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Introduction: Utilizing allografts from donors after cardiac death (DCD) has improved organ availability, and DCD livers comprise a growing proportion of transplantations. However, it has been suggested that DCD transplantations have worse outcomes. Research Questions: We aimed to characterize outcomes in a large cohort of DCD transplantations, identify trends in outcomes over time, and identify factors associated with the development of biliary complications. Design: We conducted an observational retrospective cohort study of patients receiving DCD liver allografts within a large academic teaching hospital with a high transplantation volume. Consecutive patients who underwent Type III DCD liver transplantation from 2006–2016 were included in our cohort. Re-transplantations and multi-organ transplant recipients were excluded. Results: Ninety-six type III DCD transplantations occurred between 2006–2016. We report a 1one-year patient survival of 90.6% (87) and a 5five-year patient survival of 69.8% (67). Twenty-nine (30.2%) patients experienced any biliary complication in the first year following discharge, with 17 (17.7%) experiencing ischemic cholangiopathy. Five-year patient (P = 0.04) and graft (P = 0.005) survival improved over time. Post-operative biliary complications experienced during index admission and prior to discharge were found to be associated with the development of biliary complications (P = 0.005) and ischemic cholangiopathy (P = 0.01) following discharge. Conclusion: Our data suggested that outcomes using DCD allografts have improved, however biliary complications remain a significant issue in DCD transplantation. Patients who experienced post-operative biliary complications during index admission may require more frequent screening to allow the initiation of earlier treatment for biliary complications.

Liver transplant recipients (LTRs) are at high risk for cardiovascular disease (CVD). We sought to characterize LTR, informal caregiver, and health care provider perceptions about CVD care after liver transplantation (LT) to inform the design of solutions to improve care. Participants included adult LTRs, their caregivers, and multispecialty health care providers recruited from an urban tertiary care network who participated in 90-minute focus groups and completed a brief survey. Focus group transcripts were analyzed using thematic analysis, and survey data were analyzed using descriptive statistics. A total of 17 LTRs, 9 caregivers, and 22 providers participated in 7 separate focus groups. Most (93.3%) LTRs and caregivers were unaware of the risk of CVD after LT. Although 54.5% of providers were confident discussing CVD risk factors with LTRs, only 36.3% were confident managing CVD risk factors in LTRs, and only 13.6% felt that CVD risk factors in their LTR patients were well controlled. Barriers to CVD care for LTRs included (1) lack of awareness of CVD risk after LT, (2) lack of confidence in an ability to provide proper CVD care to LTRs, (3) reluctance to provide CVD care without transplant provider review, and (4) complexity of communication with the multidisciplinary LTR care team about CVD care. Participant recommendations included improved education for LTRs and caregivers about CVD risk factors, electronic health record alerts for providers, clearly defined CVD care provider roles, increased use of the transplant pharmacist, and multidisciplinary provider meetings to discuss care plans for LTRs. Multiple barriers to CVD care after LT were identified, and targeted recommendations were proposed by participants. Transplant centers should integrate participants' recommendations when designing interventions to optimize CVD care for LTRs.

Background Most interventions for conditions with a small cohort size, such as transplantation, are unlikely to be part of a clinical trial. When condition-specific evidence is lacking, expert consensus can offer more precise guidance to improve care. Management of cardiovascular risk in liver-transplant recipients is one example for which clinicians have, to date, adapted evidence-based guidelines from studies in the general population. However, even when consensus is achieved, implementation of practice guidance is often inadequate and protracted. We report on a novel mixed-methods approach, the Northwestern Method©, for the development of clinical-practice guidance when condition-specific evidence is lacking. We illustrate the method through the development of practice guidance for managing cardiovascular risk in liver-transplant recipients. Methods The Northwestern Method© consists of (i) adaptation of relevant, existing, evidence-based clinical-practice guidelines for the target population; (ii) consensus by experts of the proposed practice guidance; (iii) identification of barriers to guidance adherence in current practice; and (iv) recommendation for implementation and dissemination of the practice guidance. The method is based on an iterative, user-centered approach in which the needs, wants, and limitations of all end users, including patients, are attended to at each stage of the design and development process. Conclusions The Northwestern Method© for clinical-practice-guidance development uses a mixed-methods approach to bring together broad representation from multiple disciplines and practice settings to develop consensus considering the unique needs and preferences of patients, caregivers, and practitioners who are directly impacted by clinical-practice-guidance recommendations. We hypothesize that a priori involvement of end users in the guidance-development process will lead to sustainable implementation of guidance statements into clinical practice.

