Evidence Of Clinical Deterioration Research Articles

Abstract 329: Unrecognized Clinical Deterioration Prior to In-Hospital Cardiac Arrest and Associated In-Hospital Mortality

Introduction: Physiologic abnormalities often precede in-hospital cardiac arrest (IHCA). Critical Care Outreach Teams (CCOTs) are designed to respond to patients that meet standardized rapid response team (RRT) activation criteria including vital sign abnormalities, neurologic changes, and nursing concern. However, these systems often rely on clinical staff recognizing signs of clinical deterioration and initiating a rapid response. Research Question: The purpose of this post-hoc analysis was to identify if there was an in-hospital mortality difference between two different adult patient groups: 1) patients who met standardized RRT criteria but did not receive an RRT prior to IHCA and 2) patients who had no evidence of clinical deterioration prior to IHCA. Goals: The primary goal was to explore the association of unrecognized clinical deterioration on patient mortality. A secondary goal was to identify the timing onset of RRT criteria in patients who had an IHCA but did not receive an RRT activation. Methods: All non-ICU IHCAs during a 5-year period (January 1st, 2018, to December 31st, 2022) were reviewed to identify whether: 1) standardized RRT criteria had been met in the 24 hours prior to IHCA, 2) the onset of RRT criteria if present, 3) sustained return of spontaneous circulation (ROSC) occurred during the IHCA, and 4) if the patient died during their hospitalization. Results: There were 271 adult non-ICU IHCAs without a preceding RRT activation. Of those, 203 (79.4%) met RRT criteria prior to IHCA. In patients who had evidence of clinical deterioration, patients displayed at least one RRT criterion an average of 13.1 hours prior to IHCA. Sustained ROSC was higher in the patient group without RRT criteria (79.4%, 54/68 vs 72.9%, 148/203), but this was not significant. In-hospital mortality was significantly higher patients who met RRT criteria without RRT activation compared to patients who did not meet RRT criteria prior to IHCA (67.9%, 65/138 vs 54.4%, 31/37, p<0.05). Conclusions: Most patients who experienced an IHCA demonstrated physiologic abnormalities hours prior to IHCA. Patients who met RRT criteria without RRT activation had a significantly higher mortality rate when compared with patients who did not have evidence of clinical deterioration.

Safe and time-saving treatment method for acute cerebellar infarction: Navigation-guided burr-hole aspiration - 6-years single center experience.

While patients with medically intractable acute cerebellar infarction typically undergo suboccipital craniectomy and removal of the infarcted tissue, this procedure is associated with long operating times and postoperative complications. This study aimed to investigate the effectiveness of minimally invasive navigationguided burr hole aspiration surgery for the treatment of acute cerebellar infarction. Between January 2015 and December 2021, 14 patients with acute cerebellar infarction, who underwent navigation-guided burr hole aspiration surgery, were enrolled in this study. The preoperative mean Glasgow Coma Scale (GCS) score was 12.7, and the postoperative mean GCS score was 14.3. The mean infarction volume was 34.3 cc at admission and 23.5 cc immediately following surgery. Seven days after surgery, the mean infarction volume was 15.6 cc. There were no surgery-related complications during the 6-month follow-up period and no evidence of clinical deterioration. The mean operation time from skin incision to catheter insertion was 28 min, with approximately an additional 13 min for extra-ventricular drainage. The mean Glasgow Outcome Scale score after 6 months was 4.8. Navigation-guided burr hole aspiration surgery is less time-consuming and invasive than conventional craniectomy, and is a safe and effective treatment option for acute cerebellar infarction in selected cases, with no surgery-related complication.

One-year outcome of combination therapy with intravitreal anti-vascular endothelial growth factor and photodynamic therapy in patients with pachychoroid neovasculopathy.

