Updates on LINX - GERD reflux management system

Updates on LINX - GERD reflux management system

By Brian E. Louie, MD
Director of Thoracic Research and Education

Since my initial LINX blog post 20 months ago, we have been engaged in a dialogue with patients from around the world who suffer from gastroesophageal reflux disease or GERD.  Despite my initial trepidation to “blogging”, this has been a rewarding experience to hear about patient’s problems, their concerns about the current treatments (PPI’s and Nissen fundoplication) and simply interacting with them.  I thank the patients who have taken time to share their thoughts on the blog.

 

When our social media manager asked me to provide an update on LINX, I realized that I have been simply responding to patient’s questions and I haven’t posted any of my thoughts or updates on what is happening with the LINX device.
 
There are some exciting developments for patients who are interesting in having a LINX implanted.

 
Use of MRI and LINX
  • Torax, the company who designed and manufactures the LINX device, has received FDA support for the use of MRI with the LINX device.  This conditional approval allows for patients to undergo and MRI that is 0.7 Tesla or less.   I am trying to clarify with our radiologists what a 0.7 Tesla MRI will cover.
Medicare coverage
 
  • For medicare patients, LINX now has a dedicated procedure code that allows for payment to cover the cost of the hospital portion of implanting the LINX device.  The surgeon’s fee is a separate code and fee and is usually covered.
Insurance update
 
  • For patients with non-medicare insurance, the battle continues.  But, the data from around the country shows that more patients are successful in getting approval for LINX than previously with upwards of 50% being approved.  It is still taking up to 120 days for approval but with more data accruing each month I think insurers are beginning to pay attention.
 
Since the insurance battle has been about lack of data supporting the LINX compared to Nissen, we (Drs. Farivar, Aye and Vallieres) have just completed a study comparing the two devices.  As I write this, I am on my way to the Society for Thoracic Surgeons annual meeting to present our findings, which will hopefully be published in the Annals of Thoracic Surgery later this year.
 
This study shows that LINX and Nissen are the same in terms of treating the patient’s symptoms of GERD, improving the patient’s quality of life and normalizing the level of reflux in the esophagus without the need for PPIs.   However, LINX is a shorter operation, has less complications and results in a more physiologic sphincter since patients are able to belch and have less bloating or gas the Nissen patients.
 
This promises to be an exciting year for patients with reflux.  The addition of LINX to the treatment options for GERD allows us to individualize the treatment.  For patients with large hiatal hernia, Barrett’s esophagus and severe reflux, a Nissen fundoplication performed in an experienced center is still a better option.  But, for patients with a small hiatal hernia who are dependent on PPIs but whose reflux is not well controlled, a LINX device is a great option.
 
Thank you to all the patients who have read and interacted in this blog.  I look forward to reading your posts in the coming year.
Comments
Brian E. Louie, MD
Tonie,

Congratulations on being approved for LINX implantation.

It's natural to be afraid or concerned about any potential complications that arise from a surgical procedure regardless of how small or big the surgery may be. Most physicians quote the chances of a complication based on their own experience but also based on large studies completed around the world. The numbers are important but for the patient its effectively all or none event since in most cases you'll never be a recipient of a complication or you will get the complication.

Of the three potential issues you have listed, two of the three have some data to tell you about.

Erosion has been talked about a lot. Fortunately, as far as we know it has only occurred 4 times since the device was introduced. More than 2100 cases have now been completed so the likelihood of erosion is very small.

Pleural complications occur during Nissen fundoplication and repair of large hiatal hernias very routinely and rarely cause an significant problems. That being said, the likely chance of this occurring during a LINX procedure is unheard of because the surgeon shouldn't be anywhere near there.

Vagal nerve injury is more difficult to provide accurate information on. This is also very uncommon but even when it occurs it is not always clear what happened. Both vagal nerves can be seen and nothing done to them yet, the patient may have vagal nerve symptoms. At the same time, both vagal nerves can be injured and the patient may never even have a symptom. This should also be very uncommon after a LINX

I don't think I can allay your fears. The concerns you raise are important but fortunately are very, very uncommon after the LINX procedure.

