GERD Treatment has a New Ring to It
People who suffer from gastroesophageal reflux disease (GERD) know the trial and error of finding even a little relief, let alone proper treatment and a lasting cure. As a longtime contributor and featured expert in the field, Dr. James Rosser shares hope and his latest medical breakthroughs for treating GERD on The Dr. Oz Show website. Now those who have long suffered with GERD can explore the possibility of a new magnetic device that’s currently in development for a permanent treatment to this troubling disease. To learn more about Link Reflux Management System, the surgical implantation of a ring prosthesis around the junction between the stomach and the esophagus (which keeps the acid down), click here.
What Is It?
Gastroesophageal reflux disease (GERD) is a condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus (the tube from the mouth to the stomach). When you eat, food passes from the throat to the stomach through the esophagus or food pipe. Once food is in the stomach, a ring of muscle prevents food from moving backward into the esophagus. These muscle fibers are called the lower esophageal sphincter (LES). If this sphincter muscle doesn’t close well, food, liquid, and stomach acid can leak back into the esophagus. This is called reflux or gastroesophageal reflux. This action can irritate the esophagus, causing heartburn, other symptoms and damage that can lead to cancer. (Figure 1)
What Are The Symptoms?
There are two groups of symptoms that are produced with reflux. I refer to them as the “Two Faces of Gastroesophageal Reflux Disease (GERD)”. There is the face that represents the most commonly noted symptoms and a more sinister face that represents what are called the “silent symptoms”. The common symptoms are:
- Burning breast plate (sternal) chest pain; increased by bending or lying down, worse at night, and relieved by antacids
- Food sticking after swallowing behind breast plate
- Acid in back of throat/sour taste on awakening
- Upper abdominal pain
- Temporary relief obtained with off the shelf antacids
These are classic symptoms of reflux that many of us will have as part of our lives. When these symptoms are aggressive there is no doubt that there is a problem. A more concerning presentation are those patients that do not have this symptom pattern. These symptoms are not the ones listed earlier and historically have not been associated with reflux. Silent reflux is an often overlooked or misdiagnosed scourge that most patients do not know they have. Many physicians are not familiar with their significance and relationship to reflux. Silent reflux symptoms include:
- Postnasal drip
- Persistent cough
- Lump in throat
- Raspy or hoarse voice
- Non-cardiac chest pain
Frequently, the patient will present initially with these symptoms and none of the typical symptoms listed above. Classic reflux is absent in 60% of asthmatics, 43-75% of patients with chronic cough and 54%-94% of patients with ENT complaints such as hoarseness, post-nasal drip and chronic sinusitis. There are direct and indirect reasons for this association. Understandably, if acid refluxes all the way back up into the larynx and bronchus, there is a direct cause and effect that leads to laryngitis, chronic cough, or asthma. However, there is a little known indirect causation that can be explained by the fact that the esophagus and bronchial tree share a common embryologic and neural origin via the vagus nerve. When acid comes into the distal esophagus there is stimulation of the acid-sensitive receptors. This can cause non-cardiac chest pain, cough, or bronchoconstriction and asthma. This is a problem that has a strong footprint. Up to 38% of pulmonary referrals are for patients with a chronic cough of up to 3 weeks duration. Furthermore, there are 15 million people in the US with asthma, 50-80% may have GERD.
How Common Is It?
It is absolutely shocking how many people this disease affects. I was recently featured on a Fox News television program in Orlando to increase the awareness of GERD to the public. After the show was over, I stayed almost an hour extra entertaining comments and questions from the station staff. It was amazing how many people knew of relatives and friends who suffered from the disease and more alarming was how many people suffered from the disease or symptoms of the disease themselves. Here are some startling facts about the widespread nature of GERD and I call this segment: “Gosh, I Didn’t Know That”.
- Upwards of 40 percent (60-120 million) Americans have heartburn once a month
- 20 percent (60 million) Americans have heartburn once a week
- 3-7 percent (9-21 million) Americans have a more serious problem called GERD where they have reflux every day
- 1 in 33 people in the US have GERD
- The incidence is rising
- 22% of the primary care visits in this country involve GERD symptoms and this is an increase of 46%
- One theory is that the increase in obesity has also increased the incidence of GERD
Why Should We Be Concerned?
