Lap Band Long-term Outcome: A New Study from Switzerland

A well conducted study by a group of Swiss surgeons was recently published in Surgery for Obesity and Related Diseases (SOARD). A total of 405 Lap Band patients were retrospectively analyzed using prospectively collected data. The follow up rate was 85% and ranged from 8 to 18 years. One hundred patients exceeded 15-year follow-up.

The authors found that the majority of patients lost their band due to band intolerance defined or band slippage. Band intolerance occurred when patients developed reflux, dysphagia, food intolerance and abdominal pain not improving with band adjustment. Around 30% of evaluated patients maintained their bands and 15% of 334 patients had good to excellent weight loss outcomes.

The authors conclude that adjustable gastric banding should no longer be offered to obese patients. The evidence they present is the last nail in the Lap Band coffin. This is an important study with excellent long-term follow up rate. A restrictive device applied on the stomach to force patients to eat less and result in durable weight loss is a naïve assumption. Obstructing or restricting esophageal outflow can only result in complications like heartburn, food regurgitation, esophageal dysmotility and dilation. I have managed a number of Lap Band cases with significant esophageal dysmotility requiring complicated surgical repair and conversion to gastric bypass to remedy the condition.

Lap Band surgery, a procedure that had been rapidly and irrationally adopted, has failed as a bariatric and metabolic procedure. It is time for the FDA to withhold the device from the market. ASMBS has yet to publish a clear statement on Lap Band complications and ineffectiveness as a weight loss procedure. The evidence is overwhelmingly strong against Lap Band usage. I don’t see any indication for Lap Band use in our fight against obesity.

Adjustable Gastric Band Reoperation Cost

I read with great interest this large retrospective study, titled “Reoperation and Medicare Expenditures After Laparoscopic Gastric Band Surgery” that was recently published in JAMA surgery. The authors analyzed the outcomes of 25 042 obese Medicare patients who underwent gastric band surgery between 2006 and 2013. They found that 20% of analyzed patients underwent gastric band related revision procedure at a staggering cost of 224 million dollars. Of note, during the study period, Medicare paid $470 million for laparoscopic gastric band–associated procedures. Reoperations included band removal, band replacement or revision to a different bariatric procedure like gastric bypass or sleeve gastrectomy. 80% of the reoperations were elective suggesting that weight loss failure or development of severe GERD rather than acute band slippage were the main cause for revision.

The study highlights the long-term complication rate of adjustable gastric banding and associated cost. The results are no surprise to the majority of bariatric surgeons in Houston, TX. Indeed, adjustable gastric band surgery is no longer performed in Houston. Band removal for weight loss failure and intractable GERD is the main band related operation we currently perform at Houston Weight Loss Surgery Center. Most band patients referred to our practice have gastric pouch and esophageal dilation as well as hiatal hernia leading to severe acid reflux disease.

Gastric band was developed based on the assumption that gastric volume reduction by itself results in durable weight loss. This erroneous assumption has been largely debunked by multiple studies showing that obesity is a hormonal disorder. Effective weight loss surgery like sleeve gastrectomy alters some of these hormones leading to durable weight loss. Surprisingly, some bariatric surgeons still advocate the use of gastric banding like Jon Gould, MD who wrote an invited commentary to this study titled “Considering the Role of the Laparoscopic Adjustable Gastric Band: Do Not Throw the Baby Out with the Bathwater”. He argues that gastric band surgery still has a role to play in bariatric surgery. According to Dr. Gould it takes a committed bariatric surgeon and equally committed patient for gastric banding to succeed. They say old habits die hard and despite the overwhelming evidence regarding obesity pathophysiology bariatric surgery mechanism of actions some surgeons still linger in the past. Neither patient will power nor bariatric surgeon commitment can reverse the complex neuro-hormonal disorder that lead to fat accumulation. These false assumptions that are still being used to push for procedures like gastric balloon and endoscopic sleeve gastropalsty no longer have a place in a twenty first century bariatric and metabolic surgery practice. So, let’s throw this baby out for good, with its bathwater, and save our patients unnecessary complications and disappointment. There is no role for gastric banding in any obese patient population. It is time for the FDA to withdraw its approval of such a device.

