Use Of Antireflux Medications Research Articles

Complications and Antireflux Medication Use After Antireflux Surgery

Although antireflux surgery is increasingly common, few studies have assessed the associated complications and health care use after surgery. The aim of this study was to estimate postoperative complications and continued use of antireflux medications and to identify predictors of complications. Through a review of the Department of Veterans Affairs administrative databases, all patients undergoing antireflux surgery from October 1, 1990, through January 29, 2001, were identified. Of 3367 patients identified, 222 were excluded as a result of a diagnosis of esophageal cancer, achalasia, or because there was no diagnosis related to gastroesophageal reflux disease. Medication use was determined for 2406 patients who had a minimum of 1 year of follow-up, including 1 or more outpatient visits at least 6 months after surgery and during the time when national pharmacy records were available. Dysphagia was recorded in 19.4%, dilation was performed in 6.4%, and a repeat antireflux surgery was performed in 2.3%. The surgical mortality rate was .8%. Prescriptions were dispensed repeatedly for H2 receptor antagonists in 23.8%, proton pump inhibitors in 34.3%, and promotility agents in 9.2% of patients. Overall, 49.8% of patients received at least 3 prescriptions for one of these medications. A moderate proportion of patients undergoing antireflux surgeries experienced complications and approximately 50% of patients received multiple prescriptions for antireflux medications at a median of 5 years of follow-up evaluation. Therefore, before surgery is performed, patients considering surgery should be counseled fully about the risk for complications and the likelihood of continued antireflux medication use.

Amelioration of Gastroesophageal Reflux Symptoms following Roux-en-Y Gastric Bypass for Clinically Significant Obesity

Symptoms of gastroesophageal reflux disease (GERD) are frequent in patients with clinically significant obesity and are reported to improve after Roux-en-Y gastric bypass (RYGB). The purpose of this study is to determine timing and duration of improvement of GERD symptoms in patients undergoing RYGB. Prospectively collected data from patients who underwent RYGB from January 1998 to August 2004 were analyzed. Patients answered a standardized questionnaire pre- and postoperatively inquiring about frequency of GERD symptoms (none, one episode/ week, one episode/day, more than one episode/day) and medication use. Of 606 patients undergoing RYGB, 239 patients (39%) reported GERD symptoms preoperatively (mean age 43 +/- 1 years; body mass index 51 +/- 1 kg/m2). Of these, 89 per cent of patients reported improved at 3 months post-op and 94 per cent of patients 9 months post-op (P < 0.001). Medication usage decreased from 30 per cent to 3 per cent by 3 months and 5 per cent beyond 9 months (P < 0.001). Percentage of excess weight loss was 18 +/- 1 per cent and 75 +/- 2 per cent at 3 and 9 months, respectively. Symptoms of GERD significantly improve and use of antireflux medications is reduced after RYGB independent of weight loss. RYGB may be the treatment of choice for GERD in obese patients.

An infant with persistent wheezing due to non-acidic esophageal reflux

RATIONALE: We report the case of an 18 month old girl who presented with emesis, gagging, chronic cough, and wheezing. Despite the use of aggressive anti-reflux and asthma controller medications, her symptoms persisted. This case exemplifies the need to utilize a combined multichannel intraluminal impedance and pH study (MII-pH) to evaluate both acidic and non-acidic reflux as potential contributors to the supra-esophageal morbidity found in some cases of persistent respiratory distress.

Laparoscopic gastric banding and crural repair in the obese patient with a hiatal hernia.

