Advancements in Obesity Treatment for the Low BMI Patient Population: Part 2

| December 10, 2014

This column investigates current research in the surgical and clinical aspects of obesity treatment and educates bariatric care professionals on the most up-to-date information on emerging technologies in the field.

Part 2: The Outside the United States Perspective

An Interview with

Gontrand López-Nava, MD
Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain

Theodore Ngatchu, MD, FRCP
Consultant Gastroenterologist, London, United Kingdom

Funding: No funding was provided in the preparation of this manuscript.

Financial disclosures: Drs. López-Nava and Ngatchu have acted as independent consultants for ReShape Medical, San Clemente, California.

Bariatric Times interviewed Drs.López-Nava and Ngatchu, gastroenterologists practicing outside of the United States. Here, they share their perspectives on obesity treatment, especially in the low BMI patient population in their countries. They discuss minimally invasive treatment modalities, such as adjustable gastric banding, endoscopic suturing, and intragastric balloons, in helping to treat this vast patient population. Part 1, which appeared in the November 2014 issue of Bariatric Times, focused on the United States perspective. Part 2 describes the outside of the United States experience.

Q1: Thank you for taking the time to speak with us. Please begin by telling us about your history in performing endoscopic bariatric procedures, specifically gastric balloons.

López-Nava: I started performing the intragastric balloon procedure in 2002. To date, I have performed about 3,000 intragastric balloon procedures using two products on the market—Orbera (Apollo Endosurgery, Inc., Austin, Texas, United States) and the ReShape™ Non-Surgical Weight Loss Procedure (ReShape Medical®, San Clemente, California, United States). I have published my experience with the Orbera balloon in obesity surgery and I have also been involved in clinical trials for the ReShape Procedure—in a prospective evaluation of 60 patients conducted in Spain, the procedure demonstrated clinically significant weight loss and a favorable safety profile.[1]

Dr. Ngatchu: I started performing the intragastric balloon procedure over four years ago. I work in a center with a bariatric unit, so I was excited about the opportunity to perform endoscopic weight loss procedures when they became available. I feel that intragastric balloons are good devices. The technique of balloon placement and removal was easy to learn and I felt the safety measures and outcomes were very good. Currently, I perform the ReShape Procedure.

Q2: Please tell us about endoscopic bariatric intervention using gastric balloons. What are the indications for patients to undergo the procedure?

López-Nava: The procedure is indicated for patients who have not been able to lose weight with diet, exercise and behavior modifications. Patients can be considered for the procedure at varying body mass indices between 27 and 40kg/m2. The average BMI of patients undergoing intragastric balloon procedures is 38kg/m2. In patients with BMIs in the higher range, the intragastric balloon may be considered as an intervention to lose weight before undergoing a traditional bariatric surgery, such as laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG), or endoscopic sleeve gastroplasty (OverStitch™ from Apollo Endosurgery).

I have found that patients who are overweight or obesity class I with comorbidities do not want to undergo traditional surgery because they do not want to expose themselves to associated possible risks (e.g., lengthy recovery, adverse reactions to anesthesia, blood clots, infection, scars, etc.) In Spain, 95 percent of the population with obesity is not being treated with weight loss surgery. I believe this is because they are afraid of the risks mentioned previously. The intragastric balloon offers a solution for this patient population that is resistant to undergoing surgery. When a patient has a BMI of 30kg/m2 or more we must intervene to prevent progression of the obesity disease and related comorbidities, rather than waiting for him or her to decide to have traditional weight loss surgery. In my opinion, patients should not have to wait to seek treatment for the disease. Patients and healthcare providers do not wait to treat other diseases, such as heart disease and cancer. The disease of obesity should be met with the same urgency.

Dr. Ngatchu: Obesity is a problem everywhere in the world. It continues to present a problem in the United Kingdom, where 20 to 30 percent of the adult population is classified as overweight. These patients have comorbidities that need to be managed, and data show that weight loss can help improve these conditions. Obesity with comorbid conditions is considered a disease state. I believe that in the years to come, obesity—with or without comorbidities—will be treated as a disease and not as a lifestyle problem. Currently, the United Kingdom National Health Service funds the following weight loss treatments: Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding. These procedures are only indicated for patients with high BMIs. In some cases, these patients are funded to get the intragastric balloon procedure before undergoing traditional weight loss surgery. This was one of the main drivers that led me to want to learn how to perform intragastric balloon procedures at the start.

Overall, there are two major contraindications of the intragastric balloon procedure. First, those who have already had weight loss surgery, and second, those who have a large hiatal hernia. Outside of these two contraindications, I think that many individuals would be good candidates for the intragastric balloon procedure as long as they have a BMI above 27kg/m2

Q3: What is the difference between intragastric balloons and other weight loss procedures?

López-Nava: The intragastric balloon is an outpatient procedure, whereas many weight loss surgeries are inpatient. The balloon procedure takes approximately 30 minutes to perform and the patient is discharged after a short recovery of approximately two hours. The patient is usually able to eat a liquid diet and exercise the following day.

Another difference between the intragastric balloon and other weight loss surgeries is that patients can be treated multiple times using the intragastric balloon. The procedure may be repeated—however, this is not the aim of the treatment. The aim of the treatment is to teach patients how to modify their behaviors and maintain a new, healthier lifestyle. This is the reason why a comprehensive aftercare program and a multidisciplinary team—including an endocrinologist, psychologist and sport assessor—is mandatory to attain a good outcome. Also, compared to traditional weight loss procedures, the anatomy remains intact after a balloon is removed.

Dr. Ngatchu: The intragastric balloon procedure does not require incisions. It teaches patients to change their lifestyle by teaching them portion control.

