Updates on LINX - GERD reflux management system

January 27, 2014

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

This is very exciting news!Has there been much research on the satisfaction of LPR patients with the Linx procedure?
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.
Would this be an option for people with Bile reflux?
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?
Wondering how many of this procedure Swedish has performed to date.
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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.
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 candidatefor the LINX and he told me to keep taking PPI's for nowbecause 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.
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.
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.
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?
I have been treated for Barretts for well over 15 yrs, my medication works but I am a long time patient.
Hello!Am i still a candidate for Linx if i had erosive esophagitis (grad B by LA classification) ?
I have had a partial gastrectomy due to cancer 6 years ago. I do not have les. Is this procedure still an option?
Alexandra,Yes, you are a candidate.
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?
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
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
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.
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.
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.
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.
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.
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.
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 r...
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?
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.
Certain operations, procedures eg: MRI, cannot be done following LINX implantation. Is this accurate?
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?
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.
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.
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
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.
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,
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.
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 termPray for me. Thanks.
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...
I had the LINX procedure on May 20 after over 20 years of trying to manage reflux and small hiatal hernia with meds. About a month after surgery, I started having esophageal spasms -- very painful. My doctor prescribed baclofen and elavil. After a month, I was weaned off both meds. I still have spasms, but my doctor says I shoukd not need to take pain meds or baclofen. I also still have nausea and cannot vomit -- just saliva. I have bern told to be patient, that it might take 6-9 months before these spasms abate. This is debilitating, to say the least, and I'm wondering if there is anything I can do to improve my situation. I also have chronic sinusitus. I have greenish discharge but my ENT says my sinuses are clear.
Cheryl,I'm sorry that your experience with LINX has not been as satisfying as others have reported.I have had a patient in my practice with a similar experience. Here, I don't use baclofen but prefer to use Levsin for the spasms. For my patient, we re evaluated the esophagus at 3 months after sugary with a pH probe and manometry to see if we could understand what was going on. He did have high pressures in his esophagus. We considered using different medications to relieve the spasms but it began to subside about month 4 and he declined more meds since he was getting better.I think you should see your surgeon again. You may wish to ask the surgeon about reassessment. You could also ask about smooth muscle relaxing medications such as viagra, calcium channel blockers which have been used in spasms. Hopefully with some medication and time, things will settle down. If they don't, removal of the device is an option and in the studies 2-3% of the devices were removed for symptoms such as you are experienci...
Halito, My name is Katharine. I have spent the past 9 years battling GERD in Kenai, Alaska. The past 5 of those years I have had to learn to manage having severe laryngo spasms after coming down with whooping cough. I have had 4 endoscopy and many other tests, years of nexium and reglan therapy and as of now am considered a failed case and the only option I am given at this time by doctors is to have a fundoplication surgery or botox injections into my laryngo folds. My plan is to travel to Seattle if I decide to move forward with the surgery but if this may be another option for me please can you contact me. Thank you kindly
How many Linx have been removed and a Nissen done immediately during the same procedure.
Pat, I don't think we have an accurate number for that scenario. We know that at most 1 % may be removed. After removal the decision that the patient and surgeon must make are to do nothing and use PPIs, create a Nissen or create a partial wrap such as a Toupet. Each of these has been done but I don't have an exact number. That decision should be individualized to the patient and discussed with the surgeon
