A Double-Blind Sham-Controlled Study of the Effect of Radiofrequency Energy on Symptoms and Distensibility of the Gastro-Esophageal Junction in GERD.
J Arts MD, PhD, R Bisschops MD, PhD, K Blondeau PhD, R Farre PhD, R Vos Ir, L Holvoet MSc, P Caenepeel MD, PhD, A Lerut MD, PhD adn Jan Tack MD, PhD. Am J Gastroenterol advance online publication 22 November 2011; doi: 10.1038/ajg.2011.395.
OBJECTIVES: Several studies have reported symptom relief in gastro-esophageal reflux disease (GERD) patients treated with radiofrequency delivery (Stretta procedure) at the gastro-esophageal junction (GEJ), but the mechanism underlying this improvement is unclear. The objective of this study was to test the hypothesis that Stretta alters GEJ resistance.
METHODS: We conducted a double-blind randomized cross-over study of Stretta and sham treatment. Consecutive GERD patients were included in the study. The study was conducted in a tertiary care center. Patients underwent two upper gastrointestinal endoscopies with 3 months interval, during which active or sham Stretta treatment was performed in a randomized double-blind manner. Symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the GEJ were done before the start of the study and after 3 months.
RESULTS: Barostat distensibility test of the GEJ before and after administration of sildenafil was the main outcome measure. In all, 22 GERD patients (17 females, mean age 47+12 years) participated in the study; 11 in each group. Initial sham treatment did not affect any of the parameters studied. Three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure. In contract, symptoms score was significantly improved and GEJ compliance was significantly decreased. Administration of Sildenafil, an esophageal smooth muscle relaxant, normalized GEJ compliance again to pre-Stretta level, arguing against GEJ fibrosis as the underlying mechanism.
CONCLUSIONS: The limitation of this study was reflux evaluation did not include impedance monitoring. In this sham-controlled study, Stretta improved GERD symptoms and decreased GEJ compliance. Decreased GEJ compliance, which reflects altered LES neuromuscular function, may contribute to symptomatic benefit by decreasing refluxate volume.
Radiofrequency energy delivery to the lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: A meta-analysis.
Ambar Banerjee, W.S. Melvin, Steven J. Naber, Kyle A. Perry. Accepted for publication, Surg Lap Endosc Percut Tech.
INTRODUCTION: Several endolumenal approaches to the management of gastroesophageal reflux disease (GERD) have been developed as an intermediate therapy between conservative medical management and the more invasive surgical fundoplication. One such intervention, the Stretta Procedure (Mederi Therapeutics Inc, Greenwich, CT), utilizes application of radiofrequency energy to the lower esophageal sphincter to control gastroesophageal reflux. Multiple studies have debated its short and long-term effectiveness. The objective of this study is to review the published data and perform an in-depth statistical analysis of the efficacy of this procedure in the management of GERD.
METHODS: A systematic search of the literature, published to date in English and indexed in MEDLINE and PubMed, was carried out in November 2010 with device and condition specific keywords. Studies were selected on the basis of availability of data on at least two of the following parameters: esophageal manometry, pH study, quality of life indices and medication usage. Exclusion criteria included studies involving children or those with a follow-up less than 3 months. Data are presented as weighted mean values based on the number of patients in each included study so the analysis represents the mean change in each outcome variable over all patients studied. The metaanalysis consists of weighted t-tests on the difference between mean pre-Stretta and post-Stretta values of various outcome variables. Analysis was restricted to the reported mean values of outcomes for pre-operative and latest post-operative observations for single Stretta procedures and for results summarized across all patients.
RESULTS: 20 studies, containing 1441 patients, published between 2001 and 2010 met the inclusion criteria. The mean follow-up was 17.1 months (range 4 to 53 months). Outcome data are outlined in the table below. GERD health related quality of life (HQRL), quality of life reflux and dyspepsia (QOLRAD), heartburn, and patient satisfaction scores were all significantly improved following the Stretta procedure. Esophageal acid exposure and DeMeester score were both significantly reduced following Stretta treatment. Lower esophageal sphincter pressure showed a trend toward increased post-treatment pressures, but failed to reach statistical significance in this analysis.
CONCLUSION: Radiofrequency ablation of the lower esophageal sphincter produces significant improvement in both subjective and objective reflux indices. These findings suggest that the Stretta procedure provides significant symptomatic relief for many patients and represents an alternative to medical treatment and surgical fundoplication in select patients.
