Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes.

INTRODUCTION: Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed. METHODS: This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition. PRIMARY ENDPOINTS: technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction. RESULTS: July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m2) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m2 (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved. CONCLUSION: The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss. GOV IDENTIFIER: NCT05322122.

Magnetic compression anastomosis gastrojejunostomy: feasibility and efficacy of a novel device in a swine model.

BACKGROUND: Means of addressing technical challenges in forming gastrojejunostomy (GJ) anastomoses and maintaining their patency are sought. OBJECTIVES: Evaluation of preclinical feasibility and healing efficacy of a novel linear magnetic compression anastomosis (MCA) device to form a patent GJ versus sutured jejunal enterotomy (JE) sites in swine. SETTING: Single-center veterinary testing facility. METHODS: Feasibility of 3 prototype sizes (4, 6, and 8 cm) of a metal MCA device (MCAD) to form a patent GJ was evaluated over 6 weeks. A distal magnet was laparoscopically inserted in the jejunum, a proximal magnet was placed gastroscopically in the stomach; magnets were aligned to gradually form an anastomosis, self-detached, and be expelled. At necropsy, MCAs were assessed for patency and compared with JE tissues to evaluate wound healing. RESULTS: MCADs aligned at the GJ location without complications. In 5/6 MCAD pairs, dislodgement occurred between 7 and 26 days; expulsion 13-31 days; 1 MCAD pair was retained in the stomach. At necropsy, all pigs were healthy, gaining a mean 15.0 kg. Anastomoses were not adequately patent in 2/4 pigs receiving the 4-cm or 6-cm MCADs because their linear length was too small. But, anastomoses of both pigs receiving the 8-cm MCADs maintained full patency. Minimal inflammation and fibrosis were seen in MCA specimens versus sutured enterotomies. CONCLUSIONS: A novel linear MCA device was feasible and effectively created a patent GJ anastomosis in swine with minimal inflammation and fibrosis. The MCAD may be appropriate for clinical evaluation.

Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy.

BACKGROUND: Conventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs). OBJECTIVES: The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anastomosis device (Magnet Anastomosis System [MS]). SETTING: Multicenter: private practices and university hospitals. METHODS: In patients with body mass index ([BMI, kg/m2] ≥35.0 to ≤50.0 with/without type 2 diabetes [T2D] glycosylated hemoglobin [HbA1C > 6.5 %]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating magnet fusion and gradual DI (MagDI). The MagDI-after-SG group had undergone prior sleeve gastrectomy (SG); the MagDI + SG group underwent concurrent SG. AEs were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and May 30, 2023, 43 patients (88.0% female, mean age 43.7 ± 1.3 years) underwent the study procedures. The MS met feasibility criteria of magnet device placement, creation of patent anastomoses confirmed radiologically, and magnet passage in 100.0% of patients. There were 64 AEs, most were CDC grade I and II, significantly fewer in the MagDI-after-SG group (P < .001). No device-related AEs including anastomotic leakage, bleeding, obstruction, infection, or death. The MagDI-after-SG group experienced 6-month mean weight loss of 8.0 ± 2.5 kg (P < .01), 17.4 ± 5.0% excess weight loss (EWL). The MagDI + SG group had significantly greater weight loss (34.2 ± 1.6 kg, P < .001), 66.2 ± 3.4% EWL. All patients with T2D improved. CONCLUSIONS: In early results of a multicenter study, the incisionless, sutureless Magnet System formed patent, complication-free anastomoses in side-to-side DI with prior or concurrent SG.

Sleeve gastrectomy with duodenoileal bipartition using linear magnets: feasibility and safety at 1-year follow-up.

