Frequently Asked Questions
Questions about GERD
Questions about treatment options
Questions about the Plicator® procedure
Questions about GERD
What is GERD (gastroesophageal reflux disease)?
What are the symptoms of GERD?
What is the difference between GERD and heartburn?
What causes GERD?
How common is GERD?
Are there long-term consequences of GERD?
Questions about treatment options
Can diet or lifestyle changes treat GERD?
Are there medications to treat GERD?
What surgical options exist for treating GERD?
Questions about the Plicator® procedure
What is the Plicator® procedure?
How is the Plicator® procedure performed?
Am I a candidate for the Plicator® procedure?
Will I experience any pain during or after the Plicator® procedure?
Do I need to undergo general anesthesia?
Are there any diet restrictions post-procedure?
When should I expect my symptoms to improve?
What are your clinical study results?
What is GERD (gastroesophageal reflux disease)?
GERD is a term used to describe a variety of symptoms and forms of tissue damage resulting from the chronic reflux of stomach contents and the backflow of acid into the esophagus. While the tissue lining of the stomach is able to handle digestive agents such as acid and other gastric contents, the lining of the esophagus is not. As a consequence, when stomach contents back up into the esophagus, it can cause a burning sensation commonly referred to as heartburn, the hallmark symptom of GERD.
What are the symptoms of GERD?
The most common symptoms of GERD include heartburn, regurgitation, and difficulty swallowing. Other symptoms associated with GERD include chest pain, hoarseness, wheezing, and chronic cough. GERD patients may also present with dental problems (i.e., increased cavities and need for root canals) due to stomach acid that reaches the mouth and dissolves tooth enamel.
What is the difference between GERD and heartburn?
GERD is a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Heartburn is defined as a rising, burning sensation in the back of the chest caused by reflux into the esophagus. While nearly everyone experiences heartburn from time to time, persistent heartburn is one of the hallmark symptoms of GERD.
What causes GERD?
GERD is caused by the chronic reflux of stomach contents into the esophagus. This is often due to a weakening of the tissues that make up the valve-like barrier between the esophagus and stomach. Most patients exhibiting GERD have an abnormal function of this valve, allowing stomach contents to flow freely into the esophagus. Problems with the valve function may include: opening at inappropriate times, having a lower than normal pressure, or displacement into the chest (hiatal hernia). Left untreated, GERD can lead to a variety of esophageal complications including inflammation, ulceration, bleeding, and strictures. In addition, GERD patients are at risk of developing a pre-cancerous condition known as Barrett’s esophagus.
How common is GERD?
Over 15 million Americans suffer from daily heartburn, the most common symptom of GERD.1 According to a study performed by the AGA, GERD was found to be the most costly gastrointestinal disorder in the United States, with direct and indirect costs totaling $10 billion per year.2
Are there long-term consequences of GERD?
Persistent GERD can lead to damage of the esophagus. Typically this damage consists of breaks in the lining of the esophagus which leads to inflammation (esophagitis), and occasionally the development of ulcers. In some patients, GERD damage may result in scarring and narrowing of the esophagus, which may make swallowing difficult or painful. Some patients may have damage to the vocal chords or teeth from acid reflux caused by GERD. Patients with GERD are also at risk to develop Barrett’s esophagus, a condition whereby the cells of the esophagus are replaced with stomach cells. Patients with Barrett’s esophagus are 40 times more likely to develop esophageal cancer compared to the normal US population.3
Can diet or lifestyle changes treat GERD?
Infrequent heartburn may be controlled by lifestyle modifications such as weight reduction, smoking cessation, and eating modifications. Eating smaller meals may reduce reflux since large meals increase stomach pressure which may allow contents to back up into the esophagus. Since stomach acid production is at its peak after eating, many reflux sufferers will avoid lying down for several hours following a meal. Certain foods may aggravate symptoms (such as spicy foods, coffee, and alcohol), but diet alone does not cause GERD. For patients with moderate to severe heartburn, lifestyle changes alone may not completely relieve symptoms.
Are there medications to treat GERD?