Radiofrequency treatment on respiratory symptoms due to gastroesophageal reflux disease.
GAO Xiang, WANG Zhong-gao, WU Ji-min, JI Feng, ZHANG Cheng-chao, NING Ya-chan, LI Zhi-tong, HU Zhi-wei, CHEN Xiu and TIAN Shu-rui. Chin Med J 2011;124(7):1006-1009
METHODS: From April 2006 to October 2008, 505 GERD patients with mainly respiratory presentations such as wheezing, chronic cough or hoarseness, were treated by endoscopic RF. A questionnaire was completed before and after treatment, using a six-point scale ranging from 0 to 5 to assess symptom severity and frequency. The symptom score was the sum of frequency and severity.
RESULTS: Symptom scores were significantly improved at the end of the follow-up period. The mean heartburn score decreased from 5.31 to 1.79. The mean regurgitation score decreased from 5.02 to 1.64; mean cough score decreased from 6.77 to 2.85; mean wheezing score decreased from 7.83 to 3.07; and mean hoarseness score decreased from 5.13 to 1.81 (P <0.01). No major complications or deaths occurred. Minor complications included temporary post-procedural retrosternal unease or pain (n=106; 21.0%), mild fever (n=86; 17.0%), transient nausea/vomiting (n=97; 19.2%), and transient dysphagia (n=42; 9.3%). Thirty-five (6.9%) patients had recurrence of symptoms. Endoscopic RF treatment was repeated in six patients, and laparoscopic fundoplication was performed in seven.
CONCLUSION: Endoscopic RF is an effective and safe means to treat RSs in patients with GERD.
Long-term results of radiofrequency energy delivery for the treatment of GERD. Results of a 48 month prospective study.
Luca Dughera MD, Monica Navino MD, Paola Cassolino MD, Mariella De Cento MD, Luca Cacciotella, Fabio Cisarò MD, Michele Chiaverina MD, Turin Italy. Presented at the Italian Congress of Gastroenterology,
March 5, 2011. Published online August 2011, Journal Diagnostic and Therapeutic Endoscopy.
BACKGROUND: In April 2000 the FDA approved the Stretta® system (Curon Medical, Fremont CA, USA) for use as an endoscopic treatment for patients with GERD  that was increasingly offered as first-line therapy before more invasive surgical procedures for selected GERD patients, with clinical data supporting its efficacy, safety, and patient satisfaction. [6-10] The device imparts RF ablation to the dysfunctional lower oesophageal sphincter via the endoscopic balloon-mounted needles. Energy is applied at six to eight levels circumferentially around the oesophageal junction. Two main goals are achieved: first, scarring of the distal oesophageal muscular wall improves the reflux barrier of the lower oesophageal sphincter; second, reduced transient lower oesophageal sphincter relaxations occur due to ablation or demodulation of vagal afferent fibres in the vicinity. The current study reports our experience using the Stretta® procedure in strictly selected patients suffering of GERD who have been followed up for 4 years.
RESULTS: All 56 patients completed the protocol and accepted to undergo oesophageal manometry at 24 and 48 months. RF treatment significantly improved heartburn scores, GERD-specific quality of life scores, and general quality of life scores at 24 and 48 months in 52 out of 56 patients (92,8%) At each control time both mean heartburn and GERD HRQL scores decreased (p = 0.001 and p = 0.003, respectively) and both mental SF-36 and physical SF-36 ameliorated (p = 0.001 and 0.05, respectively). (Figure 1). Whereas in our cohort of patients the median LES pressure was previously described to increase at 12 months, [15,16] only an overall not significant effect from baseline and post-treatment values was finally observed at 24 and 48 months (Figure 2). At 48 months, 41 out of 56 patients (72,3%) were completely off PPIs, someone using only occasionally oral antacids (figure 3). There were no post procedure perforations, mucosal lacerations, bleeding episodes requiring transfusion, or deaths (Table 2). Minor complications were temporary post procedure chest discomfort, requiring only oral analgesics, mild fever, transient nausea and vomiting and transient dysphagia. The only major adverse event was a prolonged transient gastroparesis in a 52 years old male patient. The patient had to be hospitalized for 3 weeks and treated with prokinetics, prostigmine and enteral nutrition. The problem was completely resolved within approximately 8 weeks.
