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.     

First year experience of patients undergoing the stretta procedure

Background: The Stretta procedure is a new, totally endoscopic treatment for GERD, where radiofrequency energy is delivered to the smooth muscle of the gastroesophageal junction. Methods: Forty-one patients undergoing the Stretta procedure between August 2000 and August 2001 were prospectively evaluated. Under an IRB-approved protocol, patients were studied preoperatively and postoperatively with esophageal manometry, 24-h pH testing, SF12 surveys, and GERD-specific questionnaires (QOLRAD). Results: Results are reported as mean ± SEM. All procedures were performed on an outpatient basis; 33 were under conscious sedation and 8 were under general anesthesia. Prior to treatment, patients had a mean LES pressure of 25 ± 2.4 mmHg, Johnson–Demeester score of 32.8 ± 4.6 mmHg, and % time reflux 8.4 ± 0.9%. The quality-of-life scores were significantly improved at 6 months: QOLRAD score increased from 3.7 ± 0.2 to 5.1 ± 0.2 (p = 0.002), SF12 mental score increased from 44.3 ± 2.0 to 51.8 ± 1.7 (p = 0.001), and SF12 physical score increased from 26.2 ± 2.4 to 33.1 ± 3.8 (p = 0.001). Eighteen patients returned for esophageal manometry and 24-h pH testing at a mean of 6.8 ± 0.5 months. There was a significant decrease in esophageal acid exposure time (8.4 ± 0.9% to 4.4 ± 1.3%, p = 0.03) and Johnson–Demeester score (32.8 ± 4.6 to 22.9 ± 5.3, p = 0.04). There was no significant change in mean LES pressure (25.3 ± 2.4 mmHg to 26.8 ± 2.6 mmHg, p = 0.63). Twenty of 31 patients (65%) available for 6 months follow-up were completely off proton pump inhibitors. The only complication related to Stretta was a case of gastroparesis 10 days post-operatively that resolved completely. Conclusions: The Stretta procedure is a promising new endoscopic treatment for GERD. It significantly improves GERD symptoms and quality of life while eliminating the need for proton pump inhibitors in the majority of patients.     

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     

Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) does not provide long-term symptom control

The Stretta procedure (radiofrequency energy application to the lower esophageal sphincter) is a unique endoluminal technique for the management of gastroesophageal reflux. This article reports on the long-term effectiveness of the Stretta procedure in patients with significant gastroesophageal reflux disease (GERD) referred to a surgical practice. Patients who underwent Stretta with a minimum of 36 months follow-up were included. Thirty-two patients with an average follow-up of 53 months were included; 19 proceeded to anti-reflux surgery. Those not undergoing surgery showed a significant improvement in their GERD satisfaction from 3.14 to 1.46 (P = .0006) but had significantly lower preprocedure heartburn scores (2.43) than those who proceeded to surgery (3.66, P = .0401). The Stretta procedure was effective in reducing symptoms in 40% of patients. Responders had less severe preoperative heartburn. Radiofrequency energy delivery to the lower esophageal sphincter may be effective in selected patients for the treatment of gastroesophageal reflux.     

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.     

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.     

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.     

Three year’s experience with the Stretta procedure: did it really make a difference?

