Predictors and benefits of multiagent chemotherapy for pancreatic adenocarcinoma: Timing matters.

INTRODUCTION: Adjuvant (A) multiagent chemotherapy (MC) is the standard of care for patients with pancreatic adenocarcinoma (PDAC). Tolerating MC following a morbid operation may be difficult, thus neoadjuvant (NA) treatment is preferable. This study examined how the timing of chemotherapy was related to the regimen given and ultimately the overall survival (OS). METHODS: The National Cancer Database was queried from 2006 to 2017 for nonmetastatic PDAC patients who underwent surgical resection and received MC or single-agent chemotherapy (SC) pre- or postresection. Predictors of receiving MC were determined using multivariable logistic regression. Five-year OS was evaluated using the Kaplan-Meier and Cox proportional hazards model. RESULTS: A total of 12,440 patients (NA SC, n = 663; NA MC, n = 2313; A SC, n = 6152; A MC, n = 3312) were included. MC utilization increased from 2006-2010 to 2011-2017 (33.1%-49.7%; odds ratio [OR]: 0.59; p < 0.001). Younger age, fewer comorbidities, higher clinical stage, and larger tumor size were all associated with receipt of MC (all p < 0.001), but NA treatment was the greatest predictor (OR 5.18; 95% confidence interval [CI]: 4.63-5.80; p < 0.001). MC was associated with increased median 5-year OS (26.0 vs. 23.9 months; hazard ratio [HR]: 0.92; 95% CI: 0.88-0.96) and NA MC was associated with the highest survival (28.2 months) compared to NA SC (23.3 months), A SC (24.0 months), and A MC (24.6 months; p < 0.001). CONCLUSION: Use and timing of MC contribute to OS in PDAC with an improved 5-year OS compared to SC. The greatest predictor of receiving MC was being given as NA therapy and the greatest survival benefit was the NA MC subgroup. Randomized studies evaluating the timing of effective MC in PDAC are needed.

Downstaging of Pancreatic Adenocarcinoma With Either Neoadjuvant Chemotherapy or Chemoradiotherapy Improves Survival.

BACKGROUND: Neoadjuvant chemotherapy (NAC) or chemoradiation (NAC+XRT) is incorporated into the treatment of localized pancreatic adenocarcinoma (PDAC), often with the goal of downstaging before resection. However, the effect of downstaging on overall survival, particularly the differential effects of NAC and NAC+XRT, remains undefined. This study examined the impact of downstaging from NAC and NAC+XRT on overall survival. METHODS: The National Cancer Data Base (NCDB) was queried from 2006 to 2015 for patients with non-metastatic PDAC who received NAC or NAC+XRT. Rates of overall and nodal downstaging, and pathologic complete response (pCR) were assessed. Predictors of downstaging were evaluated using multivariable logistic regression. Overall survival (OS) was assessed with Kaplan-Meier and Cox proportional hazards modeling. RESULTS: The study enrolled 2475 patients (975 NAC and 1500 NAC+XRT patients). Compared with NAC, NAC+XRT was associated with higher rates of overall downstaging (38.3 % vs 23.6 %; p ≤ 0.001), nodal downstaging (16.0 % vs 7.8 %; p ≤ 0.001), and pCR (1.7 % vs 0.7 %; p = 0.041). Receipt of NAC+XRT was independently predictive of overall (odds ratio [OR] 2.28; p < 0.001) and nodal (OR 3.09; p < 0.001) downstaging. Downstaging by either method was associated with improved 5-year OS (30.5 vs 25.2 months; p ≤ 0.001). Downstaging with NAC was associated with an 8-month increase in median OS (33.7 vs 25.6 months; p = 0.005), and downstaging by NAC+XRT was associated with a 5-month increase in median OS (30.0 vs 25.0 months; p = 0.008). Cox regression showed an association of overall downstaging with an 18 % reduction in the risk of death (hazard ratio [HR] 0.82; 95 % confidence interval, 0.71-0.95; p = 0.01) CONCLUSION: Downstaging after neoadjuvant therapies improves survival. The addition of radiation therapy may increase the rate of downstaging without affecting overall oncologic outcomes.

Prognostic Role of Lymph Node Sampling in Adolescent and Young Adults With Fibrolamellar Carcinoma.

