Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) in patients with recurrent reflux after antireflux surgery

BACKGROUND: Recurrent reflux following antireflux surgery (ARS) can be difficult to manage, especially in patients who also fail medical management. In these patients, redo ARS remains the only treatment option. Endoscopic radiofrequency energy delivery to the lower esophageal sphincter (the Stretta procedure; Stretta, Curon, Sunnyvale, CA) has been shown to significantly decreased symptom scores and improve quality of life in patients with gastroesophageal reflux disease (GERD). The aim of this study was to evaluate the use of the Stretta procedure in treating patients with recurrent reflux after fundoplication. METHODS: Between March 2002 and December 2003, eight patients with recurrent reflux following ARS underwent the Stretta procedure. All patients were asked to complete an institutional symptom survey pre-Stretta and at 1, 6, and 12 months after the procedure. Patients rated 7 reflux-related symptoms (heartburn, dysphagia, regurgitation, cough, voice changes/hoarseness, asthma, chest pain) on a 0 (none) to 3 (severe) scale. Data were analyzed using a Wilcoxon matched pairs signed rank test where appropriate. RESULTS: Complete data were obtained for seven of the eight patients, with a median follow-up of 253 days (range, 67-378 days). One patient was lost to follow-up and not included in our analysis. Symptom scores decreased significantly, with six patients noting both improved typical and atypical symptoms. Overall, six patients (85%) were satisfied with their results. CONCLUSIONS: Based on this small series, the Stretta procedure significantly reduces subjective symptoms of GERD. The Stretta procedure may serve an important role as an additional management strategy to help manage recurrent GERD after ARS.     

Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease

Background Radiofrequency (RF) energy treatment is increasingly offered before invasive surgical procedures for selected patients with gastroesophageal reflux disease (GERD).Methods Thirty-two patients undergoing the Stretta procedure were prospectively evaluated with upper endoscopy, manometry, 24-hour pH testing, SF-36 surveys, and GERD-specific questionnaires (GERD HRQL).Results Significant clinical improvement was observed in 91% of patients (29/32). Mean heartburn and GERD HRQL scores decreased (p = 0.001 and p = 0.003, respectively), and physical SF-36 increased (p = 0.05). At a minimum follow-up of 12 months, median esophageal acid exposure decreased (p = 0.79) and was normalized in eight patients. Median lower esophageal sphincter (LES) pressure was unchanged. Esophagitis healed in six of eight patients, but two patients with nonerosive disease developed asymptomatic grade A esophagitis during follow-up. At 12 months, 56% of patients were off proton pump inhibits. Morbidity was minimal.Conclusions RF delivery to LES is safe and significantly improves symptoms and quality of life in selected GERD patients.     

Initial experience with the stretta procedure for the treatment of gastroesophageal reflux disease

BACKGROUND: The Stretta device (Curon Medical, Sunnyvale, CA) is a balloon-tipped four-needle catheter that delivers radiofrequency (RF) energy to the smooth muscle of the gastroesophageal junction. It can be used for the endoscopic treatment of gastroesophageal reflux disease (GERD). PATIENTS AND METHODS: Data prospectively collected on the first 25 consecutive patients undergoing the Stretta procedure at Vanderbilt University Medical Center between August 2000 and March 2001 are reported. Patient evaluation included esophageal manometry, ambulatory 24-hour pH testing, a standard GERD-specific quality-of-life survey (QOLRAD), a general quality-of-life survey (SF12), and endoscopy. Stretta surgery was performed following a standardized protocol. Thermocouple-controlled RF energy was delivered to the lower esophageal sphincter (LES) after endoscopic location of the z-line. Patients were followed up 3 months after endoscopic treatment. Results are presented as mean +/- SEM. RESULTS: Prior to treatment, patients had a mean DeMeester score of 31.0+/-11.4, an LES pressure of 24+/-2 mm Hg, and normal esophageal peristalsis. Of the 25 outpatient procedures, 19 were done under conscious sedation and 6 under general anesthesia. There was a small learning curve (76+/-8 min for the first three procedures; 50+/-2 min for the subsequent 22). The mild to moderate pain during the first 24 postoperative hours was controlled with over-the-counter medication. Two complications were noted: one patient presented with ulcerative esophagitis and gastroparesis 10 days after the Stretta treatment, and one patient developed pancreatitis on postoperative day 27, which was probably unrelated to the Stretta procedure. Eight of the thirteen patients (62%) available for 3-month follow-up were off all antisecretory medication. The other five patients were still taking medications but had been able to reduce the amount considerably. The average daily dose of proton pump inhibitors was 43.0+/-5.0 mg/preoperatively and 6.4+/-2.2 mg/3 months postoperatively (P < 0.001). Other classes of GERD treatment such as metoclopramide had been completely abandoned. In all patients, QOLRAD scores improved (3.5+/-0.4 to 5.5+/-0.5; P < 0.001) as did SF12 physical (23.7+/-3.0 to 31.0+/-3.4; P < 0.008) and mental (40.5+/-2.9 to 47.7+/-3.2, P < 0.017) scores. All patients would undergo a Stretta procedure again except one 78-year-old man with progressive Alzheimer's disease. CONCLUSION: The Stretta procedure is a promising new modality in the management of GERD. It can be safely performed in one short session with gastroesophageal endoscopy under conscious sedation in an outpatient setting. It improves GERD symptoms and quality-of-life scores in patients at 3 months and eliminates or significantly reduces the need for antisecretory drugs.     

Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease

Purpose

Recurrent gastroesophageal reflux disease (GERD) after gastroesophageal surgery is a troublesome problem. Reoperative surgery often is complicated by adhesions and recurrence. Radiofrequency ablation or energy delivery (RF or the Stretta procedure) is a new method for treating GERD. This study is the first report describing the use of the Stretta procedure in pediatric patients.

Methods

Six patients who underwent previous gastroesophageal surgery presented with recurrent GERD. Medical records were reviewed and the severity of reflux graded using a modified scoring system. All underwent RF and were graded for GERD at 6 months postprocedure.

Results

Mean operating time was 80 ± 12 minutes. Mean age at initial operation was 12 ± 4 years and for the RF, 18.0 ± 3.4 years. All patients were discharged as outpatients. Early complications occurred in one child with self-resolving acute gastric distension. Five of 6 patients were completely asymptomatic at 3 months after the procedure, and 3 stopped anti secretory agents. One patient was improved but still symptomatic and needed a redo fundoplication. Another required a repeat application of RF 10 months after the initial one. Mean GERD score pre-Stretta was 5.2 ± 1.0, which improved to 1.6 ± 1.9 at 6 months postprocedure (P < .05; paired t test).

Conclusions

Use of RF treatment of the lower esophageal sphincter is a potentially successful modality to treat recurrent GERD in children. Long-term follow-up is required.     

A current assessment of endoluminal approaches to the treatment of gastroesophageal reflux disease

Over the past decade, a number of endoscopic techniques have been developed as alternatives to medical and surgical treatment of gastroesophageal reflux disease (GERD). The driving force was to provide an outpatient transoral, endoscopic procedure effective in controlling reflux in a portion of patients with GERD. Three major technologies emerged, although each use different approaches to augment the barrier function of the lower esophageal sphincter, mechanisms may be similar. These include Endocinch which tightens the gastroesophageal junction via a set of suture plications around the lower esophageal sphincter, Stretta, which delivers radiofrequency energy at the cardia, and Enteryx, which is an inert polymer injected into the muscle layer of the gastroesophageal junction. To date, the underlying mechanism of action of these procedures has not been completely elucidated, although each alters the compliance of the GEJ and thus its ability to respond to a "refluxogenic stress". The target population currently consists of proton pump inhibitor-dependent GERD patients, with little or no hiatal hernia and without severe esophagitis or Barrett's. The Stretta procedure is the only procedure to date to be subjected to a sham-controlled trial. Registries of complications suggest that these techniques are relatively safe, but serious morbidity including rare mortality have been reported. All can be performed on an outpatient basis. Future comparative studies with predetermined end points, validated outcome measures, prolonged follow-up, and complete complication registries are needed to determine the role of endoscopic procedures in the clinical practice of patients with GERD. Evolution of the current technologies will almost certainly occur, and a commonly performed, efficacious endoscopic antireflux procedure is likely to emerge.     

Stretta as the initial antireflux procedure in children

Background

The Stretta procedure is an endoluminal antireflux procedure using radio frequency to induce collagen tissue contraction, remodeling, and modulation of lower esophageal sphincter physiology in an effort to treat gastroesophageal reflux disease (GERD). Although Stretta has been widely reported in the adult GERD literature as a viable initial surgical option, similar use in children has not been reported. The authors present the first report of Stretta as the initial antireflux procedure in children with GERD, evaluating indications, safety, and efficacy.

