Endoscopic Gastric Plication Using an Articulating Endoscopic Circular (ACE) Stapler: Technique and Preliminary Results.

Laurent Biertho, MD, Stefane Lebel, MD, Frederic Hould, MD, Simon Marceau, MD, Santiago Horgan, MD, P Omelanczuk, MD, R Onguay, MD, M Sanchez, MD, N Pampillon, MD, C Penutto, MD, V Lasagni, MD, S Omelanczuk, MD, A Grigaites, MD, R Buxhoeveden, MD, V Gorodner, MD, E Santo, MD, S Fishman, MD, N Bouvy, MD, G Paulus, MD, M Avesaat, MD, T Verlaan, MD, E Mathus-Vliegen, MD, P Fockens, MD, S Biron, MD. Quebec Heart and Lung Institute, Department of Bariatric and Metabolic Surgery, Quebec, QC, Canada.

BACKGROUND: Endoscopic surgery, by avoiding any traumatism to the abdominal wall, has the potential to reduce the complication rate associated with a standard abdominal surgery. It has thus become an intensive research field in bariatric surgery. The Articulated Circular Endoscopic stapler (ACE, Boston Scientific Corp, Natick, USA) was developed to mimic the physiological effects of a sleeve gastrectomy, by creating a plication of the greater curvature of the stomach.

OBJECTIVES: (1) to describe the surgical technique of the ACE stapler procedure; (2) assess the safety and (3) to evaluate efficacy (weight loss) over a 24 month follow-up period

METHODS: We present the surgical technique and preliminary results of a pre-market, prospective, non-randomized, multi-center, phase I Trial. Multiple plications of the greater curvature of the stomach were created, under general anaesthesia, using a specifically designed endoscopic stapler. Primary endpoints included serious adverse events and mortality rate, evaluated after a mandatory overnight stay and at 3, 6, 9 and 12 months. Data are reported as a mean ± Standard Deviation for continuous variables.

RESULTS: 69 patients (57F/12M) were enrolled and treated at 6 centers in 4 countries.  The mean age of patients was 40±7 years, with an initial weight of 102±18kg, and BMI of 38±4kg/m2. A mean operative time of 104±40 minutes was required to create 9±1 (7-10) gastric plications per patient. There was no major intra-operative complication. Average hospital stay was 1.1±0.3 day. All patients were available for follow-up during a mean 7±3 months. Mean excess weight loss was 30±15% at 3m and 32±20% at 6m. Total body weight loss was 9.7±5% at 3m, and 10.3±6% at 6m. There was no mortality. One hundred twenty-nine adverse events (AE) were deemed related to the procedure or device. The most frequently occurring AEs were: abdominal pain 22.5% (29), oropharyngeal pain 17.8% (23), nausea 17.1% (22), and vomiting 14.7% (17). At 138 days post procedure, one patient experienced vertebro-basilar insufficiency which resulted in fainting. The patient was hospitalized and received medication for treatment. This event was considered serious (SAE) and unrelated to the procedure or device.

CONCLUSION: The preliminary results of this Phase I trial show a very favourable safety profile with encouraging weight loss. Long-term results are required to assess the risk/benefit ratio of this new endoscopic procedure.

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