Predictors Of Serious Adverse Events Research Articles

Predictors of Serious Adverse Events and High-Level Cardiorespiratory Support in Patients Undergoing Transcatheter Pulmonary Vein Interventions.

Patients with pulmonary vein stenosis (PVS) often require frequent transcatheter pulmonary vein (PV) interventions for management of restenosis. Predictors of serious adverse events (AEs) and need for high-level cardiorespiratory support (mechanical ventilation, vasoactive support, and/or extracorporeal membrane oxygenation) 48h after transcatheter PV interventions have not been reported. This is a single-center retrospective cohort analysis of patients with PVS who underwent transcatheter PV interventions from 3/1/2014 to 12/31/2021. Univariate and multivariable analyses were performed using generalized estimating equations to account for within-patient correlation. 240 patients underwent 841 catheterizations involving PV interventions (median 2 catheterizations per patient [1,3]). At least one serious AE was reported in 100 (12%) cases, the most common of which were pulmonary hemorrhage (n = 20) and arrhythmia (n = 17). There were 14 severe/catastrophic AEs (1.7% of cases) including three strokes and one patient death. On multivariable analysis, age less than 6months, low systemic arterial saturation (< 95% in patients with biventricular [BiV] physiology, < 78% in single ventricle [SV] physiology), and severely elevated mean PA pressure (≥ 45mmHg in BiV, ≥ 17mmHg in SV) were associated with SAEs. Age less than 1year, hospitalization prior to catheterization, and moderate-severe RV dysfunction were associated with high-level support after catheterization. Serious AEs during transcatheter PV interventions in patients with PVS are common, although major events such as stroke or death are uncommon. Younger patients and those with abnormal hemodynamics are more likely to experience serious AEs and require high-level cardiorespiratory support after catheterization.

Abstract TMP92: Effect Of Serious Adverse Events After Endovascular Thrombectomy On Clinical Outcome In Acute Ischemic Stroke With Large Vessel Occlusion: A Pooled Analysis From DEVT And Rescue BT Trial

Background: Using the pooled database of the DEVT and the RESCUE BT Trial, the objective of this study was to assess the serious adverse events (SAE) profile and their clinical impacts among patients with ischemic stroke due to large vessel occlusion treated with endovascular thrombectomy. Methods: A post hoc analysis was performed by using database of the multicenter, randomized DEVT and RESCUE BT clinical trials. SAEs as reported by investigators at any time-point during the hospitalization and the 90-day follow-up period were analyzed on their frequency and that of any of their outcomes (death, and life threatening, new and/or prolonged hospitalization, disability/incapacity). The primary end point was favorable outcome, as defined by a score of 0 or 1 on the modified Rankin scale (mRS) of neurologic disability (which ranges from 0 [no symptoms] to 6 [death]) at 90 days. Logistic regression analysis was used to determine the effect of SAE on clinical outcome and the predictors of SAE. Results: Among 1182 randomized patients undergone endovascular thrombectomy, 1758 SAE occurrences were identified, affecting 828 (70.1%) patients. The three most frequent SAEs were pneumonia (n=620, 52.5%), intracranial hemorrhage within 48 hours (n=359, 30.4%) and systemic bleeding (n=174, 14.7%). Patients suffering from at least one SAE had a lower odds of reaching a favorable outcome at 90 days (adjusted odds ratio, 0.350 [95% CI, 0.249-0.492], P &lt;0.001). Higher age ( P =0.001), higher NIHSS ( P &lt;0.001), intracranial segment of internal carotid artery (ICA) ( P =0.012) and puncture to recanalization time ( P &lt;0.001) were predictors for the occurrence of SAE. Conclusions: SAEs were observed in about 7 in ten patients, and were more frequent in elderly, functionally-impaired, longer procedure time, and intracranial ICA-occluded among patients with ischemic stroke treated with endovascular thrombectomy. These findings may provide clinicians and patients with more accurate risk of SAEs after endovascular thrombectomy.

Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid.

Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with "advanced cirrhosis" because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy. Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs). One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42-2.12), INR (1.37, 1.00-1.87), Child-Pugh score (1.79, 1.28-2.50), MELD (1.17, 1.04-1.30) and bilirubin (1.83, 1.11-3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10-3.36), lower albumin levels (0.18, 0.06-0.51), Child-Pugh score (2.43, 1.50-4.04), history of ascites (3.5, 1.85-6.5) and bilirubin (1.30, 1.05-1.56), were associated with hepatic SAEs. A total bilirubin≥1.4mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4mg/dl should discourage from its use.

