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LAP-BAND Myths

Dispelling LAP-BAND Myths

At the recent XXIV IFSO World Congress in Madrid, Spain, Professors Jean-Marc Chevallier (Bariatric Surgeon at Hospital European Georges Pompidou, Paris, France) and Jan Willem Greve (Gastrointestinal and Bariatric Surgeon, Zuyderland MC, Heerlen, and Maastricht University Medical Center, Maastricht, the Netherlands) addressed some of the incorrect myths surrounding the LAP-BAND® System.

At the recent XXIV IFSO World Congress in Madrid, Spain, Professors Jean-Marc Chevallier (Bariatric Surgeon at Hospital European Georges Pompidou, Paris, France) and Jan Willem Greve (Gastrointestinal and Bariatric Surgeon, Zuyderland MC, Heerlen, and Maastricht University Medical Center, Maastricht, the Netherlands) addressed some of the incorrect myths surrounding the LAP-BAND® System.

The session was introduced by Mr Vernon Vincent, LAP-BAND Clinical Specialist and Medical Affairs of ReShape Lifesciences™, who outlined some of the prior misinformation generated under the watch of previous administration, and their company’s strategy to revive the product.

“The popularity of the LAP-BAND suffered due to a lack of focus from multiple organizations on the benefits of the device, including minimal field representation, limited clinical support, suspended professional education for new surgeons and a near total cessation of marketing and advertising.  This occurred concurrently with the growth of alternative procedures requiring less patient follow-up such as the sleeve,” he explained.

Despite the decline in procedure numbers, Mr Vincent explained that the LAP-BAND Portfolio remains unchanged – the device has nearly two decades of proven results with over 860,000 procedures performed and has maintained a strong safety profile.  Additionally, the technology has CE Mark, is FDA approved, and has insurance reimbursement. He emphasised what will be the difference in ownership this time and that as a laparoscopic surgery focused company, ReShape Lifesciences is fully dedicated to promoting the LAP-BAND and the company’s experienced leadership will drive the future direction for the device.

“Our strategy is straightforward, we will focus on our customers by increasing field support with an emphasis on facilitating comprehensive aftercare through access to integrated patient support resources. Our commercial team will drive patient awareness of the LAP-BAND by embracing digital marketing and social media to promote the device via targeted advertising for certified practices. On the clinical front, ReShape Lifesciences will provide enhanced professional education and drive correlated research to validate our evidence-based promotion.”

The Truth about LAP-BAND

Professor Jean-Marc Chevallier

Next, Professor Chevallier and Professor Greve outlined some of the common myths regarding the LAP-BAND and presented clinical evidence that contradicts these misconceptions.

“There are several myths surrounding the LAP-BAND that when compared to the evidence do not hold up to scrutiny, including; a large number of devices have been removed, banding does not work, patients do not want bands and that laparoscopic gastric banding is not a metabolic procedure. However, the evidence paints a different picture.”

Regarding device removal, Professor Chevallier cited one-year data from the Helping Evaluate Reduction in Obesity (HERO) Prospective Registry (Cobourn, Chris et al. Journal of the American College of Surgeons, Volume 217, Issue 5, 907 – 918), which reported outcomes from 834 patients who received  a LAP-BAND. The outcomes showed 39.8% EWL and 16.9% TBWL and overall BMI dropped from 45.1 to 37.7. The most common device-related complications were port displacement (n=20, 1.8%), pouch dilation (n=12, 1.1%), band slippage (n=7, 0.6%) and band erosion (n=5, 0.5%). Only 18 patients (1.6%) had the device explanted.

“Reasons for the lower explant rates have been attributed to appropriate band management with a focus on early satiation and prolonged satiety, rather than restriction/obstruction as the mode of action, with small adjustments made to maintain patients in the ‘’Green Zone’” 

Furthermore, five-year data report by John Dixon et al (LAP-BAND for BMI 30–40: 5-year health outcomes from the multicenter pivotal study. International Journal of Obesity; volume 40; 291–298 (2016), reported that the procedure was safe and effective for people with BMI 30–39.9 and  demonstrated improvements in weight loss, comorbidities and quality of life, with a low explant rate through five years following treatment (explants 2.7% at one- year; 5.4% at 54 months. Importantly, the authors noted that band removal was offered to patients at study exit.

An additional paper by Dixon et al (Health Outcomes and Explant Rates After Laparoscopic Adjustable Gastric Banding: A Phase 4, Multicenter Study over 5 Years. Obesity, 26: 45-52), which included 651 patients found that the mean total weight loss was 18.7% at two years and weight loss was maintained through to five years. All patient-reported outcomes showed improvement following banding treatment throughout the five years.