A hiatal hernia is present in up to 50% of patients undergoing bariatric surgery. It has been claimed that laparoscopic adjustable gastric banding (LAGB) can both improve and induce reflux symptoms. The effect of a simultaneous crural repair and gastric banding has not yet been reported. Since 1999, all patients undergoing LAGB have a simultaneous crural repair if a hiatal hernia is present. Gastroesophageal reflux disease and dysphagia were assessed preoperatively and postoperatively using the modified DeMeester symptom-scoring system and the use of anti-reflux medication. 62 patients with a hiatal hernia have undergone simultaneous LAGB and crural repair, with a median follow up of 14 (3-38) months. There was no mortality, and complications occurred in 3 patients, namely pulmonary embolus, slippage requiring repositioning of the band and persistent dysphagia requiring band removal. 24 months following LAGB and crural repair, median BMI had fallen from 43 to 31 kg/m2 and median excess weight loss was 53%. Modified DeMeester symptom-score fell from a preoperative median of 3 (0-5) to a postoperative median of 0 (0-2) (P < 0.01, Mann Whitney U), and the number of patients on anti-reflux medication decreased from 44 to 6 (P < 0.01, Chi-squared). Crural repair in addition to LAGB does not increase the risk of slippage or dysphagia, significantly improves reflux symptoms and decreases the need for anti-reflux medication.

Management of Benign Vocal Fold Lesions: A Survey of Current Opinion and Practice

Empirical data are often not available to guide clinical practices in the treatment of benign mucosal lesions of the vocal folds. The purpose of this report is to describe opinions and practices in order to identify areas of consensus and discrepancy and thus guide future inquiry. A 16-item survey mailed to all active US members of the American Academy of Otolaryngology-Head and Neck Surgery (n = 7,321) included questions on the use of voice therapy; diagnostic testing; perioperative use of steroids, antibiotics, and antireflux medications; and use of lasers. Responses used a Likert 5-point scale with end anchors of 1 equaling "never" and 5 equaling "always" and were stratified according to lesion (nodules, polyps, cysts). A 16.5% response rate (n = 1,208) was obtained. A lack of consensus was most evident in the use of voice therapy for lesions other than nodules; antireflux medication; and intravenous steroids. Disagreement was also noted regarding the use of lasers, oral steroids, and antibiotics. Other than voice therapy as initial intervention for nodules, no statistically significant differences by lesion type exist regarding use of voice therapy, laser, or any medication. Prospective clinical trials addressing voice therapy, antireflux medications, steroids, and antibiotics are needed to inform clinical practice. Furthermore, treatment practices appear to be largely independent of lesion type. Therefore, traditional diagnostic categories do not seem to be useful guides to treatment, and may need to be reevaluated in light of improvements in diagnostic technology and surgical technique.

Endoscopic treatment of gastro-oesophageal reflux disease (GORD): a systematic review.

Gastro-oesophageal reflux disease represents an extremely common disorder which has a substantial impact on patients' quality of life and use of health care resources. Gastro-oesophageal reflux disease is a chronic relapsing disease for which a lifelong solution is needed. Until now the two competing therapeutic modalities have been the medical and surgical therapies. Quite recently a third option has become available. A number of endoscopic anti-reflux procedures have been described, with the common goal of creating an anti-reflux barrier, thus obviating long-term proton pump inhibitors and the cost and potential risk of laparoscopic Nissen fundoplication. In this review the different techniques are thoroughly examined and the results are critically evaluated, giving special emphasis to efficacy, safety and durability of these new anti-reflux procedures. Available data show that these anti-reflux techniques produce significant improvement in gastro-oesophageal reflux disease symptomatology and quality of life as well as reduce the use of anti-reflux medication, without causing serious morbidity or mortality. However, the majority of these techniques have failed to adequately control oesophageal acid reflux. Endoscopic anti-reflux therapies therefore sound very attractive-being less invasive than surgery-and show a significant promise, but are still in the early stages of assessment. Large-scale randomized multi-centre trials comparing control groups with sham procedures are essential to confirm their efficacy. Further studies are also necessary to determine what modifications these techniques require in order to produce maximum clinical efficacy and durability. However, considering that current therapies (both medical and surgical) of gastro-oesophageal reflux disease are highly effective, the need for such new endoscopic modalities may be questionable. Moreover, appropriate trials in dedicated centres should be carried out to assure that the enthusiasm commonly associated with new technology is justified and can be generalized to open-access endoscopists.

Symptoms are a poor indicator of reflux status after fundoplication for gastroesophageal reflux disease: role of esophageal functions tests.

