Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up

BACKGROUND: The Stretta endoscopic antireflux procedure has effectively controlled symptoms of patients with GERD refractory to proton pump inhibitor (PPI) medication up to 1 year. OBJECTIVE: The aim of this study was to evaluate the efficacy of the Stretta procedure for patients with GERD based on symptom control, quality of life (QOL), and medication use. DESIGN: Prospective single-center case series. SETTING: Academic endoscopy referral center. PATIENTS: Adults with GERD symptoms and partial response to daily antisecretory medication. INTERVENTION: We have used the Stretta procedure for patients with GERD diagnosed by endoscopic or pH testing since 2000. Our primary assessment was a validated health-related QOL score for heartburn and regurgitation and GERD symptoms index performed at baseline, 12, 36, and 48 months after treatment. A secondary outcome measure was the dose and the frequency of antisecretory pharmaceutical use. RESULTS: We performed the Stretta procedure in 83 consecutive patients with persistent GERD symptoms. Complete matched data for follow-up evaluations are reported at 12, 36, and 48 months. The mean GERD QOL score was 2.4 (baseline), 4.6 (36 months), and 4.3 (48 months, P < .001). The mean GERD symptom score was 2.7 (baseline), 0.3 (36 months), and 0.6 (48 months P < .001). Daily medication usage was 100% (baseline) and 13.6% (48 months, P < .001). LIMITATIONS: Nonrandomized study design, lack of control arm, and lack of 24-hour pH. CONCLUSIONS: For these GERD patients followed to 4 years, the Stretta procedure was a safe, effective, and durable treatment, with significant and sustained improvements in GERD symptoms, QOL, and PPI elimination.     

Feasibility, safety, and efficacy of the Stretta procedure in Japanese patients with gastroesophageal reflux disease: first report from Asia

Background In recent years, various endoscopic treatments have become available to treat gastroesophageal reflux disease (GERD) in Western countries. The Stretta procedure, which uses radiofrequency energy, is one type of safe and effective endoluminal treatment for GERD. However, the feasibility, safety, and efficacy of the Stretta procedure in Japanese patients with GERD, who differ from Western peoples in their physiological characteristics, are not known. In 2006, we imported a Stretta system from the United States and investigated important clinical aspects of the system in Japanese patients with GERD. Methods This study was an open-label trial that enrolled patients with GERD who desired to undergo the Stretta procedure. Heartburn scores, medication use, overall satisfaction with the procedure, and adverse events were evaluated. Results Nine patients received the Stretta treatment between February and September 2006. Esophagogastroduodenoscopy just after treatment revealed a remarkable reduction in the expansion of the gastric cardia and small erosions in all patients. At 3 or 6 months after treatment, heartburn scores were significantly improved compared with pretreatment scores (5.0 ± 1.7 pretreatment vs. 0.7 ± 1.4 posttreatment, P = 0.007). In six of nine patients (66.7%), treatment significantly (P = 0.009) decreased medication use. There were no major adverse events. All patients were satisfied with this treatment. Conclusions The Stretta procedure safely reduced GERD symptoms and decreased medication use in Japanese patients with GERD. This treatment may thus be very useful for such patients, and it is hoped that a nationwide trial will be undertaken in Japan to obtain more extensive data.     

Improvement of objective GERD parameters after radiofrequency energy delivery: a European study

