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Per oral endoscopic Nissen fundoplication: The introduction of a new era
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P E R ORAL ENDOSCOPIC N I S S E N FUNDOPLICATION: THE INTRODUCTION OF A NEW ERA Rodney J. Mason, Tom R. DeMeester, Univ of Southern CA, Los Angeles, CA; Marc 0. Schurr, Gerhard F. Buess, Daniel Kalanovic, Eberhard-KarlsUniversity, Tuebingen Germany A new endoscopic procedure for the treatment of gastroesophageal reflux disease (GERD) is being developed. The goal of the procedure is to constrnct a fundoplication using an entirely endoscopic technique, potentially reducing the risks and costs of surgery. The procedure involves the invagination and fixation of the gastroesophageal junction creating a functional nipple-valve at the lower esophageal sphincter. It utilizes a system of per oral devices developed in cooperation between Boston Scientific/Microvasive, Natick, MA, the Steinbeis Transfer Center Healthcare Technologies, and the Section for Minimally Invasive Surgery of the Eberhard Karls Universit3; Tuebingen, Germany. These devices grasp, fold, and remodel the distal esophagus and proximal fundus to create a valvular structure comparable to that created by a Nissen fundoplication (Fig 1-3). A 6ram gastroscope is advanced through the lumen of the grasping device so that the procedure can be performed under direct vision. Bioabsorbable clips are used to fasten the esophageal and gastric tissue folds (Fig 4). Feasibility studies have been successfully performed in ten adult baboons. Two tissue clips were placed in each quadrant around the gastroesophageal junction to form each valve. One animal died 6 days postoperatively from a mediastinal abscess. Endoscopic evaluation a t ~ r six weeks demonstrated an intact nipple-valve in 8 of 9 animals. This new procedure is promising and may prove to be an effective, endoscopic means of managing chronic, symptomatic GERD.
I
ENDOSCOPIC IMPLANTATION OF A BIOPOLYMER IN THE LOWER ESOPHAGEAL SPHINCTER FOR GASTROESOPHAGEAL REFLUX : A PILOT STUDY. Jacques Deviere, ULB - Hosp Erasme, Brussels Belgium; David Silverman, Enteric Medical Tech, Palo Alto, CA; A. Pastorelli, Policlinico Gemelli, Rome Italy; Hubert Louis, ULB - Hosp Erasme, Brussels Belgium; Glen Lehman, Indiana Univ Medical Ctr, Indianapolis, IN; Olivier Le Moine, ULB - Hosp Erasme, Brussels Belgium; Guido Costamagna, Policlinico Gemelli, Rome Italy Background : gastroesophageal reflux disease (GERD) is the most frequent disorder of the esophagus. Endoscopic minimally invasive treatment is desirable. Up to now, mid-term results of injections techniques have been disappointing. Methods : a pilot study was conducted in patients with GERD needing continuous PPI therapy who accepted to receive injections of Ethinyl-Vinyl-Alcohol (EVA, Enteryx TM) into the muscle of the cardia. Primary endpoints were the safety of the procedure, the effect on LES pressure and the stability of the injected material. Secondary endpoint was the effect of treatment on heartburn score evaluated off PPI. Results : EVA injection into the cardia resulted in the creation of a circular diffusion of the product in 10/15 cases, suggesting that implantation into the muscle is feasible. It resulted in an increase of LES pressure in 13/15 cases, at 1 month, which was sustained at mid-term (4 to 12 months) (LES pressure of 12.2±0.9,18.1±1.6" and 16.7±1.3" at baseline, I month and 4-12 months, respectively ; p<0.01 from baseline). This was also associated in a sustained reduction of the heartburn score evaluated off PPI (3.40±0.13 vs 1.53±0.24 and 1.80±0.26 at baseline vs 1 month and 4-6 months, respectively ; p<0.01). Nine of the 15 patients had m ore than 50% of the material remaining in place at 4-12 months and only 2 had lost more than 75% of the EVA injected. Persistence of >50% of the material was associated with the obtention of a circular injection. Only 4/15 patients had to go back to low doses of PPI after 4-12 months; Only mild retrosternal discomfort was observed in 8/15 patients, always disappearing aider a maximum of 3 days. Conclusions : EVA implantation in the muscle of the cardia is feasible and safe. It leads to a sustained increase in resting LES pressure. This is associated with a sustained improvement of heartburn score measured off PPI in patients previously needing continuous therapy.