Opioids Safety in Pediatric Procedural Sedation with Ketamine

To evaluate the effects of pre- and intraprocedural opioids on adverse events in children undergoing procedural sedation with ketamine in the emergency department (ED). We conducted a retrospective cohort study of all children aged 0-18years who underwent procedural sedation with intravenous ketamine alone, or in combination with an opioid, at a tertiary-care pediatric ED between June 1, 2018, and August 31, 2020. We explored predictors of serious adverse events (SAEs), desaturation or respiratory intervention, and vomiting. Of 1164 included children (694 male, 59.6%; median age 5.0years [IQR 2.0-8.0]), 80 (6.8%) vomited, 63 (5.4%) had a desaturation or required respiratory interventions, and 6 (0.5%) had SAEs. Pre- and intraprocedural opioids were not independent predictors of sedation-related adverse events. A concurrent respiratory illness (aOR 3.73; 95% CI 1.31-10.60, P=.01), dental procedure (aOR 3.05; 95% CI 1.25-7.21, P=.01), and a greater total ketamine dose (aOR 1.75; 95% CI 1.21-2.54, P=.003) were independent predictors of desaturation or respiratory interventions. A greater total ketamine dose (aOR 1.86; 95% CI 1.16-2.98, P=.01) and older age (aOR 1.15; 95% CI 1.07-1.24, P<.001), were independent predictors of vomiting. Pre- and intraprocedural opioids do not increase the likelihood of sedation-related adverse events. SAEs are rare during pediatric procedural sedation with ketamine in the ED.

Evaluating changes in “good safety monitoring” for cancer clinical trial participants during the COVID-19 pandemic.

217 Background: Comprehensive and frequent safety monitoring is an essential component of clinical trial conduct to accurately characterize potential toxicities of a study drug and to minimize potential harm to study participants. The COVID-19 pandemic substantially impacted the delivery of cancer care with reduced frequency of overall and in-person visits. We hypothesized that reporting of serious adverse events (SAEs) occurring on clinical trials may have been impacted by these care delivery changes. The current study evaluated pandemic-related changes in the frequency of safety monitoring for cancer patients (pts) enrolled on a clinical trial and identified predictors of SAE reporting before and during the pandemic. Methods: This study included all adult cancer pts enrolled in interventional therapeutic clinical trials at an academic cancer center between 1/1/2019 and 12/30/2020. In this analysis, the "pre-pandemic" period was defined as the time between 1/1/19 and 3/14/20, and the pandemic period between 3/15/20 and the data cutoff date of 12/30/2020. SAE was defined as a grade 3 or grade 4 adverse event (AE) as reported by the trial. Demographic characteristics of pts, visit type (virtual vs in-person), and frequency of SAE reporting were summarized pre-pandemic and during the pandemic. A multivariate logistic regression model was employed to identify predictors of SAE reporting, with the outcome defined as report of at least one SAE from the time pts went on study until the data cutoff date. Covariates included age, gender, race (white vs. non-white), having at least one virtual visit, and enrollment on a trial before versus during the pandemic. Results: This study included 190 pts; 138 (73%) enrolled on trial pre-pandemic and 52 (27%) enrolled during the pandemic. During-pandemic participants were more likely to be older than pts enrolled pre-pandemic, but otherwise the groups were similar in terms of race and gender. Overall, 78 pts (41%) reported an SAE. Among pre-pandemic enrollees, 50% reported at least one SAE, compared to 17% among during-pandemic enrollees. In the multivariate logistic regression model, only enrolling on trial pre-pandemic was associated with a higher likelihood of reporting at least one SAE. Visit type (virtual vs. in-person) was not recorded in over half of during-pandemic patient encounters. Conclusions: There was a significant decline in frequency of SAE reporting during the COVID-19 pandemic. While having at least one virtual visit was not a significant predictor of SAE reporting in the multivariate regression model, our analysis may underrepresent the association of virtual visits and SAE reporting. As the number of virtual visits is expected to stay high post-pandemic, further work is needed to characterize the association of virtual visits and SAE reporting to ensure ongoing adequate safety monitoring for clinical trial patients.

