Bariatric Times - June 2008 - (Page 27)

Bariatric Times • June 2008 Emerging Technologies 27 As these technologies are developed, it is important that PATIENT SAFETY is ensured while designing devices that are both EFFECTIVE AND TECHNICALLY EASY TO DEPLOY. suturing platforms to combine restrictive and malabsorptive devices. The most important issue in developing devices for less invasive weight loss surgery is to ensure their safety. Usage data from the intra-gastric balloon, which are discussed in this article, demonstrate that patients are willing to undergo these procedures without clinical evidence of success and moderate safety profiles. As these technologies are developed, it is important that patient safety is ensured while designing devices that are both effective and technically easy to deploy. patients, and Mallory-Weiss tears in 11 percent of patients.7,8 Given poor patient tolerability and efficacy, the device was removed from the market in 1988. BioEnterics Corporation (Carpinteria, California) worked to develop an improved version of the Garren-Edwards Bubble and released the BioEnterics Intragastic Balloon (BIB) system in the mid1990s.9 The device is available internationally but currently is not FDA approved for use in the United States (US). However, clinical trials are currently underway in the US. Several case studies have demonstrated good short- to midterm results with the device, suggesting that this can be successfully delivered and is associated with weight loss. A clinical trial randomized 43 patients to the BIB or a sham procedure for three months, followed by balloon placement and exchange every three months for an additional nine months. Patients were then followed for 12 months after BIB removal. Overall, patients in the study lost 30 percent excess weight and had some sustained weight loss at one year after removal. However, both the sham and BIB groups lost weight and no significant difference was appreciated between groups. Patients in both groups experienced frequent symptoms with the BIB in place, including nausea, vomiting, and pyrosis occurring over 50 percent of follow-up days. All of these complaints were more prevalent in the group that had the sham procedure before BIB placement. The authors concluded that the BIB was safe, though patients had frequent complaints, but the benefit of balloon over sham was not proven. Subsequent reports have found that the BIB can be deployed for up to six months without significant morbidity.10 More recently, the gastric retention technologies group of BaroNova Therapeutics, Inc. (Foster City, California) has developed a polymer pill that expands to take up space in the stomach for one week after ingestion or delivery. In theory, this pill would degrade and pass through the gastrointestinal (GI) system and can be taken at regular intervals and titrated based upon response.11 While this technology has not yet been clinically tested, it appears promising. Suture and staple-based devices. Many manufacturers have attempted to develop endoscopic suturing and stapling devices to promote volume reduction as well as add possible elements of malabsorption. Concepts have included endoluminal gastroplasties, restrictive valves, and combined approaches to restriction and malabsorption. While many of these devices are promising for endoluminal approaches to bariatric surgery, few of the devices or techniques are proven in terms of efficacy or safety. An endoscopic vertical banded gastroplasty (VBG) has been reported and uses a vertical ring gastroplasty created with an endoscopic sewing machine (Endoscopic Sewing Machine; CR Bard, Inc., Murray Hill, New Jersey) mounted at the tip of a flexible endoscope. This procedure utilizes a 3cm plastic ring sutured to the lesser curvature of the stomach 8cm from the gastroesophageal junction. Next, an 8cm-long tube is created along the lesser curvature by suturing the anterior and posterior walls of the stomach with the endoscopic sewing machine. Survival studies have not shown this to be durable or effective.12 Other suturing devices are in various stages of development. Satiety (Palo Alto, California) has developed The TOGATM System transoral gastroplasty (Figures 1–3). A safety trial in 21 patients was successfully completed. In this group, at six months patients had lost an average of 26.5 pounds and 24.4 percent of their excess body weight.13 The side effects of the procedures were transient and included nausea, vomiting, dysphagia, and pain. There were no serious adverse events. At the sixmonth follow-up endoscopy, however, there was some staple-line ENDOSCOPIC RESTRICTION PROCEDURES Balloon and obstructivebased devices. One of the first endoluminal devices for morbid obesity was the Garren-Edwards bubble, a cylindrically shaped, space-occupying device placed endoscopically into the gastric lumen. The initial concept was proposed in 1982 and the device received FDA approval in 1985. The device was embraced by the clinical community and 25,000 devices were placed despite minimal clinical data to support its use. Subsequently, several sham-controlled trials showed minimal benefit of the device. Complications including ulcers and erosion were found in 40 percent of patients, small bowel obstruction in two percent of FIGURE 1. TOGATM device with tissue retraction and positioning device in place. (Courtesy of Satiety) FIGURE 2. TOGATM device stapling on a double layer of stomach to create a gastric sleeve. (Courtesy of Satiety) FIGURE 3. Deployment of the TOGATM restrictor at the bottom of the gastric sleeve. (Courtesy of Satiety)

Table of Contents Feed for the Digital Edition of Bariatric Times - June 2008

Bariatric Times - June 2008 Endoluminal Treatment Options for Morbid Obesity: Devices and Techniques for Natural Orifice Approaches The Multidisciplinary Approach to Weight Loss: Defining the Roles of the Necessary Providers Acute Bleeding after Gastric Bypass Editorial Message Contents ASMBS: 25 Years Editorial Board Surgical Site Infection In The Morbidly Obese Patient: A Review Consultant's Corner The Link Between Sleep Loss and Obesity: Understanding the Mechanisms Responsible for Weight Gain with Sleep Deprivation Volume Matters Journal Watch Advertiser Index

Bariatric Times - June 2008

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