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Critical limb ischemia (CLI) is a frequent and major vascular problem and can lead to amputation and death despite surgical revascularization. Women have been shown to have 3 to 4 per cent lower revascularization rates for CLI compared with men as well as inferior outcomes. We hypothesize that this difference is a result of women being more likely admitted to low-volume hospitals, which in turn perform fewer revascularizations. Prospective cohort study. Data from the Nationwide Inpatient Sample 2007 to 2010 were used to identify admissions with primary International Classification of Diseases-9 codes for CLI (International Classification of Diseases-9 codes: 440.22, 440.23, 440.24, 707.1, 707.10-707.15, or 707.19). Hospitals were grouped in quintiles by annual revascularization procedures. Bivariate analyses were performed and multivariable logistic regression was used to analyze the odds of revascularization, amputation, and mortality while controlling for patient and hospital-level factors. Of 113,631 admissions, 54,370 (47.8%) were women, who were more likely admitted to low-volume hospitals (very low: 49.6% vs very high: 47.1%; P < 0.001). Revascularization rates were lower in women (31.6% vs 35.1%, P < 0.001) across all volume quintiles, whereas the difference was greatest in the use of open surgical revascularization (12.5% vs 16.0%, P < 0.001). In multivariable analysis, female gender [odds ratio (OR) 0.87, 95% confidence interval (CI) 0.83-0.92, P < 0.001] and very-low hospital volume (OR 0.21, 95% CI 0.17-0.26, P < 0.001) were both significantly associated with lower rates of revascularization. Women had lower odds of major amputation compared with men (OR 0.75, 95% CI 0.69-0.82, P < 0.001), whereas treatment in a very high-volume hospital was associated with increased odds for amputation (OR 1.37, 95% CI 1.09-1.73, P = 0.008). Neither gender nor hospital volume were independently associated with in-hospital mortality in the multivariable regression model. Women are more likely to be admitted to low-volume hospitals for treatment of CLI. Because of this, they are less likely to undergo revascularization, although they also had lower rates of major amputation.

Aim: To evaluate the clinical and financial impact of introducing electromagnetic navigation bronchoscopy (ENB) at a community center., Methods: This retrospective, single-arm, single-center study evaluated 90 consecutive patients who had undergone ENB in 2012. Radial probe endobronchial ultrasound was used to localize the lesion after initial ENB. ENB-aided diagnoses, follow-up procedures and treatments, and adverse events were collected through 2 years., Results: ENB was conducted for lung biopsy (86 patients), fiducial placement (five), and/or dye marking (two). ENB-aided diagnostic yield was 82.6% (71/86), including 36 malignant and 35 nonmalignant cases. NSCLC was stage I-II in 84.6%. There were four false negatives. Sensitivity and negative predictive value were 90.0 and 88.6%. Pneumothorax occurred in 6/90 (5/6 with chest tube) and minor bleeding in four. The downstream revenue of new ENB cases was US$363,654., Conclusion: ENB introduction provided high diagnostic yield, early-stage diagnosis, acceptable safety, and was financially justified., Competing Interests: Financial & competing interests disclosure N Hevelone, KL Hood and S Pidgeon are full-time employees of Medtronic and assisted SK Garwood in data compilation (S Pidgeon), analysis (N Hevelone) and manuscript writing (KL Hood). The study was sponsored and funded by Medtronic (Minneapolis, MN), which provided input into the study design, data analysis and manuscript writing. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing assistance was provided by KL Hood and was funded by Medtronic.

Objective: Major lower extremity (MLE) amputation is a common procedure that results in a profound change in a patient's life. We sought to determine the association between social support and outcomes after amputation. We hypothesized that patients with greater social support will have better post amputation outcomes., Methods: From November 2011 to May 2013, we conducted a cross-sectional, observational, multicenter study. Social integration was measured by the social integration subset of the Short Form Craig Handicap Assessment and Reporting Technique. Systemic social support was assessed by comparing a United States and Tanzanian population. Walking function was measured using the 6-minute walk test and quality of life (QoL) was measured using the EuroQol-5D., Results: We recruited 102 MLE amputees. Sixty-three patients were enrolled in the United States with a mean age of 58.0. Forty-two (67%) were male. Patients with low social integration were more likely to be unable to ambulate (no walk 39% vs slow walk 23% vs fast walk 10%; P = .01) and those with high social integration were more likely to be fast walkers (no walk 10% vs slow walk 59% vs fast walk 74%; P = .01). This relationship persisted in a multivariable analysis. Increasing social integration scores were also positively associated with increasing QoL scores in a multivariable analysis (β, .002; standard error, 0.0008; P = .02). In comparing the United States population with the Tanzanian cohort (39 subjects), there were no differences between functional or QoL outcomes in the systemic social support analysis., Conclusions: In the United States population, increased social integration is associated with both improved function and QoL outcomes among MLE amputees. Systemic social support, as measured by comparing the United States population with a Tanzanian population, was not associated with improved function or QoL outcomes. In the United States, steps should be taken to identify and aid amputees with poor social integration., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Although various studies have documented increased life-sustaining treatments among racial minorities in medical patients, whether similar disparities exist in surgical patients is unknown., Methods: A retrospective cohort study using the Nationwide Inpatient Sample (2006 to 2011) examining patients older than 39 years who died after elective colectomy was performed. Primary predictor variable was race, and main outcome was the use of life-sustaining treatment., Results: In univariate analysis, significant differences existed in use of cardiopulmonary resuscitation (CPR; black, 35.9%; Hispanic, 29.0%; other, 24.5%; white, 11.7%; P = .002) and reintubation (Hispanic, 75.0%; other, 69.0%; black, 52.3%; white, 45.2%; P = .01). In multivariate analysis, black (odds ratio [OR], 3.67; P = .01) and Hispanic (OR, 4.21; P = .03) patients were more likely to have undergone CPR, and Hispanic patients (OR, 4.24; P = .01) were more likely to have been reintubated (reference: white)., Conclusions: Blacks and Hispanics had increased odds of experiencing CPR, and Hispanics were more likely to have been reintubated before death after a major elective operation. These variations may imply worse quality of death and increased associated costs., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Face transplantation is an increasingly feasible option for patients with severe disfigurement. Donors and recipients are currently matched based on immune compatibility, skin characteristics, age, and gender. Aesthetic outcomes of the match are not always optimal and not possible to study in actual cases due to ethical and logistical challenges. We have used a reproducible and inexpensive three-dimensional virtual face transplantation (VFT) model to study this issue., Methods: Sixty-one VFTs were performed using reconstructed high-resolution computed tomography angiographs of male and female subjects aged 20-69 years. Twenty independent reviewers evaluated the level of disfigurement of the posttransplant models. Absolute differences in 9 soft-tissue measurements and 16 bony cephalometric measurements from each of the VFT donor and recipient pretransplant model pairs were correlated to the reviewers' evaluation of disfigurement after VFT through a multivariate logistic regression model., Results: Five soft-tissue measurements and 3 bony measurements were predictive of the rating of disfigurement after VFT (odds ratio; 95% confidence interval): trichion-to-nasion facial height (1.106; 1.066-1.148), endocanthal width (1.096; 1.051-1.142), exocanthal width (1.067; 1.036-1.099), mouth/chelion width (1.064; 1.019-1.110), subnasale-to-menton facial height (1.029; 1.003-1.056), inner orbit width (1.039; 1.009-1.069), palatal plane/occlusal plane angle (1.148; 1.047-1.258), and sella-nasion/mandibular plane angle (1.079; 1.013-1.150)., Conclusions: This study provides early evidence for the importance of soft-tissue and bony measurements in planning of facial transplantation. With future improvements to immunosuppressive regimens and increased donor availability, these measurements may be used as an additional criterion to optimize posttransplant outcomes.

