Can you give us a briefing about history of endoscopic bariatric surgery?
It is evident that anatomic manipulations of the stomach and small intestines produced by surgical interventions such as Roux-en-Y gastric bypass also result in physiological alterations in gut neuroendocrine signaling, gastrointestinal (GI) motility, autonomic nervous system signaling, bile acid production and absorption, and gut microbiota, all of which contribute to weight loss and to improvement in obesity and related comorbidities. However, given the poor penetrance of surgery among patients with obesity, it is clear that minimally invasive options; akin to coronary artery stenting in the field of cardiovascular medicine, are needed to complement bariatric / metabolic surgery and offer scalability, increased patients awareness, and acceptance. Capitalizing on selective targeting of similar peripheral and central gastrointestinal pathways, endoscopic bariatric and metabolic therapies (EBMT) were developed to selectively reproduce the benefits of surgical interventions.
What are the options available for primary endoscopic bariatric procedures?
We can separate EBMT to gastric and small-intestinal techniques. Gastric EBMTs include space-occupying devices that most commonly take the form of temporarily placed prostheses. These include intragastric balloons. The TransPyloric Shuttle (BAROnova Inc, Goleta, CA), which intermittently seals the pyloric channel and delays gastric emptying in the fed state to induce early satiation and prolonged satiety. The Full Sense Device (BFKW, Grand Rapids, MI), is a modiﬁed fully covered gastroesophageal stent with a cylindrical esophageal component and a gastric disk connected by struts that exerts constant gentle pressure on the gastric cardia triggering afferent vagal signaling to the central nervous system and sensation of fullness resulting in weight loss. Additional gastric devices include gastric remodeling techniques that reduce the gastric reservoirs by creating an endoscopic tubular sleeve along the greater curvature of the stomach with transoral endoscopic suturing (Overstitch, Apollo Endosurgery, Austin, Tx) or plication (POSE, USGI Medical, San Clemente, CA). Finally, Aspiration therapy is a treatment approach for obesity that allows obese patients to dispose of a portion of their ingested meal via a specially designed percutaneous gastrostomy tube, known as the A-Tube (Aspire Bariatrics, King of Prussia, PA).
The proximal small intestine plays a central role in the pathogenesis of type II diabetes and metabolic disease orchestrated through a variety of pathways resulting in insulin resistance and chronic inflammation. These pathways include alteration of gut incretin to anti-incretin neurohormonal signaling, changes in the gut microbiome and mucosal barrier function, and activation of innate immune reactions caused by excess free fatty acid, bacterial lipopolysaccharide, chemokines, cytokines, and adipokines. Exclusion of the proximal small intestines by impermeable polymer duodenojejunal bypass liners (EndoBarrier, GI Dynamics, Lexington, MA) (Metamodix, Minneapolis, MN) and ablative duodenal resurfacing techniques that regenerates the proximal small intestinal mucosal barrier by thermal ablation (Fractyl Laboratories, Cambridge, MA) have shown promise and improvement in insulin resistance and NAFLD through weight loss dependent and independent pathways. Finally, primary and secondary bile acids concentration and composition in the intestinal, portal and systemic circulations play an essential role in insulin secretion and resistance. Capitalizing on incretin mediated distal small intestinal pathways and alteration in bile acid signaling, self-assembling magnets for endoscopy (GI Windows, Boston, MA) creates a dual-path enteral bypass between the proximal jejunum and ileum; thus, partially diverting bile to the terminal ileum resulting in diabetes and metabolic improvement.
What is the selection criteria for choosing one option versus the other?
EBMTs should be considered in patients with mild to moderate obesity (BMI 30-40kg/m²) who have been unsuccessful in losing or maintaining weight loss with lifestyle interventions. EBMTs can be used in patients with severe obesity (BMI ≥ 40 kg/m² as a bridge to traditional bariatric surgery or unrelated interventions that are unable to be performed or outcomes improve with significant pre-operative weight loss; such as joint replacement surgery, solid organ transplantation, and fertility treatment. Selective EBMTs targeting metabolic pathways can be used independent of body weight for treatment of metabolic syndrome, non-alcoholic fatty liver disease, polycystic ovarian syndrome, and type II diabetes.
What is the safety profile of these procedures and what are the potential complications?
The appeal and promise of EBMTs is secondary to their safety and anatomic preserving nature eliminating the need for lifetime micronutrients monitoring and replacement, and complex revisional surgery. Safety of EBMT has been established from years of use outside of the US and multiple large high quality randomized controlled pivotal trials performed in the US. Based on the published literature, mortality that is directly attributed to EBMTs is close to 0% with rates of serious adverse events under 5%, most secondary to accommodative symptoms, such as abdominal pain and nausea, which are usually self-limited and expected. Through medical device reporting, the FDA has recently issued 3 alerts between February 2017 and June 2018 to educate providers on the potential risks of acute pancreatitis, spontaneous balloon hyperinflation, and 12 reports of unanticipated deaths worldwide that occurred in patients while fluid-filled intragastric balloons was in place. Seven of these 12 deaths occurred in the United States (4 with the Orbera system and 3 with the ReShape system), with mortality rate, per the manufacturer, of 0.036% (4 deaths per 10,000 patients) for the Orbera system and 0.06% (3 deaths per 5,000 patients) for the ReShape system. Although these reported death might not be directly related to intragastric balloon, the discrepancy in the mortality rate between the large body of published literature and FDA reporting highlight few important points. First, when patients are appropriately selected and followed in a multidisciplinary program, EBMT are very safe interventions. Second,
most of these reports were related to gastric perforations, in which most of them typically occur in patients with previous gastrointestinal surgery, underscoring the importance of a proper evaluation with careful baseline endoscopic assessment. Third, and more importantly, inadequate periprocedural management of retching, nausea, and vomiting leads to gastric perforation, re-enforcing the need for close follow-up
after these interventions.
