Efficacy and Safety of a Tofacitinib-based Immunosuppressive Regimen After Kidney Transplantation: Results From a Long-term Extension Trial.

BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor. This open-label, long-term extension (LTE) study (NCT00658359) evaluated long-term tofacitinib treatment in stable kidney transplant recipients (n = 178) posttransplant. METHODS: Patients who completed 12 months of cyclosporine (CsA) or tofacitinib treatment in the phase IIb parent study (NCT00483756) were enrolled into this LTE study, evaluating long-term tofacitinib treatment over months 12 to 72 posttransplant. Patients were analyzed by tofacitinib less-intensive (LI) or more-intensive (MI) regimens received in the parent study. For both groups, tofacitinib dose was reduced from 10 to 5 mg twice daily by 6 months into the LTE. Patients were followed up through month 72 posttransplant, with a focus on month 36 results. RESULTS: Tofacitinib demonstrated similar 36-month patient and graft survival rates to CsA. Biopsy-proven acute rejection rates at month 36 were 11.2% for CsA, versus 10.0% and 7.4% (both P > 0.05) for tofacitinib LI and MI, respectively. Least squares mean estimated glomerular filtration rates were 9 to 15 mL/min per 1.73 m2 higher for tofacitinib versus CsA at month 36. The proportions of patients with grade 2/3 interstitial fibrosis and tubular atrophy in month 36 protocol biopsies were 20.0% for LI and 18.2% for MI (both P > 0.05) versus 33.3% for CsA. Kaplan-Meier cumulative serious infection rates at month 36 were numerically higher for tofacitinib LI (43.9%; P = 0.45) and significantly higher for MI (55.9%; P < 0.05) versus CsA (37.1%). CONCLUSIONS: Long-term tofacitinib continued to be effective in preventing renal allograft acute rejection and preserving renal function. However, long-term tofacitinib and mycophenolic acid product combination was associated with persistent serious infection risk.

Risk of acute kidney injury in critically ill surgical patients with presumed pneumonia is not impacted by choice of methicillin-resistant staphylococcus aureus therapy.

BACKGROUND: Vancomycin and linezolid are standard treatment options for nosocomial methicillin-resistant Staphylococcus aureus (MRSA) pneumonia. While acute kidney injury (AKI) is commonly attributed to vancomycin, existing data has not definitely confirmed vancomycin as an independent risk factor for AKI. AIMS: This study aimed to quantify the incidence of AKI in Surgical Intensive Care Unit (ICU) patients receiving empiric vancomycin or linezolid for nosocomial pneumonia and to identify risk factors for AKI with a focus on MRSA antibiotic therapy. MATERIALS AND METHODS: A retrospective cohort analysis of surgical ICU patients who received at least 48 h of vancomycin or linezolid for pneumonia was performed. Patients who received vancomycin were compared to those who received linezolid with a primary endpoint of AKI as defined by the risk/injury/failure/loss/end-stage renal disease (RIFLE) criteria. A modified RIFLE criteria assessing only changes in serum creatinine was also used. RESULTS: One hundred one patients were evaluated (63 vancomycin and 38 linezolid). AKI occurred in 51 (81.0%) and 32 (84.2%) patients in the vancomycin and linezolid groups (P = 0.79), respectively. Using the modified RIFLE criteria, AKI occurred in 19 (30.2%) and 14 (36.8%) patients in the vancomycin and linezolid groups (P = 0.448). After adjustment for age, diabetes mellitus, Charlson comorbidity index, and concomitant nephrotoxins, there was no difference in risk of AKI between groups (P = 0.773). CONCLUSIONS: Patients who received empiric vancomycin or linezolid for nosocomial pneumonia experienced high, but similar rates of AKI. The results suggest MRSA antibacterial therapy in this setting may not be independently indicative of AKI risk, rather the risk is likely multifactorial.

Zinc in Wound Healing Modulation.