Sex-based differences are known to significantly contribute to outcomes in patients with chronic liver diseases; however, the role of patient sex in cirrhosis is unclear. We aimed to study the relationship between patient sex and cirrhosis.We analyzed a cohort of 20,045 patients with cirrhosis using a Chicago-wide electronic health record database that was linked with the United Network for Organ Sharing and cause of death data from the state death registry. Adjusted Cox survival analyses and competing risk analyses were performed to obtain subdistribution hazard ratios (HRs) for liver-related cause of death.Female and male patients had similar age, racial distribution, insurance status, and comorbidity status by Elixhauser score. Females had higher rates of cholestatic liver disease (17.1% vs. 6.2%, p0.001) and non-alcoholic steatohepatitis (29.8% vs. 21.2%, p0.001) than males. They were less likely to have portal hypertensive complications and had lower peak MELD-Na scores during follow-up. Female sex was associated with a decreased hazard of all-cause mortality (adjusted HR 0.85; 95% CI 0.80-0.90). This effect was attenuated when liver-related mortality was examined (subdistribution HR 0.93; 95% CI 0.87-1.00). No significant difference was noted for women who were 'ever-listed' in competing risk analyses for either all-cause mortality (subdistribution HR 1.09; 95% CI 0.88-1.35) or liver-related death (subdistribution HR 1.12; 95% CI 0.87-1.43), despite lower rates of listing (7.5% vs. 9.8%; p0.001) and transplant (3.5% vs. 5.2%; p 0.001).In this longitudinal study of patients with cirrhosis, female sex was associated with a survival advantage likely driven by lower rates of non-liver-related death. Women were not at an increased risk of liver-related death despite lower rates of listing and transplantation.Patient sex is an important contributor in many chronic diseases, including cirrhosis. Prior studies have suggested that female sex is associated with worse outcomes. We analyzed a cohort of 20,045 patients with cirrhosis using a Chicago-wide electronic health record database. Using multivariate competing risk analyses, we found that female sex in cirrhosis is actually associated with a lower risk of all-cause mortality and has no association with liver-related mortality. Our findings are novel because we show that women with cirrhosis have a similar risk of liver-related death as their male counterparts, despite lower rates of listing and transplantation.

BACKGROUND: Peripheral nerve injuries can be devastating complications of surgery, potentially resulting in severe functional disability and decreased quality of life. Long surgeries with considerable tissue manipulation, for example, liver transplantation, may present increased risk; however, neuropraxia in transplantation has not been well investigated. MATERIALS AND METHODS: This is a retrospective study of all adult patients undergoing liver transplantation at a large academic center between January 2013 and December 2015. Descriptive analyses, logistic regressions, and forward selection procedures were used to determine the odds of developing neuropraxia and associated factors. RESULTS: Of the 283 liver recipients, the mean age was 55.8 y, 35.1% were female, 65.6% were Caucasian, 8.9% were African American, 16.7% were Hispanic, and mean model for end-stage liver disease sodium score at transplant was 24.2 ± 10.9. The underlying etiology was alcohol (26.2%), hepatitis C (34.8%), nonalcoholic steatohepatitis (13.1%), and other (14.2%). The incidence of neuropraxia after liver transplantation was 8.3% (n = 25), with 60% (n = 16) upper extremities, 82% left sided, and 84% male. There was no difference in age, race, body mass index, hypertension, diabetes, hyperlipidemia, or smoking in those with neuropraxia versus those without. In multivariate analysis, neuropraxia was significantly associated with male gender, lower model for end-stage liver disease score, and longer duration of surgery (P < 0.05). Symptoms lasted median 5 d, with a wide range up to 187 d. Neuropraxia-specific treatment (physical therapy or medications) was required in 32% (n = 9). CONCLUSIONS: Peripheral nerve injuries are an unexplored complication of liver transplantation. Although transient, a high number (8.2%) of patients developed neuropraxia, negatively affecting their ability for recovery. Exploration of mechanisms for minimizing risk and intraoperative detection and prevention should be considered to mitigate this complication.

In preparation of a clinical trial of norovirus treatment, there were concerns raised by FDA about risk of self-storage of stool from patients infected with norovirus affecting quantitative assessments of norovirus RNA. Specifically, most home freezers are frost-free and may expose the samples to multiple rounds of freeze-thaw. Stool samples collected by the study team were stored at different lengths in a frost-free freezer and at -80°C. Quantitative PCRs of norovirus were performed on all samples using the same assay. By all measures, there was no significant change in measured viral load with home storage.

Background: The average readability level in the USA is a sixth grade level and for patients with chronic disease it is lower. Cirrhosis is a prevalent chronic disease that requires complex knowledge and instructions to manage. No research has been done about the understandability of online educational content for cirrhotic patients. Patients can find online materials curated by both general health platforms and high-volume liver transplant centers, and thus these materials were analyzed. Methods: After determining exclusion criteria, the websites of the top 20 general health platform results and the websites of the top 20 high-volume hepatology centers were analyzed. Readability was assessed using the Patient Education Materials Assessment Tool (Audiovisual Materials) (PEMAT-A/V), Flesch-Kincaid Grade Level tests, word counts, sentence counts, words per sentence, and time for an average sixth grader to read. Results: The mean grade level readabilities were 12.3 and 11.3 for the general resources and the transplant center resources, respectively. The online resources ranged from 9 to 389 sentences requiring an average of 9.8 min to read. The mean PEMAT-A/V scores were 70.05% for the general resources and 72.45% for the transplant center resources. There was a statistically significant difference in the Flesch-Kincaid grade level, sentence number, words per sentence, word count, and time for an average sixth grader to read the general resources and transplant center resources (P < 0.05). Conclusions: The online resources both from health platforms and hepatology centers available to patients with cirrhosis are too long and complex and underscore the need for simpler and shorter resources. J Curr Surg. 2020;10(1-2):1-6 doi: https://doi.org/10.14740/jcs401

