Adjusting Baseline Characteristics Research Articles

Naldemedine and Magnesium Oxide as First-Line Medications for Opioid-Induced Constipation: A Comparative Database Study in Japanese Patients With Cancer Pain.

Introduction Naldemedine and magnesium oxide are common first-line early laxative medications used in the real-world scenario in Japan, for patients with cancer pain who receive opioid prescriptions, as per a nationwide hospital claims database study. However, the real-world prescription patterns and associated outcomes are unknown. Methods In this retrospective, cohort study using the Medical Data Vision (MDV) database (January 2018 to December 2020), data were collected from eligible patients (who had a long-term prescription of strong opioids, for >30 days) in Japan with naldemedine or magnesium oxide as the first-line laxative prescription, for a long-term opioid prescription for cancer pain with ≥6 months post-opioid observation period. A laxative prescription within three days after the opioid prescription date was termed an "early" prescription. The composite incidence of dose increase or addition/change of laxatives at three months after the start of the opioid prescription was the primary endpoint after adjusting baseline characteristics between the treatment arms by propensity score matching. Results After propensity score matching, 1717 and 544 patients who were prescribed naldemedine and magnesium oxide each were included in the early prescription and non-early prescription groups, respectively. Even after matching, the incidence of death was not adjusted enough and was significantly higher in the naldemedine arm than in the magnesium oxide arm in the non-early group but comparable in the early group. The incidence of addition, change, or dose increase was significantly higher in the naldemedine arm than in the magnesium oxide arm of the early prescription group (hazard ratio (95% confidence interval), 1.08 (1.00, 1.17); p=0.0402); the incidence was comparable between the arms of the non-early group. Conclusion These findings may provide valuable insights into real-world clinical treatment patterns and preliminary evidence for the selection of first-line medications to mitigate opioid-induced constipation in Japanese patients with cancer pain.

Weak to no correlation between quantitative high-resolution computed tomography metrics and lung function change in fibrotic diseases.

Identifying systemic sclerosis (SSc) and idiopathic pulmonary fibrosis (IPF) patients at risk of more rapid forced vital capacity (FVC) decline could improve trial design. The purpose of the present study was to explore the prognostic value of quantitative high-resolution computed tomography (HRCT) metrics derived by Imbio lung texture analysis (LTA) tool in predicting FVC slope. This retrospective study used data from patients who were not treated with investigational drugs with and without background antifibrotic therapies in tocilizumab phase 3 SSc, lebrikizumab phase 2 IPF, and zinpentraxin alfa phase 2 IPF studies conducted from 2015 to 2021. Controlled HRCT axial volumetric multidetector computed tomography scans were evaluated using the Imbio LTA tool. Associations between HRCT metrics and FVC slope were assessed through the Spearman correlation coefficient and adjusted R2 in a linear regression model adjusted by demographics and baseline clinical characteristics. A total of 271 SSc and IPF patients were analysed. Correlation coefficients of highest magnitude were observed in the SSc study between the extent of ground glass, normal volume, quantification of interstitial lung disease, reticular pattern, and FVC slope (-0.25, 0.28, -0.28, and -0.33, respectively), while the correlation coefficients observed in IPF studies were in general <0.2. The incremental prognostic value of the baseline HRCT metrics was marginal after adjusting baseline characteristics and was inconsistent across study arms. Data from the SSc and IPF studies suggested weak to no and inconsistent correlation between quantitative HRCT metrics derived by the Imbio LTA tool and FVC slope in the studied SSc and IPF population.

The association of calcium channel blocker with risk of adverse limb events in patients with chronic limb-threatening ischemia after endovascular treatment.

Symptoms of lower-extremity artery disease (LEAD) emerge from impaired vascularization in distal circulation of the extremities. Calcium channel blockers (CCB) can improve distal circulation when used as adjunctive therapy with endovascular treatment (EVT), but few studies have evaluated that. We investigated the relationship between CCB therapy and post-EVT outcomes. Through a consecutive EVT registry, we evaluated those relationships in whole cohort and the following 2 subgroups; the patients suffered from intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI), with adjusting baseline characteristics by propensity score matchings. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE, a composite endpoint of all death, nonfatal myocardial infarction, and nonfatal stroke), and major adverse limb event (MALE, a composite of major amputation, acute limb ischemia, and surgical reintervention). The group that received CCB had less MALE in whole cohort (HR 0.31; 95% confidence interval (CI) 0.20-0.47), and less MACCE and MALE in CLTI cohort (HR 0.67; 0.50-0.89 and 0.32; 0.20-0.52 respectively) compared to the group that did not receive CCB. The relationships were common in the cohorts with baseline adjustment. MACCE and MALE in IC (HR 1.01; 0.57-1.80 and 0.60; 0.25-1.45, respectively) showed no significant differences both with and without baseline adjustment. CCB use was related to fewer MACCE and MALE events in adjusted patients who underwent EVT, and the trend was more evident, especially in the adjusted CLTI cohort. This study highlights the necessity of future studies regarding CCB. Clinical Trial Registration: URL: https://www.umin.ac.jp ; Unique identifiers: UMIN000015100.