If a patient develops foregut symptoms after a fundoplication, it is assumed that the operation has failed, and acid-reducing medications are often prescribed. Esophageal function tests (manometry and pH monitoring) are seldom performed early in the management of these patients. In patients who are symptomatic after fundoplication for gastroesophageal reflux disease, a symptom-based diagnosis is not accurate, and esophageal function tests should be performed routinely before starting acid-reducing medications. Prospective study. University hospital. One hundred twenty-four patients who developed foregut symptoms after laparoscopic fundoplication (average, 17 months postoperatively) underwent esophageal manometry and pH monitoring. Sixty-two patients (50%) were taking acid-reducing medications. Postoperative symptoms, use of antireflux medications, grade of esophagitis, esophageal motility, and DeMeester scores. Seventy-six (61%) of the 124 patients had normal esophageal acid exposure, while the acid exposure was abnormal in 48 patients (39%). Only 20 (32%) of the 62 patients who were taking acid-reducing medications had reflux postoperatively. Regurgitation was the only symptom that predicted abnormal reflux. These results show that (1) symptoms were due to reflux in 39% of patients only; (2) with the exception of regurgitation, symptoms were an unreliable index of the presence of reflux; and (3) 68% of patients who were taking acid-reducing medications postoperatively had a normal reflux status. Esophageal function tests should be performed early in the evaluation of patients after fundoplication to avoid improper and costly medical therapy.

“Floppy” Nissen vs. Toupet Laparoscopic Fundoplication: Quality of Life Assessment in a 5-Year Follow-Up (Part 2)

Quality of life as an outcome variable has become an important measure in clinical research. This study is the second part of a prospective assessment of the quality of life outcome, in a 5-year follow-up of patients who underwent laparoscopic Nissen fundoplication or Toupet fundoplication. Data from a 1-year follow-up have been previously published (part I). Using the Gastrointestinal Quality of Life Index (GIQLI), the quality of life data of 169 consecutive patients who had undergone a laparoscopic Nissen fundoplication (LNF; n = 104) or a laparoscopic Toupet fundoplication (LTF; n = 65), were evaluated 3 years and 5 years postoperatively. Six patients out of the initial study group (n = 175), including three from each group, were excluded from the main analysis because they had undergone laparoscopic re-fundoplication during the 1-year follow-up. Data from patients with repeat surgery have been analysed separately. In addition to administering the GIQLI, we evaluated patient satisfaction with surgery, possible surgical side effects or recurrent disease-related symptoms, the use of antireflux medication, and also surgical interventions in relation to initial antireflux surgery. In those patients, who were willing (n = 111) we also performed esophageal manometry and 24-hour pH monitoring 5 years postoperatively. At 3 years and 5 years postoperatively, the analysis of quality of life data showed that the GIQLI score remained stable in comparison with the 1-year follow-up data, with mean scores of 121 +/- 8.7 points in the LNF-group and 119.8 +/- 9 points in the LTF-group, at 5 years after surgery. Laparoscopic re-fundoplication was necessary in four patients due to a "slipping" Nissen (LNF group n = 1) or recurrent symptoms (LTF group, n = 3). In two patients in the LTF group herniation of a trocar incision was found. No patient suffered from severe surgical side effects. Patient satisfaction with surgery was rated as "excellent" or "good" in 97.9 % of patients. There were no significant differences between the groups concerning these data. The results of esophageal manometry and 24-hour pH monitoring also remained stable and showed normal values in all but two patients (in the LTF group), who suffered from mild and infrequent symptoms of recurrent heartburn without endoscopic signs of esophagitis. The outcome in patients who underwent laparoscopic re-fundoplication is comparable to the outcomes for those with a successful primary intervention. Both Nissen and Toupet laparoscopic fundoplication can significantly improve patients' quality of life during the 5 years following surgical intervention. Quality of life scores for both surgical groups were almost equal and postoperative outcomes were comparable to values in healthy controls. Patient satisfaction with surgical treatment was very high, even though repeat laparoscopic surgery was necessary in some cases. Patients who had a repeat procedure experienced nearly identical outcomes.

Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: Efficacy and potential mechanism of action

OBJECTIVES: The endoluminal delivery of radiofrequency energy to the gastroesophageal junction has been shown to decrease symptoms of gastroesophageal reflux disease in a multicenter study. In this single-center trial, we sought to further examine its efficacy and physiological effects in patients with uncomplicated gastroesophageal reflux disease. METHODS: Patients with chronic heartburn requiring maintenance antisecretory therapy but without a hiatal hernia >2 cm, severe esophagitis, or complications of gastroesophageal reflux disease were prospectively studied. Radiofrequency energy was delivered to the gastroesophageal junction using a transorally delivered, flexible bougie-tipped catheter and a thermocouple-controlled generator, under sedation and analgesia. The primary outcome measure was effect on reflux symptoms, assessed at baseline and at 1, 3, and 6 months, after treatment. Other outcome measures included effects on antireflux medication use, quality of life, overall patient satisfaction, esophageal motility, esophageal acid exposure, esophageal wall thickness, appearance of the cardioesophageal flap valve, and vagal efferent function. RESULTS: A total of 18 patients underwent successful outpatient treatment without a serious adverse event. A significant improvement in symptom scores (Gastroesophageal Reflux Disease [GERD] Activity Index: 112.5 [range 76.2–140.6] vs 81.0 (74.2–97.6); p < 0.0001) and antacid use (17/wk [range 0–81] vs 0 (0–10); p < 0.0001) was noted at 6-month follow-up. No adverse effect on abdominal vagal function was identified and no significant change in any esophageal motility parameter was seen; however, a trend was noted toward a reduction in the number of transient lower esophageal sphincter relaxations induced by gastric air distension (3.5/h vs 1.0/h, p = 0.13). No detrimental effects on peristalsis or swallow-induced lower esophageal sphincter relaxation pressure were seen. Nonsignificant trends ( p = 0.06) were noted regarding a decrease in the Hill score and an increase in esophageal wall thickness after treatment. Finally, although a decrease in all pH parameters in both the upper and lower esophagus was seen, none reached statistical significance. CONCLUSIONS: Radiofrequency energy delivery to the region of the gastroesophageal junction provides effective symptom relief over the short term in patients with uncomplicated gastroesophageal reflux disease. It may achieve its therapeutic effect by reducing the frequency of transient lower esophageal sphincter relaxations triggered by gastric distension.

Esophagectomy for adenocarcinoma in patients 45 years of age and younger

Esophageal adenocarcinoma in patients 45 years of age or younger is uncommon. We reviewed our experience with the surgical management of these patients to determine their clinical characteristics, pathologic findings, and treatment results. Thirty-two patients were identified through our surgical pathology database, and their medical records were reviewed to determine clinical characteristics, treatment, treatment-associated mortality, tumor staging, presence of Barrett's mucosa, and survival. In our series, patients were white (100%) males (96.9%) with a history of reflux (56.3%), cigarette smoking (40.6%), and alcohol consumption (59.4%), who presented with progressive solid food dysphagia (78.1%). A prior diagnosis of Barrett's mucosa or use of antireflux medications was noted in five patients each (15.6%). There were no operative deaths. Actuarial survival was 81.1% (95% confidence interval [CI] 66.1 to 96.2) at 12 months, 68.5% (95% CI 49.5 to 87.5) at 24 months, and 56.9% (95% CI 34.6 to 79.1) at 60 months. Our findings show that patients with esophageal adenocarcinoma 45 years of age or younger have similar clinical findings to those reported in other large series where the median age is in the sixth or seventh decade of life, supporting a uniform theory of tumor pathogenesis. Esophagectomy may be performed with low mortality, and survival is reasonable for early-stage disease. Young patients with Barrett's esophagus are not immune from the development of adenocarcinoma and need to be screened accordingly.

Dysphagia without endoscopically evident disease: to dilate or not?