Method

The charts of 8 children (aged 11-16 years) who received Stretta between January 2003 and September 2003 were retrospectively reviewed under an Institutional Review Board protocol. All patients had documented GERD preoperatively. Three children required concomitant feeding tube placement (percutaneous gastrostomy tube, group A). Five children with isolated severe GERD refractory to aggressive medical therapy received Stretta only (group B).

Results

Stretta was successfully completed in all 8 children. In group A, 1 child developed a postoperative aspiration, which was successfully treated. All 3 children had resolution of their GERD symptoms (ie, feeding intolerance, emesis) and were able to tolerate full enteral nutrition post-Stretta. In group B, 3 of 5 children are currently off medications and asymptomatic on short-term follow-up (6-15 months). Of the remaining 2, 1 experienced symptomatic relief immediately postprocedure, but symptoms recurred off medications. Stretta was deemed unsuccessful in the remaining patient, and Nissen fundoplication was subsequently performed without difficulty.

Conclusions

Stretta can be safely and successfully used as the initial antireflux procedure for children with GERD. Concomitant Stretta with PEG is an attractive option in children with preexisting GERD who require long-term feeding access. Longer follow-up and a larger patient population are needed to better confirm the safety and efficacy of Stretta presented in this report.     

The treatment of gastroesophageal reflux disease with laparoscopic Nissen fundoplication: prospective evaluation of 100 patients with "typical" symptoms.

OBJECTIVE: To evaluate prospectively the outcome of laparoscopic fundoplication in a large cohort of patients with typical symptoms of gastroesophageal reflux. SUMMARY BACKGROUND DATA: The development of laparoscopic fundoplication over the past several years has resulted in renewed interest in the surgical treatment of gastroesophageal reflux disease (GERD). METHODS: One hundred patients with typical symptoms of GERD were studied. The study was limited to patients with positive 24-hour pH studies and "typical" symptoms of GERD. Laparoscopic fundoplication was performed when clinical assessment suggested adequate esophageal motility and length. Outcome measures included assessment of the relief of the primary symptom responsible for surgery; the patient's and the physician's evaluation of outcome; quality of life evaluation; repeated upper endoscopy in 30 patients with presurgical esophagitis; and postsurgical physiologic studies in 28 unselected patients, consisting of 24-hour esophageal pH and lower esophageal sphincter manometry. RESULTS: Relief of the primary symptom responsible for surgery was achieved in 96% of patients at a mean follow-up of 21 months. Seventy-one patients were asymptomatic, 24 had minor gastrointestinal symptoms not requiring medical therapy, 3 had gastrointestinal symptoms requiring medical therapy, and 2 were worsened by the procedure. Eighty-three patients considered themselves cured, 11 were improved, and 1 was worse. Occasional difficulty swallowing not present before surgery occurred in 7 patients at 3 months, and decreased to 2 patients by 12 months after surgery. There were no deaths. Clinically significant complications occurred in four patients. Median hospital stay was 3 days, decreasing from 6.3 in the first 10 patients to 2.3 in the last 10 patients. Endoscopic esophagitis healed in 28 of 30 patients who had presurgical esophagitis and returned for follow-up endoscopy. Twenty-four-hour esophageal acid exposure had returned to normal in 26 of 28 patients studied after surgery. Lower esophageal sphincter pressures had also returned to normal in all patients, increasing from a median of 5.1 mmHg to 14.9 mmHg. CONCLUSIONS: Laparoscopic Nissen fundoplication provides an excellent symptomatic and physiologic outcome in patients with proven gastroesophageal reflux and "typical" symptoms. This can be achieved with a hospital stay of 48 hours and a low incidence of postsurgical complications.     