Background Endoscopic treatment is merging as a new option for GERD treatment. Many modalities have been used with modest short-term success, but no long-term follow-ups have been published. We present our 3-yr experience at Vanderbilt University using endoscopic radiofrequency energy (Stretta procedure) for GERD treatment.Methods Patients with follow-up >6 months were prospectively studied under IRB protocol. All were mailed SF-12 health status questionnaire and GERD specific quality-of-life (QOLRAD) questionnaires, queries about satisfaction with Stretta, and medication use. All were invited for 24-hour pH study.Results Eighty-six Stretta procedures were performed between 8/2000 and 7/2003 on 85 patients; all were outpatients, 89% under conscious sedation. Seventy-seven patients qualified for the study; 61 completed the survey, 24 returned for pH study. Follow-up was 26.2 +/- 7.5 months (6-36). All were on daily PPIs, with proven GERD by pH study or endoscopy. Mean preoperative acid exposure time was 7.8+/-2.6%, mean DeMeester score was 40.2+/-17.6. Postoperative mean acid exposure time was 5.1+/-3.3 (p=0.00l), DeMeester score was 29.5+/-20.5 (p=0.041). Normal postoperative acid exposure time (pH<4 in <4.2%) was achieved in 42% of patients tested. Patients were then divided according to medication use at the end of f/u in 2 groups: Responders (off or >50% decrease in PPI dose), and nonresponders (on >50% of original PPI dose, or had fundoplication). Response rate was 60% (39 patients), 8 nonresponders underwent fundoplication (12%). Satisfaction rate was 73%. Statistically significant difference was found between the 2 groups in all measurements; SF-12 physical and mental score for responders were 45.5+/-10.2, and 52.6+/-7.8; and for nonresponders were 37.8+/-11.2 and 40.9+/-11.3 (p=0.012, p=0.000l), respectively. Statistically significant difference was also found between responders and nonresponders in postoperative acid exposure (4.5+/-3.34 vs 7.2+/-2.3, p=0.034), and DeMeester score (26.3+/-20.4 vs 39.7+/-20.2, p=0.05). Paired T test was used to compare pre- and postoperative acid exposure in each group; statistically significant difference was found only among responders: total reflux time was 7.50+/-2.3 preop and 4.5+/-3.34 postop (p=0.000l), whereas for nonresponders it was 8.6+/-3.7 and 7.2+/-2.3 (p=0.8), DeMeester scores pre- and postop among responders were 40.0+/-19.7 and 26.3+/-20.4, respectively (p=0.016), whereas for nonresponders it was 40.5+/-14.3 and 39.7+/-20.2 (p=0.79).Conclusions Stretta is a safe modestly effective, totally endoscopic treatment for GERD. Symptomatic improvement when achieved is often associated with correlating improvement in distal acid exposure. This exposure normalizes in nearly half the treated patients.Presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), Denver, CO, USA, 31 March-3 April 2004     

Endoscopic antireflux therapy: the Stretta procedure

The Stretta procedure is safe and effective for the treatment of GERD. There are well-documented clinical trial data supporting its use, including a randomized sham-controlled study, single- and multi-center prospective trials, and community practice reports. The complication rate is within the acceptable range for therapeutic endoscopic procedures and less than the published complication rate for laparoscopic fundoplication. The durability of effect also is established beyond 2 years in several studies. Stretta should be added to the GERD management algorithm specifically for patients considering an antireflux surgical procedure but who are not accepting of the risks of surgery and anesthesia. These patients typically present with incomplete GERD control, despite optimal antisecretory drug therapy, or intolerance to medical therapy. Stretta should be considered only for patients who fit the anatomic inclusion criteria, whereas antireflux surgery should be reserved for those who do not. The decision to undergo antireflux surgery or Stretta must be based on the relative risks and benefits of each procedure. Although antireflux surgery provides better control of esophageal acid exposure than Stretta, the outcomes for GERD symptoms, quality of life, and reduction in PPI use are comparable. Stretta has a low risk of acute adverse events, has no reported cases of long-term dysphagia, and obviates general anesthesia and hospitalization, whereas antireflux surgery has a reported adverse event rate of approximately 2%, a considerable incidence of dysphagia, and requires general anesthesia and 1 to 2 days in the hospital. Another advantage of the Stretta procedure is that antireflux surgery still can be performed in the case of failures. In conclusion, the Stretta procedure offers a minimally invasive, safe, and effective alternative to antireflux surgery for those patients who have GERD who are controlled unsatisfactorily on antisecretory medications, who are considering surgery, and who meet the anatomic criteria that make the procedure technically feasible and safe.     

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.     

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.     