Case of The Week: Lap Band and Pseudo-achalasia

Adjustable gastric banding results in the formation of a thick fibrous capsule around the distal esophagus. In most cases the capsule is around 3 to 4 mm in thickness and spontaneously resolves after band removal. The patient I am presenting in this blog developed a thick fibrous capsule following lap Band placement measuring more than one cm in thickness. She is 30-year-old female with BMI=55 who presented to my office for evaluation of failure to lose weight 3 months after lap band placement at an outside institution. Her initial bariatric surgeon has attempted several times to adjust her band. Each adjustment had resulted in obstructive symptoms including nocturnal cough, food regurgitation, vomiting and inability to tolerate regular diet. The band was completely emptied and the patient was recommended lap band removal.

Prior to band removal, an esophagogram showed a dilated and tortuous esophagus with distal tertiary esophageal contractions. Contrast emptying from the esophagus into the stomach was delayed and incomplete. The lap band was in good position. There was evidence of narrowing of the distal esophagus at the level of the band. Esophageal manometry showed 90% failed contractions, weak contractile wave amplitude and decreased distal contractile integral. Residual lower esophageal sphincter pressure was slightly elevated at 17 mmHg while basal lower esophageal sphincter pressure was within normal. These findings are consistent with esophageal outflow obstruction. Weak contractions are either the result of prolonged esophageal outflow obstruction or intrinsic esophageal motility disorder. The patient may also evolve into achalasia with absent peristalsis and failure of the lower esophageal sphincter to relax. Currently, however, she does not meet the diagnostic criteria for achalasia.

The decision was made to remove the lap band and associated fibrous capsule as a possible cause of lower esophageal partial obstruction. Intraoperatively, a thick fibrous capsule, measuring more than one cm in thickness, was noted around the distal esophagus. The capsule was easily dissected off the esophageal wall and most of the anterior capsule was resected. Intraoperative endoscopy revealed a patent GEJ.

6 months after band removal, repeat esophagogram and manometry showed resolution of distal esophageal tertiary contractions, improvement in esophageal dilation, mild distal esophageal narrowing, and increased contractile wave amplitude and normal residual lower esophageal pressure. Patient subsequently underwent sleeve gastrectomy. Inspection of the GEJ revealed no residual fibrosis that might have prevented proper tissue stapling.

This case represents an unusual fibrotic reaction to Lap Band placement. The fibrous capsule that developed over a short period of time, has resulted in a pseudo-achalasia. Esophageal outflow obstruction led to nocturnal cough and food regurgitation that prevented band adjustment and possible weight loss. Performing a concomitant sleeve gastrectomy at the time of band removal might have been possible after capsulotomy. However, waiting 6 months and allowing the tissue to heal and recover prior to stapling is associated with a lower leak rate and better outcome.

Long-Term Outcomes of Lap Band Surgery: The Big Lesson

Fabrizio Vinzens et al have recently published a study titled “Long-term outcome of laparoscopic adjustable gastric banding (LAGB): Results of a Swiss single-center study of 405 patients with up to 18 years follow-up”. The follow up rate was 85%. Follow up duration ranged from 8 to 18 years after Lap Band placement with one hundred patients exceeding 15 years in follow up. During this long-term follow-up 71% of adjustable gastric bands were removed. Most these patients were converted to sleeve gastrectomy, Roux-en-Y gastric bypass or duodenal switch. 29% this patient cohort still has their band in place and half of them report good to excellent outcome. Overall, 15% of the total patient population has benefited from Lap band surgery.

