Five-year outcomes reveal RefluxStop surgery can offer sustained safe and effective relief from GERD

The five-year outcomes from a prospective, single-arm, multi-centre clinical study investigating RefluxStop surgery, has revealed the procedure can offer sustained safe and effective relief from gastroesophageal reflux disease (GERD) symptoms and significantly reduce the need for ongoing medical therapy in the long-term with only one subject taking PPI medications at five years.

The study included 50 patients with chronic GERD who had symptoms for at least six months, confirmed by 24-h pH monitoring, were recruited at four centres between December 2016 and September 2017. Patients with hiatal hernia >3cm were excluded from the study.

Through laparoscopic access, RefluxStop surgery includes repositioning of hiatal hernia (if present), extensive mediastinal dissection of the esophagus with a vagal- and pleura-conserving approach (to attain at least 5 cm of intraabdominal length), hiatal hernia repair with cruroplasty, dissection of the gastric fundus with division of four fundic short gastric vessels, and posterior dissection of the fundus to achieve a tension-free and ‘floppy’ fundus. Plication of the fundus and esophagus is executed between the vagal trunks on the patient’s left side, on 90–120° of the esophageal circumference, thus not encircling the esophagus. Suturing > 140° was contraindicated in this study.

The RefluxStop device (Implantica) was then loosely and fully invaginated in a pouch on the outside of the gastric fundus at its most superior aspect, and close to esophagus. The study authors noted it is paramount to avoid overly tight suturing of the fundic pouch around the device to prevent potential device migration/erosion into the stomach cavity. The position of the device should be in proximity to the esophagus and with its entire body above the upper edge of the lower esophageal sphincter (LES).

The upper edge of the device should be positioned at least 4cm above the angle of His. Dysphagia may be particularly avoided by the RefluxStop procedure since it does not encircle or put pressure on the esophagus, as long as crural repair is not performed too tightly, and instead a looser hiatus closure than in Nissen fundoplication should be performed. The supplied deployment tool allows the surgeon to position and maintain the RefluxStop device in place during its invagination.

Patient-reported outcomes were assessed annually via a battery of questions from the GERD Health-Related Quality of Life (GERD-HRQL) questionnaire providing a total score between 0 and 50, as well as questions related to other parameters such as regurgitation, inability to belch and/or vomit, and PPI use. At the five-year visit, further evaluation was conducted via 24-h pH monitoring with acid exposure time and contrast-swallow x-ray imaging to assess for re-herniation, migration, or dislocation of the device. If therapy failure occurred, defined as PPI use or < 50% improvement of GERD-HRQL score since baseline, additional 24-h pH monitoring and contrast-swallow x-ray were performed. Additionally, gastroscopy was performed if pH testing was normal, and manometry was performed per the surgeon’s assessment/discretion. All secondary endpoints were included in the five-year follow-up.

For the primary endpoints, the total GERD-HRQL score and 95%-confidence intervals (CIs) for the percentage of patients with ≥ 50% improvement in total GERD-HRQL score, were calculated via the Clopper-Pearson exact method formula. For the secondary effectiveness endpoint of acid exposure time measured by 24-h pH monitoring, the percentage of overall time with pH < 4 was analysed by Wilcoxon signed rank test comparing baseline and follow-up visits.

Outcomes

Of the initial 50 patients who underwent the RefluxStop procedure, a total of 44 subjects completed five-year follow-up (mean 5.7 years). At baseline, the mean (SD) age was 51.5 (11.8) years, the mean (SD) weight was 78.2 (14.7) kg, the mean (SD) body mass index (BMI) was 26.81 (4.41) kg/m2, 56% were male, and the mean (SD) hiatal hernia size was 2.51 (0.58) cm. Of the remaining 44 subjects that completed follow-up with the GERD-HRQL questionnaire and AE reporting, 40 (91%) also completed 24-h pH testing and contrast-swallow x-ray imaging.

The median (IQR) improvement in total GERD-HRQL score (n=44) of 90% (72–98%) was based on a baseline score of 29.5 (24.0–33.0) reduced to 3.0 (0.5–7.5) at five-year follow-up (p<0.001). As illustrated, the GERD-HRQL scores significantly decreased shortly after surgery and were sustained in the long-term for up to five years. Only one subject had <50% improvement in total GERD-HRQL score and pathologic 24-h pH total time with pH<4 at five years.

The lower esophageal acid exposure time in all subjects saw a significant reduction in the duration of exposure was observed at six months (p<0.001) and five years (p<0.001), compared to baseline. Specifically, the mean (SD) duration decreased from 16.35% (16.60%) at baseline to 1.57% (2.10%) at five years, representing a 90.4% reduction at five years. For additional context, the mean duration of 1.57% at five years was substantially lower than the pathologic threshold value.

At five-year follow-up, 97.7% (n = 43/44) were not taking daily PPI therapy. The one subject using PPIs did not complete 24-h pH testing to objectively confirm indication of acid reflux, and this subject started with PPI therapy after falling ill with serious kidney disease after four-year follow-up. At five-years, 93.6% (n = 44/47) of subjects reported no or minimal regurgitation, demonstrating the effectiveness of the device in treating acid reflux, as it successfully prevents regurgitation in most subjects over a long-term follow-up period. Also at five-years, 97.9% (n = 46/47) of subjects reported no dysphagia, gas-bloating improved or was eliminated in 95.7% of subjects, and the ability to belch/vomit was completely (100%) maintained.

The results of contrast-swallow x-ray imaging, primarily performed at six months follow-up and repeated at the five-year follow-up visit. No subjects presented with re-herniation, device dislocation or device migration, suggesting that the device maintains its intended position and effectiveness over a long-term period.

During the entire five-year study period, there were no device-related serious or non-serious events. A total of 16 procedure-related AEs occurred in 11 subjects during the study with 88% occurring before the one-year visit. The most common AEs were unrelated to GERD and included gastritis (i.e., eight cases in n = 7 subjects), upper abdominal pain typical for gastritis (i.e., five events in n = 5 subjects), Coronavirus infection (i.e., five events in n = 5 subjects), and dyspepsia (i.e., four events in n = 4 subjects). Notably, no esophageal dilatations were performed.

The findings were reported in the paper, ‘Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: a prospective multicenter trial of safety and effectiveness’, published in Surgical Endoscopy. To access this paper, please click here