Objective: To identify the timing and relative frequency of common postoperative complications in a contemporary, diverse surgical population and develop a mnemonic for teaching and clinical decision support., Patients and Methods: We enrolled a cohort of general and vascular surgical patients undergoing elective, inpatient surgery in the American College of Surgeons National Surgical Quality Improvement Program database between 2005 and 2011. Index complications were noted by postoperative day (POD). Timing and incidence were compared within each day., Results: Among 614,525 patients, 51,173 (9.88%) experienced the following index complications over 30 days: pneumonia (n = 5947), urinary tract infection (n = 9459), superficial surgical site infection (sSSI) (n = 20,460), deep/organ space surgical site infection (dSSI) infection (n = 11,847), venous thromboembolism (n = 4478), kidney injury (n = 2620), and myocardial infarction (n = 1813). Median time to complication differed significantly for index complications (p < 0.0001). On POD 0, the most common complication was myocardial infarction (incidence 4.26/10,000 patient days; 95% CI: 3.75-4.78). On POD 1 and 2, pneumonia was the most common complication, with peak incidence on POD 2 (20.36; 95% CI: 19.22-21.51). On POD 3, pneumonia (16.3; 95% CI: 15.27-17.33) and urinary tract infection (15.5; 95% CI: 14.49-16.51) were significantly more common than other complications. On POD 4, the most common complication was sSSI (16.24; 95% CI: 15.20-17.28). From POD 5 to POD 30, sSSI and dSSI were the 2 most common complications. Risk of venous thromboembolism declined only slightly through POD 30., Conclusion: We propose a mnemonic for postoperative complication timing and frequency, independent of fever, as follows: Waves (myocardial infarction), Wind (pneumonia), Water (urinary tract), Wound (sSSI and dSSI), and Walking (venous thromboembolism) in the order of likelihood., (Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Wound complications negatively affect outcomes of lower extremity arterial reconstruction. By way of an investigator initiated clinical trial, we tested the hypothesis that a silver-eluting alginate topical surgical dressing would lower wound complication rates in patients undergoing open arterial procedures in the lower extremity., Methods: The study block-randomized 500 patients at three institutions to standard gauze or silver alginate dressings placed over incisions after leg arterial surgery. This original operating room dressing remained until gross soiling, clinical need to remove, or postoperative day 3, whichever was first. Subsequent care was at the provider's discretion. The primary end point was 30-day wound complication incidence generally based on National Surgical Quality Improvement Program guidelines. Demographic, clinical, quality of life, and economic end points were also collected. Wound closure was at the surgeon's discretion., Results: Participants (72% male) were 84% white, 45% were diabetic, 41% had critical limb ischemia, and 32% had claudication (with aneurysm, bypass revision, other). The overall 30-day wound complication incidence was 30%, with superficial surgical site infection as the most common. In intent-to-treat analysis, silver alginate had no effect on wound complications. Multivariable analysis showed that Coumadin (Bristol-Myers Squibb, Princeton, NJ; odds ratio [OR], 1.72; 95% confidence interval [CI], 1.03-2.87; P = .03), higher body mass index (OR, 1.05; 95% CI, 1.01-1.09; P = .01), and the use of no conduit/material (OR, 0.12; 95% CI, 0.82-3.59; P < .001) were independently associated with wound complications., Conclusions: The incidence of wound complications remains high in contemporary open lower extremity arterial surgery. Under the study conditions, a silver-eluting alginate dressing showed no effect on the incidence of wound complications., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Breast cancer diagnosed in young women may be more aggressive, with higher rates of local and distant recurrence compared to the disease in older women. Epidemiologic evidence suggests that Korean women have a lower incidence of breast cancer than women in the United States, but that they present at a younger age than their American counterparts. We sought to compare risk factors and management of young women with breast cancer in Boston, Massachusetts (US) with those in Seoul, South Korea (KR)., Materials and Methods: A retrospective review was performed of consecutive patients less than 35 years old with a diagnosis of breast cancer at academic cancer centers in the US and KR from 2000-2005. Patient data were obtained by chart review. Demographic, tumor and treatment characteristics were compared utilizing Pearson's chi- square or Wilcoxon rank-sum tests where appropriate. All differences were assessed as significant at the 0.05 level., Results: 205 patients from the US and 309 from KR were analyzed. Patients in US were more likely to have hormone receptor positive breast cancer, while patients in KR had a higher rate of triple negative lesions. Patients in US had a higher mean body mass index and more often reported use of birth control pills, while those in the KR were less likely to have a sentinel node procedure performed or to receive post mastectomy radiation., Conclusions: Patients under 35 diagnosed with breast cancer in the US and KR differ with respect to demographics, tumor characteristics and management. Although rates of breast conservation and mastectomy were similar, US patients were more likely to receive post mastectomy radiation. The lower use of sentinel node biopsy is explained by the later adoption of the technique in KR. Further evaluation is necessary to evaluate recurrence rates and survival in the setting of differing disease subtypes in these patients.

Background: Large facial tissue defects are traditionally treated with staged conventional reconstruction. Facial allograft transplantation has emerged as a treatment modality. Facial allografts are procured from a dead donor and transplanted to the recipient. Recipients are then subjected to lifelong global immunosuppression to prevent immunologic rejection. This study analyzes the cost of facial allograft transplantation in comparison with conventional reconstruction., Methods: Hospital billing records from facial allograft transplantation (2009 to 2011) and conventional reconstruction (2000 to 2010) patients were compiled. Comparative 1-year costs were calculated, segregated by physician, hospital, and hospital's department costs. Because most conventional reconstruction patients had smaller facial deficits than their facial allograft transplantation counterparts, regression models were used to estimate costs of conventional reconstruction for full facial defects, mirroring the facial transplantation cohort. All costs were adjusted using the medical consumer price index., Results: One-year costs for facial allograft transplantation were significantly higher than those for conventional reconstruction (mean/median, $337,360/$313,068 versus $70,230/$64,451, respectively). One-year costs for a hypothetical full-face conventional reconstruction were $184,061 (95 percent CI, $89,358 to $278,763). The per-patient cost in a hypothetical cohort of conventional reconstruction patients with deficits identical to four facial allograft transplantation recipients was $155,475 (95 percent CI, $69,021 to $241,929)., Conclusions: Initial cost comparison portrays facial allograft transplantation as significantly more costly than conventional reconstruction. However, after adjustments for case severity, the cost profiles are similar. Gains in efficiency and experience are expected to lower costs. Additional unmeasured benefits may also positively influence the cost-to-benefit ratio of facial allograft transplantation.

Objective: Although mortality after elective abdominal aortic aneurysm (AAA) repair has steadily declined, operative mortality for a ruptured AAA (rAAA) remains high. Repair of rAAA at hospitals with a higher elective aneurysm workload has been associated with lower mortality rates irrespective of the mode of treatment. This study sought to determine the association between surgeon specialization and outcomes after rAAA repair., Methods: The American College of Surgeons National Surgical Quality Improvement Project database from 2005 to 2010 was used to examine the 30-day mortality and morbidity outcomes of patients undergoing rAAA repair by vascular and general surgeons. Multivariable logistic regression analysis was performed for each death and morbidity, adjusting for all independently predictive preoperative risk factors. Survival curves were compared using the log-rank test., Results: We identified 1893 repairs of rAAAs, of which 1767 (96.1%) were performed by vascular surgeons and 72 (3.9%) were performed by general surgeons. There were no significant differences between patients operated on by general vs vascular surgeons in preoperative risk factors or method of repair. Overall 30-day mortality was 34.3% (649 of 1893). After risk adjustment, mortality was significantly lower in the vascular surgery group compared with the general surgery group (odds ratio [OR], 0.51; 95% confidence interval [CI], 0.30-0.86; P = .011). The risk of returning to the operating room (OR, 0.58; 95% CI, 0.35-0.97; P = .038), renal failure (OR, 0.54; 95% CI, 0.31-0.95; P = .034), and a cardiac complication (OR, 0.53; 95% CI, 0.28-0.99; P = .047) were all significantly less in the vascular surgery group., Conclusions: Despite similar preoperative risk factors profiles, patients who were operated on by vascular surgeons had lower mortality, less frequent returns to the operating room, and decreased incidences of postoperative renal failure and cardiac events. These data add weight to the case for further centralization of vascular services., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The indications for carotid revascularization are based almost exclusively on the results of carotid duplex ultrasonography. Noninvasive vascular laboratories show large variation in the diagnostic criteria used to classify degree of carotid artery stenosis. We hypothesize that variability of these diagnostic criteria causes significant variation in stenosis classification directly affecting the number of revascularizations and associated costs., Methods and Results: The diagnostic criteria to interpret carotid duplex ultrasounds were obtained from 10 New England institutions. All carotid duplex scans performed at our institution were reviewed from 2008 to 2012. Using the diagnostic criteria from each institution, the degree of stenosis that would have been reported was classified as 70% to 99% asymptomatic, 80% to 99% asymptomatic, and 50% to 99% symptomatic. We then calculated the theoretical number of carotid revascularization procedures that this cohort would be offered using each institution's diagnostic criteria and the costs of these procedures based on reimbursement rates. Among 10 614 patients who underwent 15 534 carotid duplex scans, 31 025 arteries were reviewed. Application of the 10 institutions' criteria to the patients from our institution yielded marked variation in the number classified as 70% to 99% asymptomatic (range, 186-2201), 80% to 99% asymptomatic (range, 78-426), and 50% to 99% symptomatic (range, 157-781). If revascularizations were based on these results, costs would range from $2.2 to $26 million, $0.9 to $5.0 million, and $1.9 to $9.2 million, respectively., Conclusions: Differences in diagnostic criteria to interpret carotid ultrasound result in significant variation in classification of carotid artery stenosis, likely leading to differences in the number and subsequent costs of revascularizations. This theoretical model highlights the need for standardization of carotid duplex criteria., (© 2014 American Heart Association, Inc.)