In my opinion, this is the best published long-term study on adjustable gastric band surgery outcome. The authors have clearly and objectively demonstrated, over an impressive mean follow up of 13 years, that lap band surgery is not an effective and durable weight loss procedure. Most importantly, the study reinforces the now established concept of metabolic surgery: mechanical restriction by itself, a naïve assumption adopted by many bariatric surgery pioneers, is not an effective weight loss solution. Yet, the FDA continues to approve weight loss procedures like gastric balloon. Other innovators in the field, are still experimenting with various endoscopic techniques of gastric volume reduction like endoscopic gastroplasty. A few bariatric surgeons still perform gastric pouch and stoma reduction procedures for gastric bypass patients. Sadly, numerous publications of successful outcomes of such non-sense procedures continue to be published in SOARD and other bariatric journals. There was a devoted session at Obesity week this year in New Orleans about new techniques in bariatric surgery. All techniques centered around gastric volume reduction and all outcomes were described as excellent and promising. Lap band surgery results in the smallest possible gastric pouch and yet it has failed to achieve any durable weight loss for most obese patients. I think this study has clearly demonstrated the futility of restrictive weight loss procedures.
It is time we learn our lessons and move forward with a new vision based on facts and a clearer understanding of metabolic surgery. Research and funds in the fields of energy metabolism, nutrition and obesity must be streamlined and centered on one important concept: Stomach volume reduction resulting in calorie reduction and starvation is not an effective weight loss solution. Once we accept this established concept, we can focus our efforts at understanding bariatric surgery mechanism of action. This will allow us to develop new less invasive and more effective solutions. It may help us develop drugs for obesity treatment. Most importantly, knowledge and evidence based medicine will allow us to test a novel weight loss procedure prior to its approval and widespread application. For instance, if increased gastric emptying is a mechanism of action of a weight loss surgery then endoscopic sleeve gastroplasty that delays gastric emptying cannot be approved for weight loss. Many patients will be spared the disappointment and frustration of a failed bariatric procedure like the current study has shown with Lap band surgery.

Public Service Announcement from the American Society for Metabolic and Bariatric Surgery (ASMBS)

ASMBS has just announced that Ethicon Endo-Surgery will discontinue the production of Gastric Band device for weight loss. ASMBS and FDA continue to endorse gastric banding as a weight loss procedure. Adjustable gastric banding is rarely being performed these days in Houston and all over the country. The procedure that has gained so much popularity few years ago has proven to be an ineffective approach to durable weight loss. Gastric banding, a purely restrictive procedure, has become the ultimate proof that gastric volume reduction by itself is not a weight loss procedure associated with durable weight loss. Calorie restriction is no longer accepted as an effective weight loss solution.

Apollo Endosurgery, Inc. continues to manufacture the Lap Band device. ASMBS continue to endorse gastric banding as an effective weight loss procedure. I don’t have an explanation behind this endorsement. I think it is time for ASMBS to update their guidelines and save new patients from falling victims of a weight loss procedure that has proven to be not only ineffective but also detrimental to esophageal motility. Indeed, gastric banding results in dilation of the distal esophagus and hiatal opening. It damages esophageal motility and results in severe acid reflux disease. We continue to deal with lap band complications and frustrated patients on a weekly basis. Let’s stop the damage today.

The ASMBS holds a central role in guiding bariatric surgeons across the country and in educating the public on obesity treatment. The ASMBS ought to help develop novel effective and safe weight loss procedure while outdating and denouncing current weight loss procedures that do not work. Our knowledge of obesity and energy metabolism has greatly evolved over the past few years. We can no longer accept weight loss procedures based on wrong outdated assumptions from the past. Obesity treatment paradigms will continue to evolve and I wish ASMBS remains a leader in our field, approving the right weight loss procedures and disproving those that do not work.

Lap Band, Achalasia, and Severe Esophagitis

The first case of the week for 2017, is a 43-year-old female who underwent lap band placement in 2013 by an outside institution. She presented to my office with epigastric pain, heartburn, food regurgitation and nocturnal cough. Her band was adjusted up to 5 cc in during the initial first few month after surgery. It was completely emptied for obstructive symptoms. The patient continued however to have several GERD related symptoms including dysphagia. She was started on high dose proton pump inhibitors by her bariatric surgeon but her symptoms did not resolve. Following office consultation, I learned that the patient had dysphagia related symptoms prior to lap band placement.

I made the decision to start with an upper endoscopy and a contrast study to evaluate the distal esophagus, rule out band erosion, and check for a hiatal hernia.

