Outcomes in adhesive small bowel obstruction from a large statewide database: What to expect after nonoperative management.

BACKGROUND: Although adhesive small-bowel obstruction (ASBO) is frequently managed nonoperatively, little is known regarding outcomes on readmission following this approach. Using a large population-based dataset, we evaluated risk factors for operative intervention and mortality at readmission in patients with ASBO who were initially managed nonoperatively. METHODS: The ASBO patients were identified in the California Office of Statewide Health Planning and Development 2007 to 2014 patient discharge database. Patients who were managed operatively at index admission or had an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code for nonadhesive obstructive small bowel disease were excluded. Associations between risk factors and both operative intervention and death following readmission were evaluated using survival analysis. RESULTS: Among 15,963 ASBO patients, 3,103 (19.4%) had at least one readmission. The 1,069 (34.5%) who received an operation during their first readmission presented sooner (175 days vs. 316 days, p < 0.001) and were more likely to die during that readmission (5.2% vs. 0.7%, p < 0.001). Operative management at first readmission was associated with younger age, fewer comorbidities, and shorter times to readmission. Patients operatively managed at first readmission had longer times to second readmission compared with nonoperative patients. Stratified analyses using nonoperative patients as the reference over the study period revealed that patients who underwent lysis of adhesions and bowel resection were 5.04 times (95% confidence interval [CI], 2.82-9.00) as likely to die while those who underwent lysis only were 2.09 times (95% CI, 1.14-3.85) as likely to die. Patients with bowel resection only were at an increased risk for subsequent interventions beyond the first readmission (hazard ratio, 1.79; 95% CI, 1.11-2.87). CONCLUSION: In a large cohort readmitted for ASBO and initially managed nonoperatively, subsequent operative intervention conferred a greater risk of death and a longer time to readmission among survivors. Prospective research is needed to further delineate outcomes associated with initial nonoperative management of ASBO. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Outcomes after single-look trauma laparotomy: A large population-based study.

BACKGROUND: Outcomes following damage control laparotomy for trauma have been studied in detail. However, outcomes following a single operation, or "single-look trauma laparotomy" (SLTL), have not. We evaluated the association between SLTL and both short-term and long-term outcomes in a large population-based data set. METHODS: The California Office of Statewide Health Planning and Development patient discharge database was evaluated for calendar years 2007 through 2014. Injured patients with SLTL during their index admission were identified using International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. Diagnosis and procedure codes were used to identify specific abdominal organ injuries, surgical interventions, and perioperative complications. Subsequent acute care admissions were examined for postoperative complications and related surgical interventions. Clinical characteristics, injuries, surgical interventions, and outcomes were analyzed by mechanism of injury. RESULTS: There were 2113 patients with SLTL during their index admission; 712 (33.7%) had at least one readmission to an acute care facility. Median time to first readmission was 110 days. Penetrating mechanism was more common than blunt (60.6% vs. 39.4%). Compared to patients with penetrating injury, blunt-injured patients had a significantly higher median Injury Severity Score (9 vs. 18, p < 0.0001) and a significantly higher mortality rate during the index admission (4.1% vs. 27.0%, p < 0.0001). More than 30% of SLTL patients requiring readmission had a surgery-related complication. The most common primary reasons for readmission were bowel obstruction (17.7%), incisional hernia (11.8%), and infection (9.1%). There was no significant association between mechanism of injury and development of surgery-related complications requiring readmission. CONCLUSIONS: Patients with SLTL had postinjury morbidity and mortality, and more than 30% required readmission. Complication rates for SLTL were comparable to those reported for emergency general surgery procedures. Patients should be educated on signs and symptoms of the most common complications before discharge following SLTL. Further investigation should focus on the factors associated with the development of these complications. LEVEL OF EVIDENCE: Prognostic and epidemiologic study, level III.

A population-based analysis of outcomes after repair of thoracic aortic emergencies in trauma.

