare the safety of ACE versus carboplatin and etoposide (CE) therapies in Japanese patients using the Diagnosis Procedure Combination (DPC) database by comparing the incidence of adverse events (AEs). Retrospective data on clinical background and AEs were extracted from the DPC database. Incidence rates and restricted mean survival times (RMSTs) up to 6 months were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method. RESULTS: A total of 330,774 patients were identified using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes, of whom 277 were included in the ACE cohort and 478 in the CE cohort. Among the 19 AEs, the incidence of skin disorder and thyroid dysfunction was significantly higher in the ACE cohort compared with the CE cohort. The adjusted incidence rate ratios were 2.38 (95% confidence interval [CI] 1.04-5.43) for skin disorder and 6.92 (95% CI 2.00-23.89) for thyroid dysfunction. The adjusted RMST differences were - 8.2 days (95% CI - 16.0 to - 0.4 days) for skin disorder and - 8.8 days (95% CI - 15.7 to - 1.9 days) for thyroid dysfunction. CONCLUSIONS: This study provides evidence regarding the safety of ACE combination therapy in Japanese clinical practice using the DPC database, with results comparable to those reported in pivotal clinical trials. TRIAL REGISTRATION: UMIN Clinical Trials Registry ID UMIN000041508.

Incidence and predictive factors of double crush syndrome in patients undergoing cervical surgery: a database study.

BACKGROUND: Double crush syndrome (DCS) is characterized by multiple compression sites along a single peripheral nerve. It commonly presents with persistent distal symptoms despite surgical treatment for cervical radiculopathy. Management typically involves nerve release of the most symptomatic site. However, due to overlapping symptoms with cervical radiculopathy, patients may undergo cervical surgery prior to DCS diagnosis. Due to its rarity and frequent misdiagnosis, the authors aim to utilize a large national database to investigate the incidence and associations of DCS. METHODS: The Pearldiver database was utilized to identify patients undergoing cervical surgery for the management of cervical radiculopathy. Patients were stratified into three cohorts based on their clinical course before and after cervical surgery. The primary outcome was the prevalence of DCS, and secondary outcomes included an evaluation of predictive factors for each Group, using a significance level of P < 0.05. RESULTS: Among 195,271 patients undergoing cervical surgery for cervical radiculomyelopathy, 97.95% were appropriately managed, 1.42% had potentially mids-diagnosed DCS, and 0.63% were treatment-resistant. Diabetes and obesity were significant predictors of potentially misdiagnosed DCS (P < 0.05). CONCLUSION: This study presents data indicating that 1.42% of patients who receive cervical surgery may have underlying DCS and potentially benefit from nerve release prior to undergoing surgery. A concurrent diagnosis of diabetes and obesity may predict an underlying DCS.

Increased Risk of Severe Cardiovascular Events Following Exacerbations of Chronic Obstructive Pulmonary Disease: Results of the EXACOS-CV Study in Japan.

INTRODUCTION: Severe exacerbations of chronic obstructive pulmonary disease (COPD) are known to increase the risk of cardiovascular events. However, this association has not been investigated specifically in patients with COPD in Japan, whose characteristics may differ from those of Western patients (i.e., western Europe, the US, and Canada). METHODS: This longitudinal retrospective cohort study analyzed secondary claims data and included patients aged ≥ 40 years with COPD (International Classification of Diseases-10 codes J41-J44). All exacerbations occurring during follow-up were measured. Time-dependent Cox models were used to estimate hazard ratios (HRs) for the association between time periods following an exacerbation of COPD (vs. time prior to a first exacerbation) and occurrence of a first hospitalization for a severe fatal or non-fatal cardiovascular event. RESULTS: The analysis included 152,712 patients with COPD with a mean age of 73.8 years and 37.6% of whom were female. During a median follow-up of 37 months, 63,182 (41.4%) patients experienced ≥ 1 exacerbation and 13,314 (8.7%) patients experienced ≥ 1 severe cardiovascular event. Following an exacerbation of COPD, the risk of a severe cardiovascular event was increased in the first 30 days [adjusted HR (aHR) 1.44, 95% confidence interval (CI) 1.33-1.55] and remained elevated for 365 days post-exacerbation (aHR 1.13, 95% CI 1.04-1.23). Specifically, the risks of acute coronary syndrome or arrhythmias remained significantly increased for up to 180 days, and the risk of decompensated heart failure for 1 year. CONCLUSION: Among Japanese patients with COPD, the risk of experiencing a severe cardiovascular event increased following a COPD exacerbation and remained elevated for 365 days, emphasizing the need to prevent exacerbations.