How effective are these procedures compared to the surgical options?
EBMTs can be effective adjunctive therapies that ﬁll an important gap in the management of obesity and metabolic disease. Expected weight-loss and diabetes resolution rates are better than medical and pharmacotherapies for obesity, but less than traditional bariatric surgery, such sleeve gastrectomy or Roux-en-Y gastric bypass. In general percent total body weight loss observed with EBMT range between 10-20% at 6-60 months. The safety and anatomic preserving nature of EBMT makes them ideal to complement the spectrum of medical and surgical management interventions for obesity and associated metabolic disease.
What is the long-term data on weight regain?
Given this field is still in its infancy, only a limited number of studies evaluated the mid-term (>2 years) efficacy of EBMT. With procedures such as endoscopic sleeve gastroplasty and Aspiration therapies, the weight loss appears to be durable in a significant percent of patients. As with any other obesity intervention; however, response to EBMTs is variable and can be temporary, as in the case of removable and anatomy-preserving devices. Thus, the potential for weight recidivism should be anticipated and managed appropriately with a combination of behavioral interventions and medications. Obesity is a chronic disease and, as such, no individual medication, device, or surgical intervention likely will offer a cure. Physicians and surgeons embarking on incorporating EBMTs into their clinical practice should develop expertise in managing obesity as a disease in conjunction with a multidisciplinary team taking care of patients with obesity, such as medical obesity specialists, behavioral therapy professionals, and registered dietitians.
When, as a bariatric endoscopist, do you refer a patient for surgical consultation?
If the patient qualifies to bariatric surgery and agrees for evaluation, I always refer them first to bariatric surgery. Currently, I reserve EBMT to patients who do not qualify for bariatric surgery or wish not to get it.
Why ASMBS has still not endorsed the endoscopic options (aside from the balloon)?
ASMBS already endorsed the use of intragastric balloons and Aspiration therapy given high quality evidence supporting their use. They have included endoscopic sleeve gastroplasty in the conditionally accepted procedures list similar to single anastomosis gastric bypass. With the completion and reporting of the US multicenter randomized ESG trail (MERIT) involving 200 patients with obesity related co-morbidities and other trials in the field, I am confident that the ASMBS will continue to update their position on different obesity interventions both endoscopic and surgical.
Do you believe that endoscopy will replace laparoscopy or robotics in the future as a treatment for morbid obesity?
The role of EBMT and Bariatric / Metabolic surgery will continue to evolve and be complimentary. In the era of less than 1-2% of patients with obesity benefiting from these intervention the tool box will need to expand with significant contribution from both fields. The way of the future will be personalizing these interventions to patients’ obesity phenotype and severity of the disease to maximize benefit and minimize risk.
Barham Abu Dayyeh M.D. M.P.H.
Associate Professor of Medicine
Mayo Clinic, Rochester
Barham Abu Dayyeh M.D. M.P.H. Associate Professor of Medicine Mayo Clinic, Rochester
Fifty years old female patient presenting for weight regain after Roux en Y gastric bypass (RYGB) done in 2010. At the time, she had morbid obesity- BMI 50; liver steatosis, gonarthrosis, reflux esophagitis. A RYGB was performed in October 2010 with a 60 cm BPL and a 120 cm alimentary limb (no info about common channel in the discharge papers). The lowest BMI she achieved was 34, at 18 month postoperatively.
During the following years she started to regain weight, mostly due to the increased tolerance for food ingestion. Affirmatively she is not a ‘sweet eater’. She had a discrete dumping syndrome in the first year, but afterwards the symptoms disappeared as she continued eating larger meals.
At the time she prsented for evaluation for the revision, her BMI was 46. Upper GI Endoscopy and Barium swallow showed wide anastomosis, approx. 3.5-4 cm; the gastric pouch not enlarged, no hiatal hernia, no anastomosis ulcerations, slightly enlarged alimentary limb below the anastomosis.
We measured the AL/BPL- we found 150 cm of AL, 60 cm of BPL and 480 cm of common channel. The gastric pouch looked normal, the alimentary limb slightly dilated below the anastomosis. We dissected the pouch and 2 cm above the anastomosis we banded the pouch, in order to offer some more restriction. We transected the alimentary limb just proximally to the jejuno-jejunal anastomosis and we performed another jejunoileal anastomosis at 350 cm of the ileocecal valve (distalization).
In conclusion, we performed:
Uneventful recovery. Three weeks after surgery the patient has no complains. She lost 8 kg (liquid diet two weeks postoperatively, followed by one week of soft food diet).