OBJECTIVE: The Stretta procedure is an endoluminal radiofrequency energy delivery system for the treatment of gastroesophageal reflux disease (GERD). The purpose of this study was to present, for the first time, the Stretta treatment experience from European centers. MATERIAL AND METHODS: Sixty patients with a history of GERD from six European centers underwent Stretta treatment from May 2001 to June 2003. All patients were at least partly responsive to daily proton-pump inhibitors. Esophageal motility, endoscopy, and ambulatory 24-h pH studies were done in all patients at baseline and 6 and 12 months after treatment. We evaluated medication use, satisfaction, GERD-health-related quality of life, 24-h pH-metry, manometry, and endoscopy. RESULTS: Sixty patients (31 M, 29 F, mean age 47+/-13 years, mean years of GERD 7.4+/-7.2) were treated with the Stretta procedure. At 12 months after treatment, 75% of the patients needed no medication or less medication than before treatment. They were more satisfied with their symptom control and had statistically significantly fewer GERD symptoms (mean lower esophageal sphincter (LES) pressure improved from 14.8+/-9.1 to 16.7+/-10.0 mmHg, p=0.002 and mean total reflux time from 16.7+/-12.8 to 8.8+/-6.6%, p=0.001). Quality of life (mean score decreased from 19.2+/-9.0 to 6.6+/-7.3, p<0.0001) and overall physical and mental health also improved significantly. CONCLUSIONS: The experience with the Stretta procedure performed at centers in Europe confirms that it is well tolerated and effective in the treatment of GERD. It has a favorable impact on medication requirements, LES pressure, esophageal acid exposure, and GERD symptom scores. The Stretta procedure should be considered for patients who are not satisfied with drug therapy, and who are considering anti-reflux surgery.     

Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure

BACKGROUND: Approximately 20% of patients with GERD do not respond to medical therapy. The Stretta radiofrequency antireflux procedure represents an alternative to failed drug therapy for GERD. OBJECTIVE: The aim of this study was to assess symptom and medication changes after the Stretta procedure during a 4-year follow-up period. DESIGN: Prospective case series on intent-to-treat basis. SETTING: Community practice. PATIENTS: Patients with GERD with persistent symptoms despite twice-daily proton pump inhibitor (PPI) medications. INTERVENTIONS: The Stretta procedure was performed in drug-refractory patients with GERD diagnosed by the presence of endoscopically evidenced esophagitis or abnormal esophageal pH testing. Symptom assessment was performed with a validated health-related quality-of-life questionnaire (with and without medication) at baseline and 6, 12, 24, 36, and 48 months after treatment. Complications of the procedure and medication usage were analyzed. MAIN OUTCOME MEASUREMENTS: Significant changes in symptom scores, GERD quality-of-life parameters, and medication usage on the basis of clinical outcomes. RESULTS: We report on a series of 109 consecutive patients treated with the Stretta procedure who have reached 4-year follow-up. Complete long-term follow-up assessment was available in matched data for 109 patients at 12 months, 108 patients at 24 months, 102 patients at 36 months, and 96 patients at 48 months. A second procedure was performed in 13 patients. Heartburn scores decreased from 3.6 to 1.18 (P < .001), total heartburn score (GERD health-related quality-of-life questionnaire) decreased from 27.8 to 7.1 (P < .001), and patient satisfaction improved from 1.4 to 3.8 (P < .001) (see ). Medication usage decreased significantly from 100% of patients on twice-daily PPI therapy at baseline to 75% of patients showing elimination of medications or only as-needed use of antacids/over-the-counter PPIs at 48 months (P < 0.005). There were no serious complications of the procedure. LIMITATIONS: This is an uncontrolled, nonrandomized case series in consecutive patients that does not include long-term pH or motility studies. CONCLUSIONS: This study in drug-refractory patients with GERD found the Stretta procedure to be a safe, effective, and durable treatment that produced significant improvements in heartburn and quality of life and decreased medication usage during a 4-year period of follow-up.     