Evaluation of Elastic Venous Compression Device dispensation in pregnant and post-partum women using the French National Health Insurance Claims Database: The ProFIL retrospective cohort study.

OBJECTIVES: To describe the real-world use of Elastic Venous Compression Devices (EVCDs) during pregnancy and post-partum using data from a representative subset of the French National Health Insurance Claims Database (the Echantillon Généraliste des Bénéficiaires, EGB). STUDY DESIGN: Women aged 15-49 who were pregnant between 1st July 2017 and 15th June 2018 were identified in the EGB using pregnancy-specific acts (certain prenatal examinations or deliveries). Subgroups were defined by age, presence of Venous Thrombo-Embolism (VTE) risk factors, history of VTE, delivery type and time period. EVCD dispensations (format, prescriber, and date) were identified among those for "standard orthotics" using their unique reimbursement tariffs. Dispensation rates were computed for all subgroups, overall and by format and were compared. RESULTS: 15,528 pregnant women were included: 7,252 [46.7 %] deliveries (5,796 vaginal [79.9 %], 482 planned cesarean sections (C-sections) [6.7 %] and 974 unplanned C-Sections [13.4 %]), 2,734 (17.6 %) terminations and 5,542 (35.7 %) unknown outcomes. Overall, 4,919 (31.7 %) women were dispensed at least one EVCD. Ante-partum dispensation occurred in 43.1 % (n = 3,122) of women whose pregnancy led to a delivery. Dispensation rates were 17.3 % (n = 1,005), 46.7 % (n = 225) and 44.1 % (n = 430) after vaginal delivery, planned C-sections or unplanned C-sections, respectively. Overall, dispensation rates significantly increased with age, the presence of VTE risk factors, and a history of VTE (p < 0.01). EVCD dispensation was most frequent (17.0 %) during the 5th month of pregnancy. Among pregnant women who were dispensed at least one EVCD during ante- or post-partum, 69.0 % had one or two units of compression (27.1 % [one unit], 41.9 % [two units]). Stockings (48.6 %, n = 6,038) were dispensed significantly more frequently than socks (36.9 %, n = 4,586) and tights (14.5 %, n = 1,806) (p < 0.01). The main contributors to mechanical VTE prophylaxis were gynecologists (26.3 % of dispensations, n = 2,280), general practitioners (20.2 %, n = 1,749) and midwives (15.1 %, n = 1,314). CONCLUSIONS: Low observed dispensation rates highlight a discrepancy between the French National Authority for Health (Haute Autorité de Santé, HAS), recommending EVCDs use during pregnancy and after delivery, and the real-life use of EVCD. Prescription sensitization combined with targeted information campaigns for pregnant women would be beneficial to contribute to the prevention of VTE, a health problem for pregnant women.

Prevalence of somatic diseases in adults with attention deficit hyperactivity disorder in Japan is highest in people aged ≥40 years with mental disorders: a cross-sectional study of a Japanese health insurance claims database.