The patient had evidence of severe distal esophagitis. Several linear ulcers covered with fibrinous exudates were found extending up to cm above the Z line. The hiatal opening was dilated and the gastric pouch above the band was quite enlarged. There was no evidence of band erosion. An esophagogram showed a very large gastric pouch with no band slippage. Contrast emptying from the esophagus into the stomach was significantly delayed suggestive of weak esophageal contractions. Interestingly, she had significant narrowing at the level of the gastro-esophageal junction where the lower esophageal sphincter is located independent of narrowing at the lap band level. The bird’s beak picture was suggestive of achalasia.

Esophageal manometry was performed and confirmed the diagnosis of type 1 achalasia. The combination of absent esophageal motility and tight lap band has led to severe acid reflux and esophagitis, as well as dysphagia. The dilated gastric pouch secreted enough acid that freely refluxed into the esophagus across the dilated hiatal opening. Due to esophageal dysmotility, mucosal acid exposure was significantly prolonged leading to ulceration. The patient was started on Carafate and instructed to continue PPI treatment. The band will be first removed hoping to decrease the esophageal inflammation prior to performing a Heller myotomy with Toupet fundoplication. Gastric bypass with Heller myotomy is also a valid option especially if the BMI is above 35. This patient has lost a total of 45 pounds since her initial lap Band surgery and is not interested in gastric bypass surgery at this point.

One Stage Gastric Band Removal and Conversion to Gastric Sleeve

Several studies have shown that a two-stage conversion of lap band to gastric sleeve is safer than a single stage approach. In the current issue of Surgery for Obesity and Related Diseases, a group of bariatric surgeons from Saudi Arabia demonstrate that a single stage approach is safe and effective. The study is based on a single-surgeon prospective database and included 209 band to sleeve conversions. Only one patient of the 209 conversions developed a staple line leak. Continue reading “One Stage Gastric Band Removal and Conversion to Gastric Sleeve”

Gastric Band Conversion to Sleeve Gastrectomy

Adjustable gastric banding, a purely restrictive procedure, is rarely performed these days. However, few years ago, it was a commonly performed procedure. Many Lap Band patients present to our Houston Weight Loss Surgery Center for revision surgery. Some have gastric band related complications like GERD or band erosion, while others have failed to lose weight. Continue reading “Gastric Band Conversion to Sleeve Gastrectomy”

The Gastric Fundus and Lap Band Removal

Last week I published a blog about acid reflux developing after gastric sleeve surgery in the setting of a hiatal hernia. Subsequently, I have received several questions from a number of followers and readers about acid reflux developing after Lap Band conversion to sleeve surgery. This is a very important topic especially that these days we are experiencing a high rate of band removal and conversion to other weight loss procedure for either worsening acid reflux related symptoms or failure to lose weight. Continue reading “The Gastric Fundus and Lap Band Removal”

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Lap Band Mechanism of Action and The Vagus Nerve

I read with great astonishment the newly published article in this month issue of SOARD titled “An investigation of the neural mechanisms underlying the efficacy of the adjustable gastric band”. The authors attempt to find an alternative mechanism of action besides mechanical restriction for the Lap Band. They rightly admit that restriction by itself does not lead to durable weight loss. Neuro-hormonal changes are the underlying mechanism for weight loss after gastric bypass and gastric sleeve surgery. Indeed, changes in Ghrelin, GLP-1 and PYY are the hallmark for successful metabolic procedures. However, no such changes have ever been demonstrated with adjustable gastric banding. This is most likely why Lap Band, as a weight loss procedure, has failed. Consequently, Lap Band has been reduced to a purely restrictive procedure, and rightly so, with poor long-term weight loss results. The assumption that filling the band with saline in order to “ optimize” restriction to controls hunger and promote weight loss has failed the test of time. This absurd assumption remains a painful reminder of how ignorant we were and how deficient our knowledge about obesity was just few years ago. Thousands of Lap Band patients have failed to loose weight. Many suffered from band related complications like erosion, slippage, esophageal dysmotility and dilation, acid reflux, aspiration pneumonia… in hopeless attempts to beat obesity and regain their healthy lives. This large-scale human trial, however, is still not enough for some Lap Band proponents and the company that manufactures Lap Bands. Continue reading “Lap Band Mechanism of Action and The Vagus Nerve”