In the Journals

TIF 2.0 procedure normalizes pH safely for patients with GERD

Hiatal hernia repair followed by Transoral Incisionless Fundoplication helped normalize pH scores in patients with GERD without some of the safety concerns associated with traditional reflux surgeries, according to data published in the Journal of the Society of Laparoendoscopic Surgeons.

Researchers analyzed data from 97 patients evaluated between October 2015 and December 2017. Of those, 55 patients underwent hiatal hernia repair with concomitant TIF procedure using the EsophyX device (EndoGastric Solutions) and 29 had matched pre- and post-operative assessments. Overall, 22 of those 29 patients had intact hiatal hernia and TIF procedure repairs, and of those, 21 experienced normalization of pH scores. Investigators also found that these patients had better GERD-related quality of life scores and Reflux Symptoms Index scores at follow-up.

Healio Gastroenterology and Liver Disease talked to lead author Glenn Ihde, MD, a general surgeon at the Matagorda Medical Group in Bay City, Texas, about the study and how it could improve treatment of patients with GERD.

Healio: Why is pH normalization an important outcome for the TIF procedure?

Ihde : In the past, we have relied on patients to describe their symptoms to diagnose the disease of reflux. Although we had good tools that would validate that description and the diagnosis, by their nature, the symptoms are subjective. Sometimes the patient’s description would change and could be affected by the kind of day they had. Other disease processes might also cause the same symptoms. There was a gap in our ability to accurately depict the disease. In contrast, pH data is objective. When stomach acid enters the esophagus, it is a measurable event and the diagnostic certainty is very high. We know we are treating the right disease, which is important when you are considering surgery.

Healio: How does the TIF procedure compare to other therapies?

Ihde : We start out with lifestyle changes and medications, but they treat symptoms, not the actual disease process. Traditional reflux procedures were very effective at treating these symptoms and the process, but they had significant side effects. This left a majority of the patients poorly controlled in terms of the disease symptoms. TIF 2.0 is a minimally invasive procedure that controls the symptoms and the disease at a very high level and avoids the side effects of the older procedures. It also has a much higher safety profile at this point than the older procedures. There is sort of a trifecta of treatment, if you will, in that it controls the disease, it is highly effective, and it is very safe. That is what we like about this procedure.

Healio: What were among the most important findings in your study?

Ihde : One of the principles of an effective reflux procedure is the closure of the hiatal hernia. Since the TIF procedure uses a specific device, that device is regulated by the FDA, and the need to close the hiatal hernia was not included in the device’s initial labelling. But that changed in 2017 when the FDA changed the labeling to include doing the TIF after the hiatal hernia repair. That enables us to publish this analysis. This study demonstrates that the outcomes after the hiatal repair and TIF 2.0 is at least equivalent to the previous gold standard procedure, the Nissen fundoplication, and it is also safer and with less side effects. I suspect the hiatal hernia with TIF repair is going to be the new standard for reflux treatment, which is a pretty significant thing.

Healio: What does this mean for future research/development? Are there any other studies planned?

Ihde : This study is limited in size, and it is retrospective. Larger prospective studies will need to be performed, and it is my understanding that those are already underway. But there are also forms of reflux disease, something like laryngeal pharyngeal reflux, which we called LPR. This patient population may also benefit significantly from an effective and safe and minimally invasive therapy. Studies in those patient populations should be performed and may expand the application of this technique. We are waiting for those studies to come out. – by Alex Young

Disclosures: Ihde reports that he is a consultant for EndoGastric Solutions.

Hiatal hernia repair followed by Transoral Incisionless Fundoplication helped normalize pH scores in patients with GERD without some of the safety concerns associated with traditional reflux surgeries, according to data published in the Journal of the Society of Laparoendoscopic Surgeons.

Researchers analyzed data from 97 patients evaluated between October 2015 and December 2017. Of those, 55 patients underwent hiatal hernia repair with concomitant TIF procedure using the EsophyX device (EndoGastric Solutions) and 29 had matched pre- and post-operative assessments. Overall, 22 of those 29 patients had intact hiatal hernia and TIF procedure repairs, and of those, 21 experienced normalization of pH scores. Investigators also found that these patients had better GERD-related quality of life scores and Reflux Symptoms Index scores at follow-up.

Healio Gastroenterology and Liver Disease talked to lead author Glenn Ihde, MD, a general surgeon at the Matagorda Medical Group in Bay City, Texas, about the study and how it could improve treatment of patients with GERD.

Healio: Why is pH normalization an important outcome for the TIF procedure?

Ihde : In the past, we have relied on patients to describe their symptoms to diagnose the disease of reflux. Although we had good tools that would validate that description and the diagnosis, by their nature, the symptoms are subjective. Sometimes the patient’s description would change and could be affected by the kind of day they had. Other disease processes might also cause the same symptoms. There was a gap in our ability to accurately depict the disease. In contrast, pH data is objective. When stomach acid enters the esophagus, it is a measurable event and the diagnostic certainty is very high. We know we are treating the right disease, which is important when you are considering surgery.

Healio: How does the TIF procedure compare to other therapies?

Ihde : We start out with lifestyle changes and medications, but they treat symptoms, not the actual disease process. Traditional reflux procedures were very effective at treating these symptoms and the process, but they had significant side effects. This left a majority of the patients poorly controlled in terms of the disease symptoms. TIF 2.0 is a minimally invasive procedure that controls the symptoms and the disease at a very high level and avoids the side effects of the older procedures. It also has a much higher safety profile at this point than the older procedures. There is sort of a trifecta of treatment, if you will, in that it controls the disease, it is highly effective, and it is very safe. That is what we like about this procedure.

Healio: What were among the most important findings in your study?

Ihde : One of the principles of an effective reflux procedure is the closure of the hiatal hernia. Since the TIF procedure uses a specific device, that device is regulated by the FDA, and the need to close the hiatal hernia was not included in the device’s initial labelling. But that changed in 2017 when the FDA changed the labeling to include doing the TIF after the hiatal hernia repair. That enables us to publish this analysis. This study demonstrates that the outcomes after the hiatal repair and TIF 2.0 is at least equivalent to the previous gold standard procedure, the Nissen fundoplication, and it is also safer and with less side effects. I suspect the hiatal hernia with TIF repair is going to be the new standard for reflux treatment, which is a pretty significant thing.

Healio: What does this mean for future research/development? Are there any other studies planned?

Ihde : This study is limited in size, and it is retrospective. Larger prospective studies will need to be performed, and it is my understanding that those are already underway. But there are also forms of reflux disease, something like laryngeal pharyngeal reflux, which we called LPR. This patient population may also benefit significantly from an effective and safe and minimally invasive therapy. Studies in those patient populations should be performed and may expand the application of this technique. We are waiting for those studies to come out. – by Alex Young

Disclosures: Ihde reports that he is a consultant for EndoGastric Solutions.