Objective: The value and cost-effectiveness of less invasive alternative imaging (AI) modalities (duplex ultrasound scanning, computed tomography angiography, and magnetic resonance angiography) in the care of peripheral arterial disease (PAD) has been reported; however, there is no consensus on their role. We hypothesized that AI utilization is low compared with angiography in the United States and that patient and hospital characteristics are both associated with AI utilization., Methods: The Nationwide Inpatient Sample (2007-2010) was used to identify patients with an International Classification of Diseases-Ninth Edition diagnosis of claudication or critical limb ischemia (CLI) as well as PAD treatment (surgical, endovascular, or amputation). Patients with AI and those with angiography or expected angiography (endovascular procedures without imaging codes) were selected and compared. Multivariable logistic regression was performed for receiving AI stratified by claudication and CLI and adjusting for patient and hospital factors., Results: We identified 290,184 PAD patients, of whom 5702 (2.0%) received AI. Patients with AI were more likely to have diagnosis of CLI (78.8% vs 48.6%; P < .0001) and receive open revascularizations (30.4% vs 18.8%; P < .0001). Van Walraven comorbidity scores (mean [standard error] 5.85 ± 0.22 vs 4.10 ± 0.05; P < .0001) reflected a higher comorbidity burden in AI patients. In multivariable analysis for claudicant patients, AI was associated with large bed size (odds ratio [OR], 3.26, 95% confidence interval [CI], 1.16-9.18; P = .025), teaching hospitals (OR, 1.97; 95% CI, 1.10-3.52; P = .023), and renal failure (OR, 1.52; 95% CI, 1.13-2.05; P = .006). For CLI patients, AI was associated with black race (OR, 1.53; 95% CI, 1.13-2.08; P = .006) and chronic heart failure (OR, 1.29; 95% CI, 1.04-1.60; P = .021) and was negatively associated with renal failure (OR, 0.80; 95% CI, 0.67-0.95; P = .012). The Northeast and West regions were associated with higher odds of AI in claudicant patients (OR, 2.41; 95% CI, 1.23-4.75; P = .011; and OR, 2.59; 95% CI, 1.34-5.02; P = .005, respectively) and CLI patients (OR, 4.31; 95% CI, 2.20-8.36; P < .0001; and OR, 2.18; 95% CI, 1.12-4.22; P = .021, respectively). Rates of AI utilization across states were not evenly distributed but showed great variability, with ranges from 0.31% to 9.81%., Conclusions: National utilization of AI for PAD is low and shows great variation among institutions in the United States. Patient and hospital factors are both associated with receiving AI in PAD care, and AI utilization is subject to significant regional variation. These findings suggest differences in systems of care or practice patterns and call for a clearer understanding and a more unified approach to imaging strategies in PAD care., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Importance: Failure to rescue (FTR), the mortality rate among surgical patients with complications, is an emerging quality indicator. Hospitals with a high safety-net burden, defined as the proportion of patients covered by Medicaid or uninsured, provide a disproportionate share of medical care to vulnerable populations. Given the financial strains on hospitals with a high safety-net burden, availability of clinical resources may have a role in outcome disparities., Objectives: To assess the association between safety-net burden and FTR and to evaluate the effect of clinical resources on this relationship., Design, Setting, and Participants: A retrospective cohort of 46,519 patients who underwent high-risk inpatient surgery between January 1, 2007, and December 31, 2010, was assembled using the Nationwide Inpatient Sample. Hospitals were divided into the following 3 safety-net categories: high-burden hospitals (HBHs), moderate-burden hospitals (MBHs), and low-burden hospitals (LBHs). Bivariate and multivariate analyses controlling for patient, procedural, and hospital characteristics, as well as clinical resources, were used to evaluate the relationship between safety-net burden and FTR., Main Outcomes and Measures: FTR., Results: Patients in HBHs were younger (mean age, 65.2 vs 68.2 years; P = .001), more likely to be of black race (11.3% vs 4.2%, P < .001), and less likely to undergo an elective procedure (39.3% vs 48.6%, P = .002) compared with patients in LBHs. The HBHs were more likely to be large, major teaching facilities and to have high levels of technology (8.6% vs 4.0%, P = .02), sophisticated internal medicine (7.7% vs 4.3%, P = .10), and high ratios of respiratory therapists to beds (39.7% vs 21.1%, P < .001). However, HBHs had lower proportions of registered nurses (27.9% vs 38.8%, P = .02) and were less likely to have a positron emission tomographic scanner (15.4% vs 22.0%, P = .03) and a fully implemented electronic medical record (12.6% vs 17.8%, P = .03). Multivariate analyses showed that HBHs (adjusted odds ratio, 1.35; 95% CI, 1.19-1.53; P < .001) and MBHs (adjusted odds ratio, 1.15; 95% CI, 1.05-1.27; P = .005) were associated with higher odds of FTR compared with LBHs, even after adjustment for clinical resources., Conclusions and Relevance: Despite access to resources that can improve patient rescue rates, HBHs had higher odds of FTR, suggesting that availability of hospital clinical resources alone does not explain increased FTR rates.

Background: Patients with critical limb ischemia (CLI) often undergo revascularization before amputation. The exact relationship between multiple procedures and increased risk of amputation is unclear. We sought to determine the increased risk of amputation for each additional revascularization., Methods: The 2007-2009 California State Inpatient Database (SID) was used to identify a cohort of CLI patients undergoing revascularization and conduct a time-to-event analysis for patients undergoing one or more revascularization procedures. One-year estimates were generated with Kaplan-Meier curves and compared with the log-rank test. The Wei-Lin-Weissfeld (WLW) marginal proportional hazards model was used to assess independent effects of number of revascularization procedures on amputation and death., Results: A total of 11,190 patients with CLI underwent revascularization between July 2007 and December 2009. Their mean age was 71.0 years (interquartile range 62-80 years) and 6255 (55.9%) were male. Over half the subjects (55.2%) were smokers and there was a high burden of comorbidities in the cohort. One-year estimates of amputation by number of revascularizations (1: 23.3%; 2: 27.1%; 3: 30.3%; 4: 26.7%; 5(+): 28.6%; P < 0.001) and death (1: 18.7%; 2: 21.1%; 3: 26.3%; 4: 23.6%; 5+: 32.1%; P = 0.012) increased significantly as procedures increased. In the WLW model for amputation, the hazard increased significantly for patients with 2 revascularization versus 1 (HR = 1.22; 95% CI 1.09-1.37; P = 0.001) and 3 revascularizations versus 2 (HR = 1.33; 95% CI 1.10-1.62; P = 0.004). In the multivariable WLW models for death, the increase in revascularization procedures for 2 compared with 1 (HR = 1.18; 95% CI 1.04-1.34; P = 0.010) was significant., Conclusions: The risk of amputation increases with each additional revascularization procedure. These findings hold true for both percutaneous transluminal angioplasty only and lower extremity bypass only subsets. In addition, increased revascularization procedures appear to result in an increased risk of death. We advocate for continued communication between clinicians and patients on the true risks and benefits of additional revascularization procedures., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: With the increasing incidence of small renal masses, there is greater use of ablation, nephron sparing surgery and surveillance compared to radical nephrectomy. However, patterns of care in the use of posttreatment imaging remain uncharacterized. The purpose of this study is to determine the rate of posttreatment imaging after various treatments for small renal mass., Materials and Methods: Using SEER (Surveillance, Epidemiology and End Results)-Medicare data during 2005 to 2009, we identified 1,682 subjects diagnosed with small renal mass and treated with open partial nephrectomy (330), minimally invasive partial nephrectomy (160), open radical nephrectomy (404), minimally invasive radical nephrectomy (535), thermal ablation (212) and surveillance (42). Use of imaging was compared within 24 months of treatment and multivariate regression models were constructed to identify factors associated with increased imaging use., Results: On adjusted analyses thermal ablation was associated with almost eightfold greater odds of surveillance imaging compared with open radical nephrectomy (OR 7.7, 95% CI 1.01-59.4). Specifically, thermal ablation was associated with increased computerized tomography (OR 5.28) and magnetic resonance imaging (OR 2.19) use and decreased ultrasound use (OR 0.59). Minimally invasive partial nephrectomy (OR 3.28) and open partial nephrectomy (OR 3.19) were also associated with increased computerized tomography use to a lesser extent., Conclusions: Subjects undergoing nephron sparing surgery undergo more posttreatment imaging compared to open radical nephrectomy. Although possibly associated with lower morbidity, thermal ablation is associated with significantly greater use of imaging compared to other small renal mass treatments. This may increase costs and radiation exposure, although further study is needed for confirmation., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: Analysis of complex survey databases is an important tool for health services researchers. Missing data elements are challenging because the reasons for "missingness" are multifactorial, especially categorical variables such as race. We simulated missing data for race and analyzed the bias from five methods used in predicting major amputation in patients with critical limb ischemia (CLI)., Methods: Patient discharges with fully observed data containing lower extremity revascularization or major amputation and CLI were selected from the 2003 to 2007 Nationwide Inpatient Sample, a complex survey database (weighted n = 684,057). Considering several random missing data schemes, we compared five missing data methods: complete case analysis, replacement with observed frequencies, missing indicator variable, multiple imputation, and reweighted estimating equations. We created 100 simulated data sets, with 5%, 15%, or 30% of subjects' race drawn to be missing from the full data set. Bias was estimated by comparing the estimated regression coefficients averaged over 100 simulated data sets (β(miss)) from each method vs estimates from the fully observed data set (β(full)), with relative bias calculated as (β(full) - β(miss)/β(full)) × 100%., Results: Our results demonstrate that reweighted estimating equations produce the least biased and the missing indicator variable produces the most biased coefficients. Complete case analysis, replacement with observed frequencies, and multiple imputation resulted in moderate bias. Sensitivity analysis demonstrated the optimal method choice depends on the quantity and type of missing data encountered., Conclusions: Missing data are an important analytic topic in research with large databases. The commonly used missing indicator variable method introduces severe bias and should be used with caution. We present empiric evidence to guide method selection for handling missing data., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Facial appearance transfer from donor to recipient in face transplantation is a concern. Previous studies of facial appearance transfer and facial appearance persistence (preservation of the recipient's facial likeness) in face transplants simulated using two-dimensional photographic manipulations found low facial appearance transfer (2.6 percent) and high facial appearance persistence (66 percent). Three-dimensional computer simulation of complex facial transplant patterns may improve the accuracy of facial appearance transfer and facial appearance persistence estimations., Methods: Three-dimensional virtual models of human faces were generated from deidentified computed tomographic angiographs and used as "donors" or "recipients" for virtual face transplantation. Surgical planning software was used to perform 73 virtual face transplantations by creating specific facial defects (mandibular, midface, or large) in the recipient models and restoring them with allografts extracted from the donor models. Twenty independent reviewers evaluated the resemblance of each resulting posttransplant model to the donor (facial appearance transfer) and recipient (facial appearance persistence). The results were analyzed using tests for equal results with one-sample and pairwise Rao-Scott Pearson chi-square testing, correcting for clustering and multiple testing., Results: Overall rates of facial appearance persistence and facial appearance transfer were high (69.2 percent) and low (32.4 percent), respectively. The mandibular pattern had the highest rates of facial appearance persistence and lowest rates of facial appearance transfer. Facial appearance persistence and transfer were similar across sexes., Conclusions: Facial appearance persistence is high and facial appearance transfer is low after virtual face transplantation. Appearance transfer and persistence after virtual face transplantation are more dependent on the anatomy than on the size of transplanted facial aesthetic units. This information may reassure recipients of partial face transplants and donor families.

