Surgical method RefluxStop™ (New)

I am often asked about the new reflux ball or the RefluxStop™ implant .

RefluxStop™ The aim is to exert pressure on the so-called "sphincter muscle" and thereby cause the surrounding diaphragm and stomach tissue to become so tightly scarred that the organs can no longer slide freely. This hardening in the upper abdomen is intended to prevent the organs from slipping back into the chest.

To do this, a "plastic ball", similar to a ping-pong ball, is wrapped in the upper part of the stomach (see picture), and everything is then sewn to the esophagus, attempting a mini-fundoplication of around 90 degrees. The RefluxStop™ procedure therefore attempts to prevent the stomach from sliding upwards by causing severe scarring and the formation of a thick plug next to the esophagus.

Does that make sense?

In the area of the ball, the foreign body reaction and the stitches cause hard scarring. This occurs directly next to the esophagus and can lead to swallowing and motility problems. The esophagus is bound by scarring. In the studies published to date, such problems have been observed significantly more frequently (up to 50%!) than after other surgical procedures.

A fundamental risk that persists even years later is that the stomach wall becomes thinner and thinner under the pressure of the sewn-in ball and eventually a hole forms. What happens in such a case is still unclear. It remains to be seen whether the ball falls from the stomach into the small intestine, threatens intestinal obstruction or can be vomited up. The total number of patients operated on so far is only around 100-150, with no long-term data.

It is difficult to remove the implant again. There is a risk that the upper part of the stomach will have to be completely removed. This is dangerous due to the particular proximity to the esophagus. We have now operated on two patients who continued to suffer from reflux after the RefluxStop™ was implanted . A look into the abdomen showed that this was precisely the situation. We were able to treat the diaphragm and cure the reflux, but we could not remove the ball. The risk of opening the stomach wall was too high due to the hard scarring. The implant was therefore left in place for the time being.

A brief explanation: The RefluxStop™ procedure is fundamentally similar to the so-called bicorn procedure, in which the upper part of the stomach, but now without the "ball", is folded in and sewn to the esophagus and diaphragm. The RefluxStop™ reinforces this principle through the strong foreign body reaction. In comparison, the bicorn procedure is considerably more gentle on the tissue.

The often-cited reconstruction of the "His angle" is also just a kind of "marketing approach" in the RefluxStop™ procedure. This angle has no influence on reflux control in humans, as was shown in numerous studies over 100 years ago. This angle varies completely from individual to individual and depends on the curvature of the diaphragm. It changes when breathing in and out. There is no fixed His angle, but rather it fluctuates individually and functionally between approx. 20-70 degrees. In both operations, this angle is set to "zero" by the sutures placed between the stomach and esophagus. This usually does no harm, but it doesn't help either.

Finally, an internal scientific note: International publications always require that potential conflicts of interest of the doctors involved in the study be pointed out. This is listed in the so-called “Conflict of Interest Statement”.

In the relevant studies on RefluxStop™ , it is noticeable that the work (see below) involved doctors who were employed by the manufacturer or otherwise paid by them. This does not necessarily reduce the value of a study, but such data should always be interpreted with caution and investigations by independent doctors and clinics should be awaited.

A final word:

The aim of therapy should not be to sew ever larger plugs, balls, bands, folds, magnetic chains, etc. into our stomachs, or even to cut off parts of the stomach and tie them around the esophagus in various forms as a fundoplication.

No, instead, only the diaphragm needs to be properly supported! Once that is addressed, all organs will return to their anatomically correct positions, allowing the entire system to function as it did before.

Yours

Dr.med. Eckhard Löhde

literature

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark

Miloš Bjelović 1 ,László Harsányi 2 ,Áron Altorjay 3 , Zsolt Kincses 4 , Peter Forsell

BMC Surg,2020 Jul20;20(1):159

DOI: 10.1186/s12893-020-00794-9

Laparoscopic Large Hiatal Hernia Repair With RefluxStop™: Outcomes of Six Months Follow-up in Thirty Patients

Fringeli, Yannick MD*; Linas, Ioannis MD†; Kessler, Ulf MD*; Zehetner, Joerg MD, MMM*

Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 34(2):p 143-149, April 2024 DOI:10.1097/SLE.0000000000001256