Supplemental Digital Content is available in the text., Background. Chronic kidney disease (CKD) is associated with cardiovascular (CV) events, a leading complication in liver transplant recipients (LTRs). Timely subspecialty care is associated with improved clinical outcomes in patients with CKD. This study sought to assess associations between nephrology comanagement and CV events among LTRs at risk for or with CKD. Methods. LTRs with CKD plus those at risk were identified in an inception cohort at a single tertiary care network between 2010 and 2016, using electronic health record data and manual chart review. CKD was defined as estimated glomerular filtration rate

Tobacco use is a modifiable risk factor for cardiovascular events (CVEs) in liver transplant recipients (LTRs), but there is a paucity of data about practitioner adherence to tobacco cessation guidelines for LTRs. We sought to assess adherence to these guidelines as a predictor of CVEs after liver transplant.We conducted a retrospective, observational, cohort study of adult LTRs from 2010 to 2016 at a large urban, tertiary care transplant network.Of 572 LTRs (mean age' 56.9; 64.1% male), 325 (56.8%) were never, 191 (33.4%) were former, and 56 (9.8%) were current tobacco users before liver transplant. Most LTRs (59%) had their tobacco use assessed annually by transplant providers. Among current users, documented tobacco cessation interventions decreased over time' and25% were offered pharmacologic treatment or referral to counseling. There was no difference in CVEs between tobacco users who received cessation interventions compared with those who did not.This single-center study suggests that although tobacco use cessation counseling and interventions were not associated with a decrease in CVEs, evidence-based interventions for tobacco use were under utilized in this high cardiac risk population. These findings underscore missed opportunities for transplant practitioners to provide tobacco use cessation interventions to LTRs, which potentially could reduce CVEs.

BACKGROUND: To identify the best possible outcomes in liver transplantation from donation after circulatory death donors (DCD) and to propose outcome values, which serve as reference for individual liver recipients or patient groups.METHODS: Based on 2219 controlled DCD liver transplantations, collected from 17 centres in North America and Europe, we identified 1012 low-risk, primary, adult liver transplantations with a laboratory MELD of ≤20points, receiving a DCD liver with a total donor warm ischemia time of ≤30minutes and asystolic donor warm ischemia time of ≤15minutes. Clinically relevant outcomes were selected and complications were reported according to the Clavien-Dindo-Grading and the Comprehensive Complication Index (CCI). Corresponding benchmark cut-offs were based on median values of each centre, where the 75th-percentile was considered.RESULTS: Benchmark cases represented between 19.7% and 75% of DCD transplantations in participating centers. The one-year retransplant and mortality rate was 5.23% and 9.01%, respectively. Within the first year of follow-up, 51.1% of recipients developed at least one major complication (≥Clavien-Dindo-Grade-III). Benchmark cut-offs were ≤3days and ≤16days for ICU and hospital stay, ≤66% for severe recipient complications (≥Grade-III), ≤16.8% for ischemic cholangiopathy, and ≤38.9CCI points at one-year posttransplant. Comparisons with higher risk groups showed more complications and impaired graft survival, outside the benchmark cut-offs. Organ perfusion techniques reduced the complications to values below benchmark cut-offs, despite higher graft risk.CONCLUSIONS: Despite excellent 1-year survival, morbidity in benchmark cases remains high with more than half of recipients developing severe complications during 1-year follow-up. Benchmark cut-offs targeting morbidity parameters offer a valid tool to assess the protective value of new preservation technologies in higher risk groups, and provide a valid comparator cohort for future clinical trials.LAY SUMMARY: The best possible outcomes after liver transplantation of grafts donated after circulatory death (DCD) were defined using the concept of benchmarking. These were based on 2219 liver transplantations following controlled DCD donation in 17 centres worldwide. The following benchmark cut-offs for the most relevant outcome parameters were developed: ICU and hospital stay: ≤3 and ≤16 days; primary non function: ≤2.5%; renal replacement therapy: ≤9.6%; ischemic cholangiopathy: ≤16.8% and anastomotic strictures ≤28.4%. One-year graft loss and mortality were defined as ≤14.4% and 9.6%, respectively. Donor and recipient combinations with higher risk had significantly worse outcomes. The use of novel organ perfusion technology achieved similar, good results in this high-risk group with prolonged donor warm ischemia time, when compared to the benchmark cohort.

BACKGROUND AND AIMS Estimates of racial disparity in cirrhosis have been limited by lack of large-scale, longitudinal data, which track patients from diagnosis to death and/or transplant. APPROACH AND RESULTS We analyzed a large, metropolitan, population-based electronic health record data set from seven large health systems linked to the state death registry and the national transplant database. Multivariate competing risk analyses, adjusted for sex, age, insurance status, Elixhauser score, etiology of cirrhosis, HCC, portal hypertensive complication, and Model for End-Stage Liver Disease-Sodium (MELD-Na), examined the relationship between race, transplant, and cause of death as defined by blinded death certificate review. During the study period, 11,277 patients met inclusion criteria, of whom 2,498 (22.2%) identified as Black. Compared to White patients, Black patients had similar age, sex, MELD-Na, and proportion of alcohol-associated liver disease, but higher comorbidity burden, lower rates of private insurance, and lower rates of portal hypertensive complications. Compared to White patients, Black patients had the highest rate all-cause mortality and non-liver-related death and were less likely to be listed or transplanted (P