Introduction: Studies have reported an association between attention deficit hyperactivity disorder (ADHD) and somatic diseases; however, the correlation of mental disorders with the association between ADHD and somatic diseases remains uninvestigated. This study investigated and compared the prevalence of somatic diseases among adults with/without ADHD, stratified by the presence or absence of mental disorders. Methods: This cross-sectional study (October 2020-September 2021), using data (June 2013-September 2021) from a Japanese health insurance claims database, included adult participants with a medical record of and receiving medication for ADHD (ADHD group); the control group (matched 1:5 by age/sex) comprised participants without ADHD. The prevalence and odds ratio (OR; ADHD versus control) of type 2 diabetes mellitus (T2DM), diabetes complications, hypertension, cardiovascular disease (CVD), dyslipidemia, gout and hyperuricemia, chronic obstructive pulmonary disease (COPD), non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH), and atopic dermatitis were investigated. Pooled ORs for stratified analysis were calculated using the Mantel-Haenszel method. Results: In the matched analysis sets, the ORs for all somatic diseases were significantly higher for the ADHD group (n=15,028) versus the control group (n=74,796). On stratified analysis, the Mantel-Haenszel ORs were significant for NAFLD/NASH (1.53; 95% confidence interval [CI]: 1.34, 1.73), diabetes complications (1.39; 95% CI: 1.09, 1.77), and gout and hyperuricemia (1.34; 95% CI: 1.19, 1.51). Furthermore, the stratum-specific ORs for T2DM, hypertension, and dyslipidemia were >1 and <1 in the presence and absence of mental disorders, respectively. The prevalence of all somatic diseases except atopic dermatitis increased with age. For participants aged ≥40 years, the Mantel-Haenszel ORs were significant for all somatic diseases except CVD, COPD, and atopic dermatitis. Conclusions: The prevalence of several somatic diseases, including chronic disorders, was high among adults with ADHD, particularly in those aged ≥40 years and those with mental disorders.

Effect of cancer cachexia on first-line chemotherapy in patients with advanced pancreatic cancer: a claims database study in Japan.

BACKGROUND: Cancer cachexia is a multifactorial syndrome leading to progressive functional impairment. How cachexia affects the treatment course of chemotherapy in patients with pancreatic cancer has not been well understood. METHODS: This is an exploratory, retrospective, observational cohort study using the Japanese medical claims database from Medical Data Vision Co., Ltd. The study population included patients diagnosed with pancreatic cancer in whom first-line FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel (GnP) was initiated between October 1, 2018, and September 30, 2020. In this study, we defined patients with cancer cachexia as those who had a weight loss of ≥ 5% in the preceding 6 months. The primary outcome was time-to-treatment failure (TTF). The observation period was six months from the initiation of first-line FFX or GnP treatment. RESULTS: A total of 1897 patients (421 patients into the cachexia group; 1476 patients into the non-cachexia group) were analyzed in this study. The median TTF was 121 days (95% confidence interval [CI] 94-146) in the cachexia group and 143 days (95% CI 134-152) in the non-cachexia group. The hazard ratio for TTF of the cachexia versus non-cachexia group was 1.136 (95% CI 0.979-1.319). The median number of doses was two doses fewer in the cachexia group than in the non-cachexia group for both FFX and GnP. CONCLUSION: Cancer cachexia was suggested to be associated with shorter TTF and a reduced number of doses in patients with pancreatic cancer who received first-line FFX or GnP treatment. Clinical Trial Registration clinicaltrials.jp: UMIN000045820.

The impact of cardiac rehabilitation for older adults with heart failure who underwent invasive cardiac treatment eligible for long-term care needs certification: A retrospective cohort study.

Background: This study aimed to assess the usefulness of cardiac rehabilitation (CR) for older adults with heart failure (HF) who need nursing care and investigate the effect of CR on cognitive function (CF) and basic activities of daily living (BADL). Methods: This was a retrospective cohort study. The study included older adults with HF eligible for long-term care insurance in fiscal year 2014 (FY2014) as the baseline and followed them up until March 2018. Patients were divided into two groups, CR (+) and CR (-), and the changes in their CF and BADL scores over time for 3 years were investigated. Results: Of the 765 patients included in the study, 36.5% performed CR. BADL scores in the CR (+) and CR (-) groups (mean (SE)) were 5.81 (0.26) vs. 5.87 (0.20) in FY2014, 5.6 (0.28) vs. 5.92 (0.21) in FY2015, 5.72 (0.31) vs. 6.15 (0.22) in FY2016, and 5.64 (0.33) vs. 6.40 (0.25) in FY2017, respectively. BADL scores worsened over time in the CR (-) group but had a trend to inhibit decline in the CR (+) group, and a significant difference was observed between both groups (p = 0.04). Multivariate analysis showed a significant difference in CR as a factor suppressing ADL decline after 1 year (adjusted odds ratios: 0.54, 95% confidence intervals: 0.36-0.82; p = 0.004). However, no significant difference in the CF scores was observed. Conclusion: CR for older adults with HF eligible for long-term care needs certification does not affect CF and may suppress ADL decline.

