Comparison of Existing Response Criteria in Patients with Hepatocellular Carcinoma Treated with Transarterial Chemoembolization Using a 3D Quantitative Approach.

PURPOSE: To compare currently available non-three-dimensional methods (Response Evaluation Criteria in Solid Tumors [RECIST], European Association for Study of the Liver [EASL], modified RECIST [mRECIST[) with three-dimensional (3D) quantitative methods of the index tumor as early response markers in predicting patient survival after initial transcatheter arterial chemoembolization (TACE). MATERIALS AND METHODS: This was a retrospective single-institution HIPAA-compliant and institutional review board-approved study. From November 2001 to November 2008, 491 consecutive patients underwent intraarterial therapy for liver cancer with either conventional TACE or TACE with drug-eluting beads. A diagnosis of hepatocellular carcinoma (HCC) was made in 290 of these patients. The response of the index tumor on pre- and post-TACE magnetic resonance images was assessed retrospectively in 78 treatment-naïve patients with HCC (63 male; mean age, 63 years ± 11 [standard deviation]). Each response assessment method (RECIST, mRECIST, EASL, and 3D methods of volumetric RECIST [vRECIST] and quantitative EASL [qEASL]) was used to classify patients as responders or nonresponders by following standard guidelines for the uni- and bidimensional measurements and by using the formula for a sphere for the 3D measurements. The Kaplan-Meier method with the log-rank test was performed for each method to evaluate its ability to help predict survival of responders and nonresponders. Uni- and multivariate Cox proportional hazard ratio models were used to identify covariates that had significant association with survival. RESULTS: The uni- and bidimensional measurements of RECIST (hazard ratio, 0.6; 95% confidence interval [CI]: 0.3, 1.0; P = .09), mRECIST (hazard ratio, 0.6; 95% CI: 0.6, 1.0; P = .05), and EASL (hazard ratio, 1.1; 95% CI: 0.6, 2.2; P = .75) did not show a significant difference in survival between responders and nonresponders, whereas vRECIST (hazard ratio, 0.6; 95% CI: 0.3, 1.0; P = .04), qEASL (Vol) (hazard ratio, 0.5; 95% CI: 0.3, 0.9; P = .02), and qEASL (%) (hazard ratio, 0.3; 95% CI: 0.15, 0.60; P < .001) did show a significant difference between these groups. CONCLUSION: The 3D-based imaging biomarkers qEASL and vRECIST were tumor response criteria that could be used to predict patient survival early after initial TACE and enabled clear identification of nonresponders.

Clostridium difficile colitis in patients undergoing lower-extremity arthroplasty: rare infection with major impact.

BACKGROUND: The prevalence of Clostridium difficile colitis is reportedly increasing in surgical patients and can negatively impact their outcome. However, as yet there are no clear estimates of the C difficile infection colitis rate and its consequences among patients undergoing total joint arthroplasty (TJA). QUESTIONS/PURPOSES: We asked: (1) What is the rate of C difficile colitis in TJA patients? (2) What are the risk factors of C difficile colitis in these patients? And (3) what is the effect of C difficile colitis on length of stay, in-hospital mortality, and estimated total charges? METHODS: Using ICD-9-CM diagnosis and procedure codes, we queried the Nationwide Inpatient Sample database for patients undergoing TJA for the years 2002 to 2010. Demographic data, comorbidities, occurrence of C difficile colitis, length of hospital stay, mortality, and hospital charges were extracted. Logistic regression was performed to identify predictors of C difficile colitis and its impact on in-hospital mortality. RESULTS: The incidence of C difficile remained less than 0.6% during the study period. Revision TJAs (odds ratio=6.9 and 4.4 for hip and knee, respectively) and number of comorbidities (odds ratio=1.5) increased risk of C difficile colitis. C difficile increased length of hospital stay by a week, hospital charges by USD 40,000, and in-hospital mortality to 4.66% from 0.24%. CONCLUSIONS: Using lower and fewer doses of antibiotics in revision TJAs and among patients with many comorbidities may diminish risk of C difficile colitis and its consequent mortality. LEVEL OF EVIDENCE: Level II, prognostic study. See Instructions for Authors for a complete description of levels of evidence.

Has the rate of in-hospital infections after total joint arthroplasty decreased?

