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Does a preoperative medically supervised weight loss program improve bariatric surgery outcomes? A pilot randomized study
Parikh, Manish; Dasari, Meena; McMacken, Michelle; Ren, Christine; Fielding, George; Ogedegbe, Gbenga
BACKGROUND: Many insurance payors mandate that bariatric surgery candidates undergo a medically supervised weight management (MSWM) program as a prerequisite for surgery. However, there is little evidence to support this requirement. We evaluated in a randomized controlled trial the hypothesis that participation in a MSWM program does not predict outcomes after laparoscopic adjustable gastric banding (LAGB) in a publicly insured population. METHODS: This pilot randomized trial was conducted in a large academic urban public hospital. Patients who met NIH consensus criteria for bariatric surgery and whose insurance did not require a mandatory 6-month MSWM program were randomized to a MSWM program with monthly visits over 6 months (individual or group) or usual care for 6 months and then followed for bariatric surgery outcomes postoperatively. Demographics, weight, and patient behavior scores, including patient adherence, eating behavior, patient activation, and physical activity, were collected at baseline and at 6 months (immediately preoperatively and postoperatively). RESULTS: A total of 55 patients were enrolled in the study with complete follow-up on 23 patients. Participants randomized to a MSWM program attended an average of 2 sessions preoperatively. The majority of participants were female and non-Caucasian, mean age was 46 years, average income was less than $20,000/year, and most had Medicaid as their primary insurer, consistent with the demographics of the hospital's bariatric surgery program. Data analysis included both intention-to-treat and completers' analyses. No significant differences in weight loss and most patient behaviors were found between the two groups postoperatively, suggesting that participation in a MSWM program did not improve weight loss outcomes for LAGB. Participation in a MSWM program did appear to have a positive effect on physical activity postoperatively. CONCLUSION: MSWM does not appear to confer additional benefit as compared to the standard preoperative bariatric surgery protocol in terms of weight loss and most behavioral outcomes after LAGB in our patient population.
PMID: 22011946
ISSN: 0930-2794
CID: 158642
Does adding a lesser-curvature gastrogastric plication suture reduce the need for revision after laparoscopic adjustable gastric band placement?
Zagzag, Jonathan; Schwack, Bradley F; Youn, Heekoung; Fielding, Christine Ren; Fielding, George A; Kurian, Marina S
BACKGROUND: The need for revision after laparoscopic adjustable gastric band (LAGB) surgery has been reduced over the past 10 years with the introduction of the pars flaccida technique, delicate band tightening, and concurrent hiatal hernia repairs. However, band revision still occurs for as many as 5% of patients. Placement of a lesser-curvature gastrogastric suture distal to the band is one newer technique suggested to lower band slippage. To evaluate the worth of this technique, the authors have investigated two groups of patients in their practice: one group with the plication stitch and one group without it. METHODS: This retrospective review examined data for 1,365 LAGB patients collected prospectively by an institutional review board-approved database between July 2007 and May 2010. One surgeon did not perform the plication stitch (n = 776) and one did (n = 589). The surgical techniques were very similar. The majority of the patients had crural repair at the primary operation. Band revision rates were assessed. RESULTS: For 1,365 patients, LAGB was performed safely. The mean follow-up period was 22 months. The two groups were similar. The no-stitch group consisted of 776 patients (496 women, 64%) with a mean age of 42 years, a mean weight of 278 