Gastric Banding Journal Club Goal: to review 4 important and clinically relevant papers from 2010 on Adjustable Gastric Banding 4 papers x 4 min each = 16 min 10/21/20151

Background  Evidence of the positive effects of gastric banding on patients with diabetes has continued to increase.  The purpose of the study was to provide the long-term outcomes of patients with diabetes undergoing laparoscopic adjustable gastric banding at one institution.

Methods  95 patients with T2DM who underwent LAGB  Followed monthly for the first year, every 3 months for the second year, and then annually  Preoperative age, gender, race, body mass index, duration of diabetes before surgery, fasting glucose level, hemoglobin A1c (HbA1c), and medications used.

Results  The mean preoperative BMI was 46.3 kg/m2 (range 35.1–71.9) and had decreased to 35.0 kg/m2 (range 21.1– 53.7) by 5 years of follow-up  Mean EWL of 48.3%.  The mean duration of the diabetes diagnosis before surgery was 6.5 years.

Results  Of 94 patients, 83 (88.3%) were taking medications preoperatively  14.9% overall taking insulin  At 5 years postoperatively, 33 (46.5%) of 71 patients were taking medications, with 8.5% taking insulin.

Results

 The mean HbA1c level was 7.53 preoperatively in 72 patients and was 6.58 at 5 years postoperatively in 64 patients (P.001).  Diabetes had resolution 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  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.

Comment / Criticisms Follow up of an “underpowered” comparison between gastric bypass, BPD, and gastric band that showed no difference between the operations Theoretical benefit of bypassing the duodenum/proximal small bowel with other operations Calls out for a randomized, prospective study 10/21/201511

Background  Long-term rates for associated complications increase with every year of follow up, and only a few long-term studies have been published that examine these rates.  Results after 14 years of postoperative follow up from 1995 to 2009 to assess the efficacy of GB for weight loss, improvement of comorbidities, and the incidence of complications.

Methods  Two hundred patients  Data collection was performed prospectively.  In retrospective analysis of weight loss, short- and long-term complications, amelioration of comorbidities and long-term outcomes.

Methods  clinical examination was performed six weeks postoperatively and then every 3 months for the first 2 years.  Follow up examinations were performed twice a year or whenever needed after the second postoperative year.  documentation of weight, eating behavior, and a short clinical examination.

Methods  Band adjustments were very rare. The band was adjusted only in cases of weight loss less than 2 kg per month or a less than 25% change in the EBWL after3 months.  In the case of discomfort from a normal diet or reflux symptoms, the filling of the band was reduced.  The injection volume depended on the weight loss and the patient’s tolerance as well as his or her eating behaviors.

Results  The mean postoperative follow up time was 94.4 months (range 2–144). The follow up rate was 83.5%.  The incidence of postoperative complications for slippage was 2.5%, for pouch dilatation was 9.5%, for band migration was 5.5% and 12.0% for overall band removal.  After 14 years, the reoperation rate was 30.5% with a reoperation rate of 2.2% for every year of follow up.

Results  Excess weight loss was 40.2% after 1 year, 46.3% after 2 years, 45.9% after 3 years, 41.9% after five years, 33.3% after 8 years, 30.8% after 10 years, 33.3% after 12 years and 15.6% after 14 years of follow up.

Results

Conclusion  The complication and reoperation rate after GB is high. Nevertheless, GB is still a therapeutic option in morbidly obese patients.  The criteria for patient selection should be carefully evaluated.

Comments / Criticism 20% open placement, 7% conversion to open 68% perigastric technique Very limited adjustments Interesting concept that most slips occurred in patients taking anti-coagulants, NSAIDs, anti- rheumatic drugs Recommend not re-banding in the case of slip 10/21/201522

Background  Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone.  Laparoscopic adjustable gastric banding has the potential to provide a safe and effective treatment.  To compare the outcomes of gastric banding with an optimal lifestyle program on adolescent obesity.

Methods  A prospective, randomized controlled trial of 50 adolescents between 14 and 18 years with a body mass index (BMI) higher than 35  Randomized to supervised lifestyle intervention or gastric banding, and followed up for 2 years.  The study was performed between May 2005 and September 2008.