OBJECTIVES: It is not known whether patients with symptoms of dysphagia but normal upper endoscopy benefit from empiric esophageal dilation. The aim of this prospective study was to determine whether patients with solid food dysphagia and normal upper endoscopy have symptomatic benefit from empiric dilation using a through-the-scope balloon. METHODS: Patients who were seen for complaints of solid food dysphagia and who had normal endoscopic examinations at our institution from 1998 through 1999 were identified. Those patients who had agreed before sedation to participate in the study, if eligible, were randomized to either sham or balloon dilation using an 18-mm through-the-scope balloon at the time of esophagogastroduodenoscopy. All potentially eligible patients who had given provisional consent completed a dysphagia questionnaire and a 10-cm visual analog dysphagia scale before endoscopy. Follow-up questionnaires were completed on day 1 and at 3 months and 6 months after the procedure. The primary endpoint of the study was the patient’s self-assessment of difficulty swallowing, based on the questionnaires. RESULTS: A total of 83 patients met the study criteria and were randomized to balloon dilation (n = 43) or sham (n = 40). The two groups were comparable in age, sex, severity of baseline dysphagia, and use of antireflux medication. Improvement in dysphagia comparing sham to balloon on day 1 was 66% versus 67% ( p = 0.99); at 3 months it was 82% versus 76% ( p = 0.56); and at 6 months it was 84% versus 73% ( p = 0.38). There were no reported complications in either group. CONCLUSION: The data from this prospective randomized, controlled study do not support the practice of empiric dilation in patients with symptoms of dysphagia without an endoscopically evident cause of dysphagia.

3554 Dysphagia without endoscopically evident disease: to dilate or not?

Background: It is not known whether patients with esophageal dysphagia and a normal EGD benefit from empiric dilation. A retrospective study suggested that such patients do have improvement following empiric dilation with a rigid dilator. We have recently reported that rigid and balloon dilators are equally effective in the treatment of benign lower esophageal strictures. Aim: The aim of this prospective study was to determine if patients with solid food dysphagia and a normal endoscopy have symptom benefit from empiric dilation using a through-the-scope (TTS) balloon. Methods: Patients with normal endoscopic exams at our institution from 1998-1999, with the complaint of lower esophageal solid food dysphagia were identified. Patients were randomized at the time of EGD to either sham or balloon dilation using an 18 mm TTS (Boston Scientific Corp, Microvasive Endoscopy, MA) balloon. All patients completed a dysphagia questionnaire and 10 cm visual analog dysphagia scale prior to endoscopy. Questionnaires were completed at day one, three-months, and six-months post-randomization. The primary endpoint of the study was the patient's self-assessment of difficulty swallowing using the questionnaires.Wilcoxon Rank Sum Test and Fisher's Exact Test were used for statistical analyses. Results: Fifty-four patients (27M; 27F) with a median age of 60 years (range 33-81 yrs) were randomized to either sham (n=26) or balloon (n=28) dilation. The two groups were comparable in age, gender, baseline dysphagia and use of anti-reflux medication. Dysphagia improvement comparing sham/balloon is shown: Day one 54% vs. 77% (p=.144); 3-month 46% vs. 44% (p=.99); 6-month 46% vs. 46% (p=.99). Although the initial response at day one was higher in the balloon group, the difference was not statistically significant. There were no reported complications in either group. Conclusion: The data from this prospective randomized controlled study would, therefore, not support the practice of empiric dilation in patients with lower esophageal solid food dysphagia without evidence of endoscopic causes for dysphagia. Background: It is not known whether patients with esophageal dysphagia and a normal EGD benefit from empiric dilation. A retrospective study suggested that such patients do have improvement following empiric dilation with a rigid dilator. We have recently reported that rigid and balloon dilators are equally effective in the treatment of benign lower esophageal strictures. Aim: The aim of this prospective study was to determine if patients with solid food dysphagia and a normal endoscopy have symptom benefit from empiric dilation using a through-the-scope (TTS) balloon. Methods: Patients with normal endoscopic exams at our institution from 1998-1999, with the complaint of lower esophageal solid food dysphagia were identified. Patients were randomized at the time of EGD to either sham or balloon dilation using an 18 mm TTS (Boston Scientific Corp, Microvasive Endoscopy, MA) balloon. All patients completed a dysphagia questionnaire and 10 cm visual analog dysphagia scale prior to endoscopy. Questionnaires were completed at day one, three-months, and six-months post-randomization. The primary endpoint of the study was the patient's self-assessment of difficulty swallowing using the questionnaires.Wilcoxon Rank Sum Test and Fisher's Exact Test were used for statistical analyses. Results: Fifty-four patients (27M; 27F) with a median age of 60 years (range 33-81 yrs) were randomized to either sham (n=26) or balloon (n=28) dilation. The two groups were comparable in age, gender, baseline dysphagia and use of anti-reflux medication. Dysphagia improvement comparing sham/balloon is shown: Day one 54% vs. 77% (p=.144); 3-month 46% vs. 44% (p=.99); 6-month 46% vs. 46% (p=.99). Although the initial response at day one was higher in the balloon group, the difference was not statistically significant. There were no reported complications in either group. Conclusion: The data from this prospective randomized controlled study would, therefore, not support the practice of empiric dilation in patients with lower esophageal solid food dysphagia without evidence of endoscopic causes for dysphagia.