“However, we must remember that ‘One-size does not fit all’. If we look at the evidence it reveals that the LAP-BAND does not require cutting of the stomach or rerouting of the intestines, it is adjustable and reversable, results in the lowest rate of early post-operative complications and mortality among the approved bariatric procedures, has long term effectiveness, reduces comorbidities and has the lowest risk for vitamin/mineral deficiencies.”

“Reasons for the lower explant rates have been attributed to appropriate band management with a focus on early satiation and prolonged satiety, rather than restriction/obstruction as the mode of action, with small adjustments made to maintain patients in the ‘’Green Zone’,” explained Chevallier. “An additional procedural switch to the Pars-flaccida approach, higher band placement just below the GE junction to produce a virtual pouch and surgeons switching to the upgraded AP LAP-BAND also helped to reduce removal rates.”

As another example, he further cited a paper by O'Brien et al. (Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-Analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding. Obesity Surgery. 2019 Jan;29(1):3-14), that reported the systematic reduction of all complications with evolution of the procedure and device seen from the initial LAP-BAND (10.0cm band, n=1,658) to the AP LAP-BAND (n=1,896).  They also showed 48.9% EWL at 20 years in 35 patients with an overall erosion rate of 3.2%, which was initially 6% in 10.0cm band era, but reduced to less than 0.7% in LAP-BAND AP era. There was a zero-mortality rate from either primary or revisional procedures and the overall explant rate was 8.6% most commonly for food intolerance, not erosion.

In summary, Professor Chevallier said that since he was trained and proctored in 1996 to carry out LAP-BAND procedures, he has performed over 2,000 cases and his results show a low removal rate as he has continuously modified his centre’s after-care protocol, including the increased frequency of patient follow-up. He also refined his adjustment technique, allowing patients to eat smaller volumes more often, while continuously utilizing best-practice ‘learned’ experiences from other successful band programmes, both in US and internationally.

Professor Jan Willem Greve

Professor Greve began his presentation by stating that there is a misconception that the LAP-BAND does not work, resulting in poor long-term weight loss, and that the procedure is not as good as sleeve gastrectomy or gastric bypass procedures.

“However, we must remember that ‘One-size does not fit all’. If we look at the evidence it reveals that the LAP-BAND does not require cutting of the stomach or rerouting of the intestines, it is adjustable and reversable, results in the lowest rate of early post-operative complications and mortality among the approved bariatric procedures, has long term effectiveness (Figure 1), reduces comorbidities (Figure 2) and has the lowest risk for vitamin/mineral deficiencies.”

Figures 1 and 2

Furthermore, he added that several studies have demonstrated that the LAP-BAND offers several advantages to alternative procedures. For example, Elaine et al (Fracture Risk After Roux-en-Y Gastric Bypass vs Adjustable Gastric Banding Among Medicare Beneficiaries. JAMA Surgery 2019), highlighted that Roux-en-Y gastric bypass (RYGB) increased risk of non-vertebral fracture by 73% compared with adjustable gastric banding, and that sleeve gastrectomy failure rates, determined as the percentage of patients with a %EWL less than 50, were 13.3%, 21.1%, and 38.5% at one-, three- and five-years, respectively (Golomb et al. Long-term Metabolic Effects of Laparoscopic Sleeve Gastrectomy. JAMA Surgery. 2015). Moreover, weight regain after sleeve gastrectomy ranged from 5.7% at two years to 75.6% at six years (Lauti et al. Weight Regain Following Sleeve Gastrectomy - a Systematic Review Obesity Surgery (2016) 26: 1326).

“The final myth is that LAGB is not a metabolic procedure. But, what are the effects of bariatric procedures? They reduce calorie/carbohydrate intake, reduce glucose load, result in weight loss and affect positive changes in gut hormones (incretins), inflammatory mediators and adipokines.”

In a comparison of complications resulting from laparoscopic adjustable gastric banding (LAGB), RYGB and biliopancreatic diversion with duodenal switch, Manish et al (Objective Comparison of Complications Resulting from Laparoscopic Bariatric Procedures, JACS. 202; 2; 2006; 252-261), concluded that LAGB is the safest operation in terms of complication rate and severity when compared with RYGB or laparoscopic malabsorptive operations. Professor Greve said that the results so far indicate that ‘alternative’ endoscopic procedures, including gastric balloons, have temporary results and lower weight loss compared to LAGB.

“There is also a perception that patients don’t want the band,” which he suggested was brought about by negative social media, inexperienced HCP commentary and a lack of continuing education of surgeons and staff. “But the evidence shows that the primary reasons leading to the decline in patients requesting the band include; reduced advertising, minimal social media and digital marketing, poor search engine optimization, increased promotions of alternative procedures, unanswered inaccurate information about the LAP-BAND, a reluctance by surgeons to defend the technology and a significant reduction in the number of surgeons trained over the past few years.”

Professor Greve said the solution was for surgeons who are proficient with the LAP-BAND to share their experiences and get the truth out, reiterating that ‘One size does not fit all’ and that it was important that surgeons are able to offer a greater number of treatment options to patients.

