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.

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.

Prescription and consumption of opioids after bariatric surgery: a multicenter prospective cohort study.

INTRODUCTION: In the current opioid crisis, bariatric surgical patients are at increased risk of harms related to postoperative opioid overprescribing. This study aimed to assess the extent to which opioids prescribed at discharge after bariatric surgery are consumed by patients. METHODS: This multicenter prospective cohort study included adult patients (≥ 18yo) undergoing laparoscopic bariatric surgery. Preoperative assessments included demographics and patient-reported measures. Information regarding surgical and perioperative care interventions (including discharge prescriptions) was obtained from medical records. Self-reported opioid consumption was assessed weekly up to 30 days post-discharge. Number of opioid pills prescribed and consumed was compared using Wilcoxon signed-rank test. Zero-inflated negative binomial regression was used to identify predictors of post-discharge opioid consumption. RESULTS: We analyzed 351 patients (mean age 44 ± 11 years, BMI 45 ± 8.0 kg/m2, 77% female, 71% sleeve gastrectomy, length of stay 1.6 ± 0.6 days). The quantity of opioids prescribed at discharge (median 15 pills [IQR 15-16], 112.5 morphine milligram equivalents (MMEs) [IQR 80-112.5]) was significantly higher than patient-reported consumption (median 1 pill [IQR 0-5], 7.5 MMEs [IQR 0-37.5]) (p < 0.001). Overall, 37% of patients did not take any opioids post-discharge and 78.5% of the opioid pills prescribed were unused. Increased post-discharge opioid consumption was associated with male sex (IRR 1.54 [95%CI 1.14 to 2.07]), higher BMI (1.03 [95%CI 1.01 to 1.05]), preoperative opioid use (1.48 [95%CI 1.04 to 2.10]), current smoking (2.32 [95%CI 1.44 to 3.72]), higher PROMIS-29 depression score (1.03 [95% CI 1.01 to 1.04]), anastomotic procedures (1.33 [95%CI 1.01 to 1.75]), and number of pills prescribed (1.04 [95%CI 1.01 to 1.06]). CONCLUSION: This study supports that most opioid pills prescribed to bariatric surgery patients at discharge are not consumed. Patient and procedure-related factors may predict opioid consumption. Individualized post-discharge analgesia strategies with minimal or no opioids may be feasible and should be further investigated in future research.

Predictors of post-discharge pain and satisfaction with pain management after laparoscopic bariatric surgery: a prospective cohort study.

BACKGROUND: Pain management after bariatric surgery remains challenging given the risk for analgesia-related adverse events (e.g., opioid use disorder, marginal ulcers). Identifying modifiable factors associated with patient-reported pain outcomes may improve quality of care. We evaluated the extent to which patient and procedural factors predict 7-day post-discharge pain intensity, pain interference, and satisfaction with pain management after bariatric surgery. METHODS: This prospective cohort study included adults undergoing laparoscopic bariatric surgery at two university-affiliated hospitals and one private clinic. Preoperative assessments included demographics, Pain Catastrophizing Scale (score range 0-52), Patient Activation Measure (low [< 55.1] vs. high [≥ 55.1]), pain expectation (0-10), and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) anxiety and depression scales. At 7 days post-discharge, assessments included PROMIS-29 pain intensity (0-10) and pain interference scales (41.6-75.6), and satisfaction with pain management (high [10-9] vs. lower [8-0]). Linear and logistic regression were used to assess the association of pain outcomes with potential predictors. RESULTS: Three hundred and fifty-one patients were included (mean age = 44 ± 11 years, BMI = 45 ± 8 kg/m2, 77% female, 71% sleeve gastrectomy). At 7 days post-discharge, median (IQR) patient-reported pain intensity was 2.5 (1-5), pain interference was 55.6 (52.0-61.2), and 76% of patients reported high satisfaction with pain management. Pain intensity was predicted by preoperative anxiety (ß + 0.04 [95% CI + 0.01 to + 0.07]) and pain expectation (+ 0.15 [+ 0.05 to + 0.25]). Pain interference was predicted by preoperative anxiety (+ 0.22 [+ 0.11 to + 0.33]), pain expectation (+ 0.47 [+ 0.10 to + 0.84]), and age (- 0.09 [- 0.174 to - 0.003]). Lower satisfaction was predicted by low patient activation (OR 1.94 [1.05-3.58]), higher pain catastrophizing (1.03 [1.003-1.05]), 30-day complications (3.27 [1.14-9.38]), and age (0.97 [0.948-0.998]). CONCLUSION: Patient-related factors are important predictors of post-discharge pain outcomes after bariatric surgery. Our findings highlight the value of addressing educational, psychological, and coping strategies to improve postoperative pain outcomes.

First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System.

PURPOSES: Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. MATERIALS AND METHODS: Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m2 with/without T2D (HbA1C ≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects. RESULTS: Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m2) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1C (%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality. CONCLUSIONS: Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05322122.

