Emerging Technologies 1 Article #1 1 Surgery for Obesity and Related Diseases 7 (2011) 15–22 11/24/2015

2 Surgery for Obesity and Related Diseases 7 (2011) 15–22 Background  Current gastric restrictive procedures include either a prosthetic device or gastric resection  Present the results of a feasibility study using laparoscopic gastric plication for weight loss achieved without stapling or banding

11/24/20153 Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods Two methods were used to achieve laparoscopic gastric volume reduction  First group  Anterior plication (AP), the anterior gastric wall was folded inward from the fundus to the antrum using 2 rows of running sutures  The greater and lesser curvatures were approximated to create an intraluminal fold of the stomach

11/24/20154  Second group  Greater curvature plication (GCP), the short gastric vessels were divided  The greater curvature was folded inward, with 2 suture lines to reduce the gastric capacity by a large intraluminal gastric fold Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/20155  Inclusion criteria  Willing to give consent and comply with the evaluation and treatment schedule  21–60 years old (inclusive), had a BMI of ≥35 but ≤50 kg/m 2 ; a BMI of 35–40 kg/m 2 with ≥ 1 significant medical conditions related to obesity  Meet the NIH criteria for bariatric surgery Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/20156  Exclusion criteria  Pregnancy or lactation  Documented history of drug and/or alcohol abuse within 2 years  Previous procedures performed for the treatment of obesity  Condition that would preclude compliance with the study (e.g. IBD, congenital or acquired anomalies of GI tract, severe cardiopulmonary disease) Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/20157  Exclusion criteria  Treatment with ˃ 50 U/day of insulin  Chronic or acute UGIB  Cirrhosis, congenital or acquired intestinal telangiectasia, esophageal or gastric disorders  Hiatal hernia, previous surgery of the foregut Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/20158  Exclusion criteria  Pancreatitis, an immunocompromised status or autoimmune connective tissue disease  Use of prescription or over-the-counter weight reduction medications or supplements within 30 days of the screening visit or during study participation Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/20159  Surgical procedures  AP Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/  Surgical procedures  GCP Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/  Study endpoints  Weight loss (weight, BMI,%EWL)  Adverse events  Endoscopic evaluation  Quality-of-life assessment [Quality of Life-Lite (IWQOL-Lite) and the Multi- purpose Short Form Survey-12 (SF- 12)] Surgery for Obesity and Related Diseases 7 (2011) 15–22 Methods

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Results  15 patients, 9 underwent AP and 6 underwent GCP (3 males)  Mean pre-op BMI was 43.3 kg/m 2 (range 36.9–49.0)  9 patients (AP), the 6- and 12-month endoscopic evaluations demonstrated comparable-size plications over time, except for in 1 patient who had a partially disrupted fold

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Results  6 patients (GCP), the 6- and 12-month endoscopic examinations demonstrated a durable intraluminal fold, except for in 1 patient, with a partial disruption at the distal fold owing to a broken suture  For patients completing 1 year of follow-up, %EWL was 23.3%±24.8% in the AP group (n=5) and 53.4%±22.7% in the GCP group (n=6)

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Results  No bleeding or infectious complications developed  The first patient in the GCP group required reoperation and plication reduction owing to gastric obstruction  AP group had no significant change in the SF-12 scores at the 12-month visit compared with the baseline scores

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Results  GCP group had significant improvement (P ˂.001) in the SF-12 scores for the physical component score (questions 1–6) at 12 months  The overall (total) IWQOL score had improved significantly (P=.0086) in the GCP group at the 12-month visit  No statistically significant improvement (P=.3753) was observed for the AP group

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Results Endoscopic images of (A) AP and (B) GCP 12 months postoperatively

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Results %EWL over time for gastric plication procedures. Black circles indicate results for AP in present study; white circles, results for GCP in present study; black triangles, results from Ramos et al. [15] for GCP; and black squares, results from Talebpour and Amoli [17] for GCP

11/24/ Surgery for Obesity and Related Diseases 7 (2011) 15–22 Conclusion  Our initial experience has suggested that a reduction in gastric capacity can be achieved by way of plication of the anterior stomach and greater curvature  The early weight loss results have been encouraging, with better weight loss in patients who underwent GCP  The use of laparoscopic GCP warrants additional investigation as a primary bariatric procedure

11/24/ Article #2 Emerging Technologies Gastrointest Endosc 2010;72:

11/24/201520Gastrointest Endosc 2010;72: Background  Medical treatment of obesity often fails, and surgical treatment, although successful, is aggressive  To evaluate the short-term safety and efficacy of an endoscopic restrictive implant procedure in the treatment of obesity  Prospective, observational study  Tertiary-care referral hospital in The Netherlands