Katherine - Thank you for your post. I would think that LINX is a possible option. You would need to undergo evaluation to determine if you are a candidate for surgery in general and then your surgeon can discuss which surgical option - LINX or fundoplication - would be best for your situation.For patients from Alaska we usually collect up your records then have a conversation on the telephone to get an idea of what we think and then we would bring you to Seattle with a plan in place.Let us know if we can help you out. Our clinic phone # is 206-215-6800.
Hello,I have a question about LINX, for which I believe I'm scheduled for on Thursday. I have a combination of both bile and acid reflux, with a weak LES. I assume that the LINX is equally as effective at handling bile as well as acid?I also belch quite a lot, and sometimes gets bloated. How does the LINX handle this with respect to allowing reflux through when belching, and increased intragastric pressure when bloating?Thanks,Paul
Paul, congratulations on choosing the LINX device.I'm surprised that these questions were not answered for you by your surgeon.Yes, both bile and acid reflux are generally controlled. After surgery, you'll have to learn how to belch with the device. Patients tell me that it can take some time to learn and others can do it without much thought. None of our patients experience reflux with the belch. No one is sure why but I suspect that the device opens just enough to vent air but keep the fluid in the stomach.
I had Fundoplication in 2/2009 for GERD,LPR,Barrett`s,Hiatal hernea and ILD in both lungs. Now I have pulmonary fibrosis with recurrence of All the above symptoms. ANY ADVICE WILL BE APPRECIATED
If you are having recurrent symptoms of GERD and you have ILD, I suggest you see you surgeon for repeat testing to see if you are truly having reflux. You may need your fundoplication revised to address the problem. In your situation a LINX device is not advisable since you have had surgery already and to protect your lungs you need the best reflux control which is with a fundoplication.
Thank you for so diligently answering questions on this thread. It is hard to find information on Linx.I have Barrett's Esophagus (only a few cms around the sphincter), and rather severe reflux and LPR. I have been very interested in the Linx surgery, but my doctor does not recommend it. He is against any surgery for reflux, citing that symptoms reoccur so often in patients that he doesn't think it is worth the trouble.Is this accurate, or should I seek a second opinion?I am currently on 10mg of Rabeprazole (the most I can be legally prescribed in Japan) and a 3x dose of Mosapride, and it isn't helping.
Jack, My response to your physician would be that there is grade 1 evidence (highest level of medical literature) that compares PPIs against surgery and shows that surgery is more effective in general and that patients taking PPIs need to take double the dose to come close to the same result as surgery. HOWEVER, those same studies do show that over 12-15 years, the Nissen does deteriorate in terms of reflux control, but PPIs also fail to control GERD over that same time frame.When most patients do not have control of their symptoms with maximal medical treatment, surgery really is the only option. But, you need to find an experienced surgeon who does a lot of surgery since the results are dependent on volume.Now, having said that everything I mentioned has to do with Nissen fundoplication. LINX has never been compared to PPI therapy. In a situation with Barrett's, severe reflux and LPR symptoms, a Nissen fundoplication would be a best bet to control reflux.
Dear Dr. Louie, I am a long-term GERD sufferer and the Nexium is losing effectiveness. I am also approaching osteoporosis. Of the surgical solutions I have researched, I like the LINX best but am not sure about the metal used. I react with a contact dermatitis type of reaction when I wear cheap rings or earrings. (As do lots of people, I think) I'm not sure what element in the cheap jewelry is causing the reaction, so how could I be sure that I wouldn't have a negative reaction to the metal in the LINX device? Thanks for your help.
Gail, the metals in the device are iron with a titanium coating. ? Most patients who have a reaction to cheap jewelry are fine with a LINX but you might see an allergist to find out what you are allergic to.
Dear Brian,Recently, I underwent 24 hours ph impedance study and it showed that my transient les relaxation were 85 as compare to 73 normal. 45 of refluxes out of 83 came all the way up in my throat area. All these refluxes were non acid so my gastro doctor simply refused any surgery due to normal exposure of acid and ph.my les pressure is with in normal range. Endoscopy and bravo study normal with a very small hernia.My throat is constantly red and I do get symptoms with foaming in my mouth. My ENT confirmed the diagnosis of LPR. My question is if I undergo Linx, would it decrease the les relaxation of les because that is main cause of my throat symptoms.