Graft rejection episodes after keratoplasty in Japanese eyes

We aimed to investigate the clinical characteristics and risk factors for graft rejection after keratoplasty in Japanese patients. We enrolled 730 cases (566 patients) of penetrating keratoplasty (PK, N = 198), Descemet’s stripping automated endothelial keratoplasty (DSAEK, N = 277), non-Descemet’s stripping automated endothelial keratoplasty (nDSAEK, N = 138), and Descemet membrane endothelial keratoplasty (DMEK, N = 117). The incidence, clinical characteristics, and possible risk factors for graft rejection were analyzed. Graft rejection occurred in 65 cases (56 patients, 8.9%). The incidence rate of rejection was highest with PK (3.45/100 person-years), followed by DSAEK (2.34), nDSAEK (1.55), and DMEK (0.24). Cox regression analysis revealed keratoplasty type, younger age, indications (such as failed keratoplasty and infection), and steroid eyedrop use as possible risk factors. In the multivariate model adjusting baseline characteristics, PK and DSAEK had significantly higher hazard ratios (HRs) than DMEK (HR = 13.6, 95% confidence interval [CI] [1.83, 101] for PK, 7.77 [1.03, 58.6] for DSAEK). Although not statistically significant, the HR estimate of nDSAEK to DMEK (HR = 7.64, 95% CI [0.98, 59.6]) indicated higher HR in nDSAEK than in DMEK. DMEK is the favorable option among the four surgical procedures to avoid graft rejection after keratoplasty.

Beneficial esthetic lightening effects of Cuscuta extract on skin darkness in healthy individuals: A clinical trial study.

Many biological activities and pharmacological usages have been revealed for the Cuscuta species. The present study aimed to assess the beneficial effects of Cuscuta on removing skin dark spots in healthy individuals, which is an important cosmetic concern, especially in women. This prospective, interventional before-after trial was conducted in 70 healthy individuals without any evidence of skin or systemic disorders who presented for consultation on removing skin darkening. The Cuscuta extract was prepared and then assessed for plant quality control and lack of microbial contamination. The content of melanin at baseline and at 1 and 3 months after intervention was assessed using Dermacatch, an accurate skin colorimetric measurement tool. Comparison of the melanin content of the lesions and treated area to the surrounding normal area at baseline and at 1 month after treatment showed a significant reduction in melanin content from 519.61 ± 45.09 to 498.50 ± 39.35 (P < 0.001). This reducing trend remained significant from the first month to the third month after treatment (from 498.50 ± 39.35 to 483.53 ± 40.99, P < 0.001). This decreasing trend was persistent even after adjusting baseline characteristics including gender, age, and duration of skin lesions. Both patients and investigators had high satisfaction level with the anti-melanogenesis effect of Cuscuta extract. Cuscuta extract is useful for removing hyperpigmented lesions and for skin lightening in healthy individuals.

Excluding Axillary Level I from the Regional Nodal Irradiation Field is not Associated with an Increased Axillary Recurrence in Patients with Breast Cancer