To identify the functional outcome and evaluate the morphologic changes of patients with pachychoroid neovasculopathy (PNV) undergoing intravitreal anti-vascular endothelial growth factor (VEGF) combined with photodynamic therapy (PDT) at the 1-year follow-up. We retrospectively studied all the treatment-naïve PNV patients who were scheduled to undergo combination therapy between September 2017 and November 2018. All the patients received three consecutive monthly injections of 0.5mg/0.05mL ranibizumab as loading doses. Full-dose PDT was performed within 1week of the first injection. Retreatment was allowed if evidence of clinical deterioration or the presence of fluid on spectral-domain optical coherence tomography examination performed at the 1-month follow-up was noted. The best-corrected visual acuity (BCVA) was compared before treatment and at 3, 6, and 12months after the initial treatment. Changes in the central foveal thickness (CFT), central choroidal thickness (CCT), and retreatment rate during the maintenance phase were also evaluated. Eleven eyes were enrolled in this study. Significantly, better BCVA was observed at 12months than at baseline (P = 0.010). The mean CFT significantly decreased from 331 ± 93 to 237 ± 72μm at 12months (P < 0.001). The mean CCT also significantly decreased from 361 ± 74 to 310 ± 83μm at 12months (P < 0.001). The mean number of injections per eye was 3.9 ± 1.3 during the follow-up period. A total of 45.5% (5 /11) of the patients required retreatment during the maintenance phase. Anti-VEGF combined with full-dose PDT was well tolerated and appeared to be effective treatment for patients with treatment-naïve PNV. Combination therapy might also reduce the treatment burden with fewer injections in patients with PNV.

Tolerability and Safety of High-Flow Nasal Therapy in Patients Hospitalized with an Exacerbation of COPD.

The effect of high-flow nasal therapy (HFNT) in individuals with an exacerbation of chronic obstructive pulmonary disease (COPD) and hypercapnia is not well studied. We assessed patient tolerance and impact of air-gas therapy delivered by humidified HFNT (20-35 L/min) on gas exchange in hypercapnic COPD patients during hospitalization for COPD exacerbation. We hypothesized that HFNT use would be safe and well tolerated in individuals hospitalized for COPD exacerbation regardless of the degree of hypercapnia. Patients hospitalized for a COPD exacerbation were included if they were hypercapnic (arterial partial pressure of carbon dioxide [PaCO2] > 45 mmHg), ≥ 10 pack-year history, and agreed to treatment with HFNT, along with daily arterial blood gas (ABG) samples and bedside spirometry. They were placed on a HFNT system following admission for at least 3 days with an air-gas blend to maintain a flow rate between 20-35 L/min and fraction of inspired oxygen (FiO2) titrated to keep oxygen saturation (SaO2) values > 90%. Patient tolerance of HFNT and evidence of clinical deterioration as defined by worsening hypoxia or hypercapnia was the primary endpoint. Ten consecutive patients participated in the study. The patients had frequent prior exacerbations, were hypercapnic, dyspneic, and gas trapped. Participants received an air-gas flow rate (median [interquartile range (IQR)] 25 (IQR 20-30) L/min and FiO2 of 30 (IQR 30-30) %. There was no increase in PaCO2- levels (p = 0.26) or dyspnea (Borg scale, p= 0.52) while using HFNT. No patient discontinued HFNT, had further decompensation, required non-invasive ventilation or intubation during the study period. In a pilot study, patients experiencing a severe COPD exacerbation were able to tolerate continuous HFNT safely regardless of degree of hypercapnia.

Predictors of recurrence and postoperative outcomes in patients with non-skull base meningiomas based on modern neurosurgical standards

Abstract Background Advances in neurosurgical techniques and neuroimaging resolution questions the modern-day reliability of the Simpson grade for predicting meningioma recurrence. Therefore, we evaluated the reliability of predictors for recurrence and outcomes in detail in patients with non-skull base meningiomas (NSBMs). Methods We retrospectively analyzed data from consecutive 175 NSBMs underwent surgical resection. We performed Kaplan–Meier analyses of recurrence-free survival (RFS) according to Simpson and World Health Organization (WHO) grades. Predictors of RFS and clinical deterioration were estimated by univariate and multivariate analyses. Correlation between the Simpson grade and change in Karnofsky Performance Scale scores was assessed by Fisher's exact test. Results Log-rank tests revealed significant correlations of both the Simpson and WHO grades with RFS for the overall cohort, convexity, and falx/tentorium meningioma. Unlike patients undergoing Simpson grade I and II resections, RFS in patients with WHO grade I and II/III tumors differed significantly from the early postoperative stage. Multivariate analysis identified tumor size, Simpson grade, and MIB-1 labeling index as significant predictors of RFS. Clinical deterioration was more frequent among patients undergoing less aggressive resection. Tumor location was the only significant predictor of clinical deterioration. Conclusions Our findings indicate that tumor size, Simpson and WHO grades, and MIB-1 labeling index are significant predictors of NSBM recurrence. Moreover, the risk of recurrence markedly decreases within the follow-up duration of 80 months. Aggressive resection appears to minimize the risk of recurrence without evidence of clinical deterioration. Follow-up schedules should be based on the WHO grade and extent of resection.