I have been a GERD patient for the past 1 1/2 years. I can tell you that my regurgitation of acid and food is crippling me beyond belief. After every meal, I usually wait an hour, regurgitate large amounts for an hour, then wait for a few hours to be able to eat again.My surgeon in Nevada is attempting to get me the LINX procedure, but my insurance company is dragging their feet as expected. We are at the first round of appeals and expect to go through another.Is there anywhere that will accept patients for the LINX without insurance? In your opinion, is it worth it to wait or will this just cause more damage to my esophagus? I don't want to alter my anatomy like the Nissen does, though I know it is a quick fix.
Jeff, I would encourage you to be patient. Unfortunately, the insurance approval takes time but can drag out for a year in some cases. The approval rate in Washington has gotten much better and turn around times shorter but it can be a long wait.We have had patients who are just too symptomatic to wait and have undergone Nissen and they are more than pleased with the results and haven't looked back. So I always counsel patients that Nissen remains a good option when you have an experienced surgeon. Many centers like ours offer a self pay option. You might ask your surgeon if you can pay for the device and procedure yourself.
Hi. Just saw your blog, and decided to drop you a quick email. I have an odd set of situations; required a RNY gastric bypass for a muscular obstruction in my duodenum caused by my chronic intestinal psuedo-obstruction. This restored the ability to pass food and liquids, but the condition is now sending bile geysers up my esophagus and into my lungs at night, which is damaging them. My LES is flaccid. The LINX system seems better in many ways than a fundoplicaton, but it seems like anyone with prior surgery such an RNY is disqualified. Is that because there is a fear the LINX band will migrate downward, or just a matter of being conservative? In my case, it might be a lifesaving intervention. thanks.
We have only recently heard about the LINX procedure from our primary physician, we consider her one of the best around. She is sending a referral to you for my husband. He is 76 years old, has Parkinson's, and lost about 65# in the past 12 months from constant "up chucking" the last many months. Do you think he may be a candidate for the procedure?
Don, Thank you for your note. In general, you are correct in your assumptions about why no one has placed a LINX after a roux en y. There are a lot of questions that I would have about your prior surgery. It's very rare after a roux en y to have bile reflux especially if it is a standard configuration. However, there are many modifications and for the disease process you describe you may not have the usual anatomy. There are several other options to fix the problem you describe. I would need a lot more information to provide more suggestions. I suggest you discuss this with an experienced esophageal surgeon close to you or consider discussing this with me off line.
Hello Doctor. I am a 68 year old woman who has been suffering with LPR and gastroparesis for many years and am currently being treated with gabapentin, Zantac and gaviscon advance. Am I correct that I would not be a candidate for LINX ? Do you have an opinion on the STRETTA procedure? Thank you
Peggy, I look forward to meeting both of you. We'll have to get your husband evaluated to determine if he is a candidate.
Hi Brian, My name is Lance, I'm a 27 year old with GERD and lower than normal esophageal motility. 3 years ago I was diagnosed with low motility, a year ago I retook the test and was told that my motility is essentially normal. I don't have too much difficulty swallowing any longer, the only time I do have difficulty swallowing is when my heartburn flares up when my Nexium isn't controlling my heartburn. I recently found out about the LINX procedure, and I must say it's extremely intriguing for me as I am not a candidate for the nissen. Would love to know your thoughts on whether or not you think the LINX may be an alternative for me. I fully understand that the decision on whether or not the LINX would work for me is based on a new evaluation, but would like to know if you believe this would even be worthwhile for me to explore. I look forward to hearing from you, and Happy Holidays.
I have a very large hiantal hurnia that is causing me severe breathing problem s, I also have been on anti acid med's for years, I am 81 but active. My doctor had referee me to a doctor at sweedish to see if there is anything he can do for me. I have been looking at my options, I would like to ask you which do you think would be the best for me, the hills or the nissan surgery? Thank you
Diane, your situation is a bit complicated because you have gastroparesis and LPR. A lot of your potential for surgery depends on the degree of gastroparesis, whether you have any GERD symptoms along with the LPR. I wouldn't say that you are not a candidate, but I think you need to have a thorough and careful evaluation to determine if surgery will address you symptoms. Possible options are to address the gastroparesis alone or to create a Nissen fundoplication to address the LPR and gastroparesis. LINX may be helpful if your gastroparesis is very mild. Stretta is unlikely to be helpful with your symptoms.
Hi, I had the LINX fitted in 2013 and since then I developed LPR and Severe Globus. I have managed to meet with an NHS surgeon who is prepared to remove the LINX and do an anterior wrap. I was wondering if you were aware of people who have had the LINX removed and a successful wrap or Nissen in its place?
