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.     

Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort

Surgical Endoscopy - Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring...     

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.     

Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure

Background Endoscopic radiofrequency energy delivery (Stretta) is effective for managing gastroesophageal reflux disease (GERD) in selected patients. One criticism, however, is a theory that a mechanism of action is partial desensitization of the esophageal body rather than a reduction in esophageal acid exposure. To resolve this question, this study sought to determine if there is a correlation between the improvement in GERD outcomes and esophageal acid exposure after Stretta.Methods Subgroup analyses were performed between responder and nonresponder groups from the U.S. Stretta open label trial (n = 118), on the basis of posttreatment responses for GERD health-related quality of life (HRQL) heartburn, satisfaction, and proton pump inhibitor use. Outcomes were analyzed within and between subgroups. Pearson correlation coefficient analysis was performed comparing distal esophageal acid exposure with each of the continuous outcomes (GERD-HRQL, heartburn, satisfaction).Results Responder subgroups had significant improvements in esophageal acid exposure, whereas nonresponders had no change or less improvement in the same. Changes in GERD-HRQL and heartburn severity were correlated with changes in acid exposure (r = 0.16, p = 0.12 and r = 0.26, p = 0.01, respectively). Changes in satisfaction were negatively correlated with changes in esophageal acid exposure (r = 0.23, p = 0.02) because satisfaction, as expected, increased as acid exposure decreased.Conclusions 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 GERD-HRQL 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.     

The motility of the lower esophageal sphincter (author's transl)

Changes in lower esophageal sphincter (LES) motility have been mainly studied by intraluminal manometry. However, it is not suitable for continuous measurement of LES pressure. With extraluminal force transducers developed and constracted in our laboratory, we measured changes in contractile activity of the LES. Three anesthetized mongrel dogs were used for preliminary experiment. A transducer was sutured on the serosal surface of the LES immediately inferior to the phrenoesophageal membrane. A catheter with a side hole was simultaneously passed into the stomach through a mouth so that the side hole was anchored at the highest pressure zone of the gastroesophageal junction. It was found that dose-related changes in motor activity of the LES to pentagastrin were obtained by both methods. This result indicate changes obtained by transducers represent those in intraluminal pressure measured manometory. Transducers were chronically implanted on the LES and the gastric body and antrum to record changes in contractile activity in conscious state. It was found that a group of contractions lasting for 25 +/- 2.5 min occurred at regular intervals of quiescence until next meal. Furthermore, these motor increase precisely coincided with the interdigestive contractions of the stomach.     

Celecoxib (celebrex) increases canine lower esophageal sphincter pressure

BACKGROUND: Prostaglandins inhibit the contraction of gastrointestinal smooth muscle and may decrease lower esophageal sphincter tone. The purpose of this study was to determine whether the cyclooxygenase-2 inhibitor celecoxib (Celebrex) could increase lower esophageal pressure (without affecting gastric emptying) compared to placebo and cisapride (Prepulsid), a compound previously used to treat reflux disease. MATERIALS AND METHODS: Six mongrel dogs were assigned to receive celecoxib, cisapride, and placebo using a randomized cross-over design with a 1-week washout period between treatments. Prior to dosing, each dog underwent an esophagopexy to provide access to the esophagus and stomach. On the fourth day of dosing, sphincter tone was measured in awake unsedated dogs using radial manometry. In a different set of six dogs, liquid and solid gastric emptying rates were scintigraphically determined. RESULTS: Celecoxib significantly increased mean and average maximum lower esophageal pressures compared to placebo without affecting the gastric emptying rate. The magnitudes of these increases were similar to that produced by cisapride. CONCLUSIONS: Celecoxib had a positive effect on canine lower esophageal sphincter tone. This finding, combined with the drug's low incidence of gastrointestinal toxicity, suggests that celecoxib may warrant consideration and investigation as a pharmacotherapy for human reflux disease.     

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.     

Changes in lower esophageal sphincter pressure (LES) after Stamm gastrostomy

Previous clinical and experimental reports have implicated placement of a Stamm gastrostomy (SG) as a cause of gastroesophageal reflux (GER) in children. This study evaluates this problem by measuring alterations in the lower esophageal sphincter pressure (LES) after SG with and without maintenance of the esophagogastric angle of Hiss. In 20 cats (2.8-3.2 kg) general anesthesia was induced using 20 mg/kg ketamine im. Esophageal manometrics were measured using a continuous perfusion catheter and recording system, evaluating three measurements for each animal. Eight cats (Group I) underwent SG placement in the anterior stomach wall two-thirds of the way down from the fundus. This was tacked to the anterior abdominal wall 3 cm lateral to the midline at the appropriate level. Six cats (Group II) had standard SG tube placement and in addition, two interrupted sutures were placed between the fundus and the esophagus maintaining the gastroesophageal angle of Hiss. Six cats (Group III) had sham laparotomy. After awakening, the animals were fed cat chow and water ad libitum. At 7 and 14 days, the animals were reanesthetized with ketamine and manometrics were repeated. Preoperative LES pressure measured 11.3 +/- 4.7 Torr. LES pressure in Group I decreased to 6.61 +/- 1.6 Torr at 7 days (P less than 0.01) and 4.8 +/- 1.6 Torr at 14 days postoperatively (P less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)     

