SAN DIEGO (Ivanhoe Newswire) - Chronic heartburn, also known as GERD, keeps millions of Americans from enjoying the foods they love. It can also lead to a dangerous form of cancer. The painful, burning sensations could only be helped by prescription drugs or a very invasive surgery. But now, tiny magnets are helping these patients find relief.
Mixing, heating and topping. It's all part of the fun for Janet. Whipping up tasty sweets is a passion and a family tradition.
"My mother was a great example," Janet told Ivanhoe. "She was a fantastic cook and baker, and she would bake cookies every single day."
She shared her mom's love of baking, but just a couple years ago food, even food that looked great, wasn't appealing.
"I always had a burning sensation. I always felt a discomfort and burning. I would always think about what I ate before I ate it," Janet said.
Janet had severe heartburn known as GERD. It happens when acids leak up from the stomach into the esophagus. The only treatments are drugs that offer short-term relief or a surgery where doctors knot the stomach around the esophagus.
Now, there's a magnetic device that stops acid reflux in its tracks.
"It completely solves their problem. These patients now have family members and friends that want the operation," Santiago Horgan, M.D., chief of minimally invasive surgery at UC San Diego Health System, explained.
In a 20-minute procedure, surgeons place the device around the bottom of the esophagus. Magnetic attraction between the beads helps the esophagus open up when food goes down, then close tightly so acid can't find its way up.
"And when food tries to come back up, it's closed, so nothing comes back up, but things can go through," Dr. Horgan said.
After the procedure, patients like Janet can eat what they want right away.
"I'm just so much happier now that I'm eating," Janet said. "I'm eating the regular food and not feeling discomfort or pain."
Janet has even started a blog, and is sharing all of her favorite recipes. She's a passionate baker who has found a way to once again enjoy her favorite treats.
The band is sized to fit each patient. Clinical trials for the device just wrapped up. Dr. Horgan says he hopes it will be FDA approved soon. He said the procedure is simple to perform and there are no food restrictions. The traditional surgery is complicated and patients had to be on a special diet for six weeks.
RESEARCH SUMMARY
BACKGROUND: Most people who experience chronic heartburn wake up in the middle of the night, sometimes with pain deep in the throat, other times with a sore throat and trouble breathing, as if they were having an asthma attack. When severe heartburn happens often it can be diagnosed as GERD. GERD is the chronic form of acid reflux, when food and stomach acids "burp" back up from your stomach after eating. More severe forms of this disease can cause a patient to experience a sore throat, cough, asthma symptoms, and laryngitis. When it is left untreated for a long period of time it could develop into esophagus cancer or other permanent damage to the esophagus.
TREATMENT FOR CHRONIC HEARTBURN: Doctors usually immediately tell a patient who is experiencing heartburn to try changing their diet or make small lifestyle changes first. Some suggestions might be:
- Try eating smaller meals, and don't eat two to three hours before bedtime.
- Cut back on alcohol, caffeine, smoking, aspirin, and pain relievers.
- Avoid foods that may trigger heartburn, such as fried food, citrus, tomato, spices, peppermint, chocolate, and carbonated drinks.
- Lose weight if doctor suggests.
Other treatments include, but are not limited to:
- OVER THE COUNTER ANTACIDS: For occasional heartburn, Antacids like Maalox, Rolaids, and Tums can be used. Digestion works with a variety of different chemicals produced when someone eats, which tell the stomach to produce stomach acid to help digestion. Antacids contain magnesium, calcium, or aluminum to neutralize excess stomach acid. However, for chronic heartburn antacids are often not enough.
- ACID BLOCKERS: These drugs are as fast-acting as antacids, but they last longer and are more effective for several hours. They are supposed to block stomach acids that the stomach produces. Over-the-counter acid blockers include Axid, Pepcid, Tagamet, and Zantac and are available in prescription strength doses. These medicines are normally used as a preventative medication and not for fast relief.
- PROTON PUMP INHIBITORS (PPI): These drugs shut down tiny proton pumps that produce acid eventually lowering acid levels dramatically. They're often used when histamine blockers don't provide enough relief. One over the counter drug is Prilosec. More aggressive medicines include Aciphex, Nexium, Prevacid, or Protonix and require a doctor's prescription. There is debate, however, over whether PPI's are safe to take for a long period of time.
- SURGERY: Sometimes with chronic heartburn the doctor might suggest surgery or a procedure called endoscopy, which allows the specialist to see inside your esophagus to see whether acid reflux has eroded the lining of the esophagus or caused other damage.
A NEW TREATMENT: LINX, A MAGNETIC DEVICE TO STOP HEARTBURN: The LINX device is a titanium ring of magnetic beads. Surgeons place the device around the lower end of the esophagus to strengthen the muscles that are usually supposed to block stomach acid and other contents from rising while also allowing liquids and foods to go down.
It is manufactured by Torax Medical of Shoreview, Minn. and has been on the market in the United Kingdom, Germany, and Italy for about two years. During Torax's clinical trial, 100 patients who have suffered from GERD for an average of 13 years and experienced around 80 heartburn attacks a week were examined before and 12 months after they had the procedure done. Just over half of the patients saw their acid level fall by at least one-half and reported that their quality of life improved as well. Three-quarters of the patients experienced side effects, the most common being difficulty swallowing, which in some cases took six months or more to resolve. The second was pain and in five patients the device had to be removed. Also because the device is a magnetic, MRI's (if needed) could not be performed. The device is still in clinical trials in the US, but an FDA advisory committee unanimously voted that the LINX device was safe and effective for treating GERD that does not respond to medication. Also, the panel unanimously voted that the benefits of LINX for those patients outweigh the risks. The FDA usually, but not always, follows its advisory committees' guidance (Source: www.webmd.com).