Wound care is a major healthcare expenditure. Treatment of burns, surgical and trauma wounds, diabetic lower limb ulcers and skin wounds is a major medical challenge with current therapies largely focused on supportive care measures. Successful wound repair requires a series of tightly coordinated steps including coagulation, inflammation, angiogenesis, new tissue formation and extracellular matrix remodelling. Zinc is an essential trace element (micronutrient) which plays important roles in human physiology. Zinc is a cofactor for many metalloenzymes required for cell membrane repair, cell proliferation, growth and immune system function. The pathological effects of zinc deficiency include the occurrence of skin lesions, growth retardation, impaired immune function and compromised would healing. Here, we discuss investigations on the cellular and molecular mechanisms of zinc in modulating the wound healing process. Knowledge gained from this body of research will help to translate these findings into future clinical management of wound healing.

Safety and Efficacy Outcomes 3 Years After Switching to Belatacept From a Calcineurin Inhibitor in Kidney Transplant Recipients: Results From a Phase 2 Randomized Trial.

BACKGROUND: In a phase 2 study, kidney transplant recipients of low immunologic risk who switched from a calcineurin inhibitor (CNI) to belatacept had improved kidney function at 12 months postconversion versus those continuing CNI therapy, with a low rate of acute rejection and no transplant loss. STUDY DESIGN: 36-month follow-up of the intention-to-treat population. SETTING & PARTICIPANTS: CNI-treated adult kidney transplant recipients with stable transplant function (estimated glomerular filtration rate [eGFR], 35-75mL/min/1.73m2). INTERVENTIONS: At 6 to 36 months posttransplantation, patients were randomly assigned to switch to belatacept-based immunosuppression (n=84) or continue CNI-based therapy (n=89). OUTCOMES: Safety was the primary outcome. eGFR, acute rejection, transplant loss, and death were also assessed. MEASUREMENTS: Treatment exposure-adjusted incidence rates for safety, repeated-measures modeling for eGFR, Kaplan-Meier analyses for efficacy. RESULTS: Serious adverse events occurred in 33 (39%) belatacept-treated patients and 36 (40%) patients in the CNI group. Treatment exposure-adjusted incidence rates for serious infections (belatacept vs CNI, 10.21 vs 9.31 per 100 person-years) and malignancies (3.01 vs 3.41 per 100 person-years) were similar. More patients in the belatacept versus CNI group had any-grade viral infections (14.60 vs 11.00 per 100 person-years). No posttransplantation lymphoproliferative disorder was reported. Belatacept-treated patients had a significantly greater estimated gain in mean eGFR (1.90 vs 0.07mL/min/1.73m2 per year; P for time-by-treatment interaction effect = 0.01). The probability of acute rejection was not significantly different for belatacept (8.38% vs 3.60%; HR, 2.50 [95% CI, 0.65-9.65; P=0.2). HR for the comparison of belatacept to the CNI group for time to death or transplant loss was 1.00 (95% CI, 0.14-7.07; P=0.9). LIMITATIONS: Exploratory post hoc analysis with a small sample size. CONCLUSIONS: Switching patients from a CNI to belatacept may represent a safe approach to immunosuppression and is being further explored in an ongoing phase 3b trial.

Modulation of wound healing and scar formation by MG53 protein-mediated cell membrane repair.

Cell membrane repair is an important aspect of physiology, and disruption of this process can result in pathophysiology in a number of different tissues, including wound healing, chronic ulcer and scarring. We have previously identified a novel tripartite motif family protein, MG53, as an essential component of the cell membrane repair machinery. Here we report the functional role of MG53 in the modulation of wound healing and scarring. Although MG53 is absent from keratinocytes and fibroblasts, remarkable defects in skin architecture and collagen overproduction are observed in mg53(-/-) mice, and these animals display delayed wound healing and abnormal scarring. Recombinant human MG53 (rhMG53) protein, encapsulated in a hydrogel formulation, facilitates wound healing and prevents scarring in rodent models of dermal injuries. An in vitro study shows that rhMG53 protects against acute injury to keratinocytes and facilitates the migration of fibroblasts in response to scratch wounding. During fibrotic remodeling, rhMG53 interferes with TGF-ß-dependent activation of myofibroblast differentiation. The resulting down-regulation of α smooth muscle actin and extracellular matrix proteins contributes to reduced scarring. Overall, these studies establish a trifunctional role for MG53 as a facilitator of rapid injury repair, a mediator of cell migration, and a modulator of myofibroblast differentiation during wound healing. Targeting the functional interaction between MG53 and TGF-ß signaling may present a potentially effective means for promoting scarless wound healing.

Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study.

Tremor is a common side effect of tacrolimus correlated with peak-dose drug concentration. LCPT, a novel, once-daily, extended-release formulation of tacrolimus, has a reduced Cmax with comparable AUC exposure, requiring a ~30% dose reduction vs. immediate-release tacrolimus. In this phase 3b study, kidney transplant recipients (KTR) on a stable dose of tacrolimus and with a reported clinically significant tremor were offered a switch to LCPT. Tremor pre- and seven d post-conversion was evaluated by independent, blinded movement disorder neurologists using the Fahn-Tolosa-Marin (FTM) scale and by an accelerometry device; patients completed the QUEST (quality of life in essential tremor) and the Patient Global Impression of Change. There were 38 patients in the mITT population. A statistically and clinically significant improvement in tremor (FTM score, amplitude as measured by the accelerometry device and QOL [p-values < 0.05]) resulted post-conversion. Change in QUEST was significantly (p = 0.006) correlated (R = 0.44) with change in FTM; 78.9% of patients reported an improvement after switching to LCPT (p < 0.0005). To our knowledge this is the first trial in KTR that utilizes a sophisticated and reproducible measurement of tremor. Results suggest LCPT is associated with clinically meaningful improvement of hand tremor and may be an alternative management approach in lieu of further dose reduction of immediate-release tacrolimus for patients experiencing tremor.

Pre-injury beta blocker use does not affect the hyperdynamic response in older trauma patients.

PURPOSE: Trauma dogma dictates that the physiologic response to injury is blunted by beta-blockers and other cardiac medications. We sought to determine how the pre-injury cardiac medication profile influences admission physiology and post-injury outcomes. MATERIALS AND METHODS: Trauma patients older than 45 evaluated at our center were retrospectively studied. Pre-injury medication profiles were evaluated for angiotensin-converting enzyme inhibitors / angiotensin receptor blockers (ACE-I/ARB), beta-blockers, calcium channel blockers, amiodarone, or a combination of the above mentioned agents. Multivariable logistic regression or linear regression analyses were used to identify relationships between pre-injury medications, vital signs on presentation, post-injury complications, length of hospital stay, and mortality. RESULTS: Records of 645 patients were reviewed (mean age 62.9 years, Injury Severity Score >10, 23%). Our analysis demonstrated no effect on systolic and diastolic blood pressures from beta-blocker, ACE-I/ARB, calcium channel blocker, and amiodarone use. The triple therapy (combined beta-blocker, calcium channel blocker, and ACE-I/ARB) patient group had significantly lower heart rate than the no cardiac medication group. No other groups were statistically different for heart rate, systolic, and diastolic blood pressure. CONCLUSIONS: Pre-injury use of cardiac medication lowered heart rate in the triple-agent group (beta-blocker, calcium channel blocker, and ACEi/ARB) when compared the no cardiac medication group. While most combinations of cardiac medications do not blunt the hyperdynamic response in trauma cases, patients on combined beta-blocker, calcium channel blocker, and ACE-I/ARB therapy had higher mortality and more in-hospital complications despite only mild attenuation of the hyperdynamic response.

Results of a prospective, randomized, controlled study of the use of carboxymethylcellulose sodium hyaluronate adhesion barrier in trauma open abdomens.

