PS-adjusted Odds Ratio Research Articles

Methylprednisolone Pulses and Prolonged Remission in Systemic Lupus Erythematosus: A Propensity Score Analysis of the Longitudinal Lupus-Cruces-Bordeaux Inception Cohort.

The objective of this study was to analyze the effect of methylprednisolone pulses (MP), given during the first year after the diagnosis of systemic lupus erythematosus (SLE), in achieving prolonged remission according to the degree of lupus activity at presentation. We conducted an observational study of routine clinical care data from the Lupus-Cruces-Bordeaux cohort. The end point was prolonged remission (ie, during five consecutive yearly visits). The effect of MP on remission during the first year was analyzed in the whole cohort and according to the baseline Systemic Lupus Erythematosus Disease Activity Index 2000 score: <6, 6 to 12, and >12, reflecting mild, moderate, and severe activity, respectively. For adjustment, logistic regression with propensity score (PS) and other therapeutic covariates was performed. Two hundred thirty-three patients were included. Prolonged remission was achieved by 132 patients (57%). MP were associated with prolonged remission (PS-adjusted odds ratio [OR] 2.50, 95% confidence interval [CI] 1.04-623, P = 0.042). A strong clinical effect was seen among patients with moderate (adjusted OR 5.28, 95% CI 1.27-21.97, P = 0.022) and moderate-severe SLE activity (adjusted OR 4.07, 95% CI 1.11-14.82, P = 0.033). The administration of MP resulted in reduced average dosages of prednisone during the first year among patient with moderate (mean 6.6 vs 10.2 mg/day, P = 0.017) and severe activity (mean 14 vs 28 mg/day, P = 0.015). The odds of prolonged remission were increased by longer-term use of hydroxychloroquine (HCQ) and decreased by higher initial doses of prednisone. This study supports the use of MP to induce prolonged remission in patients with SLE, particularly in those with moderate and severe activity. The extended use of HCQ also contributes to achieve prolonged remission.

Hybrid emergency room shows maximum effect on trauma resuscitation when used in patients with higher severity.

The hybrid emergency room (ER) system is a novel trauma workflow that uses angio-computed tomography equipment in a trauma resuscitation room. Although the hybrid ER system decreases time to start surgery and endovascular treatments and improves mortality, the optimal target benefitting from this system remained unclear. We aimed to identify a subset of trauma patients likely to receive the greatest benefits from the hybrid ER. This retrospective cohort study was conducted in a tertiary hospital in Japan from August 2007 to January 2020. We consecutively included severe adult blunt trauma patients (Injury Severity Score [ISS], ≥16) and divided them into two groups: conventional group (August 2007 to July 2011) and hybrid ER (August 2011 to January 2020) group. We evaluated the association between the hybrid ER group and 28-day mortality using multivariable logistic regression analysis. The 28-day mortality trend during the study period was evaluated with restricted cubic spline analysis. To evaluate heterogeneity of effects within various patient severities, we evaluated whether the patients' ISS modified the effect of the hybrid ER on survival. Among 1,050 trauma patients, the conventional group comprised 360 patients and the hybrid ER group comprised 690 patients. Injury Severity Score and probability of survival (Ps) were not significantly different between the groups. Twenty-eight-day mortality was significantly lower in the hybrid ER group (Ps-adjusted odds ratio, 0.48; 95% confidence interval, 0.32-0.71; p < 0.001). Restricted cubic spline analysis revealed that Ps-adjusted 28-day mortality sharply decreased approximately 200 days after installation of the hybrid ER. Increase of survival probabilities according to the increase of ISS was significantly improved in hybrid ER group (p = 0.014). Because ISS increased to >25, survival probabilities in the hybrid ER group were higher compared with those in the conventional group. The hybrid ER may improve posttraumatic mortality, especially in patients with higher baseline severity. Therapeutic/care management, level IV.

Neurological outcomes after on-pump vs off-pump CABG in patients with cerebrovascular disease.