CONCLUSION: At this time, in the long-term follow up studies the Stretta procedure has been proven to be very safe for the treatment of GERD. In conclusion, according to literature data our study confirms that RF energy delivery is safe and effective and produces durable and significant improvement in GERD symptoms and quality of life as well as reduces the use of antireflux medication, with negligible morbidity.
Gastroesophageal Reflux Disease – Clinical Practice Guidelines.
Grzegorz Wallner, Michał Solecki, Wiesław Tarnowski, Tadeusz Wróblewski, Edward Stanowski, Andrzej Budzyński, Maciej Michalik, Videosurgery and other miniinvasive techniques 2009; 4 (Suppl 1)
ENDOSCOPIC TREATMENT: As a method with expected high efficacy and low complication rate, endoscopic treatment is gaining increasing popularity and is a subject of meticulous assessment of clinical efficiency. At the moment, only two methods are accepted by FDA: Stretta and EsophyX™. Recommendations for biopolymers have been withdrawn due to the substantial complication rate. EsophyX™ is a minimally invasive method of reflux disease treatment, and has recently been approved in the European Union for endoscopic fundoplication. The Stretta method uses radiofrequency energy on the LES and the subcardial area. This results in an increase of LES tension and muscular layer hypertrophy and decreases the number of transient sphincter relaxations. It is the only method with efficacy confirmed with randomized studies. Radiofrequency is also used for Barrett’s epithelium ablation with Halo 360 and Halo 90 apparatus. More traditional measures, such as endoscopic mucosectomy, argon or laser ablation, have been used for a much longer time. Any procedure of Barrett’s epithelium removal ought to be supplemented with surgical or endoscopic fundoplication.
SUMMARY: Reflux disease is a serious problem of not only medical, but also economic significance. The costs of long-term pharmacological treatment are tremendous. Surgical treatment for the majority of these patients seems justified. Such therapy ought to be undertaken in a centre with the volume exceeding 50 anti-reflux procedures per year. The procedure performed by an experienced surgeon gives a chance for remission of symptoms for over 5 years in more than 90% of patients. Application of laparoscopic techniques has made this method of treatment much more attractive.
Endoluminal Full-Thickness Plication and Radiofrequency Treatments for GERD. An Outcomes Comparison.
Louis O. Jeansonne IV, MD; Brent C. White, MD; Vien Nguyen, MD; Syed M. Jafri, BS; Vickie Swafford, RN; Mina Katchooi, DDS; Leena Khaitan, MD, PhD; S. Scott Davis, MD; C. Daniel Smith, MD; Shahriar Sedghi, MD; Edward Lin, DO. Arch Surg. 2009;144(1):19-24
HYPOTHESIS: Endoluminal therapies have emerged as adjuncts for the treatment of gastroesophageal reflux disease (GERD) in select patients.
OBJECTIVE: To compare the effectiveness of endoscopic full-thickness plication and endoscopic radiofrequency treatments for patients with GERD.
PATIENTS: A total of 126 patients who underwent either endoscopic full-thickness plication (FTP) of the gastric cardia or endoscopic radiofrequency (RF) treatment of the esophagogastric junction during a 4-year period were included (68 underwent RF and 58 underwent FTP).
INTERVENTIONS: Follow-up data was obtained for 51% of patients (mean follow-up, 6 months).
MAIN OUTCOME MEASURES: Comparison of medication use, symptom scores, and pH values at baseline and follow-up.
RESULTS: In the RF group, patients with moderate to severe heartburn decreased from 55% to 22% (P=.01), and proton pump inhibitor (PPI) use decreased from 84% to 50% (P=.01). Decreases were also seen for dysphagia, voice symptoms, and cough. Percentage of time the pH was less than 4 was unchanged. In the FTP group, patients with moderate to severe heartburn decreased from 53% to 43% (P=.3), and PPI use decreased from 95% to 43% (P=.01). Percentage of time the pH was less than 4 decreased from 10.0% to 6.1% (P=.05). Decreases were also seen for regurgitation, voice symptoms, and dysphagia. There was no change in scores for chest pain or asthma in either group.
CONCLUSIONS: For patients with GERD, RF and FTP both resulted in a decrease in both PPI use and in scores for voice symptoms and dysphagia. In addition, RF resulted in decreased heartburn and cough, while FTP resulted in the most dramatic reduction in regurgitation. Our experience indicates that both procedures are effective, providing symptomatic relief and reduction in PPI use. For patients whose chief complaint is regurgitation, FTP may be the preferred procedure.