Objective: Acute limb ischemia remains one of the most challenging emergencies in vascular surgery. Historically, outcomes following interventions for acute limb ischemia have been associated with high rates of morbidity and mortality. The purpose of this study was to determine contemporary outcomes following lower extremity bypass performed for acute limb ischemia., Methods: All patients undergoing infrainguinal lower extremity bypass between 2003 and 2011 within hospitals comprising the Vascular Study Group of New England were identified. Patients were stratified according to whether or not the indication for lower extremity bypass was acute limb ischemia. Primary end points included bypass graft occlusion, major amputation, and mortality at 1 year postoperatively as determined by Kaplan-Meier life table analysis. Multivariable Cox proportional hazards models were constructed to evaluate independent predictors of mortality and major amputation at 1 year., Results: Of 5712 lower extremity bypass procedures, 323 (5.7%) were performed for acute limb ischemia. Patients undergoing lower extremity bypass for acute limb ischemia were similar in age (66 vs 67; P = .084) and sex (68% male vs 69% male; P = .617) compared with chronic ischemia patients, but were less likely to be on aspirin (63% vs 75%; P < .0001) or a statin (55% vs 68%; P < .0001). Patients with acute limb ischemia were more likely to be current smokers (49% vs 39%; P < .0001), to have had a prior ipsilateral bypass (33% vs 24%; P = .004) or a prior ipsilateral percutaneous intervention (41% vs 29%; P = .001). Bypasses performed for acute limb ischemia were longer in duration (270 vs 244 minutes; P = .007), had greater blood loss (363 vs 272 mL; P < .0001), and more commonly utilized prosthetic conduits (41% vs 33%; P = .003). Acute limb ischemia patients experienced increased in-hospital major adverse events (20% vs 12%; P < .0001) including myocardial infarction, congestive heart failure exacerbation, deterioration in renal function, and respiratory complications. Patients who underwent lower extremity bypass for acute limb ischemia had no difference in rates of graft occlusion (18.1% vs 18.5%; P = .77), but did have significantly higher rates of limb loss (22.4% vs 9.7%; P < .0001) and mortality (20.9% vs 13.1%; P < .0001) at 1 year. On multivariable analysis, acute limb ischemia was an independent predictor of both major amputation (hazard ratio, 2.16; confidence interval, 1.38-3.40; P = .001) and mortality (hazard ratio, 1.41; confidence interval, 1.09-1.83; P = .009) at 1 year., Conclusions: Patients who present with acute limb ischemia represent a less medically optimized subgroup within the population of patients undergoing lower extremity bypass. These patients may be expected to have more complex operations followed by increased rates of perioperative adverse events. Additionally, despite equivalent graft patency rates, patients undergoing lower extremity bypass for acute ischemia have significantly higher rates of major amputation and mortality at 1 year., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: The share of total abdominal aortic aneurysm (AAA) repairs performed by endovascular aneurysm repair (EVAR) increased rapidly from 32% in 2001 to 65% in 2006 with considerable variation between states. We hypothesized that hospitals in competitive markets were early EVAR adopters and had improved AAA repair outcomes., Methods: Nationwide Inpatient Sample and linked Hospital Market Structure (HMS) data was queried for patients who underwent repair for nonruptured AAA in 2003. In HMS, the Herfindahl Hirschman Index (HHI, range 0-1) is a validated and widely accepted economic measure of competition. Hospital markets were defined using a variable geographic radius that encompassed 90% of discharged patients. We conducted bivariate and multivariable linear and logistic regression analyses for the dependent variable of EVAR use. A propensity score-adjusted multivariable logistic regression model was used to control for treatment bias in the assessment of competition on AAA repair outcomes., Results: A weighted total of 21,600 patients was included in our analyses. Patients at more competitive hospitals (lower HHI) were at increased odds of undergoing EVAR vs open repair (odds ratio, 1.127 per 0.1 decrease in HHI; P < .0127) after adjusting for patient demographics, comorbidities, and hospital level factors (bed size, teaching status, AAA repair volume, and ownership). Competition was not associated with differences in in-hospital mortality or vascular, neurologic, or other minor postoperative complications., Conclusions: Greater hospital competition is significantly associated with increased EVAR adoption at a time when diffusion of this technology passed its tipping point. Hospital competition does not influence post-AAA repair outcomes. These results suggest that adoption of novel vascular technology is not solely driven by clinical indications but may also be influenced by market forces., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Unlabelled: What's known on the subject? and what does the study add?: Retrospective data have suggested an increased survival benefit for patients undergoing partial nephrectomy compared to radical nephrectomy, possibly as a result of the avoidance of long-term renalin sufficiency and subsequent sequelae. However, recent level-one evidence has questioned this benefit. Both retrospective studies and randomized controlled trials are not without limitations. There are few population-based data available with respect to the outcomes of partial nephrectomy vs radical nephrectomy. Additionally, there are no population-based studies analyzing the surgical approach (minimally-invasive vs open), as well as other modalities, such as ablation and surveillance. Finally, there is very little information available on the potential differences in cost for each approach. The present study comprises the first comprehensive population-based analysis of the trends, outcomes and costs of all treatment modalities for T1a renal masses from 2005 to 2007., Objective: To perform a comprehensive analysis of the outcomes and costs for treatments for small renal masses (SRM) using a population-based approach. Partial nephrectomy may be associated with improved survival, although level-one evidence has questioned this survival advantage., Patients and Methods: Using Surveillance, Epidemiology and End Results-Medicare data, we identified 1682 subjects who were diagnosed with SRM from 2005 to 2007. Treatment included open radical nephrectomy (ORN; n = 404), minimally-invasive radical nephrectomy (MIRN; n = 535), open partial nephrectomy (OPN; n = 330), minimally-invasive partial nephrectomy (MIPN; n = 160), ablation (n = 211) and surveillance (n = 42). Postoperative complications, renal insufficiency diagnosis, overall mortality, cancer-specific mortality and postoperative costs were compared. Covariates were balanced before outcomes analysis using propensity score methods., Results: Although the use of nephron-sparing surgery (NSS) increased over the study period, radical nephrectomy remained the predominant approach for SRM in 2007. Minimally-invasive approaches had shorter lengths of stay (P < 0.001), whereas open approaches had more overall complications, respiratory complications and intensive care unit admissions (all P < 0.003). MIRN and ORN were associated with more peri-operative medical complications, acute renal failure, haemodialysis use and long-term chronic renal insufficiency diagnosis vs NSS (all P < 0.001). Ablation, MIRN and ORN were associated with the highest overall mortality rates (P < 0.001), whereas MIRN and ORN were associated with the highest cancer-specific mortality rates (P < 0.001). Treatment costs were lowest for surveillance ($2911) followed by ablation ($10730), MIRN ($15373), MIPN ($15695), OPN ($16986) and ORN ($17803)., Conclusions: Although not the predominant treatment approach for SRM over the study period, the use of NSS increased and was associated with improved survival, fewer complications and less renal insufficiency. Minimally-invasive approaches confer lower costs., (© 2013 BJU International.)

Background: One of the most common and severe complications of long-term parenteral nutrition (PN) is PN-associated cholestasis. The soybean oil-based lipid emulsion administered with PN has been associated with cholestasis, leading to an interest in lipid reduction strategies. The purpose of this study was to determine whether the provision of a soybean oil-based lipid emulsion at 1 g/kg/d compared with 2-3 g/kg/d is associated with a reduced incidence of cholestasis., Methods: Retrospective review of neonates admitted between 2007 and 2011 with a gastrointestinal condition necessitating ≥ 21 days of PN support. Neonates were divided into 2 groups based on the intravenous lipid emulsion dose: 1-g group (1 g/kg/d) and 2- to 3-g group (2-3 g/kg/d). The primary outcome measure was the incidence of cholestasis., Results: Sixty-one patients met inclusion criteria (n = 29, 1-g group; n = 32, 2- to 3-g group). The 2 groups did not differ in any baseline characteristics other than associated comorbidities that were more common in the 2- to 3-g group. The duration of PN, the number of operative procedures and bloodstream infections, and enteral nutrition (EN) were similar between groups. The incidence of cholestasis was not different between groups (51.7%, 1-g group; 43.8%, 2- to 3-g group; P = .61), and there was no difference between groups in the time to cholestasis (32.6 ± 24.1 days, 1-g group; 27.7 ± 10.6 days, 2- to 3-g group; P = .48). Overall, 44.8% of patients with cholestasis were transitioned to full EN, and 55.2% were transitioned to a fish oil-based lipid emulsion after which the direct bilirubin normalized in all patients., Conclusion: Lipid reduction to 1 g/kg/d does not prevent or delay the onset of cholestasis in neonates.

