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.     

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   

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。     

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.     

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.     

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.     

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.     

Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial

BACKGROUND & AIMS: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. METHODS: Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. RESULTS: By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. CONCLUSIONS: Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.     

Improvement of clinical parameters in patients with gastroesophageal reflux disease after radiofrequency energy delivery

AIM:To evaluate the efficacy of Stretta procedure with gastroesophageal reflux disease(GERD)based on symptom control,medication changes and oesophagitis grade.METHODS:Ninety patients with a history of GERD underwent Stretta procedure from June 2007 to March 2010.All patients with GERD diagnosed by the pres-ence of endoscopically evidenced oesophagitis or abnormal esophageal pH testing.We evaluated GERD-health-related quality of life,satisfaction,medication use and endoscopy at baseline,6,12 mo after treatme...     

Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial

BACKGROUND & AIMS: This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure. METHODS: In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was > or =50% reduction in PPI use. Secondary end points included > or =50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months. RESULTS: The percentage of Enteryx-treated patients achieving a > or =50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P=.023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P=.033). GERD health-related quality of life heartburn score improvement > or =50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P <.001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P <.001). CONCLUSIONS: Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.     

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.     

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.     

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.     

Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial

BACKGROUND: Endoluminal gastroplication has shown promise for the treatment of GERD in short-term studies. Until now, long-term outcome data have been lacking. METHODS: A prospective, multicenter trial enrolled 85 patients with GERD to be treated with endoluminal gastroplication. Inclusion criteria were 3 or more heartburn or regurgitation episodes per week, >4.2% time in 24 hours with esophageal pH < 4, and dependency on antisecretory medications. Exclusion criteria were the presence of varices, achalasia, aperistalsis, or previous gastric resection. Patients underwent manometry, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patient diaries were used to assess medication use and to estimate annual medication cost. RESULTS: At 1- and 2-year follow-up, patients had significant reductions in median heartburn symptom scores (72 at baseline [interquartile range (IQR) 90-48] vs. 4 at 12 months [IQR 43-0] and 16 at 24 months [IQR 53-3.5]; p < 0.0001 vs. baseline) and median regurgitation symptoms (2 at baseline [IQR 3-1] vs. 0 at 12 months (IQR 1-0) and 1 at 24 months [IQR 1-0]; p < 0.0001 vs. baseline). Of all patients, 59% and 52% showed heartburn symptom resolution at 12 and 24 months, respectively ( p < 0.0001 vs. baseline). Also, 83% and 77% had regurgitation symptom resolution at 12 and 24 months, respectively (p < 0.0001 vs. baseline). Proton pump inhibitor use also was significantly reduced at 12 and 24 months after the procedure. At 2-year follow-up, median annualized medication costs were reduced by 88% (1381 US dollars) (p < 0.0001). Endoluminal gastroplication significantly reduced the duration and the number of episodes of esophageal acid exposure (p < 0.0001 vs. baseline). Only 7 patients experienced adverse events. CONCLUSIONS: Endoscopic gastroplication is safe and effective, and is associated with symptom reductions in patients with GERD for at least 24 months.     

Childhood GERD is a risk factor for GERD in adolescents and young adults

OBJECTIVE: The clinical course of gastroesophageal reflux disease (GERD) in children without comorbid illness (neurological deficits, congenital esophageal anomalies, chronic obstructive airway conditions) is unclear. Whether GERD in childhood progresses or predisposes to GERD in adulthood remains unknown. METHODS: We identified a cohort of individuals endoscopically diagnosed with GERD in childhood between 1990 and 1996. We excluded patients with comorbid illnesses. Eligible persons were contacted by telephone in person or through a household member and requested to complete a validated (in adults) symptom questionnaire between February 2001 and February 2003. Respondents were invited to undergo an upper endoscopy or to share results of any endoscopic examination performed within the past 12 months. We calculated the proportion of persons with GERD symptoms (monthly, weekly), and with current use of antisecretory medications (histamine-2-receptor antagonists [H2RA], proton pump inhibitors [PPI]). RESULTS: A total of 207 persons satisfied the inclusion and exclusion criteria and were contacted. Of those, 80 (39%) completed the questionnaire and 14/80 (18%) had an upper endoscopy. The mean age of participants was 20 years (SD = 4, range 10-40); most were Caucasian (73%), and 60% were female. GERD was documented at a mean age of 5 years (approximately a 15-yr duration of follow-up). Most participants (64/80, 80%) had at least monthly heartburn and/or acid regurgitation reported within the past 12 months; 18/80 (23%) reported at least weekly symptoms, and an additional three patients were asymptomatic but taking antisecretory therapy (H2RA or PPI). If all nonresponders were considered free of symptoms, then at least 31% had monthly symptoms, and 9% had weekly symptoms. Overall, 24 (30%) were currently taking either H2RA or PPI, and 19 patients had undergone fundoplication. There were no statistically significant differences between those who reported monthly GERD symptoms, weekly GERD symptoms, or no GERD symptoms as far as demographic features, age of GERD onset, receipt of fundoplication, or current GERD treatment. At endoscopy, three patients had mild to moderate erosive esophagitis. CONCLUSIONS: GERD in otherwise normal children can persist through adolescence and adulthood in a significant proportion of patients who continue to have GERD symptoms and signs, and use antisecretory medications. Childhood GERD is a risk factor for GERD in adolescence and adulthood.     