Predictors of safe discharge for pediatric drowning patients in the emergency department

ObjectivesThe purpose of this study is to determine if stable, well-appearing, drowning patients who have normal age-adjusted vital signs and pulse oximetry upon arrival to the emergency department may be safely discharged without a prolonged observation period. MethodsMedical records were retrospectively reviewed for drowning patients presenting to a single pediatric emergency department from 1995 to 2014. Data were collected on vital signs and pulse oximetry at presentation, chest x-ray results, disposition and complications for each encounter. Patients were identified as having either normal or abnormal initial vital signs and pulse oximetry, and were compared based on disposition and complication rates. ResultsTwo hundred seventy-six records were initially evaluated and 91 were excluded. Thirty-six percent had normal age-adjusted vital signs upon arrival. Patients with abnormal temperature, respiratory rate or pulse oximetry, as well as those with any abnormal initial cardiopulmonary physical exam findings, abnormal mental status, or chest radiograph findings, were more likely to be admitted to the hospital. Eight patients developed respiratory complications after presentation to the emergency department. Those with abnormal pulse oximetry readings on arrival were more likely to develop complications. Only two patients who developed complications had initially normal vital signs and each had evidence of clinical deterioration within 1h of arrival. ConclusionsThe overall complication rate in initially stable, well-appearing drowning patients is low. An abnormal pulse oximetry reading at presentation may help predict subsequent complications. Those patients with normal age-adjusted vital signs and physical exam at presentation may not require a prolonged observation period.

Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia.

Background.Induced sputum (IS) may provide diagnostic information about the etiology of pneumonia. The safety of this procedure across a heterogeneous population with severe pneumonia in low- and middle-income countries has not been described.Methods.IS specimens were obtained as part a 7-country study of the etiology of severe and very severe pneumonia in hospitalized children <5 years of age. Rigorous clinical monitoring was done before, during, and after the procedure to record oxygen requirement, oxygen saturation, respiratory rate, consciousness level, and other evidence of clinical deterioration. Criteria for IS contraindications were predefined and serious adverse events (SAEs) were reported to ethics committees and a central safety monitor.Results.A total of 4653 IS procedures were done among 3802 children. Thirteen SAEs were reported in relation to collection of IS, or 0.34% of children with at least 1 IS specimen collected (95% confidence interval, 0.15%–0.53%). A drop in oxygen saturation that required supplemental oxygen was the most common SAE. One child died after feeding was reinitiated 2 hours after undergoing sputum induction; this death was categorized as “possibly related” to the procedure.Conclusions.The overall frequency of SAEs was very low, and the nature of most SAEs was manageable, demonstrating a low-risk safety profile for IS collection even among severely ill children in low-income-country settings. Healthcare providers should monitor oxygen saturation and requirements during and after IS collection, and assess patients prior to reinitiating feeding after the IS procedure, to ensure patient safety.

Pharmacokinetic and Pharmacodynamic Equivalence of Epoetin Hospira and Epogen After Single Subcutaneous Doses to Healthy Male Subjects

PurposeThe purpose of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of single 100 U/kg subcutaneous doses of Epoetin Hospira and Epogen in healthy male subjects as part of an overall program to demonstrate biosimilarity of Epoetin Hospira to the reference product Epogen. MethodsThis single-center, open-label, randomized, 2-period, crossover study was conducted in 81 healthy male subjects. Subjects were randomized to Sequence 1, in which they received 100 U/kg of Epoetin Hospira or to sequence 2, in which they received 100 U/kg Epogen subcutaneously in the first study period and the alternative treatment in the second study period. Blood was collected for determination of baseline-adjusted epoetin concentrations (BAECs) for pharmacokinetics and for determination of reticulocyte percentage of total erythrocytes for pharmacodynamics throughout both study periods. The primary PK end points were the geometric mean ratios (GMRs) of the 2 treatments for AUC0–t and Cmax based on the BAEC, and the primary PD end points were the GMRs of the 2 treatments for AUC0–t and Cmax for reticulocyte percentage. FindingsThe GMRs of Epoetin Hospira to Epogen for the BAEC-derived PK parameters were 1.05 for AUC0–t with a 90% CI of 1.01 to 1.11, and 1.09 for Cmax with a 90% CI of 1.01 to 1.18, with both 90% CIs contained within the prespecified equivalence margin of 0.80 to 1.25. The GMRs (Epoetin Hospira/Epogen) for the reticulocyte percentage–derived PD parameters were 1.01 for AUC0–t with a 95% CI of 0.98 to 1.05, and 1.02 for Cmax with a 95% CI of 0.98 to 1.06, with both 95% CIs contained within the prespecified equivalence margin of 0.80 to 1.25. Overall, the adverse events were of similar frequency (11.7% and 13.9% for Epoetin Hospira and Epogen, respectively) and severity between treatments. One subject had a positive anti– recombinant human erythropoietin antibody result by radioimmunoprecipitation assay before dosing and throughout the conduct of the study with negative neutralizing antibodies and with no evidence of clinical deterioration or impact on the pharmacokinetics, pharmacodynamics, or safety. ImplicationsThe results of this study established the PK and PD equivalence of single 100 U/kg subcutaneous doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen in healthy male subjects and support the overall demonstration of biosimilarity of Epoetin Hospira and Epogen.

