Faculty Bibliography

BACKGROUND: At our medical center, female patients who have undergone bariatric surgery are advised to defer pregnancy for 2 years after surgery to avoid the following complications and their potential consequences for the fetus: inadequate gestational weight gain, inadequate postsurgical weight loss, hyperemesis gravidarum, nutritional deficiencies, gestational diabetes, and gestational hypertension. OBJECTIVES: To examine the effect of time from surgery to conception on pregnancy course and outcomes in bariatric patients. SETTING: University. METHODS: We identified 73 pregnancies in 54 women who became pregnant after undergoing bariatric surgery. Surgery to conception interval was compared between pregnancies that were carried to delivery and 8 pregnancies that resulted in spontaneous abortion. Of 41 pregnancies that were carried to delivery, 26 occurred in women who had undergone surgery less than 2 years before conception, and 15 occurred in women who had undergone surgery greater than 2 years before conception. Gestational age at delivery, number of neonatal intensive care unit admissions, gestational weight gain, hyperemesis gravidarum, nutritional deficiencies, gestational diabetes, and gestational hypertension during pregnancy were compared for the 2 groups. RESULTS: Eight patients who had spontaneous abortion had a significantly shorter time from surgery to conception. There were no significant differences between our 2 groups in rates of preterm deliveries, neonatal intensive care unit admission, gestational weight gain, hyperemesis, nutritional deficiencies, gestational diabetes, or gestational hypertension. CONCLUSIONS: Becoming pregnant within the first 2 years after bariatric surgery appears to have no effect on pregnancy course and outcomes. Women who miscarried had a significantly lower mean surgery to conception interval. These results fail to show an increased rate of pregnancy complications during the first 2 years after bariatric surgery.

BACKGROUND: Portomesenteric vein thrombosis (PMVT) has been increasingly reported after laparoscopic sleeve gastrectomy (LSG). Factor VIII (FVIII) is a plasma sialoglycoprotein that plays an essential role in hemostasis. There is increasing evidence that FVIII elevation constitutes a clinically important risk factor for venous thrombosis. OBJECTIVES: To report the prevalence of FVIII elevation as well as other clinical characteristics in a multicenter series of patients who developed PMVT after LSG. SETTING: University hospitals. METHODS: A retrospective review was conducted of all patients that developed PMVT after laparoscopic bariatric surgery from 2006 to 2016 at 6 high-volume bariatric surgery centers. RESULTS: Forty patients who developed PMVT postoperatively, all after LSG, were identified. During this timeframe, 25,569 laparoscopic bariatric surgery cases were performed, including 9749 LSG (PMVT incidence after LSG = .4%). Mean age and body mass index were 40 years (18-65) and 43.4 kg/m2 (35-59.7), respectively. Abdominal pain was the most common (98%) presenting symptom. Of patients, 92% had a hematologic abnormality identified, and of these, FVIII elevation was the most common (76%). The vast majority (90%) was successfully managed with therapeutic anticoagulation alone. A smaller number of patients required small bowel resection (n = 2) and surgical thrombectomy (n = 1). There were no mortalities. CONCLUSIONS: A high index of clinical suspicion and prompt diagnosis/treatment of PMVT usually leads to favorable outcomes. FVIII elevation was the most common (76%) hematologic abnormality identified in this patient cohort. Further studies are needed to determine the prevalence of FVIII elevation in patients seeking bariatric surgery.