INTRODUCTION: Hepatocellular carcinoma (HCC) is rare among adolescent and young adult (AYA) patients, and resection or transplant remains the only curative therapy. The role of lymph node (LN) sampling is not well-defined. The aim of this study was to describe practice patterns, as well as investigate the impact of LN sampling on survival outcomes in this population. MATERIALS AND METHODS: A retrospective cohort study using the 2004-2018 National Cancer Database (NCDB) was performed. Patients ≤21 y old with nonmetastatic HCC who underwent liver resection or transplant were evaluated. Clinical features of patients who underwent LN sampling were compared to those who did not, and univariable and multivariable logistic regression was performed to evaluate independent predictive factors of node positivity. Survival analysis was performed using Kaplan-Meier methods and Cox Proportional Hazard Survival Regression. RESULTS: A total of 262 AYA patients with HCC were identified, of whom 137 (52%) underwent LN sampling, 44 patients had positive nodes, 40 (95%) of them had tumors >5 cm; 87 (64%) of patients with sampled nodes had fibrolamellar carcinoma (FLC), which was an independent risk factor for predicting positive nodes (P = 0.001). There was no difference in overall survival between patients who underwent LN sampling and those who did not; however, 5-y overall survival for node-positive patients was 40% versus 79% for node-negative patients (P < 0.0001). CONCLUSIONS: In AYA patients with HCC, LN sampling was not associated with an independent survival benefit. However, FLC was an independent risk factor for LN positivity, suggesting a role for routine LN sampling in these patients.

Impact of Hepatic Metastasectomy in the Multimodal Treatment of Metastatic Breast Cancer.

BACKGROUND: Surgical management of hepatic metastases in patients with stage IV breast cancer remains controversial. The purpose of this study was to examine the impact of hepatic metastasectomy on long-term outcomes. METHODS: The 2004-2015 National Cancer Database was queried for all patients diagnosed with stage IV breast cancer with metastases isolated to the liver. Patient demographics, disease-, treatment- and outcome-related data were analyzed. RESULTS: Of 2,895 patients, only 90 (3.1%) underwent hepatic resection. Compared to patients who did not undergo metastasectomy, patients treated with metastasectomy tended to be younger (52 ± 12.7 versus 59.2 ± 14.6; P < 0.001) and have private insurance (74.4% versus 45.3%; P < 0.001). Independent predictors of metastasectomy included younger age (OR 0.98; CI 0.96-0.99; P = 0.01), lobular carcinoma (OR 2.26; CI 1.06-4.82; P = 0.03), and prior surgery of the primary site (partial mastectomy (OR 6.96; CI 3.47-13.95; P < 0.001) or total mastectomy (OR 5.74; CI 3.06-10.76; P < 0.001)). Compared to no metastasectomy, hepatic metastasectomy was independently associated with a 37% reduction in the risk of death (HR 0.63; CI 0.44-0.91; P = 0.01). CONCLUSIONS: Stage IV breast cancer with metastases to the liver is rare and few patients undergo hepatic resection. However, in this select patient population, hepatic metastasectomy was associated with a significant survival advantage when included in the multimodal treatment of synchronous stage IV breast cancer.

Rates, Predictors, and Outcomes of Portal Lymphadenectomy for Resectable Gallbladder Cancer.

INTRODUCTION: Lymphadenectomy (LND) is recommended following surgical resection of ≥ T1b gallbladder cancer (GBC). However, frequency and stage-specific survival benefits of LND remain unclear. PATIENTS AND METHODS: The National Cancer Database (NCDB; 2006-15) was queried for resected pathologic stage I-III GBC. LND performance, predictors of receiving LND, and LND association with overall survival (OS) were assessed. RESULTS: Of 2302 total patients, 1343 (58.3%) underwent LND. Patients who underwent LND were younger and more frequently had private health insurance, a negative surgical margin, higher pathologic T stage, and received adjuvant chemotherapy (all p < 0.001). LND rates were highest at academic centers (70.1%) relative to all other facility types (p < 0.001). LND was independently associated with improved OS [hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.44-0.61]. LND was associated with improved OS for pT1b, pT2, and pT3 patients (all p < 0.05) on univariate analysis. LND was independently associated with improved OS in pT2 (HR 0.44, CI 0.35-0.56) and pT3 (HR 0.54, CI 0.43-0.69) patients. CONCLUSIONS: LND is associated with a 48% reduction in risk of death in patients with resectable non-metastatic GBC, with greatest impact in pT2-3 patients. Patients without LND have similar OS to patients with node-positive disease, highlighting the importance of LND. Underutilization of LND likely results in undertreatment of patients with undiagnosed nodal disease, which may contribute to unfavorable oncologic outcomes.

Adjuvant Chemotherapy in Resectable Gallbladder Cancer is Underutilized Despite Benefits in Node-Positive Patients.