BACKGROUND: Although infections are a major cause of morbidity and mortality after total joint arthroplasty (TJA), little is known about nationwide epidemiology and trends of infections after TJA. QUESTIONS/PURPOSES: We therefore determined (1) trends of postoperative pneumonia, urinary tract infection (UTI), surgical site infection (SSI), sepsis, and severe sepsis after TJA; (2) risk factors of these infections; (3) effect of these infections on length of stay (LOS) and hospital charges; and (4) the infection-related mortality rate and its predictors. METHODS: The International Classification of Diseases, 9th Revision codes were used to identify patients who underwent TJA and were diagnosed with aforementioned infections during hospitalization in the Nationwide Inpatient Sample database from 2002 to 2010. Multivariate analysis was performed to identify risk factors of these infections. RESULTS: Rates of pneumonia, UTI, SSI, sepsis, and severe sepsis were 0.74%, 3.26%, 0.31%, 0.25%, and 0.15%, respectively. Number of comorbidities and type of TJA were independent predictors of infection. Mortality decreased during the study period (odds ratio, 0.87; 95% confidence interval, 0.86-0.89). The median LOS was 3 days without complications but increased in the presence of SSI (median, 7 days), sepsis (median, 12 days), and severe sepsis (median, 15 days). Occurrence of pneumonia, sepsis, and severe sepsis increased risk of mortality 5.2, 8.5, and 66.2 times, respectively. CONCLUSIONS: Rates of UTI, pneumonia, and SSI but not sepsis and severe sepsis are apparently decreasing. The likelihood of infection is increasing with number of comorbidities and revision surgeries. Rate of sepsis-related mortality is also decreasing. LEVEL OF EVIDENCE: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.

Vulnerability of the femoral nerve during complex anterior and posterior spinal surgery.

BACKGROUND: Femoral nerve palsy is not a common adverse effect of lumbar spinal surgery. OBJECTIVE: To report 3 unique cases of femoral nerve neuropathy due to instrumentation and positioning during complex anterior and posterior spinal surgery. METHODS: Case series RESULTS: All 3 patients demonstrated femoral nerve neuropathy. The first patient presented postoperatively but after 6 months, the palsy resolved. Femoral nerve malfunctioning was documented in the second and third patients intraoperatively; however, with rapid patient repositioning and removal of offending instrumentation, postoperative palsy was avoided. CONCLUSIONS: Use of motor evoked potential monitoring of the femoral nerve during surgery is vital for the prevention of future neuropathies, an avoidable complication of spinal surgery.

Obesity and spine surgery: relation to perioperative complications.

OBJECT: Many patients undergoing elective thoracic or lumbar fusion procedures are obese, but the contribution of obesity to complications in spine surgery has not been defined. The authors retrospectively assessed the prevalence of obesity in a cohort of patients undergoing thoracic and lumbar fusion and correlate the presence of obesity with the incidence of operative complications. METHODS: A retrospective review of consecutive patients treated by a single surgeon (J.K.R.) over a 36-month period at either Rush University Medical Center or the Neurological and Orthopedic Institute of Chicago was performed. The authors identified 332 elective thoracic and lumbar spine surgery cases; the cohort was restricted to include only patients with symptomatic degenerative conditions in need of an anterior, posterior, or combined anterior-posterior fusion. Cases of trauma, tumor, and infection and any case in which the procedure was performed for emergency indications were excluded. A total of 97 cases were identified; of these 86 procedures performed in 84 patients had adequate follow-up material for inclusion in the present study. A broad definition of complications was used. Complications were divided into adverse events (minor) and significant complications (major) based on their impact on patient outcome. Stepwise multivariate logistic regression was used to identify which variables had a significant effect on the risk of complications. Variables considered were body mass index (BMI), height, weight, age, sex, presence or absence of diabetes mellitus (DM) and/or hypertension, number of levels fused (single compared with multiple), and type of surgery performed. The mean BMI for the cohort was 28.8 (95% confidence interval 24.4-30.3); 60 patients (71.4%) were considered overweight or obese (BMI > or = 25). There were 42 complications in 31 patients (36.9%); this included 19 significant complications in 17 patients (20.2%). Logistic regression revealed that the probability of a significant complication was related to BMI (p < 0.04); the chance of a significant complication was 14% with a BMI of 25, 20% with a BMI of 30, and 36% with a BMI of 40. Positioning-related palsies were only found in extremely obese patients (BMI > or = 40). The probability of minor complication occurrence increased with age (p < 0.02), not BMI. The rate of complications was independent of sex as well as the presence of DM or hypertension. A standard collection of complications occurred, including wound infection (three cases), cerebrospinal fluid leakage (eight cases, one requiring reoperation), deep vein thrombosis (two cases), cardiac events (four cases), symptomatic pseudarthrosis (one case), pneumonia (three cases), prolonged intubation (two cases), urological issues (eight cases), positioning-related palsy (two cases), and neuropathic pain (two cases). CONCLUSIONS: Obesity is a prevalent condition in patients undergoing elective fusion for degenerative spinal conditions and may increase the prevalence and incidence of perioperative complications. In their analysis, the authors correlated increasing BMI and increased risk of significant postoperative complications. The correlation of obesity and perioperative complications may assist in the preoperative evaluation and selection of patients for surgery.