Introduction: Cholangiocarcinoma and pancreatic adenocarcinoma account for over 190,000 new clinical cases of pancreatobiliary malignancy worldwide annually. For palliation of obstructive jaundice in these patients, plastic or self-expanding metal stent (SEMS) are placed. However, re-occlusion rates for currently available stents range as high as 36% for uncovered metal stents, 25% for covered metal stents and 52% for plastic stents. Tissue ingrowth accounts for up to 76% of occlusions of bare metal stents.1, 2, 3, 4 Stent occlusion can result in recurrent obstruction and typically requires endoscopic re-intervention. Therefore there is a real clinical need to reduce tissue ingrowth and improve biliary stent patency rates. Aims & Methods: In this study we developed and tested a controlled-release paclitaxel-eluting SEMS designed to prevent tissue hyperplasia and stent occlusion. A 4 cm length uncovered, laser-cut nitinol stent was coated with a polymer matrix allowing slow release of paclitaxel. Naive Yucatan swine were assigned to one of three stent groups: bare control (n=3, no polymer), standard dose paclitaxel (n=6, 149.4 mg paclitaxel) and challenge dose (n=3, 538.0 mg paclitaxel. Two stents were endoscopically implanted in each swine from its assigned group, one in the intrahepatic/hilar region and a second in the common bile duct placed proximal to the papilla. Stents were assessed for migration via digital radiographs for the first 2 weeks and then monthly via endoscopy using SpyGlassTM DS cholangioscopy and cholangiography with a targeted 6 month study endpoint. Results: At 30 days post-implant, no significant tissue reaction to any stent was observed. However, all animals displayed mild biofilm formation and increased intraductal mucus production. Substantial dilation of the common bile duct was observed in 5/11 animals with no apparent relationship between drug coating and duct dilation. At 60 days post-implant, moderate mucus and biofilm formation was observed within the stent, however in only 3 animals biliary ductal dilation persisted and the majority of stents were fully apposed to the duct wall. Although some animals displayed minimal tissue hyperplasia at the proximal end of the stents, no tissue overgrowth or stent embedding was observed in any animal. Up to 60 days post-implant, no persistent clinical symptoms were observed in any animal. Stents in one standard dose animal migrated out of the bile duct between days 15 and 30, this animal is not included in patency results reported. At both 30 and 60 day timepoints, no apparent differences in outcome were observed among the three study groups. Conclusion: At this mid-study follow-up, paclitaxel-eluting stents appear to be safe for use in naive tissue and do not negatively impact function of the biliary system, even at challenge condition doses. Although the cause of bile duct dilation observed in all stent groups has not been conclusively identified, we hypothesize the cause may be distal stent impaction and intermittent (clinically insignificant) obstruction of the papilla and/or stent, resulting in retained mucus and bile. Bile duct dilation, in turn, has reduced the opportunity for tissue overgrowth in all stent groups, which was expected to occur in the bare stent control group by 60 days post-implant5. Given the observed 60% reduction in number of dilated ducts between days 30 and 60, we expect increased rate of apposition. Ongoing efforts include continued follow-up for an additional 120 days, and in a second cohort, determination of in vivo drug release rates in the bile duct over a 30 day period. Future cholangioscopic and histopathological assessment of these swine will further clarify the safety and effectiveness of paclitaxel stent coatings to mediate bile duct tissue ingrowth

BACKGROUND: We investigated whether the surgical Apgar score (SAS) may enhance the Veterans Affairs Surgical Quality Improvement Program (VASQIP) risk assessment for prediction of early postoperative outcomes. METHODS: We retrospectively evaluated demographics, medical history, procedure, SAS, VASQIP assessment, and postoperative data for patients undergoing major/extensive intra-abdominal surgery at the Manhattan Veterans Affairs between October 2006 and September 2011. End points were overall morbidity and 30-, 60- , and 90-day mortality. Pearson's chi-square, ANOVA, and multivariate regression modeling were employed. RESULTS: Six hundred twenty-nine patients were included. Apgar groups did not differ in age, sex, and race. Low SASs were associated with worse functional status, increased postoperative morbidity, and 30-, 60- , and 90-day mortality rates. SAS did not significantly enhance VASQIP prediction of postoperative outcomes, although a trend was detected. Multivariate analysis confirmed SAS as an independent predictor of morbidity and mortality. CONCLUSIONS: SAS effectively identifies veterans at high risk for poor postoperative outcome. Additional studies are necessary to evaluate the role of SAS in enhancing VASQIP risk prediction.