Response of the canine lower esophageal sphincter to endogenous hypergastrinemia

The effects, if any, of endogenous gastrin on the lower esophageal sphincter (LES) remain controversial. This study was designed to investigate the effects of endogenous hypergastrinemia on lower esophageal sphincter pressure (LESP). Auto transplantation of the isolated vagally innervated antrum as a diverticulum into the transverse colon produces endogenous hypergastrinemia. Five dogs underwent measurement of fasting and postprandial LESP and serum gastrin (fasting LESP 43.2 ± 3.7 (SEM) cm H₂O; fasting serum gastrin 21.9 ± 7.0 (SEM) pg/ml). Antral transplantation resulted in a marked increased in fasting serum gastrin (158.9 ± 35.5 (SEM) pg/ml) (P < 0.015). LESP, however, was unchanged by antral transplantation into the colon (42.6 ± 3.0 (SEM) cm H₂O) (P > 0.2). The response of the sphincter to a protein stimulus was not altered by endogenous hypergastrinemia. This study provides the first concrete evidence that endogenous gastrin plays no significant role in the regulation of lower esophageal sphincter pressure.     

Response of the lower esophageal sphincter to gastric distention by carbonated beverages

Gastroesophageal reflux disease often occurs in patients with normal resting pressure and length of the lower esophageal sphincter. Such patients often have postprandial reflux. The mechanism of postprandial reflux remains controversial. To further clarify this, we studied the effect of carbonated beverages on the resting parameters of the lower esophageal sphincter. Nine asymptomatic healthy volunteers underwent lower esophageal sphincter manometry using a slow motorized pull through technique after ingestion of tap water and carbonated beverages. Resting pressure, overall length, and abdominal length of the lower esophageal sphincter were measured. All carbonated beverages produced sustained (20 minutes) reduction of 30–50% in all three parameters of the lower esophageal sphincter. In 62%, the reduction was of sufficient magnitude to cause the lower esophageal sphincter to reach a level normally diagnostic of incompetence. Tap water caused no reduction in sphincter parameters. Carbonated beverages, but not tap water, reduce the strength of the lower esophageal sphincter. This may be relevant to the pathogenesis of gastroesophageal reflux disease, especially in Western society.     

Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: long-term 3-year results

Background

Electrical stimulation of the lower esophageal sphincter (LES) has been shown to improve outcomes in patients with gastroesophageal reflux disease (GERD) at 2 years. The aim of the study was to evaluate the safety and efficacy of LES stimulation in the same cohort at 3 years.

Methods

GERD patients with partial response to PPI, with % 24-h esophageal pH < 4.0 for >5 %, with hiatal hernia <3 cm and with esophagitis ≤LA grade C were treated with LES stimulation in an open-label 2-year trial. All patients were on fixed stimulation parameter of 20 Hz, 220 μs, 5 mA delivered in twelve, 30-min sessions. After completing the 2-year open-label study, they were offered enrollment into a multicenter registry trial and were evaluated using GERD-HRQL, symptom diaries and pH testing at their 3-year follow-up.

Results

Fifteen patients completed their 3-year evaluation [mean (SD) age = 56.1 (9.7) years; men = 8] on LES stimulation. At 3 years, there was a significant improvement in their median (IQR) GERD-HRQL on electrical stimulation compared to both their on PPI [9 (6–10) vs. 1 (0–2), p = 0.001] and off PPI [22 (21–24) vs. 1 (0–2), p < 0.001]. Median 24-h distal esophageal acid exposure was significantly reduced from [10.3 (7.5–11.6) % at baseline vs. 3 (1.9–4.5) %, p < 0.001] at 3 years. Seventy-three % (11/15) patients had normalized their distal esophageal acid exposure at 3 years. Remaining four patients had improved their distal esophageal acid exposure by 39–48 % from baseline. All but four patients reported cessation of regular PPI use (>50 % of days with PPI use); three had normal esophageal pH at 3 years. There were no unanticipated device- or stimulation-related adverse events or untoward sensation reported during the 2- to 3-year follow-up.

Conclusion

LES-EST is safe and effective for treating patients with GERD over long-term, 3-year duration. There was a significant and sustained improvement in esophageal acid exposure and reduction in GERD symptoms and PPI use. Further, no new GI side effects or adverse events were reported.

     

Endotherapy for a 5-cm mid-esophageal perforation with tandem stenting above the lower esophageal sphincter (with videos)

Background  

Esophageal perforation, whether spontaneous or more commonly as a result of instrumentation, is a life-threatening condition and carries high mortality despite recent advances. Outcome is dependent on etiology, location of injury, and interval between perforation and initiation of therapy. Successful management of esophageal perforation entails combination of: (1) control of the leakage site either surgically or endoscopically to prevent further contamination, (2) drainage of contamination, and (3) appropriate antibiotics along with nutritional support.     

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.     

Electrical stimulation of the lower esophageal sphincter to address gastroesophageal reflux disease after sleeve gastrectomy

Background

Laparoscopic sleeve gastrectomy (LSG) can result in de novo and worsen preexisting gastroesophageal reflux disease (GERD). Post-LSG patients with GERD refractory to proton pump inhibitors (PPI) usually undergo more invasive, anatomy-altering Roux-en-Y gastric bypass surgery. Lower esophageal sphincter (LES) electrical stimulation (ES) preserves the anatomy and has been shown to improve outcomes in GERD patients.