A Case Series on Gastroesophageal Reflux Disease and the Bariatric Patient: Stretta Therapy as a Non-surgical Option

| November 1, 2016

by A. Daniel Guerron, MD, and Dana Portenier, MD

A. Daniel Guerron, MD Assistant Professor of Surgery, Department of General Surgery, Duke University Health System, Durham, North Carolina

Dana Portenier, MD Assistant Professor of Surgery, Department of General Surgery, Duke University Health System, Durham, North Carolina

Bariatric Times. 2016;13(11):18–20.

FUNDING: No funding was provided.

DISCLOSURES: A. Daniel Guerron, MD, reports no conflicts of interest relevant to the content of this article. Dana Portenier, MD, reports a consulting relationship with Mederi Therapeutics Inc., Norwalk, Connecticut.


ABSTRACT

Background: Gastroesophageal reflux disease (GERD) among individuals who have undergone bariatric surgery is an important clinical problem and one that currently has limited treatment options. The laparoscopic sleeve gastrectomy (LSG) is growing in popularity. While it is attractive to patients because it is less invasive than a Roux-en-Y gastric bypass (RYGB), it does not resolve GERD as consistently as RYGB does. The LSG resolves GERD in some patients, but in others, it does not, and some develop de novo GERD after surgery. Patients who chose to have a sleeve for their weight loss surgery may object to the prospect of needing a revisional surgery to a RYGB to resolve their GERD. Case Presentations: This case series describes the use of non-ablative radiofrequency (RF) energy delivered endoscopically to the muscularis propria in the lower esophageal sphincter (LES) and Gastric Cardia via an endoluminal catheter (Stretta Therapy) to treat GERD in four patients who previously underwent or who were scheduled to receive LSG. All surgeries were performed at Duke University Regional Hospital. Results: Two patients were symptom free at eight months post-Stretta. Two experienced significant relief at 2 and 3 months and their remaining GERD symptoms were successfully managed with significantly reduced medication use. There were no complications related to the Stretta procedure. Conclusion: Results using Stretta Therapy on this challenging patient population were highly favorable. Stretta provides a safe and effective nonsurgical option for GERD among patients who have undergone a Sleeve Gastrectomy and may be a viable strategy for symptom relief when performed in conjunction with bariatric procedures as a means to avoid revisional surgery.


Background

Approximately one-third of the population of the United States has obesity, defined as a body mass index (BMI) >30kg/m2.[1] Epidemiologic evidence suggests that prevalence is increasing globally.[2–4]

In addition to an association with multiple health-related issues, individuals with obesity are more likely to experience gastroesophageal reflux disease (GERD).[5] Patients with obesity have a much higher incidence of GERD (about 60%-70%) compared with average weight patients (approximately 10–20%),[6] and, as obesity rates rise, these and other associated comorbidities are also expected to increase.

Bariatric surgery has been shown to be an effective approach for reducing weight in individuals with morbid obesity.[7] According to the American Society for Metabolic and Bariatric Surgery (ASMBS), 196,000 bariatric procedures were performed in 2015,[8] encompassing Roux-en-Y gastric bypass (RYGB), adjustable gastric banding (AGB), duodenal switch (DS), and laparoscopic sleeve gastrectomy (LSG)—with LSG growing in popularity, representing 11 percent of bariatric procedures in 2011, 42 percent in 2013, and 54 percent in 2015.[8]

Patients with obesity and GERD who undergo a RYGB are likely to experience symptom relief due to the anatomical alteration of the procedure. In addition, the weight loss, diet, and lifestyle modifications associated with bariatric surgery may provide benefit in terms of resolving GERD in some patients. For those who opt for a sleeve, however, GERD symptoms may continue. One study found that 84 percent of individuals with GERD prior to undergoing LSG continued to experience symptoms postoperatively, and an additional 8.6 percent developed GERD after undergoing the procedure.[9]

Treatment of GERD among patients who have undergone bariatric surgery is typically centered on pharmacotherapy, specifically proton pump inhibitors (PPIs). While this approach is effective, additional interventions may be required to control GERD symptoms. Revisional surgery is often considered the next step,10,11 but treatment options are limited due to the anatomy altering nature of the previous bariatric surgery. A nonsurgical option that would safely and effectively treat the GERD and not interrupt the anatomy would be of great clinical benefit.