BACKGROUND: Adjuvant chemotherapy (AC) is recommended following surgical resection of gallbladder cancer regardless of stage. However, stage-specific benefits of AC in gallbladder cancer are unclear. PATIENTS AND METHODS: Patients with resected pathologic stage I-III gallbladder cancer were identified using the 2006-2015 National Cancer Database. Utilization trends, predictors of use, and impact of AC on overall survival (OS) were determined. RESULTS: A total of 5656 patients were included. Use of AC increased from 9.9% in 2006 to 24.2% in 2015 (OR 2.91; 95% CI 2.06-4.09; p < 0.001). However, only 17.5% of patients overall and only 32.4% of node-positive (stage IIIb) patients received AC. Patients receiving AC were younger and had fewer comorbidities, shorter hospitalizations, more advanced disease, and more margin-positive resections (all p < 0.01). Higher pathologic T stage and positive nodal status represented the greatest independent predictors of receipt of AC. While AC demonstrated no OS advantage for stage I patients (p = 0.83), AC was associated with improved OS among stage II patients (p = 0.003), though this impact was not independently associated with improved OS on multivariable analysis. AC was independently associated with improved OS among stage IIIb patients, with a 30% reduction in risk of death (HR 0.70; 95% CI 0.58-0.83; p < 0.001). Younger age, fewer comorbidities, and shorter hospitalization all predicted receipt of AC among stage IIIb patients (all p < 0.05). CONCLUSIONS: Systemic therapy remains underprescribed, in particular among patients that would seem to benefit most. Adjuvant chemotherapy likely improves survival in node-positive gallbladder cancer, but its utility in the treatment of node-negative disease has not been demonstrated.

Examining Perioperative Risk Associated with Simultaneous Resection of Primary Neuroendocrine Tumors and Synchronous Hepatic Metastases.

BACKGROUND: Surgical debulking of primary neuroendocrine tumors (NETs) and hepatic resection of metastatic NET disease may each independently improve overall survival. However, evidence for combined primary site debulking and metastasectomy on survival and impact on short-term perioperative outcomes is limited. METHODS: The 2014-2016 ACS-NSQIP targeted hepatectomy database was queried for all patients undergoing liver resection for metastatic NET. Secondary procedure codes were evaluated for major concurrent operations. Multivariable analysis was performed to determine risk factors for 30-day morbidity and mortality. RESULTS: A total of 472 patients were identified, of whom 153 (32.4%) underwent ≥1 additional concurrent major operation. The most common concurrent procedures were small bowel resection (14.6%), partial colectomy (8.9%), and radical lymphadenectomy (7.4%). Among all patients, overall 30-day mortality and morbidity were 1.5% and 25.6%, respectively. Modifiable and treatment-related factors associated with increased major postoperative morbidity risk included >10% weight loss within six months of surgery (p = 0.05), increasing number of hepatic lesions treated (p = 0.05), and biliary reconstruction (p = 0.001). No major concurrent procedure was associated with increased 30-day morbidity (all p > 0.05). CONCLUSIONS: Approximately one-third of patients with stage IV NET underwent combined hepatic and multi-organ resection. Although modifiable and treatment-related factors predictive of perioperative morbidity were identified, performance of concurrent major procedures did not increase perioperative morbidity. These results support consideration of multi-organ resection in carefully selected patients with metastatic NET.

Early Stabilization of Femur Fractures in the Setting of Polytrauma Is Associated With Decreased Risk of Pulmonary Complications and Mortality.

Timing of definitive fixation of femoral shaft fractures is a subject of continued controversy. The purpose of this study was to determine if early definitive fixation of femoral shaft fractures in the setting of polytrauma decreased the risk of pulmonary complications and mortality. The 2009-2012 National Sample Program of the National Trauma Data Bank was queried for all patients 18 to 65 years with Injury Severity Scores (ISS) >15 who underwent definitive fixation of femoral shaft fractures. Mortality, perioperative complications, and length of intensive care unit (ICU) and hospital stay were the primary outcome measures of interest. Following multivariate analyses, increased time to surgery was found to portend a statistically significant increased risk of acute respiratory distress syndrome(ARDS), mean ventilator time, length of ICU and hospital stay, and mortality. Earlier definitive fixation of femoral shaft fractures in the setting of polytrauma is associated with significantly decreased risk of ARDS, mean ventilator time, length of ICU and hospital stay, and mortality. (Journal of Surgical Orthopaedic Advances 28(2):137-143, 2019).

Occupational outcomes following combat-related gunshot injury: Cohort study.