The possible association of off-pump coronary artery bypass graft (CABG) with reduced risk of postoperative stroke and enhanced benefits in high-risk patients support the hypothesis that patients with a positive history of cerebrovascular disease would benefit from off-pump coronary surgery. This study aims to investigate the impact of off-pump CABG on the incidence of postoperative neurologic events in patients with a previous history of cerebrovascular disease. From January 2015 to September 2018, 414 patients underwent isolated CABG with a previous history of transient ischemic attack (TIA) or stroke: 295 patients had on-pump CABG and 119 patients had off-pump CABG. Neurological outcomes of interest are postoperative stroke (transient or permanent), delirium requiring pharmacological treatment or a combination of both, collectively defined "Major Adverse Neurological Events" (MANE). Propensity score (PS) adjusted analysis has been used for regression models. Off-pump CABG carried a lower incidence of postoperative stroke (3.4% vs 9.8%, P = .046, PS-adjusted odds ratio 0.34 with P = .044). Postoperative delirium occurred more than twice as often in the on-pump group (11.5% vs 4.2%, P = .034, PS-adjusted odds ratio 2.78 with P = .043). The composite outcome of MANE occurred in 20.3% in the on-pump group, and in 7.6% in the off-pump group (P = .003). Other complications were similar between groups. In patients with a previous TIA or stroke, off-pump CABG is associated with a reduced risk of stroke, delirium, and postoperative adverse neurological events, compared to on-pump CABG. Patients with high neurological risk can potentially benefit from off-pump CABG, due to an overall reduction of postoperative neurological complications.

Association of serum asymmetric dimethylarginine, homocysteine, and l-arginine concentrations during early pregnancy with hypertensive disorders of pregnancy

BackgroundOur previous study suggested that a lower l-arginine level (<70μM) at early gestation is associated with pregnancy-induced hypertension. The maternal asymmetric dimethylarginine (ADMA) and homocysteine (Hcy) concentrations also have been reported to be increased in hypertensive disorders of pregnancy (HDP). These molecules have a key role in metabolism of nitric oxide. The aim of this study is to determine the most useful predictor of HDP at early gestation. MethodsThe concentrations of ADMA and Hcy at each of three periods in normal pregnancy were determined, and the values compared between the normal pregnancy and HDP groups. Moreover, the possible risk factors for the development of HDP also were evaluated using a multivariate logistic regression model and propensity score (PS). ResultsThe maternal ADMA concentration was significantly elevated with advance of gestational age, while Hcy concentration was decreased from early to mid-gestation and increased from mid- to late-gestation in normal pregnancy. The maternal Hcy concentration at early gestation was significantly higher in the HDP group compared to that in the normal group. A higher maternal Hcy level (>7.2μM) in early pregnancy was independently associated with the development of HDP (PS-adjusted odds ratio=4.47, 95% confidence interval=1.51–12.82), as well as pre-pregnancy overweight [body mass index (BMI)>25kg/m2], primipara status, and a lower maternal l-arginine level (<70μM). ConclusionsThe risk factors, such as overweight (BMI>25kg/m2) before pregnancy, primipara status, higher Hcy (>7.2μM), and lower l-arginine (<70μM) concentration in early pregnancy, for development of HDP were detected.

Permanent Atrial Fibrillation and 2 Year Clinical Outcomes in Patients with a Left Ventricular Assist Device Implant.

Atrial fibrillation (AF) may increase the risk of thromboembolic (TE) complications in patients with left ventricular assist devices (LVADs). In a single-center study, we investigated 205 patients with sinus rhythm (SR group) and 117 patients with AF (AF group). Our main read outs were 2 year overall survival (primary end point), perioperative right heart failure (RHF), and 2 year freedom from stroke, pump thrombosis, and gastrointestinal bleeding (secondary end points). Oral anticoagulation was performed with phenprocoumon (international normalized ratio target range: 2.3-2.8) and aspirin (100 mg/day). Propensity score (PS) adjustment was used for statistical analysis. Two year survival was 65.4% (n = 134) in the SR group and 51.3% (n = 60) in the AF group. The PS-adjusted hazard ratio (HR) of 2 year mortality was higher in the AF group than in the SR group (HR = 1.48 [95% confidence interval (CI): 1.02-2.15; p = 0.038]). Right heart failure was a more frequent cause of death in the AF group than in the SR group (p = 0.008). The PS-adjusted odds ratio of perioperative RHF was for the AF group (reference: SR group) 1.32 (95% CI: 0.80-2.18; p = 0.280). The PS-adjusted 2 year HRs of TE and bleeding events were comparable between both groups and were for stroke, pump thrombosis, and gastrointestinal bleeding (reference: SR group) 0.90 (95% CI: 0.53-1.55; p = 0.714), 0.76 (95% CI: 0.14-4.31; p = 0.639), and 1.01 (95% CI: 0.60-1.70; p = 0.978), respectively. Our data indicate that AF increases midterm mortality, but does not influence the risk of stroke, pump thrombosis, and gastrointestinal bleeding. The higher midterm mortality in AF patients is most likely disease-related and should have no influence on LVAD implantation.