<h3>Purpose/Objective(s)</h3> The efficacy of regional nodal irradiation (RNI) in patients with breast cancer has been established in several phase 3 clinical trials. However, the optimal RNI field design has not been elucidated in detail. Irradiation of upper axillary level I is controversial and tends to be done at physicians' discretion as surgical exploration is usually performed in this area. We aimed to investigate whether the exclusion of axillary level I from RNI field affects axillary recurrence. <h3>Materials/Methods</h3> We retrospectively identified women with non-metastatic and unilateral breast cancer receiving RNI after breast cancer surgery from 2007 to 2018. Patients were classified into extensive and limited RNI groups according to the inclusion of axillary level I in the nodal field. Extensive RNI and limited RNI were defined by the lateral border of the nodal field encompassing and not encompassing the humeral head, respectively. To adjust baseline characteristics between the groups, propensity score matching was performed. Additionally, non-inferiority of limited RNI was defined as ≤2% excess of the 5-year axillary recurrence rate. <h3>Results</h3> Among 1780 patients, 1020 patients were matched (510 patients in each group). The median number of positive and removed lymph nodes were 1 and 10, respectively. Initial clinical N stage was N0 in 24.1%, N1 in 51.0%, N2 in 14.0%, and N3 in 10.9%. The median follow-up of 67.9 months (interquartile range, 43.1–96.4 months). The 5-year axillary recurrence rate was 1.2% (95% CI, 0.2%–2.1%) in extensive RNI group and 1.6% (95% CI, 0.4%–2.8%) in limited RNI group (P_log-rank=0.790). Non-inferiority of limited RNI was established with a difference between groups of 0.4% (95% CI, -1.1%–1.9%, P_{non-inferiority}=0.018). Subgroup analyses were performed according to the tumor location, the number of removed nodes, the lymph node ratio (ratio of positive over removed nodes), Ki-67, cN stage, pN stage, hormone receptor, lymphovascular invasion, and perinodal extension, but axillary level I irradiation did not significantly reduce axillary recurrence rate in none of the subgroups. Multivariable analysis showed younger age (HR, 1.07, per age; P=0.034), less than 10 removed nodes (HR, 4.50; P=0.029), and the presence of lymphovascular invasion (HR, 8.13; P=0.006) were associated with the higher risk of axillary recurrence, but limited RNI was not (P=0.355). <h3>Conclusion</h3> Excluding axillary level I from the RNI field did not increase axillary recurrence in women with breast cancer. When RNI is performed, upper axillary level I area can be saved from irradiation.

Early and Long-Term Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass Grafting in Patients with Severe Left Ventricular Dysfunction and a Giant Left Ventricle.

Introduction: No previous studies comparing the outcomes between off-pump coronary artery bypass grafting (off-pump CABG, OPCAB) and on-pump CABG (ONCAB) have been performed in patients with severe left ventricular dysfunction (LVD) and a giant left ventricle. We aimed to investigate whether such patients could benefit from OPCAB. Methods: From January 2011 to January 2021, a total of 98 patients with severe LVD and a giant left ventricle underwent isolated CABG (ONCAB 46, OPCAB 52) in Wuhan Union Hospital. The clinical data were collected retrospectively and propensity score matching was performed to adjust baseline characteristics. Results: After propensity matching, the two groups were comparable in baseline variables. The OPCAB group had a higher rate of incomplete revascularization than the ONCAB group (25.0% vs. 9.1%; p = 0.047). The 30-day mortality was similar between the matched groups (4.5% vs. 4.5%; p = 1.000) but the OPCAB group had a lower risk of postoperative IABP usage (9.1% vs. 25.0%; p = 0.047) and renal insufficiency (11.4% vs. 29.5%; p = 0.034). The long-term probability of survival (log-rank test, p = 0.450) was similar between the two groups but the OPCAB group had a lower probability of major adverse cardiovascular events (log-rank test, p = 0.038). Conclusions: For patients with severe LVD and a giant left ventricle, OPCAB reduced early postoperative complications while sacrificing long-term quality of life compared to those having ONCAB.

Comparative survival risks in patients undergoing abdominoperineal resection and sphincter-saving operation for rectal cancer: a 10-year cohort analysis using propensity score matching

Abdominoperineal resection (APR) has been considered to have a higher risk of local recurrence and poorer survival outcome than sphincter-saving operation (SSO) in patients with rectal cancer. This study compared long-term oncologic outcomes and prognostic parameters in propensity score-matched patients who underwent APR and SSO. This study analyzed 958 consecutive patients with lower rectal cancer who underwent preoperative chemoradiotherapy followed by APR or SSO between 2005 and 2015. Propensity score matching analysis was performed to adjust baseline characteristics, including clinical stage, tumor distance from the anal verge, and tumor size. In the entire cohort, the APR group had larger and lower tumors and showed significantly shorter 5-year disease-free survival (DFS) than the SSO group (64.5% vs. 75.8%, p = 0.01). After propensity score matching, there were no significant between-group differences in local (9.5% vs. 8.0%, p = 0.59) and systemic (27.9% vs. 23.4%, p = 0.3) recurrence rates, and 5-year DFS (67.5% vs. 69.9%, p = 0.49) and overall survival (80.8% vs. 82.9%, p = 0.65) rates. A lower number of lymph nodes retrieved was independently associated with recurrence and survival outcomes in the APR group, whereas poorly differentiated histology was an independent associated parameter in the SSO group. Advanced stage and perineural invasion were identified as independent prognostic parameters in both groups. This study indicated that the long-term oncologic outcomes of APR were comparable to those of SSO. Because prognostic parameters associated with oncologic outcomes differed between the respective procedures, correctable parameters could be ameliorated through complete total mesorectal excision and personalized systemic treatment.