BACKGROUND: The long-term impact of gun violence on physical function and occupational disability remains poorly explored. We sought to examine the effect of combat-related gunshot injury on work capacity within a cohort of military servicemembers and identify clinical characteristics that influence the capacity to return to work. METHODS: A query was performed to identify all servicemembers injured by gunshot in the years 2005-2009. These soldiers were then followed for a period up to the end of 2014 in order to identify those separated from service due to an inability to perform military duties as a result of their injury. Socio-demographic and clinical characteristics were considered co-variates. The dependent variable in this study was inability to effectively return to work, as delineated by the proxy of medical separation from military service. A multivariable logistic regression model was used to evaluate factors associated with an increased likelihood of medical separation following gunshot injury. RESULTS: Of the 1417 individuals meeting inclusion criteria, 40% (n = 572) of the cohort were medically separated in the time-period under study. Significant predictors of separation included non-thoracic injuries, increased injury severity score (ISS; OR 1.05; 95% CI 1.04, 1.06), Senior Enlisted (OR 3.90; 95% CI 2.16, 7.01), and Junior Enlisted military rank (OR 6.99; 95% CI 3.93, 12.44). CONCLUSIONS: This is the largest study in the literature to assess the long-term capacity to return to work following gunshot injury in any population. Individuals in high-demand occupations and those with non-thoracic wounds, or elevated ISS, should be counseled in the post-gunshot injury period regarding the negative associations of these characteristics with the capacity to return to work. Enhanced access to social services in the period following injury could similarly benefit individuals of low socioeconomic background.

Predictors of hospital readmission following revision total knee arthroplasty.

PURPOSE: Hospital readmission is emerging as an important quality measure, yet modifiable predictors of readmission remain unknown. This study was designed to identify risk factors for readmission following revision total knee arthroplasty. METHODS: The National Surgical Quality Improvement Program dataset was queried to identify patients undergoing revision total knee arthroplasty from 2011 to 2012. Patient demographics, medical co-morbidities, laboratory values, surgical characteristics and surgical outcomes were examined using bivariate and multivariate logistic regression to identify significant predictors for readmission within 30 days of discharge. RESULTS: There were 108 readmissions (6.2 %) among 1754 patients. Risk factors for readmission included a history of transient ischaemic attack/cerebrovascular accident (OR 3.47; 13 95 % CI 1.30, 9.25), female sex (OR 1.75, 95 % CI 1.15, 2.68) and general anaesthesia (OR 14 1.74, 95 % CI 1.09, 2.79). Hypertension treated with medication (OR 0.61, 95 % CI 0.39, 0.96) was associated with a lower risk of readmission. Post-operative complications that were significant predictors of hospital readmission included periprosthetic joint infection (OR 15.09, 95 % CI 5.57, 40.91), superficial wound infection (OR 16.57, 95 % CI 5.82, 47.22) and deep venous thrombosis (OR 8.59, 95 % CI 2.36, 31.24). CONCLUSIONS: The preferred use of neuraxial anaesthesia and coordinated discharge planning in patients with a history of transient ischaemic attack/cerebrovascular accident may reduce the risk of readmission following discharge after revision total knee arthroplasty. Additionally, patients with post-operative infections and deep venous thrombosis following these procedures can benefit from close observation in the first weeks following discharge to minimize the likelihood of readmission. LEVEL OF EVIDENCE: III.

Occupational Outcomes and Return to Running Following Internal Fixation of Ankle Fractures in a High-Demand Population.

BACKGROUND: Literature evaluating surgical outcomes after ankle fixation in an active patient population is limited. This study determined occupational outcomes and return to running following ankle fracture fixation in a military cohort. METHODS: All service members undergoing ankle fracture fixation at a single military hospital from August 2007 to August 2012 were reviewed. Univariate analysis determined the association between patient demographic information, type of fracture fixation, and the development of posttraumatic ankle arthritis and functional outcomes, including medical separation, return to running, and reoperation. Seventy-two primary ankle fracture fixation procedures were performed on patients with mean age of 29.1 years. The majority of patients were male (88%), were 25 years of age or older (61%), were of junior rank (57%), underwent unimalleolar fracture fixation (78%), and did not require syndesmotic fixation (54%). The average follow-up was 35.9 months. RESULTS: The mean time to radiographic union was 8.6 weeks. Twelve service members (17%) were medically separated from the military due to refractory pain following ankle fracture fixation with a minimum of 2-year occupational follow-up. Among military service members undergoing ankle fracture fixation, 64% returned to running. Service members with higher occupational demands had a statistical trend to return to running (odds ratio [OR] 2.49; 95% CI, 0.93-6.68). Junior enlisted rank was a risk factor for medical separation (OR 11.00; 95% CI, 1.34-90.57). Radiographic evidence of posttraumatic ankle osteoarthritis occurred in 8 (11%) service members. CONCLUSIONS: At mean 3-year follow-up, 83% of service members undergoing ankle fracture fixation remained on active duty or successfully completed their military service, while nearly two-thirds returned to occupationally required daily running. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Patient-Based and Surgical Risk Factors for 30-Day Postoperative Complications and Mortality After Ankle Fracture Fixation.