微量射频技术治疗胃食管反流病的临床研究

目的评估内镜下微量射频技术治疗胃食管反流病的安全性,从改善胃食管反流病相关症状、提高患者生活质量、用药情况、食管炎分级等多方面探讨微量射频技术治疗胃食管反流病临床效果。方法对2007年6月至2010年3月接受微量射频治疗的90例胃食管反流病患者进行6—32个月的随访研究,选择观察患者治疗前、治疗后6个月、治疗后12个月时的胃食管反流症状积分（GERD—HRQL）、症状控制满意度、药物使用情况、食管炎程度。结果微量射频治疗后患者胃食管反流症状发作明显减轻,63例（70．0％）2个月内明显减轻,15例（16．7％）在2～6个月内减轻,8例（8．9％）6个月以后明显减轻,4例（4．4％）未显示改变。GERD—HRQL积分由治疗前的（25．6±9．0）,降至（7．3±4．1）（治疗后6个月,P〈0．01）和（8．1±3．9）（治疗后12个月,P〈0．01）;烧心积分由治疗前的（3．3±1．3）,降至（1．2±1．1）（P〈0．05）;治疗前仅31．1％的患者对药物控制症状的程度感到满意,而微量射频治疗后,86．7％的患者对症状的控制感到满意;治疗后12个月,患者满意度积分由治疗前的1．4升至4．0（P〈0．01）。射频治疗前,100．0％的患者需要使用PPI控制症状,其中有67．8％的患者需要PPI与2种或2种以上的其他药物合用,治疗后6个月,69例（76．7％）的患者不需服用PPI,或仅按需服用抗酸药或少量H2受体拮抗剂。术前41例有明确食管炎的患者,术后6个月,33例患者（80．5％）已无炎症改变,8例（19．5％）患者仍为A级轻度炎症。结论微量射频治疗技术可以显著改善胃食管反流症状,提高患者对治疗的满意度,显著减少PPI的用量,减轻食管炎的程度。该项技术具有操作简单、微创、安全、有效、副作用少、恢复快等特点,易被患者接受。微量射频治疗技术为难治性胃食管反流病患者提供了一种新的内镜下微创治疗方法。     

The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial

BACKGROUND: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. METHODS: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (相似文献   

Cost analysis of endoscopic antireflux procedures: endoluminal plication vs. radiofrequency coagulation vs. treatment with a proton pump inhibitor

BACKGROUND: Both endoluminal gastroplication and radiofrequency coagulation of the lower esophageal sphincter and gastroesophageal junction (Stretta procedure) represent emerging endoscopic therapies for GERD. The economic impact of endotherapy for GERD has not been described. The aim of this study was to apply a decision analysis model to compare the costs of endoluminal gastroplication vs. the Stretta procedures vs. a proton pump inhibitor for treatment of GERD. A cost minimization approach was used. METHODS: Model entry criteria were GERD responsive to daily or twice daily administration of a proton pump inhibitor. Performance characteristics of endotherapy were determined from published data. The baseline probabilities for annual endotherapy failure rates (20%), partial failure rates (10%), and complication rates (1%) were varied through a plausible range by using sensitivity analysis. Cost data for endotherapy were calculated from per case instrumentation costs plus professional fees plus facility fees for ambulatory patient classification codes; cost of treatment with a proton pump inhibitor was based on national average wholesale price. The endpoint was sustained resolution of GERD symptoms. RESULTS: In patients requiring twice daily use of a proton pump inhibitor for symptom relief, endotherapy proves to be the most economical strategy after 17 months. If uniform endotherapy failure rates over time are assumed, medication regains superiority after 29 months. Sensitivity analysis revealed that a proton pump inhibitor remains the most economical option beyond 3 years, provided annual endotherapy failure rates remain greater than 20% (endoluminal gastroplication) or 19% (Stretta). Pharmacotherapy is the least costly approach, irrespective of time, if the daily cost of a proton pump inhibitor is less than $140 a month or endotherapy costs more than $3400. For patients in whom symptoms are relieved with once daily dosing with a proton pump inhibitor, medication remains the most economical option regardless of endotherapy failure rate. CONCLUSION: Endotherapy appears to offer an economical treatment option for patients requiring a proton pump inhibitor twice daily, with its cost superiority enduring for 2.5 years. More long-term follow-up data are required to determine the durability of the endotherapy benefit over time.     