Comparative survival analysis of platinum-based adjuvant chemotherapy for early-stage squamous cell carcinoma and adenocarcinoma of the lung.

Background and PurposeAlthough cytotoxic platinum‐based adjuvant chemotherapy (pACT) has been recommended for patients with completely resected early‐stage (ES) non–small‐cell lung cancer (ES‐NSCLC), therapeutic regimens for NSCLC have evolved in the past two decades. The study was aimed to examine the effectiveness of postoperative pACT for resected ES‐NSCLC patients with squamous cell carcinoma (SCC) or adenocarcinoma (ADC) according to real‐world data.Methods and PatientsInverse probability treatment weighting (IPTW) was used to adjust baseline characteristics between the group receiving pACT and those not receiving any treatment (observation, OBS) within 3 months after curative surgery. Cox regression models were used to compare overall survival (OS) and treatment failure‐free survival (TFS) between the groups.ResultsOf 31,208 patients with ES‐NSCLC, 4700 undergoing complete tumor resection were eligible, with a mean follow‐up period of 4.5 years. The pACT (n = 2347) and OBS (n = 2353) groups were well‐balanced after IPTW. The median OS differed between the pACT and OBS groups (77.2 vs. 75.5 months, adjusted hazard ratio [aHR] = 0.87, 95% confidence interval [CI] = 0.79–0.95, p = 0.003), and the 5‐year survival rates were 58.2% and 55.3%, respectively (p < 0.001). In the SCC group, pACT was superior to OBS in OS (75.0 vs. 57.4 months, aHR = 0.74, 95% CI = 0.62–0.88, p = 0.001) and TFS (32.7 vs. 21.8 months, aHR = 0.74, 95% CI = 0.63–0.86, p < 0.001). Both OS and TFS did not differ between two groups in those with ADC.ConclusionReal‐world data indicated that pACT confers a survival benefit for resected ES‐NSCLC patients with SCC but not ADC, which needs to be verified by a large sample of randomized controlled studies.

Model development to improve primary care services using an innovative network of homecare providers (WinCare) to promote blood pressure control among elderly patients with noncommunicable diseases in Thailand: a prospective cohort study

BackgroundThailand has been rapidly approaching an aging society in conjunction with an increase in noncommunicable diseases (NCDs) especially hypertension and type 2 diabetes. Demographics and epidemiologic transitions create several challenges to the health system in Thailand in the case of long term care policies, in particular, modality to support home care. Therefore, the model development to facilitate primary care home services for elderly patients with NCDs using an innovative network of homecare providers (WinCare) was established. The study aimed to evaluate the effectiveness of WinCare to improve blood pressure (BP) control as well as health-related quality of life (HRQoL) among elderly patients with NCDs.MethodsA prospective cohort study was conducted between July 2019 and January 2020 in a suburban area, Chiang Mai Province, Thailand. The intervention included WinCare providers and WinCare application. WinCare provided check-in visits to measure subjects blood pressure and body weight (once weekly), played the roles of other home caregivers for the patients and recorded measurements and activities in the WinCare app for 6 months. The primary outcomes of the study were differences in systolic BP, diastolic BP, and controlled BP (systolic BP < 140 mmHg and diastolic BP < 90 mmHg) at 6-month follow-up between the intervention and control groups, adjusting for age, sex, marital status, comorbidities, alcohol consumption and smoking status.ResultsA total of 104 subjects were initially recruited. Of the remaining 98 individuals, 52 were allocated to the intervention group and 46 to the control group. After adjusting baseline characteristics, no association existed between decreasing average systolic BP and intervention groups. However, diastolic BP of patients in the intervention group was on average 5.19 mmHg (95% CI -8.22, − 2.17) lower compared than that of the control group at 6-month follow-up. Furthermore, compared with patients in the control group, those in the intervention group were more likely to control BP, (AOR 3.03; 95% CI 1.02–9.01) at 6-month follow-up.ConclusionEstablishing a network of homecare providers (WinCare) was feasible in a community setting. This innovative network was able to facilitate elderly patients with NCDs residing in a suburban community to improve BP control at least at 6-month follow-up.Trial registrationTrial identification number was TCTR20200312007, First submitted date:12/03/2020.

The No-Touch Saphenous Vein Harvesting Improves Graft Patency After Off-Pump Coronary Artery Bypass Surgery: A Propensity-Matched Analysis.