OBJECTIVE: The purpose was to calculate the incidence rates and determine risk factors for 30-day postoperative mortality and morbidity after ankle fracture open reduction and internal fixation (ORIF). METHODS: The NSQIP database was queried to identify patients undergoing ankle fracture ORIF from 2006 to 2011, with extraction patient-based or surgical variables and a 30-day clinical course. Multivariable logistic regression analysis identified significant predictors on outcome measures. RESULTS: Mean age was 50.3 (±18.2) years while diabetes mellitus (12.8%) and body mass index ≥40 kg/m(2) (9.2%) were documented from a total of 3328 patients identified. The 30-day mortality rate was 0.30%, and complications occurred in 5.1%. Chronic obstructive pulmonary disease [odds ratio (OR): 4.23, 95% confidence interval (CI): 1.19-15.06] and a nonindependent functional status before surgery (OR: 2.25, 95% CI: 1.13-4.51) were the sole independent predictors of mortality and major local complications, respectively. Major local complications occurred in 2.2% of patients, and significant predictors were peripheral vascular disease (OR: 6.14; 95% CI: 1.95-19.35), open wound (OR: 5.04; 95% CI: 2.25-11.27), nonclean wound classification (OR: 3.02; 95% CI: 1.31-6.93), and smoking (OR: 2.85; 95% CI: 1.42-5.70). Independent predictors of hospital stay >3 days were cardiac disease, age 70 years or older, open wound, partially/totally dependent functional status, American Society of Anesthesiologists (ASA) classification ≥3, body mass index ≥40 kg/m(2), bimalleolar or trimalleolar ankle fracture pattern, female sex, and diabetes. CONCLUSIONS: Chronic obstructive pulmonary disease increased the risk of mortality after ankle fracture ORIF. Risk factors for postoperative complications included peripheral vascular disease, open wound, nonclean wound classification, age 70 years or older, and ASA classification ≥3. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Postoperative myocardial infarction and cardiac arrest following primary total knee and hip arthroplasty: rates, risk factors, and time of occurrence.

BACKGROUND: Cardiac complications are a major cause of postoperative morbidity. The purpose of this study was to determine the rates, risk factors, and time of occurrence for cardiac complications within thirty days after primary unilateral total knee arthroplasty and total hip arthroplasty. METHODS: The American College of Surgeons National Surgical Quality Improvement Program data set from 2006 to 2011 was used to identify all total knee arthroplasties and total hip arthroplasties. Cardiac complications occurring within thirty days after surgery were the primary outcome measure. Patients were designated as having a history of cardiac disease if they had a new diagnosis or exacerbation of chronic congestive heart failure or a history of angina within thirty days before surgery, a history of myocardial infarction within six months, and/or any percutaneous cardiac intervention or other major cardiac surgery at any time. An analysis of the occurrence of all major cardiac complications and deaths within the thirty-day postoperative time frame was performed. RESULTS: For the 46,322 patients managed with total knee arthroplasty or total hip arthroplasty, the cardiac complication rate was 0.33% (n = 153) at thirty days postoperatively. In both the total knee arthroplasty and total hip arthroplasty groups, an age of eighty years or more (odds ratios [ORs] = 27.95 and 3.72), hypertension requiring medication (ORs = 4.74 and 2.59), and a history of cardiac disease (ORs = 4.46 and 2.80) were the three most significant predictors for the development of postoperative cardiac complications. Of the patients with a cardiac complication, the time of occurrence was within seven days after surgery for 79% (129 of the 164 patients for whom the time of occurrence could be determined). CONCLUSIONS: An age of eighty years or more, a history of cardiac disease, and hypertension requiring medication are significant risk factors for developing postoperative cardiac complications following primary unilateral total knee arthroplasty and total hip arthroplasty. Consideration should be given to a preoperative cardiology evaluation and co-management in the perioperative period for individuals with these risk factors.

Symptom monitoring, alleviation, and self-care among Mexican Americans during cancer treatment.

