Moises Jacobs, MD1, Natan Zundel, MD2, Gustavo Plasencia, MD1, Prospero Rodriguez Pumarol, MD3, Eddie Gomez, MD1. 1Jackson South., 2Jackson North FIU, 3Plaza de la Salud
BACKGROUND: Over the last 6 years, based on the historical Magenstrasse and Mills procedure, a novel approach to weight loss has been developed. A laparoscopically placed silicone covered titanium clamp ?with a closing pressure of 6.46? gr/mm2 is? placed vertically around the stomach paralleling the lesser curvature. The clamp separates the stomach into a restricted medial segment where food would pass and an excluded larger lateral gastric segment. The clamp at its
?inferior aspect has an aperture by which gastric juices created by the fundus and the body can empty into the distal ?
antrum. This aperture also allows endoscopic examination of the excluded segment. ?
Cadaver ex vivo and in vivo animal studies, and 22 animal implants were performed with up to 15 months survival, The device restricts the amount of food consumption in severely obese patients without the need for cutting, stapling, bypassing of the stomach or the intestines, or device adjustment
METHODS: Under IRB protocol, from November 2012 to
?December 2014, 6 pts were implanted at one site. Changes in excess body weight, the effect on diabetes, and the incidence of complications were assessed. During this period there were several clamp and technique modifications.?
RESULTS: Average age ?28.8 years(range 19-38),
?Average weight at baseline was 111.2 kg (range 91-134), ?
Average BMI 43.3 (range 37-5?6?).Average length of stay 1.6 days, ?89% females, avg operating time 62 minutes. A 28 F bougie was used. %Excess Weight Loss (%EWL)? at 3,6,12,18?,24? months respectively were 32.03 (5-57), 4?3?.7 (16-76), 47.4 (26-70), 52.7(30-?81), 54.9 (48-62). Eight diabetic patients preop average HbA1c levels dropped from 7.26 to 5.7. There were ?9 pts with slippage/gastric outlet obstruction, ?6? were explanted, one was revised but 3 months later required explantation?, two were treated conservatively. One pt was not satisfied with the weight loss and wanted device removed.
Other adverse events included nausea and/or vomiting (14.54%), gastroesophageal reflux (12.72%), abdominal pain (7.27%), diarrhea (5.45%)
There were no erosions, no infections, no? deaths, no conversions.With the latest fixation? technique?s, the last twenty two patients with at least 6 months f/u, had a 47.5? %EWL (range 19.6-?64.2)?. The last ?seven of these? ?pts with a slight modification in fixation had a 6 months 53.9 %EWL range (36.1-64.2)
Of the last 29 pts, with either the new fixation technique or the newest version of the devise, only one slippage has occurred.
CONCLUSIONS: The vertically placed weight loss clamp is reversible, dos not change anatomy,does not require cutting or stapling of the stomach or intestines, and does not require adjustment. Further studies are needed to delineate it's safety and efficacy in the use against morbid obesity and co-morbidities,including Diabetes.