The Stretta procedure for the treatment of GERD: a registry of 558 patients

PURPOSE: To evaluate gastroesophageal reflux disease (GERD) symptoms, patient satisfaction, and antisecretory drug use in a large group of GERD patients treated with the Stretta procedure (endoluminal temperature-controlled radiofrequency energy for the treatment of GERD) at multiple centers since February 1999. METHODS: All subjects provided informed consent. A health care provider from each institution administered a standardized GERD survey to patients who had undergone Stretta. Subjects provided (at baseline and follow-up) (1) GERD severity (none, mild, moderate, severe), (2) percentage of GERD symptom control, (3) satisfaction, and (4) antisecretory medication use. Outcomes were compared with the McNemar test, paired t test, and Wilcoxon signed rank test. RESULTS: Surveys of 558 patients were evaluated (33 institutions, mean follow-up of 8 months). Most patients (76%) were dissatisfied with baseline antisecretory therapy for GERD. After treatment, onset of GERD relief was less than 2 months (68.7%) or 2 to 6 months (14.6%). The median drug requirement improved from proton pump inhibitors twice daily to antacids as needed (P < .0001). The percentage of patients with satisfactory GERD control (absent or mild) improved from 26.3% at baseline (on drugs) to 77.0% after Stretta (P < .0001). Median baseline symptom control on drugs was 50%, compared with 90% at follow-up (P < .0001). Baseline patient satisfaction on drugs was 23.2%, compared with 86.5% at follow-up (P < .0001). Subgroup analysis (<1 year vs. >1 year of follow-up) showed a superior effect on symptom control and drug use in those patients beyond 1 year of follow-up, supporting procedure durability. CONCLUSIONS: The Stretta procedure results in significant GERD symptom control and patient satisfaction, superior to that derived from drug therapy in this study group. The treatment effect is durable beyond 1 year, and most patients were off all antisecretory drugs at follow-up. These results support the use of the Stretta procedure for patients with GERD, particularly those with inadequate control of symptoms on medical therapy.     

Treatment of refractory gastroesophageal reflux disease with radiofrequency energy (Stretta) in patients after Roux-en-Y gastric bypass

Background Morbid obesity is associated with gastroesophageal reflux disease (GERD), which, in most cases, completely resolves after Roux-en-Y gastric bypass (RYGB). Patients with persistent or recurrent symptoms have limited surgical options. This study sought to evaluate the application of the Stretta procedure for patients with refractory GERD. Methods The medical records of all patients who underwent Stretta for refractory GERD after RYGB were reviewed. Demographic, preoperative, and postoperative reflux data were collected. Data are presented as mean ± standard error of the mean. The t-test was used for comparison purposes. Results Of 369 patients, 7 received Stretta 27 ± 6 months after RYGB. All were women with a mean age of 49 ± 2 years. All the patients had experienced prebypass GERD symptoms for a duration of 45 ± 8 months. The mean prebypass body mass index was 45 ± 2 kg/m², and this was reduced to 29 ± 2 kg/m² after laparoscopic RYGB (p < 0.001). Before Stretta, all patients underwent a 48-h Bravo pH study, which demonstrated reflux with a mean fraction time of 7% ± 2% for pH lower than 4. After Stretta, five patients had complete resolution of their symptoms, with normalization of pH studies (mean fraction time of 3% ± 0% for pH < 4). The follow-up period after Stretta was 20 ± 2 months. One patient did not have adequate relief of symptoms after Stretta, and one patient was lost to follow-up evaluation. Conclusion Stretta is a valid option in the treatment of persistent GERD for patients who have undergone gastric bypass. Further study is required to evaluate the long-term efficacy of this procedure.     

Gastroesophageal scintigraphy to assess the severity of gastroesophageal reflux disease.

Thirty-six (36) patients with symptomatic gastroesophageal reflux were studied. Symptoms of heartburn, regurgitation and dysphagia were scored as to their severity and compared to quantitative tests of gastroesophageal reflux. Patients were studied with the acid reflux test, fiberoptic endoscopy, esophageal mucosal biopsy with a pinch forceps, esophageal manometry and radioisotopic gastroesophageal scintigraphy. Symptoms were scored according to an arbitrary grading system as mild, moderate, or severe. There were significant correlations between symptoms scores and both the degree of endoscopic esophagitis and the gastroesophageal reflux indices as measured by the radioisotopic scintiscan, but not with the degree of histologic esophagitis or lower esophageal sphincter pressure. Review of the findings suggests the following profile for patients who might require antireflux surgery: severe symptoms, presence of endoscopic esophagitis; resting lower esophageal sphincter pressure below 10 mmHg; and gastroesophageal reflux index above 10%.     

