One-year outcomes from a study evaluating the RefluxStop device (Implantica) has found the device is safe and effective when treating gastroesophageal reflux disease (GERD), with no complications related to the device and complications caused by the compression of the food passageway (ie. dysphagia, odynophagia and gas bloating) are not an issue with the RefluxStop procedure. The outcomes were reported in the paper, ‘Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results’, published in BMC Surgery.
The RefluxStop device is an implantable, non-active, single use device used in the laparoscopic treatment of GERD, which aims to block the movement of the lower oesophageal sphincter (LES) up into the thorax and keep the angle of His in its original, anatomically correct position. According to the device manufacturers, the device restores normal anatomy, leaving the food passageway unaffected.
According to the study authors, writing on behalf of the Investigators of the RefluxStop™ Clinical Investigation Study Group, the theory behind RefluxStop is that acid reflux is caused by two malfunctioning events, both of which are addressed with this new device. First, the belching process with fundus contraction and simultaneous relaxation of the LES also includes fluid due to the anatomical misalignment of the angle of His. Furthermore, acid reflux is caused by the lower oesophageal sphincter temporarily or permanently entering into the chest. The pressure in the abdomen supports the LES to close while when in the chest, due to the abnormal thorax position with weaker pressure support combined with the breathing process, the closing function is often not working properly resulting in acid reflux. During the breathing process, the diaphragm moves up and down.
RefluxStop reinforces the fundus to interact with the diaphragm for a dynamic treatment of acid reflux. It is placed on the outside of the stomach top fundus wall with laparoscopic surgery. The RefluxStop procedure reconstructs the angle of His and reinforces the top part of the stomach (fundus) by invagination of the device in the pocket created out of the anterior wall of the fundus. RefluxStop aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position (Figure 1). This new device restores normal anatomy (with the LES remaining in the abdomen) by dynamically acting like a mechanical stop against the diaphragm muscle parallel to the LES and the hiatus opening in the diaphragm, leaving the food passageway unaffected. Therefore, side effects associated with ‘gold standard’ surgery are reduced when avoiding compression of the food passageway.
In the prospective, single arm, multicentric CE mark clinical investigation analysing safety and effectiveness of the RefluxStop device to treat GERD, 50 subjects with chronic GERD were recruited. and followed up for one year. Questionnaires including GERD-HRQL and foregut symptom as well as 24-h pH monitoring were performed at baseline and at six months after surgery. Primary safety objective was to assess the incidence of serious adverse device effects (SADEs) and procedure-related serious adverse events (SAEs). Primary efficacy objective was to assess the percent reduction from baseline of GERD symptoms based on the GERD-HRQL total score.
Of the 50 subjects, 28 (56%) were men and 22 (44%) women. PPI consumption was halted for all subjects at least one week prior to the baseline visit. 24-h pH monitoring (percentage of overall time pH < 4) at baseline showed acid reflux in all subjects; mean result 16.35%. The mean score for the GERD-HRQL questionnaire (questions 1–10) one week off PPI at baseline was 28.8 (SD 7.3). Before surgery, all subjects took PPIs. At baseline endoscopy, 13 subjects (26.0%) had Grade A esophagitis and nine subjects (18.0%) had Grade B esophagitis. At baseline, 26 subjects reported severe regurgitation in the foregut questionnaire. Forty-five of 50 subjects were ‘dissatisfied’, four subjects ‘neutral’ and one subject ‘satisfied’ at baseline. The median score for severity of heartburn (GERD-HRQL question 1) was 4.0 at baseline (range 0 to 5). When assessed by the GERD-HRQL questionnaire at baseline, 15 subjects had difficulty swallowing (dysphagia) and 13 subjects had pain at swallowing (odynophagia). The median score for bloating or a gassy feeling was 4.0 (range 0 to 5) at baseline.
There were no SAEs related to the RefluxStop device reported during the six-month and one-year follow-up periods. No deaths, no device deficiencies and no device explantations were reported/performed during this period. Six serious adverse events (SAEs) were reported for four subjects at six months and all but one of the events described above were resolved at the time of the six-months analysis cut-off date. The subject diagnosed with an abdominal wall hernia unrelated to surgery. One SAE was reported in one subject between the six-month and one-year visit due to the release of fundoplication sutures. Reoperation was performed and the subject had a successful one-year follow-up visit.
Fifteen subjects had dysphagia at baseline, 11 were completely resolved and four subjects continued to have reduced swallowing problems at the six-month visit (GERD-HRQL score above 1). At the one-year visit, two subjects reported minimal dysphagia. No new cases of dysphagia were recorded at either visit. Thirteen subjects had pain at swallowing before surgery and none of the subjects reported pain at swallowing at the six-month visit, while at the one-year visit, one subject reported pain at swallowing at the same minimal level as at baseline. No new cases of odynophagia were recorded at the six-month or one-year visits.
The mean total GERD-HRQL score at baseline was 28.8 (SD 7.3), n=50 and at six months (n=47), the score decreased to 3.4 (SD 6.0) (p<0.001), reflecting an improvement in GERD symptoms of 88%. One subject discontinued the study with successful three-month score. Forty-five out of 47 subjects had at least 50% improvement of the GERD-HRQL total score from baseline.
At the one-year follow-up visit (n=47), >50% improvement in GERD symptoms compared to baseline was reported in 44 subjects. Two subjects with <50% improvement were shown to not have GERD and one subject had the device positioned improperly too low. The average score improvement when deducting the two subjects with failed results for reasons other than GERD was 89% and average score was 3.2.
pH testing at the six months study visit was completed by 45 subjects and the results show a mean reduction from baseline of percentage of overall time with pH<4 from 16.35 to 0.80% at the six-month visit (p<0.001) reflecting a 95% improvement of the mean value. Normal 24-h pH results in 98% of subjects. Before surgery all 50 subjects were taking PPI drugs, six months after implantation no subject (0%), n=47, took PPI medication. At the one-year follow-up visit, one subject (2.1%), n=47, who had the device positioned too low, took regular daily PPIs.
Gas bloating in the GERD-HRQL (score above 2) was present in 84.0% of the subjects at baseline and in 19.1% of the subjects at one year – it disappeared in 30 subjects; improved in seven subjects; remained unchanged in two subjects; and no subject had their gas bloating symptoms worsen. Daily regurgitation is common in acid reflux subjects and occurred in 44 subjects (88%) at baseline in the investigation, whereof 33 subjects had moderate to severe regurgitation. At one-year follow-up 46 out of 47 evaluable subjects (97.8%) operated with RefluxStop had none or minimal occasional episodes of regurgitation.
At six-months follow-up, 44 subjects (93.6%) were satisfied, one subject was neutral (2.1%) and two subjects dissatisfied (4.3%) (n=47). The two dissatisfied subjects were the same subjects as discussed previously with the device placed too low, hindering its function. Out of these, one subject was re-operated between six months and one year to improve the positioning of the device by placing it higher up and was thereafter immediately satisfied again (HRQL total score zero).
At the one-year follow-up, one subject was still neutral (2.1%) and one subject was dissatisfied due to the device being positioned too low. In addition, two subjects (4.3%) were dissatisfied for reasons other than GERD: one subject had all tests performed with a normal outcome and one subject had short-term gastritis and was satisfied at the subsequent follow-up visit and two-year visit.
“A larger post-market clinical follow-up survey is currently being set up to further evaluate subjects long-term. The results so far indicate that RefluxStop may become a breakthrough in acid reflux treatment. Both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle in all correctly operated subjects,” the authors concluded. “These one-year results are very promising and RefluxStop may cause a shift in acid reflux treatment, although further studies and follow-up are needed.”
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