Temperature-controlled radiofrequency energy delivery for gastroesophageal reflux disease: the Stretta procedure

BACKGROUND: The delivery of temperature-controlled radiofrequency (RF) energy has been utilized effectively for the treatment of benign prostatic hyperplasia, sleep-disordered breathing, joint laxity, tumors, and cardiac dysrhythmias. The mechanism of action of RF delivery, depending on the specific disease pathophysiology, is related to wound contraction/remodeling or nerve pathway ablation. More recently, temperature-controlled RF energy delivery has been applied for the treatment of gastroesophageal reflux disease (GERD). PURPOSE: To review the use of temperature-controlled RF energy in clinical applications, specifically the safety and efficacy data regarding endoluminal delivery of RF energy for the treatment of GERD (Stretta procedure). RESULTS: Endoluminal RF energy delivery to the gastroesophageal junction for the treatment of GERD is performed using conscious sedation on an outpatient basis. After treatment, medication use is significantly reduced or eliminated at 6 and 12 months, and there is a significant reduction in both the distal and proximal esophageal acid exposure on 24-hour ambulatory pH testing. All studies reviewed demonstrate improvement in GERD symptom scores, heartburn, satisfaction, and quality of life after treatment. There have been no cases of achalasia or stricture resulting from this procedure. Data support both an augmentation of the physical barrier function of the gastroesophageal junction and a reduction in triggering of transient LES relaxations as plausible mechanisms of action for this procedure. CONCLUSION: Endoluminal RF energy delivery has been shown in several studies to be safe and effective for the treatment of GERD and is a promising new technology for this chronic disorder.     

Laparoscopic fundoplication: 5-year follow-up

There are few published reports on outcomes of 5 or more years following laparoscopic fundoplication. Gastroesophageal reflux disease (GERD) specific quality of life questionnaires (QOLRAD), short form health surveys (SF12), and queries regarding current medication use and long-term satisfaction were mailed to all patients who underwent laparoscopic fundoplication at our institution. Results are reported as mean +/- SEM. Seventy-six patients underwent laparoscopic fundoplication (63 Nissen, 13 Toupet) between November 1992 and December 1997. Fifty-two patients completed questionnaires (68%). Mean follow-up was 5.1 +/- 0.2 years (range, 4-9 years). Mean QOLRAD scores were 5.8 +/- 0.2, (scale 0-7, a higher score reflecting improved QOL), which is comparable to the general population (6.0 mean). SF-12 mental and physical scores were 46.6 +/- 1.7 and 34.2 +/- 1.6, respectively, versus 50.7 and 51.2 for the general population. Forty-seven patients (92%) would have the procedure again. Eleven (21%) remained on antisecretory medications (15% proton pump inhibitor and 6% H2 receptor antagonists). None of the 11 patients underwent 24-hour pH testing to document persistent acid exposure. Furthermore, postoperative symptoms of heartburn, dysphagia, and abdominal bloating were rated as none to mild in the majority of patients. Laparoscopic fundoplication is an effective long-term treatment for GERD, resulting in high patient satisfaction, improved quality of life, and elimination of antisecretory medicines in the majority of patients.     

New endoscopic treatments for gastroesophageal reflux disease.

This article reviews the available endoscopic treatments for gastroesophageal reflux disease (GERD). Plicating gastric folds methods, like Bard's EndoCinch method (Endoscopic Gastroplication, ELGP method), NDO Surgical's Full-thickness Plicator method, and Wilson-Cook Medical's Endoscopic Suturing Device (ESD) method, are used to form new plications in the cardia. Alternatively, thermal tissue remodeling/neurolysis methods, like Curon Medical's Stretta System, can be used to denature the muscular layer of the lower esophageal sphincter (LES) region. Finally, bulking injection methods, like Boston Scientific's Enteryx Procedure and Medtronic's Gatekeeper Reflux Repair System, can be used to insert a foreign body into the LES region. All six methods resulted in the improvement of symptoms and acid reflux, but only the bulking injection methods caused an improvement of the manometric findings. Nevertheless, the improvement of symptoms and acid reflux seems to be much more important than the improvement of the manometric findings. The overall discontinuation of proton-pump inhibitor (PPI) use was about 70%. Thus, endoscopic treatments for GERD are still in the development phase. The efficacy, safety, durability, cost-effectiveness, indications, and possible combination with other treatments must be thoroughly assessed in randomized controlled trials. If the usefulness of endoscopic treatment is confirmed, however, a new minimally invasive treatment strategy for GERD will have been established.     

