Novel antireflux device shows potential for treatment of PPI-refractory GERD

Patients suffering from gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM) may benefit from the novel RefluxStop device implantation, a safe and minimally invasive technology that offers potential benefits, a study has shown.

“RefluxStop is a new alternative antireflux surgery potentially reducing postoperative dysphagia rates,” the researchers said.

“Given its minimally invasive nature and potential advantages for patients with esophageal motility disorders, initial findings suggest a low incidence of complications and quick recovery time during short-term follow-up,” they noted.

This bicentric tertiary hospital observational study included 40 consecutive patients (25 male) with proton pump inhibitor (PPI)-refractory GERD and IEM who received RefluxStop implantation. Participants underwent a safety and efficacy evaluation that included clinical examination and GERD-HRQL questionnaire.

Of the patients, 31 (77.5 percent) were on PPI at time of surgery, with a mean acid exposure time of 8.14 percent and median hospital stay of 3 days.

Postoperative quality of life significantly improved, with GERD-HRQL total score dropped from 32.83 to 6.6 (p<0.001). PPI usage also decreased by 84 percent (p<0.001). At first follow-up, 36 patients (90 percent) had no or improved symptoms and expressed satisfaction with the novel device. [Sci Rep 2024;14:15425]

In terms of safety, two severe adverse events occurred: one postoperative slipping of the RefluxStop device with required immediate revisional operation on the first postoperative day (Clavien‒Dindo Score 3b) and one device migration with no necessary further intervention.

“Further studies and longer follow-up are necessary to prove long-lasting positive effects as a novel antireflux procedure,” the researchers said.

GERD causes

One of the common diseases across the globe, GERD has a prevalence rate of up to 33 percent. Nearly 1 billion people worldwide are suffering from this condition. [Lancet Gastroenterol Hepatol 2020;5:561-581; Sci Rep 2020;10:5814]

In addition, up to 30 percent of patients have PPI-refractory GERD, which is impervious to lifestyle modifications and medication. [Med Clin N Am 2019;103:15-27]

“GERD is caused by various reasons and goes hand in hand with the loss of normal antireflux barriers, such as the pressure of the lower esophageal sphincter (LES), abdominal sphincter length, esophageal hiatus and His-angle,” the researchers said. [Chin Med J 2022;135:1750-1752]

“Especially patients with IEM suffer from worse abnormal acid burden and have a higher probability to postoperative dysphagia due to diminished motility,” they added. [Neurogastroenterol Motil 2019;31:e13584]

Eighty-five percent of GERD patients have a shorted and structural defect LES. They also have a shorter or depleted intra-abdominal length, which is characterized by the LES moving into the thoracic cavity either temporarily or permanently. [Dis Esophagus 2021;doi:10.1093/dote/doab006]

Limitations

The current study had several limitations, which include its retrospective nature, short follow-up period, and the absence of a control group.

“Future studies are currently being conducted to compare patients with and without esophageal dysmotility as well as randomized controlled trials (RCTs) to compare RefluxStop with Nissen fundoplication,” the researchers said.