INTERVIEW
Dr. Santiago Horgan, Chief of Minimal Invasive Surgery and Director for the Center for Esophageal Surgery at UC San Diego Health System, talks about different types of treatment for heartburn.
How many patients do you see every week with heartburn, with heartburn so bad, they cannot do anything about it?
Dr. Horgan: At least 20 patients a week; between patients that are overweight and patients that are not overweight, but have an abnormal valve. We see a lot of patients.
What causes it?
Dr. Horgan: It is a weakness of the valve in the esophagus and also a hernia of the stomach coming into the chest.
Until now, the only thing is prescription medication?
Dr. Horgan: Until now, the only thing was prescription medication or a bigger operation called fundoplication that we do every day. It has excellent results, but still patients do not like the invasiveness of the operation.
Can you kind of tell me what that is like?
Dr. Horgan: We make 5 holes in the abdomen, tiny incisions and then we create a knot around the esophagus with the stomach and that is called fundoplication.
There is probably more recovery time?
Dr. Horgan: The recovery time is they go home the next day and then they go through a diet that lasts 6 weeks where they have to take liquids at the beginning, soft food, baby food, and then more regular diet. But, it is a 6 week diet.
Does that work in all cases?
Dr. Horgan: Around 92% to 93% success rate in the hands of a surgeon that performs this operation daily. We now have data to support that if you do more than 100 of these operations a year, you are good enough and the data is very good. If you do less, then the outcome is not as good. That is the difficulty. Not every surgeon in the country has that number of operations every year.
But now, there is something that gives patients a choice.
Dr. Horgan: Now, potentially, we have a new device that is still not FDA approved, but we have done a trial, so it is still in trial basis where we feel strongly that this operation can be duplicated more widely by surgeons because it is a lot easier to perform than a Nissen fundoplication.
Kind of explain how this works. Does it have a name yet?
Dr. Horgan: Linx device. So, this device, called a Linx device, is a device where you see beads of magnets that they are all together like a ring and when we place this around the esophagus, it is snug, but it opens up. So, when food comes in, opens up. When food goes through the esophagus into the stomach, it closes up. So, it works like a real valve.
Are there any risks to having that?
Dr. Horgan: There are no risks. You cannot have MRIs with this device.
Large magnets, you will get picked up?
Dr. Horgan: Correct. You will get picked up and you will travel in space. But, most of the patients today we can study with CT scans. But, a few have some diseases that require MRIs all the time, and then you cannot have this device. That was good to see that patients do like the concept of having a magnetic device around their esophagus that opens and closes. Now, because, there is very little information at the time of surgery, there is no diet required. With this device, with the patients eat whatever you want tomorrow.
How many have you performed?
Dr. Horgan: We have performed around 22 of these operations. We should finish a trial of 100 patients done around the country. Now, we have 2 year follow up which is very good.
Of the patient's that you have done, has this solved their problem?
Dr. Horgan: Yes.
Does it completely solve their problem?
Dr. Horgan: It completely solves their problem. These patients now have family members and friends that want the operation. Of course, because it is a trial, we cannot, but hopefully, we will get FDA approval soon and this device will be on the market hopefully soon.
Now, did you create that device?
Dr. Horgan: No, I did not. I participated in the trial.
Why are the magnets so important?
Dr. Horgan: Because the valve in the esophagus, when it works, opens when food goes through and closes after food goes through. That is the difficulty of performing the fundoplication. You need to be very balancing when you do so, not too tight or not too loose. Now with this ring, we can adapt it to the esophagus. So, we measure the esophagus and we decide that we want 14 beads or 18 beads. So, we can tailor it to the anatomy of the patient without the difficulty that the operation creates. So, I personally believe that we are going to be able to duplicate this in the hands of surgeons without much experience, different to what is happening today with the fundoplication. So, ya know, I see that is the benefit of this.
When you first saw it, did you think, 'this is so simple that it is silly that it even works'? Like, why did I not think of that?
Dr. Horgan: When I first it, I had 2 thoughts. I said wow, this is good. But the other one is how are patients going to react to having magnets around their stomach or their esophagus. And I was impressed by that because patients do want this device. It became cool to be part of this trial because it is so advanced in technology. These are not simple magnets. These are rare magnets that are tailored to have certain strength. It is more complex then what you see, but now that we have 2-year data, really we can see why patients were so attracted to it.
The side effect, it probably heals all their arthritis too right? And it makes them better golfers?
Dr. Horgan: Golfers can play better if they have the ring around the esophagus because they are more balanced. That is correct.
Am I missing anything?
Dr. Horgan: No.
How does it stop the heartburn? It controls the opening and closing of the esophagus, but how does it exactly stop the heartburn?
Dr. Horgan: When we place it around the esophagus, like around my finger and it is going to be tight. Now, when food goes through and it is being pushed by the esophagus to go into the stomach, it is going to open. And then when food tries to come back up, it is closed. So, nothing comes back up, but things can go through. Now, if the patient has a hiatal hernia, that is a piece of stomach in the chest, we are going to fix that at the time of surgery. So, when we place the device, it is in the esophagus in the abdomen.
FOR MORE INFORMATION, PLEASE CONTACT:
Santiago Horgan, MD
UC San Diego
misresearch@ucsd.edu