Influence of Radiofrequency Energy Delivery at the Gastroesophageal Junction (the Stretta Procedure) on Symptoms,Acid Exposure,and Esophageal Sensitivity to Acid Perfusion in Gastroesophagal Reflux Disease

Several studies have demonstrated that radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) induces symptom relief in gastroesophageal reflux disease (GERD), although improvement of acid exposure on pH monitoring was usually limited. A role for decreased esophageal sensitivity has been suggested. Our aim was to evaluate the influence of Stretta on symptoms, acid exposure, and sensitivity to esophageal acid perfusion in GERD. Thirteen patients with established proton pump inhibitor (PPI)-dependent GERD (three males; mean age, 51±10 years) participated in the study. Before and 6 months after the procedure symptom score, pH monitoring and Bernstein acid perfusion test were performed. The latter was done by infusing HCl (pH 0.1) at a rate of 6 ml/min 15 cm proximal to the gastroesophageal junction for a maximum of 30 min or until the patients experienced heartburn. Results were compared by Student’s t-test. Stretta procedure time was 51±4 min and no complications occurred. After 6 months, the symptom score was significantly improved (12.5±2.0 to 7.5±2.1; P<0.05), seven patients no longer needed daily PPI, and acid exposure was significantly decreased (11.6%±1.6% to 8.5%±1.8% of time pH<4; P<0.05). The time needed to induce heartburn during acid perfusion decreased from 9.5±2.3 to 18.1±3.4 min (P=0.01), and five patients became insensitive to 30-min acid perfusion, versus none at baseline (P=0.04). In conclusion, the Stretta procedure induces subjective improvement of GERD symptoms and decreases esophageal acid exposure. In addition, esophageal acid sensitivity is decreased 6 months after the Stretta procedure. The mechanism underlying this finding and its relevance to symptom control require further studies.     

Comparison of Stretta procedure and toupet fundoplication for gastroesophageal reflux disease-related extra-esophageal symptoms

AIM: To compare the outcomes between the Stretta procedure and laparoscopic toupet fundoplication (LTF) in patients with gastroesophageal reflux disease (GERD)-related extra-esophageal symptoms.METHODS: From January 2011 to February 2012, a total of 98 patients diagnosed with GERD-related extra-esophageal symptoms who met the inclusion criteria were enrolled in this study. All patients who either underwent the Stretta procedure or LTF treatment have now completed the 3-year follow-up. Primary outcome measures, including frequency and severity of extra-esophageal symptoms, proton pump inhibitor (PPI) use, satisfaction, and postoperative complications, were assessed. The results of the Stretta procedure and LTF therapy were analyzed and compared.RESULTS: There were 47 patients in the Stretta group and 51 patients in the LTF group. Ninety patients were available at the 3-year follow-up. The total of the frequency and severity scores for every symptom improved in both groups (P < 0.05). Improvement in symptom scores of cough, sputum, and wheezing did not achieve statistical significance between the two groups (P > 0.05). However, the score for globus hysterics was different between the Stretta group and the LTF group (4.9 ± 2.24 vs 3.2 ± 2.63, P < 0.05). After the Stretta procedure and LTF treatment, 29 and 33 patients in each group achieved PPI therapy independence (61.7% vs 64.7%, P = 0.835). The patients in the LTF group were more satisfied with their quality of life than those in the Stretta procedure group (P < 0.05). Most complications resolved without intervention within two weeks; however, two patients in the LTF group still suffered from severe dysphagia 2 wk after the operation, and it improved after bougie dilation treatment in both patients.CONCLUSION: The Stretta procedure and LTF were both safe and effective for the control of GERD-related extra-esophageal symptoms and the reduction of PPI use.     

Stretta:A valuable endoscopic treatment modality for gastroesophageal reflux disease

One potential option for the management of refractory gastro-esophageal reflux disease(GERD)is the delivery of radiofrequency energy to the gastro-esophageal junction(Stretta).This endoscopic therapy is safe,effective,durable,and repeatable if necessary and serves an unmet need for many GERD sufferers.Stretta could be effective in decreasing esophageal sensitivity to acid and in decreasing the gastro-esophageal junction compliance,which in turn contributes to symptomatic benefit by decreasing refluxate volume.Therefore,Stretta may serve as an endoscopic pain modulator and should be considered in patients with refractory symptoms despite proton pump inhibitors,as well as in patients with functional heartburn.     