Outcomes of single anastomosis duodeno ileal bypass and single anastomosis stomach ileal bypass for type II diabetes: a systematic review.

INTRODUCTION: Bariatric surgery has demonstrated long-term effectiveness in inducing weight loss and improving metabolic parameters for obesity. Single anastomosis duodeno-ileal (SADI) bypass and single anastomosis sleeve-ileal (SASI) bypass have both emerged as new promising bariatric procedures. In this paper, we review the existing literature and compare the outcomes of SADI and SASI bypass procedures in regard to weight loss, complication rate, and improvement of type II diabetes (T2DM). This has not yet been done in the preexisting literature. AREAS COVERED: We conducted a systematic literature search of electronic databases focusing on weight loss outcomes, rate of complications and remission, or improvement of T2DM and other obesity-related comorbidities. Seventeen studies on SADI and nine studies on SASI were included. Both are similar in terms of surgical technique and have demonstrated fewer complications when compared to other bariatric procedures. Mean preoperative BMI was similar in both study groups: 46.4 kg/m2 in SADI and 48.8 kg/m2 in SASI. Mean %EWL at 12 months in the SADI group was 74.1% compared to 77.4% in the SASI group. Preoperative severity of T2DM appeared to be higher in the SASI patient group, with a higher preoperative HbA1c and fasting blood glucose levels. T2DM resolution was achieved in a significant proportion of both SADI and SASI patient populations (78.5% in SADI and 89.0% in SASI). Complication rates were comparable for both procedures. EXPERT OPINION: Both SADI and SASI are effective in inducing weight loss at 12 months, with a low rate of major complications and mortality. From the studies included in this review, the SASI procedure had a higher impact on T2DM resolution compared to SADI.

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results.

INTRODUCTION: Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. METHODS: In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality. CONCLUSION: In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model.

BACKGROUND: Minimally invasive metabolic/bariatric surgery (MBS) may be further advanced by magnetic compression anastomosis (MCA) technology. The study aimed to develop a magnet sized to create a patent duodeno-ileostomy (DI) and verify its effectiveness in a porcine model. METHODS: Developmental study phase: magnets with 4 different flange-offset dimensions were tested to identify a design that would successfully form a compression anastomosis. Verification phase: evaluation of the selected design's efficacy. In each 6-week phase (4 pigs/phase), one magnet was inserted laparoscopically in the jejunum, one placed gastroscopically in the duodenum. Magnets were aligned, gradually fused, formed an anastomosis, and then detached and were expelled. At necropsy, MCA sites and sutured enterotomy sites were collected and compared. RESULTS: Developmental phase: the linear BC42 magnet with a 2.3-mm flange offset design was selected. Verification phase: in 4 swine magnets were mated at the target location, confirmed radiographically. Mean time to magnet detachment 16.0 days (12-22), to expulsion 24.5 days (17-33). MCA was achieved in all animals at time of sacrifice. Animals gained a mean 9.5 kg (3.9-11.8). Specimens revealed patent anastomoses of ≥ 20 mm with smooth mucosa and minimal inflammation and fibrosis compared to sutured enterotomies. One pig underwent corrective surgery for a mesenteric hernia without sequelae. CONCLUSION: In a large-animal model, gross and histopathologic examination confirmed that the linear MCA device created a patent, well-vascularized, duodeno-ileal anastomosis. The novel MCA device may be appropriate for use in human MBS procedures.

Unveiling the effects of key factors in enhancing gastroesophageal reflux: A fluid-structure analysis before and after laparoscopic sleeve gastrectomy.

BACKGROUND AND OBJECTIVES: Gastro-oesophageal reflux disease (GERD) consists in the passage of gastric acid content from the stomach to the oesophagus, causing burns and deteriorating the quality of life. Laparoscopic Sleeve Gastrectomy (LSG) could induce de novo GERD and worsen pre-existing GERD because of the higher gastric pressurisation, reduction of stomach volume and a wider His-angle. In the proposed work, various computational gastric 2D models were developed to understand the effects of variables such as the His-angle, the antral dimension, and the bolus viscosity on the reflux increase. METHODS: Fluid-Structure Interaction (FSI) computational models which couple the solid mechanics of the gastric wall, and the fluid domain of the bolus, have been developed to shed light on biomechanical aspects of GERD after LSG. A closure was imposed to the lower oesophageal sphincter (LES) mimicking what happens physiologically after food intake. RESULTS: Results showed that the configuration prone to higher reflux flow was the post-surgical 65° model with a staple line starting directly from the pylorus without antral preservation, for all considered viscosities. Increasing viscosity, reflux flow decreased. Post-surgical refluxes were higher than pre-ones and decreased with increasing antrum preservation. CONCLUSIONS: These results could be a starting point for analysis of anatomical features, bariatric surgery and GERD occurrence. Further studies based on 3D geometries need to be performed.