IntroductionThis single-center study of propensity-matched data was performed to assess the effect of the no-touch saphenous vein (NTSV) harvesting technique on early- and long-term outcomes of patients after off-pump coronary artery bypass grafting (OPCABG) in China.MethodsA retrospective analysis of 767 patients who underwent OPCABG in the Beijing Anzhen Hospital (June 2017 to October 2021) was performed, and their data entered the conventional saphenous vein (CSV) harvesting technique group or the NTSV group. In-hospital and follow-up outcomes were evaluated by adjusting baseline characteristics using propensity score matching (1:1). Clinical outcomes and postoperative angiographic results were compared.ResultsThe saphenous vein graft patency rates at postoperative three months and one year for the NTSV group vs. CSV group were 99.6% vs. 96.2% (P<0.001) and 97.3% vs. 93.1% (P<0.001), respectively. The two matched groups received a significantly different cumulative incidence function of saphenous vein graft occlusion for the longer follow-up period in Kaplan-Meier curves (χ2=4.330, log-rank P=0.037). No difference in early- and long-term mortality or major adverse cardiac and cerebrovascular events (MACCE) were observed between the groups. The rate of MACCE was not statistically significant different between the groups, but there was a tendency favoring the no-touch technique (9.8% CSV vs. 4.8% NTSV; P=0.067). More patients in the NTSV group developed postoperative leg wound exudation (5.4% vs. 1.2%; P=0.032) and skin numbness (22.2% vs. 8.9%; P=0.001) than in the CSV group.ConclusionThe NTSV is an excellent conduit to be used in OPCABG. There remains a need to reduce leg wound complications.

The Impact of Preoperative and Postoperative Malnutrition on Outcomes for Ampullary Carcinoma After Pancreaticoduodenectomy

PurposeThe aim of this study was to investigate the effect of preoperative and postoperative malnutrition on postoperative short- and long-term outcomes for ampullary carcinoma after pancreatoduodenectomy (PD).MethodsData were collected retrospectively from 511 patients with ampullary carcinoma who underwent PD between June 2012 and June 2019. Nutritional status before and at 3, 6, and 12 months after operation was assessed by the scored Patient-Generated Subjective Global Assessment (PG-SGA). The patients were classified into well-nourished, moderately malnourished, and severely malnourished group according to the PG-SGA score. Propensity score matching (PSM) was performed to adjust baseline characteristics between preoperative group A (well-nourished and moderately malnourished group) and group B (severely malnourished group). After PSM, clinicopathological variables and postoperative complications were compared between the two groups. Univariate and multivariate Cox analysis was also conducted to investigate the prognostic factors of overall survival of patients with ampullary carcinoma who underwent PD.ResultsPreoperatively, 122 (23.9%) patients were classified into well-nourished group, 189 (37.0%) into moderately malnourished group, and 200 (39.1%) into severely malnourished group. After PSM analysis, the incidence of overall postoperative complications was higher in group B than that in group A (50.5% vs. 32.5%, p < 0.001). Multivariate Cox proportional hazards regression model showed that severe malnutrition (PG-SGA score >9 scores) before operation [hazard ratio (HR) = 1.508; 95% CI, 1.103–2.061; p = 0.01] and at 6 months (HR = 4.148; 95% CI, 2.523–6.820; p < 0.001) and 12 months (HR = 5.272; 95% CI, 3.630–7.656; p < 0.001) after operation was an independent prognostic factor of patients who underwent PD for ampullary carcinoma.ConclusionsSevere malnutrition before and at 6 and 12 months after operation significantly affects the long-term survival of patients with ampullary carcinoma who underwent PD. Additionally, the preoperative malnutrition was closely related to postoperative complications.

Emergency angiography for trauma patients and potential association with acute kidney injury

BackgroundAngiography has been conducted as a hemostatic procedure for trauma patients. While several complications, such as tissue necrosis after embolization, have been reported, little is known regarding subsequent acute kidney injury (AKI) due to contrast media. To elucidate whether emergency angiography would introduce kidney dysfunction in trauma victims, we compared the incidence of AKI between patients who underwent emergency angiography and those who did not.MethodsA retrospective cohort study was conducted using a nationwide trauma database (2004–2019), and adult trauma patients were included. The indication of emergency angiography was determined by both trauma surgeons and radiologists, and AKI was diagnosed by treating physicians based on a rise in serum creatinine and/or fall in urine output according to any published standard criteria. Incidence of AKI was compared between patients who underwent emergency angiography and those who did not. Propensity score matching was conducted to adjust baseline characteristics including age, comorbidities, mechanism of injury, vital signs on admission, Injury Severity Scale (ISS), degree of traumatic kidney injury, surgical procedures, and surgery on the kidney, such as nephrectomy and nephrorrhaphy.ResultsAmong 230,776 patients eligible for the study, 14,180 underwent emergency angiography. The abdomen/pelvis was major site for angiography (10,624 [83.5%]). Embolization was performed in 5,541 (43.5%). Propensity score matching selected 12,724 pairs of severely injured patients (median age, 59; median ISS, 25). While the incidence of AKI was rare, it was higher among patients who underwent emergency angiography than in those who did not (140 [1.1%] vs. 67 [0.5%]; odds ratio = 2.10 [1.57–2.82]; p < 0.01). The association between emergency angiography and subsequent AKI was observed regardless of vasopressor usage or injury severity in subgroup analyses.ConclusionsEmergency angiography in trauma patients was probably associated with increased incidence of AKI. The results should be validated in future studies.