The significance of pH and manometric testing after laparoscopic fundoplication

Laparoscopic antireflux surgery has become the standard operation for gastroesophageal reflux disease (GERD). This study examined the outcomes of laparoscopic antireflux surgery, hypothesizing that both subjective symptoms and objective pH would correlate with manometric parameters to reflect the absence of reflux after fundoplication. We evaluated 56 patients who underwent laparoscopic antireflux surgery. Preoperative and postoperative symptoms were documented by chart reviews and confirmed by telephone interviews with the patient. Preoperative pH probe and esophageal manometry studies were compared with postoperative studies performed 3 to 6 months after fundoplication. Subjective symptoms were correlated with objective measurements of acid reflux and lower esophageal sphincter pressure (LESP). The follow-up period was 3 to 29 months. Symptomatic improvement was seen in 91% of patients, and good to excellent improvement in preoperative symptoms was cited. Postoperatively, there was significant improvement in percentages of upright supine times when esophageal pH was less than 4 (p <0.001). There was an increase in LESP from an average of 16.9 mmHg preoperatively to 22.7 mmHg postoperatively (p <0.001). There was no correlation between postoperative LESP and symptoms or LESP and 24-h pH results. However, there was a predictive correlation between LESP and postoperative heartburn symptoms (p <0.001). These findings imply that symptom follow-up evaluation is adequate in the asymptomatic patient after laparoscopic fundoplication, and that routine physiologic testing is not necessary.     

Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication

HYPOTHESIS: Laparoscopic anterior 90 degrees partial fundoplication for gastroesophageal reflux is associated with a lower incidence of postoperative dysphagia and other adverse effects compared with laparoscopic Nissen fundoplication. DESIGN: A multicenter, prospective, double-blind, randomized controlled trial. SETTING: Nine university teaching hospitals in 6 major cities in Australia and New Zealand. PARTICIPANTS: One hundred twelve patients with proven gastroesophageal reflux disease presenting for laparoscopic fundoplication were randomized to undergo either a Nissen (52 patients) or an anterior 90 degrees partial procedure (60 patients). Patients with esophageal motility disorders, patients requiring a concurrent abdominal procedure, and patients who had undergone previous antireflux surgery were excluded from this study. INTERVENTIONS: Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication. MAIN OUTCOME MEASURES: Independent assessment of dysphagia, heartburn, and overall satisfaction 1, 3, and 6 months after surgery using multiple clinical grading systems. Objective measurement of esophageal manometric parameters, esophageal acid exposure, and endoscopic assessment. RESULTS: Postoperative dysphagia, and wind-related adverse effects were less common after a laparoscopic anterior 90 degrees partial fundoplication. Relief of heartburn was better following laparoscopic Nissen fundoplication. Overall satisfaction was better after anterior 90 degrees partial fundoplication. Lower esophageal sphincter pressure, acid exposure, and endoscopy findings were similar for both procedures. CONCLUSIONS: At the 6-month follow-up, laparoscopic anterior 90 degrees culine partial fundoplication is followed by fewer adverse effects than laparoscopic Nissen fundoplication with full fundal mobilization, and it achieves a higher rate of satisfaction with the overall outcome. However, this is offset to some extent by a greater likelihood of recurrent gastroesophageal reflux symptoms.     

Laparoscopic toupet fundoplication for gastroesophageal reflux disease with poor esophageal body motility

Impaired esophageal body motility is a complication of chronic gastroesophageal reflux disease (GERD). In patients with this disease, a 360-degree fundoplication may result in severe postoperative dysphagia. Forty-six patients with GERD who had a weak lower esophageal sphincter pressure and a positive acid reflux score associated with impaired esophageal body peristalsis in the distal esophagus (amplitude <30 mm Hg and >10% simultaneous or interrupted waves) were selected to undergo laparoscopic Toupet fundoplication. They were compared with 16 similar patients with poor esophageal body function who underwent Nissen fundoplication. The patients who underwent Toupet fundoplication had less dysphagia than those who had the Nissen procedure (9% vs. 44%;P=0.0041). Twenty-four-hour ambulatory pH monitoring and esophageal manometry were repeated in 31 Toupet patients 6 months after surgery. Percentage of time of esophageal exposure to pH <4.0, DeMeester reflux score, lower esophageal pressure, intra-abdominal length, vector volume, and distal esophageal amplitude all improved significantly after surgery. Ninety-one percent of patients were free of reflux symptoms. The laparoscopic Toupet fundoplication provides an effective antireflux barrier according to manometric, pH, and symptom criteria. It avoids potential postoperative dysphagia in patients with weak esophageal peristalsis and results teria. It avoids potential postoperative dysphagia in patients with weak esophageal peristalsis and results in improved esophageal body function 6 months after, surgery. Presented at the Thirty-Seventh Annual Meeting of The Society for Surgery of the Alimentary Tract, San Francisco, Calif., May 19–22, 1996.     

