Transoral Incisionless Fundoplication – TIF using EsophyX
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. To date, we have performed over 180 procedures, representing one of the largest experiences in the United States.
Transoral Incisionless Fundoplication – TIF using EsophyX
The TIF procedure treats GERD transorally, or 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 the 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 with 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 of May 2015, we have performed over 180 procedures, representing one of the largest practices with TIF experience in the United States.
The Role of TIF Procedure Using EsophyX in Treating GERD
The goal of any GERD treatment is to alleviate GERD symptoms with the lowest risk and degree of side effects. The EsophyX TIF procedure can 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, and laparoscopic fundoplication is not.
EsophyX TIF advantages over Laparoscopic Fundoplication:
- Less invasive – no incisions.
- Faster recovery, less pain.
- Lack of side effects, including bloating, gas, and swallowing issues.
- Can go on to laparoscopic fundoplication fairly easily if symptoms are not adequately controlled.
EsophyX TIF disadvantages over Laparoscopic Fundoplication:
- Limited to patients with hiatal hernia < 2 cm height, < 3 cm 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 (5+ year) results not fully known.
Laparoscopic Fundoplication advantages over EsophyX TIF:
- Alleviates GERD symptoms more reliably; 90% control of reflux without medication at 6 month follow-up.
- Long-term results indicate that only 15-20% of patients develop recurrent reflux over 5-10 years.
Laparoscopic Fundoplication disadvantages over EsophyX 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, and 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 Professor Guy-Bernard Cadiere in Brussels and NIcole Bouvy in Maastricht, 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 with EsophyX procedure.
Is EsophyX for Me?
Patients with gastroesophageal reflux disease (GERD) or laryngeal reflux (LPR) 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 TIF using 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 significant 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 TIF 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. Strenuous physical activity including heavy lifting is limited for 4-6 weeks to allow the tissues to adequately bond to one another.
Patients stop taking anti-acid medication after two weeks, and typically notice that their GERD symptoms like heartburn and reflux are gone. They can sleep better without having to be upright, and can enjoy acidic foods more often.