Endolumenal therapies for gastroesophageal reflux disease: are they dead?

Abstract

Since first approved for clinical use in 2000 endolumenal therapies for gastroesophageal reflux have filled a desirable niche. Patients and endoscopists alike were allured by the prospect of an outpatient procedure without skin incisions that would alleviate reflux symptoms. However, the introduction of endolumenal therapies for GERD preceded sound clinical data supporting their use. Some of the devices were either ineffective or caused an inordinate number of complications. Because of the early shortcomings of certain endolumenal therapies for GERD this type of therapy is now being scrutinized closely. Overwhelmingly positive data have been called for to support their use. In fact, endolumenal therapies are at risk of being held to a higher standard than either medical or surgical management of GERD. We must recall that our current gold standard, the laparoscopic Nissen fundoplication, provides symptom relief in 85% of patients, but about 1 in 20 experience prolonged dysphagia. There has been a series of specific criticisms of endolumenal therapies for GERD. Some commentators note the lack of sham controls in published randomized controlled trials [1], which might be critical in a disease such as reflux where a 25% to 50% placebo response is routinely reported. Additionally, the efficacy and safety of some therapies has been questioned, with the recent withdrawal of one of the prosthetic barrier devices. In order for endolumenal therapies to gain a foothold, realistic endpoints should be met. Requiring greater than 90% efficacy is unnecessary, but a durable barrier to reflux and symptom relief in 75% of patients is realistic and achievable. Herein, we review the extant literature concerning endolumenal therapies for GERD and look toward the future in this burgeoning field. Suturing devices Akin to laparoscopic Nissen fundoplication, endolumenal suturing devices serve to alter the hiatal anatomy in order to prevent reflux. Systems for both mucosal apposition and full thickness sutures have been introduced, with more durable results achieved by full thickness gastric plication.