Good luck in September.
9/2/2014 2:53:24 PM
Tonie
Dr. Louie:
I will have Linx placed at end of September.
I am scared of vagus nerve injury, possible pleural complications and future erosion of device... Please help me clarify risks and help me understand the safety of this procedure short and long term
Pray for me. Thanks.
8/29/2014 7:49:29 PM
Brian E. Louie, MD
Robecca, at the moment, I don't think anyone is offering a LINX to a patient who has had a prior Nissen fundoplication. I would clarify with your surgeon that this is in fact the plan. While it may work, I have some concerns about adding a LINX to a Nissen. I am not aware that this has been done.

If your fundoplication has failed, you could talk to your surgeon about having the repair revised without a LINX device.
8/6/2014 2:47:30 PM
Robecca
I had an open Nissen about 15 years ago. It really did great up to about 3 years ago. I have been taken meds daily and now they don't help with the heart burn, chest pain, feeling as if I have something in my throat. I go in two weeks for the Bravo pH test. Just to verify it is reflux again. My Dr. talked to me about the Linx procedure but also said he will have to research to see if I would qualify. He did explain that he would have to repair the Nissen, it has deteriorated during the procedure if I qualify for it. In your opinion do you believe I would qualify for the procedure?

Thanks,
8/4/2014 1:35:05 PM
Brian E. Louie, MD
Zeppo, You are likely experience GERD but are completely unaware of the fact that it is occurring. GERD should be thought of in terms of three areas: 1) Symptoms; 2) Endoscopic findings; and 3) Degree of acid exposure. Some patients have very little acid, lots of symptoms and normal endoscopies. Others have no symptoms, endoscopic findings and moderate acid. You would fit into the later group.

You have identified the challenges in treating you. You could take medication (PPIs) but not know whether they are working for you since you have no symptoms to gage the response. You could have surgery (LINX or Nissen) but the same applies - we won't know if surgery is working either without testing you.

I'd first consider getting a pH test off the medication and seeing how much reflux you have. Then you need to decide do you want any treatment, PPIs or surgery. Then, test you after with pH testing to see if your reflux is controlled.
8/4/2014 10:04:23 AM
Brian E. Louie, MD
Dot, the only concern I know about is the MRI and this issue hopefully will be settled by the FDA later this year. It should allow LINX patients to undergo an MRI if the machine is 1.5 tesla or less which is what most machines are ‎and provide good images
7/28/2014 10:03:20 AM
Brian E. Louie, MD
Jon,

As I mentioned in the previous post on burping, this is a difficult situation. It is even more difficult in a situation if pH test is normal despite the 100% symptom correlation.

It is very clear from the data that patients do best with surgery if they have an abnormal pH test, classic symptoms (heartburn and regurgitation) and improve with PPI treatment. So, to consider implanting a LINX becomes a challenge but it is not impossible.

Based on what you say, you have a sensitive esophagus (since your pH test is normal) and you have learned to burp to alleviate the sensations with the belching. Even if a LINX is placed you have learned this behavior of burping and it may not change after the device is placed because you've learned to compensate. Often, I'll have patients see the psychologist to retrain their brain to not focus on the sensation and to not burp.

This is a complicated decision and you should seek consultation with an experienced esophageal surgeon.
7/28/2014 10:02:49 AM
Zeppo Levy
I have never had any heartburn or pain. My symptoms have been belching and very rare occasions of active reflux that reaches my mouth, which I have stopped completely by not eating late at night.

However, I have had two upper endoscopies that show repeated acid burns that are not healing due to repeat exposure.... that I am COMPLETELY unaware of.

1) Any idea what is going on? Is this GERD or something else?
2) Because I have NO awareness of the problem (no pain, no heartburn) I have no way of knowing if the PPI is working, or how much to take. My only metric is another endoscopy. My sense is to treat the cause, (e.g LINX) rather than take meds without even knowing if they are working.