Monitoring the occurrence and severity of symptoms among Mexican American adults undergoing cancer treatments, along with their self-care to alleviate symptoms, are understudied; the current study aimed to fill this gap in the literature. A total of 67 Mexican Americans receiving outpatient oncology treatments in the southwestern United States participated. Instruments included a patient-report checklist, the Therapy-Related Symptom Checklist (TRSC), the Symptom Alleviation: Self-Care Methods tool, and a demographic and health information form. At least 40% of participants reported the occurrence of 12 symptoms: hair loss, feeling sluggish, nausea, taste change, loss of appetite, depression, difficulty sleeping, weight loss, difficulty concentrating, constipation, skin changes, and numb fingers and toes. More than a third also reported pain, vomiting, decreased interest in sexual activity, cough, and sore throat. The helpful self-care strategies reported included diet and nutrition changes; lifestyle changes; and mind, body control, and spiritual activities. Patient report of symptoms during cancer treatments was facilitated by the use of the TRSC. Patients use symptom alleviation strategies to help relieve symptoms during their cancer treatment. The ability to perform appropriate, effective self-care methods to alleviate the symptoms may influence adherence to the treatment regimen.

Risk factors for complications and in-hospital mortality following hip fractures: a study using the National Trauma Data Bank.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To describe the impact of patient demographics, injury-specific factors, and medical co-morbidities on outcomes after hip fracture using the National Sample Program (NSP) of the National Trauma Data Bank (NTDB). METHODS: The 2008 NSP-NTDB was queried to identify patients sustaining hip fractures. Patient demographics, co-morbidities, injury-specific factors, and outcomes (including mortality and complications) were recorded and a national estimate model was developed. Unadjusted differences for risk factors were evaluated using t test/Wald Chi square analyses. Weighted logistic regression and sensitivity analyses were performed to control for all factors in the model. RESULTS: The weighted sample contained 44,419 incidents of hip fracture. The average age was 72.7. Sixty-two percent of the population was female and 80 % was white. The mortality rate was 4.5 % and 12.5 % sustained at least one complication. Seventeen percent of patients who sustained at least one complication died. Dialysis, presenting in shock, cardiac disease, male sex, and ISS were significant predictors of mortality, while dialysis, obesity, cardiac disease, diabetes, and a procedure delay of ≥2 days influenced complications. The major potential modifiable risk factor appears to be time to procedure, which had a significant impact on complications. CONCLUSIONS: This is the first study to postulate predictors of morbidity and mortality following hip fracture in a US national model. While many co-morbidities appear to be influential in predicting outcome, some of the more significant factors include the presence of shock, dialysis, obesity, and time to surgery. LEVEL OF EVIDENCE: Prognostic study, Level II.

Thirty-day postoperative complications and mortality following total knee arthroplasty: incidence and risk factors among a national sample of 15,321 patients.

BACKGROUND: The purpose of this investigation was to determine the incidence rates of, and identify risk factors for, thirty-day postoperative mortality and complications among more than 15,000 patients who underwent a primary unilateral total knee arthroplasty as documented in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). METHODS: The NSQIP database was queried to identify patients who had undergone primary unilateral total knee arthroplasty between 2006 and 2010. Patient demographics, medical history, and surgical characteristics were recorded, as were thirty-day postoperative complications, mortality, and length of hospital stay. Complications were divided into categories, which included major systemic complications (complications requiring complex medical intervention) and major local complications (including deep wound infection and peripheral nerve injury). Univariate testing and multivariate logistic regression analysis were used to identify significant independent predictors of the outcome measures. RESULTS: A total of 15,321 individuals underwent primary unilateral total knee arthroplasty. The mean age (and standard deviation) of the patients was 67.3 ± 10.2 years. Obesity (a body mass index [BMI] of ≥30 kg/m²) was documented in 61.2% of cases, 18.2% of patients had diabetes, and 50% were graded as Class 3 or higher on the basis of the American Society of Anesthesiologists (ASA) classification system. The thirty-day mortality rate was 0.18%, and 5.6% of the patients experienced complications. Patient age (odds ratio [OR] = 1.12; 95% confidence interval [CI] = 1.06 to 1.17) and diabetes (OR = 2.99; 95% CI = 1.35 to 6.62) were independent predictors of mortality. A BMI of ≥40 kg/m² was an independent predictor of postoperative complications (OR = 1.47; 95% CI = 1.09 to 1.98). Patient age of eighty years or older, an ASA classification of ≥3, and an operative time of >135 minutes influenced the development of any postoperative complication as well as major and minor systemic complications. Cardiac disease (OR = 4.32; 95% CI = 1.01 to 18.45) and a BMI of ≥40 kg/m² (OR = 2.01; 95% CI = 1.02 to 3.97) were associated with minor local complications. CONCLUSIONS: Patient age and diabetes increased the risk of mortality after primary total unilateral knee arthroplasty. Predictive factors impacting the development of postoperative complications included an ASA classification of ≥3, increased operative time, increased age, and greater body mass.