Opioid Exposures Reported to U.S. Poison Centers

Objective Opioid-related deaths are a leading cause of accidental deaths in the United States (U.S.). This study aims to examine the national trends in opioid exposures reported to U.S. poison centers (PCs). Methods The National Poison Data System (NPDS) was queried for opioid exposures between 2011 and 2018. We descriptively assessed the demographic and clinical characteristics. Trends in opioid frequencies and rates were analyzed using Poisson regression. Independent predictors of serious adverse events in opioid exposures were studied. Results There were a total of 604,183 opioid exposure calls made to the PCs during the study period. The frequency of opioid exposures decreased by 28.9% (95% CI: −29.6%, −28.1%; p < 0.001), and the rate of opioid exposures decreased by 21.2% (95% CI: −24.7%, −16.9%; p < 0.001). Multiple substance exposures accounted for 48.9% cases. The most frequent age group was 20–29 years (19.3%). Suspected suicides accounted for 34.9% cases. There were 7,246 deaths in our study sample, with 6.8% of cases demonstrating major effects. Hydrocodone was the most frequently observed opioid causing a toxic exposure and naloxone was used in 20.6% cases. Important predictors of a serious adverse event were age, gender, multi-substance exposures, and reasons for exposure. Conclusions Analysis of calls to PCs indicated a decreasing trend of opioid exposures. However, the proportion of SAEs due to such exposures increased. There was a high proportion of intentional exposures and occurred in older age groups. PCs are a vital component of real-time public health surveillance of overdoses in the current opioid crisis.

Morbidity and mortality during hepatitis C treatment using sofosbuvir and daclatasvir with or without ribavirin, in a cohort of Egyptian patients.

Though direct-acting antiviral agents (DAAs) therapy is associated with a high cure rate of hepatitis C virus infection, a potential risk of serious adverse events (SAEs) exists. The aim of this study was to determine the incidence and predictors of morbidity and mortality related to DAAs therapy. This prospective study was conducted on a real word cohort of 1562 treatment naïve chronic hepatitis C (CHC) Egyptian patients, who received 12-weeks therapy with sofosbuvir (SOF) plus daclatasvir (DCV) ± ribavirin (RBV). The incidence and predictors of SAEs and mortality during treatment course and over the following 12 weeks were recorded. The mean age of study participants was 51.38 ± 9.70 years (55.22%, males). Liver cirrhosis was defined in 72.4% of participants. SAEs were recorded in 120 participants (7.68%), including hepatic decompensation, gastrointestinal bleeding, anemia and hepatocellular carcinoma. Nine patients (0.58%) died and 69 patients (4.42%) discontinued therapy due to SAEs. Severity of cirrhosis was the significant predictor of morbidities and mortality. Hepatic decompensation was predicted by baseline serum albumin [cutoff value: 3.00 g/dL, area under the receiver operating characteristic curve (AUROC): 0.953] and serum bilirubin (cutoff value: 1.75 mg/dL, AUROC: 0.940). The risk of morbidity and mortality related to SOF/DCV ± RBV therapy in CHC patients is small and is significantly linked to advanced cirrhosis.

Accuracy of remote continuous respiratory rate monitoring technologies intended for low care clinical settings: a prospective observational study

PurposeAltered respiratory rate (RR) has been identified as an important predictor of serious adverse events during hospitalization. Introduction of a well-tolerated continuous RR monitor could potentially reduce serious adverse events such as opioid-induced respiratory depression. The purpose of this study was to investigate the ability of different monitor devices to detect RR in low care clinical settings.MethodsThis was a prospective method-comparison study with a cross-sectional design. Thoracic impedance pneumography (IPG), frequency modulated continuous wave radar, and an acoustic breath sounds monitor were compared with the gold standard of capnography for their ability to detect RR in breaths per minute (breaths·min−1) in awake postoperative patients in the postanesthesia care unit. The Bland and Altman method for repeated measurements and mixed effect modelling was used to obtain bias and limits of agreement (LoA). Furthermore, the ability of the three devices to assist with correct treatment decisions was evaluated in Clarke Error Grids.ResultsTwenty patients were monitored for 1,203 min, with a median [interquartile range] of 61 [60-63] min per patient. The bias (98.9% LoA) were 0.1 (−7.9 to 7.9) breaths·min−1 for the acoustic monitor, −1.6 (−10.8 to 7.6) for the radar, and −1.9 (−13.1 to 9.2) for the IPG. The extent to which the monitors guided adequate or led to inadequate treatment decisions (determined by Clarke Error Grid analysis) differed significantly between the monitors (P = 0.011). Decisions were correct 96% of the time for acoustic, 95% of the time for radar, and 94% of the time for IPG monitoring devices.ConclusionsNone of the studied devices (acoustic, IPG, and radar monitor) had LoA that were within our predefined (based on clinical judgement) limits of ± 2 breaths·min−1. The acoustic breath sound monitor predicted the correct treatment more often than the IPG and the radar device.