Your thoughts would be much appreciated.
7/27/2014 11:12:37 PM
jon
Dr. Louie,

I also have the same burping problem and this does correlate with PH drops on my PH manometry. There was a 100 % symptom association,however my demeester score is normal. My LES pressures are also very low. Would you offer me a linx procedure?
7/26/2014 12:32:30 PM
dot
Certain operations, procedures eg: MRI, cannot be done following LINX implantation. Is this accurate?
7/23/2014 11:53:34 AM
Brian E. Louie, MD
The symptom of burping is a difficult one because it is not a symptom of GERD. It is a side effect of GERD and occurs because patients swallow air when they are swallowing the reflux or trying to swallow saliva to neutralize the acid. This becomes a habit and gets the patient into a cycle which is difficult to stop.

If the burping can be tracked with pH testing to coincide when acid is up in the esophagus, this symptom usually improves. If you have a Nissen, the burping will stop but you will pass a lot of flatulence because the air you swallow has to go somewhere. The LINX will control the reflux but you may still belch. In some cases, the patients are so used to burping they cannot stop even when the reflux is controlled. Here a psychologist who knows hypnotherapy is often helpful to retrain the brain to not focus on the belching.
7/15/2014 10:23:38 AM
Marie
I have had a problem with constant BURPING for almost 8 months. I have had 4 test, the last of which was a esophageal manometry. This last test showed that there was a problem with my LES being weak. I have tried many PPI's and am still burping. I am strongly considering the Linx procedure or the Nissen. I had 2 endoscopies done in 2013 and have a small hiatal hernia. Other symptoms include clearing of throat but the most bothersome thing is the constant BURPING! Will either of these surgeries stop the burping?
7/13/2014 2:13:13 PM
Brian E. Louie, MD
Brian,

Obviously, I can't tell you what to do. But, from your post, I can make several observations.

First, remember if you have antireflux surgery of any sort, you will be off Dexilant and your gastric acidity should return to normal. It's low now because of the medication and makes you susceptible.

Second, there is no perfect antireflux surgery. LINX is about as close as it comes. Nearly all of the LINX patients can vomit normally so I wouldn't think that's going to be an issue for you. The sensations from LINX after having it placed almost always resolve by 3 months after the procedure.

Third, EndoStim should be available in the US in late 2014 but only through clinical trial at selected centers in the US. Stay tuned for that announcement. It does seem promising and we are hopeful that we will be selected as a center for the trial.

I suggest that you sit down with a surgeon who has experience with the both fundoplication and LINX to educate more in person. You may wish to wait until Endostim is release to hear more about that as well before making a decision.
6/30/2014 9:09:47 AM
Brian
Hi Dr. Louie,

I am taking Dexilant, 60 mg, QD for two years.

My reflux is under control (barely) and I am very susceptible to gastric infections like food poisoning, due to a low acid level in my stomach, so dining out is a crap shoot.

The EndoStim seems to have much promise, but it is not FDA approved in the USA. The Linx "scares" me a bit, since there is a certain amount of force to open the LES and I don't want to feel uncomfortable, like food getting stuck in my chest. The Nissen is a non-discussion due to the side effects of the surgery.

What should I do? Am I missing something?

Thanks.
6/20/2014 10:30:13 AM
Brian E. Louie, MD
Ernesto, It does sound like you would be a great candidate for LINX.

I can't speak for your surgeon. I would ask the surgeon his or her plan. I would assess your hernia at surgery‎ and make a decision on whether to close the hernia. Often it is not needed. Regardless the goal is place the Linx below the diaphragm .

I always place the device inside the posterior vagus nerve because I think it helps keep the device next to the LES.

