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Endoscopic gastroplasty for GERD: not as good as billed? A single-center 6 month report
S22
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
65 Endoscopic gastroplasty for GERD: not as good as billed? A singlecenter 6 month report John T Maple, Jeffrey A Alexander*, Christopher J Gostout, Ian D Norton, Joseph A Murray, Ross A Dierkhlsing and Mary A Knipschield. 1 Internal Medicine, Mayo Clinic, Rochester, Minnesota, United States. Purpose: To assess the effectiveness of endoscopic gastroplasty for GERD in terms of clinical symptoms and medication usage at 6 months posttreatment. Methods: 23 consecutive patients at a tertiary care facility underwent the Bess procedure for symptoms of GERD, chiefly heartburn and acid regurgitation. Initial pertinent data was obtained from a review of clinical charts and procedure logs. Then, a 25-question, multiple-choice survey was mailed to the patients at a mean time of 6.7 months after their procedures which contained previously validated questions about GERD symptoms and medication usage both before and after the procedure. The symptom scores were based on frequency (0 – 4, from less than once a month to daily) and severity (1– 4, from mild to very severe). The medication score was a 1– 8 scale, from antacid use as needed to twice daily double-dose PPI plus a nocturnal H2 blocker. 21 of the 23 patients were successfully contacted and participated in the study. Results: Of the 21 patients studied, a relatively large number of them (5/21, 23.8%) underwent repeat Bess procedures shortly after their first procedure, presumably due to an unfavorable initial response. This portends a significant difference in outcomes as demonstrated in the table below. A complete response was defined as symptoms or medication usage occuring less than once a month, whereas a partial response was defined as any improvement in the frequency or severity of symptoms, or taking a less intensive medicine regimen. Response After 1st Procedure Heartburn Acid Regurgitation Medication Response After Last Procedure Heartburn Acid Regurgitation Medication
None
Partial
Complete
10 (55.6%) 10 (62.5%) 10 (50.0%)
6 (31.6%) 2 (12.5%) 6 (30.0%)
2 (10.5%) 4 (25.0%) 4 (20.0%)
None 6 (33.3%) 5 (31.3%) 7 (35.0%)
Partial 9 (50.0%) 6 (37.5%) 9 (45.0%)
Complete 3 (16.7%) 5 (31.3%) 4 (20.0%)
Partial or Complete 8 (44.4%) 6 (37.5%) 10 (50.0%) Partial or Complete 12 (66.7%) 11 (68.8%) 13 (65.0%)
Total 18 (100%) 16 (100%) 20 (100%) Total 18 (100%) 16 (100%) 20 (100%)
The variables of age, gender, time of procedure, and number of sutures placed did not affect the responses in this relatively small cohort. None of the patients had hiatal hernias ⬎2 cm. The most common side effect following the procedure was a sensation of early satiety, experienced by 3/21 (14.3%) of the patients.
Conclusions: The Bess endoscopic suturing procedure in our hands has led to only moderate success: about one-third of patients had no significant response, and only one-fifth were able to be managed off of GERD medications.
66 The impact of gastroesophageal reflux disease (GERD) on quality of life (QOL) in patients with systemic sclerosis Houssam E Mardini, MD1, Hiran Fernando, MD2*, Thomas A Medsger, Jr., MD3, James Luketich, MD2, Mo Rosenblatt, MD1 and Arnold Wald, MD4. 1Medicine, UPMC Shadyside, Pittsburgh, Pennsylvania, United States; 2Thoracic Surgery, UPMC Presbyterian, Pittsburgh, Pennysylvania, United States; 3Rheumatology, and Clinical Immunology, UPMC Presbyterian, Pittsburgh, Pennsylvania, United States; and 4 Gastroenterology, UPMC Presbyterian, Pittsburgh, Pennsylvania, United States. Purpose: Many patients with systemic sclerosis (SSc) will develop severe GERD. This study was performed to evaluate the incidence and effect of GERD on QOL in patients with SSc.