Comparison of Time to Retreatment and Visual Function Between Ranibizumab and Aflibercept in Age-Related Macular Degeneration

To compare time to retreatment and visual function between patients with treatment-naïve neovascular age-related macular degeneration (AMD) treated with either intravitreal ranibizumab (IVR) or intravitreal aflibercept (IVA) in routine clinical practice. Retrospective, interventional comparative case series. A total of 200 eyes of 197 patients with neovascular AMD. A total of 99 patients in the IVR group and 101 patients in the IVA group who met the inclusion criteria with 12months of follow-up were included in the present study. All patients received 3 consecutive monthly injections of 0.5mg/0.05mL ranibizumab or 2.0mg/0.05mL aflibercept as loading doses. Retreatment was allowed if evidence of clinical deterioration or the presence of intraretinal edema or subretinal fluid on spectral-domain optical coherence tomography examination performed at the 1-month follow-up was noted. The time to retreatment after the third injection during the loading phase to the first recurrence during the maintenance phase was compared between treatments using the Kaplan-Meier analysis. Functional and anatomic outcomes were also compared between the IVR and IVA groups. The median time to retreatment after the last induction dose was 5months in both groups. The proportion of IVR patients who required injection retreatment was not significantly higher than that of IVA patients (67.7% and 63.4%, respectively, at the 12-month follow up; log-rank test, P= .554). In both groups, significant improvements in postoperative best-corrected visual acuity (BCVA) compared with preoperative visual acuity was observed over the 12-month follow-up period (P< .05 for both). Central foveal thickness (CFT) decreased from the baseline values in both groups during the follow-up period (P < .001 for both). Although there was a trend toward greater BCVA improvements in the IVA group, no significant differences in BCVA or CFT were observed between the treatment groups. Both IVR and IVA were well tolerated and demonstrated efficacy in improving the visual acuityin treatment-naïve patients with AMD. Despite a trend toward greater BCVA improvements in the IVAgroup, a similar injection burden was observed following the loading phases of both ranibizumab andaflibercept.

Pharmacodynamic and Pharmacokinetic Equivalences of Epoetin Hospira and Epogen® After Multiple Subcutaneous Doses to Healthy Male Subjects

PurposeThe purpose of this study was to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) equivalences of multiple doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen⁎⁎Epogen® (epoetin alfa; Amgen, Thousand Oaks, California)., when each is administered three times per week over 28 days to healthy male subjects MethodsThis single center, open-label, randomized, parallel group study was conducted in 129 healthy male subjects. Subjects were randomized to receive 100 U/kg Epoetin Hospira or 100 U/kg Epogen, each administered subcutaneously 3 times per week over 28 days. Blood was collected for determination of hemoglobin (Hb) concentrations for PD properties and for determination of epoetin concentrations for PK properties. The primary PD end point was the geometric mean ratio (GMR) of the 2 treatments for area under the effect curve for Hb from day 1 through 48 hours after the final dose of study drug administration on day 26, and the primary PK end point was the GMR of the 2 treatments for AUC0–48 and Cmax for epoetin after the final dose of study drug on day 26. FindingsThe GMR (Epoetin Hospira/Epogen) for the area under the effect curve for Hb from day 1 through 48 hours after the final dose of study drug administration on day 26 was 1.006 with a 95% CI of 0.996 to 1.016, which was contained within the prespecified equivalence margin of 0.965 to 1.035. The GMRs (Epoetin Hospira/Epogen) for the epoetin-derived PK parameters were 0.974 for AUC0–48 with a 90% CI of 0.896 to 1.059, and 0.938 for Cmax with a 90% CI of 0.839 to 1.049, with both 90% CIs contained within the prespecified equivalence margin of 0.80 to 1.25. The incidence (21.2% and 23.8% for Epoetin Hospira and Epogen, respectively) and severity of adverse events were similar between the 2 groups. One subject in each treatment group had a positive recombinant human erythropoietin antibody result by radioimmunoprecipitation assay before dosing and throughout study conduct with negative immunoglobulin M and neutralizing antibodies and with no evidence of clinical deterioration or of impact on PD, PK, or safety profile. ImplicationsThe results of this study established PD and PK equivalences of multiple subcutaneous doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen in healthy male subjects, and supported the overall demonstration of biosimilarity of Epoetin Hospira and Epogen.