BACKGROUND: Large-scale assessments of outcomes in thoracic endovascular repair (TEVAR) for thoracic aortic emergencies are lacking. We evaluated perioperative outcomes of TEVAR compared with open surgery among trauma patients in a large statewide database. MATERIALS AND METHODS: We evaluated the California Office of Statewide Health Planning and Development 2007-2014 patient discharge database. Blunt-injured trauma patients with thoracic aortic emergencies were identified by International Classification for Diseases, Ninth Revision, Clinical Modification diagnosis codes and external cause-of-injury codes. Procedure codes were evaluated for TEVAR or open repair. Outcomes included mortality or complications during the index admission and readmission within 30 d. The association between both operative methods and each outcome was evaluated by two-level logistic regression adjusting for age, length of stay, admission year, trauma-related mortality probability, and comorbidity status. RESULTS: Among over 31 million hospitalizations, we identified 48,357 cases (0.2%) of thoracic aortic disease. Of these, 2159 (4.5%) were unique blunt-injured trauma patients of whom 336 (15.6%) underwent operative repair: 256 TEVAR (76.2%) and 80 (23.8%) open repair. Patients with open repair were older than TEVAR patients (mean age 52.0 versus 46.8, P = 0.038). There were no significant differences in race, sex, injury mechanism, mortality, or 30-d readmission by operative method. However, open repair was associated with greater odds for cardiac, spinal cord, and neurological complications. CONCLUSIONS: Although mortality in trauma patients who underwent TEVAR was similar to that in patients with open repair, TEVAR was associated with fewer complications. This suggests that TEVAR offers clinical benefit over open repair in treating trauma patients with aortic disease.

The evolution of care improves outcome in blunt thoracic aortic injury: A Western Trauma Association multicenter study.

BACKGROUND: The management of blunt thoracic aortic injury (BTAI) has evolved radically in the last decade with changes in the processes of care and the introduction of thoracic endovascular aortic repair (TEVAR). These changes have wrought improved outcome, but the direct effect of TEVAR on outcome remains in question as previous studies have lacked vigorous risk adjustment and long-term follow-up. To address these knowledge gaps, we compared the outcomes of TEVAR, open surgical repair, and nonoperative management for BTAI. METHODS: Eight verified trauma centers recruited from the Western Trauma Association Multicenter Study Group retrospectively studied all patients with BTAI admitted between January 1, 2006, and June 30, 2016. Data included demographics, comorbidities, admitting physiology, injury severity, in-hospital care, and outcome. RESULTS: We studied 316 patients with BTAI; 57 (18.0%) were in extremis and died before treatment. Of the 259 treated surgically, TEVAR was performed in 176 (68.0%), open in 28 (10.8%), hybrid in 4 (1.5%), and nonoperative in 51 (19.7%). Thoracic endovascular aortic repair and open repair groups had similar Injury Severity Scale score, chest Abbreviated Injury Scale score, Trauma and Injury Severity Score, and probability of survival, but differed in median age (open: 28 [interquartile range {IQR}, 19-51]; TEVAR: 46 [IQR, 28-60]; p < 0.007), zone of aortic injury (p < 0.001), and grade of aortic injury (open: 6 [IQR, 4-6]; TEVAR: 2 [IQR, 2-4]; p < 0.001). The overall in-hospital mortality was 6.6% (TEVAR: 5.7%, open: 10.7%, nonoperative: 3.9%; p = 0.535). Of the 240 patients who survived to discharge, two died (one at 9 months and one at 8 years); both were managed with TEVAR, but the deaths were unrelated to the aortic procedure. Stent graft surveillance computed tomography scans were not obtained in 37.6%. CONCLUSIONS: The mortality of BTAI continues to decrease. Thoracic endovascular aortic repair, when anatomically suitable, should be the treatment of choice. Open repair remains necessary for more proximal injuries. Process improvement in computed tomography imaging in follow-up of TEVAR is warranted. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

"Delay to operating room" fails to identify adverse outcomes at a Level I trauma center.