Methods: Mailed questionnaires were returned by 326/527(61%) patients identified from the SSc databank of the University of Pittsburgh. 74 patients selected randomly were analyzed for this pilot study. Questionnaires included a clinical data form, the SF 36 (measures global QOL), the HRQOL (measures heartburn severity with a range from 0-best score to 45-severe score), and the SySQ. The SySQ is a SSc specific instrument which can be reported as a single overall score (best score ⫽ 0, worst score ⫽ 96) or as 4 domain scores (general, musculoskeletal, cardiopulmonary, and upper GI). Patients were dichotomized based on an HRQOL score of 15 or above, a value typically seen before operation for severe GERD. Statistical analysis included independent t-tests to compare mean scores between groups Results: Median age was 58 (range 25– 86) years. GERD was reported in 62 (83.8%) of patients. severe GERD (group A) was present in 24, and no/mild GERD (group B) in 50. Duration of SSc was 125 months (group A) and 135 months group B (p ⫽ ns). Overall SySQ scores were worse in group A (46 versus 28, p ⫽ 0.000). SySQ domain scores were significantly worse in the upper GI and general domains but were similar in the other two domains. 7 SF-36 domain scores are demonstrated in the table (higher value ⫽ better score). All scores were significantly worse than US normal values. Group A scores were significantly worse than B in 4 domains. Treatment for GERD in group A included proton pump inhibitors in 18 (75%), H2 blockers in 12 (50%), cisapride in 2 (8%). Esophageal dilation was required in 7 (29.2%) patients and food impaction requiring esophagoscopy occurred in 3 (12.5%). DOMAIN/ NORMS*
PF/84.15
RP/80.96
BP/75.15
VT/60.86
SF/83.28
RE/81.26 MH/74.74
Group A 38.12 22.91 42.45 29.16 52.75 47.25 61.87 Group B 52.90 43.00 54.84 44.80 69.40 68.02 69.60 Significance** P ⫽ 0.043 P ⫽ 0.065 P ⫽ 0.039 P ⫽ 0.004 P ⫽ 0.016 P ⫽ 0.070 P ⫽ 0.121
* United States normal values. ** Significance A versus B Table 1: Mean SF-36 domain scores: PF ⫽ physical function, RP ⫽ role-physical, BP ⫽ bodily pain, VT ⫽ vitality, SF ⫽ social functioning, RE ⫽ role-emotional, MH ⫽ mental health
Conclusions: Patients with SSC often develop severe GERD. Global and disease specific QOL is impaired in patients with severe GERD. This patient group should be evaluated further. Optimization of GERD treatment may improve QOL in these unfortunate patients. 67 Impact of EGD on the management of typical GERD: a prospective study of patients from primary care and GI outpatient clinics Christian M Mendez, MD, Jerri L Kinman, Rauol Joubran, MD, Paul W McKinney, MD, Phillip F Bressoud, MD and John M Wo, MD*. 1 Division of Gastroenterology/Hepatology and Department of Internal Medicine, University of Louisville, Louisville, KY. Purpose: Impact of utilizing EGD for management of GERD is unclear, especially in primary care pts. Aim: To test the hypothesis that EGD can influence and improve management decisions in typical GERD. Methods: A survey was distributed in primary care and GI clinics to identify pts with significant heartburn (HB), defined as chief complaint for office visit or taking meds for HB. Pts were classified into: 1)Alarm Symptoms (dysphagia, odynophagia, GI bleeding) or 2)Refractory HB (HB ⬎2 days/wk despite therapy). Pt’s MD had to concur that EGD was indicated. Pre-EGD med therapy decision was made on assumption that EGD was not available. End points for EGD influencing and improving management are given in table. Endpoints were pre-determined by consensus of investigators. EGD findings and actual management decisions were collected. Pts with EGD within 3 yrs and known Barrett’s esophagus (BE) were excluded. Chi-square tests/Yates’s correction were used. Results: 676 pts from 1,413 surveys had significant HB. 183 pts (48M/ 135F, median 48 yrs) met study criteria: 135 (74%) from primary care, 118 (64%) Caucasians, and 63 (34%) on PPI. 122 pts with alarm symptoms and 59 pts with refractory HB underwent EGD with no demographic differ-