The association between the transfusion of small volumes of leucocyte-depleted red blood cells and outcomes in patients undergoing open-heart valve surgery.

The relationship between the transfusion of red blood cell (RBC) units and outcomes in patients undergoing cardiac surgery is the subject of intense debates. In this study, we investigated the relationship between the transfusion of 1-2 leucocyte-depleted (LD) RBC units and outcomes in patients undergoing open-heart valve surgery. The investigation encompassed consecutive patients undergoing open-heart valve surgery at our institution between July 2009 and March 2015 who received no (RBC- group) or 1-2 units of LD RBC (RBC+ group). End-points were 30-day mortality (primary), the incidence of in-hospital major organ dysfunctions and 1-year mortality (secondary). Propensity score (PS)-adjusted statistical analysis was used to assess the effect of RBC transfusion on end-points. Thirty-day mortality rate was 0.2% (3/1485) in the RBC- group and 0.4% (6/1672) in the RBC+ group, with a PS-adjusted odds ratio (OR) for 30-day mortality of 1.00 (95% CI: 0.21-4.83;P = 0.99). The two groups showed no significant differences in PS-adjusted ORs for major complications, such as stroke, low cardiac output syndrome, thoracic wound infection and prolonged mechanical ventilation (>24 h). The PS-adjusted ORs for prolonged intensive care unit stay (>48 h) were, however, significantly higher in the RBC+ group (OR = 1.34 [95%CI: 1.04-1.72; P = 0.02]) than in the RBC- group. One-year mortality was comparable between groups (PS-adjusted hazard ratio for the RBC+ group: 0.85 [95% CI: 0.42-1.72; P = 0.65]). Our data do not provide evidence that in patients undergoing valve surgery with cardiopulmonary bypass, transfusion of 1-2 units of LD RBC increases operative mortality, the incidence of postoperative complications or 1-year mortality.

Transfusion of 1 and 2 units of red blood cells does not increase mortality and organ failure in patients undergoing isolated coronary artery bypass grafting.

In cardiac surgery, the association between red blood cell (RBC) transfusion and clinical outcome is elusive. We investigated in a large cohort of patients who underwent isolated coronary artery bypass grafting (CABG) the effect of transfusion of 1-2 units of leucocyte-depleted RBCs on mortality and multiorgan failure. The investigation included all patients from July 2009 to June 2014 who underwent CABG at our institution and received no (n = 1478) or 1-2 units of RBCs (n = 1528). The primary end-point was 30-day mortality; secondary end-points were major organ dysfunction. A subgroup analysis assessed the effect of the duration of RBC storage on patient outcome. Statistical analysis was performed using propensity score (PS) adjustment. The 30-day mortality rate was 0.3% in the RBC- group and 0.2% in the RBC+ group. Compared with the RBC- group, PS-adjusted odds ratio (OR) of 30-day mortality in the RBC+ group was 0.29 [95% confidence interval (CI): 0.06-1.50; P = 0.14]. PS-adjusted OR of a 'prolonged intensive care unit (ICU) stay' (>48 h) was significantly higher in the RBC+ group than in the RBC- group [OR 1.49 (95% CI: 1.14-1.95); P = 0.004], but major clinical complications such as low cardiac output syndrome, stroke, haemofiltration, wound infection and prolonged mechanical ventilator support (>24 h) did not differ significantly between groups. Duration of blood storage was not independently associated with clinical outcome. Our data do not indicate a transfusion-related increase in mortality and multiorgan failure in patients undergoing isolated CABG.