Syncope, Hypotension, and Falls in the Treatment of Hypertension: Results from the Randomized Clinical Systolic Blood Pressure Intervention Trial.

To determine predictors of serious adverse events (SAEs) involving syncope, hypotension, and falls, with particular attention to age, in the Systolic Blood Pressure Intervention Trial. Randomized clinical trial. Academic and private practices across the United States (N=102). Adults aged 50 and older with a systolic blood pressure (SBP) of 130 to 180mmHg at high risk of cardiovascular disease events, but without diabetes, history of stroke, symptomatic heart failure or ejection fraction less than 35%, dementia, or standing SBP less than 110mmHg (N=9,361). Treatment of SBP to a goal of less than 120mmHg or 140mmHg. Outcomes were SAEs involving syncope, hypotension, and falls. Predictors were treatment assignment, demographic characteristics, comorbidities, baseline measurements, and baseline use of cardiovascular medications. One hundred seventy-two (1.8%) participants had SAEs involving syncope, 155 (1.6%) hypotension, and 203 (2.2%) falls. Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (hazard ratio (HR)=1.67, 95% confidence interval (CI)=1.21-2.32, P=.002), and possibly syncope (HR=1.32, 95% CI=0.98-1.79, P=.07), but not falls (HR=0.98, 95% CI=0.75-1.29, P=.90). Risk of all three outcomes was higher for participants with chronic kidney disease or frailty. Older age was also associated with greater risk of syncope, hypotension, and falls, but there was no age-by-treatment interaction for any of the SAE outcomes. Participants randomized to intensive SBP control had greater risk of hypotension and possibly syncope, but not falls. The greater risk of developing these events associated with intensive treatment did not vary according to age.

DOP006 A multicentre cohort study to assess the safety of vedolizumab for inflammatory bowel disease

We aimed to quantify rates and identify predictors of serious adverse events (SAE) with vedolizumab (VDZ) for Crohn’s disease (CD) and ulcerative colitis (UC). This was a review of a multicentre, US-based consortium of CD and UC patients treated with VDZ. Serious infections (SI) were defined as those requiring antibiotics or hospitalisation, or resulting in discontinuation of VDZ or death. SAE were defined as SI or adverse events resulting in discontinuation of VDZ or death. Multivariable logistic regression analyses with odds ratio (OR) and 95% confidence intervals (CIs) are reported for independent predictors of SI and SAE. 1087 patients (n = 650 CD; 45% male) with a median follow-up of 302 days (interquartile range 171–434) were included. SI occurred in 66 patients (6%); the most common SI were C. difficile (n = 24), abscess (n = 11), respiratory tract infections (n = 10), zoster (n = 7), and bacteraemia (n = 6). SAE occurred in 73 patients (7%), with no reported malignancies. Transverse myelitis (n = 1) and optic neuritis (n = 1) were the only two reported central nervous system adverse events. SI and SAE were observed in 3.7% and 4.3% of patients on VDZ monotherapy, 6.1% and 6.7% of patients on VDZ in combination with steroids or an immunomodulator (azathioprine, 6-mercaptopurine, methotrexate), and 9.8% and 10.7% of patients on VDZ in combination with both steroids and an immunomodulator. On multivariable analyses, after adjusting for inflammatory bowel disease type (CD vs. UC), age, and sex, concomitant immunosuppressive (steroid or immunomodulator) therapy was the only independent predictor of SI (OR 1.67 per number of immunosuppressive agents used, 95% CI 1.17–2.38) and SAE (OR 1.65 per number of immunosuppressive agents used, 95% CI 1.17–2.31). VDZ is well tolerated in clinical practice, with SI and SAE being reported in 6% and 7% of patients, respectively. The strongest predictor of SI or SAE is the use of concomitant steroids or immunomodulators, with the greatest risk seen in patients on triple therapy with VDZ, steroids, and immunomodulator therapy. Further studies are needed to identify patients who will most benefit from concomitant immunosuppressive therapy use with VDZ to optimise the safety profile in clinical practice.

