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Comparison of Endoluminal Gastroplication Configuration Techniques: A Long Term Study
*W1517 Clinical Benefits of EnteryxÒ for High-Dose PPI Patients David A. Johnson, James Aisenberg, Lawrence B. Cohen, Robert A. Ganz, Glen A. Lehman, T. Raymond Foley, Jacques Deviere, Gregory B. Haber, Jeffrey H. Peters Purpose: The primary objective was to evaluate if the effectiveness of EnteryxÒ is predictable based on the pretreatment dose of proton pump inhibitor (PPI) required to control symptoms. Background: EnteryxÒ is a biocompatible copolymer designed to help the lower esophageal sphincter (LES) form a more effective reflux barrier to treat gastroesophageal reflux disease (GERD) symptoms. Recent data 12 months post-EnteryxÒ showed a $50% decrease in PPI use or total elimination of PPIs in 80.3% of 81 patients (76.5% of 85 patients, intent to treat), with improvements in health-related quality of life (GERDHRQL) heartburn and regurgitation scores (Johnson et al., AJG 2003;98: 1921). We investigated whether the clinical benefit at 12 months was related to the baseline PPI dose, dichotomized as standard or high dose. Methods: Analyses were conducted on 117 patients with PPI use and GERD-HRQL symptom score data available at 12 month follow-up visit. Standardized doses were calculated to permit comparisons across different PPIs. Patient data were dichotomized into High Dose and Standard Dose groups. Results: Following EnteryxÒ treatment at 12 month follow-up, High Dose PPI dependent GERD patients benefited from elimination or $50% decrease in PPI use in 88% of patients and benefited from GERD-HRQL symptom score improvement in 72% of patients. In the Standard Dose group the PPI improvement was found in 82% of patients and the GERDHRQL improvement in 79% of patients. A 2 3 2 contingency table with chi-square analysis determined no significant difference between the 2 groups in terms of PPI use (p=0.461) and symptom score (p=0.406). Conclusions: Following EnteryxÒ, patients who take High Dose PPIs at baseline experience similar clinical benefits as patients who take Standard Dose PPIs at baseline.
*W1518 The Transverse Fold ‘‘Flap Valve’’ at the Gastroesophageal Junction Does Not Prevent Reflux Disease When a Hiatal Hernia Is Present Benson T. Massey Background: The Hill Grade of the gastroesophageal junction (GEJ) flap valve is a significant determinant of erosive esophagitis. A hallmark feature of this valve supposedly is the presence of ‘‘a prominent fold of tissue along the lesser curve that was closely apposed to the endoscope,’’ a feature reportedly absent in hiatal hernias (HH) (GE 1996;44:541-7). However, a transverse fold (TV) is seen in some patients with HH. Aims: To characterize endoscopic and clinical features of a TV when seen with HH. Methods: During an 18 month period 10 patients were seen having a TV at the GEJ along with a fixed HH (Gp 1). These were compared to 40 previously identified patients with a Hill Grade IV GEJ (Gp 2) for demographic features, HH size, and evidence of GERD. Results: In all GP 1 patients the TV apposed the endoscope shaft snugly for long periods, although the GEJ would open for several seconds with a swallow or belch. Gp 1 patients did not differ from Gp 2 in age (62 vs. 68 yr), but were more likely to be female (90% vs 40%, p=.013). Gp 1 patients also had a longer HH (5 vs 3 cm, p<.001). Both Groups were similar in Los Angeles grade of esophagitis (mean 1.6 in both) and for the presence of any complication of GERD (80% vs 73%). Conclusions: The TV at the GEJ and a fixed HH are not mutually exclusive; indeed the presence of a large HH may make the TV easier to identify. Presence of the TV, if this is the ‘‘flap valve,’’ does not prevent the development of severe reflux disease in the setting of a fixed HH.
VOLUME 59, NO. 5, 2004
*W1519 Comparison of Endoluminal Gastroplication Configuration Techniques: A Long Term Study Richard Davis, Janese Gerhardt, Rebecca Welch, Charles Filipi Background: Endoluminal gastroplication (ELGP) is an increasingly popular therapy for gastroesophageal reflux disease (GERD). This 18 month trial compares outcomes associated with the circumferential and helical plication patterns. Methods: Twenty patients underwent ELGP. Nine patients received the circumferential pattern (Group A) and 11 the helical pattern (Group B). Inclusion criteria were: symptomatic GERD, dependence on medication, and a positive 24hour pH monitoring score. Exclusion criteria were: grade 3-4 esophagitis, hiatal hernia >2 cm, and symptoms refractory to medical therapy. Manometry, endoscopy and 24-hour pH monitoring were performed at baseline and 6 months. Symptom scores and medication use were assessed at baseline, 1, 3, 6, 12 and 18 months. Statistical analysis was performed using the paired t-test. Results: The average number of plications in group A was 2.11 and in group B was 3.91. During the study period 2 patients dropped out and 5 had a laparoscopic Nissen fundoplication. Out of the remaining 13 patients at 18 month follow-up the average Heartburn Score decreased from 68.1 to 22.5 (p<0.001), with associated significant decreases in heartburn severity (23.85 to 10.77, p=0.0005) and frequency (2.8 to 1.3, p<0.001). The average regurgitation score decreased from 2.0 to 0.5 (p=0.005). The average of all patients had an improvement in pH monitoring (2.24%) but it did not reach statistical significance. 25% of patients’ pH normalized per DeMeester Score. There was no change in manometric LES parameters. Group A did not differ significantly from Group B in measured parameters. If symptoms scores of patients were included that dropped out or underwent an anti-reflux operation there was no significant improvement in symptoms scores except heartburn frequency (2.9 to 1.8, p<0.01). Conclusions: Endoluminal gastroplication improves heartburn and regurgitation scores at 18 months. There is no benefit to additional plications using the helical pattern.