BACKGROUND: There is debate regarding preoperative endoscopy (EGD) in patients undergoing bariatric surgery. Some centers perform EGD routinely in all patients; others perform EGD selectively. The objective of this study was to perform a systematic review and meta-analysis of the existing literature to estimate how frequently preoperative EGD changes management. METHODS: Our review yielded 28 studies encompassing 6616 patients. Baseline characteristics including age and body mass index (BMI) were included. Patients were grouped based on EGD findings into two groups: Group 1-findings which did not significantly change management (e.g., mild/moderate duodenitis, Grade A/B esophagitis, mild/moderate gastritis, H. pylori infection, hiatal hernia <2 cm); Group 2-findings which delayed, altered, or cancelled surgery (e.g., severe duodenitis, Grade C/D esophagitis, gastric varices, hiatal hernia >2 cm, mass/carcinoma). A general estimating equation (GEE) model accounting for the correlated data within each study was used to calculate confidence intervals around the estimate of how frequently surgery was delayed or altered. RESULTS: Mean age was 41.4 +/- 2.9 years, the majority was women, and mean preoperative BMI was 47 +/- 3.2 kg/m2. Overall 92.4 % (n = 6112) had a normal EGD or findings that did not change clinical management and 7.6 % (n = 504); 95 % CI [4.6, 12.4 %] had findings that delayed/altered surgery. The revised estimate was 20.6 %; 95%CI [14.5, 28.2 %] if all esophagitis (regardless of grade) were categorized into Group 2. The approximate incidence of Barrett's esophagus and carcinoma were 0.1 and 0.08 %, respectively. CONCLUSION: A selective approach to preoperative EGD may be considered, based on the patients' symptoms, risk factors, and type of procedure planned.

BACKGROUND: Patients with type 2 diabetes (T2D) and body mass index (BMI)<35 may benefit from metabolic surgery. The soluble form of the receptor for advanced glycation end products (sRAGE) may identify patients at greater chance for T2D remission. OBJECTIVES: To study long-term outcomes of patients with T2D and BMI 30-35 treated with metabolic surgery or medical weight management (MWM) and search for predictors of T2D remission. SETTING: University METHODS: Retrospective review of the original cohort, including patients who crossed over from MWM to surgery. Repeated-measures linear models were used to model weight loss (%WL), change in glycated hemoglobin (HbA1C) and association with baseline sRAGE. RESULTS: Fifty-seven patients with T2D and BMI 30-35 were originally randomly assigned to metabolic surgery versus MWM. Mean BMI and HbA1C was 32.6% and 7.8%, respectively. A total of 30 patients underwent surgery (19 sleeves, 8 bypasses, 3 bands). Three-year follow-up in the surgery group and MWM group was 75% and 86%, respectively. Surgery resulted in higher T2D remission (63% versus 0%; P<.001) and lower HbA1C (6.9% versus 8.4%; P<.001) for up to 3 years. There was no difference in %WL in those with versus those without T2D remission (21.7% versus 20.6%, P = .771), suggesting that additional mechanisms other than %WL play an important role for the studied outcome. Higher baseline sRAGE was associated with greater change in HbA1C and greater %WL after surgery (P< .001). CONCLUSION: Metabolic surgery was effective in promoting remission of T2D in 63% of patients with BMI 30-35; higher baseline sRAGE predicted T2D remission with surgery. Larger-scale randomly assigned trials are needed in this patient population.