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AB74
Fig 1
Fig 2
Fig 3
Fig 4
GASTROINTESTINAL ENDOSCOPY
SYMPTOMATIC RESPONSE TO ENDOLUMMqAL GASTROPLICATION (ELGP) IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD): A lVlIYLTICENTER EXPERIENCE. Isaac Raijman, Gastroenterology and Liver Assoc, PA, Houston, TX; Tamir Ben-Menachem, Henry Ford Hosp, Detroit, MI; Gurunath Reddy, Digest Disease Assoc, Houston, TX; S Weiland, Yang Chan, UHSCC, Denver, CO Introduction: ELGP is a new therapeutic option for pts with GERD. The results of a recent multicenter study were favorable with an improvement in heartburn (HB) and regurgitation (RTN) of approximately 70-80% yet no significant change in manometric or pH parameters. We report our multicenter experience including tertiary and community centers. The primary endpoint was symptomatic response. We did not systematically assess manometric or pH parameters and thus they are not reported. Methods: There were 88 pts, 54 women, mean age 42.5 years and an average weight of 201 lbs. None had significant esophageal motility disorder or clinical evidence of gastroparesis. Severe daily HB occurred in 79.5% and severe daily RTN in 75%. Ninety-two percent were on proton pump inhibitors, 18% on H-2 blockers and 19% on prokinetics. Esophagitis grade O occurred in 4%, grade I in 74%, grade II in 10% and grade IV (Barrett s) in 2%. A hiatal hernia was present in 75%, being >2 cms in 6 pts. ELGP was performed with 2 plications in 82% and 3 plications in 18%, 96% being circumferential. Seventy-one % were performed under conscious sedation and the average procedural time was 37 rain (19-73). Results: HB resolved completely in 75/88 pts (85.2%), to <3 episodes a week in 5/88 (6%) while 8/88 (9%) had no improvement. RN resolved completely in 80/88 pts (90%) while 8/88 (9%) had no improvement. Sixty-five of 88 pts discontinued medications (74%), 15/88 (17%) took Rx occasionally while 8/88 (9%) continued the same dose. There were comparable results between 3 (14/16, 87.5%) and 2 (66/72, 91%) plications. Patients with large hiatal hernias (3-4 cms) had similar response to those with hernias < 2 cms. Both pts with Barrett s esophagus had complete symptomatic response. Conclusion: The results of these study compare favorably to those from the previously reported multicenter trial. We included pts with advanced esophagitis, larger hiatal hernias and higher average body weight. These results are very encouraging and the practice of ELGP should continue including pts with apparent less favorable clinical parameters.
VOLUME 53, NO. 5, 2001
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P E R ORAL ENDOSCOPIC N I S S E N FUNDOPLICATION: THE INTRODUCTION OF A NEW ERA Rodney J. Mason, Tom R. DeMeester, Univ of Southern CA, Los Angeles, CA; Marc 0. Schurr, Gerhard F. Buess, Daniel Kalanovic, Eberhard-KarlsUniversity, Tuebingen Germany A new endoscopic procedure for the treatment of gastroesophageal reflux disease (GERD) is being developed. The goal of the procedure is to constrnct a fundoplication using an entirely endoscopic technique, potentially reducing the risks and costs of surgery. The procedure involves the invagination and fixation of the gastroesophageal junction creating a functional nipple-valve at the lower esophageal sphincter. It utilizes a system of per oral devices developed in cooperation between Boston Scientific/Microvasive, Natick, MA, the Steinbeis Transfer Center Healthcare Technologies, and the Section for Minimally Invasive Surgery of the Eberhard Karls Universit3; Tuebingen, Germany. These devices grasp, fold, and remodel the distal esophagus and proximal fundus to create a valvular structure comparable to that created by a Nissen fundoplication (Fig 1-3). A 6ram gastroscope is advanced through the lumen of the grasping device so that the procedure can be performed under direct vision. Bioabsorbable clips are used to fasten the esophageal and gastric tissue folds (Fig 4). Feasibility studies have been successfully performed in ten adult baboons. Two tissue clips were placed in each quadrant around the gastroesophageal junction to form each valve. One animal died 6 days postoperatively from a mediastinal abscess. Endoscopic evaluation a t ~ r six weeks demonstrated an intact nipple-valve in 8 of 9 animals. This new procedure is promising and may prove to be an effective, endoscopic means of managing chronic, symptomatic GERD.