Use of nonablative radiofrequency (RF) energy delivered to the muscularis propria in the lower esophageal sphincter (LES ) and gastric cardia via an endoluminal catheter (Stretta Therapy; Mederi Therapeutics Inc., Norwalk, Connecticut, USA) may provide a solution for treatment of GERD among patients with obesity, specifically those with altered anatomy from previous bariatric surgery. It may also serve as a prophylactic means to reduce the risk of developing de novo GERD and ameliorate GERD symptoms among patients who undergo bariatric procedures. The following case series demonstrates the viability of Stretta Therapy in two settings: 1) as an effective nonsurgical means to treat GERD in individuals who continued to experience GERD symptoms after LSG; and 2) as an additional step during an LSG to reduce the risk of worsening or new GERD symptoms and to avoid revisional surgery. Both categories of patients represent significant treatment challenges with respect to chronic refractory GERD symptoms.

Stretta Therapy For GERD

Performed on an outpatient basis under conscious sedation or general anesthesia, Stretta Therapy uses nonablative radiofrequency energy delivered to the muscularis propria in the lower esophageal sphincter (LES) and gastric cardia (Figure 1). The goal of this treatment is to regenerate the muscle, thereby inducing hypertrophy and an improvement (increases collagen 1 deposition) in collagen, which in turn results in improved barrier function and fewer reflux events.[12] Technical specifications for this device have been reported previously.[13]

Results from several clinical trials demonstrate that Stretta Therapy results in a number of improvements, including increased LES wall thickness,[14] decreased acid exposure,[15] increased LES pressure,[16] decreased tissue compliance, and eliminated or reduced GERD symptoms.[17] Studies show an improvement in objective and subjective GERD outcome scores: More than 40 peer-reviewed studies, including randomized controlled trials,[15],[17],[18] a meta-analysis,[19] and a 10-year outcome study,20 and have shown Stretta Therapy to be safe and effective with long lasting symptom relief. In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) clinical spotlight review guideline gave Stretta its highest grade recommendation due to the quality of clinical evidence.[21] Mattar et al studied a small series of patients with chronic GERD after RYGB and found that after Stretta, 5 of 7 patients had complete resolution of their symptoms with normalization of pH studies (mean fraction time of 3% ± 0% for pH < 4).[12]

Patients and Methods

All patients included in this case series were a minimum of 18 years of age and had either previously undergone bariatric sleeve or bypass and continued to experience symptoms of GERD for more than six months, or they were scheduled to undergo a bariatric procedure and were considered at risk for worsening or new GERD. All data were gathered through a retrospective review of a prospectively maintained database. Cases were chosen in order to provide examples of our most challenging types of patients with GERD.

Assessment and Treatment

Endoscopic evaluations and pH impedance testing were performed to confirm GERD and to determine if esophageal abnormalities or hiatal hernias were present. All patients underwent non-surgical Stretta Therapy at Duke University Regional Hospital, Durham, North Carolina. The Stretta procedure was performed using the standard technique, delivering RF energy to the muscularis propria via needles and a balloon catheter while cooling the esophageal mucosa with chilled water. The standard technique consists of 14 one-minute treatment cycles in six levels of treatment (4 antegrade in the LES and 2 retrograde in the gastric cardia). All patients in this case series had general anesthesia and procedures were performed on an outpatient basis. Patient outcome measures were symptom relief and reduction of medication use.

Case Presentation

Four female patients with a mean age of 42 years (range, 33 to 51) were treated and subsequently followed for 3 to 8 months. Assessments were performed according to the treating physician’s discretion.

Case 1: GERD in a Patient After Revision from RYGB to LSG.

A 33-year-old Caucasian female patient with morbid obesity underwent a laparoscopic RYGB procedure in 2006 at an outside hospital. She developed several complications postoperatively, including a gastrojejunostomy anastomosis stricture, chronic dumping syndrome, nausea, and vomiting. Ultimately, her nutrition was supported via enteral tube. In late 2015 she required conversion to a LSG; her BMI at the time measured 42kg/m2. Although she recovered satisfactorily and the feeding tube was removed, she developed significant reflux with recurrent aspiration pneumonia that was confirmed with pH study. Esophageal manometry performed at the time appeared normal.