Average daily glucocorticoid dose, number of prescription days, and cumulative dose in the initial 90 days of glucocorticoid therapy are associated with subsequent hip and clinical vertebral fracture risk: a retrospective cohort study using a nationwide health insurance claims database in Japan.

PURPOSE: Fracture risk assessment is recommended at three months after glucocorticoid (GC) therapy initiation. This study aimed to assess whether GC exposure in the initial 90 days of GC therapy is associated with subsequent hip and clinical vertebral fracture risk using the nationwide health insurance claims database of Japan (NDBJ). METHODS: Patients aged ≥ 50 years who were prescribed GC (≥ 70 mg prednisolone or equivalent; PSL) in the initial 90 days of GC therapy and were followed for hip and clinical vertebral fracture incidences for the subsequent 1080 days were selected from NDBJ. Associations of GC exposure with hip or clinical vertebral fracture risk were evaluated by Cox regression analysis adjusted for potential confounders. RESULTS: We selected 316,396 women and 299,871 men for the GC-exposed group and 43,164 women and 33,702 men for the reference group. Higher GC doses and longer prescription days in the initial 90 days of GC therapy were significantly and dose-dependently associated with increased fracture risk relative to the reference group. Patients receiving GC ≥ 5 mg PSL/day had a significantly increased fracture risk in the stratum of 30-59 days of GC prescription. In addition, female patients who received GC (≥ 1 and < 2.5 mg PSL/day) for 90 days in the initial 90 days of GC therapy had a significantly increased fracture risk. CONCLUSIONS: GC exposure in the initial 90 days of GC therapy was dose-dependently associated with hip and clinical vertebral fracture risk. GC may increase fracture risk with lower doses for shorter durations than previously reported. Fracture risk assessment three months after glucocorticoid (GC) therapy initiation is recommended. We found that GC exposure in the initial 90 days of GC therapy at lower daily doses for shorter durations than previously reported were significantly and dose-dependently associated with fracture risk using a nationwide health insurance claims database.

Analysis of acute extremity compartment syndrome using a genealogic population database.

INTRODUCTION: Acute extremity compartment syndrome ("CS") is an under-researched, highly morbid condition affecting trauma populations. The purpose of this study was to analyze incidence rates and risk factors for extremity compartment syndrome using a high-quality population database. Additionally, we evaluated heritable risk for CS using available genealogic data. We hypothesized that diagnosis of extremity compartment syndrome would demonstrate heritability. MATERIALS AND METHODS: Adult patients with fractures of the tibia, femur, and upper extremity were retrospectively identified by ICD-9, ICD-10, and CPT codes from 1996 to 2020 in a statewide hospital database. Exposed and unexposed cohorts were created based on a diagnosis of CS. Available demographic data were analyzed to determine risk factors for compartment syndrome using logistic regression. Mortality risk at the final follow-up was evaluated using Cox proportional hazard modeling. Patients with a diagnosis of CS were matched with those without a diagnosis for heritability analysis. RESULTS: Of 158,624 fractures, 931 patients were diagnosed with CS. Incidence of CS was 0.59% (tibia 0.83%, femur 0.31%, upper extremity 0.27%). Male sex (78.1% vs. 46.4%; p < 0.001; RR = 3.24), younger age at fracture (38.8 vs. 48.0 years; p < 0.001; RR = 0.74), Medicaid enrollment (13.2% vs. 9.3%; p < 0.001; RR = 1.58), and smoking (41.1% vs. 31.1%; p < 0.001; RR 1.67) were significant risk factors for CS. CS was associated with mortality (RR 1.61, p < 0.001) at mean follow-up 8.9 years in the CS cohort. No significant heritable risk was found for diagnosis of CS. CONCLUSIONS: Without isolating high-risk fractures, rates of CS are lower than previously reported in the literature. Male sex, younger age, smoking, and Medicaid enrollment were independent risk factors for CS. CS increased mortality risk at long-term follow-up. No heritable risk was found for CS. LEVEL OF EVIDENCE: III.