INTRODUCTION: The open abdominal (OA) approach is a management strategy used in the most severely injured trauma patients. In addition to the morbidity and mortality, a major challenge is the gradual development of dense adhesions that make reoperations progressively more difficult. This randomized, prospective, proof-of-concept study was conducted to determine the effect of carboxymethylcellulose sodium hyaluronate adhesion barrier (CMHAB; Seprafilm, Genzyme Biosurgery, Bridgewater, NJ) on abdominal adhesions and wound characteristics in trauma open abdomens. METHODS: A prospective, randomized, controlled study of wound and adhesion characteristics with or without CMHAB was conducted at 5 level I trauma centers. Consenting patients were randomized to either CMHAB or no adhesion barrier (NAB) groups. We evaluated patient demographics, injury characteristics/severity, reason for OA management, wound sizes (transverse/longitudinal), Zuhlke adhesion score, abdominal contamination score, hospital/intensive care durations of stay, morbidity, and mortality. RESULTS: Thirty patients were enrolled (17 randomized to CMHAB; 13 randomized to NAB) with mean age of 40.3, Injury Severity Score of 30, Abbreviated Injury Score (AIS)-abdomen of 3.68, APACHE II score of 14.4, and 67% blunt trauma mechanism. The groups were well-matched with regard to age, sex, Injury Severity Score/abdominal AIS, penetrating/blunt injury rates, initial lactate/base deficit, mortality, OA indications, and contamination scores. There were no differences in nonabdominal or abdominal complications (ie, fistula, abscess, wound related) between the groups. Patients with CMHAB had shorter intensive care unit durations of stay (15 vs 22 days; P < .05). Intraoperative adhesion scores were not different during the first four operations but diverged significantly at the 5th operative intervention or after about 1 week of OA therapy. After the 5th operation, adhesion scores in the NAB group were 67% greater (approximately 1 Zuhlke point) than the CMHAB group. We did not note differences between wound sizes over time, closure types, or wound closure characteristics between CMHAB and NAB. CONCLUSION: Although CMHAB did not eliminate adhesions in this proof-of-concept study, it limited their severity, particularly in abdomens left open >9 days or requiring ≥5 operations. There was no difference in wound sizes, overall or abdominal complications, or mortality between the groups. Further research is warranted to better delineate potential benefits of CMHAB, especially in the setting of reoperations in post-OA patients.

Risk factors for retained surgical items: a meta-analysis and proposed risk stratification system.

BACKGROUND: Retained surgical items (RSI) are designated as completely preventable "never events". Despite numerous case reports, clinical series, and expert opinions few studies provide quantitative insight into RSI risk factors and their relative contributions to the overall RSI risk profile. Existing case-control studies lack the ability to reliably detect clinically important differences within the long list of proposed risks. This meta-analysis examines the best available data for RSI risk factors, seeking to provide a clinically relevant risk stratification system. METHODS: Nineteen candidate studies were considered for this meta-analysis. Three retrospective, case-control studies of RSI-related risk factors contained suitable group comparisons between patients with and without RSI, thus qualifying for further analysis. Comprehensive Meta-Analysis 2.0 (BioStat, Inc, Englewood, NJ) software was used to analyze the following "common factor" variables compiled from the above studies: body-mass index, emergency procedure, estimated operative blood loss >500 mL, incorrect surgical count, lack of surgical count, >1 subprocedure, >1 surgical team, nursing staff shift change, operation "afterhours" (i.e., between 5 PM and 7 AM), operative time, trainee presence, and unexpected intraoperative factors. We further stratified resulting RSI risk factors into low, intermediate, and high risk. RESULTS: Despite the fact that only between three and six risk factors were associated with increased RSI risk across the three studies, our analysis of pooled data demonstrates that seven risk factors are significantly associated with increased RSI risk. Variables found to elevate the RSI risk include intraoperative blood loss >500 mL (odds ratio [OR] 1.6); duration of operation (OR 1.7); >1 subprocedure (OR 2.1); lack of surgical counts (OR 2.5); >1 surgical team (OR 3.0); unexpected intraoperative factors (OR 3.4); and incorrect surgical count (OR 6.1). Changes in nursing staff, emergency surgery, body-mass index, and operation "afterhours" were not significantly associated with increased RSI risk. CONCLUSIONS: Among the "common risk factors" reported by all three case-control studies, seven synergistically show elevated RSI risk across the pooled data. Based on these results, we propose a risk stratification scheme and issue a call to arms for large, prospective, and multicenter studies evaluating effects of specific changes at the institutional level (i.e., universal surgical counts, radiographic verification of the absence of RSI, and radiofrequency labeling of surgical instruments and sponges) on the risk of RSI. Overall, our findings provide a meaningful foundation for future patient safety initiatives and clinical studies of RSI occurrence and prevention.

Natural history of retained surgical items supports the need for team training, early recognition, and prompt retrieval.