Introduction: The largest randomized controlled trial that compared the efficacy of carotid endarterectomy (CEA) with carotid artery stenting (CAS) showed equivalent outcomes for the composite end point of postoperative stroke, myocardial infarction (MI), or death. However, CAS had a higher risk of postoperative stroke, and CEA had a higher risk of MI. We hypothesize that there is a differential association of postoperative stroke, compared with that of postoperative MI, with reduced long-term survival after carotid revascularization when compared with neither complication., Methods: The Vascular Study Group of New England database was used to identify all CEA and CAS procedures performed between 2003 and 2011. Patients were stratified according to whether they experienced an in-hospital postoperative stroke (minor or major), MI (troponin elevation, electrocardiographic changes, or clinical symptoms), or neither. Primary study end point was survival during the first year and the first 5 years postoperatively. Multivariable Cox proportional hazards models compared the magnitude of association of stroke and MI on survival., Results: Of 8315 patients, 81 (0.97%) experienced postoperative MI, and 63 (0.76%) experienced stroke. During the first year after operation, survival significantly differed among the three groups: neither, 96%; MI, 84%; stroke, 77% (log-rank P < .0001). After adjusting for confounders, survival after postoperative stroke (hazard ratio [HR], 6.6; 95% confidence interval [CI], 3.7-12; P < .0001) was nearly twofold less than that after postoperative MI (HR, 3.6; 95% CI, 2-6.8; P < .0001). During the first 5 years postoperatively, multivariable modeling showed postoperative stroke and postoperative MI remained independent predictors of decreased survival, but the magnitude of association was similar (HR, 2.7; 95% CI, 1.7-4.3 [P < .0001] vs HR, 2.8; 95% CI, 1.8-4.3 [P < .0001])., Conclusions: During the first year after operation, postoperative stroke conferred a twofold lower survival than that after postoperative MI. By 5 years after operation, these survival curves converged, and the survival disadvantage associated with stroke became similar to that of MI. These data suggest that different postoperative complications after carotid revascularization have different implications for patients, with decreased short-term survival in patients experiencing a postoperative stroke. These findings help to inform our interpretation of studies that have used a composite end point in order to evaluate the comparative effectiveness of revascularization strategies., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Although most prostatectomy studies emphasize optimal nerve-sparing dissection planes, subtle technical variation also affects functional outcomes. The impact of minimizing assistant/surgeon tension on urinary function has not been quantified. We assess urinary function after attenuating neurovascular bundle (NVB) and rhabdosphincter tension during robotic-assisted radical prostatectomy (RARP)., Methods: Retrospective study of prospectively collected data for 268 (RARP-T) versus 342 (RARP-0T) men with versus without tension on the NVB and rhabdosphincter during RARP. Outcomes compared include Expanded Prostate Cancer Index (EPIC) urinary function, estimated blood loss (EBL), operative time, and positive surgical margins (PSM)., Results: In unadjusted analysis, men undergoing RARP-T versus RARP-0T were older, had higher biopsy and pathologic Gleason grade, and higher preoperative prostate specific antigen (all p ≤ 0.023). Baseline urinary function was similar. Postoperatively, RARP-0T versus RARP-T was associated with higher 5-month urinary function scores (69.7 versus 64, p = 0.049). In adjusted analyses, RARP-0T versus RARP-T was associated with improved 5-month urinary function [Parameter Estimate (PE) 7.37, Standard Error (SE) 2.67, p = 0.006], while bilateral versus non-/unilateral nerve-sparing was associated with improved 12-month urinary function and continence (both p ≤ 0.035). RARP-0T versus RARP-T was associated with shorter operative times (PE 6.66, SE 1.90, p = 0.001) and higher EBL (PE 20.88, SE 6.49, p = 0.001). There were no significant differences in PSM., Conclusions: While the use of tension aids in dissection of anatomic planes, avoidance of NVB counter-traction and minimizing tension on the rhabdosphincter during apical dissection attenuates neuropraxia and leads to earlier urinary function recovery. Bilateral versus non-/unilateral nerve-sparing also improves urinary function recovery.

Objective: Major amputation is associated with increased short-term healthcare resource utilization (RU), early mortality, and socioeconomic status (SES) disparities. Our objective is to study patient-specific and SES-related predictors of long-term RU and survival after amputation., Methods: This retrospective analysis identified 364 adult patients who underwent index major amputation for critical limb ischemia from January 1995 through December 2000 at two tertiary centers with outcomes through December 2010. Age, gender, SES (race, income, insurance, and marital status), comorbidities (congestive heart failure [CHF], diabetes, diabetes with complications, and renal failure [RF]), subsequent procedures, cumulative length of stay (cLOS), and mortality were analyzed. Bivariate and multivariate Poisson regression for subsequent procedures and cLOS and Cox proportional hazard modeling for all-cause mortality were undertaken., Results: During a mean follow-up of 3.25 years, amputation patients had mean cLOS of 71.2 days per person-year (median, 17.6), 19.5 readmissions per person-year (median, 2.1), 0.57 amputation-related procedures (median, 0), and 0.31 cardiovascular procedures (median, 0). Below-knee amputation as the index procedure was performed in 70% of patients, and 25% had additional amputation procedures. Of readmissions at ≤ 30 days, 52% were amputation-related. Overall mortality during follow-up was 86.9%; 37 patients (10.2%) died within 30 days. Among patients surviving >30 days, multivariate Poisson regression demonstrated that younger age (incidence rate ratio [IRR], 0.98), public insurance (IRR, 1.63), CHF (IRR, 1.60), and RF (IRR, 2.12) were associated with increased cLOS. Diabetes with complications (IRR, 1.90) and RF (IRR, 2.47) affected subsequent amputation procedures. CHF (IRR, 1.83) and RF (IRR, 3.67) were associated with a greater number of cardiovascular procedures. Cox proportional hazard modeling indicated older age (hazard ratio [HR], 1.04), CHF (HR, 2.26), and RF (HR, 2.60) were risk factors for decreased survival. Factors associated with SES were not significantly related to the outcomes., Conclusions: This study found that RU is high for amputees, and increased RU persists beyond the perioperative period. Results were similar across SES indices, suggesting higher SES may not be protective against poor outcomes when limb salvage is no longer attainable. These findings support the hypothesis that SES disparities may be more modifiable during earlier stages of care for critical limb ischemia., (Copyright © 2013. Published by Mosby, Inc.)