Update on novel endoscopic therapies to treat gastroesophageal reflux disease: A review

Endoscopic treatments for gastroesophageal reflux disease(GERD) have become increasingly popular in recent years. While surgical intervention with the Laparoscopic Nissen Fundoplication remains the gold standard, two endoscopic interventions, specifically, are gaining traction in clinical use(Esophy X and Stretta). The Esophy X(Endo Gastric Solutions, Inc., Redmond, WA, United States) was developed as a method of restoring the valve at the GE junction through an endoluminal fundoplication(ELF) technique. Long-term data suggests that transoral incisional fundoplication(TIF) with Esophy X may be effective for symptom control and proton pump inhibitor reduction or cessation for up to 2-6 years. There is no evidence that Esophy X is more effective than surgical intervention. TIF may be most effective for patients with HH 2 cm and Hill Grade I/II valves. Stretta(Mederi Therapeutics, Greenwich, CT, United States) was approved by the Food and Drug Administration in 2000. It delivers radiofrequency energy to the lower esophageal sphincter and gastric cardia. Published reviews of the literature are conflicted in their recommendations of Stretta in the management of GERD. The literature suggests that the Stretta procedure has an acceptable safety profile and may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any sustained improvement in objective outcomes and there is no evidence that Stretta results in improved outcomes as compared to surgical intervention. Treatment modalities for GERD, as a field, suffer from a lack of standardization in primary and secondary outcomes. Although many studies have looked at health related quality of life, the tools used to do so are markedly heterogeneous. Future directions for the endoscopic treatment of GERD include novel techniques like endoscopic submucosal dissection.     

Pneumomediastinum following Enteryx injection for the treatment of gastroesophageal reflux disease

We describe the case of a 68-year-old female who developed pneumomediastinum following the "Enteryx" procedure for the treatment of gastroesophageal reflux disease (GERD). The patient required hospitalization and parenteral antibiotics and responded favorably to a conservative approach. Similar complications have been observed with other endoscopic treatment modalities for GERD such as Stretta and suturing techniques. Our patient represents the third reported case of a serious complication after Enteryx implantation.     

Treatment of gastroesophageal reflux disease using radiofrequency ablation (Stretta procedure): An interim analysis of a randomized trial

Background

Gastroesophageal reflux disease (GERD) is the most common chronic gastrointestinal disorder, affecting one third of the population worldwide. Recently, there has been a renewed interest in Stretta therapy in view of potential long-term side effects of PPIs and the durability of relief with fundoplication.

Method

Prospective randomized study comparing the Stretta treatment with controls receiving PPIs. Patient (>?18 years, n = 20) with symptoms of heartburn, regurgitation, abnormal esophageal acid exposure (≥?4%), and endoscopically confirmed esophagitis were included into the study. The primary measure was improvement in quality of life (QOL) and decrease in the frequency and severity of GERD symptoms.

Results

The mean age of the patients was 39 (±?15) years and controls were 34 (±?11) years. Three months after Stretta, 80% reported improvement in QOL compared to 40% in the control group. At the end of 3 months, significant (p < 0.05) improvement in GERD symptom score for heartburn, regurgitation, chest pain, and cough compared with the control group was observed. After Stretta treatment, 60% of the patients were free of PPIs whereas there was no change in the control group. Almost 80% of the patients on Stretta treatment were satisfied with the treatment compared to 30% of the patients in the control group.

Conclusion

Stretta was effective in the short-term for the management of GERD.

     

Gastroesophageal reflux disease and morbid obesity: To sleeve or not to sleeve?