BACKGROUND: Unintentionally retained items feature prominently among surgical "never events." Our knowledge of these rare occurrences, including natural history and intraoperative safety omission or variance (SOV) profile, is limited. We sought to bridge existing knowledge gaps by presenting a secondary analysis of a multicenter study focused on these important aspects of retained surgical items (RSIs). METHODS: This is a post hoc analysis of results from a multicenter retrospective study of RSIs between January 2003 and December 2009. After excluding previously reported intravascular RSIs (n = 13), a total of 71 occurrences were analyzed for (1) item location and type; (2) time to presentation and/or discovery; (3) presenting signs and symptoms; (4) procedure and incision characteristics; (5) pathology reports; and (6) patterns of SOVs abstracted from medical and operative records. These SOV were then grouped into individual vs team errors and single- vs multifactorial occurrences. RESULTS: Among 71 cases, there were 48 women and 23 men. Mean patient age was 49.7 ± 17.5 years (range 19 to 83 years). Mortality was 4 of 71 (5.63%, only 1 attributable to RSI). Twelve cases (16.9%) occurred at nonparticipating referring hospitals. Most RSI procedures (62%) occurred on the day of hospital admission. The median time from index RSI case to retained item removal was 2 days (range <1 to >3,600 days, n = 63). Abdominal RSIs predominated, and plain radiography was the most common identification method. Most RSIs removed early (<24 hours, n = 23) were asymptomatic. The most common clinical/diagnostic findings in the remaining group were focal pain (n = 22), abscess/fluid collection (n = 18), and mass (n = 8). Most common pathology findings included exudative reaction (n = 22), fibrosis (n = 17), and purulence/abscess (n = 15). On detailed review of intraprocedural events, most RSI cases were found to involve team/system errors (50 of 71) and 2 or more SOVs (37 of 71). Isolated human error was seen in less than 10% of cases. CONCLUSIONS: The finding that most operations complicated by RSIs were found to involve team/system errors and 2 or more SOVs emphasizes the importance of team safety training. The observation that early RSI removal minimizes patient morbidity and symptoms highlights the need for prompt RSI identification and treatment. The incidence of inflammation-related findings increases significantly with longer retention periods.

Anion gap as a predictor of trauma outcomes in the older trauma population: correlations with injury severity and mortality.

The relationship among traumatic injury, the associated metabolic/physiologic responses, and mortality is well established. Tissue hypoperfusion and metabolic derangement may not universally correlate with initial clinical presentation. We hypothesized that anion gap (AG) could be a useful gauge of trauma-related physiologic response and mortality in older patients with relatively lower injury acuity. We retrospectively analyzed data from 711 trauma patients older than 45 years. Parameters examined included demographics, injury characteristics, laboratories, morbidity, and mortality. Univariate and survival analyses were performed using PASW 18. A stepwise correlation exists between increasing Injury Severity Score and AG. Although AG less than 8 to 15 was not associated with a significant increase in mortality, greater mortality was seen for AG greater than 16 with further stepwise increases for AGs greater than 22. Anion gap correlated moderately with serum lactate and poorly with base excess. Increasing AG also correlated with morbidity and greater incidence of intensive care admissions. The presence of any complication increased from 28.6 per cent for patients with AG 12 or less to 45.5 per cent for patients with AG 22 or greater (P < 0.04). These findings support the contention that "low acuity" trauma patients with high AGs may not appear acutely ill but may harbor significant underlying metabolic and physiologic disturbances that could contribute to morbidity and mortality. Higher AG values (i.e., greater than 16) may be associated with worse clinical outcomes.

Intentional foreign object ingestions: need for endoscopy and surgery.

