German investigators have reported that the RefluxStop implantable device for the management of gastroesophageal reflux disease (GERD) has impressive two-year follow-up effectiveness and safety outcomes with patients achieving significant improvement in their symptom. The found 96.4% of patients discontinued their regular PPI medication and 90.9% reported an improvement in their GERD-HRQL quality of life score.
The findings were reported in the study, ‘Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis’, presented at the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS) 2024 Conference.
“We are delighted by the outcomes of this new procedure and the significant interest in RefluxStop at AUGIS,” Dr Moustafa Elshafei, study lead at Krankenhaus Nordwest, Frankfurt, Germany, who presented the study at the AUGIS meeting. “It is great to see my UK peers so open and willing to embrace this cutting-edge technology and help drive innovation in the surgical treatment of GERD.”
The study, from two centres in Germany, recruited 158 patients between July 2021 and November 2023. This procedure involves correcting a defunct antireflux barrier through cruroplasty (with hiatal hernia reduction, if necessary), limited (90-120°) esophagogastroplication to recreate the acute angle of His and gastroesophageal flap valve, and regional stabilization of newly constructed anatomy with implantation of the RefluxStop device in a fully invaginated fundic pouch. Clinical outcomes included GERD Health-Related Quality of Life (GERD-HRQL) score, PPI use and perioperative AEs.
“This paper shows that RefluxStop could allow me to offer more patients with large hiatal hernia the durable benefits of a surgical treatment for GERD,” said Dr Thorsten Lehmann, study lead from the Klinikum Friedrichshafen, Friedrichshafen, Germany. “I am thrilled to see such promising results in close to 200 patients I have treated over the past three years and what it could mean for many more patients who were not eligible for the traditional anti-reflux surgeries in the past.”
The mean age of the patients was 49±13.3 years and most were male (51.3%), a hiatal hernia (>3cm) was reported in 22.2% of patients. At 20±7month follow-up, the median (IQR) GERD-HRQL score improved by 90.9% to 2 (0-2) from a baseline of 22 (19-31.5) (p<.001). PPI use decreased by 96.3% and preoperative dysphagia (n=18) resolved in all patients with five cases (3.2%) of new-onset dysphagia occurring, but none requiring postoperative dilation. Hiatal hernia recurred in two patients (1.3%) and was treated with device repositioning. Device migration presented in two patients (1.3%) from excessively tight suturing of the fundic pouch. One of these patients was converted to Toupet fundoplication.
“In the UK alone, GERD impacts an estimated 9.5 million people,” added Founder and CEO of Implantica, Dr Peter Forsell. “We are thrilled to see rapidly growing interest from many NHS centres that we expect to start offering RefluxStop treatment soon.”
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