Background Postbariatric hypoglycemia (PBH) can be a devastating complication for which current therapies are often incompletely effective. More information is needed regarding frequency, incidence, and risk factors for PBH. Objectives To examine hypoglycemia symptoms following Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) and baseline and in-study risk factors. Setting Multicenter, at 10 US hospitals in 6 geographically diverse clinical centers. Methods A prospective, longitudinal cohort study of adults undergoing RYGB or LAGB as part of clinical care between 2006 and 2009 were recruited and followed until January 31, 2015, with baseline and annual postoperative research assessments. We analyzed baseline prevalence and post-operative incidence and frequency of self-reported hypoglycemia symptoms as well as potential preoperative risk factors. Results In all groups, postoperative prevalence of hypoglycemia symptoms was 38.5%. Symptom prevalence increased postoperatively from 2.8%–36.4% after RYGB in patients without preoperative diabetes (T2D), with similar patterns in prediabetes (4.9%–29.1%). Individuals with T2D had higher baseline hypoglycemia symptoms (28.9%), increasing after RYGB (57.9%). Hypoglycemia symptoms were lower after LAGB, with 39.1% reported hypoglycemia symptoms at only 1 postoperative visit with few (4.0%) having persistent symptoms at 6 or more annual visits. Timing of symptoms was not restricted to the postprandial state. Symptoms of severe hypoglycemia were reported in 2.6–3.6% after RYGB. The dominant risk factor for postoperative symptoms was preoperative symptoms; additionally, baseline selective serotonin (SSRI) and serotonin-norepinephrine (SNRI) reuptake inhibitor use was also associated with increased risk in multivariable analysis. Weight loss and regain were not related to hypoglycemia symptom reporting. Conclusion Hypoglycemia symptoms increase over time after RYGB, particularly in patients without diabetes. In a small percentage, symptoms can be persistent or severe and require hospitalization. Preoperative hypoglycemia symptoms and SSRI/SNRI use in RYGB patients without diabetes is associated with increased risk of symptoms.

BACKGROUND The vast majority of patients with cirrhosis have low Model for End-Stage Liver Disease-Sodium (MELD-Na) scores; however, the ability for the MELD-Na score to predict patient outcomes at low scores is unclear. METHODS Adult patients in a multicenter, Chicago-wide database of medical records with International Classification of Disease, Ninth Edition codes of cirrhosis and without a history of hepatocellular carcinoma were included. Records were linked with the state death registry, and death certificates were manually reviewed. Deaths were classified as "liver-related," "non-liver-related," and "non-descript" as adjudicated by a panel comprised of a transplant surgeon, a hepatologist, and an internist. A sensitivity analysis was performed where patients with hepatocellular carcinoma were included. RESULTS Among 7922 identified patients, 3999 patients had MELD-Na scores that were never higher than 15. In total, 2137 (27%) patients died during the study period with higher mortality rates for the patients in the high MELD-Na group (19.4 (41.6%) versus 4.1 (12.6%) per 100 person-y, P < 0.001). The high MELD-Na group died of a liver-related cause in 1142 out of 1632 (70%) as compared to 240 out of 505 (47.5%) deaths in the low MELD-Na group. There was no difference in the distribution of subcategory of liver-related death between low and high MELD-Na groups. Among subclassification of liver-related deaths, the most common cause of death was "Infectious" in both groups. CONCLUSIONS Despite persistently low MELD-Na scores, patients with cirrhosis still experience high rates of liver-related mortality.

Data for liver transplant recipients (LTRs) regarding the benefit of care concordant with clinical practice guidelines for management of blood pressure (BP) are sparse. This paper reports on clinician adherence with BP clinical practice guideline recommendations and whether BP control is associated with mortality and cardiovascular events (CVEs) among LTRs. We conducted a longitudinal cohort study of adult LTRs who survived to hospital discharge at a large tertiary care network between 2010 and 2016. The primary exposure was a BP of

Introduction Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. Methods This was a retrospective, single-center analysis (February–June 2016) using data from Northwestern University’s Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. Results A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5%) and 3 (5.5%) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6–10 ng/mL), and number of required dose adjustments were also similar. Conclusion Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. Funding Astellas Pharma Global Development, Inc. Plain Language Summary Plain language summary available for this article.

Objectives Hyperamylasemia (HA) is often reported in patients with acute liver failure (ALF). Direct toxic effects of acetaminophen on the pancreas have been postulated, but the occurrence of HA in other etiologies raises the question of whether multiorgan failure is part of the pathogenesis of HA in this setting. Our main aim was to describe and analyze the incidence, clinical characteristics, and outcomes of HA in ALF of different etiologies. Methods Patients enrolled in the Acute Liver Failure Study Group registry with an admission amylase value available were included. For the purpose of this analysis, HA was defined as > or =3x upper limits of normal. Patients were classified as having acetaminophen (APAP)- or non-APAP-induced ALF, and by amylase group: normal ( 345). Significant variables identified by univariate analysis were added to a multiple linear regression model. The primary outcome was overall survival. Results In total, 622 eligible patients were identified in the database, including 287 (46%) with APAP-induced ALF; 76 (12%) patients met the criteria for HA. Among patients with HA, 7 (9%) had documented clinical pancreatitis. The incidence of HA was similar among APAP (13%) and non-APAP (12%) patients. Although HA was associated with renal failure and greater Model for End-stage Liver Disease scores for both groups, HA was not an independent predictor of mortality in multivariate analysis. Conclusions Although not an independent predictor of mortality, HA in ALF was present in all etiologies and was associated with diminished overall survival. HA appeared to be related to renal dysfunction in both groups and multiorgan failure in non-APAP ALF.

