Acid reflux management device wraps itself around disease
June 10, 2009 4:00 AM
Casey Donahoe says he feels great after surgery for reflux. A LINX device was inserted around the lower esophageal sphincter as part of a clinical trial to test the device's effectiveness.
By Pohla Smith Pittsburgh Post-Gazette
Casey Donahoe was no more than 10 when he began experiencing the bitter taste of stomach acid in the back of his throat.
Mr. Donahoe had GERD, or gastroesophageal reflux disease, but it wasn't diagnosed until he was a sophomore quarterbacking the Serra High School football team. That's when a physician, the father of a teammate, spotted him drinking freely from a bottle of the over-the-counter antacid Mylanta at a game and asked why.
"I got into his office, found out what it was and started treating it [with prescription drugs] from there," said Mr. Donahoe, now 24, of White Oak.
Still, despite the drugs, total relief eluded him until this past Good Friday, when he underwent a surgical procedure that is still in a Phase 2 clinical trial being conducted at the University of Pittsburgh Medical Center. Since Dr. Jim Luketich implanted the LINX Reflux Management System, Mr. Donahoe has felt like the proverbial new man.
"I feel great, like there was nothing done," said Mr. Donahoe, who is finally eating anything he wants after years of denying himself such loves as grapefruit and orange juice. "I would highly recommend it. After several years [of suffering], to be in pain for a couple of hours [after surgery], it's well worth it.
"I had acid reflux really bad the morning of the surgery. When I woke up it was gone."
The LINX system is being tested at a total of 15 sites across the nation and two more in Europe. It is a bracelet-like device comprising magnetic titanium beads that wraps around and fortifies the lower esophageal sphincter, the valve that connects the esophagus to the stomach. When the valve doesn't close tightly it leaks stomach acid, and reflux occurs.
Why it happens is a question with multiple answers, said Dr. Luketich, director of UPMC's Heart, Lung and Esophageal Surgery Institute.
"Some foods or medications can cause it to leak, and you fill it too full of food, overeating of anything, it can be bad," he said. "One of the risk factors ... is obesity; it puts too much pressure on the valve. Some thin people get it and there may be a hereditary factor. But there's smoking, chewing tobacco, eating fatty foods, drinking two pots of coffee a day. There are things we do that are not good for the valve or the esophagus. ...
"Most of the time [GERD] can be managed without surgery," he added. "You can lose weight; give up coffee, reduce stress in your life.
GERD sufferers who want to find out if they might qualify for the LINX study should visit www.refluxstudy.com.
• Age 18 to 75 years
• Has had GERD symptoms for longer than six months
• Must take daily anti-reflux medications and still experience symptoms
• Body mass index cannot be above 35
• Patients must undergo a series of standard tests to evaluate the ability of the esophagus, as well as to measure the pH levels. The tests are part of a standard work-up for GERD and therefore aren't covered by the study, which does cover the cost of the device, the surgery to implant it, and the overnight hospital stay. However, the tests are covered by most insurance companies.
"If that doesn't work then you can take [over-the-counter] medications like Tums or Maalox, and if those don't work then you go to a [prescription] drug like Nexium."
If they don't work, or if they cause bad side effects, or if your insurance won't cover the cost, then you might want to consider surgery, Dr. Luketich added.
These days, the most common surgery is a procedure called a Nissen fundoplication, It is done laparoscopically, during which time the surgeon wraps a part of the stomach around the leaking valve to fortify it.
Dr. Luketich has done more than 4,000 of them at the rate of five or six a week. "We probably do them as well as anybody in the world, but what we noticed is that the Nissen is not perfect. It's not like the initial valve, the one you're born with. It can never be duplicated ... It is the gold standard."
The LINX system is a product of Torax Medical Inc., a firm founded in 2002 with the stated mission of creating a better treatment option for patients suffering from GERD.
In some ways and under certain circumstances, it seems to be just that, said Dr. Luketich, who had implanted six LINX systems through the first week of June. For example, he said, "this doesn't work for large hiatal hernias." The LINX can only be placed in hiatal hernias less than three centimeters in size.
But for a leaking valve, he said, "in the short run it seems as good or better as the Nissen. ... [But] we don't have long-term data."
The device is implanted via the five small incisions of a laparoscopy and it takes only about an hour. Dr. Luketich said the patients can go home after an overnight hospital stay.
Mr. Donahoe was restricted to a liquid diet for three days, and Dr. Luketich asked him not to lift anything heavier than 10 pounds for a month. There were no stitches, Mr. Donahoe said, just Steri-strips.
Dr. Luketich found two major pluses for the LINX when compared to the Nissen.
"No. 1, it's easy to place ... easier than the Nissen," he said. "That's first and foremost -- that it's safe and simple for an experienced surgeon." But he stressed that both the LINX and the Nissen should be done by experienced surgeons as the esophagus is delicate, its blood supply tiny and its nervous system intricate.
"No. 2, it does open to allow food to pass down into the stomach. ... We measure it before we put it in, and we can add one or two more beads if it's too small or we can take out one or two beads if too loose."
And the downside?
"Sometimes it still is too tight, and a patient says, 'I can't eat flank steak' or 'I can't eat my bagel.' I say, 'OK, would you rather have no heartburn or eat what you want?' They ponder that a little bit," Dr. Luketich said.
"Also a downside: It is metal, and that means for right now you can't have an MRI."
That's a problem that's being worked on, he said, "but now if you have something [that would require an MRI], you must get a different diagnostic test, like a sophisticated CT scan. ... That's a consideration for someone who might have a bad knee or epilepsy or another brain problem."
And one final downside: "We don't know how it's going to work for 10 years. Magnets are infinity; they last a lifetime ... Will it remain in position? It is in long-term animal patients and for a couple years in [early human] patients." And, so far so good, for the six patients Dr. Luketich has done over the past couple months.
"So will it work for 10 years? You can't tell for sure. Nissen ... is effective 90 percent of the time at five years; 80 percent at 10, so the Nissen isn't perfect either. ..."
For the patient who meets the criteria (see box) and who is willing to be in a clinical trial, "it's a good thing," the surgeon said. "It's not randomized, which means everybody gets the surgery; everybody gets the same treatment." And on top of that, he said, because it's a phase 2 trial approved by the Food and Drug Administration, the procedure is done at no cost to the patient.
"If it was for me or a member of my family, I'd recommend trying it. It's got closer-to-normal valve function. You can expel some gas. You can vomit if you're too full. And it stops heartburn," he said. "I'm impressed after doing more than 4,000 Nissens."
Dr. Luketich is still accepting patients to participate in the study; he hopes to do about 30 more of the procedures. For more information, call 412-647-7555 and ask for Dr. Luketich's staff.