*W1520 The Clinical Efficacy of the Endoscopic Suturing Device for Treatment of Gastroesophageal Reflux Disease Julia J. Liu, Ria Ookubo, John Saltzman Purpose: The Endoscopic Suturing DeviceTM (ESD) (Wilson-Cook Medical Inc, Winston-Salem, NC) is a flexible transoral suturing system available for soft tissue apposition in the gastrointestinal tract. The efficacy of anti-reflux procedures using ESD has not been reported. The aim of this study is to determine the efficacy and safety of endoscopic anti-reflux procedures using the ESD. Methods: Patients with typical gastroesophageal reflux symptoms despite proton pump inhibitor (PPI) therapy were evaluated with upper endoscopy, manometry and 24 hour pH studies. Those patients with abnormal pH studies underwent endoscopic antireflux procedures using ESD. The anti-reflux procedure consisted of placement of circumferential mucosal sutures at 1 to 2 cm below the squamo-columnar junction. Outcomes assessed were symptoms of heartburn (HB) and regurgitation, medication use, and procedure-related complications. Reflux symptoms were assessed using the following scoring system: heartburn symptom score (HSS) = HB frequency times HB severity; where HB frequency is: 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily; HB severity is recorded by patient using a 32 point visual analog scale. Regurgitation frequency scores (RFS): 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily. All patients were evaluated at baseline and at 1 to 9 months following the procedure. Results: Ten patients (4 M, 6 F) with an average age of 47 years underwent anti-reflux procedures using ESD with a mean follow-up of 3 months. Pre-procedure endoscopic findings were: hiatal hernias (3), circumferential erosive esophagitis (1) and Barrett’s esophagus (1). Baseline manometry and ambulatory pH study findings were: lower esophageal sphincter pressure of 14.7 6 1.2 mmHg, total percentage time esophageal pH less than 4.0 was 13.4 6 2.7 %, and DeMeester score of 45 6 8. Both heartburn and regurgitation symptoms were improved after the procedure: HSS decreased from 43 6 9 to 18 6 10 (p=0.07) and RFS was reduced from 2.4 6 0.2 to 0.7 6 0.3 (p<0.01). PPI use also significantly decreased after the procedure, from an average of 12 to 4.2 doses/week (p<0.01). The patient with circumferential esophagitis demonstrated complete healing on follow-up upper endoscopy. One patient developed self-limited bleeding after the procedure. Conclusions: An anti-reflux procedure with Endoscopic Suturing Device (ESD) shows good short-term clinical efficacy in patients with gastroesophageal reflux disease refractory to medical therapy.
GASTROINTESTINAL ENDOSCOPY
P245
*W1518 The Transverse Fold ‘‘Flap Valve’’ at the Gastroesophageal Junction Does Not Prevent Reflux Disease When a Hiatal Hernia Is Present Benson T. Massey Background: The Hill Grade of the gastroesophageal junction (GEJ) flap valve is a significant determinant of erosive esophagitis. A hallmark feature of this valve supposedly is the presence of ‘‘a prominent fold of tissue along the lesser curve that was closely apposed to the endoscope,’’ a feature reportedly absent in hiatal hernias (HH) (GE 1996;44:541-7). However, a transverse fold (TV) is seen in some patients with HH. Aims: To characterize endoscopic and clinical features of a TV when seen with HH. Methods: During an 18 month period 10 patients were seen having a TV at the GEJ along with a fixed HH (Gp 1). These were compared to 40 previously identified patients with a Hill Grade IV GEJ (Gp 2) for demographic features, HH size, and evidence of GERD. Results: In all GP 1 patients the TV apposed the endoscope shaft snugly for long periods, although the GEJ would open for several seconds with a swallow or belch. Gp 1 patients did not differ from Gp 2 in age (62 vs. 68 yr), but were more likely to be female (90% vs 40%, p=.013). Gp 1 patients also had a longer HH (5 vs 3 cm, p<.001). Both Groups were similar in Los Angeles grade of esophagitis (mean 1.6 in both) and for the presence of any complication of GERD (80% vs 73%). Conclusions: The TV at the GEJ and a fixed HH are not mutually exclusive; indeed the presence of a large HH may make the TV easier to identify. Presence of the TV, if this is the ‘‘flap valve,’’ does not prevent the development of severe reflux disease in the setting of a fixed HH.