Revision of previous bariatric operations has primarily been focused on conversion of poor results following adjustable gastric bands to the more popular sleeve gastrectomy and traditional Roux Y gastric bypass. It has becoming increasingly common to see the problem of weight regain following sleeve gastrectomy developing in those individuals who had been previously successful with weight loss Patients failing sleeve gastrectomy will often lead to almost automatic revision to a Roux Y gastric bypass or One Anastomosis Gastric Bypass. The problem of weight regains following Roux Y Gastric Bypass is however a much different problem. Traditionally the surgical options have been limited and for many years if not the past 10-20 years of my career little consensus has been reached among bariatric surgeons as to how best to manage and approach the problem of weight regain after Roux Y Gastric Bypass.
My career as a bariatric surgeon began with my first Roux Y Gastric bypass in September 2000. At that time the gastric bypass was literally the only operation that we offered our patients. The duodenal switch was being done primarily by a few open surgeons (and everyone told me not to offer it). There were no gastric balloons or lap bands and the Sleeve Gastrectomy would eventually be introduced as an operation to allow a safer approach to duodenal switch. The idea of staging an operation, breaking an operation down to its individual steps as introduced by Pomp and Gagner, was primarily a method to avoid the high complication rate associated with duodenal switch and Roux Y Gastric Bypass in the super obese, and often male patient. The sleeve gastrectomy, like the adjustable gastric band became a relatively straightforward operation to revise to Roux Y Gastric bypass or even duodenal switch. Patients who have regained weight following previous successful Roux Y Gastric Bypass have not been so fortunate and have largely been offered ineffective and relatively useless alterations of what are otherwise acceptable gastric bypass procedures. The problem of what to do or offer a failing patient with an otherwise intact Roux Y Gastric Bypass has not been answered and there is no consensus as to where to begin to revise these patients into a successful bariatric surgery patient. What can be determined is that we as bariatric surgeons still have much to learn when selecting which operation to recommend to our patients when trying to decide between Roux Y Gastric Bypass, sleeve gastrectomy, SADI, OAGB, Duodenal Switch and others. What I have learned after 20 years as a bariatric surgeon is that among the thousands of RYGB that I performed on my patients, many of them would have had a better more successful result had I recommended a duodenal switch or now SADI.
The initial evaluation of a patient who has undergone Roux Y Gastric Bypass but has either failed to achieve their weight loss goals or has gained enough weight to be considered morbidly obese, has traditionally started with an evaluation to find a problem with the original operation. Thousands of upper GI swallows and EGDs were performed in an attempt to discover dilated gastro jejunostomies or dilated gastric pouches or gastrogastric fistulas or large (stretched?) gastric pouches. During this eternal search for the reason why the Gastric Bypass had failed our therapies were focused on how to make the pouch smaller and how to “sleeve” the pouch and the jejunum. We invented multiple ways to imbricate the pouch, how to trim the pouch, how to internally plicate the pouch and other ways to try to make the gastric bypass once again successful. We tried decreasing the size of the stoma from 20 mm to 8 mm and whether these techniques were done open or endoscopically they rarely worked and typically failed to achieve any significant new measure of success for these patients. For these patients finding a gastro gastric fistula or a large pouch or a dilated stoma did not result in an operative intervention that would allow their operation to function in a way which would result in weight loss goals being achieved. Most of these patients were branded as “Non-Compliant” or “failures” and little effort has been allocated to determining if the patient failed the operation or the operation failed the patient.
In addition to these challenges the Roux Y Gastric Bypass was not really designed to be an operation that could be easily altered or reversed. For more than ten years I believed that the RYGB should not be even attempted to be reversed, that this was more or less a permanent operation. As the era of revision surgery has grown over the past ten years the problem of what to do with the patient who has regained weight after a RYGB has become the fastest growing group of patients that we currently see and evaluate in our bariatric practice in California. After ten years of looking for dilated pouches, dilated gastojejunostomies, fistulas, big pouches, short Roux Limbs and other seemingly less than perfect operations I came to the conclusion that the problem was for many patients very simple. They had simply undergone the wrong operation. With the published series of long term outcomes with SADI the idea of reversing a gastric bypass and converting a failed gastric bypass into a staged duodenal switch (SADI), has offered our program the opportunity to help many patients with a metabolically different operation and one that been more successful and reliable than traditional gastric bypass. We have over time succeeded at changing a failed gastric bypass into an operation that is different, successful, reliable and reproducible way to achieve weight loss. In addition, recent publications by Higa introducing the concept of total limb length (TLL) and lengthening the biliopancreatic limb may offer an additional opportunity to more effectively and reliably manage the patient who has regained weight after Roux Y Gastric Bypass, especially when complications in the foregut and gastric pouch may make reoperation in that region difficult or even dangerous.
