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Additional Reference Information

ENDOLUMINAL GASTROPLICATION (ELGP)
CLINICAL LITERATURE

Presented at Digestive Disease Week, 2002

Chen, YK et al. One-year follow-up of endoluminal gastroplication: clinical and economic outcomes of the U.S. multicenter trial. Gastrointest Endosc 2002; 55, abstract M1887. Summary: 183 patients studied 12 months post ELGP reported significant improvements in heartburn and regurgitation, while noting substantial cost-savings due to the elimination or reduction of GERD prescriptions, especially PPIs (p>0.0001). Pre-ELGP annual drug costs = $2,379 compared to $351 at 12 months following ELGP (p<0.0001), for an average annual drug cost-savings = $2,028.

Raijman, I et al. Endoluminal gastroplication improves GERD symptoms in patients with large hiatal hernia. Gastrointest Endosc 2002; 55, abstract W1576. Summary: GERD patients with large hiatal hernias followed up to one-year post-ELGP reported significant symptom relief and less need for prescriptive drugs (p<0.0001). These results compared favorably with patients presenting with hiatal hernias <2cm. To date, ELGP is the only endoscopic modality shown to work safely and effectively in patients with a large hiatal hernia.

Caca, K., et al. Endoluminal gastroplication for gastroesophageal reflux disease. Gastrointest Endosc 2002; 55, abstract M1888. Shahrier, M et al. Endoluminal gastroplication improves acid-related pulmonary symptoms in GERD patients. Summary: ELGP offers relief to GERD patients with acid-related pulmonary symptoms, as well as classic symptoms of heartburn and regurgitation. Comparison of pre and post-ELGP outcomes demonstrated significant clinical improvements at a mean follow-up of 6 months (p<0.0001).

Mahmood, Z et al. A comparison of Bard EndoCinch transoesophageal endoscopic plication with laparoscopic Nissen fundoplication for the treatment of gastroesophageal reflux disease. Gastrointest Endosc 2002; 55, abstract 463. Summary: Authors demonstrated that both techniques showed significant improvements in symptom score, reduction in proton pump inhibitors intake and quality of life assessments (p<0.001); Nissen procedure and recovery times are longer.

Lui, J, et al. The impact of anesthesiologist experience on endoluminal gastroplication. Gastrointest Endosc 2002; 55, abstract M1992. Summary: Study of 21 patients. Demonstrated that procedure time is 30% shorter when using an experienced anesthesiologists.

Chen, YK, Raijman, I, et al. U.S. multicenter study of ELGP for GERD patients: is it cost-effective? Summary: Report on 142 patients. Significant improvement in HB frequency, HB severity, HB symptom score and regurgitation frequency. Annualized cost savings from reduced antisecretory medications was $1,863 per patient (p<0.0001).

Raijman, I, Ben-Menachem, T, et al. Endoluminal gastroplication in patients with larger hiatal hernia. Summary: Report on 142 patients (same patient group as Chen; evaluation of large and small hiatal hernia sub groups). Noted significant symptom improvement in both groups. Noted significant improvement in regurgitation frequency in both large and small hiatal hernia groups. Reported the per patient cost savings was $2,509 in the large hiatal hernia group and $1,678 in the small hiatal hernia group (p<0.0001).

Presented at American College of Gastroenterology 66th Annual Scientific Meeting, 2001

Patel, V. Clinical utility of ELGP for GERD disease in private practice. Am J Gastroenterol 2001;9: abstract 89 Summary: A prospective study of 55 patients in the southwest. Symptom score reduced on average 66 points (p<0.001). Near complete resolution of regurgitation in 85% (p<0.001). 76% of patients off PPI completely, 11% on PPI <3x/wk, 13% unchanged.

Rothstein, R. Endoscopic Gastro Plication for the treatment of GERD: two year follow up results. Am J Gastroenterol 2001;9: abstract 107. Summary: Significant symptom reduction at 2-year follow up (mean follow up 25m, range 20.7-29.9). Heartburn severity (p-value 0.003). Heartburn score (p-value 0.006). Regurgitation ≥3d/wk was reported by 35.5% v. 67.7% at baseline (p-value 0.660). All patients were on medical therapy at baseline. At 2 yr follow up, 53% were completely off medication or required <1/2 of their original dose; 40% were on full dose medication.

*Starpoli, A., et al. Hiatal hernia and symptomatic response following Endoluminal Gastroplication in chronic gastroesophageal reflux disease. Am J Gastroenterol 2001;9: abstract 91. Summary: Report on experience in 21 patients. Heartburn symptom score improved from 48 to 12 in one group (small hiatal hernia) and from 54 to 19 in another (large hiatal hernia). Significant improvement in regurgitation; 60% - 75% reported no regurgitation at follow up.

Weiland, S., et al. Impact of ELGP on cost of medical therapy for patients with GERD. Am J Gastroenterol 2001;9: abstract 132. Summary: Heartburn resolved completely in 68%, partially in 11%, unresolved in 21%. Mean HB symptom score 71 pre-procedure and 16 post-procedure (p<0.001). Regurgitation resolved completely in 89%, partially in 4%, no improvement in 7%. Per patient annualized cost savings of $1,634 from reduced medications.

Additional Publications
Raijman I. Symptomatic response to endoluminal gastroplication in patients with gastroesophageal reflux disease: a multicenter experience. Submitted and under review Annals of Internal Medicine.

Goldsmith, H. Endoluminal gastroplication: a new therapeutic endoscopic procedure for gastroesophageal reflux disease. Gastroenterology Nursing, 2002, 25, (1), 15-19.

Mahmood Z. et al. EndoCinch Therapy for gastro-oesophageal reflux disease: a one year prospective follow-up. Accepted by GUT, May, 2002.

Filipi, C., et al. Transoral endoscopic suturing for gastroesophageal reflux disease: a multi-center trial. Gastrointest Endosc 2001, 53: 416-22.

Haber, G, et al. A 2 year follow up of 25 patients undergoing Endoluminal Gastroplication for gastroesophageal reflux disease. Gastrointest Endosc 2001, 53, AB116, abstract 3430.

Mahmood, Z. et al. Transesophageal endoscopic gastroplication (TEG) treatment for gastro-esophageal reflux disease (GERD). Gastrointest Endosc 2001, 53, AB141, abstract 4108.

Park, P. et al. Results of endoscopic gastroplasty for gastroesophageal reflux disease. Gastrointest Endosc 2001, 53, AB115, abstract 3427.

Pohl, H., Wood, K., Rothstein, R. Endoscopic therapy for gastroesophageal reflux disease: early experience with the Bard endoscopic suturing system and Stretta in one institution. Gastrointest Endosc 2001, 53, AB126, abstract 3464

Raijman, I. et al. Symptomatic response to endoluminal gastroplication (ELGP) in patients with gastroesophageal reflux disease: a multi-center study. Gastrointest Endosc 2001, 53, AB74, abstract 738.

Park, P., Swain, C.P. Endoscopic gastroplasty for GERD. Proceedings of the 8th International Congress of the European Association for Endoscopic Surgery 2000; Ed. Mouiel, J., Montori, A., 307-13.

Filipi, C. et al. Transoral endoscopic suturing for GERD: a multi-center trial," Gastrointest Endosc 2000, 51, AB143, abstract 4469.

Swain, C., Park, P. Endoscopic gastroplasty for GERD. Gastrointest Endosc 2000, 51, AB143, abstract 4470.

Swain, C. et al. Endoscopic gastroplasty for GERD. Gastrointest Endosc 1997; 45:AB85, abstract 242.