Michael Schweitzer

Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease

ObjectiveTo determine the risks and benefits of gastric bypass-induced weight loss on severe venous stasis disease in morbid obesity. Summary Background DataSevere obesity is associated with a risk of lower extremity venous stasis disease, pretibial ulceration, cellulitis, and bronze edema. MethodsThe GBP database was queried for venous stasis disease including pretibial venous stasis ulcers, bronze edema, and cellulitis. ResultsOf 1,976 patients undergoing GBP, 64 (45% female) met the criteria. Mean age was 44 ± 10 years. Thirty-seven patients had pretibial venous stasis ulcers, 4 had bronze edema, 23 had both, and 17 had recurrent cellulitis. All had 2 to 4+ pitting pretibial edema. Mean preoperative body mass index (BMI) was 61 ± 12 kg/m2 and weight was 179 ± 39 kg (270 ± 51% ideal body weight), significantly greater than in patients who underwent GBP without venous stasis disease. Two patients had a pulmonary embolus and four had Greenfield filters in the remote past. Additional comorbidities included obesity hypoventilation syndrome, sleep apnea syndrome, hypertension, gastroesophageal reflux, degenerative joint disease symptoms, type 2 diabetes mellitus, pseudotumor cerebri, and urinary incontinence. Comorbidities were significantly more frequent in the patients with venous stasis disease than for those without. At 3.9 ± 4 years after surgery, patients lost 55 ± 21% of excess weight, 62 ± 33 kg, reaching 40 ± 9 kg/m2 BMI or 176 ± 41% ideal body weight. Venous stasis ulcers resolved in all but three patients. Complications included anastomotic leaks with peritonitis and death, fatal pulmonary embolism, fatal respiratory arrest, wound infections or seromas, staple line disruptions, marginal ulcerations treated with acid suppression, stomal stenoses treated with endoscopic dilatation, late small bowel obstructions, and incisional hernias. There were six other late deaths. ConclusionsSevere venous stasis disease was associated with a significantly greater weight, BMI, male sex, age, comorbidity, and surgical risk (pulmonary embolus, leak, death, incisional hernia) than in other patients who underwent GBP. Surgically induced weight loss corrected the venous stasis disease in almost all patients as well as their other obesity-related problems.

Contribution of male sex, age, and obesity to mechanical instability of the upper airway during sleep

Male sex, obesity, and age are risk factors for obstructive sleep apnea, although the mechanisms by which these factors increase sleep apnea susceptibility are not entirely understood. This study examined the interrelationships between sleep apnea risk factors, upper airway mechanics, and sleep apnea susceptibility. In 164 (86 men, 78 women) participants with and without sleep apnea, upper airway pressure-flow relationships were characterized to determine their mechanical properties [pharyngeal critical pressure under hypotonic conditions (passive Pcrit)] during non-rapid eye movement sleep. In multiple linear regression analyses, the effects of body mass index and age on passive Pcrit were determined in each sex. A subset of men and women matched by body mass index, age, and disease severity was used to determine the sex effect on passive Pcrit. The passive Pcrit was 1.9 cmH(2)O [95% confidence interval (CI): 0.1-3.6 cmH(2)O] lower in women than men after matching for body mass index, age, and disease severity. The relationship between passive Pcrit and sleep apnea status and severity was examined. Sleep apnea was largely absent in those individuals with a passive Pcrit less than -5 cmH(2)O and increased markedly in severity when passive Pcrit rose above -5 cmH(2)O. Passive Pcrit had a predictive power of 0.73 (95% CI: 0.65-0.82) in predicting sleep apnea status. Upper airway mechanics are differentially controlled by sex, obesity, and age, and partly mediate the relationship between these sleep apnea risk factors and obstructive sleep apnea.