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
65 Endoscopic gastroplasty for GERD: not as good as billed? A singlecenter 6 month report John T Maple, Jeffrey A Alexander*, Christopher J Gostout, Ian D Norton, Joseph A Murray, Ross A Dierkhlsing and Mary A Knipschield. 1 Internal Medicine, Mayo Clinic, Rochester, Minnesota, United States. Purpose: To assess the effectiveness of endoscopic gastroplasty for GERD in terms of clinical symptoms and medication usage at 6 months posttreatment. Methods: 23 consecutive patients at a tertiary care facility underwent the Bess procedure for symptoms of GERD, chiefly heartburn and acid regurgitation. Initial pertinent data was obtained from a review of clinical charts and procedure logs. Then, a 25-question, multiple-choice survey was mailed to the patients at a mean time of 6.7 months after their procedures which contained previously validated questions about GERD symptoms and medication usage both before and after the procedure. The symptom scores were based on frequency (0 – 4, from less than once a month to daily) and severity (1– 4, from mild to very severe). The medication score was a 1– 8 scale, from antacid use as needed to twice daily double-dose PPI plus a nocturnal H2 blocker. 21 of the 23 patients were successfully contacted and participated in the study. Results: Of the 21 patients studied, a relatively large number of them (5/21, 23.8%) underwent repeat Bess procedures shortly after their first procedure, presumably due to an unfavorable initial response. This portends a significant difference in outcomes as demonstrated in the table below. A complete response was defined as symptoms or medication usage occuring less than once a month, whereas a partial response was defined as any improvement in the frequency or severity of symptoms, or taking a less intensive medicine regimen. Response After 1st Procedure Heartburn Acid Regurgitation Medication Response After Last Procedure Heartburn Acid Regurgitation Medication
None
Partial
Complete
10 (55.6%) 10 (62.5%) 10 (50.0%)
6 (31.6%) 2 (12.5%) 6 (30.0%)
2 (10.5%) 4 (25.0%) 4 (20.0%)
None 6 (33.3%) 5 (31.3%) 7 (35.0%)
Partial 9 (50.0%) 6 (37.5%) 9 (45.0%)
Complete 3 (16.7%) 5 (31.3%) 4 (20.0%)
Partial or Complete 8 (44.4%) 6 (37.5%) 10 (50.0%) Partial or Complete 12 (66.7%) 11 (68.8%) 13 (65.0%)
Total 18 (100%) 16 (100%) 20 (100%) Total 18 (100%) 16 (100%) 20 (100%)
The variables of age, gender, time of procedure, and number of sutures placed did not affect the responses in this relatively small cohort. None of the patients had hiatal hernias ⬎2 cm. The most common side effect following the procedure was a sensation of early satiety, experienced by 3/21 (14.3%) of the patients.
Conclusions: The Bess endoscopic suturing procedure in our hands has led to only moderate success: about one-third of patients had no significant response, and only one-fifth were able to be managed off of GERD medications.
66 The impact of gastroesophageal reflux disease (GERD) on quality of life (QOL) in patients with systemic sclerosis Houssam E Mardini, MD1, Hiran Fernando, MD2*, Thomas A Medsger, Jr., MD3, James Luketich, MD2, Mo Rosenblatt, MD1 and Arnold Wald, MD4. 1Medicine, UPMC Shadyside, Pittsburgh, Pennsylvania, United States; 2Thoracic Surgery, UPMC Presbyterian, Pittsburgh, Pennysylvania, United States; 3Rheumatology, and Clinical Immunology, UPMC Presbyterian, Pittsburgh, Pennsylvania, United States; and 4 Gastroenterology, UPMC Presbyterian, Pittsburgh, Pennsylvania, United States. Purpose: Many patients with systemic sclerosis (SSc) will develop severe GERD. This study was performed to evaluate the incidence and effect of GERD on QOL in patients with SSc.