Oftentimes, GERD is not controlled by lifestyle changes alone. Over-the-counter antacids such as Tums® and Mylanta® may be appropriate for mild, infrequent heartburn. For patients with persistent symptoms, prescription medications such as Nexium® and Prevacid® also known as proton pump inhibitors (PPIs) and Pepcid® and Zantac® also known as H2 blockers can provide significant relief. These drug treatments are not designed to stop the physical reflux of gastric contents, rather they reduce production of acid in the stomach so that irritation of the esophagus is minimized. Patients often need to take these drugs for their entire life; since GERD symptoms will typically return once medication has been discontinued.
What surgical options exist for treating GERD?
Anti-reflux surgery, performed through open or laparoscopic incisions in the abdominal wall, can be effective in treating the underlying mechanical defect present in GERD. One such surgery, the Nissen fundoplication, involves wrapping a portion of the stomach around the esophagus to reinforce the weakened valve mechanism that is present in GERD. While effective, these surgeries require general anesthesia, overnight hospitalization and a recovery period lasting several days.
What is the Plicator® procedure?
The Plicator® is a flexible device that is introduced through the mouth and into the stomach similar to a routine endoscopy. The Plicator tightens the muscular valve between the stomach and the esophagus, restoring the body’s natural barrier mechanism to gastric reflux. Patients are treated on an outpatient basis and are typically able to return to normal activities the following day.
In a multi-center clinical study, the Plicator procedure was shown to be effective in eliminating the need for prescription heartburn medications in 70% of treated patients out to at least 1-year post-procedure. In addition, 80% of patients treated with the Plicator experienced a reduction in the amount of gastric acid allowed to enter the esophagus.
How is the Plicator® procedure performed?
The Plicator® procedure will be performed in the outpatient unit of the hospital following an overnight fast. Typically, the sedation that is administered will keep you unaware of the procedure as it occurs, but will allow you to quickly wake up following the procedure.
The Plicator and gastroscope will be inserted through your mouth, down the esophagus and into the stomach. The stomach will then be inflated with air. While viewing the procedure on a television monitor using the gastroscope, the Plicator will be positioned in your stomach near the opening of the esophagus into the stomach (the gastroesophageal junction). A plication (or fold) will be created, and one or more sutures will be delivered to hold the fold in place. The Plicator and gastroscope will then be removed. To view the procedure, click here.
Am I a candidate for the Plicator® procedure?
Your physician will be able to discuss with you the Plicator® procedure and whether you are an appropriate candidate. The Plicator procedure may be a viable treatment alternative for many types of GERD sufferers, including:
- Patients with regurgitation (physical breakthrough) and associated symptoms (i.e. chest pain).
- Patients with laryngopharyngeal reflux (LPR) and associated reflux symptoms (i.e. chronic cough, hoarseness, laryngitis and asthma).
- Patients with GERD-related Obstructive Sleep Apnea (OSA).
- Patients seeking a less invasive alternative to open or laparoscopic anti-reflux surgery.
Will I experience any pain during or after the Plicator® procedure?
Your physician will discuss with you in detail all of the potential risks and benefits of the Plicator® procedure. Most patients undergoing the procedure can typically return to normal activities the following day. During the procedure, your physician will administer a sedative that should minimize any procedure discomfort. Following the procedure, some patients will experience sore throat or chest/abdominal pain. Your physician may have you take over the counter or prescription pain medications for a few days to relieve this discomfort.
Do I need to undergo general anesthesia?
The Plicator® procedure is typically performed under conscious sedation and allows patients to return home the same day.
Are there any diet restrictions post-procedure?
Following the Plicator® procedure, it is common to have some swelling around your stomach and esophagus which may make it difficult to ingest certain foods. Your doctor may advise you to eat a soft diet for a few days after the procedure.
When should I expect my symptoms to improve?
Patients taking prescription medications for GERD are typically able to taper off these medications within a few days following the Plicator® Procedure. In a multi-center clinical study, the Plicator Procedure was shown to be effective in eliminating the need for prescription heartburn medications in 70% of treated patients.
What are the clinical study results for the Plicator® Procedure?
In a multi-center clinical study, the Plicator™ Procedure was shown to be effective in eliminating the need for prescription heartburn medications in 70% of treated patients. In addition, 80% of patients treated with the Plicator experienced a reduction in esophageal acid exposure.