BACKGROUND: Intentional ingestion of foreign objects (IIFO) is common in the incarcerated population. This study was undertaken in order to better define clinical patterns of IIFO among prisoners. We sought to determine factors associated with the need for endoscopic and surgical therapy for IIFO. METHODS: After obtaining permission to conduct IIFO research in incarcerated populations, study patients were identified by ICD-9 codes. Patient charts were reviewed for demographics; past medical history; IIFO characteristics; and diagnostic, endoscopic, and surgical findings. Univariate and multivariate analyses were performed using statistical software. RESULTS: Thirty patients with 141 episodes of IIFO were identified. The mean number of ingested items per episode was 4.60. Endoscopy was performed in 97 of 141 IIFO instances, with failure to retrieve the ingested object in 21 of 97 cases (22%). Eleven instances (7.8%) required surgical intervention. On multivariate analyses, hospital admission was associated with elevated white blood cell count (odds ratio [OR] 1.4, P < 0.05) and number of items ingested (OR 1.3, P < 0.05). The need for endoscopy was independently associated with ingestion of multiple objects (OR 3.3, P < 0.05) and elevated white blood cell count (OR 1.3, P < 0.05). Surgical therapy was significantly associated with elevated white blood cell count (OR 1.6, P < 0.01) and with increasing number of ingested items (OR 1.07 per item, P < 0.05). Endoscopy is associated with significantly lower odds of surgery (OR 0.13, P < 0.01). CONCLUSIONS: Intentional ingestion of foreign objects continues to pose a significant human and economic burden. The need for admission or therapy is frequently associated with leukocytosis. Further investigation is warranted into resource-appropriate triage of patients who present with IIFO.

Comorbidity-polypharmacy score: a novel adjunct in post-emergency department trauma triage.

OBJECTIVE: Post-emergency department triage of older trauma patients continues to be challenging, as morbidity and mortality for any given level of injury severity tend to increase with age. The comorbidity-polypharmacy score (CPS) combines the number of pre-injury medications with the number of comorbidities to estimate the severity of comorbid conditions. This retrospective study examines the relationship between CPS and triage accuracy for older (≥45y) patients admitted for traumatic injury. METHODS: Patients aged 45y and older presenting to level 1 trauma center from 2005 to 2008 were included. Basic data included patient demographics, injury severity score, morbidity and mortality, and functional outcome measures. CPS was calculated by adding total numbers of comorbid conditions and pre-injury medications. Patients were divided into three triage groups: undertriage (UT), appropriate triage (AT), and overtriage (OT). UT criteria included initial admission to the floor or step-down unit followed by an unplanned transfer to intensive care unit (ICU) within 24h of admission. OT was defined as initial ICU admission for <1d without stated need for ICU level of care (i.e., lack of evidence for tracheal intubation or mechanical ventilation, injury-related hemorrhage, or other traditional ICU indications, such as intracranial bleeding). All other patients were presumed to be correctly triaged. The three triage groups were then analyzed looking for contributors to mistriage. RESULTS: Charts for 711 patients were evaluated (mean age, 63.5y; 55.7% male; mean ISS, 9.02). Of those, 11 (1.55%) met criteria for UT and 14 (1.97%) for OT. The remaining 686 patients had no evidence of mistriage. The three groups were similar in terms of injury severity and GCS. The groups were significantly different with respect to CPS, with UT CPSs (14.9±6.80) being nearly three times higher than OT CPSs (5.14±3.48). There were more similarities between AT and OT groups, with the UT group being characterized by greater number of complications and lower functional outcomes at discharge (all, P<0.05). The UT group had significantly higher mortality (27%) than the AT and OT groups (6% and 0%, respectively). CONCLUSIONS: In the era of medication reconciliation, CPS is easy to obtain and calculate in patients who are not critically injured. This study suggests that CPS may be a promising adjunct in identifying older trauma patients who are more likely to be undertriaged. The significance of our findings is especially important when considering that injury severity in the UT group was similar to that in the other groups. Further evaluation of CPS as a triage tool in acute trauma is warranted.

Retained surgical items: a problem yet to be solved.