- Erosive Esophagitis-occurs from irritation and subsequent erosion of the lining of the food tube secondary to acid coming up from the stomach. This leads to heartburn, inflammation and ultimately tissue damage.
- Esophageal ulcers and strictures-represents a more aggressive attack on the food tube from acid in the stomach. The inflammation goes deeper, making a crater or multiple craters that make up an ulcer. When the inflammation continues unabated it tries to heal with scar tissue. When the scar tissue becomes prominent, a stricture (a shrinkage of the opening of the food tube by scar) develops that can cause difficulty swallowing (dysphagia). Now the disease has taken a more serious debilitating profile that can change your life forever. This circumstance should be avoided at all cost.
- Barrett’s esophagus-the bathing of the esophagus (food tube) with acid is something that is absolutely not the natural state of things for the human gastrointestinal system. The body senses this imbalance and tries to adapt and compensate. The cells lining the esophagus have no protection against acid so therefore over time the cells begin to change. Slowly, the squamous cells lining the food tube began to take on the characteristics of the stomach cells. The stomach cells have characteristics that protect them from acid damage. Unfortunately, these cells cannot make the change and are in fact abnormal. This is called Barrett’s esophagus. There is no way that a patient can tell when this condition occurs and years can pass before symptoms from this situation present. The main problem with Barrett’s esophagus is that these abnormal cells can develop cancer if left untreated over many years.
- There are two types of esophageal cancer. Squamous cell carcinoma begins in the tissues that line the esophagus and can occur anywhere in the esophagus. It happens more frequently in the middle to upper part. A second type is adenocarcinoma, and it is more common as a result of Barrett’s esophagus and is found in the lower third of the esophagus. For both of these two conditions, the take a way is, do not ignore symptoms and seek proper evaluation early.
GERD recognition is more important today than at any other time in history. Esophageal cancer is the fastest growing cancer in the US and often the signs and symptoms are silent or are not taken seriously. Here are some “Gosh, I didn’t know that” facts about esophageal cancer:
- Has increased by 400% since the 1970s
- Especially in white males
- In 2012,18000 men and women were diagnosed
- 14000 men and 4000 women
- 15000 died from esophageal cancer in 2012
- 4.5 new cases per 100,000
- This is compared to 33,000 deaths from auto accidents in 2010
- Imagine if 60 airplane crashes with an average of 250 passengers being lost on each one occurred in the US each year. This would be the cause for a high level of concern.
What Can I Do?
I know that many of you are scared to death. You probably did not know that “a little heartburn” could possibly threaten your well being or life. Now that you have become aware, I want to let you know how to proceed to be evaluated and if necessary obtain a cure from the disease. The steps to the cure include performing a Heartburn Status Test. If the HST determines that you are at risk, you should proceed to the proper medical professional for a thorough evaluation. From that evaluation you usually proceed with conservative interventions (diet modification, weight loss, stop smoking, etc.), medical management and depending upon your response to treatment, more aggressive surgical options may be used. The key point to remember is that once diagnosed, this disease can be treated successfully.
Your first step should be to take the Heartburn Status Test (HST). This is a self-evaluation questionnaire that can help determine if you should seek medical evaluation. It can be done in the privacy of your home and best of all it is administered by you.
Heartburn Status Test
Sensation of sticking in back of throat 0-5
Heartburn, chest pain, acid in back of throat 0-5
Excess mucous and post-nasal drip 0-5
*You should use your judgment to determine if you have these symptoms and give your best guess on the severity using the numbers 0-5. Of course 0 represents no symptoms at all and 5 means that symptoms very bad and impact negatively on lifestyle. Add all the scores up and a score greater than 10 indicates that you should seek medical attention for further work-up.
What Should I Do Next?
