Abstract
Gastroesophageal reflux disease is commonly associated with a mechanically defective sphincter. A new intraluminal approach designed to correct the mechanical deficiency of the sphincter was developed and tested in 13 baboons. It consisted of an intussusception of the gastroesophageal junction to create a 'nipple-type' valve. Valve fixation was achieved with a 4 quadrant stapling technique which utilizes 8 receivered staples. Valve stability is maintained by an intramural injection of a sclerosant. Endoscopy and manometry were performed preop and at 6 months postop. After 6 months the gastric pressure and volume to open the valve was measured. The baboons were sacrificed and the valve submitted for histological examination. All baboons tolerated the procedure well with no evidence of any side effects. None showed any evidence of weight loss, vomiting or dysphagia. One baboon was euthenased at 5 months because of a left lung abscess. Results are presented as medians and compared using the Wilcoxon test (Table 1). Weight LES-Total Length LES - Intra-abdo Lenght RIP Pressure Vector Volume Preop 15.89 kg 2.1 cm 1.4 cm 6.3 mmHg 1273 Postop 17.6kg 3.0 cm 2.2cm 6.7 mmHg 2485 p value 0.009 0.003 0.045 0.326 0.054 After the procedure the esophageal body retained its normal contraction amplitude and peristaltic wave form. Staple site reactive mucosal changes were less with each successive endoscopy. Valve integrity was scored as 86 % intact when assessed circumferentially, and from base to apex. The dynamic features of the newly constructed valve showed that as the infused volume in the stomach increased, the LES - vector volume (a measure of resistance) increased, which countered the loss of sphincter length (Figure). The median opening eastric pressure and volume was 21 mmHg and 1525 mis. Histology revealed that the valve stability resulted from the intramural staples, and marked circumferential fibrosis This newly created valve was well tolerated, shows stability at 6 months, increases the lower esophageal sphincter's total and intra-abdominal length and functions as a flap valve as evidenced by a progressive increasing vector volume that occurs during gastric filling (Figure).