Time course of coagulation and fibrinolytic parameters in pediatric traumatic brain injury.

Coagulopathy is a well-recognized risk factor for poor outcomes in patients with traumatic brain injury (TBI). Differences in the time courses of coagulation and fibrinolytic parameters between pediatric and adult patients with TBI have not been defined. Patients with TBI and an Abbreviated Injury Scale of the head score ≥ 3, in whom the prothrombin time (PT)-international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen concentration, and plasma D-dimer levels were measured on arrival and at 3, 6, and 12 hours after injury, were retrospectively analyzed. Propensity score-matched analyses were performed to adjust baseline characteristics between pediatric patients (aged < 16 years) and adult patients (aged ≥ 16 years). A total of 468 patients (46 children and 422 adults) were included. Propensity score matching resulted in a matched cohort of 46 pairs. Higher PT-INR and APTT values at 1 to 12 hours after injury and lower fibrinogen concentrations at 1 to 6 hours after injury were observed in the pediatric group compared with the adult group. Plasma levels of D-dimer were elevated in both groups at 1 to 12 hours after injury, but no significant differences were seen between the groups. Multivariate logistic regression analysis of the initial coagulation and fibrinolytic parameters in the pediatric group revealed no prognostic significance of the coagulation parameter values, but elevation of the fibrinolytic parameter D-dimer was an independent negative prognostic factor. In the acute phase of TBI, pediatric patients were characterized by prolongation of PT-INR and APTT and lower fibrinogen concentrations compared with adult patients, but these did not correlate with outcome. D-dimer was an independent prognostic outcome factor in terms of the Glasgow Outcome Scale in pediatric patients with TBI.

Prognostic impact of neoadjuvant chemotherapy in patients with synchronous colorectal liver metastasis: A propensity score matching comparative study

BackgroundSynchronous colorectal liver metastasis (SCRLM) is at an advanced tumor stage and requires multidisciplinary treatments. Neoadjuvant chemotherapy (NAC) is thought to be an effective treatment modality, but its prognostic impact is still unclear. Materials and methodsPatients with resectable SCRLM presented to eight university hospitals between 2007 and 2017 were retrospectively reviewed. Propensity score matching (PSM) was performed to adjust baseline characteristics between patients who received NAC with those who underwent up-front hepatectomy. The prognostic impact of NAC was then evaluated. ResultsThe cohort comprised of 320 patients: 151 patients received NAC and the remaining 169 patients underwent up-front hepatectomy. After a 1:1 ratio of PSM, 102 patients per group were selected. Within the PSM cohort, 66% patients had multiple liver tumors, with 15% having five or more liver tumors. The median survival (95% confidence interval) periods for patients with and without NAC in the PSM cohort were 88.5 (68.4 – not reached) and 84.2 (52.1 – not reached) months, respectively (P = 0.51). On multivariate analysis, the postoperative events in these patients including operative complications and use of adjuvant chemotherapy after hepatectomy were prognostic factors with hazards (95% confidence interval) being 1.88 (1.18–2.98) and 0.65 (0.42–1.01), respectively. ConclusionThis PSM study was restricted to patients with SCRLM and relatively advanced tumor stagings. NAC did not show any significant prognostic impact. While operative complications had a significant prognostic impact, use of adjuvant chemotherapy after hepatectomy had only a marginal prognostic impact. Reconsideration of indications for NAC is needed.

Sparsity of burn centers and prolonged length of hospital stay: A nationwide study

IntroductionThe optimal distribution of burn centers remains unclear. We aimed to determine the appropriate number of burn centers per population (density) and examined a nationwide registry with the hypothesis that low-density burn centers would be associated with unfavorable outcomes. Patients and methodsA retrospective study was conducted using the Japanese Society of Burn Injury registry (2011–2021). Burn center density was defined as the number of burn centers per one million population in each prefecture, and centers were trisected on the basis of density. Hospital-free days until day 30 were compared between patients at high-, middle-, and low-density centers. Inverse probability weighting was conducted to adjust baseline characteristics, including age, burn mechanism, and burn severity. ResultsWe included 6764, 6209, and 2200 patients at high-, middle-, and low-density burn centers, respectively. After adjusting for patient demographics and burn severity, patients at high- and middle-density centers (≥0.4 centers per one million population) had longer hospital-free days compared with those at low-density centers (11 [0–23] vs 11 [0–23] vs 8 [0–22] days; p < 0.001). ConclusionsLow burn center density (<0.4 centers per one million population) was associated with longer hospital stay, whereas no higher limit was determined.