After having spent ten years in a futile attempt to find any significant number of gastric gastric fistulas or other significant abnormalities to account for weight regain, our clinic turned to reversal of gastric bypass and conversion to a SADI or DS in a two step approach. I have now come to the conclusion that for many Roux Y Gastric Bypass patients their operation is simply the wrong operation. In order to convert a patient to SADI we began by eliminating other causes of weight regain by using traditional Endoscopic examination, radiographic upper GI swallows, psychologic evaluation and nutritional education. Our approach has been to embark on a two stage technique involving complete anatomic reversal of the gastric bypass. Over the three to six months between reversal and conversion to SADI our patients complete ongoing nutritional and psychological assessment to improve their chances of success. To date this approach has resulted in a group of patients which are far more successful with a SADI than they ever were with a RYGB. All patients understand that by taking a stage approach to duodenal switch they have undergone the sleeve gastrectomy of a duodenal switch and the initial duodeno ileostomy of the duodenal switch to create the SADI. For those few patients who still have trouble achieving weight loss we have reserved the final jejunal to jejunum anastomosis used to create the short common channel of a duodenal switch for a later date. Just as sleeve gastrectomy results in approximately 70% of patients never needing a revision operation we hope to limit the use of traditional duodenal switch to only those patients who truly need it. Revision of SADI to DS is relatively easy and involves only the transection of the afferent limb of the loop anastomosis and translocating it to create 50-100 cm common channel. The results of our series of 30-50 patient who have been reversed and converted to SADI has been extremely successful and has encouraged us to continue offering this approach to well selected patients who have failed achieve a sustainable weight loss with their Roux Y Gastric Bypass.
It is not unusual to have patients who have regained weight following Rous Y Gastric Bypass. The innovations introduced by Antonio Torres with respect to SADI and Kelvin Higa with respect to revision and specific alteration in Total Alimentary Limb Length of the Roux, common channel and Biliopancreatic limb offers us a real opportunity to address the shortcomings of Roux Y Gastric bypass in a largely untreated group of patients who are most likely not as non-compliant as they have been labelled. The opportunity is to improve the long term outcomes with a well-defined operation such as SADI or TALL alteration has arrived and following meticulous preoperative evaluation and careful surgical planning many of these patients will be appropriate candidates to reverse their Roux Y gastric bypass and progress to SADI. Alteration of the Total Alimentary Limb Length can provide an opportunity for success in patients who have had more complicated clinical courses involving marginal ulcers, anastomotic leaks and other complications of the proximal gastric pouch where reversal of the gastric bypass is not an easy option but revision of the gastric bypass to a much more effective and different operation is the desired goal.
Viorel Dejeu MD
MedLife Genesys Hospital, Romania
Helmuth Billy MD
Ventura Advanced Surgical Associates, California
This section highlights a debate between Dr. Patrick Noel (representing the BariClip) and Dr. Amir Aryaie (representing the Sleeve Gastrectomy). The commentary is by Professor Imran Abbas.
Dr. Patrick Noel:
The BariClip: a new concept. Can you please explain to us what is the BariClip? When was it FDA approved? When was it used first? And how many patients have had the clip already?
In a design that marries the best qualities of the SG with the AGB, the BariClip (BC) is a removable medical device that is placed vertically parallel to the lesser curvature (Table 1), separating the stomach into a restricted medial segment where food passes and into an excluded larger lateral gastric segment. However, unlike the band which is placed horizontally, the BC decreases oral intake by restriction not obstruction, and the BC requires no maintenance or adjustments. Also, unlike the sleeve, it is reversible, and is placed without the use of staples and without removal of any tissue. Unlike both, the SG and the AGB, the BariClip causes minimal reflux.
The BC (Fig 1, 1a, 1b) consists of a silicone covered titanium backbone with an inferior flexible hinged opening that separates a medial lumen from an excluded lateral gastric pouch. The inferior opening allows the gastric juices to empty from the fundus and the body of the stomach into the distal antrum. It measures 14.5 cm in length, has a 2.5 cm inferior opening, and fits through a 12 cm trochar when opened flat.
BC is CE approved and the FDA trial will start soon.
It was used first on human 6 years ago and today over 200 patients have a BC.
When do you offer the BariClip to patients? What are your indications? And contraindications?
The BariClip, today, is intended for patients with lower BMI’s in the range of 30-45. Anyone without previous gastric surgery, without hx of ulcer disease, severe gastritis (after failed treatment), or allergy to Titanium or Silicone can be considered a candidate for the BC
What is the safety profile and what are the potential complications?
The major 2 complications that have been reported are slippage and erosions. Slippage rate is approximately 2-3%, erosion rate is about 1%. All erosions have been associated with a history of slippage.
Reflux has only been reported in the first few weeks after placement, and in patients with slippage. On the other hand, it appears that placement of the BC may significantly improve reflux. A hiatal hernia may also be repaired at same time of BC placement.
What is the long term data or the data available thus far in regards to weight loss and resolution of comorbidities?
3 year data shows a 50-60% EWL with an improvement of comorbidities
Have you had to do any revisions after the BariClip? And why? Do you believe the clip makes revisional surgeries harder (as any foreign object)?
To date we have little data with revisional surgery. When a slippage or erosion has been diagnosed, the BC is usually removed because of protocols. The stomach normalizes very quickly after removal, and the inflammatory reaction has only been severe (enough to prevent conversion to another procedure) when there has been a gastric outlet obstruction.
The sleeve is now performed in 70% of the bariatric cases in the US. Do you think it is going to be hard to popularize a sleeve mimicking device at this point?
The BC can be placed on an ambulatory setting, with very low risks of acute complications after placement: only acute gastric outlet obstruction requires semi-emergent surgery and patients are not septic. The BC doesn’t cause reflux and appears to resolve it, maybe becoming an indication for these patients.. Because of it’s gentleness, the BC can be placed in lower BMI patients, and in younger and older patients. There also appears to be a significant failure rate in sleeves requiring revisions—the BC may become the first procedure, and if it fails convert to sleeve.
