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) outlined some of the myths surrounding the LAP-BAND. The session was introduced by Mr Vernon Vincent, LAP-BAND Clinical Specialist and Medical Affairs of ReShape Lifesciences™, who outlined some of the prior strategies utilized by the various previous owners of the device, and the company’s strategy to revive the product.
“The popularity of the LAP-BAND suffered because of a lack of focus by multiple previous owners on the benefits of the device, including minimal sales representation, limitations on clinical support, initially intense advertising and direct-to-consumer marketing, then a near total cessation of marketing and advertising. This occurred currently with the growth of alternative procedures 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, is FDA approved and has insurance reimbursement. He emphasised that unlike the previous owners, as a surgery-focused company, ReShape Lifesciences is completely dedicated to promoting the LAP-BAND and the company’s experienced leadership will drive the future direction for the device.
“Our strategy is twofold, firstly we will re-invest our focus on our customers by increasing sales and field support with an emphasis on the provision of comprehensive band aftercare, drive patient awareness of the LAP-BAND by embracing digital marketing and social media and promote the device via targeted advertising. Secondly, on a clinical standpoint, ReShape Lifesciences will drive clinical research and evidence-based promotion, provide our customers with access to integrated patient aftercare support and seek greater assistance for patients including reimbursement approvals.”
The Truth about LAP-BAND
Next, professor Chevallier and professor Greve outlined some of the common myths regarding the LAP-BAND and presented the 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, with the 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.
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 and 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 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 five years with an explant rate of 8.74%.
“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 and higher band placement just below the GE junction to produce a virtual pouch, as well as surgeons switching to the upgraded AP LAP-BAND, also helped to reduce removal rates.”
For example, he 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, because he has continuously modified his centre’s after-care protocol including increasing the frequency of patient follow-up. He also refined his adjustment technique, so patients could eat smaller volumes, but more often, as well as utilising best-practice ‘learned’ experiences from other successful band programmes, both in US and internationally.
Professor Greve began his presentation by stating that there is a misconception that the LAP-BAND does not work and results in poor long-term weight loss, and the procedure is not as good as sleeve gastrectomy or gastric bypass procedures.
“However, we must remember that ‘One-size doesn’t 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 (Figure 1) and mortality among the approved bariatric procedures, reduces comorbidities (Figure 2) and has the lowest risk for vitamin/mineral deficiencies.”
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 range 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).
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 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’ less invasive procedures, such as gastric balloons and endoscopic procedures, 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 negative social media and HCP commentary and a lack of continuing education of surgeons and staff. “But the evidence shows that the reasons there has been a decline in patient’s requesting the band is due to reduced advertising, minimal social media and digital marketing, poor search engine optimisation, increased promotions of alternative procedures, inaccurate information about the LAP-BAND, a reluctance by surgeons to defend the band and a significant reduction in the number of surgeons trained over the few years.”
Professor Greve said the solution was for surgeons who are experienced in 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 greater options to patients.
“The final myth is that LAGB is not a metabolic procedure,” he added. “But, what are the effects bariatric procedures? They reduced calorie/carbohydrate intake, reduced glucose load, result in weight loss, as well as 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 cause and is merely a tool to lose weight, and that the failure of the technique results in weight regain and deterioration of metabolic disorders, and the long-term results for type 2 diabetes depend on weight loss.
He said that the evidence demonstrates that 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, on almost all cardiovascular parameters, but that there was no difference 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. The LAGB demonstrated a durable weight loss with 47% EWL maintained to 15 years and the systematic review shows substantial and similar long-term weight losses for LAGB and other bariatric procedures.