I
ENDOSCOPIC IMPLANTATION OF A BIOPOLYMER IN THE LOWER ESOPHAGEAL SPHINCTER FOR GASTROESOPHAGEAL REFLUX : A PILOT STUDY. Jacques Deviere, ULB - Hosp Erasme, Brussels Belgium; David Silverman, Enteric Medical Tech, Palo Alto, CA; A. Pastorelli, Policlinico Gemelli, Rome Italy; Hubert Louis, ULB - Hosp Erasme, Brussels Belgium; Glen Lehman, Indiana Univ Medical Ctr, Indianapolis, IN; Olivier Le Moine, ULB - Hosp Erasme, Brussels Belgium; Guido Costamagna, Policlinico Gemelli, Rome Italy Background : gastroesophageal reflux disease (GERD) is the most frequent disorder of the esophagus. Endoscopic minimally invasive treatment is desirable. Up to now, mid-term results of injections techniques have been disappointing. Methods : a pilot study was conducted in patients with GERD needing continuous PPI therapy who accepted to receive injections of Ethinyl-Vinyl-Alcohol (EVA, Enteryx TM) into the muscle of the cardia. Primary endpoints were the safety of the procedure, the effect on LES pressure and the stability of the injected material. Secondary endpoint was the effect of treatment on heartburn score evaluated off PPI. Results : EVA injection into the cardia resulted in the creation of a circular diffusion of the product in 10/15 cases, suggesting that implantation into the muscle is feasible. It resulted in an increase of LES pressure in 13/15 cases, at 1 month, which was sustained at mid-term (4 to 12 months) (LES pressure of 12.2±0.9,18.1±1.6" and 16.7±1.3" at baseline, I month and 4-12 months, respectively ; p<0.01 from baseline). This was also associated in a sustained reduction of the heartburn score evaluated off PPI (3.40±0.13 vs 1.53±0.24 and 1.80±0.26 at baseline vs 1 month and 4-6 months, respectively ; p<0.01). Nine of the 15 patients had m ore than 50% of the material remaining in place at 4-12 months and only 2 had lost more than 75% of the EVA injected. Persistence of >50% of the material was associated with the obtention of a circular injection. Only 4/15 patients had to go back to low doses of PPI after 4-12 months; Only mild retrosternal discomfort was observed in 8/15 patients, always disappearing aider a maximum of 3 days. Conclusions : EVA implantation in the muscle of the cardia is feasible and safe. It leads to a sustained increase in resting LES pressure. This is associated with a sustained improvement of heartburn score measured off PPI in patients previously needing continuous therapy.
**738
AB74
Fig 1
Fig 2
Fig 3
Fig 4
GASTROINTESTINAL ENDOSCOPY
SYMPTOMATIC RESPONSE TO ENDOLUMMqAL GASTROPLICATION (ELGP) IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD): A lVlIYLTICENTER EXPERIENCE. Isaac Raijman, Gastroenterology and Liver Assoc, PA, Houston, TX; Tamir Ben-Menachem, Henry Ford Hosp, Detroit, MI; Gurunath Reddy, Digest Disease Assoc, Houston, TX; S Weiland, Yang Chan, UHSCC, Denver, CO Introduction: ELGP is a new therapeutic option for pts with GERD. The results of a recent multicenter study were favorable with an improvement in heartburn (HB) and regurgitation (RTN) of approximately 70-80% yet no significant change in manometric or pH parameters. We report our multicenter experience including tertiary and community centers. The primary endpoint was symptomatic response. We did not systematically assess manometric or pH parameters and thus they are not reported. Methods: There were 88 pts, 54 women, mean age 42.5 years and an average weight of 201 lbs. None had significant esophageal motility disorder or clinical evidence of gastroparesis. Severe daily HB occurred in 79.5% and severe daily RTN in 75%. Ninety-two percent were on proton pump inhibitors, 18% on H-2 blockers and 19% on prokinetics. Esophagitis grade O occurred in 4%, grade I in 74%, grade II in 10% and grade IV (Barrett s) in 2%. A hiatal hernia was present in 75%, being >2 cms in 6 pts. ELGP was performed with 2 plications in 82% and 3 plications in 18%, 96% being circumferential. Seventy-one % were performed under conscious sedation and the average procedural time was 37 rain (19-73). Results: HB resolved completely in 75/88 pts (85.2%), to <3 episodes a week in 5/88 (6%) while 8/88 (9%) had no improvement. RN resolved completely in 80/88 pts (90%) while 8/88 (9%) had no improvement. Sixty-five of 88 pts discontinued medications (74%), 15/88 (17%) took Rx occasionally while 8/88 (9%) continued the same dose. There were comparable results between 3 (14/16, 87.5%) and 2 (66/72, 91%) plications. Patients with large hiatal hernias (3-4 cms) had similar response to those with hernias < 2 cms. Both pts with Barrett s esophagus had complete symptomatic response. Conclusion: The results of these study compare favorably to those from the previously reported multicenter trial. We included pts with advanced esophagitis, larger hiatal hernias and higher average body weight. These results are very encouraging and the practice of ELGP should continue including pts with apparent less favorable clinical parameters.
VOLUME 53, NO. 5, 2001