BACKGROUND: The American College of Surgeons Committee on Trauma devised process audit filters to identify opportunities for improvement (OFI), prevent adverse outcomes, and improve quality. Delay to the operating room for primary trauma laparotomy is a process audit filter that has not been definitively associated with improved outcomes. We sought to evaluate the effectiveness of delay to the operating room of greater than 2 hours (DOR) to independently identify an adverse outcome or an OFI at our Level I trauma center. METHODS: Trauma patients who underwent primary exploratory laparotomy from July 2006 to March 2015 were reviewed. Those with DOR were identified and compared with those without DOR. To analyze the ability of DOR to independently identify an adverse outcome or an OFI, DOR patients were further divided into those with isolated DOR and those with DOR in conjunction with one or more other process audit filter. Primary outcome was the presence of a complication. Secondary outcome was an identified OFI. Medical records of patients with either outcome were reviewed to determine if the outcome resulted directly from DOR. RESULTS: Of 472 patients, 109 (23%) had DOR and 363 (77%) did not. There were no significant differences in age, sex, or injury severity between the two groups. The rates of complications among DOR patients and those without DOR were not significantly different (35% vs. 38%, p = 0.59). The DOR was the only process audit filter flagged in 31(28%) patients in the DOR group. This subgroup had no identified complications but incurred two OFIs; neither OFI was associated with an adverse outcome. CONCLUSION: In trauma patients undergoing primary exploratory laparotomy, DOR fails to independently identify adverse outcomes. These findings suggest that DOR, as a routinely collected process audit filter, is not an effective indicator of suboptimal care or adverse outcomes at a Level I trauma center. LEVEL OF EVIDENCE: Therapeutic study, level IV; prognostic study, level III.

Routine neurosurgical consultation is not necessary in mild blunt traumatic brain injury.

BACKGROUND: The Brain Trauma Foundation guidelines provide indications for neurosurgical intervention in traumatic brain injury (TBI) with moderate or severe intracranial hemorrhage (ICH). In TBI patients with less severe ICH, the utility of neurosurgical consultation remains unclear. We sought to determine if routine neurosurgical consultation is necessary for mild blunt TBI patients with ICH. METHODS: A retrospective cohort study was conducted on 500 consecutive blunt TBI patients aged 15 years or older with Glasgow Coma Scale score of ≥13 and ICH on initial head computed tomography admitted to a Level I trauma center over 28 months. Outcomes were neurosurgical intervention (craniotomy, craniectomy, ventriculostomy, or intracranial pressure monitor placement) and in-hospital mortality. Statistical significance was assessed at a p < 0.05. RESULTS: Of 500 patients, 49 (9.8%) underwent neurosurgical intervention. Neurosurgical intervention was more frequent in male patients (75.5% vs. 61.2%, p = 0.049), patients with higher head Abbreviated Injury Scale score (4.7 vs. 3.8, p < 0.0001), patients with an abnormal initial neurological examination (30.6% vs. 12.6%, p = 0.001), or patients with skull fracture (28.6% vs. 16.0%, p = 0.026) and was associated with higher mortality (8.2% vs. 2.0%, p = 0.010). Neurosurgical intervention was not associated with intoxication, preinjury antiplatelet/anticoagulation agents, or progression of ICH on second head computed tomography. Neurosurgical consultation was documented in 466 patients (93.2%). For patients without neurosurgical intervention, consultation did not change management. CONCLUSION: Routine neurosurgical consultation for blunt TBI with ICH seems unnecessary, regardless of intoxication or preinjury antiplatelet or anticoagulation therapy. A more selective approach is warranted to decrease hospital charges and optimize use of neurosurgical consultation. LEVEL OF EVIDENCE: Care management study, level IV.

Attenuation of cardiovascular stress with sympatholytics does not improve survival in patients with severe isolated traumatic brain injury.

BACKGROUND: Studies have shown improved survival after traumatic brain injury (TBI) with the administration of sympatholytics, including ß-blockers and clonidine, which is thought to attenuate the cardiovascular stress response. However, the use of sympatholytics has not been studied in patients with isolated severe TBI (ISTBI). We hypothesized that ISTBI patients receiving sympatholytics who demonstrated a reduction in cardiovascular stress would have improved outcomes compared with similarly injured patients without these cardiovascular changes. METHODS: We reviewed the medical records of 338 ISTBI patients (head Abbreviated Injury Scale [AIS] score > 3 and associated injury AIS score < 1) admitted to a Level I trauma center from 2010 through 2014. All patients were managed according to Brain Trauma Foundation guidelines. Demographic, clinical, and survival probability data were gathered. The primary outcome was inpatient mortality. Cardiovascular stress was assessed using the rate-pressure product (RPP = systolic blood pressure × heart rate / 100) calculated both before and after sympatholytic administration. Associations between independent variables and mortality were adjusted for total hospital length of stay. RESULTS: Among ISTBI patients, observed mortality was 6% (n = 20), while predicted mortality by Trauma and Injury Severity Score (TRISS) was 11% (n = 38). Administration of sympatholytics was associated with reduction in RPP in univariate analysis (p = 0.035). After adjusting for length of stay, neither receipt of ß-blockers nor reduction in RPP was associated with survival. Mean reduction in RPP among survivors was not different from that among nonsurvivors (-4.0% vs. -11.9%, p = 0.148). In addition, RPP reduction among patients who received sympatholytics occurred at the same rate in survivors as nonsurvivors (67% vs. 68%, p = 0.894). Severity of head injury, intraventricular hemorrhage, and any intracranial operative intervention were significantly associated with mortality. CONCLUSION: Although sympatholytic administration is associated with a significant decrease in RPP, the survival benefit seen in patients with multiple injuries with TBI is not observed among ISTBI patients. Further research on the role of sympatholysis in the management of ISTBI is warranted. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Heparin versus enoxaparin for prevention of venous thromboembolism after trauma: A randomized noninferiority trial.