Methods  Main outcome measured was weight loss.  Secondary outcomes included change in metabolic syndrome, insulin resistance, quality of life, and adverse outcomes.  Lifestyle program centered on reduced energy intake, increased activity, a structured exercise schedule and behavioral modification. Compliance was monitored intermittently with food diaries and step counts.

Results  24 of 25 patients in the gastric banding group and 18 of 25 in lifestyle group completed the study.  21 (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age.

Results  mean weight loss in the gastric banding group was 34.6 kg (95% CI, ), representing an excess weight loss of 78.8% (95% CI,66.6%-91.0%)  12.7 BMI units (95% CI, ), and a BMI z score change from 2.39 (95% CI, ) to 1.32 (95% CI, ).

Results  The mean losses in the lifestyle group were 3.0 kg (95% CI, ), representing excess weight loss of 13.2% (95% CI, 2.6%-21.0%),  1.3 BMI units (95% CI, ), and a BMI z score change from 2.41 (95% CI,  2.66) to 2.26 (95% CI, ).

Conclusion  Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight, corrected for age.  There were associated benefits to health and quality of life.

Comments / Criticism Small number of patients, although adequately powered Study mainly evaluated weight loss rather than co-morbid problems Similar studies are being performed in US and similar results will be needed for FDA approval of gastric bands for adolescent patients 10/21/201536

Background  Due to constraints on resources and capacity, as well as advances in surgical technique and care, there has been progressive change toward converting surgical procedures to the outpatient setting when feasible.  This study was designed to investigate the safety of laparoscopic adjustable gastric banding (LAGB) as an outpatient procedure for morbid obesity

Methods  Retrospective analysis of outpatient LAGB from Feb 2005 to July 2009  Eligible patients must have met the NIH definition for morbid obesity: a bodymass index (BMI) ≥40 kg/m2 or a BMI≥35 and <40 kg/m2 with at least one associated comorbidity.  This study excluded patients who were not morbidly obese or who had previous bariatric surgery.

Methods  The only absolute contraindications to outpatient surgery were untreated severe obstructive sleep apnea (OSA) and cardiac or respiratory comorbidities that would make general anesthesia unsafe.

Results  1,641 patients were included  The average presurgical BMI was 46.7 kg/m2 (range 35.0 to 79 kg/m2).  15 patients (0.91%) experienced minor complications during surgery or within 30 days of surgery (dysphagia, n=5; wound infection, n=3; port infection, n=2; all other complications occurred in one patient each).

Results  Four patients required transfer to hospital from the clinic on the day of surgery, and three were admitted.  None of the complications were serious and all were resolved.  The device was explanted in two patients.

Results  Of the first 100 patients for each physician, four experienced complications (four of 200; 2.0%), in contrast to 11 of the subsequent 1,441 patients (0.8%) (P=0.0993).  One complication in a patient who did not meet the NIH criteria for morbid obesity. This patient had minor bleeding that did not require transfusion, but this patient did require overnight hospitalization for observation.

Conclusion  The ability to treat patients within 4 h and the extremely low complication rates reported here contribute to a growing literature supporting the safe performance of LAGB in an outpatient setting for the treatment of morbid obesity.

Comments / Criticism Retrospective chart review No strict guidelines for using the outpatient hospital or the surgery center, but the authors stress that the decision should be individualized Did not examine weight loss results/co- morbidity resolution This and other studies will put pressure on surgeons to perform banding as outpatient 10/21/201548

Article #5 Annals of Surgery 2011;253(2):

Background LAGB is one of the most frequently performed and effective bariatric procedures, with low morbidity & mortality However, longer-term complications of LAGB include disorders of esophageal dysfunction; – Motility disorders – Dilatation – GERD

Aim To prospectively evaluate the long-term effects of LAGB on esophageal dysfunction – Based on a 12-year experience

Methods June 1998-June 2009:All patients who underwent LAGB for the treatment of obesity were enrolled in this prospective trial,with min follow-up of 6 months. Inclusion criteria: – BMI >40 kg/m 2, or > 35 with comorbidities – Failed non-operative management of obesity (x 2 yrs) – Age <60 years – No significant intake of sweets or alcohol – No concurrent Psych illness All patients underwent upper endoscopy prior to LAGB