The sleeve gastrectomy is restrictive and hormonal (decreased ghrelin). How can the BariClip achieve similar weight loss with sleeve if it is purely restrictive?
Studies are being performed to develop the accurateness of this statement. However, data shows that Ghrelin effect disappears in sleeve patients within 1-2 years, turning the sleeve into only a restrictive procedure too.
A lot of the comments on the IBC Facebook Group platform are questioning if the BariClip is the new gastric band. Is it? Should we except erosions and slippage?
What problems does the BariClip solve that the sleeve does not? Is the leak rate zero with the clip? What about weight regain? Reflux?
The current leak rate is zero with BC
Our data is too small and short with time to conclude but like with all type of procedures (AGB, LSG, RYGB …) we will see WR.
Dr. Amir Aryaie:
Sleeve Gastrectomy. Can you share with us what are the technical details of how you perform your sleeve? Distance from pylorus? Bougie size? Reinforcement? Leak test?
I typically use a 40 French bogie (ViSiGi) to size my sleeve gastrectomy. After taking down the short gastrics with a ligasure device, I then start stapling 3 to 5 cm from pylorus. I pay close attention to avoid any narrowing at incisura. Then stay close to the bougie as I staple and ensure the entire fundus of the stomach is included. I use reinforcement for the entire staple line. Obviously if there is any hiatal hernia present, then it would be repaired at the same time. I perform a leak test with an EGD at the end of the case.
What are the indications for Sleeve Gastrectomy in your practice and what are the contraindications?
In my practice, indication for gastric sleeve would be a BMI greater than 35 with comorbidities of obesity or anyone with a BMI of 40 and higher without comorbidities. Obviously, laparoscopic sleeve gastrectomy has gained even more popularity in the past few years. Over 80% of patients in my practice are asking for sleeve gastrectomy. It’s a safe operation, operative time is short (35 to 60 minutes average), it does not alter anatomy as compared to gastric bypass or duodenal switch, and there is less vitamin and mineral deficiency as compared to other options. Absolute contraindication for laparoscopic sleeve gastrectomy would be a poor candidate for surgery, any active cancer or patients who are undergoing chemotherapy, esophageal low grade or high grade dysplasia, and long segment barrett's esophagus. Relative contraindication would be a patient with severe reflux or short segment barrett's esophagus on preoperative endoscopy. As a general rule, any patient with severe reflux or Barrett’s esophagus will receive gastric bypass in my practice.
How much excess weight loss should the patient expect with Sleeve? What about resolution of comorbidities?
I would expect to see 50% to 70% EWL within 1 to 2 years. Profile for resolution of comorbidities for laparoscopic sleeve gastrectomy is actually very good. Based on STAMPEDE trial published in 2017 in New England Journal of medicine, sleeve gastrectomy may not be as good as gastric bypass for diabetes, but for a patient with borderline diabetes and someone that may not require as much insulin, it can give excellent results (1). Most studies showed comparable results for resolution or improvement of obesity comorbidities such as sleep apnea, hyperlipidemia, hypertension, or musculoskeletal disease, when compared to gastric bypass (2).
Weight regain in sleeve is a problem that is and for some reason, not highlighted on in most of the sleeve studies. Do you see that in your practice? How often?
Weight regain can certainly be a challenge with sleeve as compared to gastric bypass or duodenal switch, especially at the 5 year follow up. However, it can still happen with any bariatric operation if the patient is not followed long term and eating behavior is not controlled. At 2 years, 50% of patients in my practice may gain 5 to 10% of their total weight loss. Based on published data and systemic review rates, regain can range from 5% at 2 years to 75% at 6 years. Casella et all reported EWL of 67% at 6 year follow up, among 148 patients (3). Similarly, Juodeikis et al published similar data from a systemic review showing 62.5% EWL at 11 years (4). Thus, sleeve gastrectomy seems to have good profile for EWL so far. Majority of weight regain can transpire from changing eating behavior and possibly stretching the sleeve. Most of the weight regain happens in patients with inadequate follow-ups with the bariatric team. As a comprehensive bariatric center and bariatric team, we strive to maintain long term follow ups to prevent weight regain. We need more long term data and publication on longevity and durability of sleeve gastrectomy at 15 to 20 years. However for some patients, revisional surgery will be needed for weight regain, as it can happen with any other bariatric surgeries.
De novo reflux post sleeve and the high risk of post sleeve Barret’s has been reported in many studies. Does this make sleeve a bad operation?