Endoscopic,deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial

OBJECTIVES: This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. METHODS: Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. RESULTS: At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. CONCLUSIONS: The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.     

Endoluminal gastroplication for the treatment of gastroesophageal reflux disease: a 2-year prospective pilot study from Taiwan

Background and Aim: Endoluminal gastroplication (ELGP) offers a minimally invasive option for the treatment of gastroesophageal reflux disease (GERD) in Western countries. However, long‐term outcomes of ELGP in Asian populations have not been investigated. The aim of this prospective study was to evaluate the long‐term benefits of ELGP in Asian patients with GERD. Methods: Taiwanese patients diagnosed with GERD were enrolled and had the procedure performed with EndoCinch. The assessment included symptom scoring, validated GERD questionnaires, esophagogastroduodenoscopy, esophageal manometry and 24‐h pH monitoring before and after the procedure over a 2‐year period. Results: Twenty‐one consecutive patients were recruited and underwent ELGP. Patients reported improved heartburn symptom score (mean 64.0 vs 21.1, P < 0.001), regurgitation frequency score (mean 2.4 vs 1.3, P < 0.001), and GERD health‐related quality of life (mean 23.1 vs 10.1, P < 0.001) at 24 months. The mean total time of pH < 4 reduced from 121.7 min to 67.1 min (P = 0.008) and mean DeMeester score reduced from 32.9 to 17.6 (P = 0.011) at 3 months. Antisecretory drug discontinuation rate was 81%, 57%, 52% and 48% at 1, 6, 12 and 24 months, respectively. Of the patients who had a favorable initial response to ELGP at 1 month, 41% resumed antisecretory medications at 24 months follow‐up. All adverse events were mild and transient. Conclusions: Endoluminal gastroplication is a safe and modestly effective endotherapy for patients with GERD. It significantly improved symptoms in an Asian population. Approximately one in two patients continues to be off medication at 24 months follow‐up. However, the long‐term efficacy and durability are still to be determined.     

Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial

BACKGROUND: A novel endoscopic full-thickness plication device has been designed to inhibit gastroesophageal reflux by placing a transmural plication near the gastroesophageal junction under direct endoscopic visualization. This study assessed the safety and efficacy of endoscopic full-thickness plication in the treatment of patients with symptoms caused by GERD. METHODS: Patients with chronic heartburn requiring maintenance therapy with antisecretory medication were recruited. Exclusion criteria were the following: hiatal hernia (>2 cm), grade III and IV esophagitis, and Barrett's esophagus. The following were assessed over a follow-up period of 6 months: GERD-Health-Related Quality of Life, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, medication use, 24-hour esophageal pH monitoring and esophageal manometry. Patients underwent a single, full-thickness plication in the gastric cardia just distal to the gastroesophageal junction. Re-treatment was not permitted. RESULTS: A total of 64 patients (mean age 46.3 years, range 23-71 years) underwent endoscopic full-thickness plication (mean procedure time 17.2 minutes). At 6 months after plication, proton pump inhibitor therapy had been eliminated in 74% of previously medication-dependent patients. Median GERD-Health-Related Quality of Life scores improved 67% (19.0 vs. 5.0; p<0.001). Improvements also were observed in median Gastrointestinal Symptom Rating Scale and SF-36 Health Survey mental and physical composite scores. Median esophageal acid exposure improved significantly (10 vs. 8; p<0.008) with normalization of pH noted in 30% of patients. No significant change in esophageal manometry was noted. One gastric perforation occurred and was managed conservatively without sequelae. CONCLUSIONS: In this study, a single full-thickness plication placed at the gastroesophageal junction reduced symptoms, medication use, and esophageal acid exposure associated with GERD.     

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.