Background The results of surgical procedures for weight loss are often described in terms of the percentage of excess weight lost. Expressing outcomes using the mean and standard deviation might not adequately describe the clinical experience. This could in part be because the use of the mean ± standard deviation assumes a normal or random distribution of outcomes. It has been our perception that the weight loss results after gastric bypass are relatively normally and tightly distributed around the mean, making it relatively predictable. However, we have found that the results after adjustable gastric banding are more highly variable. In fact, there appears to be 2 groups of patients after this restrictive operation. One group, that is able to work well and does not struggle much against the restriction, accepts the limits that it imposes, and another group, that does not easily learn to deal with the restriction and hence mal-adapts. Methods To evaluate the validity of our clinical perception, we undertook an analysis of the distribution of weight loss by the percentiles of excess weight lost. All patients with follow-up of ≥1 years after gastric bypass or adjustable banding were evaluated for this analysis. The demographics and percentage of excess weight loss were evaluated. The distribution of the percentage of excess weight loss in 10% increments was evaluated. Results Both groups were similar with respect to the mean patient age. However, the patients in the gastric bypass group had had a significantly greater mean preoperative body mass index and were more likely to be women. As expected, the weight loss of the gastric bypass patients fell in a normal single-peak distribution for ≤5 years of follow-up. The data from the adjustable gastric band patients at 1 year demonstrated a normal single-peak distribution, with a longer rightward tail. At 2 and 3 years postoperatively, the data from the band patients had a 2-peaked curve. Conclusion The initial weight loss results after gastric banding are less predictable than those after gastric bypass. A similar analysis of long-term outcomes might be enlightening and assist in making clinical decisions.

To describe the incidence, etiology, outcomes, and management of enteric leaks in patients who had undergone open or laparoscopic gastric bypass.From November 1996 to November 2006, 1133 patients underwent primary gastric bypass at Columbia University, New York-Presbyterian Hospital. A retrospective review of our prospective bariatric surgery registry identified 17 patients (1.5%) who developed a clinically apparent enteric leak after surgery. The demographic and outcome data were studied.The mean body mass index was 52 kg/m(2) (range 35-65), and 15 (88%) of the 17 patients were women. The mean number of co-morbidities per patient was 1.3 and included hypertension in 11, diabetes in 9, and sleep apnea in 6. Ten patients had previously undergone abdominal surgery. The enteric leak was diagnosed by radiographic studies in 12 patients (9 of 12 by upper gastrointestinal series and 3 of 6 by computed tomography); the remaining 5 patients were diagnosed at re-exploration. Of the 17 patients, 12 (70%) were treated by laparoscopy and 5 (29%) by laparotomy. The mean time from completion of the index procedure to the diagnosis of the leak was 2 days (range 1-5) for patients treated by laparoscopy versus 4 days (range 1-6) for patients treated by laparotomy (P.05). The patients treated by laparoscopy experienced a shorter hospital stay, but the difference was not statistically significant (mean 11.4 days, range 6-36, versus 18 days, range 7-33; P.05). One of the laparoscopic patients (5.9%) died.Enteric leak is a significant complication after gastric bypass. Prompt treatment should be based on clinical suspicion, because contrast and cross-sectional imaging studies might not be reliable diagnostic tests. A laparoscopic index procedure might be associated with an earlier diagnosis.

Banded gastric bypass has been reported to result in superior weight loss compared with standard nonbanded gastric bypass. However, an adequate comparison of these procedures has not yet been reported.A total of 90 patients were enrolled in this prospective randomized double-blind trial comparing banded and nonbanded open gastric bypass for the treatment of super obesity. The banding technique involved placement of a 1.5 x 5.5-cm polypropylene band around the proximal gastric pouch of a standard gastric bypass procedure using the technique of Capella. Chi-square testing and analysis of variance were performed to find any differences in patient characteristics (gender, age, and initial body mass index), percentage of excess weight lost at 6, 12, 24, and 36 months postoperatively, improvement or resolution of co-morbidities, and complications in the banded versus nonbanded gastric bypass groups.As expected, no differences were present in the patient characteristics or incidence of co-morbidities between the banded (n = 46) and nonbanded (n = 44) groups. The body mass index, percentage of women, and mean age was 59.5 and 56.5 kg/m2, 64% and 73.8% (P = .09), and 40.6 +/- 7.4 and 42.6 +/- 7.2 years for the banded and nonbanded groups, respectively; all differences were nonsignificant. No significant differences were found in the resolution of co-morbidities. No significant difference was present in the percentage of excess weight loss at 6, 12, and 24 months (43.1% versus 24.7%, 64.0% versus 57.4%, and 64.2% versus 57.2%, respectively) postoperatively; however, the banded patients had achieved a significantly greater percentage of excess weight loss at 36 months (73.4% versus 57.7%; P.05). The incidence of intolerance to meat and bread was greater in the banded patients. The overall number of complications was 12 (26%) in the banded and 13 (29.5%) in the nonbanded group, a nonsignficant difference. No band erosions had occurred at the last follow-up visit, and no patients in either group died.These results suggest that although the initial weight loss was not significantly different between the 2 groups, the banded patients continued to lose weight foror = 3 years. The polypropylene band appeared to be well tolerated. We plan longer follow-up to confirm the possibility of additional weight loss and the prevention of weight regain in the banded group, as well as to document any long-term band complications.

