Welcome to our weekly round-up of the latest bariatric and obesity-related papers published in the medical literature. As ever, we have looked far and wide to give you an overview of papers including outcomes from the MERIT Endoscopic sleeve gastroplasty RCT, the reasons for bariatric conversion procedures, SG vs Intensive Lifestyle Modification outcomes in class 1 patients with obesity, concomitant cholecystectomy during BPD-DS and MBS is an underutilised obesity treatment tool for both youth and adults (please note, log-in maybe required to access the full paper).
Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial
Outcomes from the Multi-center ESG Randomized Interventional Trial (MERIT) have demonstrated that Endoscopic Sleeve Gastroplasty (ESG) is a safe intervention that results in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. The results were featured in the paper, 'Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial', published in The Lancet.
The MERIT study is a multi-centre, prospective randomised clinical trial evaluating the safety and effectiveness of ESG, a minimally invasive, endoscopic weight loss procedure performed with Apollo's Endosurgery's OverStitch Endoscopic Suturing System.
In the study, patients with Body Mass Index (BMI) ≥30 and ≤40 kg/m² were randomised to treatment with ESG and lifestyle modification or to a control group which involved lifestyle modification alone. At the conclusion of the primary end point (52 weeks), qualifying patients in the control group were allowed to cross-over to ESG if they met certain conditions. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups.
At 52 weeks, the primary endpoint of mean percentage of EWL was 49.2% (SD 32.0) for the ESG group and 3.2% (18.6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13.6% (8.0) for the ESG group and 0.8% (5.0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks vs 13 (12%) of 110 in the control group (p<0·0001).
Three ESG patients (2.0%) experienced a device or procedure related serious adverse event, all of which resolved and did not require intensive care or surgical intervention.
The MERIT study was funded by Apollo Endosurgery and the Mayo Clinic.
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Bariatric Surgery Conversions in MBSAQIP Centers: Current Indications and Outcomes
Researchers from the University of Illinois Chicago, Chicago, IL, writing in Obesity Surgery, have reported that bariatric conversions (BC) represent the most frequent revisional bariatric procedure with GERD and weight loss failure (WLF) are the main causes.
In 2020, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database was expanded to include additional variables on BC. The researchers sought to analyse the indications and outcomes of BC.
Of the 168,548 bariatric surgeries analysed - 20,387 (12.1%) were revisional, and from those 15,031 (73.7%) were BC. The most converted index operations were sleeve gastrectomy (SG) (49.3%) and adjustable gastric banding (AGB) (45.9%). The most frequent conversions were SG to Roux-en-Y gastric bypass (RYGB) (40.3%) for gastroesophageal reflux disease (GERD) (54.2%) and weight loss failure (WLF) (35.8%), AGB to SG (27%) or RYGB (16.2%) for WLF (67% and 61.3%, respectively), and SG to biliopancreatic diversion with duodenal switch (3.2%) or single anastomosis duodeno-ileal bypass (2%) for WLF (91.2% and 92.4%, respectively).
Postoperative overall morbidity, serious morbidity, reoperation, and mortality rates ranged from 5.3 to 20.8%, 2.3 to 19.2%, 1.5 to 10%, and 0 to 0.8%, respectively.
The authors concluded that further research is needed to define the ideal BC according to the index procedure and indication.
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Comparison of Sleeve Gastrectomy vs Intensive Lifestyle Modification in Patients With a BMI of 30 to Less Than 35
Researchers from Sweden who compared sleeve gastrectomy (SG) with intensive non-operative obesity treatment in patients with class 1 obesity, have report that SG was associated with greater weight loss, diabetes prevention and diabetes remission, but was also associated with a higher incidence of substance use disorder and self-harm.
Writing in JAMA Network Open, the investigators compared 1,216 surgery patients and 2,432 lifestyle participants and recorded weight loss after intervention, changes in metabolic comorbidities, substance use disorders, self-harm, and major cardiovascular events.
Surgery patients had greater one-year weight loss vs controls (22.9 kg vs 11.9 kg; mean difference, 10.7 kg; 95% CI, 10.0-11.5 kg; p<.001). Over a median follow-up of 5.1 years (IQR, 3.9-6.2 years), surgery patients had a lower risk of incident use of diabetes drugs (59.7 vs 100.4 events per 10 000 person-years; hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; p=0.02) and greater two-year diabetes drug remission (48.4% vs 22.0%; risk difference 26.4%; 95% CI, 11.7%-41.0%; p<.001), but higher risk for substance use disorder (94 vs 50 events per 10 000 person-years; HR, 1.86; 95% CI, 1.30-2.67; p<0.001) and self-harm (45 vs 25 events per 10 000 person-years; HR, 1.81; 95% CI, 1.09-3.01; p=0.02). No between-group difference in occurrence of major cardiovascular events was observed (23.4 vs 24.8 events per 10 000 person-years; HR, 0.96; 95% CI, 0.49-1.91; p=0.92).
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Duodenal switch without versus with laparoscopic cholecystectomy: a perioperative risk comparative analysis of the MBSAQIP database (2015–2019)
US and Polish researchers have reported that concomitant cholecystectomy during biliopancreatic diversion with duodenal switch (BPD-DS) increases operative times but does not affect the other outcomes.
Reporting in Surgical Endoscopy, the authors conducted a retrospective analysis of the MBSAQIP database between 2015 and 2019. After performing propensity-score matching in BPD-DS with cholecystectomy (Group 1) and BPD-DS without cholecystectomy (Group 2) cohorts, 564 and 1128 patients, respectively were compared.
The BPD-DS with cholecystectomy group reported a higher rate of reoperation and reintervention compared to BPD-DS alone (3.9% versus 2.4% and 3.2% versus 2%, respectively), even though it did not reach statistical significance. The intervention time was significantly higher in Group 1 compared to Group 2 (192.4 ± 77.6 versus 126.4 ± 61.4 min). Clavien-Dindo complications (1–5) were similar between these two PSM cohorts.
The authors concluded that the decision of cholecystectomy at the time of BPD-DS should be left to the surgeon's judgment.
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Disparity Between United States Adolescent Class II and III Obesity Trends and Bariatric Surgery Utilization, 2015–2018
Researchers led by the University of Texas Health Science Center, School of Public Health, Dallas, TX, have reported that metabolic and bariatric surgery (MBS) is an underutilised obesity treatment tool for both youth and adults, and among ethnic minority groups in particular.
Reporting in the Annals of Surgery, the investigators wanted to determine the current US MBS utilisation rates in those with class II/III obesity and utilisation rates and 30-day postoperative outcomes.
The 2015 to 2018 youth and adult MBS utilization rates were calculated using MBSAQIP data (numerator) and National Health and Nutrition Examination Survey data (denominator). Two-sample tests of proportions were performed to compare the MBS utilization rates by age, ethnicity, and sex and expressed per 1000.
The overall 2015 to 2018 MBS utilisation rate for youth was 1.81 per 1000 and 5.56 per 1000 for adults (p<0.001). Adult patients had slightly higher percentage (4.2%) of hospital readmissions compared to youth (3.4%, p=0.01) but there were no other post-MBS complication differences.
From 2015 to 2018 the US prevalence of youth with class II/III obesity increased in Hispanics and non-Hispanic Blacks (P trend <0.001), but among youth who did complete MBS non-Hispanic Whites had higher rates of utilisation (45.8%) compared to Hispanics (22.7%) and non-Hispanic blacks 14.2% (p=0.006).
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