The effect of concurrent cervical spine degenerative disease on the outcome of rotator cuff repair: a national database study.

BACKGROUND: Cervical spine degenerative disease (CSD) can cause shoulder pain, potentially confounding the management of patients with rotator cuff tears. This study aimed to investigate the relationships between CSD and rotator cuff repair (RCR). METHODS: A national administrative database (PearlDiver) was used to study 4 patient cohorts: (1) RCR only (RCRo), (2) RCR with concurrent CSD (RCRC), (3) RCR after a cervical spine procedure (RCRA), and (4) RCR before a cervical spine procedure (RCRB). The outcomes of RCR were compared using multivariable logistic regression, controlling for age, sex, and Elixhauser Comorbidity Index, as well as preoperative opioid utilization in the analysis of opioid use. RESULTS: Between 2010 and 2021, a total of 889,977 patients underwent RCR. Of these patients, 784,230 (88%) underwent RCRo whereas 105,747 (12%) underwent RCRC, of whom 21,585 (2.4%) underwent cervical spine procedures (RCRA in 9670 [1.1%] and RCRB in 11,915 [1.3%]). At 2 years after RCR, compared with RCRo patients, RCRC patients had an increased risk of surgical-site infection (adjusted odds ratio [aOR] = 1.25, P = .0004), deep vein thrombosis (aOR = 1.17, P = .0002), respiratory complications (aOR = 1.19, P = .0164), and ipsilateral shoulder reoperations (débridement [aOR = 1.66, P < .0001], manipulation under anesthesia or arthroscopic lysis of adhesions [aOR = 1.23, P < .0001], distal clavicle excision [aOR = 1.78, P < .0001], subacromial decompression [aOR = 1.72, P < .0001], biceps tenodesis [aOR = 1.76, P < .0001], incision and drainage [aOR = 1.34, P = .0020], synovectomy [aOR = 1.48, P = .0136], conversion to shoulder arthroplasty [aOR = 1.62, P < .0001], revision RCR [aOR = 1.77, P < .0001], and subsequent contralateral RCR [aOR = 1.71, P < .0001]). At 2 years, compared with RCRC patients who did not undergo cervical spine procedures, RCRC patients who underwent cervical spine procedures had an increased risk of incision and drainage (aOR = 1.50, P = .0255), conversion to arthroplasty (aOR = 1.40, P < .0001), and revision RCR (aOR = 1.11, P = .0374), as well as a lower risk of contralateral RCR (aOR = 0.89, P = .0469). The sequence of cervical spine procedures did not affect the risk of shoulder reoperations. At 1 year, the risk of opioid use after RCR was less for RCRA patients compared with RCRB patients (aOR = 1.71 [95% confidence interval, 1.61-1.80; P < .0001] vs. aOR = 2.01 [95% confidence interval, 1.92-2.12; P < .0001]). CONCLUSION: Concurrent CSD has significant detrimental effects on RCR outcomes. Patients with concurrent CSD undergoing cervical spine procedures have a greater risk of ipsilateral shoulder reoperations but a decreased risk of contralateral RCR. The risk of prolonged opioid use was lower if RCR followed a cervical spine procedure. Concurrent CSD must be considered and possibly treated to optimize the outcomes of RCR.

