Abstract
Many patients with gastroesophageal reflux disease (GERD) either have symptoms refractory to proton-pump inhibitor (PPI) therapy or are worried about long-term risks of PPI. Not all patients are candidates for fundoplication. There is a need for novel endoscopic treatments for reflux, especially for those with altered anatomy who may not be candidates for fundoplication. To evaluate the safety and efficacy of a novel mucosal ablation and endoscopic suturing procedure for the management of patients with GERD. We performed a single-center prospective observational study on all patients who underwent this novel procedure. The standardized procedure involved APC ablation below the GE junction to improve tissue apposition prior to suturing. Next, in the forward viewing position, three sutures were placed along the lesser curvature of the cardia immediately below the esophagogastric junction to create a tightening and tissue bulge to prevent stomach contents from refluxing into the esophagus. Patients were discharged home after the procedure and followed up in clinic or by phone to assess treatment response. The primary outcome evaluated was reduction or cessation of medications used for treatment of GERD. The secondary outcomes evaluated were procedure tolerance and safety. 27 patients with a mean age of 67 years (range, 44-84) underwent the MASE procedure with typical procedural length of 25 minutes. Mean follow-up time was 124 days (range, 34-338). The indications for the procedure included either poorly controlled symptoms (48%) or a desire to discontinue their medication (52%). 7 patients (26%) had altered anatomy from prior surgery: Fundoplication (N=4), Billroth II (N=1), Roux-en-Y (N=1), and Sleeve gastrectomy (N=1). Pre-procedure, 22 patients (82%) were on once or twice daily PPI therapy and 5 patients were on H2-receptor antagonists/topical antacids. Of the 22 patients on daily PPI, 13 patients (59%) were able to discontinue their medication, and 3 patients (14%) were able to reduce their dose (see Figure). Of the 7 patients with altered anatomy, 4 patients (57%) were able to discontinue or reduce their PPI after the procedure. With regards to tolerance, the most common side effect was self-limited epigastric pain post-procedure (22%). One patient required an overnight stay in hospital for intravenous pain control. There were no other early or late complications. The MASE procedure represents a novel endoscopic treatment for GERD. This procedure may serve especially useful in managing complex patients with GERD, including those with altered anatomy who may not be candidates for surgical or endoscopic fundoplication.
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