Prospective single-site case series utilizing an endolumenal tissue anchoring system for revision of post-RYGB stomal and pouch dilatation.

Introduction: Interventional therapy for weight regain after gastric bypass surgery has been tempered by higher complications associated with revisional surgery. Endolumenal reduction of post-bypass stomal and pouch dilatation offers the promise of a safer approach. Questions still remain regarding safety and efficacy with these procedures. We report intra- and postoperative results to date utilizing an endolumenal suturing platform for this patient subset.

Methods: Patients who had regained significant weight 2+ years after Roux-en-Y gastric bypass (RYGB) after losing ≥ 50% of excess body weight (EBW) post RYGB underwent endolumenal stomal and pouch reduction if they endoscopically displayed post-bypass stomal and/or pouch dilatation. The platform was utilized to endolumenally reduce stoma size by creating circumferential folds with a tissue anchoring system. Anchors were also utilized to approximate gastric pouch tissue. Information regarding patient baseline status and data on procedural safety, intraoperative performance, postoperative weight loss, and anchor durability were recorded to date with use of this system.

Results: In 20/21 subjects we were able to successfully place anchors (one patient had occult G-G fistula which impaired visualization). Weight regain post RYGB averaged 59 lbs (N = 20). Stomal diameter was reduced on average by 53%, with pouch reduction averaging 41%. The number of anchors placed on average per case was 5.3. Operating room (OR) time averaged 91 min. There were no significant complications. Three- and 12-month esophagogastroduodenoscopy (EGD) results revealed preservation of most of the intraoperative stoma and pouch reduction, and presence of fibrotic tissue folds with continued presence of anchors at their original locations. Mean percentage excess weight loss (%EWL) at 6 months was 18% to date (N = 18). Mean weight loss at 6 months was 17.3 ± 15 lbs.

Conclusion: Clinical study of this endolumenal tissue approximation system has shown intraoperative safety and efficacy in reducing stoma and pouch dilatation post RYGB. Follow-up anchor durability to date is encouraging. Continuing weight loss is being tracked through ongoing endoscopic and clinical follow-up.