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Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures

      Abbreviations:

      ESG (endoscopic sleeve gastroplasty), SAE (serious adverse event)
      In response to the obesity epidemic, rates of bariatric surgery have increased, particularly laparoscopic sleeve gastrectomy, which is now the most commonly performed bariatric surgery worldwide. Laparoscopic sleeve gastrectomy excises the greater curvature of the stomach, resulting in a restricted tubular reservoir approximately 25% of its native volume. Although technically simple, safe, and effective for weight loss, sleeve gastrectomy is associated with increased health care utilization costs secondary to multiple known serious adverse events (SAEs), and increased prevalence of worsened or de novo GERD with unknown associated long-term risks of Barrett’s esophagus and esophageal adenocarcinoma.
      • Fayad L.
      • Adam A.
      • Schweitzer M.
      • et al.
      Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study.
      Given these limitations, particularly in patients with lower body mass index (between 30 to 40 kg/m2), endoscopic sleeve gastroplasty (ESG) is an attractive minimally invasive endoscopic alternative to surgery that expands the therapeutic benefits of effective obesity interventions targeting the GI tract to patients who do not qualify for or wish to pursue bariatric surgery.
      • Novikov A.A.
      • Afaneh C.
      • Saumoy M.
      • et al.
      Endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic band for weight loss: how do they compare?.
      In the largest series of patients undergoing ESG to date, Alqahtani et al
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmood A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      add to a growing body of literature that suggests ESG is ready for prime time in the evolving management paradigm of obesity and metabolic disease. In their first 1000 cases, the mean percentage of total body weight loss at 12 months was 15.0% ± 7.7%, with an SAE rate of <0.01, consistent with previously reported multicenter data.
      • Graus Morales J.
      • Crespo Pérez L.
      • Marques A.
      • et al.
      Modified endoscopic gastroplasty for the treatment of obesity.
      • Kumar N.
      • Abu Dayyeh B.K.
      • Lopez-Nava Breviere G.
      • et al.
      Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.
      • Lopez-Nava G.
      • Sharaiha R.Z.
      • Vargas E.J.
      • et al.
      Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up.
      • Sartoretto A.
      • Sui Z.
      • Hill C.
      • Dunlap M.
      • et al.
      Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study.
      To synthesize the evidence available to date to support the safety and midterm efficacy of ESG, we have collected all unique cases reported as large multicenter series, with care to avoid duplicated follow-up study results, which when combined with these data total 1607 unique cases. Across these data, percentage of total body weight loss at 6, 12, and 18 or more months was 15.8, 17.1, and 17.3, respectively (Fig. 1).
      Figure thumbnail gr1
      Figure 1Meta-analysis of percent total body weight loss after ESG.
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmood A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      • Graus Morales J.
      • Crespo Pérez L.
      • Marques A.
      • et al.
      Modified endoscopic gastroplasty for the treatment of obesity.
      • Kumar N.
      • Abu Dayyeh B.K.
      • Lopez-Nava Breviere G.
      • et al.
      Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.
      • Lopez-Nava G.
      • Sharaiha R.Z.
      • Vargas E.J.
      • et al.
      Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up.
      • Sartoretto A.
      • Sui Z.
      • Hill C.
      • Dunlap M.
      • et al.
      Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study.
      Perhaps the most critical information gleaned from the report by Alqahtani et al
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmood A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      stems from their very granular reporting of adverse events in these first 1000 cases. This information allows us to now set realistic expectations for the incidence and prevalence of SAE rates to be expected with ESG, particularly when combined with the international multicenter data now reported in the literature totaling 1607 unique cases. Across these 1607 cases, the SAE rate was 1.1%, with a total of 18 events, including 7 fluid collections, 6 cases of hemorrhage requiring blood transfusion and/or endoscopic treatment, 3 cases of refractory symptoms requiring endoscopic ESG reversal, 1 pneumoperitoneum and pneumothorax requiring percutaneous drainage, and 1 pulmonary embolism (Table 1). We anticipate the authors’ next 2000 cases will eventually be reported with an even lower adverse event rate as improvements in technique and perioperative care are made with time and experience.
      Table 1Serious adverse events across all major endoscopic sleeve gastroplasty reports totaling 1607 cases
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmood A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      • Graus Morales J.
      • Crespo Pérez L.
      • Marques A.
      • et al.
      Modified endoscopic gastroplasty for the treatment of obesity.
      • Kumar N.
      • Abu Dayyeh B.K.
      • Lopez-Nava Breviere G.
      • et al.
      Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.
      • Lopez-Nava G.
      • Sharaiha R.Z.
      • Vargas E.J.
      • et al.
      Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up.
      • Sartoretto A.
      • Sui Z.
      • Hill C.
      • Dunlap M.
      • et al.
      Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study.
      Serious Adverse EventNumber of Occurrences (%)
      Intraabdominal collection7 (0.4%)
      Hemorrhage requiring transfusion or endoscopic intervention6 (0.4%)
      Refractory symptoms requiring ESG reversal3 (0.2%)
      Pneumoperitoneum and pneumothorax1 (0.1%)
      Pulmonary embolism1 (0.1%)
      Perforation or death0 (0%)
      Total18 (1.1%)
      ESG, Endoscopic sleeve gastroplasty.
      Although weight loss outcomes and adverse event rates are in line with previous reports, the most notable difference in the experience of Alqahtani et al
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmood A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      from prior studies is the significant rate of postprocedure presentation to the emergency department. The reasons for this are multifactorial and likely involve technical and patient-specific factors. However, a notable difference in practice is the authors’ recommendation to patients for immediate presentation to the emergency department with any postprocedure symptoms of concern. This resulted in high utilization of this resource, whereby 215 patients (21.5%) were evaluated in the emergency department after the procedure. Our collective experience in the United States with readmission and emergency evaluation rate ranges from 1% to 5%, given that most of our patients are treated with postprocedure office visits and phone triage rather than compulsory emergency department evaluation.
      Several important issues remain unanswered by current studies, preventing the widespread adoption of ESG. In the United States, appropriate Current Procedural Terminology coding and insurance coverage remain significant barriers to utilization of endobariatric techniques. The impact of ESG on obesity comorbidities needs to be formally assessed and will likely provide the information and impetus necessary to lobby for widespread coverage of the procedure. A multicenter randomized trial is currently under way in the United States, which we hope will help shed light on these issues. In the meantime, endoscopists are increasingly positioned to play a vital role in the future therapy of obesity—arguably our world’s most significant public health problem to date.

      Disclosure

      Dr Abu Dayyeh is a consultant for USGI and Olympus and the recipient of research support from Apollo Endosurgery. The other author disclosed no financial relationships relevant to this publication.

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