Laparoscopic sleeve gastrectomy(LSG) has reached wide popularity during the last 15 years, due to the limited morbidity and mortality rates, and the very good weight loss results and effects on comorbid conditions. However, there are concerns regarding the effects of LSG on gastroesophageal reflux disease(GERD). The interpretation of the current evidence is challenged by the fact that the LSG technique is not standardized, and most studies investigate the presence of GERD by assessing symptoms and the use of acid reducing medications only. A few studies objectively investigated gastroesophageal function and the reflux profile by esophageal manometry and 24-h p H monitoring, reporting postoperative normalization of esophageal acid exposure in up to 85% of patients with preoperative GERD, and occurrence of de novo GERD in about 5% of cases. There is increasing evidence showing the key role of the surgical technique on the incidence of postoperative GERD. Main technical issues are a relative narrowing of the mid portion of the gastric sleeve, a redundant upper part of the sleeve(both depending on the angle under which the sleeve is stapled), and the presence of a hiatal hernia. Concomitant hiatal hernia repair is recommended. To date, either medical therapy with proton pump inhibitors or conversion of LSG to laparoscopic Rouxen-Y gastric bypass are the available options for the management of GERD after LSG. Recently, new minimally invasive approaches have been proposed in patients with GERD and hypotensive LES: the LINX? Reflux Management System procedure and the Stretta? procedure. Large studies are needed to assess the safety and long-term efficacy of these new approaches. In conclusion, the recent publication of p H monitoring data and the new insights in the association between sleeve morphology and GERD control have led to a wider acceptance of LSG as bariatric procedure also in obese patients with GERD, as recently stated in the 5~(th) International Consensus Conference on sleeve gastrectomy.     

Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial

BACKGROUND: The aim of this study was to assess the intermediate-term (12-month) safety and efficacy of endoscopic full-thickness plication in patients with symptomatic GERD. METHODS: Sixty-four patients with chronic heartburn that required maintenance antisecretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm distal to the gastroesophageal junction. At baseline and 12 months after plication, patients completed the GERD Health Related Quality of Life questionnaire, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, as well as a medication use diary. Ambulatory 24-hour pH monitoring and esophageal manometry were obtained at baseline and 3 months after plication. At 6 months after plication, the 24-hour pH study was repeated. RESULTS: Of the 57 patients who completed the 12-month follow-up, 40 (70%) were no longer taking a proton pump inhibitor. Median GERD Health Related Quality of Life scores were improved compared with baseline while taking medication (19.0 vs. 5.0; p < 0.0001) and while not taking medication (13.0 vs. 5.0; p < 0.002). At 6 months after the procedure, an improvement in distal esophageal acid exposure was demonstrated in 40 of 51 patients (80%), with a decrease of 39% in the median percentage of time the pH was less than 4 (p < 0.0001). Normal pH scores were observed in 30% of patients. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse event was observed during extended follow-up. CONCLUSIONS: Full-thickness plication at the gastroesophageal junction is an effective endoscopic procedure for treatment of patients with symptoms caused by GERD. It reduces reflux symptoms and antisecretory medication use over at least a 1-year period.     

Is scintigraphy of value in the diagnosis of gastrooesophageal reflux disease?

One hundred and ten patients with suspected oesophageal symptoms were investigated by means of oesophageal endoscopy (OE), 24-h pH-metry, and oesophageal scintigraphy (ES). When 24-h pH-metry formed the basis for diagnosis of gastrooesophageal reflux disease (GERD), the sensitivity for ES at abdominal compression was 64%, but no statistically significant differences were found among erect refluxers (ER), supine refluxers (SR), and combined refluxers (CR). Only 4% of the GERD patients had pathologic oesophageal clearing at ES. The more severe the macroscopic oesophagitis found by OE, the more pronounced were the abnormal findings at 24-h pH-metry and at ES with abdominal compression. Increased postprandial reflux was associated with gastro-oesophageal reflux and hiatal hernia at ES with abdominal compression and the most severe form of oesophagitis, respectively. It was concluded that ES had too low sensitivity to be recommended as a screening test for GERD. Nevertheless, the specificity of 76% can to some extent help us to rule out GERD in patients.     

The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis.