The patient was referred for Stretta therapy. At the time of the procedure, her BMI was 34kg/m2 and she was taking a PPI, an H2 agonist, and sucralfate with no apparent relief of symptoms. Stretta was performed without any complications. At follow-up visits three weeks and three months after receiving treatment, the patient reported improved symptoms with no further episodes of regurgitation or pneumonia. The sucralfate and H2 agonist were stopped and the patient was maintained on a PPI only.

Case 2: De Novo Reflux in a Patient After LSG Procedure.

A 41-year-old African-American female with morbid obesity (BMI 36kg/m2 and metabolic syndrome and sleep apnea) who underwent LSG in 2014 developed GERD symptoms six months after the bariatric procedure. She reported chest pain, reflux, and regurgitation that progressively deteriorated despite therapy with 40mg of PPI twice daily to control symptoms. The patient reported significant discomfort and difficulty sleeping. Due to persistent symptoms, a follow-up esophagogastroduodenoscopy was obtained and demonstrated evidence of severe bile reflux without a hiatal hernia. Additional upper gastrointestinal imaging revealed no anatomical abnormalities, and BMI was 21.82kg/m2.

Stretta therapy was performed to treat her reflux symptoms. After treatment, the patient reported improved GERD symptoms starting at 3 to 4 weeks after the Stretta procedure, including no chest pain, burning, or regurgitation. Importantly, the patient reported no discomfort while sleeping, an indication of improved quality of life. PPI dosage was decreased to 20mg daily (omeprazole, Prilosec) and the patient is scheduled for additional follow up.

Case 3: Combined LSG with Stretta Therapy.

A 42-year-old African American female patient with a BMI of 54kg/m2 reported for a surgical consultation for bariatric surgery. Medical history included obstructive sleep apnea, recent smoking, and type 2 diabetes that was being managed with oral agents. Her A1C measured 6.3. The patient also reported using intermittent anti-acids (Ranitidine PRN) for reflux that had worsened during a previous pregnancy.

Although the patient preferred a laparoscopic RYGB, she was recommended to receive LSG due to the smoking status and known recidivism. Given her history of reflux during pregnancy and < 2cm hiatal hernia found on a preoperative endoscopy, LSG was combined with Stretta to ameliorate GERD symptoms. After surgery and Stretta treatment, the patient reported improvement of symptoms, with no reported reflux complaints after eight months of follow up.

Case 4: Prophylactic Stretta Therapy in a Patient With Small Hiatal Hernias Undergoing LSG.

Esophagogastroduodenoscopy in a 51-year-old African American female patient with a BMI of 42kg/m2 who was being evaluated for an LSG procedure revealed a 2 to 3cm hiatal hernia with mild gastritis. A decision was made to perform Stretta Therapy prophylactically in conjunction with the LSG to lower the potential risk of developing GERD postoperatively.

At the three-week postoperative follow-up visit, the patient reported increased reflux, which was controlled with low dose daily PPI. We recommended a continuance of the PPI for at least six months. At her eight month follow up she had lost 55 pounds and discontinued PPI due to complete resolution of symptoms.

Conclusion

The experience at Duke University using Stretta Therapy in this challenging patient population has been highly favorable, and has allowed us to avoid a revisional surgery in a majority of our Stretta patients. The role of LSG in GERD requires more research; however, regardless of the cause of GERD, there is a need for a nonsurgical option for patients who develop or continue to experience GERD after a bariatric procedure. Stretta could theoretically replace a conversion to RYGB as the first option in cases where medication is ineffective or undesired, and if necessary, additional bariatric surgery remains an option after Stretta.

In the case of patients who have undergone a RYGB and still experience GERD, Stretta may be a viable treatment option given the already significantly altered anatomy.[12] Additionally, Stretta may be an option that would not complicate further surgery for patients with obesity and GERD who are not ready for weight loss surgery and in whom a Nissen fundoplication has a high failure rate.[22]

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