Purpose: While higher radical prostatectomy hospital and surgeon volume are associated with better outcomes, the effect of provider volume on health care costs remains unclear. We performed a population based study to characterize the effect of surgeon and hospital volume on radical prostatectomy costs., Materials and Methods: We used SEER (Surveillance, Epidemiology and End Results)-Medicare linked data to identify 11,048 men who underwent radical prostatectomy from 2003 to 2009. We categorized hospital and surgeon radical prostatectomy volume into tertiles (low, intermediate, high) and assessed costs from radical prostatectomy until 90 days postoperatively using propensity adjusted analyses., Results: Higher surgeon volume at intermediate volume hospitals (surgeon volume low $9,915; intermediate $10,068; high $9,451; p = 0.021) and high volume hospitals (surgeon volume low $11,271; intermediate $10,638; high $9,529; p = 0.002) was associated with lower radical prostatectomy costs. Extrapolating nationally, selective referral to high volume radical prostatectomy surgeons at high and intermediate volume hospitals netted more than $28.7 million in cost savings. Conversely, higher hospital volume was associated with greater radical prostatectomy costs for low volume surgeons (hospital volume low $9,685; intermediate $9,915; high $11,271; p = 0.010) and intermediate volume surgeons (hospital volume low $9,605; intermediate $10,068; high $10,638; p = 0.029). High volume radical prostatectomy surgeon costs were not affected by varying hospital volume, and among low volume hospitals radical prostatectomy costs did not differ by surgeon volume., Conclusions: Selective referral to high volume radical prostatectomy surgeons operating at intermediate and high volume hospitals nets significant cost savings. However, higher radical prostatectomy hospital volume was associated with greater costs for low and intermediate volume radical prostatectomy surgeons., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: While bladder neck sparing may improve post-prostatectomy urinary continence, there is concern that it may lead to more positive surgical margins and compromise cancer control. We compared the continence and cancer control outcomes of bladder neck sparing vs nonsparing techniques during robot-assisted laparoscopic radical prostatectomy., Materials and Methods: Data were prospectively collected on 1,067 robot-assisted laparoscopic radical prostatectomies done from September 2005 through October 2011. We compared the procedures according to bladder neck sparing (791) and nonsparing (276). Continence was defined by zero pad responses on the EPIC (Expanded Prostate Cancer Index) item quantifying daily use. Biochemical recurrence was defined as prostate specific antigen 0.1 ng/ml or greater. Cox regression was performed to assess factors associated with post-prostatectomy continence and biochemical recurrence-free survival., Results: Median followup for bladder neck sparing vs nonsparing was 25.8 vs 51.7 months. Men treated with bladder neck sparing were more likely to have clinical T1c tumors (p <0.001) and less likely to have biopsy Gleason grade 6 or less disease (p = 0.023). They experienced fewer urinary leaks (p = 0.009) and shorter length of stay (p = 0.006). Regarding cancer control outcomes, there was no difference in bladder neck sparing vs nonsparing base (1.2% vs 2.6%, p = 0.146) and overall surgical margin positivity (each 13.8%, p = 0.985). On adjusted analyses bladder neck sparing vs nonsparing was associated with better continence (HR 1.69, 95% CI 1.43-1.99) and similar biochemical recurrence-free survival (HR 1.20, 95% CI 0.62-2.31, p = 0.596)., Conclusions: Bladder neck sparing is associated with fewer urinary leak complications, shorter hospitalization and better post-prostatectomy continence without compromising cancer control compared to bladder neck nonsparing., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Patients with advanced peripheral artery disease (PAD) have a high prevalence of cardiovascular (CV) risk factors and shortened life expectancy. However, CV risk factors poorly predict midterm (<5 years) mortality in this population. This study tested the hypothesis that baseline biochemical parameters would add clinically meaningful predictive information in patients undergoing lower extremity bypass operations., Methods: This was a prospective cohort study of patients with clinically advanced PAD undergoing lower extremity bypass surgery. The Cox proportional hazard model was used to assess the main outcome of all-cause mortality. A clinical model was constructed with known CV risk factors, and the incremental value of the addition of clinical chemistry, lipid assessment, and a panel of 11 inflammatory parameters was investigated using the C statistic, the integrated discrimination improvement index, and Akaike information criterion., Results: The study monitored 225 patients for a median of 893 days (interquartile range, 539-1315 days). In this study, 50 patients (22.22%) died during the follow-up period. By life-table analysis (expressed as percent surviving ± standard error), survival at 1, 2, 3, 4, and 5 years, respectively, was 90.5% ± 1.9%, 83.4% ± 2.5%, 77.5% ± 3.1%, 71.0% ± 3.8%, and 65.3% ± 6.5%. Compared with survivors, decedents were older, diabetic, had extant coronary artery disease, and were more likely to present with critical limb ischemia as their indication for bypass surgery (P < .05). After adjustment for the above, clinical chemistry and inflammatory parameters significant (hazard ratio [95% confidence interval]) for all-cause mortality were albumin (0.43 [0.26-0.71]; P = .001), estimated glomerular filtration rate (0.98 [0.97-0.99]; P = .023), high-sensitivity C-reactive protein (hsCRP; 3.21 [1.21-8.55]; P = .019), and soluble vascular cell adhesion molecule (1.74 [1.04-2.91]; P = .034). Of the inflammatory molecules investigated, hsCRP proved most robust and representative of the integrated inflammatory response. Albumin, eGFR, and hsCRP improved the C statistic and integrated discrimination improvement index beyond that of the clinical model and produced a final C statistic of 0.82., Conclusions: A risk prediction model including traditional risk factors and parameters of inflammation, renal function, and nutrition had excellent discriminatory ability in predicting all-cause mortality in patients with clinically advanced PAD undergoing bypass surgery., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: While radical prostatectomy surgeon learning curves have characterized less blood loss, shorter operative times, and fewer positive margins, there is a dearth of studies characterizing learning curves for improving sexual function. Additionally, while learning curve studies often define volume thresholds for improvement, few of these studies demonstrate specific technical modifications that allow reproducibility of improved outcomes., Objective: Demonstrate and quantify the learning curve for improving sexual function outcomes based on technical refinements that reduce neurovascular bundle displacement during nerve-sparing robot-assisted radical prostatectomy (RARP)., Design, Setting, and Participants: We performed a retrospective study of 400 consecutive RARPs, categorized into groups of 50, performed after elimination of continuous surgeon/assistant neurovascular bundle countertraction., Surgical Procedure: Our approach to RARP has been described previously. A single-console robotic system was used for all cases., Outcome Measurements and Statistical Analysis: Expanded Prostate Cancer Index Composite sexual function was measured within 1 yr of RARP. Linear regression was performed to determine factors influencing the recovery of sexual function., Results and Limitations: Greater surgeon experience was associated with better 5-mo sexual function (p = 0.007) and a trend for better 12-mo sexual function (p = 0.061), with improvement plateauing after 250-300 cases. Additionally, younger patient age (both p<0.02) and better preoperative sexual function (<0.001) were associated with better 5- and 12-mo sexual function. Moreover, trainee robotic console time during nerve sparing was associated with worse 12-mo sexual function (p=0.021), while unilateral nerve sparing/non-nerve sparing was associated with worse 5-mo sexual function (p = 0.009). Limitations include the retrospective single-surgeon design., Conclusions: With greater surgeon experience, attenuating lateral displacement of the neurovascular bundle and resultant neurapraxia improve postoperative sexual function. However, to maximize outcomes, appropriate patient selection must be exercised when allowing trainee nerve-sparing involvement., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Although robot-assisted laparoscopic radical cystectomy (RARC) was first reported in 2003 and has gained popularity, comparisons with open radical cystectomy (ORC) are limited to reports from high-volume referral centers., Objective: To compare population-based perioperative outcomes and costs of ORC and RARC., Design, Setting, and Participants: A retrospective observational cohort study using the US Nationwide Inpatient Sample to characterize 2009 RARC compared with ORC use and outcomes., Outcome Measurements and Statistical Analysis: Propensity score methods were used to compare inpatient morbidity and mortality, lengths of stay, and costs., Results and Limitations: We identified 1444 ORCs and 224 RARCs. Women were less likely to undergo RARC than ORC (9.8% compared with 15.5%, p = 0.048), and 95.7% of RARCs and 73.9% of ORCs were performed at teaching hospitals (p<0.001). In adjusted analyses, subjects undergoing RARC compared with ORC experienced fewer inpatient complications (49.1% and 63.8%, p = 0.035) and fewer deaths (0% and 2.5%, p<0.001). RARC compared with ORC was associated with lower parenteral nutrition use (6.4% and 13.3%, p = 0.046); however, there was no difference in length of stay. RARC compared with ORC was $3797 more costly (p = 0.023). Limitations include retrospective design, absence of tumor characteristics, and lack of outcomes beyond hospital discharge., Conclusions: RARC is associated with lower parenteral nutrition use and fewer inpatient complications and deaths. However, lengths of stay are similar, and the robotic approach is significantly more costly., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: Although robot-assisted laparoscopic radical prostatectomy has been aggressively marketed and rapidly adopted, there is a paucity of population based utilization, outcome and cost data. High vs low volume hospitals have better outcomes for open and minimally invasive radical prostatectomy (robotic or laparoscopic) but to our knowledge volume outcomes effects for robot-assisted laparoscopic radical prostatectomy alone have not been studied., Materials and Methods: We characterized robot-assisted laparoscopic radical prostatectomy outcome by hospital volume using the Nationwide Inpatient Sample during the last quarter of 2008. Propensity scoring methods were used to assess outcomes and costs., Results: At high volume hospitals robot-assisted laparoscopic radical prostatectomy was more likely to be done on men who were white with an income in the highest quartile and age less than 50 years than at low volume hospitals (each p <0.01). Hospitals at above the 50th volume percentile were less likely to show miscellaneous medical and overall complications (p = 0.01). Low vs high volume hospitals had longer mean length of stay (1.9 vs 1.6 days) and incurred higher median costs ($12,754 vs $8,623, each p <0.01)., Conclusions: Demographic differences exist in robot-assisted laparoscopic radical prostatectomy patient populations between high and low volume hospitals. Higher volume hospitals showed fewer complications and lower costs than low volume hospitals on a national basis. These findings support referral to high volume centers for robot-assisted laparoscopic radical prostatectomy to decrease complications and costs., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We describe the feasibility of partial arterial clamping (PAC) during robot-assisted partial nephrectomy (RAPN)., Patients and Methods: We undertook a retrospective study of five patients who underwent PAC vs 17 who underwent complete hilar clamping (CHC). Estimated blood loss (EBL), transfusion rate, operative/console time, warm ischemia time (WIT), pathology, and postoperative glomerular filtration rate (GFR) were compared., Results: PAC patients were older (P=0.002) and more likely to have had previous abdominal surgeries (P=0.032). PAC vs CHC was associated with higher median EBL (350 mL vs 75 mL, P=0.026), although there were no differences in blood transfusions (P=0.250). PAC was associated with shorter WIT (14 min vs 21 min, P=0.023). Positive margin rate and GFR change were similar., Conclusions: PAC offers a simple and reproducible technique that limits WIT during RAPN. PAC was not associated with more transfusions or positive margins. Further study is warranted to determine the utility of PAC with larger tumor size as well as the long-term benefits on renal function.

Purpose: Although robotic assisted laparoscopic surgery has been aggressively marketed and rapidly adopted, there are few comparative effectiveness studies that support its purported advantages compared to open and laparoscopic surgery. We used a population based approach to assess use, costs and outcomes of robotic assisted laparoscopic surgery vs laparoscopic surgery and open surgery for common robotic assisted urological procedures., Materials and Methods: From the Nationwide Inpatient Sample we identified the most common urological robotic assisted laparoscopic surgery procedures during the last quarter of 2008 as radical prostatectomy, nephrectomy, partial nephrectomy and pyeloplasty. Robotic assisted laparoscopic surgery, laparoscopic surgery and open surgery use, costs and inpatient outcomes were compared using propensity score methods., Results: Robotic assisted laparoscopic surgery was performed for 52.7% of radical prostatectomies, 27.3% of pyeloplasties, 11.5% of partial nephrectomies and 2.3% of nephrectomies. For radical prostatectomy robotic assisted laparoscopic surgery was more prevalent than open surgery among white patients in high volume, urban hospitals (all p≤0.015). Geographic variations were found in the use of robotic assisted laparoscopic surgery vs open surgery. Robotic assisted laparoscopic surgery and laparoscopic surgery vs open surgery were associated with shorter length of stay for all procedures, with robotic assisted laparoscopic surgery being the shortest for radical prostatectomy and partial nephrectomy (all p<0.001). For most procedures robotic assisted laparoscopic surgery and laparoscopic surgery vs open surgery resulted in fewer deaths, complications, transfusions and more routine discharges. However, robotic assisted laparoscopic surgery was more costly than laparoscopic surgery and open surgery for most procedures., Conclusions: While robotic assisted and laparoscopic surgery are associated with fewer deaths, complications, transfusions and shorter length of hospital stay compared to open surgery, robotic assisted laparoscopic surgery is more costly than laparoscopic and open surgery. Additional studies are needed to better delineate the comparative and cost-effectiveness of robotic assisted laparoscopic surgery relative to laparoscopic surgery and open surgery., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objectives. Retroperitoneal lymph node dissection (RPLND) outcomes for testis cancer originate mostly from single-center series. We characterized population-based utilization, costs, and outcomes and assessed whether higher volume affects outcomes. Methods and Materials. Using the US Nationwide Inpatient Sample from 2001-2008, we identified 993 RPLND and used propensity score methods to assess utilization, costs, and inpatient outcomes based on hospital surgical volume. Results. 51.6% of RPLND were performed at hospitals where there were two or fewer cases per year. RPLND was more commonly performed at large urban teaching hospitals, where men were younger, more likely to be white and earning incomes exceeding the 50th percentile (all P ≤ .05). Higher hospital volumes were associated with fewer complications and more routine home discharges (all P ≤ .047). However, higher volume hospitals had more transfusions (P = .004) and incurred $1,435 more in median costs (P < .001). Limitations include inability to adjust for tumor characteristics and absence of outpatient outcomes. Conclusions. Sociodemographic differences exist between high versus low volume RPLND hospitals. Although higher volume hospitals had more transfusions and higher costs, perhaps due to more complex cases, they experienced fewer complications. However, most RPLND are performed at hospitals where there were two or fewer cases per year.