A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease

Background

Gastroesophageal reflux disease (GERD) is a prevalent disorder that often requires long-term medical therapy or surgery. Radiofrequency (RF) energy delivery (Stretta procedure) has been shown in several studies to improve GERD symptoms and quality of life for approximately two-thirds of patients. The authors proposed that increasing the dose of Stretta would further improve the response to this therapy.

Methods

For this study, 36 patients were randomized into three groups. In group A, 12 patients underwent a single-session Stretta procedure. In group B, 12 patients underwent a sham Stretta procedure (mirror of the active procedure in all aspects except there was no deployment of the electrodes). In group C, 12 patients underwent a single Stretta treatment followed by repeat Stretta if GERD health-related quality of life (HRQL) was not 75% improved after 4 months. For each patient, 56 RF lesions were created per session. The principal outcome was GERD HRQL improvement. The secondary outcomes were medication use, lower esophageal sphincter (LES) basal pressure, endoscopic grade of esophagitis, and esophageal acid exposure by pH probe.

Results

The Stretta procedure was completed successfully for all the patients in both active treatment groups. At 12 months, the mean HRQL scores of those off medications, the LES basal pressure, the 24-h pH scores, and the proton pump inhibitor (PPI) daily dose consumption were significantly improved from baseline in both Stretta groups (p < 0.01). The double Stretta was numerically but not significantly better than the single Stretta for mean HRQL, mean 24 h pH, mean LES pressure, and PPI use. Seven patients in the double Stretta treatment group had normalized their HRQL at 12 months compared with 2 patients in the single-treatment group (p = 0.035). The sham patients had a small but statistically significant decrease in their daily PPI dosages (p < 0.05) and mean HRQL scores (p < 0.05). No serious complications (bleeding, perforation, or death) occurred. However, two patients experienced significant delayed gastric emptying after the second Stretta treatment.

Conclusions

The Stretta procedure significantly reduced GERD HRQL, use of PPI drugs, esophageal acid exposure, LES pressure, and grade of esophagitis compared with the sham procedure. The double Stretta therapy had numerically superior outcomes for most parameters and a significantly more frequent normalization of HRQL scores compared with the single Stretta.     

Nissen or partial posterior fundoplication: which antireflux procedure has a lower rate of side effects?

Introduction In patients with gastroesophageal reflux disease (GERD) it is still controversial as to which type of antireflux procedure—the Nissen or the partial posterior fundoplication—offers the lower rate of side effects in the long term.Patients and methods In this follow-up study the Nissen fundoplication was performed only in GERD patients with normal oesophageal peristalsis. The partial posterior fundoplication was preserved for patients with weak peristalsis. Only patients with effective postoperative control of GERD were included in the study. The study groups consisted of 77 patients who underwent the Nissen fundoplication and 132 patients who underwent partial posterior fundoplication. Clinical assessment of side effects was performed after a median of 52 months following surgery. Manometric assessment of the lower esophageal sphincter (LES) and of esophageal peristalsis was achieved 6 months after surgery.Results Side effects such as dysphagia, bloating, inability to belch and vomit, epigastric pain and early satiety were significantly more common after the Nissen fundoplication than after partial posterior fundoplication. Improvement of the antireflux barrier was equal in both groups; however, LES relaxation was incomplete following the Nissen fundoplication but normal after partial posterior fundoplication. Partial posterior fundoplication resulted in improved oesophageal peristalsis, whereas the Nissen fundoplication caused slight impairment of peristalsis.Conclusions Partial posterior fundoplication is a more physiological antireflux procedure than the Nissen fundoplication, and, therefore, this operation has now become our preferred technique for all GERD patients.     

