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Long-term follow-up of pilot randomized trial comparing bariatric surgery vs. intensive medical weight management on diabetes remission in patients with type 2 diabetes and BMI 30-35; the role of sRAGE diabetes biomarker as predictor of success [Meeting Abstract]

Horwitz, D; Chung, M; Sheth, S; Saunders, J; Welcome, A U; Schmidt, A M; Dunn, V; Pachter, H L; Parikh, M
Introduction: To provide longer-term follow-up of a previously published pilot randomized trial comparing bariatric surgery vs. intensive medical weight management (MWM) in patients with type 2 diabetes (T2DM) and BMI 30-35. Additionally, to assess whether the soluble form of RAGE (receptor for advanced glycation end-products) is an adequate diabetes biomarker that may help determine which patient population would benefit most from surgery. Methods: Originally, 57 patients with T2DM and BMI 30-35 were randomized to surgery (bypass, sleeve or band, based on patient preference; n=29) vs. MWM (n=28). The 6 month results showed that surgery was significantly effective (previously published data). We performed an updated review of this patient cohort to evaluate weight loss and diabetes remission at 2 years. A repeated measures linear model was created to compare the change in HbA1C and BMI between the two groups. The outcomes were also compared to baseline sRAGE status using a repeated measures linear model. Patients who ultimately crossed over from MWM to surgery group (after the initial study) were included. Results: At baseline, mean BMI was 32.6 and mean HbA1c was 7.8. At 2 years the following was noted: The surgery group continued to have significantly higher diabetes remission (50% vs. 0%), lower BMI (28.5 vs. 30.9; p<0.0001) and lower HbA1c (7.0 vs. 7.9; p=0.019) than the MWM group. In the surgical group, those with a higher baseline sRAGE had a lower post-op BMI (p=0.037). Conclusion: At 2 years, bariatric surgery was very effective in patients with T2DM and BMI 30-35. Higher baseline sRAGE predicted success with surgery. However, larger studies will be required to confirm the accuracy of these observations
EMBASE:72280047
ISSN: 1550-7289
CID: 2151172

Chronic mesenteric vein thrombosis after laparoscopic sleeve gastrectomy [Meeting Abstract]

Sethi, M; Clark, J; Lee, S; Schwack, B; Fielding, C; Parikh, M; Fielding, G
Background: Mesenteric venous thrombosis (MVT) is a rare and potentially lethal complication of laparoscopic bariatric surgery. We present the diagnosis, management and surveillance of three MVT cases after laparoscopic sleeve gastrectomy (LSG). Methods: Three morbidly obese (BMIs 40kg/m2-52kg/m2) women between the ages 33-50 years presented with symptoms of abdominal pain after uncomplicated LSG. Symptoms presented between postoperative day 12 and 25. All patients underwent computed tomography (CT) scans and were found to have mesenteric vein thrombosis. Treatment modalities varied between warfarin anticoagulation in two patients and rivaroxaban in the third, who was resistant to heparin. One patient was positive for the prothrombin gene mutation, but hypercoagulability workup was negative for the other two patients. Results: Repeat imaging was available for two patients at 4 and 18 months postoperatively. At 4 months, one patient developed cavernous transformation of the portal vein and upper abdominal varices. Repeat imaging in another patient demonstrated chronic SMV thrombosis at 18 months. Conclusions: MVT can present with nonspecific abdominal symptoms after LSG. The mainstay of treatment is anticoagulation, but the duration, especially for chronic MVT, is unclear. On surveillance, two patients have chronic MVT despite anticoagulation and negative hematologic workup, which can lead to portal hypertension and its sequelae. Additional research is needed to define the incidence, symptomatology, and treatment algorithms for this rare but serious complication
EMBASE:72003289
ISSN: 0960-8923
CID: 1796862

Intraoperative leak testing has no correlation with leak after laparoscopic sleeve gastrectomy [Meeting Abstract]