“The final myth is that LAGB is not a metabolic procedure,” he added. “But, what are the effects of bariatric procedures? They reduce calorie/carbohydrate intake, reduce glucose load, result in weight loss and affect positive changes in gut hormones (incretins), inflammatory mediators and adipokines.”

He explained that although weight loss is the key to metabolic changes, bariatric surgery does not treat underlying causes and is merely a tool to lose weight with the failure of the technique resulting in weight regain and deterioration of metabolic disorders. The long-term surgical results associated with type 2 diabetes depend on sustained weight loss.

Greve further commented that the evidence demonstrates adjustable gastric banding is a metabolic procedure and cited a study by Scopinaro et al. (Biliary pancreatic diversion and laparoscopic adjustable gastric banding in morbid obesity: their long-term effects on metabolic syndrome and on cardiovascular parameters. Cardiovascular Diabetology; 8: 37. 2009), which compared the long-term effects of biliary pancreatic diversion (BPD) and LAGB procedures on metabolic and cardiovascular parameters, as well as on metabolic syndrome in morbidly obese patients. The results showed that BPD was more effective than LAGB on BMI and almost all cardiovascular parameters, but that there were no differences in effect on diabetes, hypertension and metabolic syndrome at 65 months of follow-up.

Finally, Professor Greve cited a study by O’Brien et al (Long-Term Outcomes After Bariatric Surgery Fifteen-Year Follow-Up of Adjustable Gastric Banding and a Systematic Review of the Bariatric Surgical Literature. Annals of Surgery. 257(1):87–94, January 2013), that reported the long-term outcomes (ten years) after LAGB and compared them with the published literature on bariatric surgery. This study showed greater than 50% EWL for all current procedures with the systematic review confirming substantial and similar long-term weight losses for LAGB and other bariatric procedures.

At the end of the presentations, the session included comments by prominent bariatric surgeons from around the globe confirming their personal corroboration of the data presented and the need for this information to be communicated in a broader format.  The attendees strongly reiterated the need for more anatomy-sparing surgical options to meet individual patient needs, and that while the LAP-BAND has decreased in use and support for reasons identified in the presentations, it has significant data validating its efficacy, safety and justification for increased clinical use.

ObesityWeek 2019

ReShape Lifesciences will be attending ObesityWeek 2019, taking place at the Mandalay Bay Resort in Las Vegas, Nevada, from November 3-7, 2019. The LAP-BAND® by ReShape Lifesciences™, which has nearly one million placements around the world, will be highlighted at the company's booth in the exhibit hall of the conference, where senior company representatives will be meeting with key clinical opinion leaders to discuss ReShape Lifesciences' commitment to its existing and emerging bariatric surgery technologies.  In conjunction with the conference, ReShape Lifesciences will be one of the sponsors of the ASMBS Foundation's 2019 Gala & LEAD Award Event and will present a special-invitation-only program that will review long-term data on the demonstrated safety and efficacy profiles of the LAP-BAND System. Details are below:
Tuesday, November 5
7:00 - 8:30 pm: "Dispelling LAP-BAND® Myths" Presented by Vincent Lusco III, MD, General and Bariatric Surgeon at LapBand of Louisville Surgical Associates and Keith E. McEwen, MD, Bariatric Surgeon at Community Health Network in Noblesville, Indiana. This session will be held at the Delano Hotel, 3940 S. Las Vegas Blvd. in Las Vegas, Nevada in the Indigo BC Room.

References for Figures 1 and 2

  1. Michaelson, et. al. Obesity (2013) 21:1148-1158
  2. Ray et. al. "Safety, Efficacy, and Durability of Laparoscopic Adjustable Gastric Banding in a Single Surgeon U.S. Community Practice." Surgery for Obesity and Related Diseases 7 (2011) 140-144
  3. O'Brien, Annemarie Hindle, Leah Brennan, Stewart Skinner, Paul Burton, et al. "Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-Analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding." Obesity Surgery. The Journal of Metabolic Surgery and Allied Care. Published online: 06 October 2018. https://doi.org/10.1007/s11695-018-3525-0
  4. Dixon et. al. "Marked Improvement in Asthma after Lap-Band Surgery for Morbid Obesity." Obesity Surgery, 9, 385-389
  5. Dixon et.al. "Health Outcomes of Severely Obese Type 2 Diabetic Subjects 1 Year After Laparoscopic Adjustable Gastric Banding." Diabetes Care 25:358-363, 2002
  6. Dixon et. al. "Sleep Disturbance and Obesity. Changes Following Surgically Induced Weight Loss." Arch Intern Med 2001:161:102-106
  7. Dixon et. al. "Gastroesophageal Reflux in Obesity: The Effect of Lap-Band Placement." Obesity Surgery, 9, 527-531