Case study: Upright reflux treatment with Stretta

Gastroesophageal reflux disease occurs when stomach contents backflow into the esophagus or throat leading to symptoms of heartburn, and regurgitation.

This can occur whether the patient is either upright or lying down (supine position). Supine refluxers typically experience symptoms due to an incompetent lower esophageal sphincter. In upright refluxers, however, the lower esophageal sphincter (LES) often has good muscle tone and the ability to close; but daytime stress or other simulation causes gastric distension, triggering the LES to inappropriately relax, resulting in reflux episodes. In these cases, when the upright refluxer is in a supine position, such as during the night, there is no such stimulation and the sphincter remains in its natural state—closed. In some cases, patients can have a combination of both types. There is significant evidence indicating that the large percentage of patients with GERD symptoms experience reflux in the upright position. 1, 2

For both the supine and upright reflux patient, the first line of treatment involves diet modification and administration of proton pump inhibitors. While PPI medications are proven to successfully reduce acid production, potential long-term complications, such as osteoporosis and C.difficile infections are a potential concerns.3 Although the absolute risk of complications attributable to PPIs is low 4,  the FDA has issued broad-based cautionary statements regarding the long term or overuse of PPIs. 5 As such, patients and practitioners have sought new, permanent ways to treat patients suffering from severe, chronic GERD to minimize the use of PPIs.

An alternative treatment
While there are multiple treatment modalities for GERD, Stretta Therapy (Mederi Therapeutics Inc., Norwalk, CT) is a minimally invasive outpatient procedure offering patients a viable alternative for uncontrolled GERD symptoms. Stretta involves the application of radiofrequency (RF) energy that remodels the musculature of the LES and gastric cardia. The treatment restores the barrier function of the muscle, and significantly reduces the frequency of reflux-triggering transient sphincter relaxations. Stretta is an outpatient procedure done under conscious sedation. The procedure is proven safe and has shown to be clinically effective in more than 35 studies showing lasting symptom relief for four to 10 years. 6,7

Case study presentation
A 21-year-old woman presented with reflux and vomiting episodes for more than 12 years. The daily episodes made her unable to eat or live normally, causing her to miss school frequently, and become withdrawn and malnourished.

Diagnosis
The patient's esophageal pH levels were tested with the Bravo pH Monitoring (Given Imaging) system, which involves attaching a miniature pH capsule in the esophagus during an upper endoscopy. The device wirelessly transmits data to a small recorder worn by the patient. After 48 hours, the device detaches from the esophageal lining and elimination occurs through the bowels.  

The patient experienced 103 reflux episodes, the majority in the upright position. Acid was present in the esophagus 12.6 percent of the time compared to the normal rate of less than 4 percent. The patient was confirmed to have severe gastroesophageal reflux disease in the upright position.

Treatment and outcome
The patient had previously been given PPI medications, which did not adequately control her symptoms. Additionally, concerns about the long-term implications of PPI medications, including osteoporosis, instigated the search for an alternative treatment. She looked at a variety of treatment options, including other drugs and combinations of medical therapies, as well as invasive surgical approaches. We introduced the option of Stretta, as it is the least invasive method and has an excellent safety record. Further, in the rare instance that Stretta doesn't provide full relief, there are no corrective measures necessary to be able to treat with one of the more invasive measures.

I performed the Stretta procedure in August of 2013. After an upper endoscopy to identify the location of the Z-line, a guidewire was endoscopically placed to guide insertion of the Stretta catheter. Once the catheter was in place, we inflated a securing balloon, then advanced four needle electrodes into the muscularis propria of the lower esophagus and commenced RF energy delivery for 60 seconds. Once that treatment was complete, the balloon was deflated, needles were retracted and the catheter was repositioned to deliver energy to specific levels and positions in the LES. There are a total of six levels of treatment in the esophagus, and two levels in the gastric cardia – a total of 14 one-minute treatment cycles. The entire procedure took about 45 minutes. The patient's recovery was similar to any endoscopy procedure and she was discharged home without any complications.

At three months post-treatment the patient reported no episodes of reflux or regurgitation and was no longer taking any PPIs. The patient continued to improve and at one-year was still symptom free.

Conclusion
Stretta Therapy is a the most widely studied non-surgical treatment for GERD and is of particular benefit to the patient with chronic GERD despite medications, or those concerned about long-term effects of PPI use. Stretta reduces the amount of transient relaxations of the LES – especially in upright refluxers and is shown to relieve reflux symptoms and the underlying cause of GERD without invasive surgery.

Kenneth Chang, MD, is the executive director of the UC Irvine Health H.H. Chao Comprehensive Digestive Disease Center. He has been recognized as one of America's leading doctors in the fields of gastrointestinal oncology and digestive diseases. Dr. Chang can be reached at 714-456-8063.

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1 Kahrilas PJ, Dodds WJ, Dent J, Wyman JB, Hogan WJ, Arndorfer RC. Upper esophageal sphincter function during belching. Gastroenterology 1986;91:133. Accessed September 2, 2014.
2Wyman JB, Dent J, Heddle R, Dodds WJ, Toouli J, Downton J. Control of belching by the lower esophageal sphincter. Gut 1990;31:639. Accessed September 2, 2014.
3 Johnson DA, Oldfield EC IV. Reported Side Effects and Complications of Long-term Proton Pump Inhibitor Use Clin Gastroenterol Hepatol. 2013;11(5):458-464.
4Vakil N. Prescribing proton pump inhibitors: is it time to pause and rethink? Drugs. 2012;72(4):437-45. doi: 10.2165/11599320-000000000-00000.
5 Department of Health and Human Services. FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs). FDA. http://www.fda.gov/drugs/drugsafety/ucm245011.htm. Published March 2, 2011. Accessed September 2, 2014.
6 Dughera L, Navino M, Cassolino P, et al. Long-Term Results of Radiofrequency Energy Delivery for the Treatment of GERD: Results of a Prospective 48-Month Study. Diagn Ther Endosc. 2011;2011:507157. doi: 10.1155/2011/507157. Accessed September 2, 2014.
7 Noar MD, Squires P, Noar E. Sustained Improvement in GERD-HRQL, Patient Satisfaction, and Anti-Secretory Drug Use 10-years after Stretta for Medically Refractory GERD. SSAT. http://meetings.ssat.com/abstracts/2013/Su1627.cgi. Published May, 2013. Accessed September 2, 2014

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