Endoscopic augmentation of the esophagogastric junction with polymethylmethacrylate: durability, safety, and efficacy after 6 months in mini-pigs.

ABSTRACT

BACKGROUND AND AIMS: Endoscopic augmentation of the esophagogastric junction (EGJ) with polymethylmethacrylate (PMMA) has been reported in an experimental short-term study. We assessed whether endoscopic augmentation of the EGJ with PMMA is durable, safe, and efficacious after 6 months in mini-pigs. METHODS: Ten mini-pigs were studied under anesthesia. After a pilot study in two animals, eight mini-pigs underwent lower esophageal sphincter (LES) manometry and gastrostomy with measurement of gastric yield volume (GYV) and gastric yield pressure (GYP). Endoscopic implantation of PMMA was performed aiming for the submucosa of the EGJ. Six months later, LES manometry and GYV and GYP measurements were repeated and animals were sacrificed, followed by microscopic analyses of the EGJ. RESULTS: Out of 32 implants (four per animal), 29 (91%) were identified as submucosal nodules postmortem. PMMA deposits were found at microscopic analysis in all animals and located as follows [mean (range)] submucosa 61.5% (37.5-91%), muscularis propria 21.5% (0-58%), mucosa 11% (0-25%), and subserosa 6% (0-17%). Neither esophageal perforation nor death was observed. A significant increase in GYV (1,404 versus 905 ml; p = 0.02) and a borderline increase in GYP (8.1 versus 6.5 mmHg; p = 0.057) were detected 6 months later. CONCLUSIONS: Endoscopic augmentation of the esophagogastric junction with PMMA was durable and had no complications after 6 months. However, the occurrence of implants in the subserosa requires technical refinement before use in clinical trials.