Good luck.
6/19/2014 12:23:29 PM
Ernesto
Hello there! I am seriously considering LINX. I just had an upper endoscopy and it revealed a small hiatal hernia (1.5 to 2 cms). Everything else is fine such as e. manometry, upper GI series, etc. It means I qualify for linx. My big question is about prevention of device migration. Do you think the surgeon will pull down the small hiatal hernia together with the LES (lower esophageal sphincter) below my diaphragm first then he will snug/tighter the diaphragm hiatus with a mesh or something to move the location of LES from above the diaphragm to under the diaphragm? This way, the LINX device will be implanted below the diaphragm instead of above the diaphragm. Does this make any sense? Thanks so much! Hope to hear from you. :) thanks so much for creating this blog.
6/17/2014 8:22:38 PM
Brian E. Louie, MD
David, The short answer is that placement of LINX has not been attempttd after a prior repair. You may wish to look back in the blog comments for both LINX blog posts where we had several dialogues about the reasons for not doing this. I would suggest that you see an experienced esophageal surgeon and be re evaluated to determine your options including revision of the previous repair.
6/12/2014 5:32:46 PM
David Turner
I had surgery for a hiatal hernia about 18 yrs. ago. The wrap has come undone and I am back on meds. could this procedure help with my acid reflux.
6/5/2014 1:21:40 PM
Brian E. Louie, MD
Laura,

I’m sorry that your 3 year old has to suffer with this so early in life. Unfortunately, there is no research on the LINX in anyone under 18 years of age. There is so much growing to do between 3 and 18 that there is no way to even consider implanting a device since it would need to change as your child changes.

I recently spoke at a symposium on GERD and one of the other speakers was a pediatric surgeon who specialized in childhood GERD. She was making the point that GERD at 3 is very different that GERD in adulthood. It requires very careful decision making not so much because of the inability to belch and vomit, but because a lot of children as they grow older will “out grow” the reflux.

Seeing the surgeon is reasonable to hear what their opinion is. You don’t have to agree to surgery but you should her what they have to say. Clearly, you’ll want to know that the surgeon has an interest in pediatric GERD.
5/19/2014 1:42:58 PM
Brian E. Louie, MD
David,

The decision to place a LINX in your situation will depend on the surgeon. At Swedish, we would make the decision based on several factors. First, how normal is your motility test since this is important to supporting a LINX device. Second, how much Barrett’s you have. If you have a 1 cm or so and a normal esophagus, your could support of LINX. If you have long segment Barrett’s (5 cm or greater) and a poorly functioning esophagus then a LINX may not be a good idea.

It would be best to see an experienced LINX surgeon and have your studies reviewed to make a decision about LINX
5/19/2014 1:42:24 PM
Laura
Is there any research on the pediatric use of LINX? My 3-year old has been on PPI's for almost 6 months now and still experiences reflux after every meal. The pH level of the reflux is controlled by the PPI, but the episodes continue to occur. Our GI specialist has recommended a consultation with a surgeon regarding Nissen fundoplication, but I do not like the idea of preventing his ability to belch and/or vomit for the rest of his life.
Thank You
5/15/2014 1:12:26 PM
David Rosado
Hello, I have had gerd for many years and I have a week les with a small hiatal hernia and have been diagnosed with barrets with no dysplasia. Since they have now approved the use of an MRI with the linx installed is it still possible to have it done with my barretts?
5/13/2014 10:15:28 PM
Brian E. Louie, MD
Alexandra,
Yes, you are a candidate.
5/13/2014 5:29:25 PM
Andrew
I have had a partial gastrectomy due to cancer 6 years ago. I do not have les. Is this procedure still an option?
5/9/2014 9:24:59 PM
Alexandra
Hello!