Methods LAGB: – Swedish adjustable gastric band used – Upper GI series performed 6-10 hrs postop, then liquid diet x 3 days Follow-up: – 4 wks: initial band filling (2-3ml) – 3, 6, 9, 12 months, annually thereafter …. Additional band fills if weight loss < 1kg/month, or absence of fullness reported – No band fill performed if …. any obstructive symptoms, severe solid food intolerance, nightly aspiration, or vomiting >2 times/wk – Barium swallow performed annually to evaluate status of band, pouch size and for esophageal dilatation

Methods Esophageal diameter measured digitally on radiological images Esophageal dilatation defined as diam. ≥35 mm – Classified according to Dargent Stages I - IV 1 Stage I: Moderate dilatation with delayed emptying Stage II: Hyper-contracting esophagus (nutcracker esophagus); Stage III: Significant dilatation with anterior/posterior pouch slipping Stage IV: Major achalasia-like dilatation 1. Dargent et al. Obes Surg 2005

Results 167 patients underwent LAGB (in 12 yrs) 71.8% (n=120) females Mean age 40.1 (±5.2) years Mean BMI 44.2 (±4.6) kg/m 2 Preop esophageal disorders: – Clinically reported problems (n=8, 4.8%): GERD n=5 Hiatal hernia n=3 – 95 patients (56.9%) had upper GI pathology at preop UE

Results Weight loss & efficacy data not reported here Post-op Upper GI series demonstrated a gastric perforation in 1 patient  treated non- operatively Follow-up: available for 94% (n=157) Median follow-up 79.9 months (Range 6-138) – >2yr follow-up available for 91% – 8yr follow-up available in 39.5%

Results Annual barium studies revealed esophageal dysmotility disorders in 108 patients (68.8%) – Average esophageal diam (±7.9) mm (Range 18.3–94.6 mm) – Esophageal dilatation in 40 patients (25.5%) ….mean diameter 47.3 (±6.9) mm – 34 (21.7%) patients had Stage III dilatation needing band deflation – Stage IV dilatation in 6 (3.8%) patients, which did not recover after band deflation.

Results

Stage III esophageal dilatation, 5 yrs post-LAGB

Results Stage IV esophageal dilatation, 8 yrs post-LAGB

Results Band deflation required in 29.9% In 18.5% (n=29) of the patients, UE was carried out because of heartburn and/or dysphagia …Normal in 18, GERD in 9, hiatal hernia in 1, stenosis in 1 The 6 pts with Stage IV dilatation required reoperation for band removal – 4 underwent Sleeve Gastrectomy – 2 declined further bariatric surgery – In all 6, the esophageal dilatation was reversible on further follow-up

Conclusions/Recommendations Esophageal motility disorders after LAGB are frequent, poorly appreciated, and significant complications Preoperative esophageal manometry should be performed if a clinical suspicion of esophageal motility disorder is present, or at the time of preoperative pathological endoscopy Should consider RYGB in patients with defective esophageal motility LAGB should probably not be considered the procedure of first choice; should be performed only in selected cases, until reliable criteria for patients with a low risk for these long-term complications are developed

Comments / Criticisms All “Obtec” bands Technique (perigastric vs pars flaccida) not elucidated < 20 bands per year placed by the entire center Band adjustments every 3 months the first year and annually therafter Often dilation is due to overtightening, not underlying esophageal dysmotility 10/21/201563

Other papers of interest Gastric Banding

10/21/201565

Long Term Diabetes Study… Small, French study (24 patients) 5 year follow up Good control in 13 patients Complete remission in 1 patient LAGB improved metabolic outcomes and QoL in patients with type 2 diabetes but rarely led to prolonged remission in long-standing diabetes 10/21/201566

New Bands Study Lap Band AP compared with Realize C and Realize Band Retrospective review with uneven sample sizes LapBand AP had superior weight loss Realize C had worst weight loss 38% of Realize C band patients had fill volumes above recommended 10/21/201568