BACKGROUND: Research comparing enoxaparin with unfractionated heparin (UFH) given every 12 hours for venous thromboembolism (VTE) prophylaxis after trauma overlooks original recommendations that UFH be given every 8 hours. We conducted a prospective, randomized, noninferiority trial comparing UFH every 8 hours and standard enoxaparin every 12 hours. We hypothesized that the incidence of VTE in trauma patients receiving UFH every 8 hours would be no more than 10% higher than that in patients receiving enoxaparin every 12 hours. METHODS: Trauma patients who met criteria for VTE prophylaxis at a Level I trauma center were randomly assigned to 5,000-U UFH every 8 hours or 30-mg enoxaparin every 12 hours between November 2012 and September 2014. Surveillance duplex ultrasound was performed twice weekly on intensive care unit patients and weekly on ward patients. Primary end points were deep vein thrombosis diagnosed by duplex ultrasound and pulmonary embolism diagnosed by computed tomography angiography. RESULTS: Of 495 randomized patients, 220 received UFH and 216 received enoxaparin for analysis. Overall, 105 in the UFH group and 103 in the enoxaparin group underwent VTE surveillance or diagnostic testing. In the analysis of randomized patients who received treatment, UFH was noninferior compared with enoxaparin (absolute VTE risk difference, 3.1%; 95% confidence interval, -1.6% to 7.7%; p = 0.196); however, in the screening ultrasound group, the noninferiority of UFH was inconclusive (absolute VTE risk difference, 6.5%; 95% confidence interval, -2.9% to 15.8%; p = 0.179). The two treatments did not differ with regard to adverse events. The pharmaceutical cost for the regimen of UFH ($2,809) was nearly 20-fold lower than that for enoxaparin ($54,138). CONCLUSION: A regimen of UFH every 8 hours may be noninferior to enoxaparin every 12 hours for the prevention of VTE following trauma. Given UFH's cost advantage, the use of UFH for VTE prophylaxis may offer greater value. LEVEL OF EVIDENCE: Therapeutic/care management study, level II.

Venous thromboembolic risk assessment models should not solely guide prophylaxis and surveillance in trauma patients.

BACKGROUND: Venous thromboembolism (VTE) risk assessment models exist to stratify patients at risk for VTE and guide surveillance and prophylaxis. We evaluated the only two models developed specifically for trauma patients: the Trauma Embolic Scoring System (TESS) and the Risk Assessment Profile (RAP). METHODS: Clinical and demographic data on patients admitted from July 2006 to December 2011 who underwent surveillance lower extremity duplex ultrasound were recorded. Patients were excluded if they were missing one or more of the variables required to calculate either TESS or RAP. Patients received prophylaxis according to American College of Chest Physicians guidelines. TESS and RAP scores were calculated retrospectively and compared between patients with VTE and patients without VTE. High risk was defined by the models as TESS score of 7 or greater and RAP score of 5 or greater. RESULTS: A total of 2,868 patients received surveillance lower extremity duplex ultrasound. TESS score was calculated for 2,140 patients; 215 developed VTE, 110 (51%) of whom had TESS score less than 7. The sensitivity and specificity at a cutoff point of 7 were 49% and 72%, respectively. RAP score was calculated for 1,505 patients; 152 developed VTE, 26 (17%) of whom had RAP score of less than 5. The sensitivity and specificity at a cutoff point of 5 were 83% and 37%, respectively. The area under the receiver operating characteristic curve for each model was 0.66. CONCLUSION: A clinically significant number of patients who developed VTE were classified as low risk by both TESS and RAP. The indications for VTE surveillance and chemoprophylaxis should not be based exclusively on these scores. These results suggest that additional variables should be sought to improve risk assessment for VTE following trauma. LEVEL OF EVIDENCE: Care management study, level III.

