Feasibility Of The Per-Oral Transesophageal Endoscopic Cruroplasty (Potec) Of The Diaphragmatic Hiatus: A Survival Study

Transluminal and intramural endoscopic procedures continue to increase in type and variety. In an acute animal model, we developed a Natural Orifice Transluminal Endoscopic Surgery (NOTES) procedure to access the diaphragmatic hiatus and perform cruroplasty. The Per Oral Transesophageal Endoscopic Cruroplasty (POTEC) was found to reliably and repeatedly identify all important structures at the diaphragmatic hiatus and perform a cruroplasty. The goals of this survival study were to ensure animals tolerated the procedure well without post-procedural complications and also to use the endoluminal functional imaging probe to show objective evidence that the endosuturing of the crura was effective. The survival study protocol was performed under IACUC approval and completed with the assistance of a veterinary medicine team. The POTEC procedure was completed in each Yorkshire pig as previously described. Ease of procedure was assessed via a Likert scale from 1-5. The EndoFLIP (Medtronic) device was used to determine esophageal diameter and distensibility prior to the procedure, immediately following the procedure, and immediately before necropsy which was performed 4-6 weeks following the procedure. Seven animals to date underwent the POTEC procedure under the survival protocol. At necropsy, the cruroplasty was intact in all animals. Two of the seven animals were euthanized early. One was euthanized due to fasciculation and knuckling (felt secondary to anesthesia/positioning). Pleuritis was appreciated without evidence of iatrogenic injury. The second animal was euthanized for decreased PO intake. Necropsy showed an abscess at the site of the suture and pleuritis. Three of the other animals showed no post-procedural symptoms. Necropsy showed adequate healing with microabscesses located at the site of the suture which were cultured and grew porcine oral flora. Two more animals are currently awaiting necropsy. The average Likert score for the procedures was 1.57 out of 5. At the time of the analysis, data on the EndoFLIP device was available on one animal. In that animal, with balloon distention to 40cc pre-procedure, diameter was 13.55mm and distensibility was 4.05mm2/mmHg. Prior to necroscopy, diameter was reduced to 10mm and distensibility to 1.7 mm2/mmHg. A NOTES approach to the diaphragmatic hiatus is feasible and reliable as determined in the acute animal protocol. The survival study shows that despite contained microabscesses at the endosuture site, 5 of 7 animals did well post-procedurally and were without symptoms. The Likert score from the endoscopist suggests that the procedure can be accomplished without difficulty once familiar. Preliminary EndoFLIP studies suggest that cruroplasty does clinically tighten the esophagus at the level of the LES.