VOLUME 59, NO. 5, 2004
*W1519 Comparison of Endoluminal Gastroplication Configuration Techniques: A Long Term Study Richard Davis, Janese Gerhardt, Rebecca Welch, Charles Filipi Background: Endoluminal gastroplication (ELGP) is an increasingly popular therapy for gastroesophageal reflux disease (GERD). This 18 month trial compares outcomes associated with the circumferential and helical plication patterns. Methods: Twenty patients underwent ELGP. Nine patients received the circumferential pattern (Group A) and 11 the helical pattern (Group B). Inclusion criteria were: symptomatic GERD, dependence on medication, and a positive 24hour pH monitoring score. Exclusion criteria were: grade 3-4 esophagitis, hiatal hernia >2 cm, and symptoms refractory to medical therapy. Manometry, endoscopy and 24-hour pH monitoring were performed at baseline and 6 months. Symptom scores and medication use were assessed at baseline, 1, 3, 6, 12 and 18 months. Statistical analysis was performed using the paired t-test. Results: The average number of plications in group A was 2.11 and in group B was 3.91. During the study period 2 patients dropped out and 5 had a laparoscopic Nissen fundoplication. Out of the remaining 13 patients at 18 month follow-up the average Heartburn Score decreased from 68.1 to 22.5 (p<0.001), with associated significant decreases in heartburn severity (23.85 to 10.77, p=0.0005) and frequency (2.8 to 1.3, p<0.001). The average regurgitation score decreased from 2.0 to 0.5 (p=0.005). The average of all patients had an improvement in pH monitoring (2.24%) but it did not reach statistical significance. 25% of patients’ pH normalized per DeMeester Score. There was no change in manometric LES parameters. Group A did not differ significantly from Group B in measured parameters. If symptoms scores of patients were included that dropped out or underwent an anti-reflux operation there was no significant improvement in symptoms scores except heartburn frequency (2.9 to 1.8, p<0.01). Conclusions: Endoluminal gastroplication improves heartburn and regurgitation scores at 18 months. There is no benefit to additional plications using the helical pattern.
*W1520 The Clinical Efficacy of the Endoscopic Suturing Device for Treatment of Gastroesophageal Reflux Disease Julia J. Liu, Ria Ookubo, John Saltzman Purpose: The Endoscopic Suturing DeviceTM (ESD) (Wilson-Cook Medical Inc, Winston-Salem, NC) is a flexible transoral suturing system available for soft tissue apposition in the gastrointestinal tract. The efficacy of anti-reflux procedures using ESD has not been reported. The aim of this study is to determine the efficacy and safety of endoscopic anti-reflux procedures using the ESD. Methods: Patients with typical gastroesophageal reflux symptoms despite proton pump inhibitor (PPI) therapy were evaluated with upper endoscopy, manometry and 24 hour pH studies. Those patients with abnormal pH studies underwent endoscopic antireflux procedures using ESD. The anti-reflux procedure consisted of placement of circumferential mucosal sutures at 1 to 2 cm below the squamo-columnar junction. Outcomes assessed were symptoms of heartburn (HB) and regurgitation, medication use, and procedure-related complications. Reflux symptoms were assessed using the following scoring system: heartburn symptom score (HSS) = HB frequency times HB severity; where HB frequency is: 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily; HB severity is recorded by patient using a 32 point visual analog scale. Regurgitation frequency scores (RFS): 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily. All patients were evaluated at baseline and at 1 to 9 months following the procedure. Results: Ten patients (4 M, 6 F) with an average age of 47 years underwent anti-reflux procedures using ESD with a mean follow-up of 3 months. Pre-procedure endoscopic findings were: hiatal hernias (3), circumferential erosive esophagitis (1) and Barrett’s esophagus (1). Baseline manometry and ambulatory pH study findings were: lower esophageal sphincter pressure of 14.7 6 1.2 mmHg, total percentage time esophageal pH less than 4.0 was 13.4 6 2.7 %, and DeMeester score of 45 6 8. Both heartburn and regurgitation symptoms were improved after the procedure: HSS decreased from 43 6 9 to 18 6 10 (p=0.07) and RFS was reduced from 2.4 6 0.2 to 0.7 6 0.3 (p<0.01). PPI use also significantly decreased after the procedure, from an average of 12 to 4.2 doses/week (p<0.01). The patient with circumferential esophagitis demonstrated complete healing on follow-up upper endoscopy. One patient developed self-limited bleeding after the procedure. Conclusions: An anti-reflux procedure with Endoscopic Suturing Device (ESD) shows good short-term clinical efficacy in patients with gastroesophageal reflux disease refractory to medical therapy.
GASTROINTESTINAL ENDOSCOPY
P245