Dr. Simoni of Advanced GI Inc. in Thousand Oaks, California is featured in this webinar, broken down into pivotal segments. Since his initial procedures in 2009, Dr. Simoni has extensive experience, including TIF procedures that were included in both the TEMPO and the US registry clinical studies. He is one of the first interventional gastroenterologists in the United States to integrate the TIF procedure in his practice, and remarkably, he has always been very supportive and acknowledged the importance of concomitant procedures, repairing the hiatal hernia before a TIF procedure. He has worked side-by-side with several general surgeons, who laparoscopically repair the hiatal hernia before he performs the TIF 2.0 procedure with the EsophyX® device.
Webinar Highlights
Webinar Series: Gastroesophageal valve anatomy. Gilbert Simoni, MD Advanced Gastroenterology, Thousand Oaks, CA
Dr. Simoni opens with a slide of the anatomy of the gastroesophageal valve (GEV) explaining and highlighting the three components: the intrinsic, which is smooth muscle; the extrinsic, which is the striated muscles of the crura; as well as the phrenoesophageal ligament. Disruption of any of these compartments can lead to gastroesophageal reflux disease (GERD). He then explains how, even if you have a normal-looking anatomy, you can still have gastroesophageal reflux disease, and the more abnormality you have in your anatomical structures, the more severe GERD you’re going to have. This notion is supported in a 2013 study by Shahin and DeMeester at DDW. What is staggering here is that about half of those patients, 406 patients, had a normal-looking lower esophageal sphincter, but they had an abnormal DeMeester score (the level of acid reflux). The second observation here was that as you had more and more components being affected, you had more and more reflux. Dr. Simoni emphasizes that the earliest issue with gastroesophageal reflux disease is the dynamic failure of the lower esophageal sphincter. You do not have to have a huge hiatal hernia to have acid reflux. You can have a normal-looking valve, and still have significant reflux and symptomatic reflux. He affirms that GERD is a clinically progressive disease and that we need to recognize the early stages and mild symptoms. Giving patients PPIs puts a bandaid on their symptoms, because as time goes on, if we do not correct the actual problem, patients will eventually develop complications, some of which can be irreversible.
Webinar Series: Expanded Indication for TIF procedure. Gilbert Simoni, MD Advanced Gastroenterology, Thousand Oaks, CA
In this segment of the webinar, Dr. Simoni expands on an earlier slide provided by EndoGastric Solutions indicating that there are a significant number of patients who have uncontrolled reflux, and not a lot of them are given options for surgical treatment. That’s partially because of the prior experience of primary care physicians and GIs, having had patients post-Nissen experiencing significant dyspepsia, and an inability to vomit. However, after June 2017 the indication for a TIF procedure was expanded to be able to correct even larger anatomical defects. Equally, early disease can also have non-anatomic causes, or have a normal lower esophageal sphincter. Physicians should be able to offer these patients the possibility of a TIF procedure, and give them an option to correct their reflux, therefore providing significant relief and preventing any further complications.
In the evolution of the procedure to its present form, TIF 2.0 is essentially the same as Nissen for manometric appearance and very similar to a high-pressure zone. The TIF procedure has almost the same technical aspects of anti-reflux surgery, laparoscopic-type fundoplication, but should be one of the first lines in the surgical treatments for gastroesophageal reflux disease. TIF resolves patients’ symptoms off PPIs. There are no de novo dysphasia, bloating, or flatulence reported with TIF procedures. As a matter of fact, patients that did have baseline dysphasia and bloating got better. The other aspect here is that you can use TIF to fix a failed Nissen and if you have another anti-reflux surgery, TIF is not going to affect your lower esophageal area or the area of your hiatal hernia, or result in significant surgical complications.
Webinar Series: Selecting patients for concomitant procedures. Gilbert Simoni, MD Advanced Gastroenterology, Thousand Oaks, CA
Dr. Simoni concludes by answering a common question among surgeons: “So why do I have to come in and do your hernia repair when it takes me another few minutes to just wrap the stomach?” Dr. Simoni gives two reasons: first, there are no de novo side effects or post-Nissen fundoplication issues following a TIF procedure. Second, when you do a Nissen fundoplication, your stomach is not distended, so you can’t really see how tight or how loose the valve is going to be. Therefore, the best way to recreate the lower esophageal sphincter is to endoscopically visualize it through a TIF procedure.
Finally, Dr. Simoni provides an executive summary highlighting the transparency of EGS as one of the few device companies that base their success on patient outcomes. The evidence behind the TIF procedure is very solid, with 80 peer-reviewed papers in both surgical and GI publications, on 1,500 unique patients. More than 22,000 patients have had the TIF procedure since 2007, by both surgeons and gastroenterologists, with significant improvement over the years. Numerous randomized clinical trials have proven TIF to be highly effective and durable, providing consistent improvement, and TIF is extremely safe, with less than 0.5 percent significant adversity events, further re-enforcing Dr. Simoni’s position that TIF should be one of the first lines of endosurgical treatments for gastroesophageal reflux disease.
Dr. Gilbert Simoni Webinar on GERD Work-up and TIF Patient Selection
View the full webinar below, to see each of the highlighted segments, in their context, from Dr. Gilbert Simoni, MD, Advanced GI Inc. Thousand Oaks, California, He is one of the first interventional gastroenterologists in the United States to fully adopt the TIF procedure in his practice, and an early adopter of the notion of concomitant procedures, repairing the hiatal hernia before a TIF procedure. After his presentation, Dr. Simoni takes questions from the audience, such as “How much time do you spend evaluating the hiatal hernia during the endoscopy?” adding his recommendations for doing a concomitant repair with TIF if the hiatal hernia is more than 2cm. Dr. Simoni talks about informing patients unfamiliar with TIF about the procedure, and options for follow-up. He discusses chronic gastric distension from gastric balloons and how this might make GERD worse, and the need for the public to be educated about TIF as a frontline option for successfully and safely treating GERD.
