The TIF procedure treats GERD transorally (through the mouth). It improves reflux symptoms more effectively than anti-acid medications, and enables many patients to stop taking anti-acid medications altogether. No incisions are required and recovery is even faster than the laparoscopic fundoplication. The EsophyX procedure reinforces the gastroesophageal junction by folding (plicating) the upper portion of the stomach (the fundus) around the gastroesophageal junction for about 270 degrees and securing it in place by special fasteners. It is based on the same principles that have been shown to be effective in the Nissen fundoplication. It is FDA approved and has been in use since 2006. We began performing this procedure in November 2008. As ofApril 2011 we have performed over 120 procedures, representing one of the largest experiences in the United States.

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The Role of TIF Procedure using EsophyX in Treating GERD
The goal of any treatment of GERD is to alleviate GERD symptoms with the lowest risk and degree of side effects.The TIF procedure will sometimes be successful at improving GERD symptoms without the need for supplemental medication. In other instances medication and TIF together are required to alleviate symptoms; the endpoint of treatment is to improve the quality of life for GERD patients. The TIF procedure frequently works better than medical therapy alone (e.g. Prilosec, Nexium, Protonix, etc.) in allowing patients to eat spicy, acidic, or other reflux-causing foods. EsophyX also enables more patients to exercise and sleep without reflux symptoms. As medication infrequently alleviates laryngeal reflux symptoms, the EsophyX TIF procedure may be an appropriate option for patients with these symptoms.

Transoral Fundoplication (TIF) in Comparison to Laparoscopic Fundoplication:
The TIF procedure is in general limited to patients with no or small hiatal hernias (< 3 cm) and a body mass index (BMI) < 35; laparoscopic fundoplication is not.

TIF ADVANTAGES OVER LAPAROSOCPIC FUNDOPLICATION:
Less invasive - no incisions.
Faster recovery, less pain.
Lack of side effects of bloating, gas, swallowing issues.
Can go on to laparoscopic fundoplication fairly easily if symptoms not adequatly controlled.

TIF DISADVANTAGES OVER LAPAROSOCPIC FUNDOPLICATION:
Limited to patients with hiatal hernia < 2 cm height, < 3cm across. (May require surgeon's endoscopy to evaluate precisely).
Limited to patients with Body Mass Index (weight corrected for height) < 35.
Controls symptoms adequately (with or without supplemental medication) in about 75% of patients at 6 months follow-up. Long term (3+ year) results not fully known.

LAPAROSCOPIC FUNDOPLICATION ADVANTAGES OVER TIF:
Alleviates GERD symptoms more reliably; 90% control of reflux without medication at 6 month follow-up.
Long-term results indicate that 15-20% of patients develop recurrent reflux over 5-10 years.

LAPAROSCOPIC FUNDOPLICATION DISADVANTAGES OVER TIF:
More invasive than TIF.
Takes longer to recover from surgery, and for normal swallowing.
Side effects of bloating, excess gas, and loose bowel movements are seen after surgery in about 5%-10% of patients. (The frequency depends on how severely the side effects are rated. Mild side effects that don't impact quality of life are noted by 15-30% of patients; about 5% report the side effects have an impact daily on their quality of life. 1% may wish revisional surgery for these side effects.)

(Both procedures require general anesthesia, typically an overnight stay in the hospital, and a similar diet for the first four weeks afterwards.)

Results of the TIF Procedure using EsophyX:
The TIF procedure was initially evaluated in Europe by Prof. Guy-Bernard Cadiere in Brussels and NIcole Bouvy in Maastrich, Netherlands. Both of their series demonstrated that over 75% of patients were able to stop using acid-suppressive medication as a result of the procedure. A two year follow-up published by Professor Cadiere reported that 79% of patients experienced complete cure or remission of their GERD symptoms. In May 2010 we completed a review of our first 37 patients at a median of 6 months after the procedure. We found that 82% were off of acid-suppressive medication with significant improvement in their quality of life (measured by standardized questionnaires). Additionally, reflux testing demonstrated that 73% of patients had a significant improvement in the amount of acid reflux present, which is better than other reported series of the TIF procedure.

Is EsophyX for Me?
Patients with GastroEsophageal Reflux or Laryngeal Reflux may wish to consider the EsophyX procedure if:
-increasing doses of medication are needed; or
-patients are having to switch medications because one is not working; or
-heartburn, reflux, or other GERD symptoms persist despite taking medication; or
-upper airway or laryngeal symptoms are due to non-acid reflux; or
-the patient is already at high risk for osteoporosis,
In order to be a candidate for Esophyx, patients must have gastroesophageal reflux disease and a reducible hiatal hernia of 2 cm or less. We often confirm that a patient has GERD by a pH or impedance test. We assess hiatal hernia by a upper GI X-ray series and/or upper GI endoscopy. Patients with significant obesity (BMI >35), Barrett's esophagus, or signficant narrowing in the upper esophagus, are generally not candidates for the procedure.

Details of the Esophyx Procedure:
The Esophyx procedure is performed under a general anesthetic in an operating room. The procedure takes 1-2 hours. A flexible endoscope is introduced through the mouth into the stomach to visualize the operation. The EsophyX device slips over the endoscope and into the lower esophagus and stomach. The EsophyX device then folds the stomach wall against the esophagus. This recreates the flap-valve mechanism and reduces the hiatal hernia. Once tissues are properly positioned, the surgeon places H-shaped-fasteners in between the esophagus and stomach wall using the EsophyX device. These H-fasteners function like sutures to hold the valve mechanism in place.
Following the procedure patients are typically observed overnight and go home the following day. They are started on liquids the day of the procedure and follow a graduated diet plan for the next month. Pain in the upper abdomen, throat, or chest is typically short-lived. Nausea, though not frequent, is treated with anti-nausea medications to prevent disruption of the repair.
Many patients return to desk work or light duty within a week. Stairs, walking, and mild aerobic activity are permitted immediately. Strenuos physical activity including heavy lifting is limited for 4-6 weeks to allow the issues to adequately bond to one another.
Patients stop taking anti-acid medication after two weeks, and typically notice that their heartburn and reflux is gone. They can sleep better without having to be upright, and can enjoy acidic foods more often.
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