Does Transoral Incisionless Fundoplication Reduce GERD?



REDWOOD CITY, Calif.―EndoGastric Solutions (EGS), a company that focuses on endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced the presentation of two-year data from the Transoral Incisionless Fundoplication (TIF®) US Registry at the 2013 SAGES Annual Meeting during the therapeutic endoscopy scientific session in Baltimore.





The TIF procedure was safe and effective in eliminating or improving a range of typical and atypical GERD symptoms, including heartburn and reflux, in up to 81 percent of patients in the study, EGS reported today. Also, in 81 percent of patients undergoing endoscopy 24 months after their TIF procedure, esophagitis was fully healed or notably improved.

“This two-year data demonstrates the long-term value of a transoral anatomic correction in the treatment of GERD patients with mild to moderate disease,” said Mike Kleine, president and CEO of EGS. “We are very encouraged by the sustained response seen by patients with either typical or atypical symptoms.”

Twenty-four months after the EsophyX2 device was used in TIF procedures, more than two-thirds of patients completely eliminated the need for daily proton pump inhibitor (PPIs) therapy, according to EGS. Symptom control achieved at six months remained stable over time, indicating durability of the TIF procedure.

“The TIF procedure is an attractive option because it dramatically shifts the risk-benefit ratio associated with correcting the underlying anatomical defect and allows a majority of patients to stop taking daily medication for reflux,” said Karim Trad, MD, FACS, SAGES presenter and an investigator in this prospective multicenter registry of patients with chronic GERD.

The risks associated with medical management of GERD patients for years or decades are becoming more evident. Traditional surgical interventions for GERD have historically been reserved for patients with the most severe disease. However, most patients have been unwilling to accept the well-documented side effects of difficulty swallowing and gas bloat associated with traditional surgery. In stark contrast, the TIF procedure offers an alternative option to select GERD patients because almost none of these side effects occurred in the TIF registry population.

The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. TIF is a surgical solution that corrects the root cause of GERD—a disease that affects more than 60 million people in the United States.

The TIF procedure is based on traditional surgical principles, is minimally invasive and offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide.

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'GERD' label for infant fussiness leads to unnecessary treatment …

When a healthy baby’s spitting up and crying are labeled by a doctor as symptoms of gastroesophageal reflux disease (GERD), parents become eager to give the baby medications, even when they are also told the medications are unlikely to be effective, according to a new study from researchers at the University of Michigan and the University of Missouri.

The study’s findings underscore how the medicalization of ordinary behaviors can lead to unnecessary and even harmful treatments.

This study, published Monday in the journal Pediatrics, was undertaken, say its authors, out of a growing concern that GERD, a condition in which stomach acid flows back (or refluxes) into the esophagus, is being overdiagnosed and overtreated in infants. In recent years, the number of babies treated with acid-suppressing drugs known as proton pump inhibitors (PPIs) has skyrocketed. One study found that between 1999 and 2004 the use of PPIs in infants under the age of 1 year increased sevenfold.

Yet when babies spit up, the refluxed content is rarely acidic. Not surprisingly, therefore, research has shown that PPIs are no more effective than placebos in relieving unexplained crying, irritability and spitting up in babies under a year old — behaviors that are actually quite common and normal in infants. The U.S. Food and Drug Administration does not currently approve PPIs for use in children that young, but that hasn’t stopped doctors from prescribing the drugs “off label.”

Sometimes, of course, it’s the parents who demand the drug for their infant, often after learning about it online or through various advocacy groups.

Study details

For this study, researchers recruited 175 parents (average age: 35) who had made appointments at a University of Michigan pediatrics clinic between May 2011 and February 2012. The parents were randomly assigned to respond to hypothetical scenarios. Each scenario described a fussy infant who cries and spits up excessively, but is otherwise healthy — in other words, developing normally and gaining weight. In one scenario, a doctor gives the baby the GERD “disease” label. In the other, no disease is diagnosed. In half of each of these scenarios, the parents are informed that existing medications would be ineffective for the baby. In the other half, they’re told nothing about the medications’ ineffectiveness.

The parents were mostly women (82 percent), white (59 percent) and highly educated (66 percent had a college degree). Some 37 of them (21 percent) said that one or more of their children had been previously diagnosed with GERD, and 26 said they had given their child medication as a result of that diagnosis.

The researchers found that parents who were presented with the scenario with the GERD diagnosis expressed interest in giving medication to the baby — even when explicitly told the medication was ineffective. This was especially true for parents whose own children had been diagnosed in the past with GERD.

When the baby’s behaviors were not labeled as GERD, the parents were still interested in the medications for the child — but not when the ineffectiveness of the drugs was explained to them.

“These findings lend support for our hypothesis that the use of the GERD label can influence interest in using potentially ineffective medical interventions,” the study’s authors conclude.

Resisting medicalization

“As doctors we need to appreciate that the words we use when talking with patients and parents have power — the power to make a normal process seem like a disease,” said Dr. Beth Tarini, one of the study’s authors and a pediatrician at the University of Michigan, in a prepared statement that accompanied the study. “As pediatricians, our job is to make sick children healthy, not to make healthy children sick.”

But doctors aren’t the only ones with some responsibility in this and similar situations. It’s also our job as parents — and health consumers — to be alert to the growing and disturbing trend in our culture to turn normal human conditions into disease symptoms that require medical treatment.

As one scholar has put it:

Medicalization isn’t the most elegant noun … but it’s the best one we have for describing how common emotions and traits are turned into treatable conditions. Bad breath becomes halitosis, for example, and impotence erectile dysfunction. Even overdoing plastic surgery gets a brand-new name: body dysmorphic disorder. To put it bluntly, this process of pathologizing has gotten out of control. It’s become a juggernaut that no one seems able to stop.

Heartburn (GERD) – 5 Facts About Gastroesophageal Reflux …





Millions of people experience gastroesophageal reflux disease (GERD) on a regular basis.

When food passes from the esophagus down into the stomach, a ring known as the lower esophageal sphincter opens up to let food in and then closes to keep it in the stomach.

If the ring is weak and does not close tightly, food and stomach acid can come back up into the esophagus, resulting in mucosal changes and symptoms of heartburn.

Here are five facts about GERD you may not know:

1. Diagnosis is often made by symptoms however an endoscopy may also be performed. During an endoscopy, a tube with a camera on the end is passed through the mouth and down the throat in order to best view all the tissue down into the stomach. If warranted, a biopsy may need to be done

2. Extra weight around the middle is considered a real risk factor for those with both GERD and heartburn. A primary treatment is weight loss as it may help avoid taking acid blockers.

3. Eosinophilic esophagitis is being seen more regularly in patients who have GERD. A biopsy of the esophagus will help determine if someone has this disease.

Eosinophilic esophagitis involves an increased number of particular white blood cells known as eosinophils that cause a number of chronic symptoms. Symptoms include difficulty swallowing, sensation or actual choking, coughing, regurgitation, chest pain particularly behind the breast bone and vomiting.

4. Consider the possibility of eliminating foods that may cause allergy from the diet. In eosinophilic esophagitis, the most common food allergies are dairy, gluten, soy, eggs, peanuts, fish/shellfish.

These foods are also the most common food allergies to humans therefore if someone eats a food that causes inflammation, GERD may occur.

These are the foods that people are most commonly allergic to, therefore if someone eats a food that causes inflammation, GERD may occur.

5. Most that have GERD symptoms are on some form of acid blocker, either as needed or daily. In fact, some take them twice a day because their symptoms are so severe.