Using a simplified pre-hospital 'MET' score to predict in-hospital care and outcomes.

Medical emergency team (MET) activation criteria serve as a predictor of serious adverse events on hospital wards and in the emergency department (ED). We aimed to determine whether in-hospital MET activation criteria would be useful in identifying patients at risk in pre-hospital care. The data were collected retrospectively from 610 adult patients treated by physician-staffed helicopter emergency medical services. Pre-hospital vital signs were compared with MET activation criteria and scored accordingly to receive a simplified pre-hospital 'MET' score. The primary outcome measure was hospital mortality. The secondary outcome measures were admission to intensive care unit and the length of ED stay, intensive care unit (ICU) stay and hospital stay. The simplified pre-hospital 'MET' score was also compared with Emergency Severity Index (ESI) used as a triage tool in ED. Higher simplified pre-hospital 'MET' scores were associated with hospital mortality (P<0.001), the need for ICU treatment (P<0.001) and a more urgent ESI class in the ED (P<0.001). Higher simplified pre-hospital 'MET' scores were associated with shorter stay in the ED (P<0.001), longer stay in the ICU (P<0.001) and longer hospital stay (P<0.001). A simplified pre-hospital 'MET' score was an independent predictor for hospital mortality (odds ratio 2.42, confidence interval 1.84 3.18, P<0.001), regardless of age or patient's previous overall physical health classified by American Society of Anesthesiologists physical status classification system. A simplified pre-hospital 'MET' score is a predictor for patient outcome and could serve as a risk assessment tool for the health care provider on-scene.

Derivation of a risk scale and quantification of risk factors for serious adverse events in adult emergency department syncope patients

Determining the appropriate disposition of emergency department (ED) syncope patients is challenging. Previously developed decision tools have poor diagnostic test characteristics and methodological flaws in their derivation that preclude their use. We sought to develop a scale to risk-stratify adult ED syncope patients at risk for serious adverse events (SAEs) within 30 days. We conducted a medical record review to include syncope patients age ≥ 16 years and excluded patients with ongoing altered mental status, alcohol or illicit drug use, seizure, head injury leading to loss of consciousness, or severe trauma requiring admission. We collected 105 predictor variables (demographics, event characteristics, comorbidities, medications, vital signs, clinical examination findings, emergency medical services and ED electrocardiogram/monitor characteristics, investigations, and disposition variables) and information on the occurrence of predefined SAEs. Univariate and multiple logistic regression analyses were performed. Among 505 enrolled patient visits, 49 (9.7%) suffered an SAE. Predictors of SAE and their resulting point scores were as follows: age ≥ 75 years (1), shortness of breath (2), lowest ED systolic blood pressure < 80 mm Hg (2), Ottawa Electrocardiographic Criteria present (2), and blood urea nitrogen > 15 mmol/L (3). The final score calculated by addition of the individual scores for each variable (range 0-10) was found to accurately stratify patients into low risk (score < 1, 0% SAE risk), moderate risk (score 1, 3.7% SAE risk), or high risk (score > 1, ≥ 10% SAE risk). We derived a risk scale that accurately predicts SAEs within 30 days in ED syncope patients. If validated, this will be a potentially useful clinical decision tool for emergency physicians, may allow judicious use of health care resources, and may improve patient care and safety.