Jo, it's likely that you are seeing one of my partners‎ - Dr. Aye or Dr. Farivar since we do almost all of the hiatal hernia repairs at Swedish At 81, I would tell you there isn't any difference between the repairs. They will both improve your quality of life. We published our experience 5 years ago when we operated on large hernias in patients who were over 70 and confirmed the improvement in quality of life and low risk to surgery. This year we looked at those patients who are more than 5 years ‎after surgery and found that the quality of life remains the same.
Lance, I think you'd be a candidate for both a Nissen or a LINX as long as you don't have a larger hiatal hernia. The motility test is not perfect and so it can be abnormal and when repeated ‎normal. As you mention, the surgeon will want to review all of the data and may wish to update some of it. Good luck
Shirley, Thank you for your post. I'm sorry that your outcome with LINX wasn't better. The symptoms you developed are a bit unusual in my experience. I've not see that after a LINX. It is possible to have it removed and a traditional antireflux surgery performed such as a Nissen, Toupet or other partial fundoplication.
Dr. Louie, I am a 64 year old male in generally good health with a long history of GERD. Prior to starting on PPI's about 20-25 years ago I had severe heartburn, but it was an episode of dysphagia that brought me to the doctor. He diagnosed me with esophagitis, but it cleared up after the start of the PPI treatment as was confirmed by subsequent endoscopies. I have two concerns about continuing on PPI's - 1) my symptoms are manageable, but by no means completely resolved as I often need to supplement my daily PPI with antacids and suffer from an easily irritated throat, and 2) I worry about the effect PPI's have on mineral absorption and some of the recent research showing links to kidney damage. Also, since my GERD is not fully controlled, I worry about long term damage to my esophagus, i.e. Barrett's or esophogeal cancer. My gastroenterologist does not see these concerns as meriting surgical intervention. He has recommended that I double up on the PPI during those periods when the GERD seems worse (it does tend to flare up for a week or two and then calm down a bit). Given that I am for the most part responding well to PPI treatment, am I risking too much for too little by undergoing a LINX procedure? Am I over valuing the risks of continuing on the PPI regimen?
Steve, What you are describing is very common. As many as 40-50% of patients do not get complete relief from PPI’s. The PPI’s do a very good job of reducing acid in the stomach and thus less in the esophagus, but studies show that the number of reflux episodes are unchanged by PPIs. All they do is shift the acid content. Many gastroenterologists see surgery as a last resort and for patients who fail therapy. In 2015, I think this idea is outdated. The research trials comparing surgery to PPIs show that the outcomes are the same except that PPIs requires double the dose to achieve the same results as surgery – meaning a Nissen. However, the Nissen gets a bad rap because of the potential side effects. But, as you are aware PPI’s are not without side effect either. A recent patient of mine who underwent a Nissen very eloquent outlined his improvement after surgery – it included, not only improvement in lifestyle since he could sleep flat and not elevated, but also improved kidney function on his lab tests and he simply felt better off the medication. The data is also very clear that twice a day PPI’s doesn’t get you double the improvement. It seems to me that you should seek a surgical opinion to discuss your options. It sounds like you’d be a good candidate for surgery whether it be LINX or Nissen. An experienced esophageal surgeon should be able to help you sort out the concerns that you have. I think patients who are incompletely controlled on PPIs are the most grateful for surgery but also are the first to say, “I wished I’d done that sooner”.
I'm interested in a consultation regarding the LINX surgery. Do I need a referral from my ND or MD (I have both)? Is it true your BMI needs to be lower than 35?
I'm a candidate for the LINX procedure. I have mild reflux symptoms but I also have Barrett's. Friends of mine in Germany have told me about a new surgery/procedure in Europe for GERD called EndoStim. Can anyone tell me where clinical trials are being held in the US and if they know anything about efficacy results in clinical trials in Europe? Thank you for this discussion; great information and insight.
Speaking of the Tesla numbers on an MRI machine...how does that equate to a PA System for a musical preformance? The BL numbers are 15.27 on some of the speakers in the floor cabinets. Musicians are surounded by these in stage. Will this type of magnet effect the Linx Braclet? Reason is this LES weakness is common amongst professional vocalists. Does this limit their ability to be in close contact with the equipment that they work with?
I have GERD for 20 years. I am taking Dexilant , zantac, and pepsid every day but no help. Always have the burning feeling. I would like to have the Linx system, how do I find an experience surgeon for it? Live in NJ