LigaSure versus monopolar cautery for recipient hepatectomy in liver transplantation: A propensity score-matched analysis

The recipient hepatectomy process during liver transplantation is one of the most challenging parts of surgery because massive bleeding may be expected. The energy device has an excellent hemostatic effect with the sealing effect compared to the monopolar cautery. The purpose of this study was to compare and analyze the usefulness of the energy device with monopolar cautery in liver transplantation. We reviewed those who underwent liver transplantation from March 2019 to June 2020. A total of 187 recipients who underwent liver transplantation were included in this study. Sixty-nine cases of recipient who underwent recipient hepatectomy with LigaSure 118 cases included as a control group. We used propensity score matching to adjust baseline characteristics and possible factor that affects postoperative bleeding. Blood loss and total amounts of RBC transfusion were not different between both groups (mean, 5,486.5 ± 9,024.6 vs. 4,754.3 ± 6,819.5 cc; p = 0.592; 11.01 ± 13.75 vs. 10.21 ± 12.52 pack; p = 0.447). The rates of bleeding and infectious complication were significantly lower in the LigaSure group than in the monopolar cautery group (3/69, 4.35% vs. 13/69, 18.8%; p = 0.015 and 1/69, 1.45% vs. 9/69, 13.0%; p = 0.017). The length of postoperative hospital stay was shorter in the LigaSure group (mean, 23.1 ± 16.1 vs. 39.6 ± 58.2 days; p = 0.024). Recipient hepatectomy using the LigaSure energy device had a shorter hospital stay due to fewer re-operations rate and postoperative bleeding. And it also had fewer secondary complications related to bleeding than the conventional monopolar cautery group.

Racial, ethnic, and socioeconomic disparities in treatment outcomes in patients (pts) with diffuse large B-cell lymphoma (DLBCL): A U.S. real-world study using a de-identified electronic health record (EHR)-derived database.

e18514 Background: DLBCL, an aggressive disease, is the most common subtype of non-Hodgkin lymphoma. Few studies have addressed socioeconomic and racial/ethnic disparities in treatment patterns and health outcomes for pts with DLBCL. We present a retrospective cohort study, leveraging real-world data from a nationwide database, to investigate these disparities. Methods: Pts with DLBCL treated with first-line (1L) therapy within 90 days of diagnosis were selected from the nationwide Flatiron Health EHR-derived de-identified database from January 2011 to May 2020. During the study, the de-identified data originated from approximately 280 US cancer clinics (̃800 sites of care). Pts’ baseline characteristics, treatment patterns, overall survival (OS), time to next therapy or death to any cause (TTNTD) were compared between race groups (non-Hispanic White [W], non-Hispanic African American [AA], Hispanic or Latino [H], non-Hispanic Asian [A]) and socioeconomic groups (Medicaid without Commercial [Medicaid] vs Commercial without Medicaid [Commercial]). Baseline characteristics were compared using Fisher’s exact, chi-squared or t-tests. Time to event endpoints were compared using Cox models adjusting baseline characteristics. Results: In total, 4,648 pts with DLBCL (82% W, 7% AA, 8% H, 3% A) were included. Compared with other race groups, W pts were older (mean age: 67 vs 60, 62, 62 [W vs AA, H, A]), had a higher proportion of pts with Eastern Cooperative Oncology Group score ≥2 (8% vs 5%, 4%, 4%), and fewer pts with Medicaid insurance (1.7% vs 5%, 6%, 3%). Across race groups, 1L treatments received were similar; 82% had R-CHOP. There were no significant differences in OS (P = 0.278; HR [AA, H, A vs W]: 0.87, 0.85, 0.84) and TTNTD (P = 0.158; HR: 0.89, 0.88, 1.19). There were statistically significant differences in time from diagnosis to treatment (P &lt; 0.0001; HR: 0.83, 0.79, 1.12), although the magnitude of the median differences were relatively small (22, 24, 25, 19 days [W, AA, H, A]). In pts aged &lt; 65, commercially insured pts had less advanced disease (Group Stage IV: 28% vs 59%), better OS (HR [95% CI]: 0.50 [0.31–0.81], P = 0.005) and later TTNTD (HR: 0.70 [0.48–1.03], P = 0.067) compared with Medicaid insured pts. In pts aged ≥65, commercially insured pts had similar disease stage, OS (HR: 1.09 [0.65–1.84], P = 0.756) and TTNTD (HR: 0.94 [0.61–1.44], P = 0.763) compared with Medicaid insured pts. Insurance was not a significant factor for time from diagnosis to treatment for pts aged &lt; 65 (HR: 1.05 [0.80–1.37], P = 0.727) and ≥65 (HR: 1.05 [0.78–1.42], P = 0.742). Conclusions: In this analysis of over 4,500 pts with DLBCL treated in the real-world, access to commercial insurance was associated with health outcomes in pts under 65 years of age, possibly due to earlier diagnosis; race was not a significant factor.