Antegrade selective cerebral perfusion and moderate hypothermia in aortic arch surgery: clinical outcomes in elderly patients

To evaluate the outcome in elderly patients (≥ 75 years) undergoing elective aortic arch surgery with the aid of selective antegrade cerebral perfusion (SACP) and moderate hypothermic circulatory arrest (HCA). A series of 95 patients ≥ 75 years (median age 77 years, median EuroSCORE 28) undergoing elective aortic arch surgery with SACP and moderate HCA were analysed with regard to clinical outcome. Risk factors for serious adverse events (mortality, neurological injury) were determined. Sixty-three patients (66%) underwent ascending aorta and hemiarch replacement, whereas 32 patients (34%) underwent ascending aorta and total arch replacement. Isolated arch replacement was rare. Additionally, 27% of patients underwent aortic valve replacement and 26% underwent root replacement. In-hospital mortality was 7%. Permanent neurological deficits occurred in 5%, transient neurological deficits occurred in 2%. Median SACP time was 24 min. Univariate analysis revealed femoral cannulation site (OR: 3.4; CI: 1.25-9.22, P = 0.016) as well as HCA ≥ 40 min (OR: 4.21; CI: 1.83-12.58, P = 0.001) as predictors of serious adverse events (mortality, neurological injury). Summarizing, elective aortic arch surgery in elderly patients using SACP and moderate HCA provides excellent results regarding mortality and postoperative neurological outcome. Prolonged HCA time and femoral cannulation were the only predictors of serious adverse events (mortality, neurological injury).

A retrospective analysis of proceduralist-directed, nurse-administered propofol sedation for implantable cardioverter-defibrillator procedures

There is controversy whether proceduralist-directed, nurse-administered propofol sedation (PDNAPS) is safe. To assess the frequency of adverse events when PDNAPS is used for implantable cardioverter-defibrillator (ICD)-related procedures and to determine the patient and procedural characteristics associated with adverse events. Consecutive ICD-related procedures using PDNAPS from May 2006 to July 2009 at a tertiary-care hospital were evaluated. Serious adverse events were defined as procedural death, unexpected transfer to an intensive care unit, respiratory failure requiring intubation/bag-mask ventilation, or hypotension requiring vasoconstrictor/inotrope support. Nonserious adverse events were defined as hypotension requiring fluid resuscitation or hypoxemia requiring augmented respiratory support with non-rebreather mask, oral airway, or jaw lift. Of 582 patients (age 64 ± 14 years, 72.3% males) undergoing ICD-related procedures using PDNAPS, 58 (10.0%) patients had serious adverse events with no procedural death and 225 (38.7%) had nonserious adverse events. Longer procedure duration (relative risk [RR] = 2.1 per hour; 95% confidence interval [CI] = 1.6-2.8; P < .001) and biventricular implant (RR = 2.7; CI = 1.4-5.3; P = .003) were independent predictors of serious adverse events. A longer procedure duration (RR = 1.4 per hour; CI = 1.1-1.7; P = .001), heart failure class (RR = 1.4 per 1 class; CI = 1.1-1.7; P = .002), and use of propofol infusion (RR = 3.5; CI = 2.2-5.7; P < .001) were independent predictors of nonserious adverse events. PDNAPS for shorter ICD procedures including single- and dual-chamber implants, generator changes, and defibrillation threshold testing have acceptable rates of serious adverse events and manageable nonserious adverse events and should be considered for further study. Biventricular implants and other complex procedures should be done with an anesthesiologist.

Emergency Physician–Administered Propofol Sedation: A Report on 25,433 Sedations From the Pediatric Sedation Research Consortium

We describe the adverse events observed in a large sample of children sedated with propofol by emergency physicians and identify patient and procedure characteristics predictive of more serious adverse events. We identified sedations performed by emergency physicians using propofol as the primary sedative, included in the Pediatric Sedation Research Consortium database from July 2004 to September 2008. We describe the characteristics of the patients, procedures, location, adjunctive medications, and adverse events. We use a multivariable logistic regression model to identify predictors of more serious adverse events. Of 25,433 propofol sedations performed by emergency physicians, most (76%) were performed in a radiology department. More serious adverse events occurred in 581 sedations (2.28%; 95% confidence interval 2.1% to 2.5%). There were 2 instances of aspiration, 1 unplanned intubation, and 1 cardiac arrest. Significant predictors of serious adverse events were weight less than or equal to 5 kg, American Society of Anesthesiologists classification greater than 2, adjunctive medications (benzodiazepines, ketamine, opioids, or anticholinergics), nonpainful procedures, and primary diagnoses of upper respiratory illness or prematurity. We observed a low adverse event prevalence in this largest series of propofol sedations by emergency physicians. Factors indicating greater risk of more serious adverse events are detailed.