Background: Rates of obesity are increasing rapidly among young patients and nonsurgical methods of treating this epidemic are largely ineffective in this population. Bariatric surgery has proved to be safe and effective even in prepubertal children for weight loss and resolution of obesity associated comorbidities such as diabetes. However, these benefits have to be weighed against the risks of bariatric surgery including operative complications and post-operative micronutrient deficiencies. There is a scarcity of literature examining weight loss over time associated with bariatric surgery in young patients as compared to their older counterparts. Objective: The objective of this study is to determine whether a difference exists in weight loss following bariatric surgery in female patients who are less than or equal to 25 years of age and those greater than 25 years of age at the time of bariatric surgery. Setting: University Hospital Methods: Our institutional database was queried for premenopau-sal women o50 years old who had bariatric surgery between 01/2012-04/2015. Information regarding type of surgery was obtained for each patient. These patients were divided into two groups, those less than or equal to 25 years of age and those greater than 25 years of age at the time of bariatric surgery. Preoperative weight and height were collected and BMI was calculated. Weights were measured at time periods: 30 days (20-40 days were accepted), 90 days (60-120 were accepted), 180 days (121-240 days were accepted), 360 days (270-450 days were accepted) and 720 days (630-810 days were accepted) following surgery. Percent weight loss, change in BMI and percent excess BMI lost was calculated for each of these time periods and the means for each group were obtained. A t-test was run and p-values were obtained for each time period, with p values o 0.05 considered as statistically significant. Results: 253 patients r25 years old (15.9%) and 1337 patients 425 years old (84.1%) underwent bariatric surgery during this time period. Of these, approximately 10% underwent gastric band, 66% underwent sleeve gastrectomy and 24% underwent Roux-en-Y gastric bypass. Initial BMI was 43.86/41.97 (po.0001) for these groups, respectively. Table 1 shows the mean change in BMI, percentage weight loss and change in excess BMI for each group at 30/90/180/360/720 days following surgery. Figure 1 shows the change in BMI in these two groups over time. BMI was similar for these two groups at 30, 90 and 180 days (p =.23,.45,.12). However, after 180 days, the two groups diverge and the difference in BMI becomes statistically significant at 360 and 720 days (p=.0083,.0304), with the younger patients experiencing greater weight loss over time. A similar pattern is observed in the % weight loss and the change in excess BMI between the younger and older groups at these time points (figure 2 and 3). Complications requiring re-admission, including infection, small bowel obstruction, and dehydration, were similar in both groups (5.14% in r25 years vs. 6.96% in 425 years). Conclusion: Though both groups had the same initial rates of weight loss, the change in BMI, change in excess BMI and % weight loss for the two groups began to diverge after 6 months postoperatively. The younger cohort continued to lose weight, whereas the older cohort not only plateaued but actually regained some of the weight that had been lost at 2 years. Though a notable limitation to this study is that we only included premenopausal females, this patient population accounts for the majority of bariatric operations so we believe it is a valuable cohort to examine. We conclude that bariatric surgery is more effective for weight loss in younger patients when compared to their older counterparts. These surprising results suggest that patients should be encouraged to undergo bariatric surgery at a younger age and not to delay their surgeries until they are older, as younger patients have greater and more sustained weight loss associated with bariatric procedures. We look forward to future research examining long-term weight loss, rates of complications, and resolution of obesity-related disorders in this population

Background: Though the pathogenesis of polycystic ovarian syndrome (PCOS) is incompletely understood, it has been linked to obesity, metabolic syndrome and insulin resistance. The NIH suggests that patients with two of the following: oligo/anovulation, hyperandrogenism and polycystic ovaries on ultrasound, meet the Rotterdam criteria for diagnosis of PCOS.1 The incidence of PCOS is 8% in the general female population and is suspected to be much higher in individuals with obesity as the majority of these patients are undiagnosed. Though not sufficient for diagnosis, oligo/amenorrhea is an important component of the condition and PCOS should be suspected in these patients as the majority of PCOS patients first present with oligomenorrhea. Bariatric surgery has been shown to correct menstrual irregularity and androgen levels in these individuals, but there exists a dearth of literature examining weight loss in women with PCOS compared to those without this diagnosis. Objectives: The objective of this study is to determine whether a difference exists in weight loss following bariatric surgery in patients with PCOS, in patients with menstrual irregularity alone and in patients with no reported menstrual irregularity. Setting: University Hospital. Method: Our institutional database was queried for premeno-pausal women o50 years old who had bariatric surgery between 01/2012-04/2015. Information regarding type of surgery was obtained for each patient. These patients were divided into those who self-reported PCOS, those who reported menstrual irregularity and those who reported neither. Preoperative weight and height were collected and BMI was calculated. Weights were measured at time periods: 30 days (20-40 days were accepted), 90 days (60-120 were accepted), 180 days (121-240 days were accepted), 360 days (270-450 days were accepted) and 720 days (630-810 days were accepted) following surgery. Percent weight loss, change in BMI and percent excess BMI lost was calculated for each of these time periods and the means for each group were obtained. Analysis of variance (ANOVA) was run and p-values were obtained for each time period. Results: 119 patients with PCOS (7.48%), 278 with menstrual irregularity (17.5%) and 1193 with neither (75.0%) underwent bariatric surgery during the time period. Of these, approximately 10% underwent gastric band, 66% underwent sleeve gastrectomy and 24% underwent Roux-en-Y gastric bypass. Starting BMI was 42.83/41.73/42.33 for these groups, respectively (p=.25). Table 1 shows the mean change in BMI, percentage weight loss and change in excess BMI for each group at 30/90/180/360/720 days following surgery. The p values were obtained and are all found to be 44.05 indicating no statistically significant difference between the three groups. Conclusions: There was no difference in weight loss between patients with a diagnosis of PCOS, those with menstrual irregularity, and those without menstrual irregularity in the 2 years following bariatric surgery. Given that patients with PCOS are at higher risk of obesity related complications such as type 2 diabetes and dyslipidemia than those without PCOS, this is an encouraging result as it illustrates the efficacy of bariatric surgery for weight loss in the PCOS cohort. We look forward to further research to clarify the true incidence of PCOS in individuals with obesity as the high incidence of menstrual irregularity in our population leads us to suspect a substantially higher incidence of PCOS than is diagnosed