BACKGROUND: Retained surgical items (RSI) continue to occur. Large RSI studies are few due to low RSI frequency in single institutions and the medicolegal implications. Consequently, RSI risks are not fully defined, with discrepancies persisting among published studies. The goals of this study were to better define risk factors for RSI, to clarify previously discrepant risk factors, and to evaluate other potential contributors to RSI occurrence, such as trainee presence during an operation. STUDY DESIGN: Multicenter case-match study of RSI risk factors was conducted between January 2003 and December 2009. Cases complicated by RSI were identified at participating centers using clinical quality improvement and adverse event reporting data. Case match controls (non-RSI) were selected from same or similar-type cases performed at each respective institution. Retained surgical item risk factors were evaluated by univariate and multivariate conditional logistic regression. RESULTS: Fifty-nine RSIs and 118 matched controls were analyzed (RSI incidence 1 in 6,975 or 59 in 411,526). Retained surgical items occurred despite use of confirmatory x-rays (13 of 27 instances) and/or radiofrequency tagging (2 of 32 instances). Among previously discrepant results, we confirmed that body mass index, unexpected intraoperative events, and procedure duration were associated with increased RSI risk. The occurrence of any safety variance, and specifically an incorrect count at any time during the procedure, was associated with elevated RSI risk. Trainee presence was associated with 70% lower RSI risk compared with trainee absence. CONCLUSIONS: Longer duration of surgery, safety variances, and incorrect counts during the procedure result in elevated RSI risk. The possible positive influence of trainee presence on RSI risk deserves additional study. Our findings highlight the need for zero tolerance for safety omissions, continued study and development of novel approaches to RSI reduction, and establishing anonymous RSI reporting systems to better track both the incidence and risks associated with this problem, which has yet to be solved.

Comorbidity-polypharmacy scoring facilitates outcome prediction in older trauma patients.

OBJECTIVES: To determine the association between comorbidity-polypharmacy score (CPS) and clinical outcomes in a large sample of older trauma patients, focusing on outcome prognostication. DESIGN: The CPS combines number of preinjury medications and comorbidities to more objectively quantify the severity of comorbid conditions. SETTING: An urban tertiary care level 1 trauma center in the Midwest. PARTICIPANTS: Trauma patients aged 45 and older. METHODS: Participants were stratified into four groups according to CPS ranges. Survival analyses were performed using Kaplan-Meier/Mantel-Cox testing. Factors influencing mortality, complications, and survivor discharge destination were evaluated using analysis of covariance and multivariate logistic regression. RESULTS: Records for 469 individuals (mean age 62.1, mean injury severity score 9.3) were reviewed. Higher CPS is associated with greater mortality, complications, longer hospital and intensive care unit stay, and need for discharge to a facility. Higher CPS is associated with lower 90-day survival (Mantel-Cox, P < .001). Mortality was independently associated with older age (odds ratio (OR) = 1.06 per year), higher injury severity score (OR = 1.19 per point), and higher CPS (OR = 1.11 per point) in multivariate analysis (all P < .01). Complications and need for discharge to a facility were independently associated with older age and higher injury severity score and CPS. CONCLUSION: CPS can be readily determined in the era of medication reconciliation. Trauma patients with CPS of 15 or greater are at greater risk of poor clinical outcomes. CPS constitutes a useful adjunct to currently available injury severity scoring tools as a predictor of morbidity, mortality, hospital resource utilization, and postdischarge disposition in older trauma patients.

Intravascular retained surgical items: a multicenter study of risk factors.

INTRODUCTION: Retained surgical items (RSIs) have been previously studied in patients undergoing major surgical procedures. This is the first study that specifically examines potential risk factors for intravascular RSI (ivRSI). METHODS: Multicenter retrospective review of 83 RSIs was performed. Among these, 13 cases involved ivRSI. Cases in the ivRSI group were compared with a group of similar control cases to determine potential risk factors for ivRSI, including procedural factors (urgency and complicating factors), patient factors (body mass index), equipment failure (structural or functional), and safety variances. Fisher's exact testing was performed. RESULTS: Thirteen ivRSI cases and 14 controls were examined. There were no differences between the two groups with regard to age, gender, or body mass index. ivRSI items included guide wires (8/13), catheter/catheter fragments (4/13), and a coil (1/13). The incidence of unexpected procedural factors was significantly higher among ivRSI cases (10/13) than among controls (3/14) (P < 0.007). Equipment failure occurred in five ivRSI cases, with none among controls (P < 0.016). There were no differences between the two groups with regard to number of urgent procedures, bleeding >500 mL, evening procedures, or trainee involvement. Both groups had a very high proportion of safety variances (8 in ivRSI and 11 in control group, P = not significant). In addition, seven of 13 ivRSIs were missed on initial confirmatory postprocedural imaging. DISCUSSION: Unexpected procedural factors and equipment failure are significantly associated with ivRSI. Of concern, over half of all ivRSIs were missed on confirmatory postprocedural imaging. Strict adherence to established protocols and stringent radiographic review for intravascular procedures is required to prevent ivRSI.