74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis

IntroductionThe objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting.MethodsThis was a prospective, multi-center, open-label, 74-week observational study in patients with active RA despite treatment with methotrexate and at least one other disease-modifying anti-rheumatic drug. Patients were treated with 3 mg/kg infliximab at weeks 0, 2, and 6 and then every 8 weeks. At weeks 0, 6, 26, 50, and 74, patients answered a health assessment questionnaire, a swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered.ResultsFive hundred and seventy-five patients were treated with infliximab, of which 346 were still on infliximab at the study end, 158 discontinued treatment, and 71 were lost to follow-up. Reasons for discontinuation included safety (n = 74), elective reasons (n = 43), and inefficacy (n = 41). Infusion reactions (n = 33) and infections (n = 20) were the most common AEs causing discontinuation and the most common AEs overall. There were four cases of tuberculosis, all of which occurred in patients negative at screening. Total AEs, serious AEs, and infusion reactions as well as discontinuations for AEs were most frequent during the first 26 weeks. Higher age was a predictor of serious adverse events (SAEs), infection, and discontinuation due to an SAE, but odds ratios were close to one.ConclusionsAEs and discontinuations due to AEs occur most frequently during the first half year of infliximab treatment in refractory RA patients. The main reasons for discontinuing treatment are infections and infusion reactions. Tuberculosis and other infections remain an important concern in these patients.

Predictors of serious complications due to Clostridium difficile infection

Identifying individuals with severe Clostridium difficile infection (CDI) at risk for major complications has become an important objective. Presence of clinical variables that predict complications from CDI would have the potential to strongly influence management. To determine which clinical variables predict complications from CDI. Cross-sectional study of all individuals admitted to Temple University Hospital between 12/1/03 and 7/1/08 with the primary discharge diagnosis of CDI were eligible. Only patients experiencing their first episode of CDI were included. Abstracted data included demographic, physiological, laboratory, radiological, endoscopic, pharmacy and outcome data. Response was categorized as none, partial or complete. Complications attributed to CDI were defined as colon resection or death. Overall 32 of 200 patients (16%) experienced a complication due to CDI including death (n = 20) and colectomy (n = 12). White blood cell count above 30,000 cells/mm(3) (OR = 4.06; 95% CI, 1.28-12.87) and a rise in the creatinine to over 50% above baseline (OR = 7.13; 95% CI, 3.05-16.68) predicted a complication. AROC for percent rise in serum creatinine was 0.73 (95% CI: 0.64-0.85) and 0.62 (95% CI: 0.58-0.80) for white blood cell count. Severe white blood cell count elevation and a rise in the creatinine to over 50% above baseline are important independent predictors of serious adverse events due to CDI. These patients likely would benefit from more intensive care and early surgical consultation.

Predictors of morbidity and mortality with endovascular and open thoracic aneurysm repair

Open and endovascular thoracic aneurysm repairs are associated with significant complications including paraplegia, stroke, vascular insufficiency, and death. Predictors of adverse outcomes are not well-defined in this patient population. The database of the GORE TAG (W.L. Gore, Flagstaff, Ariz) Pivotal Trial comparing the TAG endograft to open repair was interrogated. Univariate (UVA) and multivariate analyses (MVA) of demographic, clinical, anatomic, and procedural variables were conducted to discover possible predictors of serious adverse events for the whole group and for the TAG and open cohort groups separately. Early adverse outcomes occurred within 30 days or the initial hospitalization. P value of < or = .05 was significant. A total of 140 TAG and 94 open descending thoracic aneurysm (DTA) patients were analyzed, consisting of 128 men and 106 women. Perioperative deaths were 9/94 for open surgery and 3/140 for TAG patients, with 10/12 (7 open, 3 TAG) deaths occurring in men. Two female deaths were both after open surgery. Multivariate analysis showed predictors of death for all patients were symptomatic aneurysms and male gender. Analysis of a combined morbidity/mortality endpoint (stroke/paralysis/MI/death) showed elevated creatinine predicted these events for the whole group. Open surgery (P < .001) and increasing aneurysm diameter (P < .001) predicted an increased likelihood of any major adverse event. Open surgery was significantly associated with an increased risk of paraplegia (P = .002). Vascular complications were more frequent in the TAG (19%) than in open DTA patients (9%) (P = .038). Female gender (P = .01) predicted vascular complications within the endovascular group. For all analyses, long procedure times were correlated with adverse events. Women were noted to have longer procedure times for both TAG and open repairs. Elevated creatinine levels and symptomatic aneurysms predict morbidity and mortality, respectively, regardless of repair type. Male gender predicted death after open surgery, and since most deaths (9 of 12) were in this group, male gender predicted death overall, despite women's more difficult endovascular TAA repairs as evidenced by longer procedure times and higher vascular complication rates. All major adverse events and paraplegia were more common for open surgery patients.