BACKGROUND: Single-anastomosis metabolic/bariatric surgery procedures may lessen the incidence of anastomotic complications. This study aimed to evaluate the feasibility and safety of performing side-to-side duodenoileal (DI) bipartition using magnetic compression anastomosis (MCA). In addition, preliminary efficacy, quality of life (QoL), and distribution of food through the DI bipartition were evaluated. METHODS: Patients with a body mass index (BMI) of ≥35.0 to 50.0 kg/m2 underwent side-to-side DI bipartition with the magnet anastomosis system (MS) with sleeve gastrectomy (SG). By endoscopic positioning, a distal magnet (250 cm proximal to the ileocecal valve) and a proximal magnet (first part of the duodenum) were aligned with laparoscopic assistance to inaugurate MCA. An isotopic study assessed transit through the bipartition. RESULTS: Between March 14, 2022 to June 1, 2022, 10 patients (BMI of 44.2 ± 1.3 kg/m2) underwent side-to-side MS DI. In 9 of 10 patients, an SG was performed concurrently. The median operative time was 161.0 minutes (IQR, 108.0-236.0), and the median hospital stay was 3 days (IQR, 2-40). Paired magnets were expelled at a median of 43 days (IQR, 21-87). There was no device-related serious advanced event within 1 year. All anastomoses were patent with satisfactory diameters after magnet expulsion and at 1 year. Respective BMI, BMI reduction, and total weight loss were 28.9 ± 1.8 kg/m2, 15.2 ± 1.8 kg/m2, and 34.2% ± 4.1%, respectively. Of note, 70.0% of patients reported that they were very satisfied. The isotopic study found a median of 19.0% of the meal transited through the ileal loop. CONCLUSION: Side-to-side MCA DI bipartition with SG in adults with class II to III obesity was feasible, safe, and efficient with good QoL at 1-year follow-up. Moreover, 19% of ingested food passed directly into the ileum.

Spanish Experience with Latero-Lateral Duodeno-Ileostomy + Sleeve Gastrectomy with Magnet Anastomosis System.

BACKGROUND: The partial diversion of intestinal contents facilitates achieving and maintaining weight loss and improving glycemic control in patients with obesity and with or without T2DM. The purpose of this study is to report our experience and 1-year follow-up with novel modification of SADI-S. METHODS: This study is a part of a multicentric trial of patients that underwent primary side-to-side duodeno-ileostomy and sleeve gastrectomy (SG) with GT metabolic solutions magnetic anastomosis system. Feasibility, safety, and initial efficacy were evaluated. RESULTS: The mean age of the patients included was 48 ± 8.75 years and the preoperative BMI was 43.32 ± 2.82 kg/m2. The complications were present in 30% of patients. The anastomosis patency was confirmed by the passage of radiological contrast under fluoroscopy at a mean of 17 days (17-29 days), and the mean expulsion time was 42 days (32-62). The mean diameter of the anastomosis after the magnet expulsion was 13.8 × 11.4 mm. The percentage of total weight lost at 1 year was 38.68 ± 8.48% (p < 0.001). The percentage of excess weight loss 82.5 ± 18.44% (p < 0.001) and improvements in glucose profiles were observed. Mean baseline HbA1c 5.77 ± 0.31% was reduced to 5.31 ± 0.26% (p < 0.024). CONCLUSIONS: Latero-lateral duodeno-ileostomy + SG with magnetic duodenal bipartition is afeasible and reasonably safe technique and induces weight loss in patients with obesity and improvement of glycemic control. This modification could be considered as an option to standard SADI-S or as a first step in two stages procedure. However, larger studies are needed. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: #NCT05322122.

Metabolic and Bariatric Surgeon Criteria-An International Experts' Consensus.

PURPOSE: With the global epidemic of obesity, the importance of metabolic and bariatric surgery (MBS) is greater than ever before. Performing these surgeries requires academic training and the completion of a dedicated fellowship training program. This study aimed to develop guidelines based on expert consensus using a modified Delphi method to create the criteria for metabolic and bariatric surgeons that must be mastered before obtaining privileges to perform MBS. METHODS: Eighty-nine recognized MBS surgeons from 42 countries participated in the Modified Delphi consensus to vote on 30 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus. RESULTS: Consensus was reached on 29 out of 30 statements. Most experts agreed that before getting privileges to perform MBS, surgeons must hold a general surgery degree and complete or have completed a dedicated fellowship training program. The experts agreed that the learning curves for the various operative procedures are approximately 25-50 operations for the LSG, 50-75 for the OAGB, and 75-100 for the RYGB. 93.1% of experts agreed that MBS surgeons should diligently record patients' data in their National or Global database. CONCLUSION: MBS surgeons should have a degree in general surgery and have been enrolled in a dedicated fellowship training program with a structured curriculum. The learning curve of MBS procedures is procedure dependent. MBS surgeons must demonstrate proficiency in managing postoperative complications, collaborate within a multidisciplinary team, commit to a minimum 2-year patient follow-up, and actively engage in national and international MBS societies.