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Banded Sleeve Gastrectomy: Is there a method to this madness?

Wed, 11/11/2020 - 09:17
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On 29th September 2020, the International Bariatric Club (IBC) hosted the 16th iteration in its series of IBC ‘Oxford Hot Topics in Surgery’ webinars, entitled ‘Banded sleeve gastrectomy - Is there a method to this madness?’. The webinar featured presentations from world renowned experts in banded sleeve gastrectomy including Professors Phil Schauer (USA) and Jodok Fink (Germany), and Dr Paolo Gentileschi (Italy), as well as a video presentation by Dr Mohit Bhandari (India).

The presentations were followed by a fascinating discussions by an expert panel including Professor Rudi Weiner (Germany), Professor Enrique Elli (USA), Mr Michael Van Den Bossche (Guernsey/UK), Dr Helmuth Billy (USA) and Professor Jan Willem Greve (The Netherlands). The webinar was chaired by Professor Ariel Ortiz Lagardere (Mexico/USA), Dr Luc Lemmens (Belgium) and Professor Mal Fobi (USA/India).

Phil Schauer
Phil Schauer

In the first presentation ‘The Plethora of Bands for Banded Laparoscopic Sleeve Gastrectomy’, Professor Schauer looked at the various rings used when banding the sleeve. He began by saying that the concept of using rings started in the 1970’s with vertical banded gastroplasty and their use was slowly adopted and adapted to other procedures in the following decades to include banded gastric bypass and banded gastroplasty, with the first banded sleeve gastrectomy procedures occurring in 2006 (reported in a paper published in 2009, Banded Sleeve Gastrectomy - Initial Experience. Obes Surg 2009. 19:1591–1596). He noted that some surgeons, particularly in the US, prefer use ‘home-made’ or synthetic rings from materials such as Goretex, Marlex Mesh, Ethibond sutures etc. In addition, there are also ‘biologic rings’ made from bovine or porcine grafts. There are many papers in the literature reporting the outcomes from banded sleeve procedures woth home-made rings, but no randomised clinical trials.

When comparing home-made with commercial rings, Professor Schauer highlighted that although the former cost less and do not require any regulatory approval, the commercial rings are prefabricated, quality assurance is carried out by the company/manufacturer so there is reduced liability on the surgeon, they are easier (reduced learning curve) and quicker to place, and have a moderate and growing body of evidence supporting their use in the literature. There are no FDA approved bands/rings in the US (other than the Lap Band, primarily used in gastric banding procedures), but an array of approved devices in Europe.

The first specifically manufactured ring was the GaBP Ring (Bariatec), introduced in 2006 and invented by Professor Fobi. There are at least five studies with 3-5 years follow-up. The device’s CE Mark was rescinded in 2016. The first adjustable rings for bypass (MiniMizer Ring, Bariatric Solutions International, the MidCal Ring, MID and the B-Band, AMI) were launched in 2012. These devices are made of silicone and are radiopaque and are adjustable to four sizes 65, 70, 75 and 80mm. The MiniMizer Ring has at least five studies with 3-5 years follow-up and the MidCal Ring has at least one study with three to five years follow-up, according to Professor Schauer, who could not find any published data on the B-Band.

Asked why there were no approved devices in the US and why there was a reluctance by US surgeons to adopt the procedure, he explained that approval of these devices in the US would require studies demonstrating the ring’s safety and efficacy, and the cost of establishing such studies, as well as the cost of going through the regulatory process, has thus far, been a deterrent to companies. In addition, US surgeons had concerns of introducing a device that could cause complications such as nausea and vomiting (food intolerance). However, he added that experienced surgeons know that the purpose of the rings is to not restrict food but prevent pouch dilatation, so they insert those rings loosely around the gastric pouch. A further perceived problem was ring erosion, however, he noted that with the silicone rings the erosion rate was less than 1% and, if removal is required, can be carried out endoscopically.

Jodok Fink
Jodok Fink

In the next presentation, ‘Banding the Sleeve: How Strong is the Evidence?’, Professor Fink examined the safety and efficacy of the procedure. He started by emphasising that these banded procedures should not be confused with the adjustable gastric bands and the complications that can occur with gastric banding procedures. During a banded bypass or sleeve, the ring is not placed tightly around the gastric pouch, but loosely to prevent dilatation and pressure is only applied when a patient eats too much/too quickly, whereas in a classic Lap Band procedure there is tight, constant pressure.