Deb - It is preferable to have a referral from your primary care doctor so we have a way to collect records and communicate. BMI is only one criteria that is used in determining if LINX will be of value to you ‎. There are many others as well. We are currently researching the impact of BMI and it's influence on the outcomes.
Ted, Endostim appears to be an intriguing option. Early trials show its as good as LINX. Unfortunately the US clinical trial is on hold last we heard from the organizers. A number of US sites hope to participate including Swedish. No word on when it will be available.
Hi Kim, Surgeons who are implanting LINX can be found on the website Linxforlife.com Unfortunately, there are no surgeons in New Jersey, but there are surgeons in Pennsylvania and New York.
Ali, I am not sure what the units on the speakers you are referring to mean. Its very unlikely that being around speakers on stage will impact the device. The 1.5 Tesla machines are housed in special rooms. I'll reach out to the company engineers and see what their take on this is
Just wondering when or if Australia ever plans to allow the Linx device? Are the surgeons waiting for more long term studies on the patients who received the Linx as they usually do here ? Only been on ppi since December for sudden gerd after a sulfur antibiotic and already so sick of them, the side effects and the fact that they don't really take the burn away for the entire day. The ppi has also caused more problems with my digestion than I could ever have imagined.
Hello Dr. Louie, you did my surgery to implant the LINX device in July 2014. It has been a huge success. No more PPI'S or (major symptoms). I may have to have an orthopedic MRI scan in the future. Can I do so safely with the LINX implant? Thank you.
This link http://www.refluxmd.com/linx-device-safe-mri-imaging/ says that some LINX implants are rated safe for MRIs up to to 3T. Do you agree? Are those implants effective for LPR?
Hello - I know at least a couple Swedish Hospital employees have had the Linx procedure. Do you know if Premera Blue Cross/Blue Shield (the current Swedish Employee health insurer) covered it? Thank you...
Susan, please contact Dr. Louie's office, 206-215-6800, to discuss this. They'll need to look up your device to ensure they have the all the details needed to provide appropriate guidance.
Charley, There are two versions of the LINX. The original version was able to tolerate an MRI to 0.7 Tesla. The current version is fine with a MRI that has a 1.5 Tesla magnet. Anything higher is not recommended. You'll need to check with the center nearest to you as to which implants they have. LINX appears to generally be effective with LPR symptoms but there are no studies dedicated to just this group.
I have suffered with a chronic cough for most of my adult life. The various docs I saw came to the same conclusion... that it resulted from reflux. Even though I used PPIs, along with other meds, for years the cough never subsided and my quality of life has been greatly impacted. I had the LINX implanted a year ago as a last resort. For a few months after the procedure the cough seemed to abate but gradually increased to being as severe as before the LINX. I have been having swallowing problems and a UGI a few weeks ago revealed a change in my esophagus from a year ago resulting in small irregular spasms. An ENT doc and an allergist I recently visited both think the coughing is resulting from reflux. I thought the LINX device kept anything from coming back out of stomach? Could the LINX allow acid to still reflux into my esophagus resulting in the cough? Did I have this procedure for nothing?
Hello - At present, my insurer doesn't cover LINX. Do you know what some patients are doing to get their insurance provider to cover the cost of the surgery?
Stefanie, There are several options. Torax has engaged a company called Pria Healthcare to help the patients get approval. Even if your insurer denies the initial pre authorization, you can appeal and after several appeals will have to get an independent review from someone who doesn't work for the insurance company. If they feel LINX is appropriate the insurer is bound to provide the service. This can take anywhere from 3-12 months in our experience. You cannot do this on your own, you need to see the surgeon and work through the process. The other option is to participate in the CALIBRE research trial that is open at 10-15 LINX centers across the country. In this trial, you are randomly assigned to get the LINX or to remain on PPIs. After 6 months if you are still symptomatic, you can then get your LINX. There are requirements to get into the trial and again you'd need to be assessed by one of the LINX surgeons. Other than these options, most centers also offer a self pay option.
I was told I have a motility disorder after having 2 motility tests and a ph test, I have weak peristotic pressure and weak les pressure, can I still get Linx surgery with weak movement in my esophagus? I heard Linx has not been studied in patients with motility disorders. I hope to have something done other than a Nissan surgery.
I was diagnosed with GERD (bile) and decided to do the Linx surgery. Currently I don't experience any success as my reflux is still very active. My question would be if there are any figures are available until when I can accept that the surgery was a success or not? Or the other way around if there's no improvement directly after the surgery until when it can/should happen?
Jo