lb, and a mean body mass index (BMI) of 44.6 kg/m(2). The stitch group consisted of 589 patients (426 woman, 72%) with a mean age of 40 years, a mean weight of 278 lb, and a mean BMI of 44.8 kg/m(2). The no-stitch group had an estimated weight loss (EWL) of 44% at 12 months and 50% EWL at 2 years. The stitch group had 37% EWL at 12 months and 45% EWL at 2 years. Both groups had very low revision rates. The no-stitch group had 4 revisions in 776 patients (0.26%), and the stitch group had 9 revisions in 589 patients (1.5%). CONCLUSION: Adding gastrogastric plication sutures offers no benefit of reducing the rate of revision after LAGB surgery
PMID: 21938578
ISSN: 1432-2218
CID: 149947
Impact of laparoscopic adjustable gastric banding on pregnancy, maternal weight, and neonatal health
Carelli, Allison M; Ren, Christine J; Youn, Heekoung Allison; Friedman, Erica B; Finger, Anne E; Lok, Benjamin H; Kurian, Marina S; Fielding, George A
BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a proven method for weight reduction. Less is known about pregnancies in patients after LAGB. METHODS: Information was gathered, through database and survey, on women who underwent LAGB at NYU Medical Center between 2001 and 2008 then became pregnant. RESULTS: Pregnancy occurred in 133 women, resulting in 112 babies, including six sets of twins. The average pre-pregnancy body mass index (BMI) was 32.7. Average weight gain was 11.5 kg, but was higher for those with pre-pregnancy BMI <30.0 compared to BMI >30.0 (16.4 vs 8.6 kg). Of singleton pregnancies, 89% were carried to full term, with cesarean section in 45%. Those with pre-pregnancy BMI <30.0 had a lower rate of cesarean section (35.71%), but it was not statistically significant (p = 0.55). Average birth weight was 3,268.6 g. Eight percent of babies from singleton pregnancies were low birth weight (<2,500 g), and seven percent were high birth weight (>4,000 g). Average Apgar scores at 1 and 5 min were 8.89 and 9.17. Four percent of patients developed gestational diabetes, and 5% developed pre-eclampsia. Band adjustments were performed in 71% of patients. Weight gain was higher in those who had their bands loosened in the first trimester (p = 0.063). Three patients had intrapartum band slips; one required surgery during pregnancy. CONCLUSIONS: LAGB is tolerable in pregnancy with rare intrapartum band slips. Weight gain is less in those with higher pre-pregnancy BMI and those who had their bands filled or not adjusted. Babies born to these mothers are as healthy as the general population
PMID: 20835780
ISSN: 1708-0428
CID: 138309
Intrahepatic natural killer T cell populations are increased in human hepatic steatosis
Adler, Michael; Taylor, Sarah; Okebugwu, Kamalu; Yee, Herman; Fielding, Christine; Fielding, George; Poles, Michael
AIM: To determine if natural killer T cell (NKT) populations are affected in nonalcoholic fatty liver disease (NAFLD). METHODS: Patients undergoing bariatric surgery underwent liver biopsy and blood sampling during surgery. The biopsy was assessed for steatosis and immunocyte infiltration. Intrahepatic lymphocytes (IHLs) were isolated from the remainder of the liver biopsy, and peripheral blood mononuclear cells (PBMCs) were isolated from the blood. Expression of surface proteins on both IHLs and PBMCs were quantified using flow cytometry. RESULTS: Twenty-seven subjects participated in this study. Subjects with moderate or severe steatosis had a higher percentage of intrahepatic CD3+/CD56+ NKT cells (38.6%) than did patients with mild steatosis (24.1%, P = 0.05) or those without steatosis (21.5%, P = 0.03). Patients with moderate to severe steatosis also had a higher percentage of NKT cells in the blood (12.3%) as compared to patients with mild steatosis (2.5% P = 0.02) and those without steatosis (5.1%, P = 0.05). CONCLUSION: NKT cells are significantly increased in the liver and blood of patients with moderate to severe steatosis and support the role of NKT cells in NAFLD.