3506 COMPARISON OF CONTROLLED RADIAL EXPANSION BALLOON DILATORS TO CONVENTIONAL BALLOON DILATORS IN PATIENTS WITH BENIGN ESOPHAGEAL STRICTURES.

BACKGROUND: The current treatment of benign esophageal strictures often relies on the use of successively larger reusable Savary dilators or disposable balloon catheters. Recently, a new balloon catheter has been designed in which the balloon material has been preprogrammed to reach three successively larger sizes, depending upon the inflation pressure. This allows one balloon to provide dilatation to three different diameters (CRETM balloon, Microvasive). AIM: To provide a prospective, multi-center, randomized comparison of the CRETM balloon to a standard balloon dilator with regards to ease of use, complications, and effectiveness in patients with benign esophageal strictures. METHODS: A total of 60 patients were studied. Forty men and 20 women, mean age of 67 (range 24-87), with benign esophageal strictures were randomized based on stricture severity. At the time of entry, the two groups were comparable with regards to age, gender, history of previous dilatation, presence of esophagitis, use of antireflux medication, severity of dysphagia, and stricture severity. The mean lumen diameter prior to dilatation was 12.3 mm in the CRETM group and the standard group was 12.7 mm. RESULTS: In comparing the effectiveness of the two groups, the dysphagia score within the first day was reduced by 3.5 in the CRETM group vs. 2.6 in the standard group, p=0.07. Maximum dilatation obtained was 17.3 mm in the CRETM group versus 17.1 mm in the standard group. Dilatation time was comparable, although the CRETM balloon deflated more quickly than the standard, 6 versus 28 seconds. A slightly smaller number of CRETM balloons were used per case than standard dilators, 1.2 versus 1.4. There was a trend in favor of the CRETM balloon in regards to effectiveness at one month with an improvement in dysphagia score of 2.8 vs. 1.9 (p=0.07). CONCLUSIONS: The CRETM balloon works at least as well as the standard balloon in dilatation of benign esophageal strictures. The CRETM balloon allows dilatation to progressively larger diameters using a single catheter. There is a trend that suggests the CRETM balloon might allow more effective dilatation with an increase in lumen size and reduction of symptoms. These trends should be explored in the context of a larger-scale randomized trial. BACKGROUND: The current treatment of benign esophageal strictures often relies on the use of successively larger reusable Savary dilators or disposable balloon catheters. Recently, a new balloon catheter has been designed in which the balloon material has been preprogrammed to reach three successively larger sizes, depending upon the inflation pressure. This allows one balloon to provide dilatation to three different diameters (CRETM balloon, Microvasive). AIM: To provide a prospective, multi-center, randomized comparison of the CRETM balloon to a standard balloon dilator with regards to ease of use, complications, and effectiveness in patients with benign esophageal strictures. METHODS: A total of 60 patients were studied. Forty men and 20 women, mean age of 67 (range 24-87), with benign esophageal strictures were randomized based on stricture severity. At the time of entry, the two groups were comparable with regards to age, gender, history of previous dilatation, presence of esophagitis, use of antireflux medication, severity of dysphagia, and stricture severity. The mean lumen diameter prior to dilatation was 12.3 mm in the CRETM group and the standard group was 12.7 mm. RESULTS: In comparing the effectiveness of the two groups, the dysphagia score within the first day was reduced by 3.5 in the CRETM group vs. 2.6 in the standard group, p=0.07. Maximum dilatation obtained was 17.3 mm in the CRETM group versus 17.1 mm in the standard group. Dilatation time was comparable, although the CRETM balloon deflated more quickly than the standard, 6 versus 28 seconds. A slightly smaller number of CRETM balloons were used per case than standard dilators, 1.2 versus 1.4. There was a trend in favor of the CRETM balloon in regards to effectiveness at one month with an improvement in dysphagia score of 2.8 vs. 1.9 (p=0.07). CONCLUSIONS: The CRETM balloon works at least as well as the standard balloon in dilatation of benign esophageal strictures. The CRETM balloon allows dilatation to progressively larger diameters using a single catheter. There is a trend that suggests the CRETM balloon might allow more effective dilatation with an increase in lumen size and reduction of symptoms. These trends should be explored in the context of a larger-scale randomized trial.