Introduction: Endoscopic stent placement after sleeve gastrectomy (LSG) leak is usually considered part of the treatment algorithm. We have experienced varying success with stents and have also seen patients who have difficulty tolerating the stent or who have experienced worsening leak with the stent. The purpose of this study is to review our experiences with these stents to contribute to the growing literature of the effectiveness in the management of sleeve leaks. Setting: Academic medical center. Methods: A retrospective review of all reported sleeve leaks between 2 high-volume bariatric surgery centers were reviewed. Data was collected on the presentation of these leaks as well as the entire post-operative course. Cases spanned from 2006 to 2016. Information was collected on clinical presentation, radiographic findings, endoscopic findings, stent placement, stent complications, re-intervention rate, and re-operation rate. Stent complications were defined as any persistent leak, PO intolerance, nausea/vomiting, radiographic evidence of migration, or abdominal pain that required either replacement/repositioning or removal of the stent. Results: 32 sleeve leaks were identified across our institutions. Two cases were excluded for lack of post-operative course data. 18 (60%) of 30 were treated at some point with an endoscopic stenting procedure. Complications that could be attributed directly to the stent were identified in 14 of the 18 cases (78%).The average number of interventions in the stent group was 3.7 compared to 0.75 in the no stent group (p<0.005).The average number of total admitted days was significantly higher in the stent group with 25.5 days versus 12.58 (p = 0.006). Conclusion: Patients who undergo stenting for the management of leak following a sleeve gastrectomy appear to require more interventions and have higher length of stay. Further studies are needed in order to better identify those patients who may benefit from endoscopic interventions and those who should be managed alternatively

Background: At our medical center, female patients who have undergone bariatric surgery are advised to defer pregnancy for two years after surgery, due to the theoretical risk that becoming pregnant during the period of rapid weight loss after surgery will adversely affect long term weight loss. Methods: We examined our database of bariatric surgery patients from a large, urban, public hospital from March 2011 to January 2014. Out of over 2000 patients, we identified 49 women who became pregnant and carried to term after undergoing bariatric surgery. 29 pregnancies occurred in women who had undergone bariatric surgery less than 2 years prior to conception, and 20 occurred in women who had undergone bariatric surgery greater than 2 years prior to conception. Weight data were recorded and BMI was calculated for each patient from pre-op to post-delivery. Percentage of excess weight loss (%EWL) based on an ideal BMI of 25 at three different time points after delivery (3-12 months, 1-2 years, > 2 years) was compared for the two groups. Results: The two groups were statistically similar with regards to baseline weight, BMI, and BMI loss from surgery to conception. The mothers with <2 years between bariatric surgery and conception had a higher percentage of RYGB and LSG surgeries (p=0.020). %EWL was significantly higher for the <2 year group at 3-12 months post-delivery (57.1% vs. 37.5%, p=0.028), 12-24 months post-delivery (61.1% vs. 37.7%, p=0.012), and >2 years post-delivery (59.9% vs. 38.7%, p=0.044). However, when stratifying by surgery type, there were no significant differences in %EWL between the two groups at any time point (Table). A multiple linear repeated measures model showed that mothers in the <2 year group had significantly greater %EWL after adjusting for age of mother, surgery type, and baseline BMI (+5.6% EWL at 3-12 months post-delivery, +11.1% at 12-24 months, and +16.5% at >2 years; p=0.031). Conclusions: In this study, long term weight loss was significantly greater in women who conceived earlier than 2 years after undergoing bariatric surgery. This result may also have been affected by surgery type, as there were higher percentages of RYGB and LSG in the early pregnancy group. However, after controlling for this difference between the two groups, there remained a significant difference in %EWL at all three time points, suggesting that patients who become pregnant within 2 years after surgery may have greater long term weight loss