Methods: Mailed questionnaires were returned by 326/527(61%) patients identified from the SSc databank of the University of Pittsburgh. 74 patients selected randomly were analyzed for this pilot study. Questionnaires included a clinical data form, the SF 36 (measures global QOL), the HRQOL (measures heartburn severity with a range from 0-best score to 45-severe score), and the SySQ. The SySQ is a SSc specific instrument which can be reported as a single overall score (best score ⫽ 0, worst score ⫽ 96) or as 4 domain scores (general, musculoskeletal, cardiopulmonary, and upper GI). Patients were dichotomized based on an HRQOL score of 15 or above, a value typically seen before operation for severe GERD. Statistical analysis included independent t-tests to compare mean scores between groups Results: Median age was 58 (range 25– 86) years. GERD was reported in 62 (83.8%) of patients. severe GERD (group A) was present in 24, and no/mild GERD (group B) in 50. Duration of SSc was 125 months (group A) and 135 months group B (p ⫽ ns). Overall SySQ scores were worse in group A (46 versus 28, p ⫽ 0.000). SySQ domain scores were significantly worse in the upper GI and general domains but were similar in the other two domains. 7 SF-36 domain scores are demonstrated in the table (higher value ⫽ better score). All scores were significantly worse than US normal values. Group A scores were significantly worse than B in 4 domains. Treatment for GERD in group A included proton pump inhibitors in 18 (75%), H2 blockers in 12 (50%), cisapride in 2 (8%). Esophageal dilation was required in 7 (29.2%) patients and food impaction requiring esophagoscopy occurred in 3 (12.5%). DOMAIN/ NORMS*
PF/84.15
RP/80.96
BP/75.15
VT/60.86
SF/83.28
RE/81.26 MH/74.74
Group A 38.12 22.91 42.45 29.16 52.75 47.25 61.87 Group B 52.90 43.00 54.84 44.80 69.40 68.02 69.60 Significance** P ⫽ 0.043 P ⫽ 0.065 P ⫽ 0.039 P ⫽ 0.004 P ⫽ 0.016 P ⫽ 0.070 P ⫽ 0.121
* United States normal values. ** Significance A versus B Table 1: Mean SF-36 domain scores: PF ⫽ physical function, RP ⫽ role-physical, BP ⫽ bodily pain, VT ⫽ vitality, SF ⫽ social functioning, RE ⫽ role-emotional, MH ⫽ mental health
Conclusions: Patients with SSC often develop severe GERD. Global and disease specific QOL is impaired in patients with severe GERD. This patient group should be evaluated further. Optimization of GERD treatment may improve QOL in these unfortunate patients. 67 Impact of EGD on the management of typical GERD: a prospective study of patients from primary care and GI outpatient clinics Christian M Mendez, MD, Jerri L Kinman, Rauol Joubran, MD, Paul W McKinney, MD, Phillip F Bressoud, MD and John M Wo, MD*. 1 Division of Gastroenterology/Hepatology and Department of Internal Medicine, University of Louisville, Louisville, KY. Purpose: Impact of utilizing EGD for management of GERD is unclear, especially in primary care pts. Aim: To test the hypothesis that EGD can influence and improve management decisions in typical GERD. Methods: A survey was distributed in primary care and GI clinics to identify pts with significant heartburn (HB), defined as chief complaint for office visit or taking meds for HB. Pts were classified into: 1)Alarm Symptoms (dysphagia, odynophagia, GI bleeding) or 2)Refractory HB (HB ⬎2 days/wk despite therapy). Pt’s MD had to concur that EGD was indicated. Pre-EGD med therapy decision was made on assumption that EGD was not available. End points for EGD influencing and improving management are given in table. Endpoints were pre-determined by consensus of investigators. EGD findings and actual management decisions were collected. Pts with EGD within 3 yrs and known Barrett’s esophagus (BE) were excluded. Chi-square tests/Yates’s correction were used. Results: 676 pts from 1,413 surveys had significant HB. 183 pts (48M/ 135F, median 48 yrs) met study criteria: 135 (74%) from primary care, 118 (64%) Caucasians, and 63 (34%) on PPI. 122 pts with alarm symptoms and 59 pts with refractory HB underwent EGD with no demographic differ-