Donation after cardiac death (DCD) has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL) outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n=60) to those of donation after brain death (DBD) liver recipients (n=669) during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P<0.001) and a trend toward lower rates of 5-year patient survival (P=0.064) when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC). Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P<0.05). While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

Laparoscopic gastric bypass (LGBP) is the gold standard operation for long-term weight control in the United States. Laparoscopic adjustable silicone gastric banding (LASGB) is the preferred operative method for morbid obesity worldwide. Limited data are available comparing the two procedure in the United States. This study compares weight loss, complications, and early outcome of comorbidity resolution in patients who underwent LGBP versus LASGB. A review of prospectively collected data was performed on 392 patients undergoing primary LGBP (n = 232) and LASGB (n = 160) procedures between February 2001 and July 2004. Differences in percentage excess weight lost (%EWL) at 3, 6, 12, 18, and 24 months postop, improvement or resolution of comorbidities, and complications across procedure types were evaluated. Mean initial body mass index between groups was not significantly different (LGBP 47.2 vs LASGB 47.1, p < 0.53). There were significant differences in age, gender, and self-reported sweet-eating behavior between operative groups. There was a significantly greater %EWL in patients who underwent LGBP compared to patients of the LASGB groups 3, 6, 12, and 18 months after surgery. There were no significant differences in resolution or improvement of comorbidities between the groups. Although LGBP patients experienced more complications compared to LASGB patients (5.6 vs 4.3%, respectively; p < 0.56), this did not reach statistical significance. Early after surgery, LGBP patients lose more weight than LASGB patients but have similar improvements in comorbidities. Further follow-up is needed to determine the relative long-term efficacy of these procedures.

To help understand the mechanisms by which weight loss is maintained after Roux-en-Y gastric bypass (RYGBP), we measured circulating concentrations of total and bioactive octanoylated ghrelin, peptide YY (PYY), glucose, and insulin in the fasted state and in response to a liquid test meal in three groups of adult women: lean (n = 8); weight-stable 35 +/- 5 months after RYGBP (n = 12; mean body mass index, 33 kg/m(2)); and matched to the surgical group for body mass index and age (n = 12). Fasting plasma total ghrelin levels were nearly identical between RYGBP (425 +/- 54 pg/ml) and the matched controls (424 +/- 28 pg/ml) and highest in lean controls (564 +/- 103 pg/ml). The response to the test meal was comparable between lean and RYGBP groups, with 27% and 20% maximal suppression, respectively, whereas the magnitude of suppression was significantly diminished in the matched controls (17%) compared with the lean group. Fasting levels of octanoylated ghrelin were highest in the lean controls, 220 +/- 36 pg/ml vs. 143 +/- 27 in the RYGBP group (P = 0.05) and 127 +/- 12 pg/ml in the matched controls (P < 0.05). The magnitude of maximal postmeal suppression of octanoylated ghrelin was more marked than with total ghrelin, but similar among groups, ranging from 44-47%. In response to the test meal, there was an early exaggerated rise in PYY in the RYGBP group, such that the peak PYY concentration was 163 +/- 24 pg/ml compared with 58 +/- 17 (P < 0.01) and 77 +/- 23 (P < 0.05) in the matched and lean controls, respectively; area under the curve at 90 min was significantly greater compared with both control groups. Leptin and fasting insulin concentrations and homeostasis model of assessment insulin resistance indices were nearly identical between lean and RYGBP subjects and significantly higher in the body mass index-matched controls. In summary, the absence of a compensatory increase in ghrelin concentrations that usually occurs with diet-induced weight loss, and the exaggerated postprandial PYY response after RYGBP, may contribute to weight loss and to the ability of an individual to maintain weight loss after this surgical procedure.

Background Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Methods Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. Results A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). Discussion The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants.

The field of solid organ transplantation has historically concentrated research efforts on basic science and translational studies. However, there has been increasing interest in health services and outcomes research. The aim was to build an effective and sustainable, inter- and transdisciplinary health services and outcomes research team (NUTORC), that leveraged institutional strengths in social science, engineering, and management disciplines, coupled with an international recognized transplant program. In 2008, leading methodological experts across the university were identified and intramural funding was obtained for the NUTORC initiative. Inter- and transdisciplinary collaborative teams were created across departments and schools within the university. Within 3 years, NUTORC became fiscally sustainable, yielding more than tenfold return of the initial investment. Academic productivity included funding for 39 grants, publication of 60 manuscripts, and 166 national presentations. Sustainable educational opportunities for students were created. Inter- and transdisciplinary health services and outcomes research in transplant can be innovative and sustainable.