A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease
Ayman M. Abdel Aziz, Hisham R. El-Khayat, Ahmed Sadek, Samer G. Mattar, Gail McNulty, Pradermchai Kongkam, Mohamed F. Guda, Glen A. Lehman. A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease. Surg Endosc; 03 September 2009.
CONCLUSION: 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.
Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients
J.P. Galmiche, E. Coron, V. Sebille, G. Cadiot, F. Zerbibs, P. Ducrotte, F. Ducrot, P. Pouderoux, J. Arts, M. Le Rhun, T. Piche, S. Bruley Des Varannes. Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients. Aliment Pharmacol Ther 2008, 28, 1147-1158.
CONCLUSION: Radiofrequency energy delivery is a safe and effective therapeutic option, allowing reduction in or discontinuation of PPI therapy in patients with PPI-dependent symptoms, without loss of quality of life. However, in a majority of patients, PPI therapy cannot be completely stopped. The efficacy of RF does not seem to be related to a decrease in OAE.
Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction.
Noar M, Noar E. Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction. Surg Endosc 2008; 22:2440–2444.
CONCLUSION: In summary, the large majority of patients in this study had statistically significant improvement and correction of gastroparesis. There were corresponding improvements in patients’ symptoms, with a demonstrated difference between responder and nonresponder groups. The need for PPI therapy was eliminated for almost all gastric emptying scan responders. The symptom improvements were maintained for at least 12 months. The safety record and sustained efficacy indicate that the Stretta procedure is a viable, minimally invasive, endoluminal procedure for the management of GERD patients considering alternatives to failed drug therapy and those with coexistent GERD associated gastroparesis.
Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure.
Noar M, Lofti-Emran S. Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure. Gastrointest Endosc 2007;65:367-72.
CONCLUSION: The results in this large group of patients document important long-term durability of beneficial symptomatic effects and elimination of medication usage effects of the Stretta procedure in patients who have failed escalated PPI therapy...the patients in this study had statistically significant improvement and sustained effect in all parameters for up to 4 years.
Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up.
Reymunde A, Santiago N. Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc 2007;65:361-6.
CONCLUSION: For these GERD patients followed to 4 years, the Stretta procedure was a safe, effective, and durable treatment, with significant and sustained improvements in GERD symptoms, QOL and PPI elimination.
Treatment of Refractory Gastroesophageal Reflux Disease with Radiofrequency Energy (Stretta) in Patients with Roux-en-Y Gastric Bypass.
Mattar SG, Qureshi F, Taylor D, Schauer PR. Treatment of Refractory Gastroesophageal Reflux Disease with Radiofrequency Energy (Stretta) in Patients with Roux-en-Y Gastric Bypass. Surg Endosc 2006; 10.1007/00464-006-0513-6.
CONCLUSION: In conclusion, we present objective evidence for the efficacy of applying endoluminal technology, specifically radiofrequency energy, for the treatment of patients with recurrent GERD after LRYGB. This method represents a valid option for patients whose gastric anatomy was altered. Furthermore, this outpatient therapy has been delivered safely and, in the current study group, with morbidity. Additional studies are required to determine the long-term effect of Stretta in this patient population, and also to compare its outcomes with those of other endoluminal methods.
Endoscopic Antireflux Therapy: The Stretta Procedure.
Yeh RW, Triadafilopoulos G. Endoscopic Antireflux Therapy: The Stretta Procedure. Thoracic Surgery Clinics, 2005.03.006; 15 395-403.
CONCLUSION: 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.
Three year’s Experience with the Stretta procedure: did it really make a difference?
Lufti RE, Torquati A, Kaiser J, Holzman M, Richards WO. Three year’s Experience with the Stretta procedure: did it really make a difference? Surg Endosc 2004; 10.1007/s00464-004-8938-2.
CONCLUSION: In conclusion, the Stretta procedure is a safe and modestly effective endoscopic treatment option for GERD patients that does not preclude or increase the difficulty of surgery if it is needed at a later time. There is no evidence for the development of long-term complications, such as esophageal strictures or dysmotility. Symptoms and quality of life are improved in most of patients, and improvement in those patients, is associated with a decrease in distal esophageal acid exposure. The new paradigm (suggested by our group) of using Stretta in patients with a small hiatal hernia (<3 cm), an LES pressure >8 mmHg, and no presence of Barretts esophagus or evidence of recurrent aspiration and pulmonary disease remains our treatment algorithm for patients who present for the surgical management of GERD.
Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease (GERD).
Torquati A, Houston HL, Kaiser J, Holzman M, Richards WO. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease (GERD). Surg Endosc 2004;18:1475-9.
CONCLUSION: In conclusion, the Stretta procedure is a safe, moderately effective, and durable endoscopic treatment for GERD. Over the long term, this therapeutic intervention significantly improves GERD symptoms and quality of life, and eliminates the need for PPIs in the majority of patients.
Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux.
Go MR, Dundon JM, Karlowicz DJ, Domingo CB, Muscarella P, Melvin WS. Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Surgery 2004.07.006; 13 (4) 786- 794.
CONCLUSION: Stretta improves heartburn symptoms both overall and in patients with poor outcome after antireflux surgery, with a low procedural risk. It may have a role in the treatment of patients with primary reflux and in those who have failed antireflux surgery or who are a high risk for surgery.
Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure.
Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc (2004) 18: 1038-1044 DOI: 10.1007/s00464-003-8243-5.
CONCLUSION: Responders had significant improvement in esophageal acid exposure, whereas nonresponders had less or no change. There was a positive correlation between esophageal acid exposure and both GERDHRQL and heartburn. This evidence suggests that symptomatic improvement after Stretta is attributable to a decrease in esophageal acid exposure and not to desensitization of the esophagus.
Improvement of Gastroesophageal Reflux Symptoms After Radiofrequency Energy: A Randomized, Sham-Controlled Trial.
Corley DA., Katz P, Wo JM., Stafan A, Patti M, Rothstein R, Emundowicz S, Kline M, Mason R. Wolfe MM. Improvement of Gastroesophageal Reflux Symptoms After Radiofrequency Energy: A Randomized, Sham-Controlled Trial. Gastroenterology 2003; 125(3):668-676.
CONCLUSION: Radiofrequency energy delivery significantly improved gastroesophageal reflux disease symptoms and quality of life compared with a sham procedure, but it did not decrease esophageal acid exposure or medication use at 6 months. This procedure represents a new option for selected symptomatic gastroesophageal reflux disease patients who are intolerant of, or desire an alternative to, traditional medical therapies.
Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease.
Tam WCE, Schoeman MN, Zhang Q, Dent J, Rigda R, Utley D, Holloway RH. Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease; Gut 2003; 52:479-485.
CONCLUSION: In summary, our study demonstrates that RFe treatment has significant effects on LOS function that are associated with improvement in the antireflux barrier. Uncontrolled clinical data also suggest a beneficial effect in the control of reflux symptoms in these patients. Further studies are needed to evaluate the mechanism of effects on transient lower oesophageal sphincter relaxations, and to gather placebo controlled data with long term follow up.
Paradigm shift in the management of Gastroesophageal Reflux Disease.
Richards WO, Houston HL, Torquati A, Khaitan L, Holzman MD, Sharp KW. Paradigm shift in the management of Gastroesophageal Reflux Disease. Annals of Surgery 2003; 237(5):638-649.
CONCLUSION: In summary, we present a new paradigm for the surgical management of patients with refractory GERD. While not all patients may have a complete response to Stretta, we truly have an effective, less invasive therapy for GERD that does not burn any bridges. Stretta is a reasonable procedure to use in well-selected patients. It should not be used in patients with Barrett’s esophagus, LES pressure less than 8mm Hg, or large hiatal hernia (2 cm). It may have specific utility in morbidly obese patients, patients with previous gastric resection or gastric bypass, or after failed fundoplication. The adoption of an endoscopic treatment for GERD has allowed us to stratify (Stretta v. LF) the management of our reflux patients according to size of hiatal hernia, LES pressure, and the presence or absence of Barrett’s esophagus or significant pulmonary symptoms.
The Stretta procedure for the treatment of GERD: a registry of 558 patients.
Wolfsen HC, Richards WO. The Stretta procedure for the treatment of GERD: a registry of 558 patients. J laparoendosc adv surg tech 2002;12 (6):395-402.
CONCLUSION: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 result support the use of the Stretta procedure for patients with GERD, particularly those with inadequate control of symptoms on medical therapy.