It is true that many surgeons are reluctant to operate on patients with weak or poor motility regardless whether it is a LINX or Nissen

However, it doesn't mean that we cannot place a LINX. ‎At Swedish, we usually put patients who have poor motility through an extensive evaluation to determine if surgery will work .

We have placed a LINX in a handful of patients with poor motility. Most have no trouble but a couple still feels like food sticks and have to eat slowly and drink water with meals. However, if you ask them they would have do it again and have no regrets since their GERD is controlled.

Definitely an individual choice. You should meet a LINX surgeon to discuss.
Tom

I'm sorry to hear that your LINX doesn't appear to be working, you don't mention ‎how long you've had it.

There is no defined time frame to determine if it is working. Most patients experience significant relief right after surgery.

However, not all burning after surgery is reflux. If you have unresolved symptoms I think you should speak to your surgeon about undergoing repeat endoscopy and pH testing to confirm if reflux is present.

We know that 15% of patients will have ongoing symptoms that will require them to take PPIS. This is usually due to the 2 way valve effect of LINX.

Since you have bile reflux, PPIs are not likely going to be effective. You may need to contemplate removal of the device and creation of a Nissen if you truly have reflux - bile or acid.
I had Nissen surgery in 2008 for control of GERD. I was a good candidate in all the work ups and chose this remedy vs meds. I had a "rather large" (as the surgeon put it) hernia repair also. I had good results until one year later I required an emergency revision due to my stomach twisting and cutting off flow in my stomach completely. The revised wrap now is called a "Doore". I'm sure I spelled that wrong. After that my GI doc recommended additional low level PPI therapy which I have been on since. A few months ago GERD and heartburn returned in earnest. I'm now seeing a Thorasic surgeon who is currently working me up with tests. He has suggested a possible course of action might be to for him to put my anatomy "back to normal" and place a Linx. From what I'm reading, I'm a double contraindication with a hernia (now know it's 5-7cm) and two previous fundlipication surgeries. I will be seeing the surgeon again soon after all these tests are completed.
Thank you so much for taking our questions. I am trying to decide between a LINX and a Nissen, since PPIs have only provided partial relief and my test scores show objective evidence of substantial non-acidic reflux. I'm only 24 years old and am otherwise in very good health, so my main consideration has to do with the long-term effectiveness of each option. I guess I have two questions: 1.) do you think the LINX is a good idea for someone in their twenties, given the device is meant to last a lifetime? is the risk of device migration or erosion likely to increase in the very long term? and 2.) Is there any substantial impediment to putting a LINX in after a fundoplication, or has it just not yet been studied? I guess I'm wondering about getting a fundoplication now and then, 10-15 years down the line, if the fundoplication loses effectiveness, trying to do a LINX. Thank you very much.
Thank you for all of the information you presented. I was particularly interested in Laura's question from 2014 about her 3yo. My 2 year (2-1/4) was just recommended to have a Nissen due to her severe GERD and "significantly abnormal" pH impedance test. She's been on PPIs as well as a baclofen and bethanochol for 2 years. She's an otherwise heathy girl born full term without any complications. I'm finding very little support from other parents whose children have had the procedure that don't also have a gtube and other major healthy issues such as CP or CF. Someone pointed me to LINX and I was curious if since you answered the question about age 2 years ago if any new information or studies had come out. I also was curious if you could share who the Pediatric GI was that presented as I am seeking a 2nd opinion and a solution or procedure that doesn't change her anatomy. Thank you!
Dr.Louie, I saw your blog, but was not able to post my question on it. ( The blog site said my email address Dr. Louie) I hope you can help me. I have had heartburn off and on for over 30 years, gradually worsening. At first it was only during pregnancies, then it returned a few years later and began getting worse and worse. I have also felt food refluxing up my throat during that entire time, but didn't realize what it was for quite a while. When OTC heartburn meds and bland diet no longer worked for the heartburn pain, I saw a GI doctor who started me on PPIs and ran a few tests. I have GERD and a small hiatal hernia. No Barrett's as of a scope from 8-10 years ago. My symptoms have been well controlled on them for about 10 years. My problem is that I've just found out my kidney function is decreasing (stage 3 CKD with a GFR of 46), so I have stopped taking the PPIs and have been put on sucralfate & famotidine, with partial relief of symptoms. I am interested to see if the LINX would work for me. Thank you, Ellen
I had the lynx procedure at Swedish about 2 months ago. I lost about 20 lbs since I received it and my appetite is nil. Finally the food sticking and esophageal vomiting stopped but I am still have intermittent abdominal pain which can be so bad that I get a frontal headache until the abdominal pain resolves. Are all these symptoms typical? I had an extensive GI work up before the surgery that was negative except for the Bravo Study and xray reflux study
Ellen -