He noted that in the short-term (12 months), the procedure has little impact on weight loss. However, long-term data (five years follow-up) from four retrospective studies and two randomised controlled trials demonstrates the effectiveness of the procedures on weight loss around two years after surgery and weight regain around three years after surgery - in favour of those patients who had the banded procedure vs the patients who had the non-banded procedure (Figures 1 and 2).

Figure 1: Percent excess weight loss from banded sleeve vs non banded sleeve patients after three years (Fink et al. Banded Versus Nonbanded Sleeve Gastrectomy: A Randomized Controlled Trial With 3 Years of Follow-up. Ann Surg; November 2020;272(5):690-695)
Figure 1: Percent excess weight loss from banded sleeve vs non banded sleeve patients after three years (Fink et al. Banded Versus Nonbanded Sleeve Gastrectomy: A Randomized Controlled Trial With 3 Years of Follow-up. Ann Surg; Nov 2020;272(5):690-695)
Figure 2: Percent Excess Body Mass Index Loss from banded sleeve vs non banded sleeve patients after four years (Gentileschi et al. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. Journal of Obesity. June 2020)
Figure 2: Percent Excess Body Mass Index Loss from banded sleeve vs non banded sleeve patients after four years (Gentileschi et al. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. Journal of Obesity. June 2020)

Regarding complications, Professor Fink concentrated on what he believes are the two major concerns - reflux and regurgitation. In his centre’s retrospective study, they found that reflux rates were similar in patients who had the banded and non-banded procedures and in the prospective studies there was even a benefit (a reduction in reflux symptoms) for banded patients after three years. Furthermore, in the prospective study 11 patients had reflux oesophagitis prior to having a banded sleeve gastrectomy and at three years post-surgery the majority of patients saw their symptoms improve. There were also no instances of symptoms worsening in the banded patients.

For regurgitation, Professor Fink reported that in the prospective study there were higher rates of regurgitation (more than one event per week) in the banded patients. However, during this study the diameter of the ring was changed from 6.5cm to 7.5cm and this change directly correlated with a decline in regurgitation rates.

Professor Fink concluded that there is high level of evidence for better weight loss when banding a sleeve with a small percentage of side effects (mostly regurgitation) and to date, the main limitation is that there is no true long-term data, adding that the banded sleeve gastrectomy is an underused and underestimated procedure.

Paolo Gentileschi
Paolo Gentileschi

Next, Dr Paolo Gentileschi, who has been using the MiniMizer Ring since 2015, looked at the ‘Technical Aspects of Banding the Sleeve’. He echoed the views of Professor Fink and said the Ring should be placed very loosely around the pouch preventing the risk of stricture or increasing the intragastric pressure or a higher leak rate. Indeed, in his patients the leak rate is the same for non-banded and banded patients. He explained that during the x-ray swallow the day after banded surgery, the contrast media passes quickly through the Ring, however, three or four years later the media passes slowly through the Ring demonstrating that the Ring works effectively over a long time period.

When implanting the Ring, Dr Gentileschi explained that the most important technical aspect was the creation of the retrogastric tunnel of which there are two – the pars flaccida and perigastric techniques. To create the tunnels, he starts medially to lateral 4cms from the esophagogastric junction. The Ring is grabbed at the ‘dark blue side’ and pulled over the sleeve, the Ring is then closed over the bougie at 8cms. He closes at 8cms because he wants the Ring to be as loose as possible and then passes a grasper in the space between the Ring and the pouch to ensure the Ring is not too tight (Figure 3).

Figure 3: Image showing a grasper passing in the space between the Ring and the pouch (Image courtesy of Dr Chris Couch, Perth Obesity Surgery Clinic, Perth Australia)
Figure 3: Image showing a grasper passing in the space between the Ring and the pouch (Image courtesy of Dr Chris Couch, Perth Obesity Surgery Clinic, Perth Australia)

After the Ring is closed and after the methylene test to ensure there is no perforation, the bougie is then removed. He said the Ring is fixed with two non-absorbable sutures to reduce the risk of complications such as slippage. In his randomised study, the outcome showed the banded patients had a statistically significant greater weight loss at three years, compared to non-banded patients (Figure 2).

In the subsequent panel discussion, Dr Lemmens commented that in patients with weight regain and  pouch dilation, he would re-sleeve and insert a Ring, however, the problem was those patients who present with weight regain without pouch dilatation as you cannot re-sleeve and without dilatation there is no point in placing a Ring. The reason for weight regain is more likely to be because of patient snacking, grazing or sweet-eating, and then another type of procedure maybe required.