Adult-to-adult living donor liver transplantation (LDLT) is a complex procedure that poses serious health risks to and provides no direct health benefit for the donor. Because of this uneven risk-benefit ratio, ensuring donor autonomy through informed consent is critical. To assess the current knowledge pertaining to informed consent for LDLT, we conducted a systematic review of the empirical literature on donors' decision-making process, comprehension about risks and outcomes, and information needs for LDLT. Of the 1423 identified articles, 24 met final review criteria, representing the perspective of approximately 2789 potential and actual donors. As donors' decisions to donate often occur before evaluation, they often make uninformed decisions. The review found that 88% to 95% of donors reported understanding information clinicians disclosed about risks and benefits. However, donors reported unmet information needs, knowledge gaps regarding risks, and unanticipated complications. Few donors reported feeling pressure to donate. Most studies were limited by cultural differences, small sample sizes, inconsistent measures, and poor methodological approaches. This systematic review suggests that informed consent for LDLT is sub-optimal as donors do not adequately appreciate disclosed information during the informed consent process, despite United Network for Organ Sharing/CMS regulations requiring formal psychological evaluation of donor candidates. Interventions are needed to improve donor-clinician communication during the LDLT informed consent process such as through the use of comprehension assessment tools and e-health educational tools that leverage adult learning theory to effectively convey LDLT outcome data.

Background The current National Institutes of Health guidelines have recommended bariatric surgery for patients with a body mass index (BMI) >40 kg/m 2 or BMI >35 kg/m 2 with significant co-morbidities. However, some preliminary studies have shown that patients with a BMI that does not meet these criteria could also experience similar weight loss and the benefits associated with it. Methods An institutional review board-approved protocol was obtained to study the effectiveness of laparoscopic adjustable gastric banding in patients with a low BMI. A total of 66 patients with a BMI of 30–35 kg/m 2 and co-morbidities (n = 22) or a BMI of 35–40 kg/m 2 without co-morbidities (n = 44) underwent laparoscopic adjustable gastric banding. These patients were compared with 438 standard patients who had undergone laparoscopic adjustable gastric banding who met the National Institutes of Health criteria for bariatric surgery. The excess weight loss at 3, 6, 12, and 18 months and the status of their co-morbidities were compared between the 2 groups. Results The average BMI for the study group was 36.1 ± 2.6 kg/m 2 compared with 46.0 ± 7.3 kg/m 2 for the control group. Both groups had significant co-morbidities, including hypertension, diabetes, hyperlipidemia, arthritis, gastroesophageal reflux disease, stress incontinence, and obstructive sleep apnea. The mean percentage of excess weight loss was 20.3% ± 9.0%, 28.5% ± 14.0%, 44.7% ± 19.3%, and 42.2% ± 33.7% at 3, 6, 12, and 18 months, respectively. This was not significantly different from the excess weight loss in the control group, except for at 12 months. Both groups showed similar improvement of most co-morbidities. Conclusion Moderately obese patients whose BMI is less than the current guidelines for bariatric surgery will have similar weight loss and associated benefits. Laparoscopic adjustable gastric banding is a safe and effective treatment for patients with a BMI of 30–35 kg/m 2 .

Background Although gastric bypass is the most common bariatric procedure in the United States, it is has been associated with a failure rate of 15% (range 5–40%). The addition of an adjustable gastric band to Roux-en-Y gastric bypass has been reported to be a useful revision strategy in a small series of patients with inadequate weight loss after proximal gastric bypass. Methods We report on 22 patients who presented with inadequate weight loss or significant weight regain after proximal gastric bypass. All patients underwent revision with the placement of an adjustable silicone gastric band around the proximal gastric pouch. The bands were adjusted at 6 weeks postoperatively and beyond, as needed. Complications and weight loss at the most recent follow-up visit were evaluated. Results The mean age and body mass index at revision was 41.27 years (range 25–58) and 44.8 ± 6.34 kg/m 2 , respectively. Patients had experienced a loss of 19%, 27%, 47.3%, 42.3%, 43%, and 47% of their excess weight at 6, 12, 24, 36, 48, and 60 months after the revisional procedure, respectively. Three major complications occurred requiring reoperation. No band erosions have been documented. Conclusion The results from this larger series of patients have also indicated that the addition of the adjustable silicone gastric band causes significant weight loss in patients with poor weight loss outcomes after gastric bypass. That no anastomosis or change in absorption is required makes this an attractive revisional strategy. As with all revisional procedures, the complication rates appear to be increased compared with a similar primary operation.

Several studies have suggested that morbid obesity is associated with vitamin D deficiency and elevated parathyroid hormone (PTH). Studies have also suggested that there is an increase in vitamin D deficiency, bone resorption, and elevated PTH after gastric bypass surgery. Few studies have evaluated markers of bone and calcium metabolism after laparoscopic adjustable gastric banding or compared these results to those after gastric bypass. Data on all patients undergoing primary gastric bypass (GBP; n = 979) and laparoscopic adjustable gastric banding (LAGB; n = 269) procedures at a tertiary-referral center from June 1996 through March 2005 were reviewed from a prospective database. Only patients with 25OH vitamin D levels available were included in this study (n = 534; GBP = 403, LAGB = 131). All patients were advised to take at least 1,200 mg calcium and 800–1,200 IU of vitamin D daily before and subsequent to their operation. Markers for bone metabolism [25OH Vitamin D, corrected serum calcium, alkaline phosphatase (AP), and PTH] were evaluated preoperatively and 3, 6, 12, and 24 months postoperatively. An analysis of variance and chi-square were performed to determine differences between the operative groups. Linear regression analysis was performed to evaluate the relationship between preoperative body mass index (BMI) and 25OH vitamin D and PTH levels and between percent excess weight loss and 25OH vitamin D and PTH after surgery. Sixty-four percent of all patients presented with vitamin D deficiency (