BACKGROUND: The Stretta procedure is an endoscopic therapy for gastroesophageal reflux disease. OBJECTIVE: To evaluate the cost-effectiveness of the Stretta procedure and that of competing strategies in the long-term management of gastroesophageal reflux disease. METHODS: A Markov model was designed to estimate costs and health outcomes in Canadian patients with gastroesophageal reflux disease over five years, from a Ministry of Health perspective. Strategies included the use of daily proton pump inhibitors (PPIs), laparoscopic Nissen fundoplication (LNF) and the Stretta procedure. Probabilities and utilities were derived from the literature. Costs are expressed in 2006 Canadian dollars. Units of effectiveness were symptom-free months (SFMs) and quality-adjusted life years (QALYs), using a five-year time horizon. RESULTS: In the analysis that used SFMs, the strategy using PPIs exhibited the lowest costs ($40 per SFM) and the greatest number of SFMs, thus dominating both the LNF and Stretta systems. But the cost-effectiveness analysis using QALYs as the measure of effectiveness showed that PPIs presented the lowest cost-effectiveness ratio, while both the LNF and Stretta strategies were associated with very high incremental costs (approximately $353,000 and $393,000, respectively) to achieve an additional QALY. However, the PPI strategy did not dominate the two other strategies, which were associated with better effectiveness. CONCLUSIONS: If SFMs are used as the measure of effectiveness, PPIs dominate the Stretta and LNF strategies. However, if QALYs are used, the PPIs still present the lowest cost and LNF gives the best effectiveness. Regardless of the units of effectiveness or utility used in the present cost analysis, an approach of prescribing PPIs appears to be the preferred strategy.     

Gastro-oesophageal reflux disease and obesity: Pathogenesis and response to treatment

The link between obesity and GERD is clear on all measures of the disease: clinical symptoms, erosive oesophagitis, acid esophageal exposure, and complications. The pathogenesis of this link may be due to general factors such as visceral adiposity, oestrogen levels, or decrease of Helicobacter pylori infection with increased gastric acid secretion. Increased abdominal pressure leads to disruption of the esophago-gastric junction and hiatal hernia, and esophageal motility may be modified by obesity. Weight loss does improve GERD, but lifestyle modifications and diet are usually insufficient in the long-term for morbid obesity. GERD and hiatal hernia are key issues in bariatric surgery, and are widely discussed because of important implications. It is not currently certain which procedure should be favoured in case of GERD; yet gastric bypass offers the best guarantee of success. Hiatal hernia repair is also deemed necessary by some authors at the same time of the bariatric surgery. Minimally invasive techniques pose a new challenge to this issue, both technically and theoretically.     

Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial

BACKGROUND: A totally transoral outpatient procedure for the treatment of GERD would be appealing. METHODS: A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded. RESULTS: Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all improved (p > 0.0001 for each). Twenty-four-hour pH monitoring showed improvement in number of episodes below pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months (p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics. CONCLUSION: Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.     

On-demand treatment in patients with oesophagitis and reflux symptoms: comparison of lansoprazole and omeprazole

BACKGROUND: There are few data on how patients on maintenance treatment of reflux oesophagitis take their medication. This study was designed to investigate the dosing patterns of patients on on-demand treatment and to compare lansoprazole with omeprazole in this regard. METHODS: Patients with reflux oesophagitis, initially treated until absence of symptoms, took capsules of either lansoprazole (30 mg) or omeprazole (20 mg) for 6 months; they were instructed to take the medication only when reflux symptoms occurred. In order to document dosing patterns, the medication was dispensed in bottles supplied with a Medication Event Monitoring System recording date and time the bottles were opened. There were regular follow-up visits with assessment of symptoms. RESULTS: Three-hundred patients were eligible for analysis according to 'all patients treated'. A dosing pattern was found of an increased intake mornings and evenings and constant intervals between intakes. Although there was no correlation between oesophagitis grade or initial symptoms and the amount of medication consumed, the patients had significantly fewer reflux symptoms the more medication they consumed. There was no difference in the number of capsules consumed between the lansoprazole (0.73 capsules/day) and omeprazole groups (0.71 capsules/day). Nor was there any difference between the groups in reflux symptoms during the course of the study. CONCLUSION: Despite rigorous instructions to take medication on demand, the results suggest that it is patient habits more so than symptoms that determine the frequency and interval of medication intake. Symptoms are not therefore decisive for the amount of medication consumed.