Management of gastroesophageal reflux disease: medications, surgery, or endoscopic therapy? (Current status and trends)

Gastroesophageal reflux disease (GERD) is a common chronic disorder in the Western world. The basic cause of GERD has been well characterized--the fundamental defect is a loss of integrity of the gastroesophageal barrier. What is less clear is the most appropriate means of addressing this reflux. GERD has a variety of symptoms, ranging from typical presentations of heartburn and regurgitation (without esophagitis) to atypical presentations, such as severe erosive esophagitis and its associated complications. Because of its symptomatic diversity, physicians may select from a variety of therapeutic approaches. Medical therapy aims at decreasing acidity by suppressing proton secretion and has been well established. Available medications include antacids and alginates, H2-receptor antagonists, motility agents, and proton pump inhibitors (PPIs). Antireflux surgery, commonly performed laparoscopically, aims at reinforcing and repairing the defective barrier through plication of the gastric fundus. The earliest performed successful procedures were the Nissen and Toupet fundoplications, to which several modifications have since been made. It has been demonstrated in preliminary studies and long-term outcomes of such open surgery and preliminary studies of such laparoscopic surgery that antireflux surgery is an effective approach, with overall outcomes superior to those achieved with medications. The precise indications for the surgical treatment of patients with GERD, however, remain controversial. In recent years, endoscopic intraluminal antireflux approaches have attracted the attention of physicians, surgeons, and commercial companies, especially after the approval of two endoscopic intraluminal methods by the United States FDA in 2000. The common element is prevention of acid reflux by construction of a functional or controlled barrier in the lower esophageal sphincter zone. Three main methods are currently employed: endoscopic intraluminal valvuloplasty, endoscopic radiofrequency therapy, and endoscopic injection or implantation of foreign material. The endoluminal suturing method is highly demanding technically, and its short-term results are encouraging, although largely dependent on the experience of the endoscopist. Several prospective cohort studies have shown that the radiofrequency procedure (Stretta) significantly improves GERD symptoms and quality of life while reducing esophageal acid exposure and eliminating the need for antisecretory medications in the majority of patients within 6-12 months. Most recently, some researchers have studied the endoluminal implantation of polymers, such as Plexiglas (polymethyl-methylacrylate), Gatekeeper hydrogel, and Enteryx (ethylene vinyl alcohol copolymer). The preliminary results of these studies showed that the implantation method was feasible and safe; however, the only multicenter trial related to outcome that has been published has included just 1 year of follow-up. Here, we review the treatment of GERD: medical, surgical, and endoscopic. In addition, we provide an algorithm based on symptoms and response to treatment for management of these patients.     

Paradigm shift in the management of gastroesophageal reflux disease

OBJECTIVE: To compare the short-term results of the radiofrequency treatment of the gastroesophageal junction known as the Stretta procedure versus laparoscopic fundoplication (LF) in patients with gastroesophageal reflux disease (GERD). SUMMARY BACKGROUND DATA: The Stretta procedure has been shown to be safe, well tolerated, and highly effective in the treatment of GERD. METHODS: All patients presenting to Vanderbilt University Medical Center for surgical evaluation of GERD between August 2000 and March 2002 were prospectively evaluated under an IRB-approved protocol. All patients underwent esophageal motility testing and endoscopy that documented GERD preoperatively, either by a positive 24-hour pH study or biopsy-proven esophagitis. Patients were offered the Stretta procedure if they had documented GERD and did not have a hiatal hernia larger than 2 cm, LES pressure less than 8 mmHg, or Barrett's esophagus. Patients with larger hiatal hernias, LES pressure less than 8 mmHg, or Barrett's were offered LF. All patients were studied pre- and postoperatively with validated GERD-specific quality-of-life questionnaires (QOLRAD) and short-form health surveys (SF-12). Current medication use and satisfaction with the procedure was also obtained. RESULTS: Results are reported as mean +/- SEM. Seventy-five patients (age 49 +/- 14 years, 44% male, 56% female) underwent LF and 65 patients (age 46 +/- 12 years, 42%, 58% female) underwent the Stretta procedure. Preoperative esophageal acid exposure time was higher in the LF group. Preoperative LES pressure was higher in the Stretta group. In the LF group, 41% had large hiatal hernias (>2 cm), 8 patients required Collis gastroplasty, 6 had Barrett's esophagus, and 10 had undergone previous fundoplication. At 6 months, the QOLRAD and SF-12 scores were significantly improved within both groups. There was an equal magnitude of improvement between pre- and postoperative QOLRAD and SF-12 scores between Stretta and LF patients. Fifty-eight percent of Stretta patients were off proton pump inhibitors, and an additional 31% had reduced their dose significantly; 97% of LF patients were off PPIs. Twenty-two Stretta patients returned for 24-hour pH testing at a mean of 7.2 +/- 0.5 months, and there was a significant reduction in esophageal acid exposure time. Both groups were highly satisfied with their procedure. CONCLUSIONS: The addition of a less invasive, endoscopic treatment for GERD to the surgical algorithm has allowed the authors to stratify the management of GERD patients to treatment with either Stretta or LF according to size of hiatal hernia, LES pressure, Barrett's esophagus, and significant pulmonary symptoms. Patients undergoing Stretta are highly satisfied and have improved GERD symptoms and quality of life comparable to LF. The Stretta procedure is an effective alternative to LF in well-selected patients.     