I don’t necessarily think that makes it a bad operation. Most weight loss surgeries can have side effects, such as internal hernias, vitamin deficiency, and in case of sleeve gastrectomy possible worsening reflux and possible higher rate of barrett’s esophagus (BE). Incidence of BE after gastric sleeve has been reported anywhere from 1% to 18%. A most recent study from Sebastianelli et al, published in Obesity Surgery May 2019, reported 18.8% prevalence of BE among 90 patients with 78±15 months follow up(5). However, weight loss failure was significantly associated with BE (P< 0.01). Reflux and BE is multifactorial and we still don’t know the exact pathophysiology for higher incidents of BE with gastric sleeve. Perhaps better patient selection, repair of hiatal hernia, close monitoring, and persistent follow ups may reduce prevalence of BE and help with early detection of BE for intervention. As a general rule, BE is relative contraindication for sleeve gastrectomy in my practice. We also need to remember the risk of developing esophageal cancer in patients with BE is quite low, approximately 0.5% per year. However, for every 5 unit increase in BMI there is a 29% increase risk of coronary heart disease (6), and average increase in all-cause mortality of 30% (7). Therefore, given the safety profile of sleeve gastrectomy, its benefits outweigh the side effects, such as BE.
If cases of esophageal cancer get reported after sleeve, would you stop offering it to your patients?
If large populational studies show a higher rate of esophageal cancer incidents in patients who underwent sleeve gastrectomy, then I would be hesitant to offer this procedure to my patients. So far I am not aware of any studies that reported higher rates of esophageal cancer in patients who underwent sleeve gastrectomy. Aside from a few case reports, there is no large study to prove this. In general we know that there is a relationship between obesity and certain cancers. There seems to be a lower incident of all cancers reported in patients who undergo bariatric surgery compared to patients who remain obese.
Sleeve leaks and although rare, are very hard to manage. Why would you not use a device like BariClip that potentially has minimal chance of leak and is reversible?
I agree that sleeve leaks can be difficult to manage. Based on published data, the incident of sleeve leak is between 0.5% to 7%. More acceptable leak rate for primary index sleeve gastrectomy is less than 1%. I suspect incident of leak has and is going to decrease over time as we are getting more experienced with this procedure and stapler technology is improving. We also have learned to manage gastric sleeve leaks safely and effectively, with tools such as stent, endo-VAC, and double pig tail, depending on the situation and patient presentation. Currently BariClip is not available in the United States and it is in its infancy stages as compared to data available for sleeve gastrectomy. We need longer follow ups and data to evaluate long term safety, effectiveness, and feasibility of BariClip. Data published by Jacobs et all showed 66% excess weight loss which is comparable to sleeve gastrectomy (8). However, 2 patients out of 117 had their implanted clips removed due to displacement. I wonder if we would eventually see similar complications of laparoscopic gastric band with this device, such as erosion, infection, displacement, and gastric outlet obstruction.
If BariClip proves its efficacy and a good safety profile, what would prevent it from becoming the best “restrictive” operation instead of the sleeve gastrectomy?
Perhaps we have to wait for that data before debating over this question. If data becomes available for 10 to 15 years post implantation of BariClip, that proves its efficacy and safety then the only hesitation from the patient standpoint would be living with a foreign body or implant.
Commentary by Dr. Imran Abbas
The ongoing debate comparing BariClip and Sleeve Gastrectomy continues to be topical; both procedures are restrictive. The weight loss results and metabolic effect of both techniques are about same. Limitations of both techniques BC and Sleeve gastrectomy like previous gastric surgery, hx of ulceration, severe gastritis is also same.
Heterogeneity exists for sleeve gastrectomy with variation in technique like size of bougie, distance from pylorus, distance from EG junction, hiatal repair ,reinforcement of stapler line, omentopexy etc. That cause different results after sleeve gastrectomy but in BariClip there is no such a heterogeneity and indicated only for low BMI(30-45),with a standardized size (14.5 cm length with 2.5 cm inferior opening).
In discussion about BariClip complications, Patrick Noel has mentioned early and late complications like early reflux in the first few weeks ,slippage and erosions of BariClip like gastric banding. In discussion about complications of sleeve gastrectomy, Amir Aryaie ,has mentioned early and late complications like, leak, Barret’s(1-18%),weight regain(>75% after 6 years) and majority of weight regain is due to stretching of sleeve.
Sleeve gastrectomy is most popular bariatric surgery procedure at the globe with a history of more than 20 years. We know short and long term complications of sleeve gastrectomy as well as management of such a complications. Regarding BariClip that is apparently new procedure but has complications like gastric banding a procedure with its notorious complications like slippage and erosions but at limited area due to its small size. BariClip will face same notorious complications erosions, slippage and adhesions with wide range and strong adhesions with retrogastric area especially with pancreas. Due to lot of adhesions after BariClip revisional surgery will be a challenge especially dissection of retrogastric area.
Barret,s after sleeve gastrectomy is a serious concern, There are multiple factors causing BE after sleeve but main factor is migration of sleeve gastric tube to mediastinum, In BariClip there is no chance of gastric tube migration and also much less chance of GE reflux and Barret’s esophagus, As mentioned by Patrick Noel BariClip may significantly improve reflux. That may be a game changer in near future especially as a restrictive procedure without GE Reflux. We have a long term experience of gastric banding and now we are experiencing band for different bariatric surgeries like banded sleeve, banded RNYGBP, banded OAGB etc.
Bariatric surgery is still in evolutionary stage and we must respect all types of Bariatric Surgeries with their complications and benefits. BariClip due to its easy technique, less physiological intervention and less restrictive procedures complication like GE Reflux(BE) and leak may be more popular as a restrictive procedure especially in low BMI, adolescents and elder patients with more comorbidities(Cleveland Metabolic Surgery Score with points 100-200). Perhaps we have to wait for more data about BariClip.