Time on Treatment and Survival Outcomes for Patients Treated With First-line Osimertinib vs. Other Tyrosine Kinase Inhibitors, for EGFR Mutation-positive Metastatic Non-small Cell Lung Cancer: Real-world Experience Data.

BACKGROUND/AIM: In this observational study, we analyzed the time on treatment (ToT) and overall survival (OS) of patients with metastatic non-small cell lung cancer (mNSCLC) in a 2.7-million-member public health provider in Israel. PATIENTS AND METHODS: Newly diagnosed patients with mNSCLC who initiated first-line tyrosine kinase inhibitor (TKI) therapy between Jan 2017-Dec 2020 were identified from the National Cancer Registry and Maccabi Healthcare Services database. Outcomes were assessed at a minimum of 23 months of follow-up (cutoff: 30th November 2022). All analyses compared first-line treatment osimertinib vs. standard TKIs (erlotinib, afatanib or gefitinib). RESULTS: A total of 165 patients (59% female, median age 68 years) were identified, including 58% smokers, 95% with adenocarcinomas, 33% with brain metastases, and 62%/15%/23% with 0-1/2-4/unknown performance status (PS). Of these, 77 (47%) were treated with standard TKI drugs and 88 (53%) with osimertinib as first-line treatment. The median duration of follow-up was 33.6 months (95%CI=29.9-37.3) and 58.5 months (95%CI=52.5-64.4) for patients who received osimertinib and standard TKIs, respectively. The median ToT (in months) was significantly (p<0.0001) longer with osimertinib (17.6; 95%CI=13.71-23.9) vs. standard TKIs (9.40; 95%CI=7.17-12.1). The 24-month survival rate was 58.0% among patients who received osimertinib and 50.6% among those who received standard TKI therapy (p=0.18). From second-line treatment initiation, 43.8% of those who received second-line osimertinib and 17.7% of those that received other second-line treatment were still alive at 24 months. CONCLUSION: Compared to standard TKIs, first-line osimertinib treatment was associated with a significantly longer ToT, and a longer OS. Our cohort also included patients with PS 2-4 who would not necessarily be included in clinical trials, allowing analysis of a real-world population.

Ninety day adverse events following single level posterior lumbar interbody fusion in patients with sickle cell disease.

BACKGROUND CONTEXT: Sickle cell disease (SCD) is an inherited disorder of red blood cells caused by mutation in the hemoglobin beta chain and is the most common inherited genetic disorder in the United States. Postoperative outcomes following single-level posterior lumbar interbody fusion (PLIF) in patients with SCD are not well characterized. PURPOSE: To examine 90-day postoperative outcomes among a matched cohort of patients with and without SCD who underwent single level PLIF utilizing a national administrative database. STUDY DESIGN/SETTING: Retrospective database study. PATIENT SAMPLE: Adult patients without and with SCD who underwent single level PLIF from 2010 to 2021 Q1 were identified and matched 10:1 based on age, sex and ECI. Exclusion criteria included: age <18 years old, recent history of infection, neoplasm, or trauma, as well as not being active in the database for 90 days following their procedure. OUTCOME MEASURES: Ninety-day postoperative adverse events and emergency department (ED) visits. METHODS: The matched cohorts were defined, and 90-day adverse event and ED visit rates were compared with univariable analyses and multivariable logistic regression, controlling for age, sex, and Elixhauser comorbidity index (ECI). RESULTS: Overall, 191,765 PLIF patients were identified, of which SCD was noted for 76 (0.04%). On multivariable analysis of the matched populations, patients with SCD were at increased odds ratio (OR) of the following (in decreasing OR order): transfusion (OR 17.69), pneumonia (OR 6.30), sepsis (OR 4.86), aggregated minor adverse events (OR 4.65), aggregated all adverse events (OR 3.87), ED visits (OR 3.53), and aggregated severe adverse events (OR 2.80) (p<.05 for all). CONCLUSIONS: The current study examined a relatively small, but largest to date, cohort of SCD patients undergoing PLIF. Patients with this condition were at greater odds of several perioperative adverse events, and these findings may be helpful for patient counselling and surgical planning.

