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IFSO Europe seminar

The future of gastric banding

Dr Carel le Roux advocated careful patient selection
Carel le Roux and Paul Super discuss their banding techniques at IFSO Barcelona 2012
Le Roux: thorough patient assessment and achievement of the optimal zone for band pressure are vital
Super: gastric banding is a viable operation for super-superobese patients

New approaches to gastric banding were explored at the recent IFSO European Chapter meeting in Barcelona in a symposium hosted by Allergan.The session aimed to examine the approaches to metabolic surgery and how laparoscopic gastric banding (LAGB) works and its application in the super-superobese population.

In the first presentation of the symposium, entitled 'A physician’s approach to metabolic surgery', Dr Carel le Roux, professor at the Conway Institute, University College Dublin, Ireland, outlined the treatment goals when treating an obese patient, how lap banding reduces appetite and the importance of long-term management of patients.

“Therefore, the morbidly obese patient will require a multi-module strategy and the assessment can determine whether the treatment or specific therapy is successful or not,” said le Roux. “The treatment goals are the optimisation of metabolic state and to achieve resolution of co-morbid conditions such as type 2 diabetes mellitus and hypertension, as well as reducing microvascular complications including retino, nephro, neuropathy and macrovascular complications like CVD, and PAD.”One of the first aspects when assessing a patient in the clinic is to examine the type of weight management treatment they require, as those patients who are initially unsuccessful in losing weight can quickly become disillusioned.

Le Roux explained that he used International Diabetes Federation (IDF) definition of the "optimisation of the metabolic state":

"But banding does not work through restriction - indeed, restriction is just a side-effect."Dr Carel le Roux

  • HbA1c <6% (42mmol/mol)
  • no hypoglycaemia
  • total cholesterol <4mmol/l;LDL
  • <2mmol/l
  • triglycerides <2.2mmol/l
  • blood pressure <135/85mmHg
  • >15% weight loss
  • reduced medication OR without other medications

A "substantial improvement in the metabolic state" according to the IDF is defined as:

  • lowering of HbA1c by >20%
  • LDL <2.3mmol/l
  • blood pressure <135/85mmHg
  • reduced medication from the pre-operated state

Laparoscopic gastric banding

One paper that hypothesised that LAGB provides prolonged satiety was published by the Monash team in Australia. They also noted that identifying the mechanisms underlying LAGB-induced satiety may assist the understanding of human energy homeostasis and obesity

“But banding does not work through restriction - indeed, restriction is just a side-effect,” said le Roux. “We now believe that the vagal fibres that sit at the gastro-oesophageal junction where the band is positioned are actually important when it comes to signalling to the hypothalamus, as it is the pressure on these fibres that may reduce hunger and induces satiety.”

He added that patients should be losing weight because they are eating fewer calories, not because they are restricted and can’t eat by restriction. Therefore, physicians should look for the "optimal zone" of banding pressure in their Lap-Band patients.

If patients are hungry, eat big meals and looking for food to satisfy their craving; or if they have difficulty swallowing, present with reflux/heartburn, suffer from regurgitation and have poor eating behaviour, the patient’s band is not having the optimal affect.

Patients in the “optimal zone” eat small satisfactory meals, have early and prolonged satiety and record satisfactory weight loss and maintain the loss.

With regards to T2DM, le Roux said that there are differences depending on the procedure. Pournaras et al showed that following gastric bypass, T2DM could be improved and even rapidly put into a state of remission irrespective of weight loss, compared with banding. 

“However, what does remission of T2DM really mean?” he asked. The consensus definitions and recommendations from the American Diabetes Association state that partial remission is defined as:

  • Glucose <7mmol/l, 
  • HbA1c <6.4% at least one year's duration 
  • No active pharmacologic therapy 
  • No ongoing procedures 

Whereas complete remission is defined as:

  • Glucose < 5.6mmol/L, 
  • HbA1c <6% at least one year's duration 
  • No active pharmacologic therapy 
  • No ongoing procedures 
  • Complete remission of at least five years' duration

He said that the screening for microvascular complications should be linked to the definition as diabetes. Screening should continue during, partial or complete remission for at least five years.

It is only when a patient reaches prolonged remission/cure that screening frequency can be reduced, although this should only happen in patients who never had any microvascular complications in the first place. 

Therefore, le Roux recommended that patients should continue to receive metformin therapy if tolerated as the evidence suggests a reduction in patient’s microvascular risk and emergent risk reductions for myocardial infarction and death from any cause, particularly if they are still overweight.

In conclusion, le Roux said that reducing glycated haemoglobin (HbA1c <7%), low-density lipoprotein (<2.3mmol/l) and blood pressure (<135/85mmHg), as well as reducing medication from the pre-operated state, assists the physician in achieving their overall goal, which is to make patients healthier - not thinner.

LAGB in the super-superobese population

Although the majority of the literature regarding LAGB focuses on patients with lower body mass index (BMI >25-45), according to Mr Paul Super, consultant bariatric surgeon, Upper GI and Minimally Invasive Unit, Heartlands Hospital, Birmingham, UK, the procedure can be carried out in super-superobese patients (BMI>60) and result in weight loss, and the outcomes are comparable in the patients, regardless of the baseline BMI (>25-60).

Super began by stating that there are numerous studies in the literature that support notion of banding for super obese (BMI>50) patients. For example, Parikh et al. concluded that in their cohort of super obese patients, LAGB resulted in the lowest operative times, the lowest conversion rate, the shortest hospital stay and the lowest morbidity in this high-risk cohort of patients, compared with patients who received Roux-en-Y gastric bypass or biliopancreatic diversion with/without duodenal switch.

