Nitin Kumar, MD1, Gontrand Lopez-Nava Breviere, MD2, Nicole P Sahdala, MD3, Manoel P Galvao Neto4, Barham K Abu Dayyeh, MD5, Natan Zundel6, Christopher C Thompson, MD1. 1Harvard Medical School, Brigham & Women’s Hospital, 2Hospital Universitario Madrid Sanchinarro, 3Universidad Pedro Henriquez Urena, 4Gastro Obeso Center and Mario Covas Hospital, 5Mayo Clinic, 6Florida International University Herbert Wertheim College of Medicine
Objective of the technology
Endoscopic sleeve gastroplasty entails gastric volume reduction via placement of full-thickness plications. This procedure potentially offers a reversible and minimally invasive option for the treatment of obesity. The objective of this study was to evaluate safety, technical feasibility, and patient outcomes after endoscopic sleeve gastroplasty.
Technology and methods
The series included four centers. Patients underwent gastroplasty using the Apollo OverStitch and tissue helix (Apollo Endosurgery, Austin, TX). Procedures were performed using running sutures with 6-12 stitches each. These were initiated in the gastric antrum. Once a sleeve had been formed in the antrum and gastric body, the fundus was reduced in a retroflexed position to reduce volume and accommodation. The fundus was sutured to the lower esophageal sphincter. Interrupted stitches were then placed to ensure complete closure and to reinforce the sleeve. Alternatively, the sleeve was formed by placing two parallel rows of interrupted stitches along the gastric body, and then the fundus was closed. Patients had nutritional and behavioral evaluation prior to the procedure, and dietary and lifestyle counseling postprocedure. Means are reported with standard error.
Results
The series included 104 patients (age 40.8 ±0.9 years and 80.2% female) at four centers. There were no significant adverse events. Patients had mean weight of 99.1 ±1.7 kg and BMI of 35.6 ±0.5 kg/m2 at the time of the procedure. Weight loss at 6 months was 17.0 ±1.0 kg and BMI had decreased to 29.7 ±0.7 kg/m2. Patients who reached 1 year of follow-up had 17.4 ±2.1 kg weight loss, and BMI had decreased to 29.1 ±0.9 kg/m2. Total body weight loss averaged 17.2 ±0.9% at six months and 17.6 ±1.9% at one year. Safety and feasibility were demonstrated; there were no significant adverse events.
Conclusions
Endoscopic sleeve gastroplasty demonstrated safety and feasibility in this interim analysis. Additionally, these multicenter results have demonstrated meaningful weight loss in the setting of dietary and lifestyle counseling. Further study is ongoing.
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