Objective: The American Board of Surgery now permits general surgery residents to complete their clinical training over a 6-year period. Despite this new policy, the level of interest in flexible scheduling remains undefined. We sought to determine why residents and program directors (PDs) are interested in flexible tracks and to understand implementation barriers., Design: National survey., Setting: All United States general surgery residency programs that participate in the Association of Program Directors in Surgery listserv., Participants: PDs and categorical general surgery residents in the United States., Main Outcome Measures: Attitudes about flexible tracks in surgery training. A flexible track was defined as a schedule that allows residents to pursue nonclinical time during residency with resulting delay in residency completion., Results: Of the 748 residents and 81 PDs who responded, 505 residents and 45 PDs were supportive of flexible tracks (68% vs 56%, p = 0.03). Residents and PDs both were interested in flexible tracks to pursue research (86% vs 82%, p = 0.47) and child bearing (69% vs 58%, p = 0.13), but residents were more interested in pursuing international work (74% vs 53%, p = 0.004) and child rearing (63% vs 44%, p = 0.02). Although 71% of residents believe that flexible-track residents would not be respected as the equal of other residents, only 17% of PDs indicated they would not respect flexible-track residents (p < 0.001)., Conclusion: Most residents and PDs support flexible tracks, although they differ in their motivation and perceived barriers. This finding lends support to the new policy of the American Board of Surgery., (Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Although subtle technical variation affects potency preservation during robot-assisted laparoscopic radical prostatectomy (RARP), most prostatectomy studies focus on achieving the optimal anatomic nerve-sparing dissection plane. However, the impact of active assistant/surgeon neurovascular bundle (NVB) countertraction on sexual function outcomes has not been studied or quantified., Objective: To illustrate technique and compare sexual function outcomes for nerve sparing without (NS-0C) versus with (NS-C) assistant and/or surgeon NVB countertraction., Design, Setting, and Participants: This is a retrospective study of 342 NS-0C versus 268 NS-C RARP procedures performed between August 2008 and February 2011., Surgical Procedure: RARP., Measurements: We used the Expanded Prostate Cancer Index Composite (EPIC) sexual function and potency scores, estimated blood loss (EBL), operative time, and positive surgical margin (PSM)., Results and Limitations: In unadjusted analysis, men undergoing NS-0C versus NS-C were older, had worse baseline sexual function, higher biopsy and pathologic Gleason grade, and higher preoperative prostate-specific antigen (PSA) levels (all p ≤ 0.023). However, NS-0C versus NS-C was associated with higher 5-mo sexual function scores (20 vs 10; p < 0.001), and this difference was accentuated for bilateral intrafascial nerve sparing in preoperatively potent men (35.8 vs 16.6; p < 0.001). Similarly, 5-mo potency for preoperatively potent men was better with bilateral intrafascial NS-0C versus NS-C (45.0% vs 28.4%; p = 0.039). However, no difference in sexual function or potency was observed at 12 mo. In adjusted analyses, NS-0C versus NS-C was associated with improved 5-mo sexual function (parameter estimate: 10.90; standard error: 2.16; p < 0.001) and potency (odds ratio: 1.69; 95% confidence interval, 1.01-2.83; p = 0.046). NS-0C versus NS-WC was associated with shorter operative times (p = 0.001) and higher EBL (p = 0.001); however, there were no significant differences in PSM. Limitations include the retrospective, single-surgeon study design and smaller numbers for 12-mo comparison., Conclusions: Reliance on countertraction to facilitate dissecting NVB away from the prostate leads to neuropraxia and delayed recovery of sexual function and potency. Subtle technical modification to dissect the prostate away from the NVB without countertraction enables earlier return of sexual function and potency., (Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: To develop standardized metrics for expected outcomes in lower extremity revascularization for critical limb ischemia (CLI), the Society for Vascular Surgery (SVS) has developed objective performance goals (OPGs) based on aggregate data from randomized trials of lower extremity bypass (LEB). It remains unknown, however, if these targets can be achieved in everyday vascular surgery practice., Methods: We applied SVS OPG criteria to 1039 patients undergoing 1039 LEB operations for CLI with autogenous vein (excluding patients on dialysis) within the Vascular Study Group of New England (VSGNE). Each of the individual OPGs was calculated within the VSGNE dataset, along with its surrounding 95% confidence intervals (CIs) and compared to published SVS OPGs using χ(2) comparisons and survival analysis., Results: Across most risk strata, patients in the VSGNE and SVS OPG cohorts were similar (clinical high-risk [age >80 years and tissue loss]: 15.3% VSGNE; 16.2% SVS OPG; P = .58; anatomic high risk [infrapopliteal target artery]: 57.8% VSGNE; 60.2% SVS OPG; P = .32). However, the proportion of VSGNE patients designated as conduit high-risk (lack of single-segment great saphenous vein) was lower (10.2% VSGNE; 26.9% SVS OPG;P < .001). The primary safety endpoint, major adverse limb events (MALE) at 30 days, was lower in the VSGNE cohort (3.2%; 95% CI, 2.3-4.6) than the SVS OPG cohort (6.2%; 95% CI, 4.2-8.1; P = .05). The primary efficacy OPG endpoint, freedom from any MALE or postoperative death within the first year (MALE + postoperative death [POD]), was similar between VSGNE and SVS OPG cohorts (77%; 95% CI, 74%-80%) SVS OPG, 74% (95% CI, 71%-77%) VSGNE, P = .58). In the remaining safety and efficacy OPGs, the VSGNE cohort met or exceeded the benchmarks established by the SVS OPG cohort., Conclusion: Community and academic centers in everyday vascular surgery practice can meet OPGs derived from centers of excellence in LEB. Quality improvement initiatives, as well as clinical trials, should incorporate OPGs in their outcome measures to facilitate communication and comparison of risk-adjusted outcomes in the treatment of CLI., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: • o determine differences in surgical outcomes by surgical approach during a period of rapid adoption of minimally invasive surgical approaches in radical prostatectomy., Patients and Methods: • We identified 19 542 men undergoing minimally invasive (MIRP), perineal (PRP), and retropubic (RRP) radical prostatectomy from 2003 to 2006 from the MarketScan® Medstat database, a national employer-based administrative database. • We assessed for temporal trends in perioperative complications, use of postoperative cystography and anastomotic strictures by surgical approach., Results: • Between 2003 and 2006, MIRP use increased 33.6% vs 31.8% and 1.7% decreases in RRP and PRP, respectively. During the 4-year study, median length of stay for MIRP decreased from 2.0 to 1.0 day (P = 0.004) and overall perioperative complications decreased from 13.8 to 10.7%, (P = 0.023). • These findings were driven by reductions in genitourinary complications (3.3 to 2.5%, P = 0.049), miscellaneous surgical complications (3.6 to 2.3%, P = 0.006) and intestinal injury (1.5 to 0.1%, P= 0.009). • Median length of stay for RRP decreased from 3.2 to 2.9 days, (P < 0.001), overall perioperative complications decreased from 18.1 to 14.6%, (P = 0.007), because of reductions in both wound/bleeding complications (2.0 to 1.1%, P = 0.002) and heterologous blood transfusions. • Men undergoing MIRP vs RRP were less likely to have perioperative complications (12.5 vs 17.1%, P < 0.001), blood transfusions (1.5 vs 8.9%, P < 0.001) and anastomotic strictures (6.3 vs 12.8%, P < 0.001), and they had shorter mean lengths of stay (1.8 vs 3.1 days, P < 0.001) during the study period., Conclusion: • The increased use of MIRP corresponds with a decreasing trend for complications, blood transfusions, lengths of stay and need for reoperation. Additionally, MIRP was found to have fewer associated complications compared with men undergoing open procedures. Further study is needed to assess the impact of tumour characteristics and surgeon volume on these perioperative outcomes as well as effects on long-term cancer control., (© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.)

Objective: To evaluate contemporary national practice pattern trends in the use of thermal ablation (radiofrequency ablation and cryoablation) in the management of stage I renal cell carcinoma (RCC), and the factors that lead to using thermal ablation (TA) vs partial (PN) or radical nephrectomy (RN) in the United States., Methods: Within the Surveillance, Epidemiology and End Results (SEER) database, we identified subjects with T1-N0M0 RCC treated with either PN, RN, or TA between 2004 and 2007. Proportions, trends, and multivariable logistic regression models tested the predictors of the use of TA., Results: In total, 15,145 patients underwent a procedure for an RCC that was organ-confined and ≤7 cm. Of these, 578 underwent TA, 4402 underwent PN, and 10,165 underwent RN. On unadjusted analyses, patients who received TA were more likely to be older, single, have smaller tumor size, be diagnosed in more recent years, and have more unspecified histologic subtype and tumor grade. In multivariable adjusted analyses, single status (P=.02), male gender (P=.01), increasing age (P<.01), year of diagnosis (P<.01), and smaller tumor size (P<.01) were strong independent predictors of TA use compared with surgery (PN or RN). Further adjusted analyses showed no statistical difference in cancer-specific or overall survival between TA vs PN or RN., Conclusions: TA use for stage I RCC increased over a relatively short period and was performed more commonly in patients of older age and with smaller tumor size. Longer follow-up is needed to assess the comparative effectiveness of TA vs surgery., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Large prostate size, median lobes, and prior benign prostatic hyperplasia (BPH) surgery may pose technical challenges during robot-assisted laparoscopic prostatectomy (RALP)., Objective: To describe technical modifications to overcome BPH sequelae and associated outcomes., Design, Settings, and Participants: A retrospective study of prospective data on 951 RALP procedures performed from September 2005 to November 2010 was conducted. Outcomes were analyzed by prostate weight, prior BPH surgical intervention (n=59), and median lobes >1 cm (n=42)., Surgical Procedure: RALP., Measurements: Estimated blood loss (EBL), blood transfusions, operative time, positive surgical margin (PSM), and urinary and sexual function were measured., Results and Limitations: In unadjusted analysis, men with larger prostates and median lobes experienced higher EBL (213.5 vs 176.5 ml; p<0.001 and 236.4 vs 193.3 ml; p=0.002), and larger prostates were associated with more transfusions (4 vs 1; p=0.037). Operative times were longer for men with larger prostates (164.2 vs 149.1 min; p=0.002), median lobes (185.8 vs 155.0 min; p=0.004), and prior BPH surgical interventions (170.2 vs 155.4 min; p=0.004). Men with prior BPH interventions experienced more prostate base PSM (5.1% vs 1.2%; p=0.018) but similar overall PSM. In adjusted analyses, the presence of median lobes increased both EBL (p=0.006) and operative times (p<0.001), while prior BPH interventions also prolonged operative times (p=0.014). However, prostate size did not affect EBL, PSM, or recovery of urinary or sexual function., Conclusions: Although BPH characteristics prolonged RALP procedure times and increased EBL, prostate size did not affect PSM or urinary and sexual function., (Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Little is known about the patterns of care relating to the diagnosis of chronic lymphocytic leukemia (CLL), including the use of modern diagnostic techniques such as flow cytometry., Methods: The authors used the SEER-Medicare database to identify subjects diagnosed with CLL from 1992 to 2002 and defined diagnostic delay as present when the number of days between the first claim for a CLL-associated sign or symptom and SEER diagnosis date met or exceeded the median for the sample. The authors then used logistic regression to estimate the likelihood of delay and Cox regression to examine survival., Results: For the 5086 patients analyzed, the median time between sign or symptom and CLL diagnosis was 63 days (interquartile range [IQR] = 0-251). Predictors of delay included age ≥75 (OR 1.45 [1.27-1.65]), female gender (OR 1.22 [1.07-1.39]), urban residence (OR 1.46 [1.19 to 1.79]), ≥1 comorbidities (OR 2.83 [2.45-3.28]) and care in a teaching hospital (OR 1.20 [1.05-1.38]). Delayed diagnosis was not associated with survival (HR 1.11 [0.99-1.25]), but receipt of flow cytometry within thirty days before or after diagnosis was (HR 0.84 [0.76-0.91])., Conclusions: Sociodemographic characteristics affect diagnostic delay for CLL, although delay does not seem to impact mortality. In contrast, receipt of flow cytometry near the time of diagnosis is associated with improved survival., (Copyright © 2010 American Cancer Society.)