Patrick Noel MD
MedClinic Parkview Hospital
Amir Aryaie MD FACS
Assistant Professor of Surgery
Texas Tech University, Texas
Imran Abbas MD FACS
Iranian Hospital Dubai
Revisional bariatric surgery is the third most common bariatric surgery in the US after sleeve gastrectomy and gastric bypass. The authors extrapolated data covering 2 years from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database to compare laparoscopic revisional weight loss surgery (LRWLS) and robotic revisional weight loss surgery (RRWLS). Of the total of 37,917 patients who required revision after undergoing a bariatric procedure, 94.9% (n = 35,988) were LRWLS, and 5.1% (n = 1929) were RRWLS. Baseline demographics were comparable of both groups. RRWLS had significantly longer operative time (167 min vs 103 min) and interestingly also higher length of stay (2.3 days Vs 1.7 days) compared to the LRWLS group. The post-operative complications were comparable in the two groups. They concluded that RRWLS is as safe as LRWLS.
Clapp B, Liggett E, Jones R, Lodeiro C, Dodoo C, Tyroch A. Comparison of robotic revisional weight loss surgery and laparoscopic revisional weight loss surgery using the MBSAQIP database. Surg Obes Relat Dis. 2019 Mar 22.
First, congrats on the study. What made you tackle the issue of robotic versus laparoscopic revisional bariatric surgery?
I was trained on the robot in my fellowship (back in the old days when we had to wind the rubber bands ourselves). Half of my bypasses were straight stick and I found them more enjoyable and quicker. The cost and time was also an issue and the robot has its own learning curve. So when I would hear surgeons say “I like it for revisions” that didn’t make any sense. Revisions are more difficult than primary cases so to only use it in selected (more difficult) cases when it’s not used for primary cases by the same surgeon is a recipe for disaster. But that was only my opinion so I wanted to look at the MBSAQIP to become more informed.
Can you reflect on the high revisional rates in bariatric surgery in the 2015-2016 MBSAQIP database (11.9%). How are these cases subdivided?
This paper does not really break down the cases by type. It’s actually hard to determine what constitutes a revision. We used the tag REV_CONV and PREVIOUS_FOREGUT_SURGERY and that gave us our study group. That is the 11.9%, third most common reported operation(s) in the MBSAQIP. However, I did submit an abstract to ObesityWeek this year in Vegas and found that about 26% of revision patients are band removals, 28% are band to sleeve, 19% are band to bypass, and 14% are unlisted. These are likely band to sleeve. These are the aggregate numbers for the years 2015-2017 using the MBSAQIP.
The robot has been in use for years now. What is your comment on the fact that the robot is only used in 5.1% of the revisional bariatric cases (versus 94.9% use of laparoscopy)?
Others have published on the MBSAQIP and robot. Higgens et al looked at 2015-16 MBSAQIP and found a rate of 6.7% robotic cases for primary bariatric surgery. This would indicate that those are probably the same surgeons. However there is a lack of granularity in the MBSAQIP database and we did not determine this.
You have noted that there is an increased operative time and length of stay with robotic revisional bariatric surgery with no difference in complication rates between the two groups. Do you believe that this is only due to the learning curve of the robotic platform or these results may always be like this?
The learning curve could partially account for that. There were 1929 patients that had a robotic revision, but we didn’t look at individual surgeon volume. With a sample of patients and surgeons of this size, the percentage of surgeons still in their learning curve is probably small. However, the MBSAQIP cannot specifically address learning curves. I do discuss that in the discussion and review the published literature on that.
If there is no shown advantage of robotic versus laparoscopic, why should surgeons attempt the usage of the robot in these cases?
I feel that most of the time they should not. If they are a surgeon well trained and experienced in robotics, then yes, they should tackle these cases. I think one of the take home points is that this should not be “dabbled in” and the surgeon should not make the mistake of thinking the robot will allow them to do something they couldn’t otherwise do. It is a not a replacement for sound surgical judgement or experience.
Do you use the robot yourself for your revisional bariatric cases? And if yes, would the results of your study change your practice? Should they change other surgeons’ practices?
No. It will not change my practice and I have fallen away from using it altogether. Other surgeons have become experts in robotic surgery and that is just their preference. If they can safely and efficiently do robotic surgery, then they should. But I do not think the robots time and cost are justifiable in today’s climate and I address some of these issues in the Discussion section. Despite the company’s claims, the cost is never recovered.
Ben Clapp MD FACS
Associate Clinical Professor of Surgery
Texas Tech School of Medicine Texas
Ben Clapp MD FACS Associate Clinical Professor of Surgery Texas Tech School of Medicine Texas
Hypoproteinemia and chronic diarrhea are a concern after Single Anastomosis Duodeno-ileal Bypass – Sleeve Gastrectomy (SADI-S). The authors present their experience from a single center in USA to treat these with common channel lengthening (CCL). It is a surgical procedure to increase absorption in the small intestine to decrease diarrhoea. The operative time was a modest 56.5 minutes. The mean bowel movements reduced significantly to 2.6 times a day from 9.1 times a day after reconstruction. Protein level were improved in the 2 patients who experienced hypoproteinemia. They conclude that when medical therapy fails in patients with SADI-S, CCL can be successful to alleviate these problems.
