LES electrical stimulation shows promise for treating refractory GERD

Electrical stimulation of the lower esophageal sphincter (LES) to compensate for sphincter incompetence seems a rather direct approach to treating GERD, and the data presented by Dr. Soffer seem to indicate that this can work. Most convincing is the reduction in esophageal acid exposure from a mean of 10.3% at baseline to a mean of 3.7% after implantation. True, there is the variable of surgical correction of hiatal hernia done in 13 of the 32 implanted patients to deal with, but nonetheless, these are very encouraging proof-of-concept data.

Dr. Peter J. Kahrilas

So now the more difficult questions: Who needs this therapy, and how should its efficacy be further evaluated? With regard to who needs this therapy, I would argue against it being a mainstream approach. PPIs are simply too good, too inexpensive, and too safe to compete with. However, there are a number of intriguing niche applications for which the EndoStim device might be suitable, for example, patients with poor peristalsis or obesity for whom the conventional surgical approaches are not advised, lung transplant or bariatric surgery patients, or patients with excessive regurgitation after gastrostomy placement. In these situations, conventional approaches of PPIs or Nissen fundoplication are either ineffective or ill-advised. A true unmet need exists.

The other question that arises is how to further test the device. The issue raised by Dr. Richter of discriminating between the benefits from hiatus hernia repair and from the stimulator itself needs to be resolved. Certainly, a subgroup analysis of the stimulator-only population is in order, as is a future study of the device in hernia patients without adding a hernia repair. Another interesting potential with this device is that it can serve as its own control in future trials, assuming that the implanter can resist the temptation to attempt an anatomical correction at the time of implantation and presuming that the stimulator can be switched on and off. Then, as in the studies done with gastric pacing, patients could be studied physiologically or symptomatically with the device on or off in a blinded fashion. I look forward to hearing more on the development of the LES stimulator.

Dr. Peter J. Kahrilas is the Gilbert H. Marquardt Professor of Medicine at the Feinberg School of Medicine, Northwestern University, Chicago. He is a consultant for AstraZeneca, GlaxoSmithKline, Pfizer, Torax, and Reckitt Benckiser.