Physician-staffed ambulance and increased in-hospital mortality of hypotensive trauma patients following prolonged prehospital stay: A nationwide study.

The benefits of physician-staffed emergency medical services (EMS) for trauma patients remain unclear because of the conflicting results on survival. Some studies suggested potential delays in definitive hemostasis due to prolonged prehospital stay when physicians are dispatched to the scene. We examined hypotensive trauma patients who were transported by ambulance, with the hypothesis that physician-staffed ambulances would be associated with increased in-hospital mortality, compared with EMS personnel-staffed ambulances. A retrospective cohort study that included hypotensive trauma patients (systolic blood pressure ≤ 90 mm Hg at the scene) transported by ambulance was conducted using the Japan Trauma Data Bank (2004-2019). Physician-staffed ambulances are capable of resuscitative procedures, such as thoracotomy and surgical airway management, while EMS personnel-staffed ambulances could only provide advanced life support. In-hospital mortality and prehospital time until the hospital arrival were compared between patients who were classified based on the type of ambulance. Inverse probability weighting was conducted to adjust baseline characteristics including age, sex, comorbidities, mechanism of injury, vital signs at the scene, injury severity, and ambulance dispatch time. Among 14,652 patients eligible for the study, 738 were transported by a physician-staffed ambulance. In-hospital mortality was higher in the physician-staffed ambulance than in the EMS personnel-staffed ambulance (201/699 [28.8%] vs. 2287/13,090 [17.5%]; odds ratio, 1.90 [1.61-2.26]; adjusted odds ratio, 1.22 [1.14-1.30]; p < 0.01), and the physician-staffed ambulance showed longer prehospital time (50 [36-66] vs. 37 [29-48] min, difference = 12 [11-12] min, p < 0.01). Such potential harm of the physician-staffed ambulance was only observed among patients who arrived at the hospital with persistent hypotension (systolic blood pressure < 90 mm Hg on hospital arrival) in subgroup analyses. Physician-staffed ambulances were associated with prolonged prehospital stay and increased in-hospital mortality among hypotensive trauma patients compared with EMS personnel-staffed ambulance. Therapeutic, level IV.

The Impact of Left Atrial Reduction During Surgical Ablation of Atrial Fibrillation

Enlarged left atrium (LA) is a risk factor for ablation failure after atrial fibrillation (AF) surgery. It predisposes patients to thromboembolic events, even in successful ablation; therefore, concomitant resection of the LA wall during surgical ablation was introduced. This study examined the clinical impacts of LA reduction in patients undergoing concomitant ablation for AF. This study enrolled 1484 patients with enlarged LA (≥50 mm) who underwent surgical AF ablation during major cardiac surgery between January 2001 and August 2018. Among them, 876 (59%) patients underwent concomitant LA reduction (Reduction group), whereas in the remaining 608 (41%), the LA wall was unresected (Preservation group). The primary outcome of interest was overall stroke. The secondary outcomes were overall mortality, late recurrence of AF, early postoperative complications and postoperative echocardiographic parameters. Outcomes were compared after adjusting baseline characteristics with inverse probability of treatment weighting (IPTW) using propensity score. The median follow-up was 60.1 months. After IPTW adjustment, long-term mortality (P = 0.250) and AF-free rates (P = 0.196) did not significantly differ between groups. However, the Reduction group showed a decreased risk of stroke (hazard ratio 0.54; 95% confidence interval 0.32-0.90; P = 0.018). Early postoperative complications rate such as mortality or reoperation for bleeding, was not significantly different between the 2 groups. The Reduction group showed smaller LA diameter (50.6 ± 8.0 mm vs 53.6 ± 8.9 mm; P < 0.001) on follow-up echocardiography. LA reduction effectively decreased LA size and appeared to decrease the stroke risk in patients with enlarged LA undergoing ablation for AF.