Sethi, M; Zagzag, J; Patel, K; Magrath, M; Parikh, M S; Saunders, J K; Ude-Welcome, A O; Schwack, B F; Kurian, M S; Fielding, G A; Ren-Fielding, C J
Introduction: Staple line leak is the most feared complication after sleeve gastrectomy. Intraoperative methylene blue and air leak tests are routinely used to evaluate for leak, however the utility of these tests is controversial. The 2012 International Sleeve Gastrectomy Expert Panel failed to reach a consensus about whether routine intraoperative leak tests should be performed. Additionally, these tests are not benign - they introduce increased instrumentation, with reports of nasogastric tubes causing esophageal perforation, as well as increased costs in the form of resource utilization. We hypothesize that the practice of routine intraoperative leak testing is unnecessary during sleeve gastrectomy. Methods and Procedures: A retrospective cohort study was designed using a prospectively-collected database of seven bariatric surgeons from two institutions. 1,257 consecutive patients who underwent sleeve gastrectomies between March 2012 and June 2014 were included. The performance of intraoperative leak testing and the type of test (air or methylene blue) were based on surgeon preference. Data obtained included BMI, patient demographics, comorbidity, presence or absence of intraoperative leak test, result of leak test, and type of test. The primary outcome was leak rate between the leak test (LT) group and the non-leak test (NLT) group. SPSS-22 was used for univariate and multivariate analyses. Results: Of the 1,257 sleeve gastrectomy cases, most (99.68 %) were laparoscopic, except for two (0.16 %) open and two (0.16 %) converted cases. 1,164 (92.6 %) patients had routine intraoperative leak tests performed; there were no positive intraoperative leak tests in the entire cohort. 93 patients (7.4 %) did not have intraoperative leak tests performed. Thirteen (1 %) patients developed staple line leaks, with no difference in leak rate between the LT and NLT groups (1 % vs. 1.1 %, p = 1.000). There were some baseline differences between the groups, however (Table 1). After adjusting for these differences and other possible confounders with binary logistic regression, the observed lack of association between leak and intraoperative leak test remained. In this cohort, leaks presented at a mean of 11.3 days postoperatively (range = [1,35]), with only two leaks presenting during the index admission. Of those two, one patient with a leak seen on postoperative day 1 esophagram underwent a repeat leak test during diagnostic laparoscopy, which was negative. Despite suture reinforcement, the leak persisted and the patient eventually required conversion to gastric bypass. Conclusion: Intraoperative leak testing has no correlation with postoperative leak occurrence after laparoscopic sleeve gastrectomy and is not predictive of the later development of staple line leak. (Table Presented)
EMBASE:71871568
ISSN: 0930-2794
CID: 1601352

Reduction of knee osteoarthritis symptoms in a cohort of bariatric surgery patients [Meeting Abstract]

Wilder, E; Leyton-Mange, A; Lin, J; Parikh, M; Ren-Fielding, C; La, Rocca Vieira R; Abramson, S B; Samuels, J
Purpose: Obesity is a modifiable risk factor of knee osteoarthritis (KOA). While diet, exercise and other conservative treatments can have limited and often transient beneficial effects, an alternative strategy would target weight loss via surgery to delay or avoid joint replacement. Some retrospective data, including a study from our group, have in fact shown sustained improvement in KOA pain after bariatric surgery. We initiated a prospective study to evaluate painful KOA in the obese population, and track whether weight loss after bariatric surgery affects KOA-related pain and physical function. Methods: We screened consecutive patients prior to laparoscopic adjustable gastric banding (LAGB), sleeve gastrectomy, or gastric bypass (RYGB), at NYU Langone Medical Center and Bellevue Hospital Center. Patients age >21 with knee pain for >1 month and a visual analog scale pain score >30mm were enrolled, excluding those with lupus, rheumatoid arthritis, psoriatic arthritis, or psoriasis. Baseline pre-op assessments included x-rays for OA severity by Kellgren-Lawrence (KL) grade, the Knee Injury and Osteoarthritis Outcome Score (KOOS), and the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) with a Likert scale calculated from the KOOS. Patients were consented for optional tissue collection (blood, urine and intra-operative adipose samples) for future biomarker analysis. They are (still) completing the questionnaires and being measured for BMI and % excess weight loss (%EWL) at 1,3,6 and 12 month post-op intervals. Results: In total, we screened 537 patients planning to have bariatric surgery, found that 309 (58%) of them reported knee pain - and enrolled 176who met criteria and consented for the study. Our cohort is 89.7% female, with a mean BMI of 43.6 kg/m2+/-7 (31.6-60.6), a mean age of 42.4 +/-11 (18-73), and radiographic severity as follows: KL0=43 (25%), KL1=34 (19%), KL2=38 (22%), KL3=34 (19%), KL4=27 (15%). The mean pre-op KOOS scores were 45.4 for pain and 46.0 for ADL (0=worst, 100=best), the mean pre-op WOMAC pain score (Likert scale) was 11 (0=best, 20=worst), and the mean overall WOMAC index was 52 (0=best, 96=worst). Before surgery, a higher KL correlated with symptoms; mean KOOS pain was 53.2, 48.1 and 36.7 for KL0, KL1-2, and KL3-4 (p=0.00002 for KL0 vs KL3-4, and p=0.0005 for KL1-2 vs KL3-4), with similar trends across other KOOS and WOMAC scores. Higher BMI also trended with worse pre-op knee symptoms, as the tertiles with the lowest and highest BMIs (31-39 and 46-61) had mean KOOS pain scores of 46.8 and 43.7 (p=0.37). While 23 ultimately decided against weight loss surgery, we are collecting post-operative data on the 153 patients (40 RYGB=26%, 93 sleeve=61%, 20 LAGB=13%). Improvement in average KOOS and WOMAC scores over baseline has been observed at all intervals (67, 71, 65, and 42 responses at 1,3,6,12 month visits), with more improvement farther after surgery. At 6 months post-op, mean KOOS scores available thus far improved 29 points for pain, with mean WOMAC pain and index improving by 6 and 22 points. The %EWL correlated with knee symptoms at each interval and for all followups combined, as the smallest and largest %EWL quartiles (4-29%, 54-92%) showed mean improvements of 18 and 31 points (p=0.03) in KOOS pain - mirrored across KOOS and WOMAC scores. RYGB and sleeve yielded higher %EWL than LAGB (44%, 43% vs. 37%) across all intervals, and greater improvement in mean KOOS and WOMAC scores (e.g. mean KOOS pain increased by 28, 29 and 8). Neither presence nor severity of KOA severity affected knee pain improvement from weight loss. Conclusions: These data suggest that bariatric surgery improves patients' KOA pain proportional to percent excess weight loss, with durability over time. RYGB and sleeve gastrectomy have more impact on knee symptoms than LAGB. While patients with worse KL grades report more baseline pain and disability, as expected, x-ray severity did not impact the response to surgical weight loss
EMBASE:71907212
ISSN: 1063-4584
CID: 1644382