The impact of resident involvement on post-operative morbidity and mortality following orthopaedic procedures: a study of 43,343 cases.

BACKGROUND: Few studies have addressed the role of residents' participation in morbidity and mortality after orthopaedic surgery. The present study utilized the 2005-2010 National Surgical Quality Improvement Program (NSQIP) dataset to assess the risk of 30-day post-operative complications and mortality associated with resident participation in orthopaedic procedures. METHODS: The NSQIP dataset was queried using codes for 12 common orthopaedic procedures. Patients identified as having received one of the procedures had their records abstracted to obtain demographic data, medical history, operative time, and resident involvement in their surgical care. Thirty-day post-operative outcomes, including complications and mortality, were assessed for all patients. A step-wise multivariate logistic regression model was constructed to evaluate the impact of resident participation on mortality- and complication-risk while controlling for other factors in the model. Primary analyses were performed comparing cases where the attending surgeon operated alone to all other case designations, while a subsequent sensitivity analysis limited inclusion to cases where resident participation was reported by post-graduate year. RESULTS: In the NSQIP dataset, 43,343 patients had received one of the 12 orthopaedic procedures queried. Thirty-five percent of cases were performed with resident participation. The mortality rate, overall, was 2.5 and 10 % sustained one or more complications. Multivariate analysis demonstrated a significant association between resident participation and the risk of one or more complications [OR 1.3 (95 % CI 1.1, 1.4); p < 0.001] as well as major systemic complications [OR 1.6 (95 % CI 1.3, 2.0); p < 0.001] for primary joint arthroplasty procedures only. These findings persisted even after sensitivity testing. CONCLUSIONS: A mild to moderate risk for complications was noted following resident involvement in joint arthroplasty procedures. No significant risk of post-operative morbidity or mortality was appreciated for the other orthopaedic procedures studied. LEVEL OF EVIDENCE: II (Prognostic).

The nature and extent of war injuries sustained by combat specialty personnel killed and wounded in Afghanistan and Iraq, 2003-2011.

BACKGROUND: Previous studies regarding combat wounding have a limited translational capacity due to inclusion of soldiers from all military branches and occupational specialties as well as a lack of information regarding soldiers who died in theater. METHODS: A search was performed of the Department of Defense Trauma Registry and Armed Forces Medical Examiner data set for the years 2003 to 2011 to identify all injured personnel with the military specialty 19D (cavalry scout). A manual search was conducted for each record identified, and age, rank, location and manner of injury, mechanism of injury, Injury Severity Score (ISS), and extent of wounding were abstracted. The incidence of injuries by body region and rates for specific types of wounds were determined. Statistically significant associations between rank, location of injury, manner of injury, body region involved, and injury mechanism were assessed using χ2 analysis. Associations between ISS, rank, manner of injury, and survival were evaluated by t test with Satterthwaite correction. RESULTS: A total of 701 casualties were identified with 3,189 distinct injuries. Mean (SD) age of injured personnel was 25.9 (6.0) years. Thirty-five percent of the cohort was composed of soldiers who died in theater. Explosions were the most common mechanism of injury (70%), while 18% of wounds occurred owing to gunshot. Extremity wounds and injuries to the head and neck represented 34% of casualty burden. Thoracic trauma occurred in 16%, and abdominal injuries occurred in 17%. Wounds with a frequency exceeding 5% included skin, extremity, facial, brain, and gastrointestinal injuries. Vascular injury occurred in 4%. Gunshot wounds were a greater cause of injury in Afghanistan (p = 0.001) and resulted in a higher percentage of thoracic injuries (p < 0.001). CONCLUSION: The nature and extent of trauma sustained by combat-specific personnel seems to be different from that experienced by all soldiers deployed to a war zone.

Patient-based and surgical characteristics associated with the acute development of deep venous thrombosis and pulmonary embolism after spine surgery.