The Plicator procedure for the treatment of gastroesophageal reflux disease: a registry study

Background  Endoscopic full-thickness plication of the gastric cardia using the Plicator is shown to be effective for the treatment of symptomatic gastroesophageal reflux disease (GERD) in both prospective and randomized controlled trials. This registry study aimed to evaluate Plicator procedure safety and efficacy among GERD patients treated in routine clinical practice at multiple academic and nonacademic centers. Methods  An open-label, prospective multicenter trial was conducted at seven centers under institutional review board approval. Patients with symptomatic GERD completed a series of questionnaires at baseline to assess GERD symptoms, heartburn/regurgitation scores, antisecretory medication use, and treatment satisfaction. All the patients then underwent the Plicator procedure with placement of a single transmural pledgeted suture in the anterior gastric cardia. The patients were reevaluated at 12 months after plication. Results  The 12-month follow-up assessment was completed by 81 patients. At 12 months, the mean GERD Health-Related Quality-of-Life score had improved significantly compared with the baseline score (12.0 vs 26.6; p < 0.001), with 66% of the subjects showing an GERD-HRQL score improved 50% or more. Statistically significant improvements also were observed in median heartburn and regurgitation symptom scores. At 12 months, the need for daily proton pump inhibitor (PPI) therapy was eliminated for 58% of the patients. At baseline, 18% of the subjects had been satisfied with their GERD symptom control while on antisecretory therapy. At 12 months, 75% of the patients were satisfied with their GERD symptom control after undergoing the Plicator procedure, and 86% would recommend the procedure to family or friends. There were no serious adverse events and no late onset of any adverse events. Conclusions  In this multicenter study, the Plicator procedure effectively improved GERD quality-of-life scores, reduced GERD symptoms and medication use, and yielded higher treatment satisfaction than with the use of chronic antisecretory therapy. These effects all were seen 12 months after plication, and no major adverse effects were observed.     

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.     

Initial Experience of Endoscopic Radiofrequency Waves Delivery to the Lower Esophageal Sphincter (Stretta Procedure) on Symptomatic Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy

Background

Gastroesophageal reflux disease (GERD) occurs de novo or intensifies after sleeve gastrectomy (LSG). Endoscopic radiofrequency (Stretta) is a minimally invasive, effective tool to treat GERD. However, Stretta safety and efficacy are unknown in patients with GERD after LSG. To evaluate the safety and efficacy of Stretta treatment post-LSG GERD, quality of life, and PPI dose up to 6 months.

Methods

A retrospective review of all patients’ data who underwent Stretta procedure in our center. Demographics, pre-Stretta lower esophageal manometry, 24-h pH monitoring, endoscopic and radiological findings, GERD symptoms using Quality of Life (HR-QoL) questionnaire, and PPI doses at 0, 3, and 6 months were reviewed.

Results

Fifteen patients had an initial BMI of 44.4?±?9 kg/m². Pre-Stretta BMI was 29.7?±?6.3 kg/m² with an EWL% of 44?±?21.4%. Pre-Stretta endoscopic reflux esophagitis was found in 26.7%, and barium imaging showed severe reflux in 40%. The mean DeMeester score was 27.9?±?6.7. Hypotensive LES pressure occurred in 93.3% of patients. Patients’ mean HR-QoL scores were 42.7?±?8.9 pre-Stretta and 41.8?±?11 at 6 months (P?=?0.8). One case (6.7%) was complicated by hematemesis. At 6 months, 66.7% of patients were not satisfied, though the PPI medications were ceased in 20%. Two patients (13.3%) underwent Roux-en-Y gastric bypass at 8 months post-Stretta to relieve symptoms.