Professor Schauer highlighted two areas of concern – erosion and reflux – adding that although the report 1% rate of erosion in the literature was ‘tolerable’, this type of complication does require further investigation. He referred to reflux as the “Achilles’ heel” of sleeve gastrectomy and it would seem to be intuitive that a ring would increase reflux, and he again called for more data to establish whether this is the case.

Dr Billy said he would wait for more long-term data before deciding whether to perform banded sleeve procedure because not every sleeve fails because it dilates. He added that it was important to discuss the causes of sleeve failure, which he estimates is some 30-40% of sleeve procedures, as well as understand the causes of weight regain. He argued patient’s eating habits should be scrutinised and questioned whether a ring would work as a revision procedure suggesting some patients might benefit from a more aggressive second procedure.

He added that he can see how the banded sleeve could be useful in the right patient but if 50% of his patients do not present with weight regain unnecessarily adding a ring does add the risk of an erosion and a potential unknown risk of reflux. By using the banded procedure, he argued, surgeons are trying to protect the patients from themselves, but a significant proportion will not require the band. In his experience of removing gastric bands, in many patients the lower oesophageal sphincter was ‘destroyed’ and he agreed with Professor Schauer that more data was needed.

Professor Greve said the risks of complications from the Ring are low and the data on banded sleeve procedures was looking ‘quite good’ and agreed more long-term data was needed. He added that he is not ‘sleeve believer’ and rarely performs the procedure but if he has too for specific reasons, he performs a banded sleeve and the patients do ‘quite well’.  However, he said in cases of failed sleeve he could perform a banded bypass or in really poor responders a single anastomosis duodeno–ileal bypass with sleeve gastrectomy (SADI). Professor Greve again underlined the idea that the banded procedure is not about restriction and it was crucial to select the appropriate size so there is space between the band and the pouch.

Professor Weiner commented that after three years the weight loss is better in banded sleeve patients, but the outcomes from re-sleeving with a Ring were mixed with a mean BMI loss of four. Regarding the MiniMizer Ring, he explained one advantage was that a surgeon can tighten or loosen the Ring, if necessary.

Dr Gentileschi said talk of complications such as slippages and erosions was unnecessary as the rates from these complications were extremely low, the key issue was more data to convince people that the banded sleeve is a more effective procedure than the standard sleeve.

Mr Michael Van Den Bossche, who has been performing banded sleeves since 2012, said the procedure requires very few revisions (none for weight regain), except for dysphagia caused by the Ring being too tight. In non-banded sleeve revisions are primarily for weight regain or reflux, and these patients would have a bypass or mini bypass.

Professor Schauer noted that the diameter of these prefabricated Rings were 3mm so when erosions do occur, as rare as they might be, they can gently be removed endoscopically, a completely different solution compared to removing a gastric band erosion.

Dr Gentileschi’s take home message was that ‘expert opinion is the lowest level of evidence so let’s do some randomised controlled trials and see where we are in five years!’ Professor Fink warned surgeons not to put the Ring in too low or make it too tight, if surgeons do that they will find it is a wonderful procedure. Professor Greve commented that surgeons should not be alarmed by the Ring complications caused by poorly placed Lap Bands and a badly managed patient, these banded procedures are a completely different procedures. He repeated the need to place the band above the anastomosis in RYGB and make sure it is loose.

Dr Lemmens, who has performed more than 2,000 banded procedures, noted that he has treated patients with Ring migrations but all were after revision procedures and he also emphasised the importance of placing the Ring loosely on healthy stomach tissue­­ and fixing the band with stitches. He concluded by saying that once the longer-term data confirms reduced weight gain more people will be convinced banded sleeve is superior to standard sleeve.

Mohit Bhandari
Mohit Bhandari

Surgeons must remember to place the band at least 4cms from the esophagogastric junction commented Mr Michael Van Den Bossche, adding that as well as establishing additional studies and clinical trials, all the procedural data from banded procedures should be collected in a national or international database as this would add a lot more value to the evidence for the procedure.

The banded sleeve is particularly suited to patients with super obesity, according to Dr Bhandari, as his study published in SOARD (Sept 2019; 15; Issue 9; 1431-1438) consistently showed weight loss was substantially greater following banded sleeve compared to standard sleeve at two, three, four and five years. He also agreed with Professor Schauer regarding endoscopic removal of a Ring was simple and not as complex as removing a larger gastric band.

To watch the webinar, please click here