Baseline Predictors of Serious Adverse Events at One Year Among Patients With Bipolar Disorder in STEP-BD

Little is known about serious adverse events that occur in the context of clinical care for bipolar disorder. This study examined predictors of serious adverse events in a large cohort of patients with bipolar disorder. Types and frequency of serious adverse events were tabulated on the basis of data from the first 1,000 participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). STEP-BD follows a large cohort of patients longitudinally. Treatments are provided as deemed most appropriate by the treating psychiatrist. Logistic regression was used to identify variables present at study entry that were associated with the occurrence of a serious adverse event within one year. A total of 161 serious adverse events were reported among 118 participants. The most frequent serious adverse event was hospitalization for suicidal ideation (44 participants, or 27 percent). A greater number of previous psychiatric medications was predictive of the occurrence of a psychiatric serious adverse event among participants who had less than one year of study follow-up data. A history of psychosis, current substance abuse, lower household income, and a fully syndromic baseline mood state were associated with the occurrence of a psychiatric serious adverse event among participants who had one full year of follow-up data. These data identify clinical and demographic factors that warrant closer clinical follow-up, because these factors may be predictive of poor outcomes in the following year, even in the context of expert care.

Catheterization of the radial or brachial artery in neonates and infants

In neonates and small children, percutaneous insertion of arterial catheters may be very difficult because of the small diameter of the arteries. Multiple attempts at cannulation are common and may be a predictor of serious adverse events following arterial cannulation. As an end artery, the brachial artery is usually not recommended for cannulation. However, limited data exist about brachial artery catheterization in neonates and young children. In this retrospective study, we report our experience with arterial indwelling catheters placed in neonates and small children prior to surgery for congenital heart defects. We reviewed 1473 patient medical files containing information about 1574 arterial lines for perioperative and intensive care monitoring. Patient data (age and weight), cannulation characteristics (site, type, percutaneous or cut down insertion), duration of catheterization and complications were documented using the anesthesia and/or intensive care unit files. Patients were divided into three groups according to body weight. Group I: patients with a bodyweight up to 5 kg (n = 561), group II: bodyweight 5-10 kg (n = 615), and group III: bodyweight 10-20 kg (n = 297). The vast majority of our patients had radial or brachial artery catheterization. In group 1, we placed 200 brachial artery lines. Radial artery insertion was more successful with increasing body weight. Two 'cut downs' were necessary to place the arterial cannula (0.3%). The mean duration of the arterial cannula in place was 5.8 + 4.3 days in group I, which was significantly longer than in group III (2.9 + 2.2 days). Multiple attempts at catheter insertion were required for 200 patients in group I (P < 0.05 compared with groups II and III). The number of guide wires used was similar in all study groups. Generally, we preferred 24 and 22 G catheters for cannulation. Serious complications such as permanent ischemic damage were not observed. Temporary occlusion of an artery occurred in five of 1473 patients. The rate of local infection was 0.5% in group I, 0.7% in group II and 2.3% in group III. Local hematoma were observed more frequently, but with no relevant consequences. Most of our patients were cannulated on the right side. In group I, 112 brachial artery catheters were placed. The greater the weight, the more radial catheters were used compared with a brachial approach. The mean functional time of the catheters (5.8 +/- 4.3 days in group I) was significant shorter compared with patients from group III (2.9 +/- 2.2 days). In 33.3% (n = 200) multiple punctures were needed to place a catheter in group I (P < 0.05 compared with the other groups) whereas the use of a guide wire was evenly distributed throughout the study groups. Small catheters (24 and 22 G) were preferred for most patients. In total only eight 20 G sized catheters were used in the children of group III. Even considering the nature of a retrospective study design, we conclude that the brachial artery could be considered for cannulation in neonates and small children.