Effects of Adjustable Gastric Banding on Altered Gut Neuropeptide Levels in Morbidly Obese Patients

Background: Patients with gastroesophageal reflux disease (GERD) have alterations of gut neuropeptides, such as neurotensin (N) and motilin (M), which are resolved following antireflux surgery. Obesity is associated with GERD. Since the adjustable gastric band prevents gastroesophageal reflux in morbidly obese patients, this study was performed to investigate plasma levels of N and M before and after adjustable gastric banding (AGB). Methods: 47 morbidly obese patients were operated laparoscopically using the Swedish AGB. Preand postoperatively basal plasma levels of N and M were investigated. Symptoms such as heartburn, regurgitation and dysphagia were documented, and esophageal manometry as well as 24-hour pH-monitoring were performed pre- and postoperatively. 11 non-obese, asymptomatic, age-matched volunteers served as controls. Results: After a median postoperative follow-up period of 268 days, a significant weight reduction was observed. Preoperatively, 14 patients suffered from reflux symptoms. An insufficient lower esophageal sphincter (LES) was found in 8 patients, and 2 patients had impaired esophageal body motility. Pathologic pH-testing was found in 6 patients. Postoperatively, reflux symptoms were present in 4 patients; LES findings and pH-testing were normalized in all patients. However, there was significant impairment of esophageal peristalsis. Preoperatively, levels of N were significantly decreased and levels of M increased compared with control subjects. Postoperatively, there was a significant increase of N and levels of M were normalized. Alterations in gut neuropeptides did not correlate with reflux symptoms, impaired gastroesophageal motility, age, gender or BMI. Conclusion: Morbid obesity alters gut neuropeparetides, which are resolved by AGB. This may be caused by reduction of hypercaloric nutrition post-operatively rather than by improvement of gastroesophageal reflux.     

Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease

Background The endoscopic delivery of temperature-controlled radiofrequency energy to the gastroesophageal junction (Stretta procedure) recently has been shown effective for patients with gastroesophageal reflux disease (GERD). However, its effectiveness has been assessed mainly over short periods (6–12 months). This study aimed to evaluate long-term results of the Stretta procedure.Methods All patients undergoing the Stretta procedure since August 2000 were prospectively evaluated under an institutional review board–approved protocol. All patients with a follow-up period longer than 18 months were recruited for a 24-h pH study and mailed a follow-up survey, which included the following: Short Form 12 (SF-12) health status questionnaire, GERD-specific quality-of-life questionnaire (QOLRAD), and queries regarding long-term satisfaction and medication use.Results The Stretta procedure was performed on 82 patients, and 41 patients with a follow-up period longer than 18 months qualified for the study. Follow-up surveys were completed by 36 patients (88%) during a mean follow-up period of 27.1 ± 3.7 months. Of these 36 patients, 30 (83%) were highly satisfied with the procedure and would have it performed again. More than half of the Fifty Stretta patients (56%) had completely discontinued their use of proton pump inhibitors (PPIs), and an additional 31% had reduced their dose significantly. The mean PPI equivalent doses were 37.8 ± 22.2 mg/day before the Stretta procedure and 11.6 ± 14.6 mg/day at 27-month follow-up assessment (p = 0.001). According to the patient outcomes for daily PPI use (yes/no), the patients were divided into two groups: responders (n = 20) and nonresponders (n = 16). The responder group scored higher in QOLRAD score (p = 0.0001), SF-12 physical score (p = 0.038), and SF-12 mental score (p = 0.003). In the 24-hour pH study, the responder group demonstrated a significant decrease in distal esophageal acid exposure time (6.4% ± 1.5% to 3.1% ± 1.4%; p = 0.0001).Conclusion The Stretta procedure results in a statistical significant long-term decrease in GERD symptoms and PPI use. The treatment effect is durable beyond 2 years, and 56% of patients had discontinued their user of all antisecretory drugs.Presented at the European Association for Endoscopic Surgery (EAES) Glasgow 2003, 15–18 June 2003