False-positive rate of positron emission tomography/computed tomography for presumed solitary metastatic adrenal disease in patients with known malignancy

Kuritzkes, Benjamin; Parikh, Manish; Melamed, Jonathan; Hindman, Nicole; Pachter, H L
PURPOSE: The aim of this study was to determine the diagnostic accuracy of positron emission tomography (PET) in cancer patients undergoing adrenalectomy for presumed metastatic disease, utilizing the gold standard of histopathology. METHODS: We retrospectively reviewed all adrenalectomies for metastatic disease performed at our institution over the last 12 years. Preoperative PET scans were compared with final pathology reports. Statistical analyses were performed with Fisher's exact test for categorical variables and Student's t test for continuous variables. RESULTS: Forty-nine adrenalectomies were performed for metastatic disease. Thirty had preoperative PET imaging and were included in this analysis. Mean age was 65.5 +/- 13.6 years (29-91) and 54 % were male. Mean size was 3.8 cm (0.4-7.1). Primary tumor distribution was 61 % (n = 17) pulmonary; 11 % (n = 3) breast; 7 % (n = 2) gastric; 7 % (n = 2) renal; and 4 % (n = 1) each of brain, lymphoma, melanoma, and uterine. Mean standardized uptake value (SUV) was 11 +/- 7.3 (3.2-30.0). Final pathology revealed that 80 % (25/30) were positive for metastatic disease and 20 % (5/30) were negative. The positive predictive value of PET in correctly identifying adrenal metastatic disease was 83 % (24 true-positive cases and 5 false-positive cases); there was one false-negative PET. False-positive PET results were not correlated with sex (p = 0.35), age (p = 0.24), or maximum SUV units (p = 0.26). CONCLUSIONS: The 20 % false-positive rate for PET-positive adrenalectomies performed for metastatic disease should warrant its inclusion in preoperative counseling to the patient and interaction with the treating oncologist.
PMID: 25160737
ISSN: 1068-9265
CID: 1459802

Bariatric Surgery versus Intensive Medical Weight Management for Type 2 Diabetes

Sethi, Monica; Parikh, Manish
PMID: 26299497
ISSN: 0065-3411
CID: 1742012

Reduction of Treatment Needed for Knee Osteoarthritis after Bariatric Surgery [Meeting Abstract]

Wilder, Evan; Lin, Janice; Bomfim, Fernando; Mukherjee, Thayer; O'Shaughnessy, Lucy; Browne, Lauren; Weill, Myriam; Gernavage, Kevin; Taufiq, Farah; Vieira, Renata La Rocca; Ren-Fielding, Christine; Parikh, Manish; Abramson, Steven B; Samuels, Jonathan
ISI:000370860201317
ISSN: 2326-5205
CID: 2029482