Elevation of troponin I in acute ischemic stroke.

Background. Cardiac morbidities account for 20% of deaths after ischemic stroke and is the second commonest cause of death in acute stroke population. Elevation of cardiac troponin has been regarded as a prognostic biomarker of poor outcome in patients with acute stroke.Methods. This retrospective study enrolled 871 patients with acute ischemic stroke from August 2010 to March 2015. Data included vital signs, laboratory parameters collected in the emergency department, and clinical features during hospitalization. National Institutes of Health Stroke Scale (NIHSS), Barthel index, and modified Rankin Scale (mRS) were used to assess stroke severity and outcome.Results. Elevated troponin I (TnI) > 0.01 µg/L was observed in 146 (16.8%) patients. Comparing to patients with normal TnI, patients with elevated TnI were older (median age 77.6 years vs. 73.8 years), had higher median heart rates (80 bpm vs. 78 bpm), higher median white blood cells (8.40 vs. 7.50 1,000/m3) and creatinine levels (1.40 mg/dL vs. 1.10 mg/dL), lower median hemoglobin (13.0 g/dL vs. 13.7 g/dL) and hematocrit (39% vs. 40%) levels, higher median NIHSS scores on admission (11 vs. 4) and at discharge (8 vs. 3), higher median mRS scores (4 vs3) but lower Barthel index scores (20 vs. 75) at discharge (p < 0.001). Multivariate analysis revealed that age ≥ 76 years (OR 2.25, CI [1.59–3.18]), heart rate ≥ 82 bpm (OR 1.47, CI [1.05–2.05]), evidence of clinical deterioration (OR 9.45, CI [4.27–20.94]), NIHSS score ≥ 12 on admission (OR 19.52, CI [9.59–39.73]), and abnormal TnI (OR 1.98, CI [1.18–3.33]) were associated with poor outcome. Significant factors for in-hospital mortality included male gender (OR 3.69, CI [1.45–9.44]), evidence of clinical deterioration (OR 10.78, CI [4.59–25.33]), NIHSS score ≥ 12 on admission (OR 8.08, CI [3.04–21.48]), and elevated TnI level (OR 5.59, CI [2.36–13.27]). C-statistics revealed that abnormal TnI improved the predictive power of both poor outcome and in-hospital mortality. Addition of TnI > 0.01 ug/L or TnI > 0.1 ug/L to the model-fitting significantly improved c-statistics for in-hospital mortality from 0.887 to 0.926 (p = 0.019) and 0.927 (p = 0.028), respectively.Discussion. Elevation of TnI during acute stroke is a strong independent predictor for both poor outcome and in-hospital mortality. Careful investigation of possible concomitant cardiac disorders is warranted for patients with abnormal troponin levels.

Long-term results of intravitreal ranibizumab for the treatment of retinal angiomatous proliferation and utility of an advanced RPE analysis performed using spectral-domain optical coherence tomography

PurposeTo report the results of 3-year follow-up examinations after intravitreal ranibizumab (IVR) injection for the treatment of retinal angiomatous proliferation (RAP) and to examine the utility of an advanced retinal...