Healthcare Resource Utilization and Costs Among Commercially Insured Patients With Advanced or Recurrent Endometrial Cancer Initiating First-Line Therapy in the United States.

Background: Endometrial cancer (EC) represents a substantial economic burden for patients in the United States. Patients with advanced or recurrent EC have a much poorer prognosis than patients with early-stage EC. Data on healthcare resource utilization (HCRU) and costs for patients with advanced or recurrent EC specifically are lacking. Objectives: To describe HCRU and costs associated with first-line (1L) therapy for commercially insured patients with advanced or recurrent EC in the United States. Methods: This was a retrospective cohort study of adult patients with advanced or recurrent EC using the MarketScan® database. Treatment characteristics, HCRU, and costs were assessed from the first claim in the patient record for 1L therapy for advanced or recurrent EC (index) until initiation of a new anti-cancer therapy, disenrollment from the database, or the end of data availability. Baseline demographics were determined during the 12 months before the patient's index date. Results: A total of 7932 patients were eligible for inclusion. Overall, mean age at index was 61 years, most patients (77.3%) had received prior surgery for EC, and the most common 1L regimen was carboplatin/paclitaxel (59.1%). During the observation period, most patients had at least one healthcare visit (all-cause, 99.9%; EC-related, 82.8%), most commonly outpatient visits (all-cause, 91.4%; EC-related, 68.7%). The highest mean (SD) costs (US dollars) were for inpatient hospitalization for both all-cause and EC-related events ($8396 [$15,130] and $9436 [$16,784], respectively). Total costs were higher for patients with a diagnosis of metastasis at baseline than for those without a diagnosis of metastasis. Discussion: For patients with advanced or recurrent EC in the United States, 1L therapy is associated with considerable HCRU and economic burden. They are particularly high for patients with metastatic disease. Conclusions: This study highlights the need for new cost-effective treatments for patients with newly diagnosed advanced or recurrent EC.

Weight loss makes the difference: perioperative outcomes following posterior lumbar fusion in patients with and without weight loss following bariatric surgery.

BACKGROUND CONTEXT: Morbid obesity (MO) has been associated with increased risk of adverse events following procedures such as posterior lumbar fusion (PLF). While preemptive bariatric surgery (BS) has been considered for those with MO (body mass index [BMI] ≥35 kg/m2), not all undergoing such intervention have significant weight loss, and the impact of BS has been shown to correlate with weight loss after different related procedures. PURPOSE: To examine outcomes following isolated single level PLF among patients with history of BS who subsequently did and did not transition out of the morbidly obese category. STUDY DESIGN/SETTING: Retrospective case-control study. PATIENT SAMPLE: The PearlDiver 2010-Q1 2020 MSpine database was used to identify adult patients undergoing elective isolated PLF. Patients were excluded if they had a history of infection, neoplasm, or trauma in the 90-days prior to their PLF and if they were not active in the database for at least 90 days following their surgery. Three sub-cohorts were defined: 1) MO controls without a history of BS (-BS+MO), 2) patients with prior BS procedure who remained MO (+BS+MO), and 3) patients with prior BS who were no longer MO at the time of PLF (+BS-MO). Matched 1:1:1 populations were created for these three sub-cohorts based on age, sex and Elixhauser Comorbidity Index (ECI). OUTCOME MEASURES: Ninety-day adverse events and readmission rates were assessed and compared between the three sub-cohorts (-BS+MO, +BS+MO, +BS-MO). METHODS: Univariable analyses and multivariable logistic regression were performed on the matched population to compare 90-day adverse events and readmission rates controlling for age, sex, and ECI. RESULTS: The current study identified PLF patients who were MO at the time of surgery but did not have a history of BS (-BS+MO, n=34,236), those who had BS and remained MO (+BS+MO, n=564), and those who had MS and were no longer MO (+BS-MO, n=209 which was only 27% of those who had BS). On multivariable analysis of the matched populations, those that had BS but remained MO (+BS+MO) were not at reduced odds of 90-day adverse events. However, those that had BS and were no longer MO (+BS-MO) were at reduced odds of 90-day any, severe, and minor adverse events (OR 0.41, 0.51, and 0.37, respectively with p<0.05 for all). CONCLUSIONS: Only 27% of those with a history of BS prior to PLF transitioned out of the MO category. Compared to those who were morbidly obese without BS, those who had BS were only at reduced risk of 90-day adverse events if they actually lost weight sufficient to drop out of morbidly obesity. These findings should be taken into account when counseling patients and interpreting prior studies.

