SAN DIEGO — Electrical stimulation therapy of the lower esophageal sphincter significantly improved esophageal acid exposure, GERD symptoms, PPI use and quality of life in patients with GERD partially responsive to PPIs, according to 1-year results from a multicenter trial presented at DDW 2016. The treatment was also found to be safe and well tolerated.
This treatment, developed by EndoStim, involves a minimally-invasive device that is implanted laparoscopically and uses low-energy neurostimulation targeting the lower esophageal sphincter to restore normal esophageal function, according to a press release. Previous trials and an ongoing international patient registry have demonstrated the treatment’s safety and efficacy.
Peter D. Siersema
In this prospective, international, multicenter trial, Peter D. Siersema, MD, PhD, chief of the department of gastroenterology and hepatology at the University Medical Center, Utrecht, the Netherlands, and colleagues evaluated 42 GERD patients (median age, 51 years; 24 men) who were treated with the EndoStim device.
“These patients all were ... partly symptomatic on PPIs and had a small hiatal hernia of no more than 2 cm,” Siersema told Healio Gastroenterology.
The devices were implanted partly endoscopically but mainly laparoscopically, and 12 electrostimulation sessions lasting 30 minutes each were performed, generally at 20 Hz for 250 microseconds and a low current of 5 to 8 milliamps, Siersema said during his presentation. “The beauty about this treatment is that the therapy can be individually optimized.”
Among the 37 patients who completed 12-month follow-up, median GERD health-related quality of life improved from 31 off-PPI and 17 on-PPI at baseline to 5 (P < .001), and median esophageal acid exposure improved from 10% at baseline to 4.4% (P < .001). Moreover, 81% were off PPIs at 1 year, 8% used them intermittently and 11% continued to use them regularly. Mental health, physical health and activity impairment also improved significantly.
“The results basically showed that there was a dramatic improvement ... not only in symptoms but also in objective measurements of pH normalization in the esophagus, ... quality of life [and] work capability, [and] the good news was that there were almost no side effects,” Siersema said.
Three serious adverse events did occur, including two electrode erosions and a trocar perforation.
“We can conclude that electrostimulation of the lower esophageal sphincter is safe, effective, seems reversible and can be used in patients with severe symptoms of GERD who are partially or not responsive to PPI therapy, and at the same time do not have a hiatal hernia that is larger than 2 cm,” Siersema said. “In fact, when they have a hiatal hernia that’s 3 cm or even 4 cm, it is possible to correct this when surgery is being performed, and in these patients the results are comparable to those who have a smaller hiatal hernia.” – by Adam Leitenberger
Siersema PD, et al. Abstract #1085. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.
Disclosures: Siersema reports grant/research support and other financial benefits from Endostim, Boston Scientific, Cook Medical and Corpak Medsystems, and consulting for Boston Scientific and EndoChoice. Please see the DDW disclosure list for all other researchers’ relevant financial disclosures.