Also, once the diagnosis is made and the proper medication at the right dose taken at the right time is prescribed, documentation of the results of treatment has to be established. The diagnosis is usually made by an esophagogastroduodenoscopy (EGD) with or without biopsy. The biopsy can provide definitive evidence of inflammation or tissue change caused by acid reflux. Frequently, there is evidence of erosions, ulcers or strictures that represent aggressive disease that cannot be cured by medicines. These patients should be strongly considered for surgery very early in their treatment. Once the diagnosis is made, many gastroenterologists will right away try to determine if your form of GERD is amenable to a surgical approach. A 24-48 hour exam to determine the quantity of acid reflux is ordered. This can be done by an older method that places a catheter down your nose and a newer method that leaves a capsule in place at the same time of your EGD. If the acid level (DeMeester Score) is two to three times normal, medication may not be effective and surgery is indicated early. An esophageal strength and motility study is also usually ordered. It gives the physician a suggestion of the pumping power of the food tube. This can determine what type of operation will be offered (Nissen-Full wrap, Toupet-partial wrap, or the Linx system-magnet). It also can give you the strength of the door between your stomach and food tube. If it is less than 6 mm of mercury of pressure, medicines are not going to affect a cure. It is very important for you to choose your physicians carefully. If you have a tentative, non-aggressive physician you may have a different treatment plan. The promotion of this more aggressive strategy has also been secondary to the discovery that the miracle meds are fraught with very significant side effects with long term use that had not been previous appreciated. (More discussion to follow) It should be noted that x-rays (Upper GI series) have only limited and specialized use in the diagnosis of GERD. It is very useful in determining if you have a specialized hernia called a paraesophageal hernia that is famous for causing an upside down stomach to reside in the chest. The study’s greatest use is for follow up for surgical reflux procedures.
How do I take care of the problem?
The bad news so far is that you have a problem. The good news is that there are things that can be done to cure or help you live with the problem. First, lets talk about lifestyle changes. Changing your usual and customary way of conducting your life can make a big impact on your GERD. First, lets talk about something as simple as changing your diet. When it comes to GERD and food there is good food and bad food. Below is a listing in both categories:
- Grilled and baked meat
- All veggies
- Breads, rice, oatmeal
- Alkaline water, soy and coconut milk
- Chamomile tea
- Manuka honey
- Corrosive C’s
- Carbonated and Citrus beverages
- Canned Foods
- Whopper Woes
- Raw tomatoes
- Breath mints
Other lifestyles changes can be very important in your efforts to take control of this disease. It should be remembered that it is not just what you eat that can be important but when you eat. Try to eat a lighter meal in the evening and limit consuming large amounts of food near bedtime. Also, remember to sleep with your head elevated on multiple pillows. All of this fits in well with an overall weight lost program, which can also be very pivotal in controlling symptoms. Clothing should not be tight-fitting as it can increase the pressure in the stomach and cause an increase in reflux. Finally, decreasing smoking can significantly assist in the control of your symptoms because it decreases the pressure of the lower esophageal sphincter. The lower the pressure of the lower esophageal sphincter, the more acid is allowed to come from the stomach and into the food tube (esophagus).
Medicines can also play a significant role in curing and controlling reflux. Some of the more important ones are Nexium, Prevacid, Prilosec, Protonix, and Aciphex. Remember they have different names but the same game: the reduction in the release of acid in the stomach. Less acid in the stomach means less acid to reflux into the esophagus. When first introduced, these medicines were touted as being the “magic pill”. “Take one everyday and keep reflux and heartburn away.” The fact is 45% of patients properly diagnosed and treated with these meds will be treated, cured and not have this problem again. Unfortunately, this type of treatment behavior has now been shown to be in error. Twenty percent of patients with the disease and treated properly will have treatment failures. Furthermore, there are increasing reports and academic evidence of side effects of the medication and evidence that “the magic pill” cannot be taken forever. The following are some of the side effects of GERD drug therapy:
- Nexium, Prevacid, Prilosec, Protonix, Aciphex are all included (Different name/same game)
- Increase in the rate of hip fractures
- Anemia (Iron, B12)
- C. Difficile colitis
- Increased risk of community acquired pneumonia
- Extremely expensive
- 13 billion spent on these meds in 2006
What is the next step if lifestyle changes and medicines do not work?