Conclusions

Stretta did not improve GERD symptoms in patients post-LSG at short-term follow-up, and about 6.7% complication rate was reported. Patients were not satisfied despite the decrease in PPI dose.

     

Mini invasive transendoscopic and laparoscopic treatment of gastroesophageal reflux disease

The purpose of the article is to present, based on the data collected from the literature of specialty, new considerations regarding the treatment through miniinvasive transendoscopic and laparoscopic procedures of the patients diagnosed with gastroesophageal reflux disease (GERD). The 3 procedures of the miniinvasive transendoscopic treatment of GERD, mentioned bellow have shown a significant improvement of the parameters related to the quality of life. Due to the action of high frequency currents at the gastroesophageal junction level, Stretta procedure creates a collagen contraction followed by a reduction of the esophageal lumen. After successive sutures, the "EndoCinchTM" endoscopic suture system described by C.R. Bard realizes a pleat on the inferior esophagian sphincter recovering the valve mechanism. The endoscopic submucosal implant of inert polymers (microspheres of plexiglas/beads of polymethylmethacrylat = PMMA) within the pleats of the inferior esophagus remakes the valve mechanism by pleats expansion. The miniinvasive surgical treatment of GERD (laparoscopic antireflux operations) generates through different techniques, still much debated by the literature of specialty (Dor, Toupet, Nissen, Rosetti, etc.), an increased pressure at the level of esophageal sphincter. In conclusion even are expensive, the medical and miniinvasive surgical treatments have given the best results. The miniinvasive transendoscopic procedure follows to be evaluated in the future by long term comparative trials.     

Long-term evaluation of patient satisfaction and reflux symptoms after laparoscopic fundoplication with Collis gastroplasty

Background Esophageal shortening is a complication of advanced gastroesophageal reflux disease (GERD). For patients with short esophagus, Collis gastroplasty combined with fundoplication provides excellent symptomatic relief from GERD disease. The literature lacks studies comparing satisfaction and reflux symptoms between patients who underwent Nissen fundoplication with Collis gastroplasty and those who had primary fundoplication alone. This study aimed to assess long-term satisfaction and GERD-related quality of life after laparoscopic Collis–Nissen fundoplication, and to compare them with those for Nissen fundoplication alone. Methods A nested case–control study was conducted. In this study, 14 cases of laparoscopic Collis–Nissen fundoplications were matched for age, gender, and length of the follow-up period to a cohort of 120 control subjects who underwent laparoscopic Nissen fundoplication. All the patients were mailed a follow-up survey which included a Short Form-12 (SF-12) health status (quality-of-life) questionnaire (a validated quality-of-life instrument), a Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire (a GERD-specific quality-of-life instrument), and queries regarding long-term satisfaction and medication use. Results Both groups showed a significant postoperative increase in QOLRAD mean scores (p = 0.01). However, the difference in the delta (postoperative–preoperative) score between the two groups was not significant (Fig. 1). There were no differences in mental (MCS) or physical (PCS) SF-12 scores between the two groups. The rate of satisfaction with the surgery was similar in the Nissen–Collis fundoplication (87.5%) and Nissen fundoplication (87%) groups. Fig. 1 Quality of Life in Reflux and Dyspepsia (QOLRAD) score in the two groups. (* p = 0.01 vs preoperative value)

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Conclusions Collis gastroplasty combined with Nissen fundoplication is an effective procedure for patients with a shortened esophagus diagnosed intraoperatively during antireflux surgery. Patient satisfaction, postoperative quality of life, and QOLRAD score improvement after this procedure are comparable with those observed in patients treated with Nissen fundoplication alone.