Routine repeat brain computed tomography in all children with mild traumatic brain injury may result in unnecessary radiation exposure

Computed tomography (CT) for pediatric traumatic brain injury (TBI) is common. Evidence suggests that 1 in 1,200 children undergoing CT will die of malignancy from radiation exposure. Presently, there is no protocol for surveying children with mild TBI; repeat CT (rCT) is often performed. We hypothesized that rCT could be avoided. Outcomes of similar patients who underwent rCT were compared with those of patients followed by clinical examination alone. An 8-year retrospective review was performed of patients admitted to a Level I pediatric trauma center with TBI, CT evidence of TBI, and Glasgow Coma Scale (GCS) score of 14 to 15. There were two groups, those who underwent rCT (rCT+) and those who did not (rCT-). Data included age, Injury Severity Score (ISS), mechanism of injury, type of TBI, and outcome. Patients with coagulopathies, ventriculoperitoneal shunts, developmental disabilities, nonaccidental trauma, concomitant injuries, or medical problems resulting in intubation or sedation not attributed to TBI were excluded. Of 391 patients admitted with TBI, 120 were included in the study. A total of 106 patients were rCT+, and 14 were rCT-. rCT+ children were older (mean, 98.7 ± 7.3 vs. 35.3 ± 11.5 months; p = 0.0025) and more likely to have epidural hematoma (EDH) (100% rCT with EDH vs. 76% rCT all other TBI, p = 0.044). Mechanism of injury and mean ISS (15.2 ± 0.6 vs. 13.0 ± 1.1, p = 0.195) were not different between the groups. There were no worsening neurologic symptoms or need for surgery in rCT- children. rCT identified seven patients (6.6%) with CT progression of their injury. Five had an EDH, and two had a subarachnoid hemorrhage. Two children with EDH underwent operation. Our study indicates that routine rCT without evidence of clinical deterioration is not indicated in children with admission GCS score of 14 to 15 and TBI on CT scan. Children with EDH seem to have a higher potential for progression, and rCT seems to be indicated in this subgroup. Therapeutic study, level IV.

VARIABLE RESPONSE OF VASCULARIZED PIGMENT EPITHELIAL DETACHMENTS TO RANIBIZUMAB BASED ON LESION SUBTYPES, INCLUDING POLYPOIDAL CHOROIDAL VASCULOPATHY

The purpose of this study was to evaluate the prognosis and response to intravitreal ranibizumab (IVR) of neovascular age-related macular degeneration, according to the type of pigment epithelial detachment (PED). The authors prospectively studied 57 eyes of 57 consecutive patients with PED associated with exudative age-related macular degeneration, who were treated by IVR. All patients received 3 consecutive monthly injections of 0.5 mg/0.05 mL of ranibizumab as induction treatment. Retreatment was allowed if evidence of clinical deterioration was noted or spectral domain optical coherence tomography at the 1-month follow-up showed intraretinal edema, subretinal fluid, or recurrent PED. The best-corrected visual acuity (BCVA) values measured before and at 3, 6, and 12 months after the first injection were compared according to the type of PED. Changes in the height of PED to treatment with IVR were also investigated. Fifty-six eyes were assessed at the 12-month follow-up examination. There were 4 types of PED, including serous PED in 11 patients (19.6%), fibrovascular PED in 28 patients (50.0%), mixed PED with serous and fibrovascular component in 7 patients (12.5%), and hemorrhagic PED in 10 patients (17.9%). Eyes with serous PED showed significant improvement of the mean logarithm of the minimum angle of resolution (logMAR) BCVA as compared with the value at the baseline, which was sustained throughout the 12-month period (P < 0.05). Regarding the eyes with fibrovascular and mixed PED, significant improvement of the mean logMAR BCVA was observed compared with the value at the baseline at 3 months; however, a slight decrease was observed at 6 and 12 months. In the eyes with hemorrhagic PED, no significant difference in the mean BCVA values compared with the value at the baseline was observed at any follow-up time point. In relation to the height of the PED, all eyes in the serous and mixed PED group, 17 eyes in the fibrovascular PED group (60.7%), and 9 eyes in the hemorrhagic PED group (90.0%) showed reduction of the maximum PED height by 100 μm or more. The PED response to IVR was not correlated with the final BCVA. Intravitreal ranibizumab for the treatment of exudative age-related macular degeneration is effective for stabilizing vision in patients with PED, but it may be better tolerated in patients with serous PED. Although it may be important to consider the type of PED to predict the visual acuity in patients treated by IVR, the anatomical response of the PED may not correlate directly with the visual outcome.