The treatment of GERD usually follows a stair step approach that goes from the simple to the complex. Lifestyle changes and medicines make up the simple, less aggressive arm of the treatment options. If these fail, invasive treatment must be considered. There are degrees to the level of invasiveness ranging from endoscopic procedures that do not require incisions, all the way to procedures that require full-blown open surgery (incisions may be 12 inches or more). Regardless, all of the procedures that are involved with the treatment of GERD are meant to correct the continuous or episodic incompetence of the lower esophageal sphincter. Both my partner, Jay Redan, MD, FACS, Director of Minimally Invasive Surgery at Celebration Health in Orlando, Florida, and myself have been performing these procedures for twenty years. With Dr. Redan’s extensive experience, he has seen the gamut of anti-reflux procedures from minimally invasive to invasive. I asked him to provide a review of procedures and products that were introduced with high promise, only to fail the test of time.
Historical Innovative Treatments of GERD: A Bridge Too Far!
Jay Redan, MD FACS
Director of MIS
Over the last 30 years there have been several innovative devices that have been advocated for the treatment of GERD. One of the first devices introduced over 30 years ago was an Angelchik prosthesis (fig). This is a device that was placed around the esophagus in the location of the lower esophageal sphincter. It was a hard, plastic device, which was very easy to implant. It was performed before the era of laparoscopy (key hole surgery) and therefore was performed as an open surgical procedure. People who had this device implanted did have short-term success with the correction of GERD. However, this device had a large number of erosions from the outside to inside the stomach. This and numerous other complications caused a tremendous amount of pain and suffering for patients and it is no longer in use.
Another treatment that utilized an endoscopic approach was called the Gatekeeper (fig). This was a gel that was injected in the area of the lower esophageal sphincter to decrease the lower esophageal sphincter opening and prevent GERD with this mechanism. The big advantage was that it was placed endoscopically and could be performed as an outpatient procedure. However, the difficulty with this “device” is that there were several deaths associated with erroneous injection of this material through the esophagus into the aorta, the main artery of the body, and, as with the previous example, it is no longer on the market.
An endoscopic device that is still on the market, however rarely used, is called the EndoCinch (fig). This was the first GERD device placed solely by endoscopic visualization. It tried to strengthen the lower esophageal sphincter by narrowing the lower esophageal sphincter and creating an anti-reflux valve. This did have success in some patients. Ultimately, it was found to be most successful in the repair of surgically Nissen fundoplications that “came loose.” But as a frontline, first to fight procedure, it has a significant failure rate. However, it certainly does have its place in the history of endoscopic treatment of GERD.
Another endoluminal/endoscopic procedure was the NDO Plicator (fig). This was a large, device placed with an endoscope through the esophagus. It was fast and easy to perform and could be done under conscious sedation. However, the large scope used to place this device was difficult to manipulate. No esophageal strictures or hiatal hernias could be present to qualify for this device. However, the expense associated with the NDO Plicator is prohibitive, and it is no longer manufactured.
A device placed endoscopically still on the market which uses radiofrequency (radio wave) ablation is called the Stretta procedure (fig). It is also used for fecal incontinence. This device creates approximately 30 superficial burns in the lower esophageal sphincter. The thought behind this procedure involves the creation of a scar in the area of the lower esophageal sphincter. This scar tightens the lower esophageal sphincter “valve” and therefore prevents reflux episodes. A major disadvantage of this device is that it did take several months before it would start to work, and its reproducibility was erratic and well below the standard associated with other invasive procedures.
Another device placed by putting an endoscope into the esophagus is EsophyX. It is still on the market and does have an approximately 70% success rate (fig). This device is very large and cannot be used in patients with a hiatal hernia greater than 2 cm. In addition, patients that have an esophageal stricture are not candidates for this procedure. The device has been limited to use by skilled endoscopic and laparoscopic surgeons, which has minimized any complications associated with this device. However, the long-term effectiveness has to be studied more before it can be touted as a goal standard treatment for GERD.