Renal Transplant Patients Have a Lower Risk of Complications and Mortalities After Total Knee Arthroplasty Compared to Those on Hemodialysis: A Large National Database Study.

BACKGROUND: Total knee arthroplasty (TKA) in end-stage renal disease is associated with complications. Controversy exists whether elective TKA should be performed while patients are on hemodialysis (HD) or following renal transplant (RT). This study compares TKA outcomes in HD versus RT patients. METHODS: A national database was retrospectively reviewed using International Classification of Diseases codes to identify HD and RT patients who underwent primary TKA from 2010 to 2018. Demographics, comorbidities, and hospital factors were compared using Wald and Chi-squared tests. The primary outcome was in-hospital mortalities while secondary outcomes included quality outcomes and medical/surgical complications. Multivariate regressions were used to determine independent associations. Significance was determined with a 2-tailed P value of .05. There were 13,611 patients who underwent TKA (61.1 HD and 38.9% RT). Patients who had RT were younger, had fewer comorbidities, and more likely to have private insurance. RESULTS: The RT patients had a lower rate of mortality (odds ratio (OR) 0.23, P < .01)), complications (OR 0.63, P < .01), cardiopulmonary complications (OR 0.44, P = .02), sepsis (OR 0.22, P < .001), and blood transfusion (OR 0.35, P < .001) during the index hospitalization. This cohort was also found to have decreased length of stay (-2.0 days, P < .001), non-home discharge (OR 0.57, P < .001), and hospital cost (-$5,300, P < .001). Patients who had RT had a lower rate of readmission (OR 0.54, P < .001), periprosthetic joint infection (OR 0.50, P < .01), and surgical site infection (OR 0.37, P < .001) within 90 days. CONCLUSION: These findings suggest that HD patients are a high-risk population in TKA compared to RT patients and warrant stringent perioperative monitoring.

Disease Burden and Health Status among People with Severe Obesity Who Do Not Receive Bariatric Surgery: A Retrospective Study.

INTRODUCTION: The aim of the study was to compare eligible individuals who were or were not treated with bariatric surgery and describe disease burden, treatment, and healthcare costs over 3 years in individuals who were not. METHODS: Adults with obesity class II and comorbidities, or obesity class III, were identified in IQVIA Ambulatory EMR - US and PharMetrics® Plus administrative claims databases (January 1, 2007-December 31, 2017). Outcomes included demographics, BMI, comorbidities, and per patient per year (PPPY) healthcare costs. RESULTS: Of 127,536 eligible individuals, 3,962 (3.1%) underwent surgery. The surgery group was younger, a greater proportion were women, and mean BMI and rates of some comorbidities (obstructive sleep apnea, gastroesophageal reflux disease, and depression) were higher than in the nonsurgery group. Mean healthcare costs PPPY in the baseline year were USD 13,981 in the surgery group and USD 12,024 in the nonsurgery group. In the nonsurgery group, incident comorbidities increased during follow-up. Mean total costs increased by 20.5% from baseline to year 3, mostly driven by an increase in pharmacy costs; however, fewer than 2% of these individuals initiated antiobesity medications. CONCLUSIONS: Individuals who did not undergo bariatric surgery showed a progressive worsening of health and increasing healthcare costs, indicating a large unmet need for access to clinically indicated obesity treatment.