M1359 Restore: Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction: A Double-Blind, Sham-Controlled Multicenter Study for Treatment of Inadequate Weight Loss or Weight Regain Following Roux-en-Y Gastric Bypass

Background and aims: Roux-en-Y gastric bypass technique (RYGBP) by inducing bacterial stasis could promote small intestinal bacterial overgrowth (SIBO). In a previous study performed in 146 patients with morbid obesity (1) we found an increase in the prevalence of SIBO compared to healthy subjects 17.1% vs.2.5% (p=0.03). The aim of this study was to evaluate prospectively the prevalence of SIBO in a larger population of patients withmorbid obesity, before and after bariatric surgery and its potential effect on vitamin deficiencies after surgery. Patients and methods: from October 2001 to July 2009, a glucose hydrogen (H2) breath test (BT, positive if fasting breath H2 concentration > 20 ppm and or increase > 10 ppm over baseline within the first 2 hours) was proposed to all obese patients referred for bariatric surgery (BMI > 40 kg/m 2 or > 35 in association with comorbidities) before and after bariatric surgery to assess the presence of SIBO. Vitamin levels (B12, B1, PP) were measured while vitamin supplementation was systematically prescribed after RYGBP. Results(mean ± SE, median (IQR) : 378 patients (336 women (88.9%), 39.6± 11.7 yrs, BMI : 45.7±6.3 kg/m 2 ) were included : 357 patients had a preoperative BT that was positive in 55 cases (15.4%), negative in 290 cases (81,2%) and doubtful or uninterpretable in 12 cases (3.4%). Twenty patients had BT after gastric banding [time since surgery 36 months (26-47), weight loss 22.9±14.1 kg] that was negative in 18 cases (90%) and positive in 2 cases (10%) (p = NS compared with preoperative situation). Sixty-five patients had a BT after RYGBP [time since surgery 9.2 months (6.8-23), weight loss 34.4± 11.5 kg] that was negative in 39 cases (60%) and positive in 26 cases (40%) (p<0.001 compared with preoperative situation). After RYGBP the percentage of patients with or without vitamin deficiencies was not different in patients with positive or negative BT (p = NS). Conclusion: in this study with a large number of patients, we confirm the presence of SIBO in 15% of patients with morbid obesity. After gastric banding, there is no increase in this prevalence while after RYGBP it increases to 40% of patients. In patients with systematic vitamin supplementation, a positive BT is not associated with an increase in the frequency of vitamin deficiencies. (1) Sabate et al. Obes Surg 2008 ; 18:371-377

Prevalence of and risk factors for hypoglycemic symptoms after gastric bypass and sleeve gastrectomy: Postsurgical Hypoglycemic Symptoms

Objective To determine the prevalence of and risk factors for postprandial hypoglycemic symptoms among bariatric surgery patients. Design and Methods A questionnaire including the Edinburgh hypoglycemia scale was mailed to patients who underwent either Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG) at a single center. Based on the questionnaire, we categorized the patients as having high or low suspicion for post-surgical, postprandial hypoglycemic symptoms. Results Of the 1119 patients with valid addresses, 40.2% (N=450) responded. Among the respondents, 34.2% had a high suspicion for symptoms of post-bariatric surgery hypoglycemia. In multivariate analyses, in addition to female sex (p=0.001), RYGB (p=0.004), longer time since surgery (p=0.013), lack of diabetes (p=0.040), the high suspicion group was more likely to report preoperative symptoms of hypoglycemia (p<0.001), compared to the low suspicion group. Similar results were observed when the high suspicion group was restricted to those requiring assistance from others, syncope, seizure with severe symptoms or medically confirmed hypoglycemia (N=52). Conclusion One third of RYGB or VSG reported postprandial symptoms concerning for post-surgical hypoglycemia, which was related to the presence of pre-operative hypoglycemic symptoms. Pre-operative screening for hypoglycemic symptoms may identify a group of patients at increased risk of post-bariatric surgery hypoglycemia.To determine the prevalence of and risk factors for postprandial hypoglycemic symptoms among bariatric surgery patients.