PMCID:3072637
PMID: 21483633
ISSN: 1007-9327
CID: 156284
Midterm results for gastric banding as salvage procedure for patients with weight loss failure after Roux-en-Y gastric bypass
Irani, Katayun; Youn, Heekoung A; Ren-Fielding, Christine J; Fielding, George A; Kurian, Marina
BACKGROUND: Studies reporting the revisionary options for weight loss failure after Roux-en-Y gastric bypass (RYGB) have been complex, underpowered, and lacking long-term data. We have previously shown that short-term (12-month) weight loss is achievable with laparoscopic adjustable gastric banding (LAGB) for failed RYGB. To report the midterm outcomes of LAGB after RYGB failure. METHODS: A retrospective review of prospectively collected data before and after RYGB, when available, and before and after LAGB was performed at the New York Langone University Hospital (New York, NY). The data collected included weight, height, body mass index (BMI), gender, race, age, operative time, length of stay, postoperative complications, and the percentage of excess weight loss. RESULTS: A total of 43 patients (9 men and 34 women) underwent LAGB after weight loss failure with RYGB. Of the 43 patients, 27 patients had undergone RYGB at other institutions, and preoperative RYGB data were available for 23 total patients. The average interval to LAGB was 6.6 years. The mean BMI before RYGB was 50.4 kg/m(2) and before LAGB was 43.3 kg/m(2) (%EWL was 17% after RYGB). At follow-up after LAGB, the average BMI was 35.2 kg/m(2), with a %EWL of 38% (calculated from LAGB only) at 26 months (range 6-66). At the 1- and 2-year follow-up visit, the BMI had decreased by 8.7 kg/m(2). The reoperation rate for complications related to LAGB was 10% and included 2 band erosions, 1 band slip, and 1 port flip. CONCLUSION: The results of our study have shown that LAGB had good midterm data as a revisionary procedure for weight loss failure after RYGB
PMID: 21130044
ISSN: 1878-7533
CID: 138308
The effectiveness of adjustable gastric banding: a retrospective 6-year U.S. follow-up study
Weichman, Katie; Ren, Christine; Kurian, Marina; Heekoung, Allison Youn; Casciano, Roman; Stern, Lee; Fielding, George
BACKGROUND: This study aimed to assess the efficacy of laparoscopic adjustable gastric banding (LAGB) during a 6-year follow-up period. METHODS: A retrospective database analysis of patients who underwent LAGB at New York University Medical Center between 1 January 2000 and 29 February 2008 was conducted. Patients were included for the efficacy analysis if they were 18 years old or older at the surgery date and had one or more visits with a recorded weight after surgery. Efficacy was assessed using percentage of excess weight loss (%EWL) at 1-year intervals after surgery. Missing weight values were interpolated using a cubic spline function. Linear regression models were used to assess the characteristics that affected the last available %EWL. All patients had implantation of the LAP-BAND system. RESULTS: The inclusion criteria for the efficacy analysis were met by 2,909 patients. The majority of the patients were white (83.3%) and female (68.4%). The mean patient age was 44.6 years, and the mean baseline body mass index (BMI) was 45.3 kg/m2. The %EWL 3 years after surgery was 52.9%, which was sustained thereafter. In multivariate models, increased number of office visits, younger age, female gender, and Caucasian race were significantly associated with a higher maximum %EWL. CONCLUSIONS: The LAP-BAND patients achieved a substantial and sustainable weight loss of approximately 50% at 6 years after surgery
PMID: 20574855
ISSN: 1432-2218
CID: 138310
Safety of the laparoscopic adjustable gastric band: 7-year data from a U.S. center of excellence
Carelli, Allison M; Youn, Heekoung Allison; Kurian, Marina S; Ren, Christine J; Fielding, George A
BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has become one of the most common weight-loss procedures performed in the United States. The authors' high-volume academic medical center has gathered a database of almost 3,000 patients who have undergone LAGB since January 2001. The goal of this series, the largest to date on LAGB outcomes at a single institution, was to assess complications associated with LAGB. METHODS: A retrospective analysis was performed using longitudinal data from adult patients who underwent LAGB between 1 January 2001, and 29 February 2008. General and band-related complications were reported for all patients. Death and reoperation for weight gain (LAGB followed by either a second band insertion or a gastric bypass) also were reported. RESULTS: Of the 2,965 patients who received LAGB during the study period, 2,909 met the criteria for inclusion in this analysis, and 363 (12.2%) experienced one or more complications. The most common complications were band slip (4.5%) and port-related problems (3.3%). Other complications were rare. Only seven patients (0.2%) had band erosion. Eleven patients (0.4%) underwent reoperation for weight gain. A total of 10 deaths (0.34%) occurred during the study period. Three patients died within 30 days of surgery. Two of these deaths (0.06%) were related to surgery, and one resulted from a motor vehicle accident. Seven patients died of causes unrelated to surgery during the course of the study. CONCLUSIONS: The LAGB technique is a relatively safe procedure with few early or late complications. Few LAGB patients undergo reoperation for weight gain, and mortality is very rare
PMID: 20135179
ISSN: 1432-2218
CID: 138189
Evaluating gastric erosion in band management: an algorithm for stratification of risk
Kurian, Marina; Sultan, Sammy; Garg, Karan; Youn, Heekoun; Fielding, George; Ren-Fielding, Christine
BACKGROUND: Laparoscopic gastric banding has several known complications, including gastric erosion. No clear factors have been determined for the development of band erosion, but technical factors such as covering the buckle of the band have been implicated. The objective of the present study was to determine whether band management after surgery, band size, or filling beyond the manufacturer-determined maximal volume has an effect on the incidence of erosion at a university hospital in the United States. METHODS: We performed a retrospective review of a prospective institutional review board-approved database. All patients who had been followed from 2002 to 2008 were identified. The maximal band volume was 4 cm(3) for the 9.75-cm/10-cm band and 10 cm(3) for the Vanguard band. The bands were considered overfilled if they had been filled to greater than the maximal volume for >/=3 months. RESULTS: A total of 2437 patients had undergone Lap-Band surgery. Of these 2437 patients, 14 developed erosion (.57%). The primary erosion rate was .39% (9 of 2359). These patients were divided into 3 groups according to the type of band placed: group 1, Vanguard (n = 735); group 2, 9.75-cm/10-cm band (n = 1624); and group 3, revisions to Vanguard, including a band placed around a bypass (n = 78). The incidence of gastric erosion by group was .95% (7 of 735) in group 1, .12% (2 of 1624) in group 2, and 6.41% (5 of 78) in group 3. The difference in the erosion rate among the groups was significant (group 1 versus 2, P = .005; group 3 versus 1, P = .003; and group 3 versus 2, P = .001). Erosions developed in each group without overfilling. Also, comparing the erosion rate in the overfilled versus underfilled bands, statistical significance was found only for group 1 at 3.18% versus .35% (P = .006). The erosion rate in the overfilled versus underfilled was 1.01% versus .07% in group 2 and 11.11% versus 3.92% in group 3. CONCLUSION: A band that needs to be overfilled might be a sign of erosion, and patients should undergo endoscopy. Band revision has a greater rate of erosion than primary banding. The Vanguard band has a greater risk of erosion than the 4-cm(3) bands
PMID: 20176510
ISSN: 1878-7533
CID: 138390
Five-year outcomes of patients with type 2 diabetes who underwent laparoscopic adjustable gastric banding
Sultan, Samuel; Gupta, Deepali; Parikh, Manish; Youn, Heekoung; Kurian, Marina; Fielding, George; Ren-Fielding, Christine