Esophageal dilation can occur after laparoscopic adjustable gastric banding (LAGB). There are few studies in the literature that describe the outcomes of patients with esophageal dilation. The aim of this article is to evaluate weight loss and symptomatic outcome in patients with esophageal dilation after LAGB.We performed a retrospective chart review of all LAGBs performed at Columbia University Medical Center from March 2001 to December 2006. Patients with barium swallow (BaSw) at 1 year after surgery were evaluated for esophageal diameter. A diameter of 35 mm or greater was considered to be dilated. Data collected before surgery and at 6 months and 1, 2 and 3 years after surgery were weight, body mass index (BMI), status of co-morbidities, eating parameters, and esophageal dilation as evaluated by BaSw.Of 440 patients, 121 had follow-up with a clinic visit and BaSw performed at 1 year. Seventeen patients (10 women and 7 men) (14%) were found to have esophageal dilation with an average diameter of 40.9 +/- 4.6 mm. There were no significant differences in percent of excess weight lost at any time point; however, GERD symptoms and emesis were more frequent in patients with dilated esophagus than in those without dilation. Intolerance of bread, rice, meat, and pasta was not different at any time during the study.In our experience the incidence of esophageal dilation at 1 year after LAGB was 14%. The presence of dilation did not affect percent excess weight loss (%EWL). GERD symptoms and emesis are more frequent in patients who develop esophageal dilation.

l Roux-en-Y gastric bypass is arguably the reference stanard weight loss operation at present, with a wealth of xperience in operative technique and proven surgical outomes. Since 1994, various laparoscopic versions of the peration have been described and are widely performed. he open operation, however, is still commonly practiced 1]. Three cases of complications after open Roux-en-Y astric bypass are described, each with slightly different anifestations of a shared etiology, a reverse peristaltic limentary limb. Two of the cases were referred to us after he primary procedure, and one operation was performed at ur institution. All primary procedures were performed by ifferent surgeons using an open technique, by way of ertical midline laparotomies above the umbilicus.

Background Inadequate weight loss after proximal gastric bypass presents a clinical challenge to bariatric surgeons. Pouch size, stoma size and limb length are the variables that can be surgically altered. Aside from conversion to distal bypass, which may have significant negative nutritional sequelae, revisional surgery for this group of patients has not often been reported. The addition of adjustable silicone gastric banding (ASGB) to Roux-en-Y gastric bypass (RYGBP) may be a useful revision strategy because it has potential safety benefits over other revisional approaches. Materials and methods We report on 8 patients who presented with inadequate weight loss or significant weight regain after proximal gastric bypass. All patients underwent revision with the placement of an ASGB around the proximal gastric pouch. Bands were adjusted at 6 weeks postoperatively and beyond as needed. Complications and weight loss at the most recent follow-up visit were evaluated. Results Mean age and body mass index (BMI) at the time of revision were 39 +/- 9.9 years and 44.0 +/- 4.5 kg/m2 respectively. No patients were lost to follow-up, and they lost an average of 38.1 +/- 10.4% and 44.0 +/- 36.3% of excess weight and 49.1 +/- 20.9% and 52.0 +/- 46.0% of excess BMI in 12 and 24 months respectively. Patients lost an average of 62.0 +/- 20.5% of excess weight from the combined surgeries in 67 (48-84) months. The only complication was the development of a seroma overlying the area of the port adjustment in one patient. There have been no erosions or band slippages to date. Conclusions These results indicate that the addition of an ASGB causes significant weight loss in patients with poor weight loss outcome after RYGBP. The fact that no anastomosis or change in absorption is required may make this an attractive revisional strategy. Long- term evaluation in a larger population is warranted.

Background: Laparoscopic adjustable silicone gastric banding (LASGB) for morbid obesity has been reported to provide long-term weight loss with a low risk of operative complications. Nevertheless, esophageal dilation leading to achalasia-like and reflux symptoms is a feared complication of LASGB. This study evaluates the clinical benefit of routine preoperative esophageal manometry in predicting outcome after LASGB in morbidly obese patients. Method: A review of prospectively collected data on 77 patients who underwent routine esophageal manometry prior to LASGB for morbid obesity from February 2001 to September 2003 was performed. Aberrant motility, abnormal lower esophageal sphincter (LES) pressures, and other nonspecific esophageal motility disorders noted on preoperative esophageal manometry defined patients of the abnormal manometry group. Outcome differences in weight loss, emesis, band complications, and gastroesophageal reflux disease (GERD) resolution or improvement were compared between patients of the abnormal and normal manometry groups after LASGB. Analysis of variance (ANOVA) and chi-square tests were performed to determine the significance of these outcomes. Results: Of the patients tested, 14 had abnormal esophageal manometry results, whereas 63 had normal manometry results before LASGB. There was no significant difference in percent excess weight loss (%EWL) at 6 and 12 months between the groups after gastric banding. Severe postoperative emesis occurred more frequently in patients with abnormal manometry results than in those with normal manometry results. There were two band-related complications, both of which occurred in patients of the normal manometry group. Conclusions: Preoperative esophageal manometry does not predict weight loss or GERD outcomes after LASGB in morbidly obese patients. Postoperative emesis was more common in patients with abnormal manometry findings, but such symptoms were manageable and did not lead to poor weight loss or to band removal or increased band-related complications.