Medicine is an evolving science, requiring physicians to regularly reevaluate treatment options based on new evidence. This is underscored by two recent publications pertaining to the treatment of gastroesophageal reflux disease (GERD).
One, a study by Stanford University researchers published in the journal PLOS One, links the use of proton pump inhibitors (PPI) to an increased risk of heart attack . According to published data, in 2011, the PPI omeprazole was the sixth most commonly dispensed prescription medication in the U.S., with over 59 million prescriptions written . The researchers found a 16-20 percent increased risk of heart attack in patients taking these drugs.
In addition, the American Society for Gastrointestinal Endoscopy (ASGE) published new guidelines on the role of endoscopy in the management of GERD, which invites the consideration of endoscopic treatment for chronic GERD and provides an overview to assist physicians in caring for these patients .
Together, these two studies encourage a closer look at the tools used to manage GERD.
Proton pump inhibitors remain the first-line therapy for GERD. But, besides the roughly 30 percent of patients who are refractory to medications, a large number of patients would prefer not to be on long-term medications. In light of the Stanford study, physicians may be reconsidering if a patient is a good candidate for PPI therapy and, given the widespread publicity this study has received, professionals will likely see more patients seeking alternatives to long-term medications.
Treatment Options Emerge
For refractory patients with the most severe symptoms, laparoscopic fundoplication has long been considered to be the standard solution. However, many patients have less severe symptoms, are not good surgical candidates, or may balk at any surgical procedure. For these “middle ground” patients, non-surgical endoscopic procedures may make sense. Endoscopic treatments are performed transorally with no incisions, and have fewer complications and side effects than surgical options.
Stretta Therapy uses non-ablative radiofrequency (RF) energy delivered to the muscularis propria of the lower esophageal sphincter (LES) and gastric cardia. Studies show that this treatment stimulates the growth of smooth muscle, creating a thicker muscle wall, resulting in improved barrier function and a corresponding reduction in symptoms, acid exposure and improved quality of life. Stretta is a 45-minute outpatient procedure that received FDA clearance in 2000, and has since garnered 37 peer-reviewed studies, including 10-year data confirming its safety and durability . Stretta was also included in the SAGES Clinical Spotlight Review Guideline in 2013, receiving the strongest grade recommendation . Additionally, Stretta doesn’t alter the anatomy, making it a versatile option for patients with recurring GERD who already have a surgically altered anatomy, such as post-bariatric (especially sleeve gastrectomy) or post-fundoplication patients.
The EsophyX transoral incisionless fundoplication (TIF) procedure is an endoscopic technique that creates a partial fundoplication by fastening the fundus of the stomach around the esophagus to augment the reflux valve and improve GERD symptoms. The first iteration of TIF was FDA approved in 2007. Approximately 20 peer-reviewed studies have been done on the Esophyx1 and Esophyx2 versions of the device. The TIF procedure allows the physician to perform a 270° fundoplication without incisions, and with fewer complications than the traditional lap Nissen .
Introduced as an alternative to a surgical fundoplication, the relatively new Linx device received a conditional FDA approval in 2012. Designed as a way to standardize the potentially variable surgical fundoplication, the Linx device uses a bracelet of magnets that open and close permitting contents to appropriately pass between the esophagus and stomach. The device is surgically implanted, similar to a complete fundoplication, and may offer fewer adverse events than a fundoplication. While short term results of Linx have produced results similar to complete fundoplication, long-term safety and efficacy has yet to be established [7-8].
Offering a complete continuum of care
Across the field of foregut surgery we have seen an increase in patients seeking treatment for their GERD symptoms, and we offer a full arsenal of treatment options. This breadth of offering enables us to customize the therapy that is best for each patient, and when appropriate, to give patients choices in their treatment option. Patients generally prefer to begin with the least invasive option first, then move on to next steps. A logical progression would be:
- Endoscopic RF
- Endoscopic Fundoplication (TIF)
- Linx or Laparoscopic fundoplication
Given the concerns around long-term PPI therapy, physicians owe it to their patients to carefully weigh the benefits and risks, and determine if an alternative endoscopic solution may be a more suitable treatment option.
- Shah NH. PLoS One. 2015 Jun 10:10(6):e0124653
- IMS Institute for Healthcare Informatics. The use of medicines in the United States: Review of 2011. Published April 2012.
- www.giejournal.org Volume 81, No. 6: June 2015, Pp. 1305 – 1310
- Noar MD et al. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: A decade later. Epublished Surgical Endoscopy February 2014
- Short-Term Outcomes Using Magnetic Sphincter Augmentation Versus Nissen Fundoplication for Medically Resistant Gastroesophageal Reflux Disease, Louie, Brian E. et al., The Annals of Thoracic Surgery , Volume 98 , Issue 2 , 498 – 505
Reavis has no financial disclosures to report on behalf of Stretta/ Mederi Therapeutics.