BACKGROUND: Evidence of the positive effects of gastric banding on patients with diabetes has continued to increase. The long-term follow-up of such patients, however, has been limited. The purpose of the present study was to provide the long-term outcomes of patients with diabetes undergoing laparoscopic adjustable gastric banding at our institution. METHODS: From January 2002 through June 2004, 102 patients with type 2 diabetes mellitus underwent laparoscopic adjustable gastric banding. The study parameters included preoperative age, gender, race, body mass index, duration of diabetes before surgery, fasting glucose level, hemoglobin A1c (HbA1c), and medications used. Preoperative data from all patients were collected prospectively and entered into an institutional review board-approved database. Beginning in 2008, efforts were made to collect the 5-year follow-up data. RESULTS: Of the 102 patients, 7 were excluded because they had not reached the 5-year follow-up point (2 patients had had the band removed early and 5 patients had died; 2 of cancer and 3 of unknown causes), leaving 95 patients for the present study. The mean preoperative age was 49.3 years (range 21.3-68.4). The mean preoperative body mass index was 46.3 kg/m(2) (range 35.1-71.9) and had decreased to 35.0 kg/m(2) (range 21.1-53.7) by 5 years of follow-up, yielding a mean percentage of excess weight loss of 48.3%. The mean duration of the diabetes diagnosis before surgery was 6.5 years. Of 94 patients, 83 (88.3%) were taking medications preoperatively, with 14.9% overall taking insulin. At 5 years postoperatively, 33 (46.5%) of 71 patients were taking medications, with 8.5% taking insulin. The mean fasting preoperative glucose level was 146.0 mg/dL. The glucose level had decreased to 118.5 mg/dL at 5 years postoperatively (P = .004). The mean HbA1c level was 7.53 preoperatively in 72 patients and was 6.58 at 5 years postoperatively in 64 patients (P <.001). Overall, diabetes had resolved (no medication requirement, with HbA1c <6 and/or glucose <100 mg/dL) in 23 (39.7%) of 58 patients and had improved (use of fewer medications and/or fasting glucose levels of 100-125 mg/dL) in 41 (71.9%) of 57 patients. The combined improvement/remission rate was 80% (64 of 80 patients). CONCLUSION: Our data have demonstrated that laparoscopic adjustable gastric banding results in a substantial sustained positive effect on diabetes in morbidly obese patients, with a significant reduction in HbA1c and an 80% overall rate of improvement/remission
PMID: 20627708
ISSN: 1878-7533
CID: 111359
Laparoscopic major hepatectomy: an evolution in standard of care
Dagher, Ibrahim; O'Rourke, Nicholas; Geller, David A; Cherqui, Daniel; Belli, Giulio; Gamblin, T Clark; Lainas, Panagiotis; Laurent, Alexis; Nguyen, Kevin Tri; Marvin, Michael R; Thomas, Mark; Ravindra, Kadyalia; Fielding, George; Franco, Dominique; Buell, Joseph F
OBJECTIVE: To analyze the results of 6 international surgical centers performing laparoscopic major liver resections. SUMMARY BACKGROUND DATA: The safety and feasibility of laparoscopy for minor liver resections has been previously demonstrated. Major anatomic liver resections, initially considered to be unsuitable for laparoscopy, are increasingly reported by several centers worldwide. METHODS: Prospective databases of 3 European, 2 U.S., and 1 Australian centers were combined. Between 1997 and 2008, 210 major liver resections were performed: 136 right and 74 left hepatectomies. Results and differences in surgical techniques between the 6 centers are outlined. RESULTS: Surgical duration was 250 minutes (range: 90-655 minutes). Operative blood loss was 300 mL (range: 20-2500 mL). Thirty patients (14.3%) received blood transfusion. Conversion to open surgery was required in 26 patients (12.4%). Portal triad clamping was performed in 24 patients (11.4%). Median tumor size was 5.4 cm (range: 1-25 cm) and surgical margin was 10.5 mm (range: 0-70 mm). Two patients died during the postoperative period from pulmonary embolism and urosepsis. Liver-specific and general complications occurred in 17 (8.1%) and 29 patients (13.8%), respectively. Hospital length of stay was 6 days (range: 1-34 days). A further analysis of early (n = 90) and late (n = 120) experience showed improved surgical and postoperative results in the latter group. CONCLUSIONS: This multicenter study demonstrates that laparoscopic major liver resections are feasible in selected patients and results improve with experience. However, proficiency in both open liver surgery and advanced laparoscopy is compulsory and surgeons must begin with minor laparoscopic resections
PMID: 19806057
ISSN: 1528-1140
CID: 133729