Evaluation and management of small-bowel obstruction

Small-bowel obstruction (SBO) represents as many as 16% of surgical admissions and more than 300,000 operations annually in the United States. The optimal strategies for the diagnosis and management of SBO continue to evolve secondary to advances in imaging techniques, critical care, and surgical techniques. This updated systematic literature review was developed by the Eastern Association for the Surgery of Trauma to provide up-to-date evidence-based recommendations for SBO. A search of the National Library of Medicine MEDLINE database was performed using PubMed interface for articles published from 2007 to 2011. The search identified 53 new articles that were then combined with the 131 studies previously reviewed by the 2007 guidelines. The updated guidelines were then presented at the 2012 annual EAST meeting. Level I evidence now exists to recommend the use of computed tomographic scan, especially multidetector computed tomography with multiplanar reconstructions, in the evaluation of patients with SBO because it can provide incremental clinically relevant information over plains films that may lead to changes in management. Patients with evidence of generalized peritonitis, other evidence of clinical deterioration, such as fever, leukocytosis, tachycardia, metabolic acidosis, and continuous pain, or patients with evidence of ischemia on imaging should undergo timely exploration. The remainder of patients can safely undergo initial nonoperative management for both partial and complete SBO. Water-soluble contrast studies should be considered in patients who do not clinically resolve after 48 to 72 hours for both diagnostic and potential therapeutic purposes. Laparoscopic treatment of SBO has been demonstrated to be a viable alternative to laparotomy in selected cases.

Phase II study of weekly paclitaxel as a second line chemotherapy for metastatic/recurrent gastric carcinoma

14059 Background: There is currently no standard treatment for gastric carcinoma patients (pts) who failed initial chemotherapy. Since performance status of these pts deteriorates rapidly, moderate and dose-fractionated single agent regimens have been preferred in Japan in the second line setting. Weekly paclitaxel, one of commonly used regimens in this setting, was explored for the first time in a formal phase II study. Methods: Pts with histologically confirmed gastric carcinoma who had unresectable or recurrent disease with ≥1 measurable lesions per RECIST were eligible. Other eligibility criteria included confirmed progressive disease (PD) per RECIST during a front line chemotherapy, PS ≤2, adequate liver, kidney, and marrow functions, no active gastrointestinal bleeding, and written informed consent. Patients received 80 mg/m2 of paclitaxel weekly for 3 successive weeks with one week of rest. The cycle was repeated until objective disease progression or drug intolerance. Results: 35 pts were enrolled: 29 men and 6 women, age 62 (48∼74), 6 unresectable and 29 recurrent cancers, 13 with poorly differentiated phenotype and 20 with differentiated type, 22 PS0, 8 PS1, and 6 PS2. All front line treatments involved oral fluoropyrimidines and had been S-1 in 29, S-1/CDDP in 5, S-1/CPT-11 in one, and UFT in one patient. One pt declined to continue the treatment due to a Grade 2 taste disturbance after a single dose of paclitaxel, and 34 other pts were evaluable for response. Partial response was observed in 6 pts (response rate 17.6%). Median time to progression was 97 days and median survival time was 214 days (467 days among 22 PS0 patients). The incidence of ≥Grade 3 adverse events were as follows: neutropenia in 7 pts, leucopenia in 5, anemia in 4, anorexia in 4, neurological disorder, nausea, diarrhea, asthenia, and dyspnea in one. Conclusions: Activity of weekly paclitaxel was modest for pts with fluoropyrimidine-refractory gastric carcinoma, but median survival time was satisfactory, with a mild toxicity profile. Further phase II study under less strict eligibility criteria (e.g. inclusion of patients with elevated tumor markers or subjective evidence of clinical deterioration during the front line therapy as the sole indication of disease progression) is underway. No significant financial relationships to disclose.

Glucose/insulin infusions in the treatment of subarachnoid haemorrhage: a feasibility study

Hyperglycaemia following subarachnoid haemorrhage (SAH) is well recognized and has been shown to be associated with a worse prognosis. It is currently unclear whether this is a secondary phenomenon reflecting the magnitude of the stress response or whether it contributes directly to the pathophysiological disturbances within the brain. There is significant experimental work on ischaemic stroke to suggest that hyperglycaemia increases infarct volume. The authors propose that controlling blood glucose following SAH is safe and that it might improve outcome. All patients admitted with SAH were treated with insulin to control plasma glucose with a target range of 5.0 – 7.0 mmol/l. Episodes of hypoglycaemia were recorded. Outcome was assessed at 3 months using the Glasgow Outcome Scale. Fifty-five patients were recruited. 32/3389 (0.94%) of glucose readings fell below 3.5 mmol/l. All were treated with i.v. glucose without evidence of clinical deterioration. Insulin treatment for hyperglycaemia following SAH is feasible and safe. A randomised trial is required to assess any effect on outcome.