"Just because a patient presents with a BMI 60 or over, it should not be a reason to deny laparoscopic gastric banding, as it remains the safest surgical intervention with low re-operation rate."  Mr Paul Super

They also reported that mean percent excess weight loss (%EWL) was 35.3±12.6, 45.8±19.4, and 49.5±18.6 with follow-up of 87%, 76% and 72% at 1, 2 and 3 years (compared with 57.7±15.4, 54.7±21.2, and 56.8±21.1 with follow-up of 76%, 33% and 54% at 1, 2 and 3 years, for RYGBP). The difference in %EWL between RYGBP and LAGB at two and three years was not statistically significant. 

Furthermore, Angrisani et al. reported mean %EWL at six months, one, two, three and four years was 24.1, 34.1, 38.8, 38.9, and 52.9% following LABG placement on 253 patients with a BMI>50 .The number of patients with <25% EWL at 12, 24, 36, and 48 months follow-up were 34, 10, 4, and 0. They concluded that although super-obese patients following the LAGB remain obese with BMI >35, in the short-term most lose their co-morbidities, with a very low morbidity and mortality rate. 

In reference to patients with BMI>60, Super cited the study by Torchia et al. in which 95 patients received a Lap-Band. One or more preoperative co-morbidities were diagnosed in 90 of 95 (94.7%) patients.

After one year, co-morbidity-free patients increased from five of 95 (5.3%) to 27 of 95 (28%; p<0.001). Patients with three or more co-morbidities decreased from 62 of 95 (65.3%) to 0 (p< 0.001). The %EWL at one, two, three and four years was 53.6, 69.7, 81.3, and 82.1 and percent excess BMI loss (%EBL) was 50, 66, 90, and 91.

The authors concluded that LAGB can be considered an appropriate bariatric surgical option in super-superobese patients both for low morbidity rate and weight loss, and the end-point of BMI<30 can be achieved with a multidisciplinary follow-up.

Super then cited his own centre’s six-year (2003-2009) experience of 153 super-superobese patients (female=104). Baseline characteristics revealed that the mean age was 42.5 (19–65), mean pre-operative weight 185.5 kg (132–268) and mean pre-operative BMI 66.7 kg/m2 (60–100.9), and just over half of the patients (n=80) presented with a BMI>60-64. A complete breakdown of the distribution of patients by BMI is shown in the table below.

BMI 60-64 65-69 70-74 75-79 80-84 85-80 90-94 95+
No. of patients 80 35 18 13 14 2 0 1

Table 1: Distribution of patients by BMI

All the patients underwent a pre-operative work up, which included patients seeing a specialist in the weight clinic. They were then provided with a pre-operative diet for 6-12 weeks (1000cal/day) and had a pre-operative assessment four weeks before surgery. All patients were admitted to the hospital on the day of surgery.

“It is essential to have the right things in place for surgery and this includes having an adequate operating table, bed transfer equipment and most importantly, teamwork,” he advised.

For all the procedures, Super utilised the five port technique (12mm, 10mm, 5mm, 5mm, 5mm) and the mean duration of the procedure was 52.5 minutes (30–95 minutes). The length of stay for the overwhelming majority of patients (151/153 patients) was 24 hours; the remaining two patients were discharged after two days.

Super described in short video clips personal tricks and tips on lap banding in the super-super obese.

All ports must be inserted in the direction of the hiatus as laparoscopic instrument pivot and control is limited in this subgroup of patients. He prefers a peri-crural insertion technique where the band is placed directly across the anterior pillars of each crus under direct vision – ensuring correct placement when the anatomy can be distorted by dense fat. This technique also ensures a tiny gastric pouch as band placement is higher.

He then went on to describe his preferred technique of band fixation, which incorporates the “Birmingham Stitch” - a suture fixing the plicated fundus to the left crus.

Super reported an operative complication rate of 4.45%, which included one band infection (the band was removed and replaced after six months), three instances of band malposition (all repositioned at three months), three patients presented with pouch dilatation (at 10, 18 and 24 months and were treated by partial band deflation and elective re-positioning) and two patient developed oesophageal dilatation (one partial deflation, one diet advice only).

“Following surgery, all patients were placed on oral fluids for two to four weeks and a soft diet or puree for the next two weeks,” explained Super.

“Patients resumed normal food intake six to eight weeks after surgery. In patients with a BMI>60, radiological band adjustment occurred at three, six and nine months. In this group of patients additional radiological adjustments may be indicated if there is poor weight loss, hunger, lack of satiety or restriction.”

Outcomes

Presenting the outcomes from 153 patients, he noted that all patients had at least two years' follow-up, with the mean follow-up reported as 3.6 years (range 2-8 years). At two years, Super highlighted that the team had captured >95% data, with >80% data capture at successive time internals.

The outcome at the initial three months follow-up period of %EBL loss was 21.4, rising to 26.2 at six months, 31.8 at one year, 38.9 at 18 months, 40.2 at two years, 40.9 at 30 months, 39.1 at 36 months and 39.9 at four years. The outcomes can be seen in Figure 1 below.

Figure 1: Excess %BMI loss and proportion of patients available for follow-up at each time point

The results reveal that the outcomes from Super’s series of patients are comparable with the excess weight loss (%) in the literature.

Conclusion

“In order to achieve these results, good long term follow-up is required, although excess BMI loss may take longer to achieve in high BMI patients,” concluded Super. “Just because a patient presents with a BMI 60 or over, it should not be a reason to deny laparoscopic gastric banding, as it remains the safest surgical intervention with low re-operation rate. The evidence shows that weight loss is comparable in the patients regardless of the BMI.”

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