Am i still a candidate for Linx if i had erosive esophagitis (grad B by LA classification) ?
5/7/2014 8:37:30 AM
Lee Trujillo
I have been treated for Barretts for well over 15 yrs, my medication works but I am a long time patient.
5/6/2014 9:40:50 PM
LINDA
I HAD THE LINX PROCEDURE ABOUT 7 WEEKS AGO AND I WAS VERY HAPPY UNTIL LAST WEEK WHEN I BEGAN FEELING THAT BURNING SENSATION AGAIN. IT'S NOT AS BAD BUT I WONDER IF WHAT COMES NEXT? I WILL SEE MY DOCTOR SOON BUT DOES ANYONE KNOW WHAT THE NEXT STEP MIGHT BE?
4/16/2014 12:09:46 AM
Brian E. Louie, MD
Leslie, I think that your candidacy for LINX will heavily depend on your gastroparesis. You should have studies to determine how severe your gastroparesis is. It's likely that your bloating symptoms are from the gastroparesis as is your reflux. LINX will help with your reflux but won't help the gastroparesis and you are likely to have ongoing symptoms. From what you tell me, your best to make sure the treatment you get treats both. In that case, a Nissen is likely to be better if you have moderate gastroparesis since the Nissen will help your stomach empty.

It sounds like you are seeing a gastroenterologist and not a surgeon. I'm not sure if that is correct, but your situation is more complicated than a patient with no gastroparesis. You may wish to see both a surgeon and gastroenterologist to get several opinions.
4/7/2014 4:07:54 PM
Brian E. Louie, MD
Joanne,

Thanks for your post. Your story is very similar to many patients with GERD. They start on PPIs and feel improved. Overtime, they have more symptoms and undergoing an increase in the dose of PPIs. It sounds like you'd be a great candidate for LINX. I would not classify us as "still working" on the LINX. I think we have a very good idea of who will benefit.

I think your worries over Barrett's and cancer are real to you. The numbers would suggest that your risk is really small. These reasons should not be your primary reason for deciding about surgery for reflux. At the moment, the key would be better control of symptoms and reflux control. Both Nissen and LINX would be suitable alternatives.

I suggest you go back to your surgeon for more discussion. If you are not comfortable with the surgeon, then seek one you are comfortable with.
4/7/2014 4:07:23 PM
Joanne Taravella
I am interested in the LINX surgery.
I read PPI's don't stop the progression of GERD.
Also I read that they don't prevent Barrets or cancer.
I went to a surgeon last year to see if I was a candidate
for the LINX and he told me to keep taking PPI's for now
because there still working for the most part.
I have had GERD for many years now and I have to take
these PPI meds.every, and this year I am noticing breakthrough symptoms more and had to go up on my dose.
My fear is that I will get Barrets or worse and won't be able to get the LINX.
The surgeon said to come back in a year.
He also told me that I seem like the nevous type and would worry alot after the opetation about the device inside me.
I worry now anyway so what's the difference.
He mentioned having a nissen and I am hesitant about it because of what I read and heard.
4/4/2014 8:13:42 PM
Leslie Mercer
I have gerd esophagitis and gastroparesis with frequent belching.Would I still be a candidate? Is there much gastointestinal bloating from the Linx?I'm being following by GI who does Linx and has "scheduled" me to see him on April 20.
4/4/2014 1:03:58 PM
Brian E. Louie, MD
36
3/5/2014 3:35:26 PM
Gary
Wondering how many of this procedure Swedish has performed to date.
3/5/2014 3:14:24 PM
Kevin Owens
I had a Nissen in 2006 that is in a failure mode. A recent endoscopy showed light from the stomach escaping around the device shaft. I hate to think of having a repeat Nissen surgery every 8-10 years. Can I have LINX surgery this time around and reverse the previous Nissen and expect more longevity out of the Linx?
3/5/2014 11:44:42 AM
Amanda
Would this be an option for people with Bile reflux?
2/26/2014 2:26:18 PM
Brian E. Louie, MD
Yes, very exciting.

there has not been much research on the satisfaction of LPR patients with LINX. there was one study looking at patients with atypical symptoms for which LPR fits into that category. Patients did benefit but it was not designed specifically for LPR.

In our own experience the LPR patients do very well, but its not perfect. However, it may be more suitable than a Nissen for most LPR patients who don't have severe GERD symptoms as well.
2/24/2014 10:28:16 AM
David
This is very exciting news!

Has there been much research on the satisfaction of LPR patients with the Linx procedure?
2/14/2014 6:18:09 AM
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