Patient preferences and bariatric surgery procedure selection; the need for shared decision-making

Weinstein, Andrew L; Marascalchi, Bryan J; Spiegel, Matthew A; Saunders, John K; Fagerlin, Angela; Parikh, Manish
BACKGROUND: Bariatric surgery is the most effective treatment for patients suffering from obesity-related comorbidities. There is little data regarding how patients choose one particular bariatric procedure over another. This study aimed to better define the relationship between preferences of patients considering bariatric surgery and the procedure patients undergo. METHODS: A bilingual questionnaire was administered to all prospective patients seen between March 1 and August 31, 2012. The questionnaire assessed basic knowledge of bariatric surgery (based on the information seminar) as well as patient preferences of the various outcomes and complications for sleeve gastrectomy, gastric bypass, and gastric banding. RESULTS: One hundred seventy-two patients completed the questionnaire. Fifty-eight percent of patients chose "maximum weight loss" as the most important outcome, and 65 % chose "leak" as the most concerning complication. Subgroup analysis of patients with diabetes revealed that 58 % chose "curing diabetes" as the most important outcome. Nineteen percent of patients were either not sure which procedure they wanted or changed their decision after consultation with the surgeon. CONCLUSIONS: The decision to choose one bariatric procedure over another is complex and is based on factors beyond absolute patient preferences. Although maximum weight loss is a commonly reported preference for patients seeking bariatric surgery, patients with diabetes are more focused on diabetes remission. Most patients have already decided which procedure to undergo prior to surgeon consultation. Patients may benefit from shared decision making, which integrates patient values and preferences along with current medical evidence to assist in the complex bariatric surgery selection process.
PMID: 24788395
ISSN: 0960-8923
CID: 1310562

Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success

Parikh, Manish; Chung, Mimi; Sheth, Sheetal; McMacken, Michelle; Zahra, Tasneem; Saunders, John K; Ude-Welcome, Aku; Dunn, Van; Ogedegbe, Gbenga; Schmidt, Ann Marie; Pachter, H Leon
OBJECTIVE: To compare bariatric surgery versus intensive medical weight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery. BACKGROUND: There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35. METHODS: Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE. RESULTS: The surgery group had improved HOMA-IR (-4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P < 0.0001) than the MWM group at 6 months. Compared to MWM, the surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DM medication requirements (20% vs 88%; P < 0.0001) at 6 months. The surgery group lost more weight (7. vs 1.0 BMI decrease, P < 0.0001). Higher baseline sRAGE was associated with better weight loss outcomes (r = -0.641; P = 0.046). There were no mortalities. CONCLUSIONS: Surgery was very effective short-term in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies.ClinicalTrials.gov ID: NCT01423877.
PMCID:4691842
PMID: 25203878
ISSN: 0003-4932
CID: 1186772

Bariatric surgery may improve employment status in unemployed, underserved, severely obese patients

Turchiano, Michael; Saunders, John K; Fernandez, Gregory; Navie, Livia; Labrador, Luis; Parikh, Manish
BACKGROUND: The purpose of this study was to determine the impact of bariatric surgery on employment status in underserved, unemployed patients with severe obesity. METHODS: A retrospective review of all unemployed severely obese patients seen in our urban safety-net bariatric surgery program was performed. Preoperative patient questionnaires and medical records were reviewed to evaluate patient employment status at the time of initial evaluation by the multidisciplinary bariatric surgery team. Follow-up data was obtained on all available patients (including those who did not undergo surgery), including weight and employment status. A standardized telephone questionnaire was administered to supplement details regarding employment. Changes in employment status and body weight were determined in both groups. RESULTS: Here, 193 unemployed severely obese patients were evaluated by the multidisciplinary obesity team. The vast majority of patients (>80 %) were minorities (primarily Hispanic) and publicly insured. Seventy-two underwent bariatric surgery and 121 did not. Twenty-four percent of the surgical patients and 9 % of the non-surgical patients had acquired full-time employment at least one year postoperatively (p = 0.043). There was a 10-point body mass index reduction in the surgical group, compared to 1-point reduction in the non-surgical group after one year. CONCLUSIONS: Bariatric surgery may improve employment status in an unemployed severely obese patient cohort. Future research in this area should collect detailed prospective data on employment prior to surgery and assess changes longitudinally to provide a more complete picture of the impact of bariatric surgery on employment.
PMID: 24307435
ISSN: 0960-8923
CID: 866802