Death after discharge: predictors of mortality in older brain-injured patients.

BACKGROUND: Older patients with traumatic brain injury (TBI) may be at high risk of death after hospitalization. The purpose of this study was to characterize long-term mortality of older TBI patients who survived to discharge. We hypothesized that predictors of postdischarge mortality differed from those of inpatient mortality. METHODS: A retrospective cohort study was performed on TBI patients older than 55 years admitted to our Level I trauma center between July 1, 2006, and December 31, 2011. Postdischarge deaths were identified by matching patient data with local vital records up to December 31, 2011, when data collection was terminated (censoring). Patients were categorized by age, comorbidities, history of preinjury anticoagulant/prescription antiplatelet agent therapy, injury severity indices, initial TBI type, prehospital living status, discharge location, and discharge condition. The effect of risk factors on postdischarge mortality was evaluated by Cox proportional hazards modeling. RESULTS: Of 353 patients, 322 (91.2%) survived to discharge. Postdischarge mortality was 19.8% (n = 63) for the study period. Of the postdischarge deaths, 54.0% died within 6 months of discharge, and 68.3% died within 1 year. Median days to death after discharge or censoring were 149 and 410, respectively. Factors associated with death after discharge included age, preinjury anticoagulant use, higher number of Charlson comorbidities, discharge to a long-term care facility, and severe disability. Factors related to injury severity (i.e., Injury Severity Score [ISS], initial Glasgow Coma Scale [GCS] score) and preinjury prescription antiplatelet agent use, previously found to predict inpatient death, did not predict postdischarge mortality. CONCLUSION: Older TBI patients who survive to discharge have a significant risk of death within 1 year. Predictors of postdischarge mortality and inpatient death differ. Death after discharge is largely a function of overall health status. Monitoring health status and continued aggressive management of comorbidities after discharge may be essential in determining long-term outcomes. LEVEL OF EVIDENCE: Epidemiologic study, level III.

Pulmonary embolism without deep venous thrombosis: De novo or missed deep venous thrombosis?

BACKGROUND: Pulmonary embolus (PE) is thought to arise from a deep venous thrombosis (DVT). Recent data suggest that PE can present without DVT, inferring that PE can originate de novo (DNPE). We examined the relationship between DVT and PE in trauma patients screened for DVT with duplex sonography (DS). We sought to validate the incidence of PE without evidence of DVT and to examine the clinical significance of this entity. METHODS: We reviewed the medical records of all trauma patients from July 2006 to December 2011 with PE who also had serial surveillance DS (groin to ankle). Demographics, severity of injury, interventions, signs and symptoms of PE, as well as chest computerized tomography findings were collected. Patients with no DS evidence of DVT either before or within 48 hours of PE diagnosis (DNPE) were compared with those with DVT (PE + DVT). RESULTS: Of 11,330 patients evaluated by the trauma service, 2,881 patients received at least one DS. PE occurred in 31 of these patients (1.08%): 19 (61%) were DNPE, and 12 (39%) were PE + DVT. Compared with patients with PE + DVT, patients with DNPE were significantly younger and had more rib fractures, pulmonary contusions, infections, pulmonary symptoms, and peripherally located PEs on computerized tomography. CONCLUSION: This is the first report of the clinical course of DNPE without embolic origin in a population with comprehensive duplex surveillance. In our series, DNPE seems to be more prevalent after trauma, to be clinically distinct from PE following DVT, and to likely represent a local response to injury or inflammation; however, further research is warranted to fully understand the pathophysiology of DNPE. LEVEL OF EVIDENCE: Care management study, level III.

Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin.

BACKGROUND: Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. METHODS: We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1mg of DNA/injection. RESULTS: All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of > or =40 and 4-fold rises from baseline were achieved in 47-67% of subjects and H5-specific T-cell responses in 75-100%. Trivalent cohorts had lower HI response rates (< or = 20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens. CONCLUSIONS: Vaxfectin-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control.