3454 Efficacy of radiofrequency energy delivery to the lower esophageal sphincter in the treatment of gerd.

Background: The delivery of radiofrequency energy (RFe) to the lower esophageal sphincter (LES) has been shown to augment the antireflux barrier in a porcine model. We sought to examine its effects in humans with GERD. Methods: Patients with chronic heartburn requiring maintenance PPI or high-dose H2RA therapy but without a hiatal hernia, severe esophagitis or complication of GERD were recruited. The following outcomes were measured at baseline and 3 months after RFe treatment: a)GERD symptoms, utilizing a validated GERD-Activity Index, b)use of antireflux medications, c)esophageal motility, including the frequency of transient LES relaxations (TLESRs) before and after stimulation with gastric air insufflation, d)ambulatory dual-channel esophageal pH testing, e)quality of life, and f)overall patient satisfaction. Results: Thus far, ten patients have completed the 3-month period of assessment. All underwent successful outpatient RFe treatment without serious adverse event. A single patient experienced some minor bleeding during the procedure. One patient failed treatment and resumed PPI therapy after 1 month. The other 9 remain off their previous antireflux medications. A dramatic improvement in symptom scores (113.4 vs. 82.4; p=0.023) and antacid use (14.5/week vs. 2.3/week; p=0.008) was noted. Improvements were also demonstrated in quality of life and overall patient satisfaction after treatment. No significant change in any esophageal motility parameter was seen; although, a trend was noted toward a reduction in the number of TLESRs induced by gastric air distension (5.3/hr vs. 3.3/hr; p=0.086). There were no detrimental effects on peristalsis or LES residual pressure. Finally, while a decrease in all pH parameters, in both the upper and lower esophagus, was seen, none reached statistical significance. Conclusions: Radiofrequency energy delivery to the region of the lower esophageal sphincter is a promising new modality in the management of GERD. It may achieve its effect by reducing stimulated TLESRs.

20: The Effect of Medical Treatment of Gastroesophageal Reflux on the Severity of Obstructive Sleep Apnea

Objective: To determine the extent to which gastroesophageal reflux (GER)—initiated laryngeal chemoreflexes contribute to obstructive sleep apnea (OSA). Methods: This study is a prospective clinical trial of an antireflux treatment protocol as a means of reducing the severity of OSA. The study population consists of male patients, ages 20 to 64 years, who have not received prior treatment for OSA or GER. Patients undergo ambulatory pH probe monitoring and overnight polysomnography. Patients with evidence of both GER and OSA are treated for 30 days with omeprazole, 20 mg by mouth twice daily, as well as a standard antireflux regimen. After this treatment, patients undergo repeat polysomnography to document changes in apnea index (AI), hypopnea index (HI), respiratory disturbance index (RDI), and minimum oxyhemoglobin saturation. Results and Conclusions: Changes in AI, HI, RDI, and minimum oxyhemoglobin saturation will be presented and discussed, as will the use of antireflux medications as a modality for the treatment of OSA.