Bariatric Times - June 2008 - (Page 28)

28 Emerging Technologies Bariatric Times • June 2008 Adoption and implementation of any new technology should be based on SAFETY, EFFICACY, AND BENEFIT OVER EXISTING PROCEDURES. disruption in 13 patients. Despite these shortcomings, this is the most promising of the gastric restrictive devices to date. The Eagle Claw prototype endoscopic suturing device (Olympus Corporation, Tokyo, Japan) has been used in a porcine model to create a gastric pouch entirely from within the gastric lumen.14 While no survival studies with this approach have been published, work is ongoing to refine and perfect the technique in animal models. The SafeStitch device may also be used for an endoluminal gastroplasty (Figures 4–5). This device uses a suction-facilitated endoluminal mucosectomy followed by suture placement to create a gastric pouch while excluding mucosa from the suture line. Clinical trials are starting this year. Endoluminal placement of intragastric mesh has also been attempted. In this procedure, mesh was passed transorally and secured with laparoscopic intragastric suturing. The final outcome was a 30mL to 50mL gastric reservoir emptying through a 1.5cm central aperture. Two of 10 dogs in the study had 100-percent adherence of the mesh. Four of 10 had some adherence. This left 4 of the 10 with no mesh adherence, suggesting that this approach is not conducive to broader therapeutic applications without novel ways to increase mesh adherence.15 Other devices have been developed that may have use in endoluminal restrictive procedures. Power Medical (Power Medical Interventions, Inc., Langhorne, Pennsylvania) has recently released a transoral stapling device that can provide endoluminal stapling. The Endoscopic Suturing Device by Wilson-Cook (Wilson-Cook Medical, Winston-Salem, North Carolina) could also be applied for this technique. While these devices have not yet been studied specifically in endoluminal restrictive procedures, they may facilitate some transoral procedures involving gastric restriction. Endoscopic revision procedures. Several devices have been developed to facilitate endoscopic revision of prior bariatric procedures. The Stomaphyx device is currently available for the treatment of a dilated gastric pouch following gastric bypass. This device uses Tfasteners to create endoluminal plications that will decrease pouch size. The morbidity of this procedure appears minimal, but the benefit has yet to be proven. The Endocinch device (CR Bard, Inc., Murray Hill, New Jersey) has been successfully used for treatment of gastro-gastric fistulae and management of anastomotic dilatation.16 The company has launched a multi-center, randomized, controlled trial to determine if stoma reduction with the Endocinch device promotes additional weight loss in patients that have had gastric bypass. Results are to be announced in the end of 2008. Others have also reported success with this device for endoscopic management of gastrojejunal anastomotic dilation.17,18 The G-prox device (USGI, Inc., San Clemente, California), which can be used for mucosectomy and gastric plication or pouch formation, has received 510k approval and is currently being studied. Other companies are developing similar devices as the endoscopic approach to surgical revision is very appealing. The NDO Plicator (NDO Surgical, Inc., Mansfield, Massachusetts) also may have bariatric applications, but case reports with this device are limited. Y gastric bypass. The device is anchored past the duodenal bulb and can be endoscopically removed, allowing for relatively easy reversibility. In addition to weight loss, this device may also have value in the management of type 2 diabetes.19 The endoluminal sleeve has been tested in clinical trials with 10 successfully placed sleeves in 12 patients. Average percent of excess weight loss (%EWL) at 12 weeks was 23.6 percent, with all patients experiencing at least 10%EWL. The four diabetic patients were successfully managed off medication with normal fasting blood-glucose levels. There were two pharyngeal tears at extraction and some GI symptoms within the first two weeks of deployment.20 This device shows much promise for both weight and metabolic management. ENDOSCOPIC MALABSORPTIVE PROCEDURES An endoluminal bariatric sleeve has been developed by GI Dynamics (GI Dynamics, Newton, Massachusetts). This device is a flexible, endoscopically placed sleeve that is open at both ends and can be positioned in the duodenum past the ligament of Trietz. The sleeve allows food to pass while preventing duodenal mixing of chyme with biliary and pancreatic secretions. This is intended to mimic the duodenal and proximal jejunal bypass impact of a Roux-en- ENDOSCOPIC COMBINED RESTRICTIVE AND MALABSORPTIVE PROCEDURES More complex devices have been developed to allow for surgical techniques that employ multiple modalities to promote weight loss. Many of these techniques involve restrictive, malabsorptive, and neurohormonal physiologic manipulations. While these devices are considerably more complex than some endoluminal devices, they are appealing as they provide combined approaches to promote satiety, and, hence, are more appealing for long- FIGURE 4. Locations of SafeStitch gastric plications. (Courtesy of SafeStitch) FIGURE 5. SafeStitch device for endoluminal gastroplasty. (Courtesy of SafeStitch)

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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