Horsley B, Cottam D, Cottam A, Cottam S, Zaveri H, Surve A, Medlin W1. Bowel Reconstruction to Treat Chronic Diarrhoea and Hypoproteinaemia Following Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy: A Single-Site Experience. Obes Surg. 2019 May 18. doi: 10.1007/s11695-019-03847-y.
The authors hypothesized that surgeon factors are responsible for sleeve gastrectomy being the number one performed procedure in the world. With the aim to determine the distribution of bariatric procedures performed at the surgeon level they performed population-level analysis using the State-wide Planning and Research Cooperative System (SPARCS) for a decade. Logistic regression was performed to determine the impact of surgeon, patient and hospital factors on receiving a RYGB. If a patient had diabetes (odds ratio 1.45) or gastroesophageal reflux disease (OR 1.36), the chances of him receiving a RYGB were higher. Interestingly, the most correlated factor was whether the surgeon had a RYGB case volume >66th percentile in the preceding year (OR 33.8). They concluded that there was wide variation at the surgeon level with a significant proportion predominantly performing a single procedure and surgeon factors were strongly correlated with procedure selection compared to patient or hospital factors.
Udelsman BV1, Jin G2, Chang DC3, Hutter MM3, Witkowski ER. Surgeon factors are strongly correlated with who receives a sleeve gastrectomy versus a Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2019 Mar 26. pii: S1550-7289(19)30105-4.
Using the National database, the authors analysed patients with a principal discharge diagnosis of acute MI (n=2,218) and patients with ischemic CVA (n= 2,168), both of who also had history of prior bariatric surgery. These patients were matched 1:5 with patients who had same diagnosis but without bariatric surgery (Control group). The control group was further divided into 2 sub-groups. Control group-1 included patients with obesity (BMI ≥35 kg/m2) only and control group-2 were matched according to post-surgery BMI with the bariatric surgery group. A total of 48,300 (weighted) patients were analysed. Mortality rates after MI were significantly lower in patients with a history of bariatric surgery compared with control group-1 (1.85% vs 3.03%) and control group-2 (2.00% vs 3.26%). Mortality rates after CVA were also significantly lower in patients with prior history of bariatric surgery compared with control group-1 (1.43% vs 2.74%) and control group-2 (1.54% vs 2.59%). Length of stay was significantly less in the bariatric surgery group for all comparisons. The authors concluded that bariatric surgery has protective effect and improves survival after MI and stroke.
Aminian A, Aleassa EM, Bhatt DL, Tu C, Khorgami Z, Schauer PR, Brethauer SA, Daigle CR. Bariatric Surgery is Associated with a Lower Rate of Death after Myocardial Infarction and Stroke: a Nationwide Study. Diabetes Obes Metab. 2019 May 3. doi: 10.1111/dom.13765.
The authors studied a total of 4330 patients from a state-wide database who needed removal of their adjustable gastric band (AGB) and had either simultaneous or two-stage gastric bypass (RYGB) or sleeve gastrectomy (SG) performed. The aim was to study the safety profile of one stage or two stage operation. They noted 9.1% complications, 6.42% readmissions and 13.6% ED visits. Three hundred sixty-seven matched pairs underwent RYGB; single-stage patients experienced significantly shorter length of stay (LOS), less complications, less readmissions and ED visits. Eight hundred seventy-five matched pairs underwent SG; single-stage patients experienced improved outcomes in all parameters analysed. For 809 pairs single-stage procedures, RYGB had longer LOS, and more complications, but had similar readmissions and ED visits. They concluded that conversion to SG was safer compared to conversion to RYGB and one stage conversion had lower morbidity compared to two stage operation. Overall conversion from AGB to RYGB or SG has low morbidity.
Spaniolas K, Yang J, Zhu C, Maria A, Bates AT, Docimo S, Talamini M, Pryor AD. Conversion of Adjustable Gastric Banding to Stapling Bariatric Procedures: Single- or Two-stage Approach. Ann Surg. 2019 Apr 13. Epub ahead of print.
Morbidly obese patients with end stage renal disease (ESRD) need to be < BMI 35 kg/m2 to be eligible for renal transplantation. The authors wanted to establish whether Sleeve gastrectomy or RYGB operation is the best choice in this cohort to achieve weight loss before becoming eligible for renal transplantation. Markov state transition model was created to simulate the life of a morbidly obese patients with BMI 45 kg/m2 with ESRD who were ineligible for renal transplantation. Sensitivity analysis of initial BMI was performed. Life expectancy following medical weight management (MWM), RYGB and SG were estimated. They concluded that RYGB had higher rates of transplantation and improved survival compared to SG and MWM. RYGB patients gained 1.3 and 2.6 additional years of life compared to patients who had SG and MWM respectively. They questioned suitability of SG in this group of patients.
Choudhury RA, Hoeltzel G, Prins K, Chow E, Moore HB, Lawson PJ, Yoeli D, Pratap A, Abt PL, Dumon KR, Conzen KD, Nydam TL. Sleeve Gastrectomy Compared with Gastric Bypass for Morbidly Obese Patients with End Stage Renal Disease: a Decision Analysis. J Gastrointest Surg. 2019 May 1. doi: 10.1007/s11605-019-04225-w. [Epub ahead of print]