An Animal Study of Implantation of an Esophageal Pacemaker Based on Per-Oral Endoscopic Myotomy Approach for Alleviation of Esophageal Peristalsis Disorders.

BACKGROUND To restore esophageal peristalsis of achalasia patients by sequenced electric stimulation, an appropriate method must be established to implant the electrodes and pacemaker safely and effectively. We combined POEM (per-oral endoscopic myotomy) and abdominal wall puncture in pigs in order to explore a feasible procedure for the implantation. MATERIAL AND METHODS Five healthy male pigs were used in the present study with the permission of the Ethics Committee of Tianjin Medical University General Hospital. The electrodes were implanted in esophageal submucosal tunnel by POEM with the end of the electrode deposited in the abdominal cavity using NOTES technique. A pacemaker was then positioned under the skin of the abdomen. Finally, the electrodes were connected with the pacemaker with the help of endoscopy in the abdominal cavity. Esophageal peristalsis of these pigs after implantation was monitored for esophageal intraluminal pressure changes using electronic gastroscopy and a high-resolution manometry (HRM). The observation lasted for 6 h. RESULTS The procedure was effective to implant the electrode and the pacemaker using POEM and NOTES techniques. The connection of the 2 devices was also successful. Esophageal intraluminal pressure changes after electrical stimulation were recorded using HRM. Vital signs of the pigs were stable during the 6-h follow-up. CONCLUSIONS From this small-sample, short follow-up animal study, it was found that the implantation of esophageal electrodes and pacemaker based on POEM and NOTES is feasible, safe, and effective. Nevertheless, there is urgent need for long-term follow-up to confirm or disprove the safety of the procedure.