STUDY DESIGN: Retrospective analysis of a prospectively collected data set. OBJECTIVE: Identify the incidence of, and risk factors for, deep venous thrombosis (DVT) and pulmonary embolism (PE) after spine surgery. SUMMARY OF BACKGROUND DATA: Determination of ideal candidates for chemoprophylaxis after spine surgery is limited by the state of the literature, including incomplete understanding regarding the incidence of DVT and PE, as well as an inability to quantify specific risk factors among patients. METHODS: The 2005 to 2011 data set of the National Surgical Quality Improvement Program was queried to identify all individuals having undergone spine surgery. Demographic data, medical comorbidities, surgical characteristics, and the presence of DVT, PE, and/or mortality were abstracted for all individuals meeting inclusion criteria. Unadjusted univariate analysis was performed to identify variables that were potentially associated with the development of DVT or PE after surgery. A multivariate logistic regression test, controlling for other factors present in the model, was subsequently performed. Predictor variables that maintained significance after multivariate testing were considered influential in the development of DVT and/or PE. RESULTS: There were 27,730 patients who received spine procedures in this cohort. The average age was 56.4 (± 15.1) years. Lumbar spine procedures made up 61% of interventions. Death occurred in 87 instances (0.3%). The venous thromboembolic rate was 1%, with 206 individuals (0.7%) sustaining DVT and 113 (0.4%) developing a PE. Body mass index 40 and greater, age 80 years and older, operative time exceeding 261 minutes, and American Society of Anesthesiologists classification 3 or higher were identified as significant independent predictors of DVT, whereas body mass index 40 and greater, operative time exceeding 261 minutes, and male sex were associated with the development of PE. CONCLUSION: Multiple independent risk factors for the development of DVT and/or PE after spine surgery were identified. Patients with these characteristics may require additional counseling, procedural modification, or prophylaxis against venous thromboembolic events.

Patient factors, comorbidities, and surgical characteristics that increase mortality and complication risk after spinal arthrodesis: a prognostic study based on 5,887 patients.

BACKGROUND CONTEXT: The impact of patient factors and medical comorbidities on the risk of mortality and complications after spinal arthrodesis has not been well described. Prior works have been limited by small sample size, single center data, or the inability to be broadly generalized. PURPOSE: To determine if there is an association between the patient demographic factors, comorbidities, nutritional status, and surgical characteristics and the occurrence of mortality and complications after spinal arthrodesis. STUDY DESIGN: Retrospective review of prospectively collected data in the National Surgical Quality Improvement Program (NSQIP). PATIENT SAMPLE: Patients who underwent spinal arthrodesis and had data registered with the NSQIP between 2005 and 2010. OUTCOME MEASURES: Primary outcomes were death or any complication after spinal arthrodesis. Secondary measures were the development of a specific complication, including wound infection, thromboembolic disease, or cardiac arrest/myocardial infarction. METHODS: The data set of the NSQIP from 2005 to 2010 was queried to identify all patients who underwent spinal arthrodesis. Demographic information, body mass index (BMI), medical comorbidities, arthrodesis procedure, operative time, American Society of Anesthesiologists (ASA) classification, and preoperative albumin were recorded for all patients identified. Mortality, the development of postoperative complications, and the presence of specific complications were also abstracted. Risk factors for mortality and complications were initially evaluated using chi-square and univariate logistic regression analyses. The risk factors that maintained p values less than .2 in univariate analysis were then combined in a multivariate fashion that identified significant, independent, predictors of mortality and complications while controlling for other factors present in the model. Sensitivity analysis was also performed, discriminating between the impact of risk factors on major and minor complications and the relative contribution to overall risk of morbidity. Multivariate analysis resulted in odds ratios (ORs) with 95% confidence intervals (CIs) for each risk factor. Only those predictors with ORs and 95% CI exclusive of 1.0 and p values less than .05 were considered statistically significant. RESULTS: In all, 5,887 patients who underwent spinal arthrodesis were identified. The average age of patients was 55.9 (±14.5) years. Twenty-five (0.42%) patients died after surgery, whereas 608 (10%) sustained a complication. Wound infection was the most common specific complication occurring in 2% of the cohort. Age (p=.03) and pulmonary conditions (p=.002) were found to have a significant association with the risk of mortality. Age exceeding 80 years was found to carry the highest risk of mortality. Age, pulmonary conditions, BMI, history of infection, ASA classification more than 2, neurologic conditions, resident (i.e., trainee) involvement, and procedural times exceeding 309 minutes increased the risk of complications. Body mass index, ASA classification more than 2, resident involvement, and procedural times exceeding 309 minutes were associated with the risk of infection. Although limited to univariate analysis, serum albumin 3.5 g/dL or less increased the risk of mortality, complications, wound infection, and thromboembolic disease. The OR for postoperative mortality among patients with albumin 3.5 g/dL or less was 13.8 (95% CI, 4.6-41.6; p<.001). CONCLUSIONS: Several factors, including patients' age, BMI, ASA classification more than 2, pulmonary conditions, procedural times, and nutritional status likely influence the risk of postoperative morbidity to varying degrees. The risk factors identified here may be more generalizable to the American population as a whole because of the design and methodology of the NSQIP in comparison with previously published studies.