11/24/201521Gastrointest Endosc 2010;72: Methods  This study involved 13 patients with body mass indexes of between 40 and 50 kg/m 2 or between 35 and 40 kg/m 2 with obesity related comorbidities  A new transoral endoscopic restrictive implant procedure in the treatment of obesity  Safety of the procedure, percentage of excess weight loss, change in BMI

11/24/201522Gastrointest Endosc 2010;72: Methods

11/24/201523Gastrointest Endosc 2010;72: Methods Procedure demonstrated by using animation images. A, The cardia was inspected with the endoscope in retroflex position, and a transmural plication was created by using the stapler. B, An anchor was then pulled through the plication. These steps were repeated until 5 plications with anchors were formed. Next, a multiple-lumen guide was used and served as a guide for the attachment of the restrictor with locking anchor graspers.

11/24/201524Gastrointest Endosc 2010;72: Methods Procedure demonstrated by using animation images. C, The restrictor with a 10-mm food exit orifice was advanced, and the locking anchor graspers were unlocked and withdrawn. D, Once all the anchors had been attached, the restrictor was inspected.

11/24/201525Gastrointest Endosc 2010;72: Methods Endoscopic images of the procedure. A, The cardia was inspected with the gastroscope in retroflex position. B, Next, 5 transmural plications were created and anchors were pulled through the plications. C, Finally, the TERIS-restrictor was in position and inspected.

11/24/201526Gastrointest Endosc 2010;72: Results

11/24/201527Gastrointest Endosc 2010;72:  In 1 patient, the procedure was abandoned after a gastric perforation related to stapler malfunctioning  In 2 patients, pneumoperitoneum was detected and desufflated with a percutaneous hollow needle in one patient and treated conservatively in the other  At 3 months postprocedure, patients obtained a median EWLof 28% and median BMI decreased from 42.1 to 37.9 kg/m 2 Results

11/24/201528Gastrointest Endosc 2010;72: Results

11/24/201529Gastrointest Endosc 2010;72: Results A graphic image shows the median BMI of the patients at baseline, 1 month, and 3 months. BMI, body mass index.

11/24/201530Gastrointest Endosc 2010;72: Results A box and whisker plot of percentage of excess weight loss, with 25% and 75% interquartile ranges.

11/24/201531Gastrointest Endosc 2010;72: Results

11/24/201532Gastrointest Endosc 2010;72: Conclusion  Preliminary results of this transoral endoscopic restrictive implant system for the treatment of obesity showed successful placement in 12 of 13 patients  Procedural complications occurred in 3 patients  Weight loss was comparable to that of laparoscopic gastric band placement  Further long-term studies are under way

11/24/ Article #3 Emerging Technologies Annals of Surgery Volume 251, Number 2, February 2010

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Background  The endoscopically placed duodenal- jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients  We report on the first European experience with this device

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Methods  A multicenter, RCT was performed  Forty-one patients were included and 30 underwent sleeve implantation  Eleven patients served as a diet control group  All patients followed the same low-calorie diet during the study period  The purpose of the study was to determine the safety and efficacy of the device

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Methods Illustration of the EndoBarrier Gastrointestinal Liner. The device is endoscopically placed in the duodenum to form a barrier between chyme and the intestinal wall, creating a duodenal-jejunal bypass effect.

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Methods The implant device with guide wire, deployment device and encapsulated sleeve. The device is comprised of an impermeable fluoropolymer sleeve of 60 cm and a nitinol anchor with barbs. The polypropylene drawstring is necessary for removal of the device.

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Methods

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Results  Twenty-six devices were successfully implanted except in 4 patients  Four devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and continuous epigastric pain (1)  The remaining patients all completed the study

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Results  Mean procedure time was 35 minutes (12– 102 minutes) for a successful implantation and 17 minutes (5–99 minutes) for explantation  During the study period the 26 duodenal jejunal bypass sleeve patients (100%) had at least one adverse event, mainly abdominal pain and nausea during the first week after implantation

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Results

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Results

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Results  Initial mean BMI was 48.9 and 47.4 kg/m 2 for the device and control patients respectively  Mean EWL after 3 months was 19.0% for device patients versus 6.9% for control patients (P ˂ 0.002)  Absolute change in BMI at 3 months was 5.5 and 1.9 kg/m 2, respectively  Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Results

11/24/ Annals of Surgery Volume 251, Number 2, February 2010 Conclusion  The EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with excellent short-term weight loss results  The device also has a significant positive effect on type 2 diabetes mellitus  Long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity

Emerging Technologies Other papers of interest

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