Demonstration of transoral gastric outlet reduction: 2-fold running suture technique

Weight regain after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of the RYGB. Endoscopic revision of a dilatated GJ, called transoral outlet reduction (TORe), has been proved effective and allows patients to avoid reoperation. A 43-year-old woman who had undergone gastric bypass 3 years previously regained 40% of her lost weight, lost postprandial satiety, and had symptoms of dumping syndrome. Endoscopy revealed a dilatated (30 mm) GJ anastomosis (Fig. 1A). Video 1 (available online at www. VideoGIE.org) demonstrates a 2-fold running suture method, a novel method to perform TORe. Before endoscopic suturing, we performed aggressive argon plasma coagulation therapy to the gastric side of the gastric outlet

Prevalence of Hypoglycemic Symptoms after Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy and Associated Risk Factors

Objective To determine the prevalence of and risk factors for postprandial hypoglycemic symptoms among bariatric surgery patients. Design and Methods A questionnaire including the Edinburgh hypoglycemia scale was mailed to patients who underwent either Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG) at a single center. Based on the questionnaire, we categorized the patients as having high or low suspicion for post-surgical, postprandial hypoglycemic symptoms. Results Of the 1119 patients with valid addresses, 40.2% (N=450) responded. Among the respondents, 34.2% had a high suspicion for symptoms of post-bariatric surgery hypoglycemia. In multivariate analyses, in addition to female sex (p=0.001), RYGB (p=0.004), longer time since surgery (p=0.013), lack of diabetes (p=0.040), the high suspicion group was more likely to report preoperative symptoms of hypoglycemia (p<0.001), compared to the low suspicion group. Similar results were observed when the high suspicion group was restricted to those requiring assistance from others, syncope, seizure with severe symptoms or medically confirmed hypoglycemia (N=52). Conclusion One third of RYGB or VSG reported postprandial symptoms concerning for post-surgical hypoglycemia, which was related to the presence of pre-operative hypoglycemic symptoms. Pre-operative screening for hypoglycemic symptoms may identify a group of patients at increased risk of post-bariatric surgery hypoglycemia.To determine the prevalence of and risk factors for postprandial hypoglycemic symptoms among bariatric surgery patients.

Tu1064 Insurance Approval Patterns for IFN-Free Regimens in HCV: Impact of National Guidelines

Introduction: Patients infected with the hepatitis C virus (HCV) have long been awaiting interferon-free regimens. The possibility of using two Direct Acting Antivirals (DAAs) became a possibility in clinical practice in December 2013, albeit at a significant financial cost. Guidelines were released in part by the AASLD on January 30th, 2014 with specific treatment recommendations in various patient populations. Included in these recommendations was that patients who have received a liver transplant should be treated with 12 or 24 weeks of daily sofosbuvir and simeprevir. We examined approval patterns for DAAs and factors affecting patient access. Methods: This was an IRB approved retrospective review. Two hundred and forty-five consecutive patients whose prescriptions for IFN-free regiments submitted by the University of Miami Hepatology Faculty were included and 82 pending prescriptions were not included. Most patients (96%) were genotype 1a or 1b, and 66 were post-transplant. 86% of prescriptions were for 12 weeks of sofosbuvir and simeprevir, and the remainder was for sofosbuvir and ribavirin. Type of insurance was noted. Those who required foundation assistance were excluded from the analysis. Statistical analysis with parametric, non-parametric or multivariate analysis was performed using JMP SAS software. Results: 71% of prescriptions were filled at an estimated cost of

Endoscopic intraluminal suture plication of the gastric pouch and stoma in postoperative Roux-en-Y gastric bypass patients.

26,090,000. A prior authorization was submitted to every insurance company on each case. There was a significant change in the approval pattern after the release of the AASLD guidelines (80 vs. 64%, p= 0.0057). After this date, post-liver transplant patients were also significantly more likely to have an IFN-free regimen approved (90 vs. 69%, p=0.04). There was also significant variation by medical insurance company. Patients with Medicare or Medicaid were most likely to have their drug approved compared with private insurance (85 vs. 68%, p=0.01). Conclusions: National guidelines appear to affect insurance company approval process. Approval rates in liver transplant patients significantly increased after AASLD guidelines indicated that they should be treated with interferon-free regimens. Those with public insurance were most likely to be approved compared to private insurance. National societies need to continue to make specific recommendation for the benefit of patient care.