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Magnetic Entero-enteral Bypass for Treatment of Metabolic Syndrome

Marvin Ryou, MD, David B Lautz, MD1, Evzen Machytka, MD2, Christohper Thompson, MD, MHES. 1Emerson Hospital, 2University of Ostrava

Our group has developed a technology based on self-assembling magnets that are delivered through conventional endoscopes and can create large-caliber anastomoses. These magnets are delivered into adjacent lumens and self-assemble into reciprocal octagons. Upon coupling, these magnets form a large compression anastomosis over several days. The fused magnets are naturally expelled.

We previously performed a proof of concept animal survival study in which jejuno-colonic bypasses were created endoscopically.

Moving into clinical studies, our group has targeted entero-enteral bypass for treatment of type II diabetes, in some ways similar to the jejunoileal bypass seen in BPD-DS.To review, reciprocal magnets are delivered by two separate scopes. Magnetic coupling leads to a compression anastomosis.The fused magnets are expelled. With the resulting side to side anastomosis, food now has two pathways. The novel pathway bypasses into the ileum. The native pathway mitigates against malabsorption

Our case is of a 54 year old male with a BMI of 41.6 and very poorly controlled type 2 diabetes.The following footage demonstrates magnetic deployment into the jejunum. The magnet changes from a linear assembly to an enclosed octagon, which can be manipulated with a catheter. Fluoroscopic guidance is required for magnetic coupling. Successful coupling produces a characteristic symmetric appearance. The magnets can be easily separated if there is concern for mal-alignment. Laparoscopic visualization was used to maximize safety in this initial human experience. Gentle pulling with the laparoscopic graspers suggests the coupling is robust. Additionally, laparosocpic graspers can easily separate the magnets as well as re-couple them. After the magnets are coupled, endoscopic scissors are used to cut the sutures. This marks the end of the procedure. The 2 month endoscopy reveals a well healed, widely patent anastomosis. Here, the endoscopist is shown exploring the 3 other limbs in this side-to-side anastomosis. The 3 month upper GI series shows significant contrast passage down the bypass.

3 month clinical data was notable for a hemoglobin A1C drop of 11.4 to 6.8, representing an absolute decrease of 4.6. Moreover, the patient had lost 9.2 kg representing an 8.7% total body weight loss. Furthermore, coupled magnets were expelled in less than 2 weeks. The patient experienced no abdominal pain and only mild self-limited diarrhea.

299

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