Q4: How does the intragastric balloon system work? What outcomes have you seen in your practice?

López-Nava: Currently, I perform the ReShape Procedure in higher BMI ones. The ReShape Procedure is designed for those who want a fast track to weight loss but do not want or qualify for surgery. The balloon is made of silicone and elastomers. When inflated, the two balloons are filled with an evenly distributed 900cc of saline to occupy volume in the patient’s stomach. The balloons are like a meal—the equivalent of about one plate and a half—which gives the patient the sensation of having a fuller stomach. I use the Orbera balloon in most of my patients. It is a single balloon, filled with 600cc, and with a high profile of safety and tolerability.

Intragastric balloons cause patients to feel less hungry and thus learn to control their portion sizes when eating. Once the intragastric balloon is placed, the aim is for the patient to work on improving three areas: psychological, nutritional and physical (exercise). I believe that the procedure helps to address all of these areas. During the six months the patient has the intragastric balloon in place, he or she is preparing for the day it will be removed, learning how to make proper nutrition choices, portion control and figuring out an exercise routine that works for him or her. If they are successful in learning and making these modifications, they will not miss the balloon when removed. In terms of outcomes, a recent clinical study I led in Spain found that patients had a mean total body weight loss of 17.1 kg, at six months. It also found that patients receiving one dual balloon with continued counseling for a mean of 7.4 months after balloon removal maintained 94 percent of their weight loss.

Dr. Ngatchu: I tell my patients during consultation that the result depends on their perspective and expectations. From the patient’s perspective, the goal of the procedure is usually only to lose weight. From my perspective as the physician, the goal of the procedure is not only for the patient to lose weight, but also for the patient to understand how the intragastric balloon helps them lose weight.

In my practice, we have a dedicated bariatric dietitian who follows up with patients after their procedure. The dietitian gives patients dietary advice and a nutrition plan to follow. The patient is in contact with the dietitian on a regular basis. We offer a 12-month program, meaning the patients have support from and access to a dietitian for the six months the balloon is in place and an additional six months when it is removed. I feel this is an extremely important part of the program because people may be at risk of going back to their old ways and habits when the balloon comes out. The dietitian helps them to stay on track.

From my experience, most patients lose weight within the first three months of having the balloon placed. After that, I find that the weight stabilizes. Some patients misread this period and think that it means the balloon has stopped working. I reassure them that it is still working. The reason for the weight stabilization in this period is that the calorie intake is equivalent to the patient’s energy expenditure. This is important to explain. It is also important that they learn what to eat to maintain that stabilized weight. To me, this is the beauty of the intragastric balloon—patients being educated on how to maintain the weight they have achieved. Most of my patients learn and adhere to the new lifestyle and are able to maintain their weight once the balloon is removed. While my center provides dietary counseling, we do not provide any exercise services to patients undergoing the procedure. Most of my patients lose about 35 pounds after having the intragastric balloon for six months. Those who work extremely hard and add exercise to their program might see a weight loss of 40 to 50 pounds, depending on their starting weight.

Q5: How about weight regain? What is your experience and how do you handle weight regain after intragastric balloon?

López-Nava: Some patients do experience weight regain after the balloon is removed. In these cases, we can offer to either repeat the procedure or recommend other bariatric endoscopy procedures or traditional bariatric surgery, if necessary. In many cases, I believe that weight regain is related to patient follow up. I find that when they lose contact with the multidisciplinary care team, they are at greater risk of regaining weight lost with the procedure.

Dr. Ngatchu: Most of my balloon patients have not come back with weight regain. Some do request a second round of undergoing the procedure. In those cases, I advise that patients wait one year from the date their first balloon was removed before they undergo a second procedure. A small amount of patients do ask for the balloon to be taken out before the six-month mark. In these cases, we try to manage initial symptoms that may be causing them discomfort, such as nausea and vomiting, which typically subsides after a few days. Only about five percent of my patients have the balloon removed before the six-month mark.

Q6: What do you believe is the future for intragastric balloon procedures in and outside of the United States?

López-Nava: Outside of the United States, we have been performing intragastric balloon procedures with success for more than 10 years. Every patient researches weight loss options before presenting for advanced bariatric endoscopy procedures or traditional surgery. When patients who need treatment are either non-eligible or afraid of traditional surgery, the balloon is there for them as an option outside the United States. I believe that less invasive procedures are the future of obesity treatments inside and outside the United States. We will be able to reach more untreated populations to prevent the progression of obesity and diminish treatment risks. I am hopeful that the intragastric balloon receives approval in the United States and would be happy to share my 10 years plus experience with the procedure with the United States.

Dr. Ngatchu: In my country, I have observed that people are becoming more aware and knowledgeable about intragastric balloons and are electing to self-pay for the procedure. Most cases I perform are for patients who self-fund. I think that in the next five to 10 years, 50 percent of weight loss procedures will be intragastric balloons. I also think that more gastroenterologists will perform the procedure. I believe gastroenterologists are the best specialists to perform the procedure for the simple reason that gastroenterologists best manage the side effects of the procedure, which are nausea and vomiting. Bariatric surgeons who hone their endoscopic skills will also be good candidates to perform the procedure. I feel that in the future, gastroenterologists will be treating overweight and morbidly obese patients with endoscopic techniques, and surgeons will be treating the super obese with surgery.

References

  1. ReShape Medical® Announces New Data Showing Clinically Significant Weight Loss with the ReShape™ Procedure in EU Commercial Use. Aug 28, 2014. http://www.reuters.com/article/2014/08/28/reshape-medical-loss-idUSnPn5w1xWf+82+PRN20140828

 

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Category: Emerging Technologies, Past Articles

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