Evidence for persistent enterovirus infection of the central nervous system in patients with previous paralytic poliomyelitis.

It has been suggested that late onset neurological deterioration after poliomyelitis may be due in some cases to persistent poliovirus infection of the central nervous system. In view of this, we decide to determine whether polioviruses and other enteroviruses can persist in the central nervous system. In a previous study, one of us (M.K.S.) reported serological evidence of persistent poliovirus infection of the central nervous system (CNS) in a proportion of these patients. We have now studied cerebrospinal fluid (CSF) from these patients for the presence of enterovirus RNA sequences using the polymerase chain reaction (PCR). Enteroviral RNA was detected in 3 of 24 patients with a clinical diagnosis of post-polio syndrome, but in none of 36 patients with stable poliomyelitis, and none of 36 patients with other neurological conditions of noninfective origin. All 3 patients in whom viral RNA was detected had high intrathecal levels of poliovirus-specific oligoclonal IgM bands. In a second study we examined formalin-fixed postmortem CNS tissue from 7 patients with a history of paralytic poliomyelitis. Enterovirus RNA was detected in tissue from the spinal cord from 3 patients, but not in the cerebral cortex. We are now conducting a larger prospective, blind study of patients with evidence of late deterioration. Analysis of the first 30 patients studied revealed the presence of enterovirus RNA in CSF of 1 of 4 patients with unexplained late-onset post-polio weakness, 1 of 6 with some evidence of clinical deterioration, but none of 20 without inexplicable signs of post-polio weakness. Enteroviral RNA was also detected in spinal cord from 2 of 3 patients who died from other causes during this study. These studies provide virological evidence that enteroviruses may persist in the CNS of man. Further study is required in order to understand fully the biological and clinical significance of these findings.

Moderate head injury: a guide to initial management.

The purpose of this study is to determine the initial treatment of patients who appear to have sustained moderate head injuries when first evaluated. The authors reviewed the records of 341 patients whose initial Glasgow Coma Scale (GCS) scores ranged from 9 to 12, as well as another 106 patients with GCS scores of 13. All patients underwent cranial computerized tomography (CT) at the time of admission. In 40.3% of these patients the CT scans were abnormal (30.6% had intracranial lesions), and 8.1% required neurosurgical intervention (craniotomies for hematoma in 12, elevation of depressed fractures in five, and insertion of intracranial pressure monitors in 19). Four patients died of their intracranial injuries. A similar incidence of lesions found on CT and at surgery suggests that an initial GCS score of 13 be classified with the moderate head injury group. Skull fractures were found to be poor indicators of intracranial abnormalities. These results suggest that all patients with head injury thought to be moderate on initial examination be admitted to the hospital and undergo urgent CT scanning. Patients with intracranial lesions require immediate neurosurgical consultation, surgery as needed, and admission to a critical-care unit. Scans should be repeated in patients whose recovery is less rapid than expected and in all patients with evidence of clinical deterioration; this was necessary in almost half of the patients in this group, and 32% were found to have progression of radiological abnormalities on serial CT scans.

The effect of subtotal thyroidectomy on Graves' ophthalmopathy.

AbstractNineteen unselected patients undergoing subtotal thyroidectomy (STT) for Graves' disease were submitted to thorough ophthalmologic assessment before and after (mean, 10 mo) thyroid surgery. All clinical examinations were performed by the same observer and findings were scored according to the American Thyroid Association (“NOSPECS”) classification. Orbital computed tomography (CT) scans were performed in all patients prior to surgery and again at follow‐up if the initial scan was abnormal or if there was evidence of clinical deterioration; all CT scans were viewed by the same individual. There was evidence of infiltrative ophthalmopathy at some stage in the course of observation in 17 (89%) of the 19 patients.No predictable ocular response to STT was apparent. Ophthalmic status was noted to improve in 6 patients, to remain unchanged in 7 patients, and to progressively deteriorate in 6 patients. This unpredictable pattern was seen irrespective of the severity of preexisting ocular involvement. The absence of any consistent or predictable ocular response to STT strongly suggests that thyroidectomy does not influence the natural course of Graves' ophthalmopathy. We believe that the presence of evolving or stable ophthalmopathy, even if severe, should not be regarded as a contraindication to STT in Graves' disease.