Objective: Disparities in limb salvage procedures may be driven by socioeconomic status (SES) and access to high-volume hospitals. We sought to identify SES factors associated with major amputation in the setting of critical limb ischemia (CLI)., Methods: The 2003-2007 Nationwide Inpatient Sample was queried for discharges containing lower extremity revascularization (LER) or major amputation and chronic CLI (N = 958,120). The Elixhauser method was used to adjust for comorbidities. Significant predictors in bivariate logistic regression were entered into a multivariate logistic regression for the dependent variable of amputation vs LER., Results: Overall, 24.2% of CLI patients underwent amputation. Significant differences were seen between both groups in bivariate and multivariate analysis of SES factors, including race, income, and insurance status. Lower-income patients were more likely to be treated at low-LER-volume institutions (odds ratio [OR], 1.74; P < .001). Patients at higher-LER-volume centers (OR, 15.16; P <.001) admitted electively (OR, 2.19; P < .001) and evaluated with diagnostic imaging (OR, 10.63; P < .001) were more likely to receive LER., Conclusions: After controlling for comorbidities, minority patients, those with lower SES, and patients with Medicaid were more likely receive amputation for CLI in low-volume hospitals. Addressing SES and hospital factors may reduce amputation rates for CLI., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: A significant portion of patients undergoing lower extremity bypass surgery (LEB) for peripheral arterial disease (PAD) will have cardiovascular or graft-related events. It has been previously demonstrated that systemic inflammation is associated with PAD and its clinical outcomes. We hypothesized that serum biomarkers of insulin resistance and inflammation would identify a subgroup at elevated risk for graft failure, limb loss, and mortality., Methods: This was a prospective longitudinal study of patients (n = 225) undergoing LEB using autogenous vein. Baseline blood samples were obtained prior to surgery in the fasting state. High-sensitivity C-reactive protein (hsCRP) and the adipokines resistin and high-molecular weight adiponectin (HMWA) were measured by enzyme-linked immunosorbent assay (ELISA). Median follow-up was 893 days. The major endpoints of primary patency (PP) and amputation-free survival (AFS) were examined using multivariable methods. Endpoints were screened against biomarkers and patient characteristics for univariate associations. Promising explanatory variables (P < .1) were included in multivariable Cox proportional hazard models., Results: The mean age of subjects was 67.6 years; 71.6% were male and 87.1% were Caucasian. One hundred thirty-three (59.1%) subjects underwent bypass for critical limb ischemia (CLI) and 73 (32.4%) had tissue loss. Patients with CLI and diabetes demonstrated elevated resistin and hsCRP levels. HMWA levels correlated with CLI and with a measure of insulin resistance (HOMA-IR) but not with clinical diabetes. Baseline biomarkers were higher in those presenting with tissue loss and in patients with postoperative events (mortality, limb loss). After multivariable analysis (including CLI, diabetes, age, estimated glomerular filtration rate [eGFR], adiponectin, resistin, and CRP), resistin (hazard ratio [HR] 1.75, 95% confidence interval [CI], 1.07-2.85; P = .025) and CRP (HR 2.39, 95% CI, 1.30-4.39; P = .005) were independently predictive of reduced AFS. However, only resistin maintained its significance when restricted to the diabetic cohort (HR 2.10, 95% CI, 1.10-3.99; P = .025). Higher levels of HMWA were found to be associated with primary graft patency (HR 0.73 for graft failure; 95% CI, 0.55 to 0.97; P = .031) in a multivariable model adjusting for diabetes, CRP, African-American race, CLI, high-risk conduits, and redo bypass procedures., Conclusion: These findings suggest that serum biomarkers of insulin resistance and inflammation may be predictive of clinical outcomes following LEB. Improving the systemic milieu of insulin resistance and inflammation in these high-risk patients may lead to reduced morbidity and mortality., (Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Introduction: Pharmacotherapies improve sexual function following treatments for localized prostate cancer; however, patterns of care remain unknown. Aim. To ascertain post-treatment utilization of pharmacotherapies for erectile dysfunction (ED) using a population-based approach., Methods: We identified 38,958 men who underwent definitive treatment for localized prostate cancer during 2003-2006 from the MarketScan Medstat data., Main Outcome Measures: We compared the use of ED pharmacotherapy at baseline (up to 3 months prior) and up to 30 months following radical prostatectomy (RP) or radiotherapy (RT) for localized prostate cancer by utilizing National Drug Classification codes for phosphodiesterase-5 inhibitors (PDE5I), intracavernosal injectable therapies (IT), urethral suppositories and vacuum erection devices (VED). In adjusted analyses, we controlled for the effect of age, comorbidity, type of treatment, health plan and use of adjuvant hormone therapy on the use of pharmacotherapies. Results. Men undergoing RP vs. RT were younger with less co-morbid conditions. Utilization of PDE5I was up to three times greater for men undergoing RP vs. RT, 25.6% vs. 8.8%, (P < 0.0001) in the first post-treatment year, and usage of these agents was greatest for men undergoing minimally-invasive RP procedures. A higher percentage of men also used IT, suppositories and VED after RP vs. RT (P < 0.001). However, more men in the RT group received adjuvant hormonal therapy (39.53% vs. 5.25% for RP, P < 0.01). In adjusted analyses, men undergoing RP vs. RT were more than two times likely (OR 2.1, 95% CI 1.98, 2.26) to use PDE5I post-treatment while men on adjuvant hormonal therapy were less likely to use PDE5I (OR 0.74, 95% CI 0.70-0.79, P < 0.0001)., Conclusion: Men undergoing RP vs. RT, particularly minimally-invasive RP, are more likely to employ IT, suppositories, VED, and PDE5I pharmacotherapy post-treatment.

Prior work has demonstrated that the memory dysfunction of Alzheimer's disease (AD) is accompanied by marked cortical pathology in medial temporal lobe (MTL) gray matter. In contrast, changes in white matter (WM) of pathways associated with the MTL have rarely been studied. We used diffusion tensor imaging (DTI) to examine regional patterns of WM tissue changes in individuals with AD. Alterations of diffusion properties with AD were found in several regions including parahippocampal WM, and in regions with direct and secondary connections to the MTL. A portion of the changes measured, including effects in the parahippocampal WM, were independent of gray matter degeneration as measured by hippocampal volume. Examination of regional changes in unique diffusion parameters including anisotropy and axial and radial diffusivity demonstrated distinct zones of alterations, potentially stemming from differences in underlying pathology, with a potential myelin specific pathology in the parahippocampal WM. These results demonstrate that deterioration of neocortical connections to the hippocampal formation results in part from the degeneration of critical MTL and associated fiber pathways.

Objective: To develop a set of suggested objective performance goals (OPG) for evaluating new catheter-based treatments in critical limb ischemia (CLI), based on evidence from historical controls., Methods: Randomized, controlled trials of surgical, endovascular, and pharmacologic/biologic treatments for CLI were reviewed according to specified criteria regarding study population and data quality. Line-item data were obtained for selected studies from the sponsor/funding agency. A set of specific outcome measures was defined in accordance with the treatment goals for the CLI population. Risk factors were examined for their influence on key endpoints, and models of stratification based on specific clinical and anatomic variables developed. Sample size estimates were made for single-arm trial designs based on comparison to the suggested OPG., Results: Bypass with autogenous vein was considered the established standard, and data compiled from three individual randomized, controlled trials (N = 838) was analyzed. The primary efficacy endpoint was defined as perioperative (30-day) death or any major adverse limb event (amputation or major reintervention) occurring within one year. Results of open surgery controls demonstrated freedom from the primary endpoint in 76.9% (95% confidence interval [CI] 74.0%-79.9%) of patients at one year, with amputation-free survival (AFS) of 76.5% (95% CI 73.7%-79.5). An additional 3% non-inferiority margin was suggested in generating OPG for catheter-based therapies. Defined clinical (age > 80 years and tissue loss) and anatomic (infra-popliteal anatomy or lack of good quality saphenous vein) risk subgroups provided significantly different point estimates and OPG threshold values., Conclusions: For new catheter-based therapies in CLI, OPGs offer a feasible approach for pre-market evaluation using non-randomized trial designs. Such studies should incorporate risk stratification in design and reporting as the CLI population is heterogeneous with respect to baseline variables and expected outcomes. Guidelines for CLI trial design to address consistency in study cohorts, methods of assessment, and endpoint definitions are provided.