Now, lets move on to the more invasive surgical anti-reflux procedures. They consist primarily of the Nissen fundoplication (360 degree), Toupet fundoplication (270 degree), and Dor fundoplication (anterior180 degree). In different ways they all try to decrease reflux by wrapping a mobilized portion of the upper stomach around the outside of the lower esophageal sphincter. In the United States, the standard of care is the Nissen fundoplication. But, the final selection of the type of wrap to be used is determined by pumping power of the esophagus. Good pumping power allows a Nissen (360 degree wrap) to be performed. Poor pumping power means that a partial wrap should be performed in order to relieve symptoms and avoid difficulty with swallowing post-operatively. The Nissen fundoplication is the gold standard of treatment of GERD. In the proper surgical hands it has over a 90% success rate over 20 plus years. However, due to the wide variations in surgical skill needed to properly perform this procedure, there have been numerous failures and poor outcomes reported. Therefore the 90% success rate has been difficult to reproduce by the average surgeon. Subsequently, gastroenterologists have been hesitant to embrace it as an early intervention. It must be stressed that there is no doubt that this procedure gives long-term relief from reflux. With this procedure now capable of being performed laparoscopically, the message to gastroenterologists and patients is to seek qualified surgeons to take advantage of this option early in the treatment cycle.
Today, our efforts to find a better GERD mousetrap continue with the introduction of the Linx anti-reflux management system. This magnet-based treatment involves the placement of a magnet bracelet around the outside of the lower esophageal sphincter (Figures 2-4). It is placed laparoscopically, and therefore general anesthesia and surgical skills are required. While the device does resemble an Angelchik-type prosthesis, the flexibility of the magnets gives hope that no erosions will occur over time. So far, over 600 of these have been placed around the world with outstanding results. Comparison of features of the Linx system to the Nissen fundoplication include:
Linx Reflux Management Magnet System
- Can be done minimally invasively
- Does not alter anatomy
- Can be reversed with minimal risk
- The Nissen fundoplication is still a treatment option
- Prefer hiatal hernia is no greater than 3 cm
- Five-year data shows results similar to Nissen fundoplication
- No MRI after being put in place
- Must wear identifying bracelet
Laparoscopic Nissen Fundoplication
- Very effective
- 50 years of experience
- 10-20 year data
- Operator dependent
- Must be in experienced hands
- Alters anatomy
- Can be done minimally invasively
- Can be reversed with increased risk to patient
Conclusion: Getting Our Arms Around GERD with Operation Bear Hug
In spite of the exciting array of treatment options for this public health menace, dark clouds surround our efforts in dealing with this disease. The truth is that only a fraction of the patients who need to be treated are getting the proper care. The problem is that we have not been aggressively using an endoscope to look down into the esophagus to see the damage from the acid during the early stage of the disease. We cannot get the job done using the current workforce of gastroenterologists and surgeons. There must be an expansion of the number of patients who can be accurately diagnosed. We must embark on a new course of care. My vision is that when patients come to their primary care physician their journey to freedom from GERD (Gastroesophageal Reflux Disease) will start. Medicines should not be given without an idea of the diagnosis. Patients should not have to wait three to six months for a gastroenterologist appointment. Rather, your primary care physicians on day one could/will perform an endoscopy and your path to a better future will begin.
Usually an endoscopy is done at a hospital or outpatient facility by a gastroenterologist or surgeon with intravenous sedation. Unfortunately, there are not enough of them to screen the 21 million patients who currently suffer with the GERD. How will we change the status quo? In two words, innovation and invention. The innovation is the use of the collateral learning assets of video games and simulation (stealth learning) to transfer the proper knowledge and judgment to primary care physicians faster and with effective empowerment. Another innovation/invention is the use of a robot (Visitor 1) and telecommunications to allow experts to interview and consult while patients are in the office, often on their first visit. In addition, with the aid of the robot, primary care physicians will perform their initial endoscopies with the assistance of an expert “wingman” that will remotely oversee and provide guidance. This will provide confidence for the physician, safeguard the patient and assure quality of care. This method of providing care while the provider is in an off site location with the help of computers and telecommunications is called telemedicine. It is important that you become familiar with this term because it promises to play an ever-increasing role in healthcare in the near future. Telemedicine will assist in getting care to patients when they need it without having to venture far from home.