Neurologic improvement after thoracic, thoracolumbar, and lumbar spinal cord (conus medullaris) injuries.

STUDY DESIGN: Retrospective. OBJECTIVE: With approximately 10,000 new spinal cord injury (SCI) patients in the United States each year, predicting public health outcomes is an important public health concern. Combining all regions of the spine in SCI trials may be misleading if the lumbar and sacral regions (conus) have a neurologic improvement at different rates than the thoracic or thoracolumbar spinal cord. SUMMARY OF BACKGROUND DATA: Over a 10-year period between January 1995 to 2005, 1746 consecutive spinal injured patients were seen, evaluated, and treated through a level 1 trauma referral center. A retrospective analysis was performed on 150 patients meeting the criteria of T4 to S5 injury, excluding gunshot wounds. One-year follow-up data were available on 95 of these patients. METHODS: Contingency table analyses (chi-squared statistics) and multivariate logistic regression. Variables of interest included level of injury, initial American Spinal Injury Association (ASIA), age, race, and etiology. RESULTS: A total of 92.9% of lumbar (conus) patients neurologically improved one ASIA level or more compared with 22.4% of thoracic or thoracolumbar spinal cord-injured patients. Only 7.7% of ASIA A patients showed neurologic improvement, compared with 95.2% of ASIA D patients; ASIA B patients demonstrated a 66.7% improvement rate, whereas ASIA C had a 84.6% improvement rate. When the two effects were considered jointly in a multivariate analysis, ASIA A and thoracic/thoracolumbar patients had only a 4.1% rate of improvement, compared with 96% for lumbar (conus) and incomplete patients (ASIA B-D) and 66.7% to 72.2% for the rest of the patients. All of these relationships were significant to P < 0.001 (chi-square test). There was no link to age or gender, and race and etiology were secondary to region and severity of injury. CONCLUSION: Thoracic (T4-T9) SCIs have the least potential for neurologic improvement. Thoracolumbar (T10-T12) and lumbar (conus) spinal cord have a greater neurologic improvement rate, which might be related to a greater proportion of lower motor neurons. Thus, defining the exact region of injury and potential for neurologic improvement should be considered in future clinical trial design. Combining all anatomic regions of the spine in SCI trials may be misleading if different regions have neurologic improvement at different rates. Over a ten-year period, 95 complete thoracic/thoracolumbar SCI patients had only a 4.1% rate of neurologic improvement, compared with 96.0% for incomplete lumbar (conus) patients and 66.7% to 72.2% for all others.

Traumatic thoracic ASIA A examinations and potential for clinical trials.

STUDY DESIGN: Retrospective review of prospective database. OBJECTIVE: To define the variability of neurologic examination and recovery after nonpenetrating complete thoracic spinal cord injuries (American Spinal Injury Association [ASIA] A). SUMMARY OF BACKGROUND DATA: Neurologic examinations after spinal cord injury (SCI) can be difficult and inconsistent. Unlike cervical SCI patients, alterations in thoracic (below T1) complete SCI (ASIA A-based on the ASIA Impairment Scale [AIS]) patients' examinations are based only on sensory testing, thus changes in the neurologic level (NL) are determined only by sensory changes. METHODS: A retrospective review of the placebo control patients in a multicenter prospective database used for the pharmacologic trial of Sygen. Patients were included if they had a complete thoracic SCI on initial evaluation, with completed ASIA examinations at follow-up weeks 4, 8, 16, 26, and 52. Specifically, pin prick (PP) and light touch (LT) were assessed and the absolute change was calculated as the number of spinal levels at a given observation time. RESULTS: Three thousand one hundred sixty-five patients were initially screened for the Sygen clinical trial, of which 51 were the control placebo patients used in this analysis. Alterations from the baseline examination (PP and LT) were fairly consistent and the median change/recovery in neurologic examination was 1 spinal level. Across all observations postbaseline, the average change for PP was 1.48 +/- 0.13 (mean +/- SE), and for LT, 1.40 +/- 0.13. There were equal proportions of directional changes (none, improved, lost). CONCLUSION: Changes in a thoracic complete (ASIA A) SCI patients ASIA examination as measured through sensory methods (PP/LT) are fairly uncommon. The overall examination had only 1- to 2-level variability across patients, indicating minimal change in the sensory examination over the follow-up period. Stability in the ASIA examination as measured through sensory methods has thus been demonstrated over time, making it an excellent tool to monitor changes in neurologic function.