It sounds as though you would benefit from a LINX. However, you need to be evaluated to determine if this is the best approach. If you are in the Seattle area, please contact Ricky in my office at 206-215-6800 for an appointment to discuss.

If you are not local, please let us know.
Holley:

It is always challenging to make these decisions in children. Unfortunately, nothing has changed with regard to LINX and children. It is not recommended in anyone under 18 years of age because of the continued growth children undergo.

I'm not sure which pediatric GI you are referring to but I think it is Dr. Gretchen Purcell Jackson.

Sorry, I can't be of more help than that.
Marty,

In general it is true that you have two major reasons not to have a LINX placed - a large hernia and two prior Nissen's. Having said that I do know that several surgeons have tried to place a LINX after a previous repair. We also have open a study looking at larger hernias and LINX placement. These are really early days for this indication for LINX. The challenge is no one knows what is going to happen when the LINX is placed.

My concern for you is that you have had two large hiatal hernias and simply pulling the hernia down and placing a LINX may still not fix your problem and the LINX will ultimately end up in your chest. Might be worth a second opinion from another LINX surgeon in your area as well.
Richard:

There is considerable discussion when deciding between a LINX and a Nissen. From what you describe, I'd favor a LINX for you. It is much easier to remove the LINX and create a Nissen down the road if the LINX doesn't work for you. It is much hard to place a LINX after a fundoplication and at the moment, only a handful have even been attempted.

We do not know what the long term risk of erosion or migration will be. We do know that most erosions (13 in total) have usually occurred within the first two years after placement Migration is another independent issue which is thought to occur in less than 1% of patients.
Ed -

Your response to LINX surgery is not typical. It is common to have some difficulty swallowing during the recovery period but usually by 2-3 months after surgery the swallowing settles down. It's important to eat small amounts frequently and at least something once per hour.

I have not had a patient tell me their appetite was poor. The abdominal pain and headache are also unique symptoms. I suggest that you get an appointment with your surgeon to evaluate these issues.
Hello I have been diagnosed with bile reflux,not any acid reflux present. Already some signs of metaplasia on egd, so the bile was bad... Furthermore the manometry showed Increased les pressure and Good persistalsis. My questions: do you have success stories for linx used only for bile reflux? I could not find this info... If I have increased les pressure no achalasia present, can I still benefit from linx? It was always suggested the weak les pressure... Thank you
I've been diagnosed with LPR and due to a patulous LES it is particularly bad at night. We've discussed Stretta and fundoplication so far but I am concerned with the side effects of the fundo. If I try the Stretta, could the Linx also be used if that isn't enough or in conjunction with the Stretta?
Anca, In general, if your symptoms are caused by either acid or bile, a LINX should control your symptoms.
Dear Dr. Louie, great blog. Thanks, I have read much of it. I have had GERD 10 years now. Last endoscopy in 2013 showed grade III and 2cm hernia. I am arranging a stay at a clinic in Gemany to test if a Linx device is a good fit. I read back in the blog somebody taking breaks from PPI and using for a few weeks h-2-receptors and then going back to PPI. Point was to prevent shortage of iron and reduce chance of bone fracture. Does this make sense? If yes, I would consider the same. My worst symptom is chest pain left side which I cannot differentiate from heart trouble. Hence have been to clinic twice in the last year suspecting heart trouble. On both accounts, heart checked out fine. This symptom started about a year ago. Could it be he hernia? Perhaps it has grown in size since 2013. Eager to hear your thoughts.
Chris, Yes, the LINX could be applied if the Stretta didn’t provide the response that you desire. I would wait until you are well healed from the Stretta to see if a LINX is required.

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