Another innovation is the Vision Science endoscopy system. It allows primary care providers to have technology in their office that previously was only available in hospital or outpatient facilities. Now diagnostic endoscopy can be done in the office without sedation and the need for a sophisticated cleaning process. In addition, if surgery is the proper option, the Linx for Life magnet reflux management system offers a less invasive surgical solution that causes less of a disruption of life style. This project that will define the future treatment approach for GERD is called Operation Bear Hug. Bear Hug is meant to change the current GERD game by achieving early diagnosis and treatment while assisting in the activation of an expanded pool of providers to perform diagnostic endoscopies. This is critical to speed up making a decision on who should have medicines and who would be better served with surgery. A pilot of this program will be put on during a community service event called the 20-minute Reflux (GERD) Check Up. This program is inspired by the 15 minute Physical and the 15-minute Heartburn check up done by Dr. Mehmet Oz around the country. Operation Bear Hug is different in scope because of its use of innovation techniques and new cutting edge technology. This April event will be held in Celebration, Florida in cooperation with the Town Center Medical Clinic, Chad Black, DO medical director and Celebration Health Hospital. April is Heartburn and Esophageal Cancer Awareness month. Please stay tune for more information about this first of its kind event. With a change in strategy, I am convinced that we will do a much better job with GERD and esophageal carcinoma treatment over the next forty years than we did in the previous forty.
Contributors to this article include:
James C. Rosser, Jr., MD, FACS (Primary Contributor)
Jay Redan, MD, FACS
Robyn Gardner, MHE, PA-C
Advanced Laparoscopic Surgeons
Suite A140 Celebration Health
Celebration, FL 34747
The Stealth Learning Company
10239 Mallard Landings Way
Orlando, Florida 32832
Chad Black, DO
Town Center Medical- Downtown Celebration
610 Sycamore Street, Seminole Building, 1st Floor
Celebration, FL 34747
J. Scott Magnuson, MD
Hilliary N. White, MD
Head & Neck Surgery Center of Florida
Suite 305 Celebration Health
Celebration, FL 34747
Device Manufacturing Information:
LINX® Reflux Management System
Torax® Medical, Inc
4188 Lexington Avenue North
Shoreview, Minnesota 55126
Fax: (651) 361-8910
EndoSheath® Transnasal Esophagoscopy
40 Ramland Road
Orangeburg, NY 10962
U.S. Telephone: 800-874-9975
International Telephone: 845-365-0600
KARL STORZ Endoscopy America, Inc.
2151 E. Grand Avenue
El Segundo, CA 90245-5017
Telephone: +1 (0)424 218-8100/800 421-0837
Fax: +1 424 218-8525
Over the last two decades, Dr. Rosser has been featured on several local radio and television programs including CNN, The Learning Channel, The Discovery Channel, The Dr Oz show, and many other national and international media outlets. He has been the subject matter of many documentaries. He has been a leader in what he calls a Digital Learning Revolution to harness the collateral learning assets of pop culture and video games to teach children and train our workforce more effectively. He is the author of the recently released book entitled: Playin’ to Win: A Surgeon, Scientist and Parent Examines the Upside of Video Games that chronicles the details of this premise. Dr Rosser has always tried to be more than a medical asset to the global community and will continue to lead the fight for better healthcare around the world.
He has traveled the world teaching and training physicians from several countries about the benefits of minimally invasive surgery and the benefits of incisionless surgery. He has published widely and also serves as a consultant, lecturer, and instructor for several laparoscopic surgical instrument manufacturers. In addition, Dr. Redan serves on the editorial staff of the Society of Laparoendoscopic Surgeons, the Journal of the Society of Robotic Surgery and Surgical Endoscopy. Additionally, Dr. Redan is a member on the Board of Trustees and President Elect for the Society of Laparoendoscopic Surgeons and is currently a President Elect to this society. Dr. Redan is also a member of the American Society of Colon and Rectal Surgeons, a Fellow of the American College of Surgeons, Charter Member of the Society of Robotic Surgery, and a member of the Society of American Gastrointestinal Endoscopic Surgeons and member of the Society for Surgery of the Alimentary Tract. He is Associate Professor of Surgery at UCF College of Medicine.
Dr. Redan received his medical degree and completed his general surgery residency at the University of Medicine and Dentistry-New Jersey Medical School. He served in the U.S. Army Reserve during Operation Desert Storm, and the U.S. Army National Guard, retiring in 1999 with the rank of Major. He is Board Certified by the American Board of General Surgery, Fellow of the American College of Surgeons, and member of the American Society of Colon and Rectal Surgeons. Locally, Dr. Redan serves on the internal review board for Florida Hospital and has worked jointly with the Association of Operating Room Nurses in the development of operating room safety and nursing safety in the perioperative surgical procedures.