Moderate Dosage of Tranexamic Acid During Cardiac Surgery With Cardiopulmonary Bypass and Convulsive Seizures

Koster, A.*; Börgermann, J.†; Zittermann, A.†; Lueth, J. U.*; Gillis-Januszewski, T.†; Schirmer, U.* Author Information

Moderate dosage of tranexamic acid during cardiac surgery with cardiopulmonary bypass and convulsive seizures: incidence and clinical outcome

Convulsive seizures (CS) occur in ∼1% of the patients after cardiac surgery with cardiopulmonary bypass. Recent investigations indicate an up to seven-fold increase in CS in cardiac surgical patients receiving high doses (≥60 mg kg(-1) body weight) of tranexamic acid (TA). In a retrospective data analysis of 4883 cardiac surgical patients, we investigated the incidence of CS in patients receiving a moderate dose of TA (24 mg kg(-1) body weight) compared with a reference group not receiving TA as a primary endpoint. Secondary endpoints were intensive care unit stay and in-hospital mortality. We performed propensity score (PS)-adjusted logistic regression analysis to test the association between TA use/non-use and clinical outcomes. Compared with the reference group, the PS-adjusted odds ratio (OR) for CS in the TA group was 1.703 [95% confidence interval (CI): 1.01-2.87; P=0.045; incidence 2.5% vs 1.2%]. Log-ICU-stay was significantly longer (P=0.004) and PS-adjusted relative in-hospital mortality risk was significantly higher for the TA group compared with the reference group (OR=1.89; 95% CI: 1.21-2.96; P=0.005). Both the TA-associated CS incidence and the in-hospital mortality risk were only significant in patients undergoing open-heart surgery (OR=2.034, 95% CI: 1.07-3.87; P=0.034 and OR=2.20, 95% CI: 1.32-3.69; P=0.003, respectively) but not in patients undergoing coronary artery bypass grafting (OR=1.21, 95% CI: 0.49-3.03; P=0.678 and OR=1.13, 95% CI: 0.42-3.02; P=0.809, respectively). In open-heart surgery, even moderate TA doses are associated with a doubled rate of CS and in-hospital mortality. Prospective trials are needed to further evaluate the safety profile of TA in cardiac surgery.

Off-pump surgery for the poor ventricle?

Severely decreased ejection-fraction is an established risk-factor for worse outcome after cardiac surgery. We compare outcomes of off-pump coronary artery bypass grafting (OPCAB) and on-pump CABG (ONCABG) in patients with severely compromised EF. From 2004 to 2009, 478 patients with a decreased EF ≤35% underwent myocardial-revascularization. Patients received either OPCAB (n = 256) or ONCABG (n = 222). Propensity score (PS), including 50 preoperative risk-factors, was used to balance characteristics between groups. PS adjusted logistic regression analysis was performed to assess mortality and major adverse cardiac and cerebrovascular events (MACCE). A composite endpoint for major non-cardiac complications such as respiratory failure, renal failure, rethoracotomy was applied. Complete revascularization (CR) was assumed when the number of distal anastomoses was larger than that of diseased vessels. There was no difference for mortality (2.3 vs. 4.1%; PS-adjusted odds ratio (PS-OR) = 1.05; p = 0.93) and MACCE (13.7 vs. 17.6%; PS-OR = 1.22; p = 0.50) including myocardial-infarction (1.4 vs. 4.9%; PS-OR = 0.39; p = 0.26), low cardiac output (2.3 vs. 4.7%; PS-OR = 0.75; p = 0.72) and stroke (2.3 vs. 2.7%; PS-OR = 0.69; p = 0.66). OPCAB patients presented with a trend to less frequent occurrence of the non-cardiac composite (12.1 vs. 22.1%; PS-OR = 0.54; p = 0.059) including renal dysfunction (PAOR = 0.77; 95% CI 0.31-1.9; p = 0.57), bleeding (PAOR = 0.42; 95% CI 0.14-1.20; p = 0.10) and respiratory failure (PAOR = 0.39; 95% CI 0.05-3.29; p = 0.39). The rate of complete revascularization was similar (92.2 vs. 92.8%; PS-OR = 0.75; p = 0.50). OPCAB in patients with severely decreased EF is safe and feasible. It may even benefit these patients in regard to non-cardiac complications and does not come at cost of less complete revascularization.

Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis

To assess pregnancy and fetal outcomes after in utero exposure to interferon-β (IFNβ) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus on the risk of spontaneous abortion. In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFNβ less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS). We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 ± 5.8 weeks). IFNβ exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio [OR] 1.08, 95% confidence interval [CI] 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted β -113.8, p < 0.0001) and length (PS-adjusted β -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFNβ exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years. Our findings point to the relative safety of IFNβ exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan.