A new treatment for GERD: The LINX - Reflux Management System

A new treatment for GERD: The LINX - Reflux Management System

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

Acid reflux, heartburn and indigestion are all forms of gastroesophageal reflux disease or GERD. This common problem afflicts over 20 million people in the United States on a daily basis. As a surgeon who treats patients with some of the most severe symptoms of GERD, I was recently struck by the fact that very little has changed in the treatment of the debilitating problem over the last several decades.

Medications have always been the primary treatment for patients with GERD. TUMS, Rolaids, alka seltzer are easy over the counter remedies that could provide instant but only short-term relief. More potent medications called H2 receptor antagonists (commonly known as Zantac, Pepcid AC) brought about longer lasting relief. These medications were great but many patients experienced a relapse of symptoms.

The newest medications for GERD are called proton pump inhibitors or PPIs (commonly know as Prilosec, Nexium, Aciphex, Protonix and Prevacid) are over 20 years old. If you seen an ad for one of these medications, they were touted as a 24 hr cure for GERD. But as many patients have come to experience, they don’t control all of the symptoms, with as few as 50% of patients getting complete 24-hour relief from symptoms.

Most patients with GERD are not even aware that surgery is an effective option for treating GERD. The 1% of GERD patients who have undergone antireflux surgery say they are tremendously grateful that their GERD symptoms controlled without having to take another pill. But, the most common procedure, Nissen fundoplication, which controls acid reflux equally if not better then twice a day Prilosec, can have side effects patients must tolerate in exchange for no symptoms of GERD.

For most patients with GERD, surgery may seem overly drastic unless you have severe symptoms. And, for many others, symptoms are not completely controlled with pills or you may have to restrict your diet considerably in addition to taking the pills to lessen the symptoms. Others will sleep sitting up right in the chair or won’t sleep at all because they are constantly having reflux.

There has been no new or revolutionary therapy for GERD in over 25 years LINX - Reflux Management Systemwhen PPI’s were introduced. This all changed in March 2012 when a new device call the LINX was approved after 4 years of evaluation and testing by the FDA.

This device is a series of magnets in the form of ring and implanted around the bottom of the esophagus by a short, 40 minute laparoscopic procedure.

The ring of magnets is designed to stay closed and prevent the reflux valve from opening thereby preventing acid from the stomach move up into the esophagus. The magnets will open up the ring when people are eating to let food in much like a person’s native reflux valve. The LINX will also open to let people belch and if necessary, vomit, which is one of the side effects of the Nissen fundoplication people tolerate.

Of all the GERD treatments I have seen, I am truly excited about the LINX and hope to have it available at Swedish in the coming months. It is a simple procedure that controls GERD in over 90% of patients and allows over 80% of patients to stop their GERD medicine and enjoy a regular diet.

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Click here to read a second blog posts with more updates from January 2014 on LINX.

Ed. note: To discuss whether you would be a candidate for LINX, you can speak with your primary care provider, or call our clinic in the Greater Seattle area at (206) 215-6800 to make an appointment. If you are not in the Greater Seattle area, please click here to find a LINX center near you

Comments
Brian E. Louie, MD
Beach,

I haven't seen this occur in our practice but I would think that it is possible. There are going to be many factors that influence the decision such as how much reflux, symptoms and likelihood that simple repair will address those symptoms. Where the linx is situated is also important

The hernias with linx are small enough that I would not use a mesh.
10/6/2014 10:33:28 AM
Brian E. Louie, MD
Sid, in that situation, LINX is suitable for treatment. You would need to undergo complete evaluation.

There have been 4 erosion out of 2300 cases. So the rate is very small but not zero.
10/6/2014 10:13:53 AM
Sid
Hello,

Small hiatel hernia has been diagnosed. On nexium since a year. No heart burn but throat tightness and constant food burp. Unable to eat properly as food comes out on every occasion.

Is linx suitable? What are the chances of erosion of device to esophagus.
10/3/2014 5:05:33 PM
Beach
If you have a Linx and later a Hiatal hernia is discovered (example one year after implant), can this hernia be repaired without disrupting the scar tissue built up around the Linx. How about the use of biological mesh. Thank you Doctor very much.
9/30/2014 5:12:02 PM
Brian E. Louie, MD
Pat, I'm told that a 0.7 tesla MRI can be used to diagnose most things. It may be as a way to determine if the LINX needs to come out for a significant issue


Hopefully, the FDA will rule on the use of a 1.5 Tesla‎ with the LINX very soon . This will alleviate most concerns
9/22/2014 10:44:16 AM
Pat
0.7 Tesla MRI. Doctor Louie, you had mentioned previously that you were going to check what this would cover. Have you an update on your comment. Also, have any of your Linx patients had an MRI post -implant and any problems. Might I ask what kind of MRI they had and what area of the body. Thank you.
9/19/2014 5:51:59 PM
Brian E. Louie, MD
Howard,

It's unlikely that your hernia is causing the bloating ‎. That is possible if you have a larger hernia bit I'm guessing your hernia is small as is more common in LPR patients.

The bloating more commonly has to do with the amount of air you are swallowing because of the reflux. Much of that is subconsciously.

Usually control of the reflux relieves the issue. The decision to repair your hernias depend on its size. You should discuss that with a LINX surgeon after evaluation
9/15/2014 5:21:17 PM
Howard
Hi, I have a small hiatal hernia and LPR. The LPR causes the usual problems, but I have constant bloating which I think is from the hernia. I have struggled to to find an exact connection between a HH and bloating as it can be caused by many things, though the hernia and my bloating symptoms came on together after a gym session. If I had the Linx, as well as curing my LPR, would stitching the hernia back in place be the answer to curing my bloating? Many thanks.
9/12/2014 9:23:19 AM
Brian E. Louie, MD
Lat, most patients have either developed a new symptom that wasn't present before or a symptom never went away or got worse. That usually prompts evaluation.

It is also why in this early period why ongoing follow up with the surgeon is crucial
9/8/2014 9:10:38 AM
Lat
Thank you. If you have no one symptom of erosion, then how would one even know to suspect erosion. What kind of changes would develop or appear to make one think of it. Thanks Dr. Louie.
9/4/2014 7:40:43 PM
Brian E. Louie, MD
Pat,

There is no one symptom that indicates an erosion. Most patients experienced a change in symptom or developed a new symptom.

There have been no titanium allergies that I know of.
9/3/2014 10:00:07 AM
Pat
Doctor Louie, thank you for your recent comments about erosions with a total of four. What were the symptoms that indicated erosions? Have not seen them mentioned. Any allergies to titanium show up. Thank you for your comments.
9/2/2014 7:23:45 PM
Brian E. Louie, MD
Ray, congratulations on receiving a LINX. I hope it's doing what ‎it is supposed to

There are 4 known erosion in the world and only one in the USA. The rate is very small and all the patients had some symptom prior to discovery. We also know they occurred in the first 2 years after LINX

I would encourage you not to worry but keep your scheduled follow up with your surgeon
9/2/2014 2:54:23 PM
Ray
Hi Dr Louie

I had asked about erosion in the past and you mentioned of 1 case that you heard of from linx. Have you heard of any other cases of erosion from linx? I had linx implant about 15 months ago and haven't had a follow up EGD yet but plan to have one soon. I have had no symptoms of erosion but wanted to ask as this is my main concern for the long term.
9/2/2014 5:26:45 AM
Brian E. Louie, MD
Pras, you should talk to your GI doctor. From what you have posted it seems like you have a slowly emptying stomach from the viral illness. This is likely giving you the symptoms you are experiencing. The pH test shows you have normal scores.

I would wait to see what happens. You might discuss with your GI doctor a trial of metoclopramide to see if that makes your symptoms better.

I don't think surgery is the right choice at the moment.
8/26/2014 11:37:33 AM
Pras
Hi Dr. Louie,

Thanks a lot for maintaining this helpful blog.

Following details about me:

- Male, mid 30s, lean (low body fat), have IBS, generally good eating habits. No other disease.
- Had 4 episodes of viral/flu. Had been given antibiotics - 4 different courses over 4 months (2 trials for IBS and thereafter 2 for cold/flu/viral).
- Have mild heartburn sensation for past 5-6 months (first time ever). Lost 10+ lbs ( from 150 to 138) over 2-3 months. Blood tests are all normal.
- Was on PPI for 2 months (40mg Omeprazole X 2).
- Symptoms returned (somewhat different) after tapering off PPIs. Mild but weekly atleast 2-3 times.

- Visual Endoscopy normal. Biopsy shows "Mild reactive changes consistent with reflux esophagitis". No hiatal hernia. Mild non-reactive stomach Erythema.

- Gastric emptying test showed borderline gastric emptying issues.

- High Resolution Manometry completely normal. Resting LES 13.4. No hiatal hernia.

- 24 Hr PH Impedence test shows (off PPIs for 1 month before test).
- 79 refluxes total.
- Acid refluxes well within normal range.
- DeeMester score of 9.4
- 0 reflux while recumbent.
- Modest symptom co-relation.


Given the above-should I consider LINX operation?
If not - what treatment options are available? Is there a risk of esophageal function impairment if no treatment is done? I absolutely don't want to undergo Nissen Fundoplication procedure ever.

Regards,
Pras
8/19/2014 7:28:43 PM
Brian E. Louie, MD
Marsha,

I'm not entirely clear about the sequence of events you are describing. I think what you are telling me is that you still have symptoms despite taking Aciphex three times per day. Those symptoms may be related to incomplete control of acid, symptoms from non-acid reflux or totally unrelated. You don't mention when your last esophageal studies were completed. It also sounds like regurgitation (movement of stomach contents backwards up your esophagus) is what you are experiencing which keeps you sleeping upright at night.

I would suggest you have a repeat evaluation with an experienced esophaeal surgeon. If you are still in southern California you could see Dr. Horan at UCSD or Dr. Lipham at Hoag in Newport Beach.
8/19/2014 10:58:40 AM
Brian E. Louie, MD
Uolevi,

The complexity of any surgery is dependent on many factors including factors such as the patient's disease and the patient's anatomy. In relative terms, the LINX procedure was designed to be simple and reproducible compared to Nissen fundoplication. Having said that, surgeon experience with this procedure and any other procedure is usually related to volume - ie: the more you do, the better you are. This may not completely apply to implantation of the LINX device. I have learned since we started implanting these devices that they are generally straight forward to place in most patients but in can be difficult in some patients and it's important that the surgeon have experience with esophageal surgery. Fortunately, most LINX centers are experienced at esophageal surgery.
8/19/2014 10:57:57 AM
Uolevi Saesmaa
Dear dr. Louie! How complex is the Linx surgery in terms of the experience of the surgeon? Is it more likely that the surgery succeed if the surgeon has a large track record of Linx implant, or is the operation "easy"?
8/17/2014 11:50:04 AM
Marsha in Santee
I have a hereditary sliding hiatal hernia. My last esophageal motility test was normal. Earlier pH test showed reflux. Originally, there was slight inflammation and friability of tissue at the LES. Now, on Aciphex 3 X per day and a "dog dish" diet of the same vegetables, nuts, and one flavor of wine 3 - 5 nites a week (milk in the AM), I am usually pain free. But I cannot ingest vitamins, most oral edications, most foods, most beverages, and sleep sitting up on "dinner nights." It appears that there are hypersensitive nerve endings at the LES from 3 years of the cheif of gastroenterology and another gastroenterologist at Scripps Clinic in La Jolla failing to diagnose GERD for 3 years (19 years ago; in other words, I now appear to have neuropathic allodynia, or pain in response to normal sensations. But, I still wonder if correcting the sliding haital hernai and the LINX might dramatically improve my situation and allow me to lay down to sleep even on dinner nights! PS. I am a molecular biologist and have dedicated my life to trying to improve the diagnosis and medical treatment of others. I wish someone could truly help me. Thank you.
8/15/2014 11:41:06 AM
Brian E. Louie, MD
Michael,

It's very unlikely that the hernia and the weak LES are the cause of the delayed gastric emptying. Delayed emptying is difficult to sort out and can be caused by diabetes, viruses and in may cases we just don't know.

There is no data that a LINX will restore gastric emptying. But, there is pretty good data that a Nissen will restore gastric emptying. I will suggest to patients who are symptomatic from delayed gastric emptying and GERD toward a Nissen since it will treat both symptoms at the same time.

You could try a LINX if you have reflux, but there would be no way to know if your delayed emptying would improve.
7/28/2014 10:00:39 AM
michael
Dear Dr. Louie,

Can a small hiatal hernia and very low LES pressures in itself cause delayed gastric emptying? Or would the presence of delayed gastric emptying usually be due to another reason?


my question is, do you think repairing a hiatal hernia with the linx could possibly increase the rate of emptying?
7/26/2014 9:30:46 AM
Brian E. Louie, MD
Nancy, yes it is possible that you may be a LINX candidate. You will need to complete the pH test and manometry to determine if you fully qualify.

Its hard to say if the diarrhea was related to stopping the Prilosec, but I suppose its possible.
7/22/2014 10:10:12 AM
Nancy in Maine
My valve tore in October of 1999 (motility studies and endoscopy confirm 'floppy' motion only). I was on Aciphex bid x 6 years and then on Prilosec 40 mg bid since. I have had breakthrough GERD, mostly mid sternal chest pain radiating to the back for about 6 months now. Currently having BRAVO study.
1. I had 24/7 vicious diarrhea starting 4 days after stopping Prilosec lasting x 4 days ? could this be related.
2. My GERD symptoms are much less intense and not as often off the Prilosec.
3. Is it possible I may be a LINK candidate?
(Ps. my dad had Barrett's esophagitis and underwent an esophagectomy so I am trying to be very diligent with my care to avoid this.)
7/21/2014 8:00:33 AM
Brian E. Louie, MD
Jayme, There are very few institutions that offer Stretta since it was taken off the market several years ago. However, it is making a come back and my partner Dr. Ralph Aye has the most experience in Seattle. Dr. Aye is hoping to offer Stretta at Swedish very soon. I suggest you call our office at 206-215-6800 and make an appointment to discuss this with Dr. Aye and see if your father would even be a candidate for this procedure.
7/14/2014 8:44:25 AM
Jayme
My dad has GERD and a hayatal hernia and has trouble swallowing and is constantly clearing his throat. I found your name online and discovered this blog. We are in Seattle area and looking for a Dr. Who might do the stretta procedure? Do you do this? Thank you.
7/7/2014 10:16:21 PM
Brian E. Louie, MD
David,

There are quite of few patients who experience respiratory or breathing symptoms associated with GERD. In my experience, patients feel improved in two different time frames. The patients who experience breathing probelms because reflux is getting immediately into their airway improve as soon as the operation is completed. Some patients who have more inflammation in the lung or more damage take longer to improve because the body needs to heal those lungs.

Both LINX and Nissen will accomplish the same improvement although, Nissen theorectially is superior because it can reduce the reflux events signficantly below what even normal people who do not have reflux experience.

Per your post, there are several possibilities. One, you may fit into that second category of patient. Two, the breathing is unrelated to GERD/LPR, Three, you may need more time for the LINX to mature with healing. Last, you may be super sensitive to any reflux and even the physiologic amount LINX allows for is too much.

Talk to your doctor – he may have you wait for a while longer and then retest your pH to see what is happening.
6/30/2014 1:49:10 PM
Brian E. Louie, MD
Kathy,

That's a great question to which I don't have an answer. In theory it could work but remember the patients normal sphincter is removed during esophagectomy. In addition, there is not alot of room to place a LINX in the region where we would need to place it.
6/30/2014 9:08:31 AM
Brian E. Louie, MD
Pat, I'm not sure what you mean by a "loose PEL". I assume you are referring to the phrenoesophageal ligament. My guess is that they identified a small hiatal hernia on you barium swallow. there is no way to see the phrenoesophageal membrane on that test.

The LINX is placed at the level of the phrenoesophageal membrane and yes, it helps reflux. You can read through the blog for the various discussions we've been having.
6/30/2014 9:06:17 AM
David
Hello Doc,

I was just wondering how many patients you have had so experienced breathing problems from reflux, if Linx or Funds helped them, and if so how long after surgery did it take for the patients to see improvement in their breathing. I had the linx procedure two months ago and though it has helped my other lpr symptoms the breathing is not much better yet. I am wondering if it just needs more time.
6/24/2014 4:22:19 PM
Pat
I have a loose PEL found on barium test. Does the Linx surround the PEL and help reflux?
6/24/2014 1:19:29 PM
Kathy
Dr. Louie,

Would the Linx work to reduce Gerd following total esophagectomy? I had an esophagectomy 6 years ago and while I sleep in an elevated bed and take medication, night time reflux occurs frequently. I had a gastric pull-up so I don't have an LES for the device to augment.

Thanks,
Kathy
6/21/2014 12:30:59 PM
Brian E. Louie, MD
Manny, that is a tough set of questions

Take the cholecystectomy out of the scenario since it is remote and no one knows the answer.

It's possible bile in your stomach is causing your symptoms. There are several possible explanations. First, you may be having bile reflux into the esophagus and are swallowing a lot of air. Second your stomach may be emptying slowly which is why bile is present. Third, there is no obvious explanation.

The question for your GI is what does he/she think is the reason for your symptoms. Bile gastritis or bile reflux into the esophagus or both. Treatment is very different
6/16/2014 10:14:56 AM
Brian E. Louie, MD
Yes, you may be a candidate for LINX. ‎ I think a discussion with one of the LINX surgeons would be advisable.

I would want to repeat your pH test with you off PPIs. This would confirm ‎the fact that you also have acid reflux driving your LPR.

I have been having discussions with my patients‎ who have symptoms like yours. When patients have heartburn symptoms with these symptoms it is often easier to make a decision. Since we know that symptom will get better. With pure throat symptoms it is often difficult to predict whether all of your symptoms will get better.

One of the recent patients who has a linx was telling me that all of her symptoms got better but her sore throat wasn't completely better. We don't know if that's because she has some reflux or not. We we talking about how the LINX is physiologic which means some reflux must occur whereas a Nissen will reduce the reflux events further. Could she have better control with a Nissen? Maybe.

I think a lot is still being learned especially with LPR.
6/16/2014 10:14:15 AM
Abdul rehman
Hi dr Louie,
I am Abdul from USA. I have lot of burning in my throat area with persistent sore during the last six months. My ent confirmed it is lpr that is causing your larynx and pharynx to keep inflamed all the time. In endoscopy, mild gastritis, in 24 hour ph monitoring, mostly were non acid refluxes as I was on ppi at that time. Only abnormality is my les valve opened 83 times in 24 hours instead of normal reading of 73. Again beside taking nexium double dose, I feel bubbly white mucus in my throat with acid taste that is not even going away with Flonase or nasal allergy sprays. Could I be suitable candidate for linx in this scenario.
6/12/2014 8:38:35 PM
Brian E. Louie, MD
Bailey,

There are multiple answers to each of your questions. LPR in very simplistic terms is the development of symptoms at the larynx and pharynx caused reflux of material from the stomach. These include hoarseness, a lump in the throat, throat clearing, and can include coughing. The LES can be normal or abnormal. A hiatal hernia may be present or may not. The tightness of the LES has nothing to do with LPR. It's unlikely PPIs will make it worse or better. Bile is unchanged by PPIs. I believe that it has to do with the sensitivity of the tissues in the pharynx/throat to refluxed material be it acid or bile. These tissues are not used to being exposed to reflux and this irritates the tissue provoking symptoms.

Control of GERD usually will cause the symptoms to abate but this degree of control requires surgery.
6/12/2014 5:31:39 PM
manny
Dr. Louie,

I had a cholecystectomy 4 years ago and I have recently developed continual fatigue/bloating over the past 6 months. I had an endoscopy that showed a small hiatal hernia, but my GI said my stomach had a lot of bile reflux/gastritis as well. Is it possible that the hiatal hernia and bile reflux is causing all my symptoms?

Do patients normally develop bile reflux symptoms years after cholecystectomy?
6/12/2014 2:47:20 PM
Bailey
Dear Dr. Louie,

I know lots of people have been asking about LPR and LINX. My question is, theoretically, what is the cause of LPR exactly and how would the LINX help to cure it? Is it always to do with a malfunctioning LES? Could it be that an LES is too tight vs too loose and spasms? Also, is it ever possible that PPis could actually make LPR worse if it's pepsin or bile that's coming up and not just acid?

Thank you very much!

Sincerely,

Bailey
6/5/2014 12:59:58 AM
Brian E. Louie, MD
Pascal,

In general, if your symptoms are due to weakly acidic reflux (your so called "light" reflux) then yes, you would be a candidate. But, it is difficult to prove that your symptoms are related and this will make most surgeons hesitant to offer you surgery if we can't be certain you will be helped. While cough can be attributed to GERD, loss of appetite is not commonly associated with GERD.

You should see an experienced esophageal surgeon to have your studies reviewed to determine your candidacy for surgery in general.
5/21/2014 10:14:49 AM
Brian E. Louie, MD
Steve,

The decision to offer surgery to control reflux is based on many factors. Three of those factors tend to predict a better outcome from surgery: classic symptoms of heartburn or regurgitation, improvement with PPIs and a pH test showing elevated acid levels. Previous research has shown that the LES whether defective or normal has minimal bearing on the outcomes of surgery. In LINX surgery, having a normal sphincter to augment may be better.

I would not exclude you from LINX placement simply based on that finding alone.
5/19/2014 1:47:12 PM
Brian E. Louie, MD
Shane,

Sorry for the delayed reply. Your post was buried in a number of them.

As you will have noted in the other blog posts with this same question, there is no data or experience to say that this will work. We have avoided doing this because of the degree of dissection needed to take apart a previous repair and repairing the hernia again. The principle has always been that the patients native structures have to be in place for the LINX to augment the sphincter. For now, this is not indicated, but it may be part of a clinical trial in the future so we can determine if it works and is safe in the situation. As more experience is accumulated, this is one area that will need to be researched further.
5/19/2014 1:46:39 PM
Pascal
Dear Sir,

I have LPR with light acid reflux (4 > pH > 7). That's why I dont have pain, but I have other symptoms, like cough, lost of appetite, etc. Can we be a candidate when we do not have acid reflux, but light acid reflux.

Best regards.

Pascal
5/19/2014 10:18:36 AM
Steve
Hello,
My doctor told me, that I cannot be operated with Linx, because my LES is normal. The reflux is caused by my hiatall hernia. Could you confirm me this?
Best regards.
Steve
5/19/2014 1:57:22 AM
Brian E. Louie, MD
Ryan,
It is possible that your back pain is related to the reflux but also to the hiatal hernia. Usually, this type of pain is seen below the shoulder blades. They may be able to correlate that symptom with reflux if you recorded that symptom during your pH analysis. Remember the esophagus runs along the spine so it is not unusual to get back pain. However, it is not always common.

You sound like a good candidate for a LINX device. Certainly, the regurgitation, lump in the throat and belching will improve. Its likely that your back pain will improve but no one could guarantee it.
5/13/2014 4:56:13 PM
Shane
Hello Dr. Louie. Thanks for taking the time to answer our questions. Following up on Luis's question. What if I were to have the stomach wrap undone, would it then be possible to have the lynx put in? I am having trouble with my wrap slipping, and the pain is so intense it has caused me go from being a very physically active person into a sedentary one. Activity agitates the pain at the wrap, even riding in a vehicle on a rough road will cause pain intense enough that I will get nauseous. I really don't want to be one of those people who ends up having the wrap redone over and over because it seems like it never ends well for those people. But I can't go with it with this much pain, I need to have it fixed. Would it be possible to have the wrap removed and replaced with a lynx?

Thank You
5/9/2014 9:30:33 PM
Shane
Following up on Lois's question; you say that the lynx cannot be done after a fundoplication. Is that still true if the fundoplication is undone. I am 13 months post op on my fundo, and am having a lot of trouble with the wrap sliding. I think that it moves up into my chest cavity, giving me extreme pain at the wrap site and up into my chest. I am going into see the surgeon again next week, and if it looks like they are going to have to redo the surgery anyways, I was wondering if it is possible to unwrap the stomach and replace it with a lynx. Thanks for your time.
5/9/2014 2:48:28 PM
Shane
Following up on Lois's question; you say that the lynx cannot be done after a fundoplication. Is that still true if the fundoplication is undone. I am 13 months post op on my fundo, and am having a lot of trouble with the wrap sliding. I think that it moves up into my chest cavity, giving me extreme pain at the wrap site and up into my chest. I am going into see the surgeon again next week, and if it looks like they are going to have to redo the surgery anyways, I was wondering if it is possible to unwrap the stomach and replace it with a lynx. Thanks for your time.
5/9/2014 2:38:25 PM
Brian E. Louie, MD
Catherine,
You are correct in your understanding.

LPR has a lot of nuance to it. Patients can have no heartburn and only symptoms from the throat area and other will have both. Only a small number of patients in either scenario have had a linx implanted ‎. In my experience they have done well but for an individual patient the result may not be the same. More data is needed to fully say that LPR is effectively treated with LINX.
5/7/2014 2:17:58 PM
Brian E. Louie, MD
Alicia,
Technically it is possible. I have several patients who have been evaluated and we are awaiting approval. The challenge is that there is no significant experience in the scenario so we hope it will work since the alternative is roux y bypass.
5/7/2014 2:16:18 PM
Catherine
Dear Dr. Louie

I have read some informations about patients with LPR only on the discussion. I'm not sure about the answers. You said it may be helpful in one message and in another that all the patients who had Linx with LPR are well now. So it means it probably works, but we need more patients to confirm that?

Thank you for your answer.
Best regards
5/5/2014 11:16:39 AM
Allicia
I'm wondering if the LINX system is possible after a vertical sleeve gastrectomy?

Thank you.
5/5/2014 6:18:22 AM
Ryan
Thank you for your helpful posts, Dr. Louie.


I have undergone EGD, manometry, and Bravo-pH testing. My DeMeester score was a 44 and I was shown to have a very small (<1cm) with the manometry testing; everything else appeared normal (e.g. peristalsis, esophageal lining).

In addition to continuous regurgitation, feeling of a lump in my throat, hoarseness, sore throat, and constant belching, I have a stabbing/burning pain in my middle/upper back between my shoulder blades after I eat and when during the night (I have the head of my bed raised and do not heat 3 hours prior to laying down).

I have been tested for pancreatitis and gallbladder problems (nothing abnormal). My doctor said that this was "referred pain" from GERD since the upper GI nerves also innervate to the back.

Have you had experiences dealing with patients with this back pain; do you think it is related to the hiatal hernia or simply reflux; and do you think the LINX will help me?

Thank you very much for your time!
5/4/2014 1:37:20 PM
Brian E. Louie, MD
Lois,
Sorry for the delay in my response

After a fundoplication has been done it currently is not possible to place a linx. ‎You should not be having that much gas pain at this point so it's important to see your surgeon .

The placement of a linx at your sons age is not indicated. He should wait till at least 18.
4/28/2014 7:34:36 AM
Brian E. Louie, MD
David,

Your post is a little confusing.

First, to be a candidate for any antireflux procedure you ideally should have symptoms of heartburn or regurgitation which is also known as reflux. A pH test should confirm this. In LPR you may not have a response to PPIS but it is helpful.

Second, Endostim as far as I know does not stimulate the diaphragm since the leads are placed in the LES. The candidates for LINX and Endostim are very similar so I would guess you ‎qualify for both.

LINX is available in Europe through Torax. Check their website. But certainly Switzerland and Italy have had sites placing LINX. In Italy it is Dr Bonavina.
4/21/2014 8:26:34 AM
lois
I had fundo 7 months ago, the gas pain wants to give me a heart attack. can the fundo be replaced and linx used instead. The vagus nerve is greatly irritated everyday.
my son is 15 has minor gerd but is jus as sick as I am, with slght palpitations. Is he too young for linx?
4/19/2014 5:14:41 PM
David Monnet
Good day,

I have read some questions about people who have LPR (larrynx-pharynx reflux). I have done an examination who shown that i have this reflux, but not heartburn. The results show that my diaphragm is not at all week, so i can't probably be a candidate for endostim (who reinforce the diaphragm). Could i be a candidate for Linx with a strong diaphragm?

Do you also know where are the places where we can do this operation. I'm leaving in Switzerland, and i dont think there is any place. What about France or Germany ?
4/18/2014 2:08:33 AM
Brian E. Louie, MD
In general terms, yes this person would be a good candidate. The patient would be a better candidate if they also had symptoms of heartburn. It sounds like you have regurgitation since you get an acid fast in the back of your both.

Its often difficult to predict the outcome for patients with pure LPR symptoms - i.e. they have no sense of heartburn or regurgitation.
4/14/2014 10:47:44 AM
Gondore
Hi Dr. Louie,

I know you can't give exact recommendations in this type of setting, but if you had a patient with a 3cm HH, grade one damage to the esophagus, DeMeester of 27, normal manometry, presenting with mainly LPR systems (i.e. chronic shortness of breath, throat clearing, throat pain/tightness, acid taste in mouth, bad breath, pain in the LES area) would you consider them to be a good candidate for Linx?
4/11/2014 12:20:30 PM
Brian E. Louie, MD
Greg,

The best tests to determine a hiatal hernia are the upper GI and the EGD together. Manometry is a poor estimator of the hernia size. If both the upper GI and the EGD confirm a hernia, you've have a small hiatal hernia.
4/3/2014 9:11:32 AM
Brian E. Louie, MD
David,

There are two theories.

First is a reflux mechanism where the fluid gets directly into the lungs or vapors are inhaled and cause an asthma like reaction

Second is a reflex mechanism due to vagal nerve stimulation.

The patients who immediately improve we think are the first variety and the ones that take longer to improve are the second.
4/2/2014 9:12:39 AM
greg
How often is there a significant discrepancy between pre-operative testing for the size of a hiatal hernia and what you find during the operation?

I have a hiatal hernia demonstrated on a manometry (0.2 cm), upper Gi series ( radiologist said 2 cm) , and endoscopy noted presence as well. Does this definitely mean I have a small hiatal hernia in your opinion?
3/31/2014 5:17:57 PM
David
Thank you so much for taking time to answer these questions. I apologize for posting so much but it's very hard to get answers from someone with so much knowledge on this subject.

My question is a followup to the previous one regarding breathing issues, LPR, and Linx. I have spoke with several people who have had breathing issues prior to Linx which seemed to resolve immediately after surgery. I have struggled to understand how this is possible as it would seem that any damage to the airways would take time to heal. The only conclusion I have come to that makes sense to me is that the vagus nerve is either being irritated by the reflux or their HH (all the cases I mentioned above had HH) is putting pressure on the vagus nerve. Based on your experience do you believe these are plausible theories?
3/27/2014 3:54:00 PM
Brian E. Louie, MD
David,

Yes, the size of the hiatal hernia is still a key factor. The bigger the hernia the more dissection is required to fix the hernia and it also usually means the key structural compoents of the reflux barrier are too deteriorated to place a LINX. The recommendation for LINX is for patients with a hiatal hernia less than 3 cm in size.

I have this exact scenario right now with a patient. If a larger hernia is found, a Nissen is still a better operation to control reflux. A well constructed Nissen is still a very good operation. In the study we just completed, the quality of life is exactly the same for patients undergoing a Nissen and those undergoing a LINX. Remember there is no data on placing a LINX with a larger hernia. So, we don't know if it will work or even migrate. So for now, if I find a larger hernia I have been doing a Nissen because I think it will serve the patient better in that situation.
3/27/2014 9:22:54 AM
Brian E. Louie, MD
Matt, there have been several exchanges in this blog about the use of LINX with LPR. I suggest you read back to see what patients are asking and what we have discussed.

We have a small number of patients who have had LINX with the scenario similar to yours and they are all doing well.
3/27/2014 9:21:52 AM
Matt
Hi Dr. Louie -

I was wondering if you could share any information on how successful Linx is treating LPR symptoms? Are there many people who chose to have Linx soley for LPR?

My symptoms are throat inflammation, globus sensation which never goes away and a raspy voice/throat clearing especially after a meal. I do not have heartburn, however, I do have silent relfux. I had manometry & 24 hr dual channel impedance monitoring which showed 66 refluxes of which 40 reached my throat. My ENT believes these throat refluxes to be the source of my sypmtoms. Medication has not been able to take away my sypmtoms.

Again, are you aware of any patients who had linx to treat these sypmtoms soley? Do you think linx would be appropriate to relieve these symptoms?

Thanks so much.
3/26/2014 7:03:53 AM
David
Is the size of a HH still a factor with the Linx? Lets say that the surgeon thinks you have a small HH based on pre-op testing but once they open you up it is large...can the HH simply be repaired and the device installed or would you have to go with a Nissen?
3/26/2014 6:30:36 AM
Pat
Thank you for your information. Appreciated! Could you please send me the link to Dr Katz article you mentioned in your earlier reply. Thanks. Pat.
3/24/2014 5:20:26 PM
Brian E. Louie, MD
David,

In general terms, control of reflux (bile or acid or both) and symptoms (heartburn vs breathing) with either a Nissen or LINX should work. However, not all breathing issues are related to GERD. About 1/3 of our patients have had some related breathing problem from GERD getting close or into the airway and those symptoms seem well controlled. Dr. Katz presented some work last year about patients with symptoms coming from the upper esophagus and airway and they seem to do well as well.
3/24/2014 9:08:58 AM
David
How many patients have you dealt with that have had Linx for breathing issues related to reflux? Have you found the procedure to be success in these cases?

Thanks,
David
3/23/2014 1:25:43 PM
Brian E. Louie, MD
Kevin,

Unfortunately, you are best to consider having your Nissen revised. The LINX device depends on you having existing anatomic structures be in place for which it then augments those structures. A previous Nissen would have dissected all of those tissues to reconstruct the reflux barrier.

For now it is not an option. More research and a clinical trial would be needed to assess the LINX. In this situation
3/14/2014 1:53:24 PM
Brian E. Louie, MD
Elizabeth,

The scenario you describe is not that uncommon. Swallowing or difficulty swallowing is assessed primarily by symptoms, manometry and barium swallow especially if the swallow was done with food.

It's sometimes difficult for patients to coordinate the manometry with a tube down your nose. It may also be related to being off PPI’S but more than likely reflects long standing reflux changes. More research needs to be done on this area where the manometry does not match the symptoms or barium.

I suspect you will be fine after LINX but you should discuss your concerns with the surgeon.
3/14/2014 1:52:48 PM
Elizabeth
Hi Dr. Louie,

When I had my manometry done, I had been off PPis for 10 days and my reflux had gotten really bad and had given me esophatitis as confirmed by an EGD biopsy taken that same day. At that time, I had only 40% normal swallows even though I've never noticed dysphasia while eating or drinking (rarely if reflux is really bad, food feels like it goes down a bit slower, but that's all). The doctor put me back on my PPis and a month later I had a completely normal barium swallow. Is it reasonable to conclude, as my doctor did, that the poor manometry results were directly related to the intense reflux I'd experienced given my normal barium swallow results once back on my medication? I've been approved for the LINX, but I wanted to see whether you think it would be necessary to repeat the manometry beforehand.

Thank you!
3/6/2014 10:54:00 PM
Brian E. Louie, MD
David,

It is one of 4 cornerstone tests to understand your esophagus. It helps to assess the size of a hiatal hernia and can help us understand your motility if food is used. It complements the EGD and the manometry testing.

So, at Swedish we consider it necessary.
3/4/2014 7:36:16 AM
David
I was just wondering if a Barium Swallow test is a requirement prior to having Linx? I have scheduled this test but I am considering canceling as I don't wan to expose myself to the radiation if it's not needed.
3/3/2014 5:48:24 PM
Brian E. Louie, MD
Amanda,

Yes, the LINX will help with reflux of acid or bile or both into the esophagus.
3/3/2014 4:01:24 PM
Brian E. Louie, MD
Susanne,

I’m sorry that you continue to have these symptoms.

pH testing is a key component of selecting patients for antireflux surgery of any kind. When patients have a normal test or one that doesn’t match the patient’s or surgeons expectations then I think you always have to wonder why was the test results different. We will have the patients try to provoke their symptoms and we want them off PPI’s for at least 7 days so that there are no medications in the system. We will encourage them to have a great time and then pay for that time with the worst symptoms. We want them to try and replicate the symptoms for example, we would have wanted you to lie on your stomach and document that time to see whether there is acid getting up to your esophagus.

So, yes repeating your pH testing is sometimes done with specific instructions or a longer period off PPI’s.

It’s hard to justify an operation with normal levels of reflux. In the Bravo development, normal patients had an average of 42 reflux events and no symptoms, yet you have 43 + 2 and have terrible symptoms. It would be hard to get you below normal with anything except a Nissen since LINX will return you to normal. I’d have to think carefully about surgery with what you’ve told me. But, seems like repeat testing would be a start.
3/3/2014 4:00:51 PM
Brian E. Louie, MD
Jean,

The MRI issue has been clarified by the FDA and the company recently. A 0.7 tesla MRI is okay with the device. I'm told that this level is good enough for most issues but the standard MRI is 1.5 tesla. For patients who have never had an MRI and subsequently needed one, I would use the lower level MRI as a way to get some answers and if necessary then remove the device if a higher level MRI was needed. For your situation, I would ask your breast physician. My understanding is that MRI is controversial in breast surveillance although lobular hyperplasis is one of the reasons. You may wish to ask the MRI center if they can image you at the 0.7 tesla level or if there are alternatives
2/26/2014 11:32:13 AM
Brian E. Louie, MD
Ray,

I don't think I have seen this occur after a LINX was placed. We did have one or two patients who had sore throats before surgery and they improved slowly over time after the LINX was placed. It is unlikely this is related to the device itself, but it could be a sign of some subtle reflux still occuring and I would be included to scope you and get a pH study to see ifyour reflux is completely controlled. This will also settle your question about erosion but this too is unlikely since the erosion patients all had dysphagia or trouble swallowing.
2/26/2014 11:31:34 AM
Ray
I had linx implanted on 5-29-13. I have experienced a mild sore throat for the better part of the last 2 months. I plan to follow up with my doc but was wondering if you think this might be related to the linx. I haven't really experienced any other symptoms, no pain at linx site, just a sore throat. It goes away for a few days then comes back for a week or 2. Have you experienced this symptom with any of your linx patients and do you believe this would be related to linx, erosion, migration etc.
2/26/2014 12:49:26 AM
Jean
I'm interested in the LINX procedure but am concerned about the MRI contraindication. Are all MRIs disallowed or does it depend on the field strength of the magnet or body part being imaged? The reason for my concern is I currently get MRIs 1-2 times a year to monitor atypical lobular hyperplasia (ALH) in my breasts. If this is an issue, would I be able to have other breast imaging studies instead (e.g. breast-specific gamma imaging, mammogram, ultrasound, etc.)?
2/25/2014 12:27:20 PM
Susanne
Dear Dr. Louie,
My question is linked to the previous one - I have a constant burning pain in my throat, caused by food and pressure on the stomach (lying flat, tight clothes, sports). I've been following an extremely strict diet since since one and a half years wich actually kind of brings down symptoms, but as soon as I eat something other than the few items on my diet-list, symptoms come back and I get throat ache, mucus, sinusitis-like symptoms for several days, belching... My quality of life is extremely reduced because of this situation. PPIs are of little help.
The real problem is, that my ph-testing showed only 2 liquid reflux events and 43 gas refluxes (all of them non-acid, although I was not taking PPIs at that time). Manometry was normal. In the light of these test-results I received the diagnisis "sensitive esophagus" and was told that an operation would not be of any use in my case.
My question now is - as I am sure my symptoms are linked to what is going on in my stomach, what I eat, if I lay down, belching etc - how reliable is ph-testing actually? In your opinion - would be worth to re-do it? Considering the number of my refluxes - would an operation really be useless?
Thank you very much, best wishes, Susanne
2/25/2014 2:43:37 AM
Brian E. Louie, MD
Yes it is possible. We often think of patients who have symptoms in this setting as having a more sensitive esophagus – meaning that the patients is able to perceive the slightest amount of reflux. There are a number of elements that go into the DeMeester score and patients can have significant reflux without achieving abnormal score. The other explanation is that the patient has non-acid reflux. Many patients taking PPI’s experience relief of the burning but when they are tested it shows a normal DeMeester score but combined with impedance shows that the number of reflux events is no different on or off PPI’s but the pH is different.
2/24/2014 10:29:44 AM
greg
Is it possible to have GERD with a normal demeester score?
2/18/2014 5:32:30 PM
Brian E. Louie, MD
Pat,

From a terminology standpoint, we should not talk about a loose phrenoesophageal ligament. This ligament is stretched out when a person develops a hiatal hernia. As much as we may want to think of this as a single entity, what it represents are a series of muscular attachments from the diaphragm to the esophagus along with a think covering. So a LINX may help if there is a small hernia or the sphincter complex is not working well.

Esophageal spasms are difficult to understand. Some people have them without an underlying problem - called primary. And, some people get them because of other problems such as GERD - secondary. If they are due to reflux, then treatment of the reflux will settle them down. If they are not from reflux, then medicine may help. These are usually diagnosed with manometry.

Yes, a number of LINX surgeons met recently. You can check out my latest blog post (www.swedish.org/linxupdate) for some of the details.
2/3/2014 8:55:51 AM
Pat
If you have a loose phrenoesophageal ligament which is usually(?) caused by reflux, wouldn't the Linx help this. What about helping esophageal spasms? What is the cause of these spasms and how does one diagnose them. Thank you very much Dr. Louie. I heard that all the Linx surgeons in the US were recently together for discussions.
1/27/2014 5:53:00 PM
Brian E. Louie, MD
Maribeth,

Patients are often surprised when the pH test shows they don't have reflux . We will repeat the testing and often use impedance testing to make sure it is not non acid reflux.

If we can't prove reflux then the stomach is a potential source. The symptoms can come from any structure in this area. Treatment depends on what we think it is. Yes gastritis could be the cause

But if he has esophagitis then reflux most likely.

Placing a linx in a 14 year old has to be considered very carefully. It is only indicated in 18 yrs and older.

Even though he is 14 he may benefit from seeing an adult physician experienced in GERD evaluation in your area.
1/27/2014 11:25:44 AM
Maribeth
Thank you so much Dr. Louie for your suggestions regarding my 14 year-old son. If they did the pH-probe and found that it was not true GERD, what would the treatment be? Also, could his gastritis be the cause of the reflux symptoms and is it possible that once his gastritis is resolved that the reflux will resolve as well? We are extremely worried about the esophagitis and want to know how we can prevent this from worsening. Would he possibly be a candidate for the LINX?

Thank you.

Maribeth
1/20/2014 8:51:57 PM
Brian E. Louie, MD
Edward, thank you for your posts to the blog.

Technically, I would think it is possible to do as you suggest. I'm not sure anyone has tried it. More importantly, I'm not sure that it matters since even if the device is a bit loose, when you look at the valve and test the pressures with manometry they are normal. Tighter is not necessarily the goal either since the tighter the device, I think there is a higher risk of erosion.
1/20/2014 4:21:36 PM
Brian E. Louie, MD
There is very little data around migration of the LINX device. There is an upcoming paper which is being published which notes that the likelihood is less than 1% I believe. Your situation is interesting because it would be hard to put the LINX below the LES. This suggests that is around the top of the stomach. Even still, I wouldn't think that it is strong enough to give you all the symptoms you are describing.

The only solution that I know of in this situation is to remove the LINX and convert you to a partial fundoplication. Or Nissen if you so desire.

Let me check around with some other surgeons as well.
1/20/2014 4:21:05 PM
Edward Gibson
Dear Dr. Louie,

I have a follow-up question. If a linx device has been sized wrongly, say it was put in one bead too loosely, is it possible to re-size it in surgery by removing a bead and reattaching?

Thank you!
1/20/2014 7:06:55 AM
Edward Gibson
Dear Dr. Louie,

I had the linx implanted 11 months ago. It has worked very well against GERD, although I've had continuing problems with food backing up and regurgitation of undigested food for hours. Recent tests revealed that the linx is located below the LES, meaning that the linx, as a second pressure point, is causing food to back up into the esophagus. Whether it was placed there, or whether it has migrated is unclear. Another possibility is that the posterior area is held in place by the distal nerve, but the anterior area has migrated downwards. I know you can't comment on my specific case, so my questions are, what experiences i are you aware of regarding migration of the linx? What are its usual causes, and, most importantly, what are the possible solutions?
1/19/2014 9:23:38 AM
Brian E. Louie, MD
George,
You have a very unique situation. Here, the data is very clear that near perfect control of your reflux is necessary for the longevity of your lung transplant. That data exists only for Nissen.

The LINX device does control reflux very well, but because it is more physiologic it is potentially prone to a leak some acid in certain patients. Patients with significant lung disease such as your was are those patients. You may not experience any symptoms of reflux but if you have some reflux that may be enough to jeopardize your lung transplant.

At Swedish, patients with GERD and significant lung disease such as pulmonary fibrosis are encouraged to consider a Nissen. Until we have more data on the LINX, that is your best option to protect your transplanted lung.

As for who is getting approved…it varies considerably across the country. Approvals vary within the same insurance company across the country. So Aetna may not approve you in your center, but they have approved others in the country.
1/14/2014 10:11:46 AM
Brian E. Louie, MD
Iulia, I am a little unclear about what you are asking. The need for a duodenal switch and a LINX are very different.

I don’t have a lot of experience with the duodenal switch procedure so I am not the best person to comment on that operation. It has been primarily used in conjunction with weight loss surgery but can be used in bile reflux. I think you need to figure out which symptoms the bile is causing. If it is heartburn or reflux related then a LINX will potentially keep the bile in the stomach. Lots of patients have bile in their stomach but very few develop symptoms or complications from its presence. If the bile is causing both esophagus and stomach symptoms then a switch may be a better options for you.

I don’t know anything about why a duodenal switch would keep you from being a cabin crew member.

There is no reason why a LINX would prevent you from flying.

The most experienced LINX center in Europe is in Milan, Italy and led by Dr. Luigi Bonavina.
1/14/2014 10:10:31 AM
Brian E. Louie, MD
Maribeth, I’m sorry that your son has experienced so much trouble at such a young age.

Without actually seeing him and reviewing his records, I can’t tell you if they are missing anything or what other tests may be needed. But, I am struck by the fact that you say he has changed medication so many times and he has undergone a lot of testing but no one has actually determined his symptoms are all due to reflux. In these types of situations, I think that a pH probe is most helpful to clarify 1) if he has true GERD and 2) which symptoms are GERD related. He may also benefit from a CT scan to see if there is any other findings in the left upper quadrant.

His treatment could be based then on data. The pH test may simply confirm that he has bad reflux, but it may also confirm that he has minimal reflux but symptoms that are much worse. You may have to wean him off the Nexium because some patients get a “rebound” level of acid reflux that makes it seem like the patient is having the worst reflux of their life. Coming off slowly often helps in my opinion.

It sounds like he may benefit from surgery if the pills are not controlling his symptoms. But, I would make that decision on the pH test and I may even go so far to test him while he is taking the medication to see if it is working. He must also take the medication correctly. Often the reason the medication seems not to work is patients are not taking it correctly. Nexium should be taken 30 minutes before eating and on an emptying stomach. It should also be taken at the same time every day
1/14/2014 10:09:54 AM
George Treadwell
I am a 68yr old male 1 year post single (left) lung transplant for IPF. I have documented GERD and am on H1 and H2 blockers 2xd, the head of my bed is elevated with blocks, small meals etc..
It is the opinion of my transplant center, Duke, as well as other centers that GERD may play a role in inducing rejection. Thus, a Nissen fundalpylcaion is frequently a standard post transplant procedure.
I was suppose to have had the Nissen 6 months ago. I do have some active reflux symptoms at times.
In reviewing my options I discovered the LINX system. The results seem better than with the Nissen. It seem to me that the LINX should be the first step. But my insurance carrier, Aetna, denied my requests for approval for the LINX. The basis of this denial was that it still "experimental."
In your blog you indicate others have been turned down as well. To my knowledge there have been no approvals amongst other transplant patients at Duke who have requested the system,
I assume the real reason for the denials is the extra cost of the LINX rings about $15,000.
What are your thoughts on the appropriate first procedure LINX vs Nissen? What type patient if any are getting approval for the LINX and on what basis? Thanks gt
1/13/2014 3:28:34 PM
Brian E. Louie, MD
Jason, I cannot comment on EndoStim's research plans since I do not have an association with the company. From what I understand from contacts of mine, the company's next goal is to conduct a larger trial in North America. Unfortunately, I suspect that trial will be conducting on patients who haven't had surgery before.

It is true, the one area of research that needs to be done is for patients with a failed fundoplication. Having said that, neither LINX nor EndoStim are designed for patients with more advanced reflux. Those with Barrett's, hiatal hernias, strictures, etc. The fundoplication is a good operation done by experienced surgeons with reasonable volume. It is not without its faults but at least in our experience can be done to benefit most patients.
1/13/2014 9:36:03 AM
Jason Jellison
Is there any research planned on Endostim for people who have previously had fundoplications? I'm sure right now that is out of the question, but is there any research planned for the future? Replacing the fundoplication would lead to a much better life for some people who have had one.
1/13/2014 6:32:23 AM
IULIA
Dear Dr Louie,
My name is Iulia and following a course of PPI's (these terrible pills that everyone think are so helpful)i developed bile reflux that is burning my stomach everyday and also coming up to my throat. I have a little blood in my saliva every morning, sometimes with small clots in it. It's terrible and of course im scared of cancer. I plan to have the duodenal switch but later in my life, since its so life-altering. I'm interested in the Linx procedure. The thing is i was a cabin crew in the past, befoe my company closed and i'm going to interviews to try to be one again. I know this job is not recommended for the duodenal switch. What is your opinion?And if i dont do the duodenal switch yet, could i still work as an air hostess after having the Lynx or not?. Also can you recommend a good doctor and clinic in Europe for the Lynx? I look forward to your answer. Thank you in advance.
Iulia.
1/12/2014 2:01:07 PM
Maribeth
Good morning Dr. Louie. I found your blog recently and would really like your opinion regarding my son's GERD. My son is 14 years old and started one year ago with upper left quadrant pain, bloating, and a feeling of having liquid in the upper left quadrant. We took him to a gastroenterologist who sent him for the H-Pylori breath test which came out negative. In March of 2013, the doctor prescribed 6 weeks of Nexium to see if that helped with his symptoms. The pain did get somewhat better but he continued with bloating and "heaviness" in the same upper left area and was complaining of reflux. The doctor switched the medicine to Omeprazol and kept him on it for 2 more months.

In July and August, he felt much better and had very few complaints. He was not taking any PPIs during this time (However, he was recovering from a clavicle surgery and may have been more focused on that.)

By September, the reflux came back with a vengeance, accompanied by pain. Another doctor, specialist in the Digestive Tract, saw my son and sent him for an abdominal echography and a barium swallow x-ray as well as blood testing. The barium xray showed reflux. No hiatal hernia was seen on the tests. The doctor put him back on Nexium combined with Urbal and Motilium. He took this medicine for 25 days with very little improvement. The reflux continued, just without the acidic taste in his mouth. The reflux by this time was almost "constant". My son said that he couldn't count the times the reflux occurred because it would be hundreds or thousands.

The doctor then ordered an endoscopy which was done on December 18th, 2013. Since the doctor saw some signs of esophagitis, he put my son back on the Nexium. THe biopsies taken during the endoscopy showed superficial chronic gastritis and acute slight esophagitis. Since Dec. 18th, he has been back on the Nexium (20 mg. twice per day), Urbal, and Motilium. He has been on a very strict diet, no fats, no acidic foods, no garlic or onion etc. He has been eating only boiled chicken, boiled carrots and spinach, oatmeal, almond/rice milk, bananas, apples, and rice. Even so, the pain continues with tremendous gas buildup and excessive flatulence. The reflux as of today continues to be "constant" in his words, although it is not acidic. The pain is greatly interfering with his ability to train, as he is an athlete and normally trains daily.


The endoscopy ruled out Celiac's and Crohn's. As far as his medical history, my son had asthma (allergy-induced) from age 5 to age 12, at which time we moved to a different climate to see if a dry, warmer climate with different vegetation would help. He has been completely off his asthma medication (which was daily) for more than 2 years. His bone growth is extremely delayed and he has not yet started puberty at 14 and a half. He was placed on growth hormone for a deficiency back in February of 2013, after the stomach problems had already started.

Do you think that the doctors are overlooking anything? What would you suggest we try? ANy suggestions you could offer would be of tremendous help to us. Thank you for all you do for people suffering from this horrible disease and their families.
1/12/2014 8:35:25 AM
Brian E. Louie, MD
Sorry for the delay in responding to this post.

Let me take a step back because I mistyped my response to the earlier post about EndoStim.

We recently reviewed the outcomes of LINX, EndoStim, TIF and Stretta. All of these procedures show that the symptoms patients experience are all improved. However, only LINX and EndoStim reduce the acid level in the esophagus to normal as measured by the pH probe.

We must be cautious in interpreting these results from EndoStim since the results are in 25 people only.

The success of any reflux procedure, in my opinion, should be measured by patient's symptomatic improvement and objective control of reflux. Only the LINX and EndoStim have data showing this. I should tell you that we did perform Stretta for a while but stopped since it didn't seem to help and we couldn't get in paid for by insurance.

I think EndoStim is interesting and we'll keep an eye on their results.
1/11/2014 4:59:32 PM
Steve
Hi,
to stay on topic with the previous question, what do you think about the Stretta Therapy? I am currently considering both the LINX and the Stretta, about which I have heard controversial facts. Thank you for your precious help.
1/6/2014 1:50:47 PM
Brian E. Louie, MD
The EndoStim device is an intriguing new application of an old technology. Using a pacemaker like device they are applying current to the sphincter to strengthen it. The initial trials were done on about 25 patients. We recently reviewed the papers for an upcoming article on new devices for GERD. Patients reported relief of GERD symptoms but the pH testing after the device was placed still showed ongoing acid reflux. The question I have is why are the patient's symptoms better yet they are still have acid reflux.

I have no idea if we would be offered a chance to trial it at Swedish. I think that it needs more evaluation before I would consider bringing it to Swedish. Certainly, we'll be following the outcomes of subsequent trials.
1/6/2014 1:14:01 PM
Boris
Greetings, Dr. Louie.

I don't wish to stray off-topic, but what is your take on the new Endostim device and procedure that is being offered (not in the USA just yet.)

Do you think that Swedish might be one of the first in trials?

You seem like a person who is on top of everything!

Thanks,

Boris :)
1/5/2014 12:36:06 PM
Brian E. Louie, MD
Yes, bile reflux into the esophagus is controlled by the LINX. Patients reported that even when they belch (probably misted) there is no acid.
12/30/2013 8:50:16 AM
Brian E. Louie, MD
In an ideal world, a randomized controlled study would be conducted. However, to conduct a study like this costs considerable amounts of money. In addition, patients have to accept randomization. Most patients after hearing about the LINX would not accept randomization in my experience. In antireflux surgery, there doesn't necessarily need to be a randomized trial because there are objective and subjective measures of GERD control such as a pH test. These can be used a measures of success and since they are independent of the procedure can be use to prove to insurers of the success of the procedure.

There are no studies that I know of at the current time. We (Swedish Thoracic Surgery) are going to release our findings in January at the Society of Thoracic Surgery meeting where we compared LINX to Nissen. This will be the first comparative trial but it is not randomized. There hopefully will be some additional news about studies after an upcoming research meeting that Torax is hosting.
12/30/2013 8:49:34 AM
Tom
Dr. Louie,

Are there any current Linx studies that are randomized and controlled? My understanding is that a lot of insurance companies are denying the procedure because the studies (released) so far are not randomized and controlled. Since the randomized, placebo controlled study is the gold standard in science, how can we (surgeons, GI's) be sure there is a statistically significant improvement in symptoms/outcomes? And if there are current studies (or soon to be released), could you point us to them? Thanks again for all of your work answering questions on this blog.
12/23/2013 6:53:09 AM
Pat
Can the Linx stop bile reflux or can bile be aerosolized (misted) into lungs and throat area. Thank you.
12/17/2013 3:40:20 PM
Brian E. Louie, MD
Ashley, There is no way to know which insurance companies will approve or deny a LINX procedure.

It has been very individualized across the country.

It is best to go through evaluation and prove that a LINX is what you require and then seek authorization.
12/12/2013 3:51:43 PM
Ashley
Hi Dr. Louie,

Do you know which insurance companies actually cover the LINX procedure? I've been doing some research on my own and coming up pretty empty handed.
12/11/2013 2:07:50 PM
Brian E. Louie, MD
Jason,

The challenge with patients who have already had surgery is that the any natural attachments or remanents of the sphincter no longer exist. The LINX device depends on having that normal attachements to augment and maintain its position. It's technically feasible to place a LINX after taking the fundoplication apart but the thinking is that it won't do much.

There is an upcoming meeting of the LINX surgeons and the company to discuss future clinical trials. This is one of the items I hope to bring up for discussion.
12/10/2013 10:11:24 AM
Brian E. Louie, MD
Yes it is possible that nausea is a symptom of GERD. In isolation it is harder to prove and often you will need testing with a pH probe and even impedance testing
12/9/2013 4:06:39 PM
Jason
Thanks for your statement on patients who are post-fundoplication. Is there any research being done as to eventually finding another way to attach the device to patients who have had fundoplications? My fundoplication is loosening after 10 years and the side effects were so severe that I certainly won't replace it. This could change my life someday. So, is there any research planned on that? Thanks so much for your posts. You're an inspiration to many fundoplication patients.
12/7/2013 9:08:58 PM
jen
Can nausea be an isolated symptom of gerd?
12/5/2013 7:54:27 PM
Brian E. Louie, MD
Unfortunately, the LINX device is only being placed in patients who have not had surgery before. Once a patient has had surgery whether it is the Hill or Nissen, the natural attachments the device depends on have been disturbed by the prior surgery and it is expected that the device will not function as well since it is designed to augment what is natural in the body.

if you symptoms are severe, I suggest that you undergo reevaluation to see if you'd be a candidate for revision of the Hill or a Nissen.
12/3/2013 9:38:17 AM
Dayna
Hello, I'm hopeful again after seeing this new treatment LINX. I am currently taking dexilant and it doesn't do much good at all.
My symptoms are severe.
Can the linx be used after you have had the " Hill's procedure". I had the Hills done 4 years ago and it didn't hold at all. My relfux is as bad as ever.Last endoscopy was 3 years ago and the said there was some evidence of the procedure but not much.
Thank you
12/2/2013 10:34:57 PM
Brian E. Louie, MD
In general, I think the LINX is an great choice for patients with symptomatic GERD. I don't think you have to feel the reflux coming back up to get a good response. You are the second person on the blog to ask about "fumes". I don't know if patients are able to distinguish between "fumes" and a small amount of acid creating a burning sensation. I think what the patients who have had a LINX would tell you is that when they burp they don't feel fumes or fluids causing reflux.
12/2/2013 2:34:52 PM
Anca
Dr. Louie,

Do you consider that LINX is a good option for patients having GERD symptoms (esophagitis visible via endoscopy, bloating, belching,nausea heartburn, etc), but who cannot feel actualy when they have reflux -no acid liquid is backing up -just acidic fumes, vapours?
Is LINX strong enough to stop these "fumes" to come into esophagus, since it is designed to open and close as natural as possible? Thank you
11/27/2013 10:31:35 PM
Brian E. Louie, MD
Shirley,

The symptoms of hoarseness, lump in the throat and dryness are not specific for any particular disease. I must admit, in our patients, we have not had this constellation of symptoms reported. Some of the symptoms can occur with proximal extension of reflux. Sounds like you should discuss this with your LINX surgeon and consider having your pH studies and EGD repeated.
11/25/2013 10:43:36 AM
shirley in uk
Hi,

I had LINX 5 months ago and have recently developed new symptoms that I have never had before. I have had them for 4 weeks and they are a sensation of lump in throat, dry throat and hoarseness and it is almost constant. Is this a common experience, Can reflux re-occur following the LINX, especially these newer symptoms?
11/23/2013 12:39:41 PM
Brian E. Louie, MD
Nail,

The issue of Barrett's esophagus has several dimensions. First, Barrett's usually represents GERD that is particularly severe and usually associated with a defective sphincter and a larger hiatal hernia. In most cases of Barrett's a LINX device isn't likely to be able to augment this type of sphincter and the hernia will be too big to support the device as well.

Second, ablation of Barrett's without dysplasia is controversial. If ablation is necessary because of dysplasia (more cancerous changes) then a LINX device is not indicated.

I would not be dissuaded from placing a LINX device especially if motility studies reveal a normal sphincter. Unless you have dysplasia, there is no reason to undergo ablation with what you describe.

As for the hernia, there are no answers to your questions at the current time since not enough time has elapsed to know. We have often thought the repairing the hernia is necessary but is appears that very small hernias may not need to be repaired. What happens in the future is unclear. There is no reason to think the hernia will get bigger, but I suppose its a possibility. Only more time and research will answer these questions.

Simple repair of the hernia was tried in the 1950's with over 50% of patients still experiencing reflux so this has been largely abandoned.
11/21/2013 4:18:25 PM
Brian E. Louie, MD
Pat, as far as I know, there is 1 confirmed erosion and I heard rumor of another but have not been made aware of any details. If there was a third erosion, I have not heard about it. Erosions fortunately remain very uncommon. They would usually be detected by endoscopy much the same way lap band erosions would be detected. Any erosion presents a problem to the patient and the surgeon. Fortunately, endoscopic release of the ring with subsequent laparoscopic remove are feasible.
11/21/2013 4:17:01 PM
Pat
Dr. Louie, I've read that there have been 3 Linx erosions. Since the Linx is placed on the outside of the esophagus LES-- then how is the erosion confirmed diagnostically. Can it be seen by endoscope? If so, then it would have to be a severe erosion to go through the esophagus. Thanks for providing this help to us.
11/17/2013 2:57:00 PM
Nail
Dr. Louie,
I've read that in Europe, surgeons generally do not place Linx on patients who have short segment Barrett's unless the Barrett's is successfully ablated. I have ultra-short segment Barrett's (<2mm). Do you think that ablation is needed in my case before Linx can be placed?

Some related questions: I also have small hiatal hernia. I understand that it is usually repaired when Linx is placed. Is it expected that the hernia would not redevelop after that? If hernia does redevelop, would it cause the Linx to fail, and what would be the recourse then? Is just repairing the hernia without placing Linx ever an option?


Many thanks.
Nail
11/16/2013 9:29:58 AM
Brian E. Louie, MD
Motility of the esophagus is an important component of any antireflux repair not just LINX. Sufficient forward propulsive power is needed to move food and to a lesser degree liquids through the reconstructed valve. Patients with limited motility are at risk for having more trouble swallowing. This limited motility can be due to age, long standing GERD, the hiatal hernia and other diseases the patient may have. Thus, if we don’t assess it, we leave the patient risk for side effects which can be addressed using a different operation. In the situation of poor motility, neither a LINX or Nissen will work and a partial fundoplication is used to control the reflux and allow the patient to swallow.

At Swedish, we assess motility by manometry, a videotaped barium swallow that uses food and liquids and a series of questionnaires. This usually gives us a good idea whether patients will tolerate a repair. However, it’s not perfect.
11/14/2013 8:58:50 AM
Rob
Can you explain why the degree or level of Motility plays a role in your decision to instal the LINX or not..?
11/9/2013 5:42:59 PM
Brian E. Louie, M.D.
Riyaz,
In LPR, patients often have a small hiatal hernia which is also addressed when the LINX is placed. This is part of the reason the reflux reaches the pharynx. In normals a little bit of acid always comes up but it doesn't produce symptoms. So I think that restoration of the valve with the LINX does the same thing.

At the moment the surgery is only available in Europe or the USA. Contact the company for details about India.
10/24/2013 5:31:45 PM
Brian E. Louie, MD
Kelli,
Your surgeon will be using the impedance test to confirm that you truly have reflux. The score is called the DeMeester score and it should be greater that 14.7 to confirm reflux. It will also show if you reflux fluid other than acid. If LPR is of concern this test will also be able to tell how any reflux events reach your throat area.

The manometry test tells us about the function of the esophagus. To support a LINX the esophagus function should be relatively normal.
10/22/2013 12:06:44 PM
Brian E. Louie, MD
Chad,
Patients who have had the LINX placed tell us it isn't a problem. The difference between now and after LINX is that your belching now is due to the reflux and you swallowing air. After when the reflux is controlled you will belch less.
10/22/2013 12:05:12 PM
Riyaz
Dear Dr Louie.

I really liked the posts and appreciate your replies on the Linx and GERD.

I am diagnosed with LPR around 6 months ago and currently suffering from the typical LPR symptoms. As long as the 2X PPIs are taken, the symptoms are manageable. If I bring down the dose, there is a flare up.

I have 3 questions.

1. If the device allows for Belching, does it not allow the stomach acids to travel up and irritate the throat as it happens with my LPR where the acids travel up every time I burp after eating for sometime.

2. Is this Surgery available in India as I am an Indian. Kindly provide the details of the Hospital if available.

3. If currently not available, is there any timeline when this will be available here.

Regards,
Riyaz.
10/22/2013 11:23:46 AM
Chad
Thanks very much for all the info you've provided on this new treatment for GERD. I'm considering getting this procedure done but I'm wondering how this device works for belching. I realize that it's supposed to allow you to belch but whenever I belch my GERD symptoms get worse and I get increased burning. Will this device likely stop the acid from coming up with belching?
10/16/2013 1:36:43 PM
Kelli
Dr.Louie,
Thank you for such a great post and for answering so many great questions! I have been suffering with sudden onset reflux since the birth of my daughter over a year ago. Never had reflux before, even while pregnant! I have completed the barium, 48hr bravo, endoscopy, hida scan, gastric emptying study, CT scan, blood work etc etc. The only thing they found was a small hiatal hernia and during the barium I refluxed. Tomorrow I will do the Manometry and Impedence study and if I "pass" my surgeon will do the Linx procedure. My question is, what results are they looking for? Is there a certain "score" I'm supposed to have in order to qualify for this procedure and if so what is that score? They suspect that I'm dealing with non-acid LPR.

Thank you for your time!
10/16/2013 10:02:31 AM
Brian E. Louie, MD
Ray,

With regard to exercise, I suggest you discuss this with your surgeon. I generally will let patients resume exercise at about 6 weeks from surgery to give the magnets a chance to get "healed" around the esophagus. It's possible that after lifting heavy objects a patient could experience reflux. That does not mean the magnets have moved. It does mean that if you increase the pressure in your abdomen you could cause reflux to occur. Remember, these are magnets and they will open when a certain amount of pressure is placed on the stomach. I had a patient recently described a single episode of reflux after eating and having his grand child sit on his stomach. Remember, this device is meant to be physiologic. That's what allows the patients to belch and vomit. A Nissen is not physiologic. It will control GERD supranormally but also prevent you from belching.

The timeline to improve your LPR symptoms is different for every patient in my experience. Most of my patients have no symptoms, but some have the hoarseness last longer. If you are still having symptoms, it may be time to undergo repeat pH and manometry studies. This will provide some information for you and the surgeon. These symptoms may have nothing to do with GERD. We just recently repeated the evaluation on two patients. One was certain the reflux was back because of persistent throat symptoms. The pH studies were normal and there was no correlation of his symptoms. He was relieved to know that these were not related.

Again, I suggest you discuss these concerns with your surgeon.
9/30/2013 9:06:02 AM
Ray
I had Linx implanted on 5-29-13, right around 4 months. I suffered from GERD for approx 8 years.

2 questions

1. In regard to exercise, are there any restrictions on weight training, lifting, running, etc? Is it possible for the Linx to shift while weight training or other strenuous exercise? I have read in a blog where one patient started experiencing reflux again after lifting heavy objects. I would like to get back into a workout regimen but would like to be reassured that Linx will stay in place. Is this something to be concerned about?

2. My reflux came with LPR type symptoms as well, hoarseness, breathing issues, throat clearing, excessive mucous, sinus issues, etc. After Linx I have noticed some improvement in those symptoms but not what I had hoped for. I have heard that these symptoms could take a while to resolve, possibly 6-12 months. Is this correct? What has your experience been with these types of patients after being fitted with Linx?


Thank you for your time
9/25/2013 9:52:00 PM
Brian E. Louie, MD
Matt,

Let me reassure you that you’re not alone in this situation. Many patients are concerned.

Let’s first consider your endoscopy findings. Just because it did not show esophagitis (inflammation) or a hernia doesn’t mean that you don’t have significant GERD. The physician appropriately scheduled you for a pH/Bravo test to determine how much acid is reaching your esophagus. This test will be required by most insurers if any surgical treatment for GERD is going to be approved and all surgeons will want to see this test result. Your task during the test is to try and have as many symptoms of GERD so that your physicians will have data to make a decision on. At Swedish, we will stop your PPI’s before the pH test so that we can see how horrible your symptoms are and to confirm that your symptoms are in fact related to reflux.

You will still need to under manometry testing if the pH test is positive to help the surgeon understand whether a LINX or Nissen will function properly.

If you’re symptoms are as bad as you describe them, I would continue with the testing to confirm the GERD diagnosis and then see an experienced esophageal surgeon to discuss your options.
9/24/2013 8:53:57 AM
Debbie
I am 3 days postop from having a Linx and so far it has been the best decision I've made. I have had no reflux whatsoever, only took pain medications the first day and have been able to sleep comfortably for the first time in years. Swallowing has been fairly easy so far. I want to thank Dr. Louie and his team at Swedish for everything they've done for me!
9/24/2013 8:52:40 AM
Matt B.
Dr. Louie,

Thanks again for your answers from before. My endoscopy came up clean for H. Pylori and Celiac. The physician noted that he saw no significant inflammation, no barret's, and no hiatal hernia, but that my LES did look loose, but explained that this could be "incidental". He was very resistant to my desire to pursue candidacy for Linx (though, he's not the surgeon that might be doing the procedure).

I'm currently scheduled to have a 48-hour Bravo pH test starting next Tuesday, 9/20. Given that I had nothing wrong but an LES, am I just wasting my money on a pH test only to be rejected by insurance because I don't have "enough need"?

It seems like general medicine dictates that you have to be miserable with GERD before you can do anything about it but I'd prefer to treat it now with Linx to know I won't have another 2 weeks of my life stolen, and as a preventative measure to prevent future problems. What are your thoughts on this?

I don't know how stringent the insurance requirements are at this point and don't want to continue to dump money into diagnostics if I'm just destined to be rejected by BlueCross BlueShield at the end of this journey.

I know you have to be careful about what you advocate or don't advocate as a physician, but just as a general rule, what would you recommend in my situation?
9/20/2013 6:42:36 AM
Brian E. Louie, MD
Tyler, you simply need to call for an appointment.
9/16/2013 8:38:14 AM
Brian E. Louie, MD
Nazim,

I think what we are learning is that the troubling swallow after LINX implant has many components to it. Remember, the device is not placed to put pressure on the LES. It is designed to keep the LES from opening thereby preventing reflux. One of the things we have learned from the patients is that the difficulty swallowing is partly related to how they eat. If they eat too quickly with large bites with repeated swallows then almost everyone has trouble. When they slow down, chew appropriately and let the food pass with each bite then dysphagia is negligible. That's not to say that there are not other reasons. More research around the issue is still required.

The case of the erosion was 1 in the first 1000 cases and was some time ago. Erosion will always be a concern for surgeons who are implanting foreign material. I don't think 1 occurrence raises too many concerns. I think it reinforces that surgeons and patients need to have a frank discussion about follow up until greater years are passed. All of our LINX patients will be followed carefully the first year and for years after. In fact, if patients are unwilling to comply with my plans for follow up, I will suggest that they consider a Nissen. In this early experience with a new device, the patients have to accept some responsibility for being part of the innovation of care. So far, we have not had any patient refuse and most are happy to participate knowing they are contributing to the experience and making it better for patients like yourself who are considering the device.
9/15/2013 4:51:40 PM
Brian E. Louie, MD
Matt,

As you no doubt have read, the standard evaluation most esophageal surgeons will require is a barium swallow, upper endoscopy, pH test (Bravo or impedance) and manometry.

There are no age restrictions on a LINX device. We have patients as young as 25 and as old as 76. All of them are pleased with there results (or at least that's what they are telling us). We have not seen any major issues. In the first 1000 cases there was the one erosion. The trouble swallowing is multifactorial. We are finding some of the trouble relates to how people eat (too fast, too much, on the run) in addition to the sensation of something different.

The only reasons to exclude a patient from LINX is the size of the hiatal hernia (> 3 cm), poor motility, and long sections of Barrett's esophagus. There are other reasons, but these are the main ones. From what you have told me, I don't see a reason for you not be considered.

There is no difference in the function of the two devices you mention. Most LINX centers will be using up the stock of devices where there are sutures as the company has introduced the snap on device.

I keep my patients of low impact activity for about 1 month to ensure the device gets scarred in. We've had patients ask about amusement rides, bungee jumping and other activities two weeks after the device is implanted but I think each surgeon will be a bit different in their recommendations.
9/15/2013 4:50:33 PM
Nazim Khan
Hi Matt,
Just thought I would add my two cents after seeing how similar our cases our -- 27-year, low body-fat, done with most lifestyle changes, and appetite ruined to the point I can't consume enough calories -- and how like you, I've read vociforously on the Internet on this issue.
Now obviously Dr Louie is the expert here, but here's what I think, till he responds.
1) "What test should I request next as we investigate what is wrong" Your docs would start with, I'd imagine, the scopy to see if anything's wrong and then decide if you're a fit candidate for surgery. If you indeed are considered as one, the routine pre-op tests done for both Nissen and Linx (24-hour pH, manometry, etc) would follow.
2) "Given what I've told you, is there any reason I wouldn't be a candidate for LINX"
I think the cases that imply exclusion are: a big hiatus hernia, Barrett's or maybe low peristalsis (the esophagus' swallowing pressure).
"I don't want to waste time trialing meds that I'm opposed to taking, but I'm worried I'll be rejected due to a doc wanting me to try all of these other regiments first."
Similar to my case. Here where I am in Bombay, India, most docs were hardly aware of LINX and kept telling me Nissen is too invasive after I told them I had only been "on and off" on PPIs (notwithstanding the fact I took 80mg PPIs for months) in the two years since my haitus hernia was diagnosed. So in your case, they might want to run you on a stringent PPI course, failing which surgery would be considered.
"Any activity-related contraindications other than MRIs" While I haven't read any doctor (or even Torax) specifically mention this, my own thinking would be LINX implantees should, for the rest of their life, avoid extremely heavy lifting, exercises that exert pressure on abdominal muscles such as crunches, etc, and not indulge in routine overeating (things that often become the original causes for the stomach to get herniated) to not put too much stress the ring.
Good luck and be well.
9/14/2013 10:14:45 PM
Tyler M
Dear Dr. Louie

I just got off the phone with the University of Washington, they said they will send the message off to refer me to the Swedish Medical center.

My doctor there has denied me surgery for my bile reflux because my esophagus and stomach linings seem to be ok at the moment. Well thats not what im affraid of. Im currently dealing with a severe case of LPR. The reflux has been getting into my throat every single day for an entire year. It has become extremely raw and it is very painful and difficult to swallow anything. Every swallow hurts and is uncomfortable. Somtimes it feels as If I will not be able to swallow. I can feel cartilage rub agianst other cartilage when I swallow since there is less tissue. I have all kinds of cracks and pops in my throat from the reflux. The pain and discomfort has never been there until I started experiencing the reflux. It hurts and I honestly dont believe I will be able to live with this for much longer. I struggle to eat, drink, and swallow everyday. It is something that has gotten worse and worse over the months with no signs of improvement. Im to the point where I dont think it could get much worse and I need the reflux to stop from coming to the throat. It feels funny breathing in air through my mouth. There has to be severe damage done to my larynx and pharnyx.
If it makes things easier I would be able to visit an ENT specialist before my visit with you. Maybe the ear, nose, and throat specialist will be able to shed some light as to how bad my throat is. I can show you the results. Ive had ct scans done on my neck for soft tissue damage awhile back and they came back ok. But the discomfort and pain is unbearable. The doctor at the University basically told me I'll have to live with this and deal with it. Well im not accepting that because its hard for me to eat drink and breath let alone dealing with the pain of moving my head and neck around. So if theres anything you could do to help speed up the appoitment process, it would be appreciated. I need help fast. I will also call soon to check if the referreal was made.
9/13/2013 5:22:28 PM
Matt B.
Hello Dr. Louie,

Firstly, thank you for this excellent blog. Knowing there is hope for normalcy in the future gives me peace of mind (as I sit here at 3AM, unable to sleep from reflux-related issues).

I'm a 27 year old male, have always been normal weight/athletic (probably 6-8% body fat), and have been told in recent appointments that I'm essentially doing everything right as it pertains to diet and lifestyle. Both parents have reflux so I guess it's hereditary. Over the last 3-4 years I've had a number of GERD "events", worse each time, culminating in my most recent event last week which has ruined my ability to exercise, sleep, or eat an effective number of calories to not persistently find myself hungry.

With no real lifestyle changes left to me I'm fed up and am determined to fix this so I can exercise, eat sufficiently, sleep horizontally and avoid the more serious long-term health effects of GERD. I've tried PPIs a number of times and hate how they make me feel, the fact that they don't resolve the actual problem, and the related immune and gastric emptying implications. Frankly, with where I am at 27 I balk at considering what GERD could do to me by age 40, 60, 80; I want a real solution (and not a Nissen...)

I've read about all there I can on LINX and other than a single case of esophageal erosion and some minor swallowing modifications I am extremely impressed with the outcomes I'm reading about everywhere.

So, to my questions:
1) I'm getting scoped by Dr. King at Vanderbilt next week. What questions should I ask him and what test should I request next as we investigate what is wrong (with the possibility of a LINX procedure in mind). Barium? pH?
2) Given what I've told you, is there any reason I wouldn't be a candidate for LINX (I.e. "too young" or "not a serious enough case"). I don't want to waste time trialing meds that I'm opposed to taking, but I'm worried I'll be rejected due to a doc wanting me to try all of these other regiments first.
3) Other than some swallowing problems, have you recognized any other issues related to LINX? ...or any activity-related contraindications other than MRIs? Maybe "no deep abdominal stretches", for example?
4) I've noticed there are two types of LINX devices, a chain that gets tied and a newer version that snaps together and is then tied. Is the second device pretty standard now? It seems like it would do a better job of remaining circular rather than slightly tear-shaped.

Sorry for being so longwinded but I very much look forward to your reply. I'm not one to rush into anything but with how relatively straightforward this surgery is and the before/afters I've read about the prospect is extremely attractive. These answers help me make a more informed decision.

Thank you!
9/12/2013 1:23:07 AM
Brian E. Louie, MD
Tyler, thank you for your post.

You have a challenging situation but in general Nissen, Roux Y and LINX will all control reflux. The answer to your specific questions are as follows:

1. A LINX device can be placed in the presence of a small hiatus hernia. Generally, it is indicated for patients with hernia's less than 3 cm in size. The hernia would be assessed and managed at the time of any of the surgeries. For LINX patients, it is not always necessary to repair a small hiatal hernia, but that is a decision that is made in the operating room. It would be standard to repair the hiatal hernia during a Nissen operation. Look back into this blog for further information.

2. I have two patients that have a LINX device who presented primarily with throat symptoms and bile reflux that are happy they went with a LINX device.

3. The LINX device is only available at Swedish Medical Center in Washington State. The University surgeons can refer you over to Swedish or you can simply call my office ((206) 215-6800) to make an appointment.
9/9/2013 9:46:59 AM
Brian E. Louie, MD
Mulian,

There are two parts to your question. First, if your motility was not good enough to have a Nissen and required a 270 degree Toupet fundoplication, a LINX would not be recommended. Second, there is no data or role for placing a LINX after prior antireflux surgery. Perhaps in the future, but not at the current time.
9/9/2013 9:44:21 AM
Brian E. Louie, MD
Don,

At the moment, the focus is on ensuring that patients with GERD who have not been operated on previously are the primary candidates for LINX. In the future, perhaps the indications will change and patients post RNY will be evaluated. Most patients with a RNY don't have reflux. If you have symptoms of GERD, you should be tested to be certain that they are related to GERD. The usual reasons are the gastric pouch may be a bit larger and if you are regurgitating, the bypassed segment may not be long enough. You still have some options and should discuss this with your surgeon.
9/9/2013 9:13:39 AM
Nazim Khan
Thanks Dr Louie for putting up this insightful post. I had a couple of queries.
From what I understand, the number of beads that are put in the LINX device (and correspondingly, the pressure it will create on the LES), is determined on the basis of the patient's esophageal diameter. My concern is: wouldn't implanting the same-number-of-beads (say, 13) device inside two patients with similar esophageal diameters but starkly different pre-procedure LES strengths create a case of being too tight for one of the patients (one that had a relatively stronger LES)? Could this explain the varying degrees of cases and symptoms of dysphagia that are seen in post-procedure patients?
Also, you mentioned in reply to another post: "Sorry there is not a lot of info. With one case in Europe and none in the US there isn't much to tell you." Was this in the context of a device erosion/migration occurring? If a case of erosion/migration has indeed been seen this early into the life of LINX, does it not raise the concern of possibly more such cases into the future as the devices will be implanted for life? Any further updates on this issue in terms of more cases coming to light or further information regarding this one case you mentioned?
9/9/2013 6:00:57 AM
Tyler M
Im considering the linxpatient the at the center in seattle. But I have a few very important questions. First off I have been diagnosed with Bile Reflux diaease. Im 20 yrs old. My pyloric valve stays open. Ive been dealing with reflux into the throat everyday for about a year. Its hard to swallow and I feel as if my throat is verry raw. I can feel clicking and cracking and poping in my throat when I swallow or when I move my head and neck. the LPR reflux into the throat has eatin away the skin tissue to where theres not much on the cartilage. Thats why I feel the clicking and craking like a pair of old knees would do. It hurst to swallow every time. I have to try real hard to swallow too. No medications work for me, im on reglan, ppi's and bile binding medicines (choleystramine). I had my first endoscopy done abouy 6 months ago. It showed an open pyloric valve and bile in stomach. My second endoscopy that happened last week showed that it is still open but now I have a sliding hiatus hernia. I still have a consistent silent to mild heartburn every day. I get a bad severe heartburn/flareup randomly throughout the weeks. Nonetheless its getting worse and worse every month and its hard for me to eat. My endoscopy shows im barretts free for now. I would like to try and stop the reflux into the esophagus and I figure I could live with bile in the stomach for now. The Rny surgery and the nissen surgery scare me with postive resuts and If I dont need to have operation or surgery on my stomach then why risk it. This can be taken off and if its not effective ill seek other options.
So question 1... Can I still get the linx procedure if I have a sliding hiatus hernia? Would any surgeon be able to tackle two jobs at once?
Question 2... Has any patient gotten the Linx with postive results for bile reflux into the esophagus?
Question 3 ... Im being seen by the University of Washington in Wa State. Can they reffer me to you guys (The swedish center) ? Or are there surgeons at UW that do the linx procedure.
9/8/2013 4:34:40 PM
Don Greene
Hi. I have a reflux problem which is leading to night aspiration and severely curtailing sleep and life quality.

I do not yet have Barrett's, although have been on PPI's for 18 years for reflux and related problems.

Last year, for a non-malignant duodenal obstruction, I was given a standard bariatric-type RNY bypass with small stomach pouch and detached remnant stomach.

I realize that LINX is not specifically permitted for such patients, but it seems to be a more elegant solution to the problem than alternatives. Is anyone experimenting with the LINX on post-RNY patients?

Thanks.
9/6/2013 1:48:41 PM
Mulian
Dear Dr. Louie:
The patient which has been done 270 degrees Nissen fundoplication two years ago,but poor efficacy.
Can she have LINX device, after Nissen fundoplication? To prior surgery reversed and then have LINX device,is it a good idea?
Thank you!
9/5/2013 2:07:56 AM
Brian E. Louie, MD
Robyn,

The concern in patients with Barrett’s esophagus is that they have severe GERD and its likely that the LINX may not be strong enough to control the GERD. The population has historically been the hardest group of patients to get a good outcome in with Nissen as well.

However, there are varying degrees of Barrett’s in terms of length. For patients with minimal or very short Barrett’s a LINX may work, but for patients with longer lengths a Nissen is probably the best choice since it has the chance to prevent further progression. It will depend heavily on the evaluation you have before surgery.
8/26/2013 8:59:46 AM
Robyn
Why can't the magnetic ring be used when a patient also has Barretts Esophagus
8/21/2013 4:23:07 PM
Brian E. Louie, MD
Paula,

The LES can be entirely normal and patients may still experience reflux. Remember the LES needs to open and close all day long to allow whatever you eat and drink to go down. This is normal for most people. This can be a long and complicated discussion.

Stress can be a factor with many people reporting more GERD symptoms during times of stress.

Some of the LINX patients have a story similar to yours.

It is important when talking about acid and non acid reflux to know how you were tested. A true pH test should be conducted when you are not taking any medications. In that situation, the majority of patients will have acid reflux. To have non-acid reflux in this situation, it means the stomach is not making any acid or very little. This is generally uncommon. Some labs will test patients while taking PPI's and then talk about non-acid reflux. In this situation, the PPIs have done their job by shutting down acid production but the reflux barrier is not working and reflux is still occurring.
8/20/2013 9:14:56 AM
Paula
Dr. Louie:

I had a mamometry that indicated 170 reflux episodes, primarily non-acid, and mostly during the day, although the strength of my LES was normal.

I have ongoing issues with a cough, phlegmy throat, chronic hoarseness, lump in thoat feeling, frequent sore throat and ear pain. Rarely have heartburn. Sometimes (2x/month) have horrific night time painful episodes of upper stomach pressure and pain, occasionally with accompanied vomiting.

PPIs, 2x/day for 6 months maybe helped slightly. I sleep upright, take 300 mg Zantac at night, and my diet is hugely restrictive. I've been struggling for 4.5 years. I just want to be normal and be able feel decent and have a slice of pizza or a soda.

3 questions:
1. If my LES is not weak but rather, opens and closes intermittently, is there something that is causing this? Could stress be a significant enough culprit?
2. Do successful linx patients have a situation similar to mine?
3. Any thing differentiating about the non-acid vs. acid reflux that is important to consider?


Thank you. Paula
8/19/2013 3:45:48 PM
Brian E. Louie, MD
Mary,

At the current time, a LINX device is only indicated for the first time repair. There is no evidence that it can be used after Nissen fundoplication. If you have mild delay in your stomach emptying, often a Nissen is useful since in usual improves mild emptying probelms. You don't say why you had your Nissen reversed but that is an important piece of information.

You have a complicated situation which I suggest you discuss with a LINX surgeon near you.
8/19/2013 9:07:12 AM
Brian E. Louie, MD
Michelle, it sounds like your son has a challenging problem. I would agree with you that I don't think a LINX device is what he needs. It sounds as though his specialists aren't quite sure what he has either. Patients with achalasia should have a sphincter that stays closed and doesn't open very easily and it sounds as though they think your son's remains open. I would not be in a rush to have surgery until his physicians are able to give you a better sense of what they think his problem is.

One option is to consider seeing Dr. John Pandolfino at Northwestern. He is an expert in diagnosing achalasia but also has a lot of experience in swallowing problems involving the esophagus. And, he is in the same area as you are.
8/19/2013 9:06:30 AM
Mary
Dr. Louie,

Can the linx procedure be done if I had a Nissan fundoplication in the past and then a reversal of the Nissan fundoplication two and a half years ago? I also have a moderate stomach emptying issue would I still be able to have the linx procedure?

Thanks.
8/16/2013 4:19:23 PM
Michelle Rivera
Dr. Louie - my 26 year old son - we THINK suffers from chronic Achalasia. He has undergone every possible test to confirm that he does NOT suffer from typical GERD (2 endoscopies - Manometry - Swallow tests - Ph strip monitoring - CT scan, etc.)
Specialists at University of Chicago - have confirmed that he has no hernias - or diseases of the esophagus - but has a definite life-long weak swallow - and his lower esophagus flap - does not stay closed when eating or drinking. Even a sip of water - comes back up -

He has suffered chronic choking and coughing/hoarseness due to this situtation - since he was a small child... his earliest memories are of always choking after meals and liquids... he thought all humans were supposed to do this...

So - what do we do? What can he do to help cure his lifelong problem? It appears from all the comments I have read... that the LINX device is too strong of a device - and not appropriate? What about surgery to strengthen/close his lower esophagus flap? partial Fundoplication or Esophyx?

Can you advise? What should be his next steps? He is desperately looking for a fix - and he is wondering if surgery would help him?

Thank you -
8/15/2013 11:48:28 AM
Brian E. Louie, MD
SAGES is a reputable society

I am reading this into your post but I am assuming you have read a Society statement about Stretta.

As a matter of disclosure, I do not perform Stretta nor have I operated on someone after Stretta. So, I have no data or experience to answer your questions.

I suspect it would not change but it could. There are always potential complications from any procedure and Stretta would be no different. In patients undergoing ablative treatment which is what Stretta is you could bleed, perforate the esophagus and developed a stricture. These are all very unlikely.

Now my partner Dr. Aye did do Stretta several years ago. He gave it up because insurance would not cover it. In his experience some people improved but most did not and most people still needed PPIs.

The first repair still has the best chance of fixing the problem. And in my opinion does not fix the underlying problem leading to the reflux.
8/12/2013 7:12:20 AM
jacob
Dr. Louie,

SAGE is a reputable society correct? If a patient decided to go with a Stretta and it did not work, would it interfere with the success of a Linx procedure?

Even if a Stretta, doesn't work there aren't significant downsides to trying it, correct?
8/10/2013 10:55:53 AM
Brian E. Louie, MD
Ronda, I am not sure in which context you are asking about LINX and achalasia.

In general achalasia is treated with division of the lower sphincter and a partial fundoplication is used to control the resultant GERD. It is very uncommon for achalasia patients to have true GERD. They have burning symptoms but that is due to the food staying in the esophagus.

Are you asking because you have had surgery for achalasia and have developed gerd? In this situation treatment would be with PPIs. A LINX will still be too much pressure and make it harder for you to swallow. Perhaps in the future if they changed the strength of the magnets could it be used in this situation.
8/9/2013 11:19:08 AM
Ronda
Would you suggest the Linx for a patient with achalasia?
8/8/2013 11:15:53 PM
Brian E. Louie, MD
Nail,

As you can imagine, what each individual patient experiences is vastly different. About half of the patients experience no symptoms of difficulty swallowing or dysphagia.

If you have ever eaten bread and swallowed several bites quickly and then experienced the bread get transiently stuck, that is what most patients experience. They don't gag or choke. Some will try to induce a vomiting episode so it will come up. Drinking water especially quickly does NOT help and may make things worse. Simply relaxing, trying not to repeatedly swallow usually allows the food to pass.

Some patients experience a different sensation than they are used to. Others get a brief sensation of pain or discomfort.

I think what happens is that patients try to eat too quickly. Then the waves that push the food down transiently stop and it takes time to recover and then push the food through. Liquids do not seem to provoke this response. When patients are reminded that they need to each slowly and let the food pass, most patients experience very little symptoms. The actions of gulping or eating quickly are not conducive to effective swallowing.

In truth, old habits die hard in most patients but they all usually figure it out. Some later than others. I will remind you that most patients experience the most trouble at 2-3 weeks after surgery when the healing is maximal and then it usually resolves over time. A liquid diet has not been necessary for any of the LINX patients.

If the food does get stuck, then it is removed by an EGD.

I don't want this to dissuade you from a LINX but in an effort to make it more difficult for GERD to occur, you will have to get used to a new sensation in the esophagus. It may take some time to get used to but assuredly, most patients are back to normal after 3 months.
8/7/2013 10:53:06 AM
Nail
Dr. Louie,
I'm seriously considering getting the LINX, but still have one issue I'd like to understanding better. Could you explain what exactly does a patient experience when he has difficulty swallowing after the implant? Does he gag, vomit, choke or having the sensation of choking? Can the food remain stuck in the esophagus, and if so what then? How does it resolve in each such episode? Does drinking water usually resolve it right away? Can a patient go on a liquid diet indefinitely if necessary?

Thank you.
Nail
8/6/2013 10:52:34 AM
Brian E. Louie, MD
You are correct, the LINX devices come in different sizes and the idea is to match the device to the outer diameter of the esophagus.

While it may make sense that a 13 bead device in two different patients with different LES pressures may produce two different results, the actual function is not as you think. There are many reasons for patients having dysphagia including the peristalsis and strength of the distal esophageal contractions. The diaphragm likely also has a role. In fact the LES basal pressure probably has very little to do with the dysphagia.

In the patients we have studied who have had a LINX implanted, all of the LES pressures are within the normal range regardless of where they started. We are also finding that how patients eat has a lot to do with the dysphagia. For example, if the patients continue to eat quickly and gulp their food they all have dysphagia. Whereas, when the slow down and eat as they are supposed to the rate of dysphagia is very low.

I can also reassure you that the dysphagia does improve over time so that most patients do not notice or feel it.
8/5/2013 3:28:08 PM
Nazim Khan
Dear Dr Louie,
Thanks for putting up this insightful post. I had a query:
As far as I understand, the number of beads to be put in the LINX bracelet (and thereby the pressure that will be provided to the LES) is decided on the basis of the patient's esophageal diameter.
Now considering two patients with the same esophageal diameter but with different LES pressures of 5 and 8 units, respectively, wouldn't, say, the same 13-bead LINX device create a greater (or more than required) LES pressure for the latter patient, resulting in more dysphagia symptoms later on, apart from also being not good for the long-term health of the LES?
Would appreciate your thoughts.
Regards,
Nazim
8/4/2013 5:53:50 AM
APL
I just want to add a big THANK YOU to Dr. Louie for starting and maintaining this blog entry. I posted questions awhile back and received quick feedback/thoughts from him - as have so many others. For that, I am so very grateful. Thanks Dr. Louie and keep up the great work!
7/30/2013 9:57:09 AM
Brian E. Louie, MD
Jacob,

I think like many people, I don’t think the use of radiofrequency ablation for GERD is viable. In some of the original studies, patients reported that their symptoms were improved or gone, but when you tested them to see if there was still acid in the esophagus an overwhelming 70% still had reflux. The only difference – the patient’s were unable to sense the reflux which is not a good outcome in my opinion.

I have not read the long term study you posted and it has not be published yet so its hard to comment. The answer will be in the details: did the patients have symptoms and was the pH normalized or greatly reduced. If both to yes, then we may have to re evaluated radiofrequency ablation.

I have a hard time with endoscopic procedures because unless they address the fundamental problems such as hiatal hernia or lower esophageal sphincter shortening, they are not likely to be successful. It’s been over 50 years since Dr. Nissen first did his fundoplication. PPI’s were introduced in 1990’s and LINX was introduced in 2012. Hard to imagine an endoscopic procedure in 5 – 10 years. There is nothing on the horizon that I’ve heard of, but I’m sure someone will have something to trial soon enough.
7/29/2013 3:13:14 PM
Brian E. Louie, MD
Sam,

All patients should undergo a thorough esophageal evaluation. At Swedish, this includes a barium swallow xray, upper endoscopy, pH probe analysis when you are off the heartburn medication and esophageal manometry. Depending on your symptoms there may be some additional tests.
7/29/2013 8:55:40 AM
jacob
Does this seem believable to you ?

http://www.prnewswire.com/news-releases/stretta-procedure-for-gerd-successful-10-year-follow-up-data-presented-at-digestive-disease-week--sustained-improvement-long-term-efficacy-208047551.html
7/28/2013 11:37:54 AM
jacob
Dr. Louie do you have an opinion on radiofrequency treatment for gerd?

Do you foresee any effective endoscopic procedures for gerd developing in the next 5-10 years, so that patients can avoid laparoscopic surgery...
7/28/2013 11:10:15 AM
Sam
What specific tests are needed to decide eligibility for LINX surgery? I have serious LPR and need some sort of help!
7/26/2013 6:59:17 PM
Brian E. Louie, MD
Raven,

Yes, theoretically if the LINX device controls your GERD then the LPR symptoms should also resolve.

I have no idea about the company's plans for Oklahoma. I think you want your surgeon to be someone who has experience in managing esophageal conditions and has experience with Nissen fundoplication. With the current sizing device, I think it would be hard to make it too tight. Some patients will have swallowing symptoms for a short period of time regardless of the tightness.
7/22/2013 3:23:47 PM
Brian E. Louie, MD
Valerie,

A Schatzki ring is a result of having reflux. There are varying degrees of severity. Often its very mild but can be significant enough to cause food to stick.

At the moment, a signfiicant Schatzki ring is a reason to avoid a LINX. However, it is possible to treat the ring if its significant, by dilating you during your evaluation for the LINX. If its insignificant I would consider simply placing the LINX device. The ring should resolve once the GERD is controlled by placement of the LINX device.
7/19/2013 1:54:15 PM
Valerie Calhoun
Based on your experience and knowledge of LINX, would you perform LINX on a patient with Schatzki's ring AND do you think the patient would be able to have the stricture dilated if needed at some point post-LINX? Loaded questions, I know.
7/16/2013 2:25:02 PM
Raven Carter
Two Questions:

1 I have GERD and LPR. I want to know if I had the LINX surgery how much would it help my LPR? I seem to have silent reflux and just when I think I get my LPR under control.... I get heartburn. So it starts all over again.

2 I live in Oklahoma when do you think the LINX will be available here and when looking for a doctor to do it... how many LINX surgeries should they have under their belt. I hear if it ts too tight you can't swallow... and I want to make sure I get someone that has done it before to try to avoid problems.
7/15/2013 5:56:11 PM
Angie Waters
I have had two gastrocopies - the first found LES was tight and the duodenum slightly pitted, the second found LES "twitchy". Bravo test was normal and gastric emptying test only mildly delayed and within UK parameters. However for the past 15 months have had a persistent right sided sore throat with right ear pain and right-sided chest pain. Thyroid scans have shown benign nodules. The camera looking down my throat through the nose found nothing to explain the pain. It has been thought that I might have NERD with a hypersensitive oesophagus. I note from discussion in this forum that right sided throat pain may be related to an lnlet at the top of the oesophagus which can secrete acid. How is this detected and can it be resolved? Would I be a candidate for the linx procedure? PPIs and H2 blockers have not been effective. I am having ian ncreasing sense of discomfort with a globus sensation on the right side of my throat but my swallowing appears normal, although I have not had any tests for this.
7/14/2013 6:55:47 AM
Brian E. Louie, MD
Jacob,

Yes it is possible to have severe symptoms and minimal changes. Part of GERD is how the patient interprets the symptoms. Some patients have horrible esophagitis and high pH scores and have no symptoms.

It would be difficult to place the linx too tight with the current technique but not impossible. If it was a bit looser the reflux control may not be as good and you may still experience swallowing trouble. I think its best to size it the same as the esophagus. The swallowing almost always returns to normal
7/8/2013 1:15:02 PM
jacob
Also is it possible that the linx is being placed on too tight if it is causing trouble swallowing. Is it possible to place the linx more loosely to avoid this problem?
7/7/2013 1:19:48 PM
jacob
Is it possible to have severe acid reflux symptoms with minimal evidence of gerd on endoscopy or ph monitoring?
7/7/2013 8:28:43 AM
Edward Gibson
For Brian (from Chicago): I had my implantation done at Northwestern Memorial by Dr. Nathaniel Soper. I understand that Dr. Michael Ujiki, of the North Shore Medical system has also started doing linx procedures.
6/25/2013 9:32:47 PM
Brian E. Louie, MD
From what you have told me it sounds like you would be a potential candidate for the LINX device. You will need to undergo some evaluation to confirm that your body can handle the device. You will notice in prior blog comments people talking about pH tests and manometry.

Cost depends on whether insurance will cover the surgery or whether you wish to self pay. Swedish has a self pay option that if you are near to us we can discuss.

So far we have not encountered any complications. But it is still an operation and thus has the potential for complications such as bleeding. The device has not had any problems but if you read earlier comments we have been discussing erosion and the temporary trouble swallowing after surgery. Fortunately erosion is very rare.

If you wish to know if you are a candidate you should find a center close to you to be evaluated.
6/24/2013 9:52:47 AM
Brian
Edward Gibson: I am from Chicago and would like to know where you had the implantation done. I want to see if I am a candidate for this.
Thanks,
Brian
6/20/2013 10:33:18 AM
rhoda
I have GERD and a smallhiatus hernia.Have used all lifestyle modifications and have been on PPI for about 2 years but still experience severe retrosternal pain .choking at night despite sleepong at an angle .repeated rhinosinusities and ear pain.I have also had esophageal ulcers . My quality of life is severaly affected and am also afraid of having barrets in future. However I will prefer to have a less invasive and reversible procedure like the linx. Am I a good candidate.what is the cost and what are the complications to expect
6/20/2013 2:03:28 AM
Brian E. Louie, MD
Ray,

To detect erosion you would need an endoscopy or scope NOT a laparoscopy.

I don't know the answer to your second question.

If an erosion of the device was found the device would need to be removed. Most times it will heal after removal.

Sorry there is not a lot of info. With one case in Europe and none in the US there isn't much to tell you. What the blog has discussed in earlier posts is the lap band erosions and this is a very different device.

I think the risk is very small but it is not zero. Patients have a LINX should be followed by the surgeon in my opinion at regular intervals.
6/17/2013 7:21:25 AM
Ray
OK. So is the only way to tell for sure if linx is eroding the esophagus to go back in laproscopically or can the erosion be seen any other way?

When will the details of this erosion case be provided to the public?

If erosion is found can it be healed once the device is removed?

Sorry for all the questions just eager to get more info on this.

Thanks

Ray
6/14/2013 7:14:05 PM
Brian E. Louie, MD
To my knowledge there has been one issue with erosion of the device in the 1000 or so placed world wide. While I can't disclose the details of the case, I can tell you that ongoing follow up of LINX patients is necessary and when we, as a group, counsel patients about this option we make sure that the patients understand that ongoing follow up is necessary. If they are unable to comply with this, I am hesitant to place a LINX since the experience is so new.

There is obviously not a lot of data around this with LINX but in the lap band experience most patients are having symptoms such as discomfort or pain. Reflux may be apparent as will trouble swallowing. But, in some cases patients have no symptoms.

For our LINX patients we are going to follow them on a regular basis to assess their symptoms. They will also undergo periodic endoscopy to evaluate the device. How frequently I haven't determined but the first patients have just undergone repeat evaluation with EGD, UGI and pH testing and manometry now 6-9 months after the procedure. I suspect that I will repeat the EGD and pH testing if they have no trouble 1 year later.
6/14/2013 9:53:55 AM
Ray
Hello. Recently had linx implanted 2 weeks ago. From what I've read there have been no issues with erosion as of yet. My question is how does one determine if any erosion has taken place? Does imaging equipment catch this? Please explain how this is monitored with current linx patients.
6/11/2013 8:03:01 PM
Brian E. Louie, MD
I don't think it will come down to which is better. I think both control GERD very well. My impression is that LINX will be advantageous in certain patients and Nissen for others. Some patients will be able to choose one or the other. This gives patients and physicians more options than simply just pills which is the key message.
6/10/2013 8:23:53 AM
Nail
Dr. Louie,
I appreciate your clarification of a complicated issue in such simple terms that I and many like myself can understand. Since it is so counter intuitive, I would have never guessed that acid actually makes bile more friendly to the esophagus. Therefore, even though the bile theory is an unproven theory, it is possible that long term use of PPI might contribute to cancer risks for a GERD patient like myself.

My main concern with Nissen is that the procedure is not reversible, and it precludes any future use of the LINX implant, if I understand it correctly. While LINX is new, it is at least reversible.
How soon do you think we will see a definitive study to show which of the two procedures is better?

Thank you.
Nail
6/6/2013 6:01:54 PM
Brian E. Louie, MD
Nail,

I think that is a very tricky and controversial area to discuss. We could have a whole separate blog simply on this post.

At this point in time, no study has shown conclusively that PPI or Nissen will prevent esophageal cancer. This is most likely because no study has included enough patients to detect whether there is a difference. There are many reasons for this but they have to do with the fact that even if you have the precursor lesion - Barrett's esophagus - the likelihood of developing cancer remains incredibly small. And, there are patients who develop esophageal cancer and never had Barrett's identified.

There are smaller studies that clearly show that show the Nissen prevents the progression of Barrett's to cancer better than PPI's, but these studies can also be criticized.

One of the difficulties in this discussion is that we do not know all of the steps in how an esophageal cancer develops. There are several theories, but the two leading theories involve the presence of bile or the role of obesity. As a surgeon, the theory that seems to have more support is the one the involves bile. Bile at or near the junction of the esophagus and stomach is not a problem when the stomach is acidic, but when patients are taking PPI's they acidity of the stomach is altered as is the acidity that reaches up the esophagus. As the acidity is lowered, bile becomes more noxious to the esophagus. Acid is required to break holes in the lining and allows the bile to reach the key cells. This is overly simplified here but does represent one of the theories.

Logically, controlling reflux in this scenario with a surgical option has more appeal. In that sense either a Nissen or a LINX to control reflux over a PPI may have more benefit. However, that is going to be difficult to prove without thousands of patients.

At this point, even though it makes logical sense, I think the decision to have surgery - either LINX or Nissen - should be entertained because you have symptoms and wish not to take the medication or you have continued symptoms that medication does not control.
5/31/2013 9:30:13 AM
Nail
Thanks, Dr. Louie, I have a follow-up. I've read that 10-yr studies have shown that Nissen does not really reduce esophageal cancer risks. I know LINX hasn't been around long enough for a similar study yet. But I would be interested in your forward-looking opinion as to whether LINX would turn out to be better in this regard. (This issue has weighed on me greatly, especially because esophageal cancer is so deadly and because I have an 8-year old daughter whom I wish to live long enough to see graduating from College.) Given that you've seen patients respond so much better to LINX, relative to all other forms of surgical GERD treatments, in reducing acidity in the esophagus, and given the known link between acid-induced inflammation and cancer risks, wouldn't it be reasonable to conclude that LINX must reduce cancer risks? Or are there other variables in play here? Thank you.
5/30/2013 6:44:58 AM
Brian E. Louie, MD
Steve, the answer to your question is difficult. None of the patients we have implanted a LINX device on have had IBS. From our Nissen experience, we know that most patients do just fine with their IBS but clearly some experience an exacerbation or worsening of their IBS.

It's hard to predict what might happen. It will depend on your GERD symptoms and the symptoms that we believe are attributable to your IBS. I think patients with diarrhea and bloating have a harder time with Nissen and whether that will translate when a LINX is done is uncertain at this point in time.
5/29/2013 8:33:47 AM
Brian E. Louie, MD
APL,

Anytime surgeon's implant medical devices into patients, I think there is a very small but real risk of developing an infection around the device. Fortunately, that risk is exceptionally small.

For a new device like LINX there is not an accumulated amount of data surrounding this question. However, if we look at other procedures we can make a reasonable conclusion. In 2012, the American Dental Association and American Academy of Orthopedic Surgeons issued a joint statement that prophylactic antibiotics are not necessary in patients with hip and knee replacements undergoing dental procedures. In patients with heart valves who are undergoing dental or upper respiratory procedures, the recommendations is to provide antibiotic prophylaxis in this high risk group. Patients undergoing gastrointestinal procedures such as colonoscopy with a heart valve are NOT recommended to have prophylaxis.

I would conclude that antibiotic prophylaxis is probably not necessary with a LINX device. One must also remember that even if antibiotics are taken this does not guarantee prevention, and it also has some risk as patients can develop c-difficile colits from a single dose of antibiotics; not to mention the risk of developing antibiotic resistance over time.

Until, researchers and Torax provide evidence and a statement about antibiotic prophylaxis, it seems that they are likely not necessary based on data from other procedures where there more evidence that current exists for LINX. One should also discuss this with the LINX surgeon who is implanting the device.
5/29/2013 8:32:45 AM
Brian E. Louie, MD
Matthew,

There is no clear time frame on the horizon. We know that many patients are being approved for LINX implantation based on the data that has been published to date and more and more insurers nationwide are approving the device. However, there is a need for more data. Several studies are close to finishing and being published. These will help the process.
5/28/2013 9:59:02 PM
Brian E. Louie, MD
Nail, thank you for sharing your story.

Based on what you have written, I think you are candidate for surgical control of your reflux if maximal medical therapy (twice daily PPIs and night time H2 blockers) does not control your symptoms.

I think you could have either a Nissen fundoplication or the LINX device. The key will be how big is a mild hiatal hernia. In either situation, I think you'd have much better control of your symptoms if not complete control with surgery.

We (Dr. Aye, Farivar - my partners, and I) have placed 18 devices so far. We have only begun to reassess the first patients that received a device. I think they will all tell you that they are 100% happy with the results. Some of them may not have been so certain during recovery but by 4-6 months after placement the patients we have evaluated are doing well.
5/28/2013 9:58:17 PM
Matthew Johnson
Hi Dr. Louie,

I was wondering if you have any estimate as to when the LINX will no longer be considered an experimental procedure by insurance companies and will be more widely available. 5 years? 10 years? I understand this is dependent on data becoming available, are there any studies currently underway that might open some doors in this area?
5/27/2013 10:26:42 PM
Nail
Dear Dr. Louie,
Thanks for this blog which has been of tremendous value to me. I'm 51 and have had GERD for 2 years, on PPI+H2 blocker and been unable to sleep flat for as long. Endoscopy 16 months ago showed that I had 2mm Barrett's and mild hiatul hernia. I'm seriously considering LINX for the following reasons:

*sleeping on a reclined position has beginning to cause back pain, which I expect it to get worse
*I have been unable to sleep well because of nite time reflux and I'm sleeping on a recliner
*effectiveness of PPI declines over time; So every 2 months I stop PPI and use H2 blocker for 1-2 weeks, then resume PPI after that; but the H2 blocker is becoming almost totally ineffectively lately
*I still suffer daily heartburn, mostly mild, even when I'm on daily medications
*I have not been able to travel much, since I can't sleep on hotel beds, and prolong sitting in cabin gives me heartburn
*My motility test last year came back normal

Do you think I'm a good candidate for a LINX implant? Also, if you don't mind me asking, how many LINX implants have you performed, and how many of those would you consider a total success? Thanks in advance for answering my question.
5/27/2013 6:33:38 PM
Steve
Thank you for your previous reply, Dr. Louie. I have one more question for you - do you know of any patient with IBS who has had the LINX surgery? What kind of impact would the surgery have on that condition? Thank you so much in advance.
5/23/2013 6:52:55 AM
APL
Dr. Louie,

How vascular is the area where the Linx is placed? Would patients have to be cautious when dealing with any infections later on in life, for fear of bacteria seating themselves to the device? For example, if someone had dental surgery, would they need to take antibiotics prophylactically? Or what of common infections like bladder and/or sinus? Would those necessitate more careful treatment because of the implanted device?
5/22/2013 6:59:12 AM
Brian E. Louie, MD
We addressed this issue in an earlier blog post.

I think the LINX device is better than Esophyx. The opinion based on the control of acid by pH probe testing after the procedure, the reduction in use of medications and the potential complications of the procedure.

In addition, the LINX is easier to place and the variability in performing the procedure is less
5/21/2013 10:56:25 AM
Jerry Moon
How does this procedure compare to a Esophyx device procedure?
5/20/2013 9:10:30 AM
Brian E. Louie, MD
Post operative pain medication will be a choice between you and your surgeon and should be discussed in preparation for surgery. We typically use hydrocodone with tylenol elixir or Loratab. Most patients will use some for a several days and then transition to Tylenol or Advil.
5/16/2013 9:53:57 AM
Tracy
Hello Dr Louis.
I am looking into this surgery and am so excited that it is now being offered in Michigan. I was wondering what kind of pain medication is used after surgery and for how long. Anti inflammatories make my gerd worse and I am not a fan of narcotics. Thank you for all of the great info!
5/15/2013 1:29:08 PM
Brian E. Louie, MD
Yes, if the studies show that you have symptoms from non-acid reflux a LINX should help.
5/15/2013 10:52:01 AM
Steve
Hello Dr. Louie,
is the LINX also suggested in case of non-acid reflux caused by gastroduodenal reflux? Thank you
5/14/2013 12:30:36 PM
Brian E. Louie, MD
Losing weight may reduce your symptoms. I don't think we fully understand the patients who have no symptoms with a hiatal hernia.
5/13/2013 1:59:51 PM
Jason Betancourt
Dr. Louie,

I don't understand why some hiatal hernias don't cause any symptoms, while others do? If losing weight won't reverse it, do you think it can maybe reduce the symptoms?
5/13/2013 12:59:03 PM
Brian E. Louie, MD
Weight loss will not change the fact that you have a hiatal hernia. Nor will it reverse the hernia.
5/12/2013 10:36:36 PM
Jason Betancourt
Dr. Louie,

I doubt my cause is congenital because my symptoms started at age 23?Is there any chance that significant weight loss, even for someone who is only slightly overweight can help reverse the hiatal hernia?

Thanks,

Jason
5/12/2013 5:29:59 PM
Brian E. Louie, MD
Tom, I'm sorry to hear that your motility will not support a LINX device.

It's hard for me to second guess your surgeon without actually reviewing your manometry myself. As I written before, we will assess esophageal function by manometry, video barium swallow and symptoms. In patients with no symptoms of dysphagia or trouble swallowing (ie things get stuck) and a normal barium swallow (ie shows passage of food covered in barium or the marshmellow goes down), I will have the patient's repeat their manometry.

I personally think its difficult to swallow normally with the manometry catheter in place. Often the patient needs to have more time to get used to the catheter and the tech or nurse needs to be patient and take more time.

You mentioned that the mid portion of your swallow is weak but your distal pressures are 50 mm Hg. The most important portion is the distal pressure, but your surgeon was being appropriately cautious about the mid portion.

At Swedish, we would have offered you a partial fundoplication if your manometry is truly poor. You still may have some swallowing difficulties but many patients are willing to have better GERD control and will accept some swallowing issues. We have also found some patients will recover their esophageal function and have no problems.

You might want to return to your surgeon and gastroenterologist and talk about these issues in greater depth. I don't think all is lost. You may wish to also get another opinion.
5/6/2013 10:21:49 PM
Brian E. Louie, MD
Jason,

Not everyone will fit the process that has been determined. Constipation has never been identified as a risk factor for GERD or hiatal hernia. However, straining or bearing down probably are not helping you out in this respect. Some of my patients will tell you that when they are constipated their GERD is worse. This probably has more to do with things moving forward than anything else.

We have also observed hiatal hernias in young thin patients who don't over eat. Often they are thin and tall. This group of patients usually have a diaphragm defect as part of their cause for GERD and hiatal hernia that is likely congenital - meaning they were born that way.
5/6/2013 10:20:55 PM
Tom in NYC
Dr. Louie,
I'm lost and don't have a clue what to do from this point. I have been a GERD sufferer for 13 years. Taking Nexium 40mg once a day for the past 13 years. I went to see my Gastor and we spoke about surgery and it tuned out the Hospital my gastro works from elected to perform Linx. I have done my due-dilligence since Linx came out in Europe several years ago. I went to go see the Surgeon we spoke and decided to move forward. Had the pre-op testing and was looking forward to scheduling my Linx operation for May or June. Last Friday I went to see the surgeon and I felt like my whole life turned upside down. We were going over my manometry reults and it tunrs out I have poor motility. Im not emptying properly, I had 6 ineffective wet swallows out of 10...my number were low. He said based on the numbers that I have Linx is not an option neither is a Nissen or Toupet. He said that I would probable "pool" if I drank and I would suffer a great deal dysphagia if I ate. He was apologetic but he said it would "theorhetically" cause me more harm than good based on the manometry. I have to continue using PPI's. Mind you Im worried out of my mind for many reasons. On my last endo this past April they found another 5mm segment of Baretts (so now I have 3). I suffer from baretts, a weak, loose esophagus, everything keeps coming up on me and I can't get an operation. Could a manometry exam be wrong? If I were to take another one would the numbers change? I feel terrible. I feel that a cancer patient has more options than I do. My distal esophageal amp was good around 50. Its the middle part of my esophagus that is weak. What do I do? I feel that either this disease or the drugs is going to end it for me, and my quality of life is terrible. Any suggestions?
5/6/2013 4:00:55 PM
Jason Betancourt
Dr. Louie,

But I am a young guy, 24, not overweight, no family history of hiatal hernia, but I did have constipation for a long time and I have a hiatal hernia. I doubt overeating caused it, but I guess it's impossible to know for sure? So most of your hiatal hernia patients don't have a history of constipation?
5/6/2013 9:03:17 AM
Brian E. Louie, MD
Jason, straining and constipation are not thought to be part of hiatal hernia development. The most common risk factors are older age and GERD. It is thought that the constant distension of the stomach due to over eating stretches out the valve and this wears on the diaphragm allowing more and more stomach to push up through the diaphragm.
5/6/2013 7:46:45 AM
Stephen Ferris
I have read somewhere that with the LINX device you can no longer have an MRI. Is that true and is there any way around this limitation? I realize a CT scan might be an alternative in some situations, but not always. Besides, I for one would like to avoid exposure to X-rays as much as possible.
5/3/2013 4:29:51 PM
Jason Betancourt
Hi Dr. Louie,

I was wondering if you think that constipation and straining on the toilet is the main reason why most adults develop hiatal hernias? Do you think that this is largely a preventable condition?
5/2/2013 11:19:33 AM
Brian E. Louie, MD
Miguel,

Yes, theoretically the device is removable and since the dissection to place it is minimal, there should be minimal scarring.

Simple closure of the hiatal hernia was performed over 50 years ago and shown not to work in the majority of people. However, some people will benefit. The challenge being that there is no way to determine who those patients are.

I personally have not removed any of our implanted devices. We have had the occasion to remove a lap band and the create a Nissen which was reasonable. I would think that creation of a Nissen after LINX removal would be feasible.
5/2/2013 9:25:30 AM
Brian E. Louie, MD
APL, the natural history of a hiatal hernia will be to enlarge very slowly over time. But, part of the change is dependent on the constant stretching of the flap valve due to over eating and the resultant acid reflux. In theory, if the reflux is stopped and then the hernia may stay the same size. Unfortunately, I don't think we have enough information to be certain about changes after the LINX device is placed.

In terms of erosion, this has nothing to do with how we eat. It has to do with pressure on the organ. Since the LINX is placed to match the circumference of the esophagus, it should not exert pressure on the esophagus and thus not erode.

I don't think anyone has determined whether antibiotics before other procedures are necessary but I think its reasonable to follow established guidelines to take antibiotics before higher risk procedures such as those involving dental work or intestinal surgery.

Since placement of the LINX is entirely elective, I would have my hip fixed first and then decide about the LINX after. However, if you are having a LINX first, you might want to wait a month to make sure everything goes smoothly before embarking on another surgery.
5/2/2013 9:24:18 AM
APL
Thanks for your response Dr. Louie.

You mentioned that the "learning curve" may involve following outcomes of repairing or not repairing a HH when placing the Linx. If you find a smaller HH (e.g. 2cm), place the Linx but do NOT repair the HH.....will the HH become larger or increase in size over time if not repaired? Or does it generally stay the same size for the remainder of your life?

With regards to possible erosion outcomes, do you think that patient eating compliance (e.g. taking smaller bites, eating smaller meals, etc) will influence the development of esophagus erosion. That is, will eating normally (i.e. larger meals) facilitate more pressure/contact from the Linx device and thus cause possible erosion.

Is there post op restrictions with respect to future surgery (e.g. similar to joint replacement operations where you are encouraged to take prophylactic antibiotics with any future surgery). I was a college tennis player who suffered a hip injury and I'm in line for a hip resurfacing this summer. If I have the linx placed, how long would I have to wait before my hip resurfacing?

Thanks again for keeping this blog. It is informative for those of us who suffer from GERD without relief from traditional relief measures.

Cheers
4/30/2013 10:46:23 AM
Miguel Toros
Dr. Louie,

Let's say you do a Linx operation with a HH repair and problems are experienced after the operation. Is this operation truly reversible?

What sort of scarring or damage is done by the procedure and will this influence my future options?

1) For instance, if a hernia is corrected and a linx device is removed, what are the odds that I could feel better without a subsequent nissen? (Just the hiatal hernia repair left over)

2) If I need a Nissen done, will there be any difficult in performing a 2nd operation after the 1st linx operation?
4/29/2013 9:41:25 PM
Brian E. Louie, MD
Since we have not identified a device that has eroded, it will be difficult to be exact. If we use the experience of patients who have a lap band that erodes, the patient may experience nothing since it happens very slowly over time or a patient may experience recurrent heartburn, difficulty swallowing or even fevers and chills. Removal of the device could be done endoscopically by identifying the sutures that hold the device together and cutting them or more likely a laparoscopy to remove the device. Both of these methods have been used in eroded lap bands. Whether that’s all that will be required will depend on the situation.

I don’t think anyone knows what the learning curve is for placing the device. It has not taken us very many cases to be comfortable putting the device in and I’m sure that an experienced surgeon like Dr. Park will have no difficulty. Having said that what my partners and I have been talking about is whether the outcomes of the device are influenced by how me manage the small hiatal hernia (to close or leave alone). This has nothing to do with the learning curve, but speaks to refining the steps of placement.

The magnetic field does not extend very far away from the magnets and is unlikely to cause problems. The examples you identify are much bigger and different fields. The tissue the device is placed on is actually very healthy and not damaged by GERD since this occurs on the inside of the esophagus and rarely involves the outside tissue.
4/29/2013 3:10:32 PM
Brian E. Louie, MD
Sergio, even a 1 cm hernia is considered abnormal since it is not supposed to be present. However, at that size, the more important questions is are you having symptoms of GERD and are you able to manage those symptoms with medication. If you are having no symptoms at all, I would not be that concerned.
4/29/2013 2:55:35 PM
Brian E. Louie, MD
Hosein – I’m sorry that you did not find my response in the blog, but it is posted below on 4/12/2013.

Your situation is fairly complicated and will be difficult to answer all of your concerns in a blog post.

In my original reply to your post, I had asked you to clarify your situation because I was uncertain when you had the pH tests. For example, if you had pH testing after the fundoplication and on PPIs with normal pH testing then one cannot determine if GERD is the cause of your symptoms. I would suggest that you have repeat testing off the medication to first determine if the fundoplication is working.

In this situation, I don’t think that LINX is going to help you since you’ve already had a fundoplication. I think the most important step for you is to undergo testing while off the medication to determine if the fundoplication is working.
4/29/2013 2:54:58 PM
HOSSEIN JALALI
dear DR.LOUIE
IN PREVIOUS EMAIL THAT I SEND FOR YOU I ASKED YOU TO HELP ME ABOUT MY GERD AND LINX THERAPY IN GERD AND BARRETS ESOPHAGITIS BUT I DIDNT RECIVE ANY ANSWER.
NOW I WANT TO KNOW:
1- IS THERE ANY CLINIC OR INSTITUTE IN ASIA(ANY COUNTRY)THAT I CAN REFER AND TAKEING DATA ABOUT LINX?
(I AM A LAWYER LIVE IN IRAN BUT I CAN TRAVEL TO ANY COUNTRY THAT NEEDED)

2-I PREVIOUSLY WENT UNDER NEISSEN FUNDAPLICATION ABOUT TWO YEARS AGO AND ALSO USE PPI FOR MANY YEARS WITHOUT SIGNIFICANT IMPROVMENT AND IN PREVIOUS WORK UP BARETTS ESOPHAGITIS WAS SEEN AND MANOMETRY AND PH-METRY WAS NORMAL .DOYOU THIK THAT I HAVE ANY BENIFITS FROM LINX?DO YOU OFFER ANY OTHER TREATMENT?
WITH THANKS
4/29/2013 8:08:59 AM
Sergio
Hi
It's a 1cm hernia something to worry about or is this normal size?
4/25/2013 6:49:05 PM
APL
Dr. Louie,

How would you know if the device was eroding into the esophagus (symptoms?) and what imaging would you use to assess and confirm? And if severe erosion occurs, how might you fix or approach that problem?

For patients that are not located near your center and searching for surgeons closer by, what do you think the learning curve is for this procedure? I scheduled to see Dr. Adrian Park here in MD and he is well respected in the area, especially for GI surgeries, but I'm not sure how many he has completed.

Any thoughts on the long-term consequences of subjecting the surrounding tissue to magnetic fields? Especially considering this is tissue that has been consistently injured due to acids exposure. The magnetic field exposure cancer link is inconsistent and generally looks at Power lines and Electric Blankets...
4/24/2013 1:01:48 PM
Brian E. Louie, MD
Mark, I think there may be a role for surgery in your case, but to make that decision you would need to have a complete evaluation or at least have your older studies reviewed. Surgery can worsen the gas bloat and the spasms, but your nutcracker esophagus could be due to the fact you have reflux/hernia and that is triggering the higer pressures. We have performed a Nissen for some of these patients and with better control of their GERD, the motility has improved.

We have not used the LINX for this scenario but there is no reason to think that we could not unless we uncovered a reasons during evaluation (like your hernia was larger than 3 cm) in which case a Nissen could be used.

Your situation has many complexities that should be discussed with an experienced esophageal surgeon.
4/24/2013 10:23:04 AM
Brian E. Louie, MD
Rick,

Unfortunately, being FDA approved does not automatically translate into the "standard of care". At this point in time, Nissen fundoplication remains the standard of care because it has a long track record. The LINX device, while it has excellent early results, needs much more accumulated evidence to be deemed standard of care.
4/24/2013 10:17:46 AM
Brian E. Louie, MD
33333, thanks for the link. Since we don't use that device for sizing I wasn't aware of it. However, I did speak with Torax and they assure me that the issue has been dealt with and corrected. Currently, there have been no issues with that device since the changes were made.
4/24/2013 10:16:40 AM
Rick
Now that the LINX procedure has passed the trial period as well as FDA approval, can it be deemed a "standard of care" I'm assuming similar to the Nissen fundoplication procedure? Having it classified as such would open the doors to the procedure being covered in the U.S. by Canadian health care insurance. much appreciated!
4/23/2013 9:15:00 PM
Mark
Dr. Louie,

I have a small hiatal hernia with intermittent reflux, nutcracker esophagus, and chronic burping. I take PPIs twice daily and have made lifestyle changes. I have read that surgery can worsen esophageal spasm and gas bloat, but doing nothing seems like an equally bad option. I'm attracted to the less invasive nature of LINX. Would a hernia repair by itself, or the LINX system be helpful?

thanks
4/23/2013 1:40:41 PM
33333
Dr. Louie,

No worries, and thanks for being thorough.

This is what I read regarding the sizing tool dislodgement:

http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con208690.pdf

Thanks!
4/22/2013 3:11:23 PM
Brian E. Louie, MD
Pat, please see my prior comment.
4/22/2013 8:46:39 AM
Brian E. Louie, MD
33333,

Sorry for taking so long to reply but I wanted to talk to the company about the other sizing device.

First, I am not sure what you mean by dislodgement.

The only sizing device used in the US is the one with the colored beads at this time. When this device is used if the magnets do not hold or dislodge that is a sign that it is too tight and we should go to a larger size. If the circumference of the esophagus is between sizes we have been going one size larger to avoid the risk of a pinch and possible erosion and because the egd shows a closed LES which we feel is appropriate.

The device is placed through a small tunnel behind the esophagus. You are correct it is not sutured in place but with the small tunnel and being placed inside a large nerve - the vagal nerve the device should be secure.

Since the normal LES has some movement to it, its likely that the device will move a little bit with it as well. I don't think this will affect the outcome.

Remember the device is not supposed to "pinch" the esophagus. The device is to prevent the LES from opening to readily. Before placement the LES may gape open but once the device is placed the LES looks closed. At Swedish we scope everyone to assess the LES after placement and they have all been closed and stay closed as more air is placed in the stomach.
4/22/2013 8:45:57 AM
Pat
Doctor Louie:
While In surgery and if your LES is relaxed, floppy, (open) , how can you determine the correct size (number of beads) for your Linx. It is my understanding that the Linx only 'supports' the LES. If that is the case then wouldn't you still be refluxing after the Linx is implanted on a relaxed LES? Thank for providing us with this wonderful service.
4/20/2013 3:28:56 PM
Brian E. Louie, MD
Cheryl, I am sorry to hear that your experience with the Nissen has not been ideal.

From the description of symptoms you have provided it does sound like something has happened to the fundoplication. The most common finding would be that the Nissen has migrated up into the chest much like a hiatal hernia. The alternative is that it loosened and is not functioning.

In either situation, I would suggest you be reevaluated especially since you have lung related issues. As I mentioned in another blog post, there is no data for the LINX in a situation like yours and given what you described you are better suited to consider having an experienced esophageal surgeon redo the fundoplication if the studies support that or discuss other alternatives.

To answer your other questions, there is no prescribed CT surveillance in your situation but many pulmonary and thoracic surgeons would repeat your scans yearly for 2 or 3 years to see if the changes are progressive or when symptoms dictate. Nexium long term is generally safe but if you are not completely symptom free with the medication it may be time to be re-evaluated.
4/17/2013 9:40:40 AM
Brian E. Louie, MD
Roman,

Thank you for your kind comments about our center and group.

How long a Nissen fundoplication will last is dependent on many factors and just about every surgeon would love to believe that they all last forever but that is not true. If we look at some of the well done long terms studies the majority of Nissen's last over 12 years. In one of the largest and well conducted trials, over 75% lasted over 12 years and this was better than patients who were on PPIs. When we look at our own results, we are just above that with between 80 and 85% doing well and off meds.

At the current time there is no data for placing a LINX after a previous fundoplication. We have been thinking about this issue but don't have any concrete answers just yet. The placement of the LINX device has to be at the bottom of the LES. If a patient has a failed fundoplication, it would have to be completely dismantled in order to place the LINX device and without any natural attachments may be prone to migrating. As we gain more experience with the device we may have a better answer to your question.

I don't think we have formed an opinion as yet about how the LINX compares with the Hill. But, as one of the few groups that have an experienced surgeon (Dr. Aye) who performs the Hill procedure, we will be comparing our results this summer to a series of Nissen repairs and Hill repairs to see if there is any difference. Stay tuned.
4/17/2013 9:38:26 AM
Roman
Dear Dr. Louie
I had an LNF in a foreign country (Saudi Arabia) in 2010. After continued suffering I saw Dr. Aye in your clinic in Feb 2011 and then Dr. Deschamps at Mayo in MN. They both couldn't find anything abnormal and told me that the surgery was well done. In the end it turned out to be a different problem (biliary+anxiety+functional) diagnosed at the U of MN, but I still was very impressed with your center and the staff. My questions are three:

1. A very famous but a bit "too specialized" functional disorders specialist told me that the Nissen would not last more then 6-10 years and eventually I would need a revision or roux-en-y for my reflux. Is that true?

2. Why wouldn't in your opinion the Linx be offered as a revision to a non-complicated failed LNF? Are you aware of any studies in that direction?

3.How does linx ccompare (even subjectively) to Hill repair? Are there any opinions on that?

thanks in advance,
your "fan".
4/16/2013 2:37:17 PM
Brian E. Louie, MD
Raul,

Our patients are telling us that the second week after surgery is the most difficult with swallowing trouble. But, as time goes on the swallowing becomes easier and easier. I think that has to do with the healing going on in the body and the need to make the magnets open and close.

I think part of the learning process after LINX implant is how people eat. We have had much less trouble when patients eat a bit slower and try not to guzzle liquids. This simply creates more trouble. It makes you marvel at how well a normally functioning sphincter works.

Only one of our patients had difficulty with the foamy nature of saliva. This is easily solved by sipping on a bit of liquid to wash the saliva down during times when nothing is being ingested or after an overnight sleep.

The bottom line is that as good as the LINX or even fundoplication are at controlling GERD, neither of them are perfect substitutes for your natural sphincter. There is always a trade off but my patients will likely tell you that they would take some minor difficulties in the short term and some minor lifestyle changes over ongoing acid reflux.
4/16/2013 9:25:39 AM
Raul Johnson
Hello Dr. Louie -

I have been reading through various online forums, including this one, that people who have had the Linx implanted are having trouble swallowing. In addition, some are having their saliva backup due to the low weight of it and not passing through the LES.

What might be your take on these problems?
How about your patients?

Thanks,

Raul Johnson
4/15/2013 11:07:12 AM
33333
Hi Dr. Louie,

After watching a LINX surgery footage, I have a few questions about the sizing and the positioning. I was hoping if you could shed some light on the following:

• I’ve read about the sizing tool dislodgement. Has this been resolved?

• From what I’ve seen, there are two kinds of sizing tool: 1) the precision sizing tool (the thin black “stick” with a white “loop” at the tip. 2) the colored beads. Which one is more precise?

• If the circumference of the esophagus happens to be in between two sizes, which size is to be used? Why?

• Let’s say the top of the stomach is point A, and the bottom of the diaphragm is point B. It looks like the LINX is placed around the esophagus between point A and point B but without being “secured” at a fixed spot (I could be wrong). So the LINX can move up and down between point A and point B without affecting the outcome? I wonder what will happen if the circumference between those two points is not the same?

• A weak LES looks like an opening on the pictures (if that really is what the LES looks like inside), if the LINX is placed around the esophagus without any additional pressure, that opening will then remain unchanged when the LINX is closed? So when someone is not eating / drinking, and there is no distension, reflux can occur as if the LINX isn’t there? This part really confuses me.

I know this is a long one!

Thank you!
4/15/2013 2:38:57 AM
Brian E. Louie, MD
There are two parts to your post.

First, the question of Barrett's and LINX. In the recently published results from the New England Journal of Medicine, patients with visible Barrett's were not included in the study so we do not have any data on patients with Barrett's and a LINX device. However, there are degrees of Barrett's that range from biopsy findings only to patients with 10 cm or more. These are vastly different patients. So, this is a long way of saying it will depend on how much Barrett's, how strong you native valve is, and how functional your esophagus is.

Second, the worsening symptoms. I'm not sure if you are saying that the PPI's have never helped you or have not been able to control your symptoms more recently. If you have never improved on PPI's then I wonder what is going on because PPI's usually help most people to some degree. You may benefit from GERD testing with pH monitors, EGD and a manometry. I would encourage you to see a specialist in esophageal disease.
4/14/2013 6:49:02 PM
cheryl carroll
I had the nissen fundoplication about 10 years ago.It disrupted about a year later and I have been on Nexium 40 mgs. each day and within last 6 months have also been taking prevacid at night..I still have to sleep almost sitting straight up in an adjustable bed. I have a feeling that is like a hiatal hernia coming back. Is this possible? Am praying for a proceedure that will work to help me. I have scar tissue in my lungs from previous aspirations of acid and bronchitis and pneumonia. The scar tissue shows up in the form of calcifications. Had ct scan 5 years ago..How often should I have ct scans? also, is it dangerous to continue on Nexium for so long? Thanx in advance for ur help.
4/14/2013 2:07:29 PM
Diane Doss
Hi are patients with Barrett's esophogous good candidates for the LINX procedure. All PPI medications have been tried without any relief of symptoms. Symptoms start late afternoon and last all night been since Nov and worsening. Thank you
4/13/2013 7:55:39 AM
Brian E. Louie, MD
Michael,
LPR or laryngo-pharyngo-reflux occurs when acid reflux reaches the back of the throat and produce symptoms such as hoarseness, throat clearing, or globus (a sensation of something stuck in your throat). In this scenario, patients may or may not have symptoms of heartburn or acid reflux.


Theoretically, since LINX is effective against acid reflux, then it should also be effective against LPR.
4/12/2013 11:30:10 AM
Brian E. Louie, MD
If I understand your situation, you had heartburn and underwent a Nissen fundoplication, but have persistent symptoms of a burning sensation on the right side of your throat. The pH studies you had were they done before surgery and after surgery? If they were after surgery and the pH studies show that you do not have acid reflux then its unlikely that your throat burning is related to acid reflux. It could be that you have an inlet patch which is an area of lining at the top of the esophagus that resembles stomach lining and secretes acid. 15 to 17% of people have an inlet patch.

LINX is unlikely to help you in this situation since you already have a Nissen.

I suggest you discuss this with your GI team.
4/12/2013 11:27:55 AM
Michael Grey
Can you explain the difference between LPR and acid reflux? If you have LPR will the linx benefit you?
4/11/2013 12:30:44 PM
hosein jalali
i have suffering from the GERD since many years and take many kinds of medications and also went under foundaplication(neissen) about 2 years ago without any significant improvment.
But i still suffer from burning sensation only in my throat(in right side)without heart burn and my problem specially worsens at night.
all previous studies as PH-METRY and manometry was normal and endoscopy showed some evidence of barret,s esophagitis.
what is your idea about my disease and how you can help me?
do you think that i can use the LINX system?
with great regards.
4/10/2013 11:45:07 AM
Brian E. Louie, MD
The risk of hernia is dependent on many factors. The single site platforms have seen a higher incidence of hernia because its single port requires an incision that is about 2 cm near the navel and in the midline. This area around the navel seems more prone to hernia formation and the pressure placed by the device seems to be a contributing factor.

By comparison, the incisions I use for LINX are 5 mm stabs in areas where hernia formation is less likely. The biggest risk is the camera incision which is 1 cm is not in the midline and doesn't have the risks of a single port. We haven't seen a hernia using these ports in over 1000 laparoscopic antireflux repairs (knock on wood) so I don't think the incisions are an issue even for cosmesis which is the reason for single port.
4/6/2013 9:02:15 PM
Jason Betancourt
Dr. L,

Doesnt each incision create risks for hernia in the future?
4/6/2013 7:37:25 PM
Brian E. Louie, MD
Jason,

The dissection is very minimal compared to fundoplication. So the scarring is usually very little

I currently use 5 incisions. 4 are less than 5 mm or 1/4 inch. I don't know if anyone has attempted this with the single incision platform but it may come with experience. Having said that the small incisions are barely visible after a year so I don't see a benefit to single incision.
4/5/2013 10:56:56 AM
Brian E. Louie, MD
Pat,

If the device has migrated then it suggests that there could be a hiatal hernia. It could also mean that the device is not around the sphincter and therefore not doing the job. In either situation, these may lead to you have some element of GERD.

There is no "usual" correction since as far as I know this is the first I have heard of a potential migration or movement of the device. I also can't speak for what your surgeon may or may not do and he/she knows what your anatomy looks like.

If it were me, I would consider a laparoscopy to see what has happened with my own eyes and not a barium swallow. If there is a hiatal hernia, I would repair it and try to preserve the LINX. If it has moved, we have to determine why it moved and if there was something we could do to keep in position and allow you to keep the LINX. It may not be possible to preserve and a fundoplication would be an option.

I would encourage you to discuss these questions with your surgeon.
4/5/2013 10:55:55 AM
Jason Betancourt
Dr. L:

How invasive is the dissection to implant the linx? Does a lot of scarring occur inside the abdomen?

Also how many incisions have to be used? Is there a way of performing the procedure with one incision?
4/5/2013 7:45:01 AM
Pat
Doctor. Louie, thank you for your response. If migration or movement is the cause of my ongoing reflux, what is the usual correction for it? I don't want the Linx removed as it has been partly helpful.
Thank you very much.
4/2/2013 4:30:32 PM
Brian E. Louie, MD
Pat,

It is hard for me to tell you what the signficance of these findings without reviewing the films. What you are describing is migration or movement of the LINX device into the thoracic cavity. It probably is part of the reason you are still having reflux symptoms.

I suggest you return to discuss these findings with your LINX surgeon.
4/2/2013 9:09:55 AM
Brian E. Louie, MD
Bradley,

The concept behind the LINX is to prevent the native sphincter from opening to easily to distension of the stomach. This in part is how reflux develops. The LINX makes is harder for the sphincter to open thereby preventing GERD.
4/2/2013 9:09:10 AM
Pat
I've had two post -implant barium swallows that show the Linx riding or tenting above the diaphragm. What is the significance of this. I still have reflux but not as bad as before. Could this be the cause. Could there be bile ? Thank you very much for all the information you provide. Thank you Doctor Louie
4/1/2013 9:59:05 AM
Brian E. Louie, MD
I look forward to meeting you in the office. In general, most patients with poor peristalsis will be able to have a partial fundoplication. The reason we suggest this is because Achalasia is a disease where the motility of the esophagus disappears and is probably the worst peristalsis. These patients do well with a partial fundoplication.

There can be a discrepancy between the barium swallow and the manometry. This is a challenging situation and we often draw upon your systems and the two tests. It's also not unheard of to repeat the manometry if we think there is something that doesn't add up.

Let's review your studies and we'll make a plan together
4/1/2013 8:30:17 AM
Brian E. Louie, MD
John,

I think this would depend on your symptoms, but mild delayed gastric emptying would not disqualify you from getting a LINX. However, there is a good rationale why fundoplication would be a better choice in this situation. Often, mild delayed gastric emptying will resolve entirely after fundoplication. There is no data that tells us that this would resolve with the LINX and theoretically would not change with simple placement of the device.
4/1/2013 6:54:41 AM
Brian E. Louie, MD
Edward,

We do not know what the causal factors are that drive the symptom of dysphagia. I have been asking my patients about their experiences and will be posting a summary of their experiences in the coming days because their experiences have been similar to what you described. For the first couple of days no trouble, then some difficulty with swallowing that lasts for several weeks which then subsides and goes away.

I don't think this has anything to do with the device and agree with your theory about what happens. I think it has to do with the phases of healing that the body goes through. Right after surgery the device is free to move. After a week it is likely covered or being healed into a fibrous capsule which pulls on the normal tissues and gives rise to the sensation. With further healing, the device is covered and functioning independently in this capsule and with the surgical swelling gone, the sensation resolves.
4/1/2013 6:54:00 AM
33333
Hi Dr. Louie,

I was just informed by my surgeon that a fundoplication was a no go because of my poor peristalsis. Even a partial fundoplication was still a no. I’m little disheartened.

It turned out that my surgeon knows you and said you are a good guy! Small world. He will be sending you a letter/referral. I believe you should receive it sometime this week. I’ll definitely contact your office.

In general, can a patient with ineffectual peristalsis have a negative barium swallow? i.e. the items used in a barium swallow flow freely to the stomach with no functional or structural abnormality.

Thank you!
4/1/2013 3:07:57 AM
Bradley Jensen
Hi Dr. Louie,

You made a comment in your post on 3/22, that The Linx is placed around to just be the size of the esophagus so as not to put any pressure on it.

Well, if that is the case, how does the Linx stop reflux?
Doesn't there need to be some additional pressure to close the LES?

I'm confused. Could you please explain this to me?

Thanks,

Bradley
3/31/2013 2:37:43 PM
John
Hi Dr. Louie,

Would mild delayed gastric emptying prevent me from qualifying for the Linx procedure?

Thank you,

John
3/28/2013 7:00:55 PM
Edward Gibson
Hi Dr. Louie,

I had the LINX device implanted in Chicago on March 12. I'm happy with results and recovery so far, but now I've entered into the dysphagia phase (which kicked in 7 days after surgery and has intensified in the past week). I know this is usually a normal phase LINX patients go through, and I'm not writing to ask you about my case specifically.

This is my question: do we know the causal factors driving dysphagia in the weeks after LINX implantation? Why does it usually start a week or two after surgery, and why does it usually subside several weeks later? Is it something about the magnetic device itself? If so, why would a magnetic mechanical device perform so variably at the outset (this isn't a "breaking in" situation, is it)? Is it something about the esophagus adjusting to the implant and the formation of the scar tissue that creates resistance and over time gains elasticity?

I know that at this point answers might be tentative, but any light that you could share on this question would be most appreciated.
3/27/2013 11:42:10 PM
Lucas in Denver
Hi Dr. Louie,

Just wanted to say thanks for all your forthright answers! This is far and away the best and most informative discussion on the Linx device I've found online.

I wish more physicians were open to interacting with patients like this!

Thanks!

Lucas
3/27/2013 9:49:47 AM
Brian E. Louie, MD
Usually the stomach stays in the abdomen. What does move is the lower esophagus since it straddles the abdomen and chest. As you swallow, there is upward and downward motion of the esophagus that helps propel food into the stomach. During shallow breathing its very likely that the stomach is moving very little. It may be that you are sensing movement of a fluid - called regurgitation up the esophagus or another sensation all together.


The assessment of a hiatal hernia is not only done with a barium swallow. Often, we use upper endoscopy to look with a fibre optic camera inside the stomach and esophagus to help understand the barium swallow.
3/27/2013 7:59:41 AM
jordan
thanks for answering.


is it normal for the stomach to move up and down very mildly when you're shallow breathing? i don't know, i've just noticed it before i had the barium swallow - in fact that was the whole reason why i had it done. test came back up as everything perfect.
3/26/2013 1:31:56 PM
Brian E. Louie, MD
Yes, a small hiatal hernia can be missed on barium swallow.
3/26/2013 8:49:17 AM
Brian E. Louie, MD
33333,

You're welcome.

At the moment, the patients who have had LINX implants have had > 70% peristalsis, but that doesn't mean with 50% peristalsis you would not be a candidate for the LINX. I would want to consider your entire history, the barium swallow and the manometry together to make that decision with you. Historically, we have seen patients with manometry similar to yours and performed a Nissen fundoplication with good success. By applying similar logic to the LINX we should be able to achieve a similar outcome.

We have just put together what's called a self pay option for patients who are out of country or have insurance plans that will not cover the LINX. We have been getting inquiries from other Canadians like yourself and have been reviewing their studies in preparation for implantation.

I suggest that you contact my office so we can review your records and provide you with the self pay details. We can decide together if this is something for you.
3/26/2013 8:48:50 AM
jordan
Can a small hernia be missed on a barium swallow? As my stomach keeps moving as I breathe in and out.

Thanks.
3/24/2013 7:11:07 PM
33333
Hi Dr. Louie,

It’s great when a doctor is willing to devote his/her time to do a blog like this, a good sign!

Generally speaking, if a patient has mild impairment of esophagus mobility (50% ineffectual peristalsis), is he/she still a candidate for LINX?

I was wondering if Swedish accepts patients from outside the US, if so, how does it work? I’m from Canada and the pre op exams are done (24 ph impedance test, barium swallow, endoscopy, manometry, etc) for a possible fundoplication, but I’m more interested in LINX.

Would you be able to provide me with a ballpark figure of how much the LINX surgery would cost (including everything)?

Thanks!
3/24/2013 3:56:21 PM
Brian E. Louie, MD
Lucas, there are no long term activity restrictions that I know of at the current time. I have been placing patients on a modified activity regimen for about 4 weeks but removing it after that time frame. Most patients are back to their usual activity by then but strenuous physical activity I would such as you are describing I would consider 3 months minimum.

There is no evidence that I am aware about strenous activity causing dislodgment but remember there is limited follow up. If you base your decision on other surgeries, nothing should prevent you from doing the activities you have listed once you are fully healed. These are questions you will want to discuss with the surgeon who does your surgery.

It is not the swallowing muscles, but the natural peristalsis of the esophagus that we worry about fatiguing or wearing out. In research studies where a ligature was placed around the esophagus, the peristalsis or motility became absent. This was a tight tie UNLIKE the LINX which is place around to just be the size of the esophagus so as not to put any pressure on it. So, in theory nothing should change.
3/22/2013 2:31:40 PM
Lucas in Denver
Hi Dr. Louie,

Thanks for all the great discussion on the Linx! I'm seriously considering it for my long standing reflux issues, but I'm curious about a couple items and I'm hoping you can help.

1. What are the long term activity restrictions for this device? I understand that scar tissue forms to prevent migration, however, I'm wondering if strenuous activity can dislodge it or make it move out of place? Some things I worry I couldn't do again are: jumping on a trampoline, pulling negative g's in an airplane (i'm a pilot), going sky diving, riding roller coasters, or lifting weights. Your thoughts?

2. Is it possible that the swallowing muscles could "wear out" or become fatigued over a long period of time having to constantly overcome a significantly stronger / augmented sphincter?

Any feedback appreciated!

Thanks!

Lucas
3/20/2013 1:40:05 PM
Brian E. Louie, MD
Casey - the short answer is you cannot. But, if you read an earlier post, we discussed the diaphragm.
3/19/2013 9:16:46 AM
casey
can u exercise the diaphragm with deep breathing after a hernia surgery with the goal to strengthen it further?
3/17/2013 12:44:47 PM
Brian E. Louie, MD
It appears that both groups are experiencing similar outcomes with excellent control of GERD. At Swedish we have not been able to identify a difference but the experience is early.
3/16/2013 7:44:19 PM
jesus
who has the best outcomes with this surgery people with small hernia or no hernias at all?
3/15/2013 10:15:29 PM
Brian E. Louie, MD
Ashley,

I am a little uncertain about your question. Are you asking about just IBS and overgrowth or do you also have GERD in addition to these other issues?

I do not know if anyone has implanted a LINX in someone with similar problems. At Swedish we have not.

We have had one patient who had significant bloating as part of their GERD. As far as I know, this patient did not have any problems.

Theoretically, the LINX may have an advantage in patients who bloat and need to belch. Often that's due to a stomach full of air rather than small bowel.

A more detailed response requires more information and testing to determine what the issues are in your specific case. You may wish to discuss that with your GI and an experienced esophageal surgeon.
3/14/2013 1:11:18 PM
Brian E. Louie, MD
Richard,

I think that, as surgeons, we always want to pay close attention when foreign material is placed into the human body to treat disease. The body’s natural response is to try an isolate that material or adjust to it. Only in rare cases is the foreign material rejected. Fortunately, there are lots of examples of foreign material that are used as medical devices include hip and knee replacements, pacemakers, artificial heart valves and meshes to repair hernias. The body adapts and utilizes these very well with usually no complications.


I can tell you that there have been no troubles with implanting the LINX to date. I think we will be very vigilant with the patients receiving a LINX device because the concern that everyone is wondering about is whether the device will erode through or into the esophagus. However, its design and function argue against this possibility, but it remains a concern. In appropriately studied device like those listed above, patients have had them for many years without complications and I think the LINX device will ultimately fit into that category.
3/12/2013 5:37:11 PM
Brian E. Louie, MD
Jon,

I don’t have any personal experience with the Endo Stim device. For other readers, the Endo Stim device treats GERD by stimulating the lower esophageal sphincter by attaching electrodes and using a pacemaker type device to provide electrical stimulation. The initial results that have been presented from trials in Europe suggest that this device may have a role in the treatment for GERD. I think the idea behind this device is interesting and it’s trying to augment the sphincter using a different method that the LINX device. While interesting, I think we need more data to see how this device will work.
3/12/2013 5:36:30 PM
Brian E. Louie, MD
Elena, at this time, we don't have enough data to say whether one is better than the other. We know that both control GERD very well. Both have potential side effects and patients have concerns about both procedures. One of the key pieces of research is to compare these procedures to see what the relative differences are. I think there will be a role for both operations and each procedure will be used in certain situations in the future.
3/11/2013 4:53:53 PM
Richard Kerry
Hello Doctor,


I've asked a doctor about the linx and he told me that it isn't a good idea to have a foreign material in your body in the long term. This makes me a bit apprehensive about the procedure as I really thought it would be the answer.



Many thanks.
3/10/2013 11:10:04 PM
Jessica Schmidt
HI,


I live in a country where the LINX isn't available, I have a small hernia which made my previous GERD worse, because now I have to take at at least two nexiums a day, the problem isn't because of the reflux it's because of the intermittent chest pains and the feeling of the stomach going in and out, it also gives me heart palpitations and chest hurts when i take a deep breath. The nissen works for a lot people, but i just think i'm not ready for it yet. I do a lot of physical activities and the hernia interferes with it, i don't mind taking medications, i just don't want the uncomfortable feeling i get from the hernia.


I know you don't recommend get it done alone, but i just want to wait and until the linx is available in my country (Australia) and the long term studies are released . If i get the nissen, I would blow my chances of getting the LINX if my nissen doesn't work out. I just want to stop these symptoms that are caused by my hernia, the back pain, shoulder pain, the feeling of something moving in and out, the deep inhalation pain etc. If i just get the hernia fixed, these problems would stop and my GERD would become manageable.


please reply.



thank you.
3/9/2013 10:45:35 PM
Jon Meyers
Hi Doctor,

What do you think of the EndoStim product that is currently being performed in Europe?
3/9/2013 8:25:41 PM
elena
do you believe the linx to be better than the nissen?
3/9/2013 7:22:15 PM
Ashley
I currently suffer with IBS (irritable bowel syndrome) caused by SIBO (small intestinal bacterial overgrowth). With that condition I often suffer from bloating. Can you provide any information on if patients that have had this procedure done experience more bloating? If so, is it only temporary?
3/8/2013 2:55:30 PM
Brian E. Louie, MD
Corky,
When your cough is related to GERD there are two mechanisms which produce the cough: 1. refluxed material gets into your airway and/or 2. the vagal nerve reflex is stimulated by GERD leading to the cough. The long term consequences of reflux getting into your airway is chronic scarring or fibrosis, pneumonia or bronchitis. As you age, these will be harder to treat and may worsen and may impact the quality of your life.

I don't think you are trading one set of problems for another. The vast majority of our patients with cough and GERD are very satisfied with their outcome from Nissen fundoplication. Remember this is a difficult area because there are so many reasons to cough.

A Nissen fundoplication done by an experienced surgeon who performs a lot of these should function very well. The comments on the internet are important but many of the patients who had great outcomes are not posting their positive comments for you to read.

I think the LINX device is an attractive option for you. Even though the experience is early, the results look very favorable. Fortunately, it can be removed if need be. I would encourage you to discuss this more with your surgeon.
3/8/2013 11:33:38 AM
Brian E. Louie, MD
Daniel,
When we repair a hiatal hernia and perform a Nissen fundoplication they are usually done minimally invasively with an overnight stay. The degree of invasiveness is not any more or less for just repairing the hiatal hernia alone. We do not recommended hiatal hernia repair alone since most patients will still experience GERD and with a moderate hernia the reconstructed reflux barrier requires both the fundoplication and the hernia repair to be performed. So, the addition of the fundoplication is not really more invasive and is needed to control GERD.

Repair of the hiatal hernia does not weaken the diaphragm. The rate of sucess is dependent on the size of the hernia. In general, a small to moderate sliding hernia has a much better success rate that a larger hernia that is fixed and contains more than half of the stomach in the chest. How we repair the diaphragm is the focus of research we are doing at Swedish and elsewhere because past experiences tell us there is room for improvement. But, from what you've described you have a very good chance of success. I would discuss your concerns with the experienced esophageal surgeon you choose to help you.
3/8/2013 11:10:02 AM
daniel
Hi


this is just a general question, can a moderate sized sliding hiatal hernia repair surgery be done on it's own without the very invasive fundoplication? and if it's fixed does it weaken the diaphragm thus leading failure, or does it have high success rate to stay intact?

please let me know, i'm desperate.

thank you.
3/8/2013 2:21:24 AM
Brian E. Louie, MD
Ron,
Thank you for your comment. I have heard other patients talk about this with mixed results. My partner Dr. Aye had a patient who was a singer and felt that this was possible since they improved with diaphragm exercises used in singing. I think that this is hard thing to prove. Logically it's more likely to work if that patient does not have a hiatal hernia since the diaphragm will still be associated with the esophagus keeping the reflux barrier together. Once a hernia has developed, there is already a separation and strengthening cannot change this.

Until I see the study, I will keep an open mind. I certainly don't think there is harm in trying this. If it works, then that is outstanding, but I think that result is not consistent and has many possibilities.
3/5/2013 7:50:21 PM
Corky
I do not have the typical symptoms of acid reflux, I have had a chronic cough for years, that was diagnoised 20 years ago by a pulmonoligist at chronic bronchitis. In July I got bronchitis and it went into pneumonia, so my family Dr. suggested I see a pulmonoligist, they ran a bunch of tests and he said I did not have chronic bronchitis, and set up an appoitment to see a GI Dr. They ran the test for acid reflux and concluded I definitely had acid reflux which was causing the chronic cough and occassional hoarsness I was encountering. He suggested I have surgery and suggested the Linx procedure, even though it is a new procedure. The reviews I have read on the Nisen fundopolication sounds dreadful. I am wondering what is the risk of not having the surgery, and would I be trading one set of problems for anothet.
3/5/2013 7:19:01 AM
Ron Mathews
Dear Dr. Louie:

I just recently read an article that claims deep breathing diaphragmatic exercises can alleviate GERD. Do you think this type of exercise could benefit someone even with a hiatal hernia?
3/4/2013 4:23:27 PM
Brian E. Louie, MD
It's easy to be confused because this is counter intuitive. As surgeons, we want to repair the small hiatal hernia since we are placing the LINX just below. However, the outcomes were not as good if the hiatal hernia was repaired. Patients also seem to experience more difficulty swallowing after surgery. I think this is the challenge with a new procedure and gaining experience with its placement. It will be best to discuss this with the surgeon where diagrams can be drawn to show you the differences.
3/3/2013 9:14:52 PM
jon
Thank you for the response Dr. Louie.

So I'm a little confused then. Why did you that surgeons are thinking it's better to not repair small hiatal hernias in order to preserve what nature gave us, if there is no difference between a simply linx placement and (linx + smalll HH repair)?
3/3/2013 3:32:05 PM
Brian E. Louie, MD
There is virtually no difference between simply placing a LINX and repairing a small hernia and then placing a LINX because the goal in to leave as much native tissue intact as possible. This keeps any damage to the reflux barrier to a minimum. Remember that natural barrier is already not functioning well since patients have reflux. The idea is to take advantage or support what remains with the device to control GERD.
3/3/2013 1:49:40 PM
jon
How much additional dissection occurs when correcting a small hiatal hernia vs. just installing the linx?

Does the amount of dissection to simply place the linx by itself harm the natural reflux barrier at all?
3/1/2013 7:12:35 PM
Brian E. Louie, MD
At the present time, it is believed that further changes in the sliding hernia are related to the ongoing acid reflux. If the reflux is stopped the assumption is that the hernia should remain stable. However, there is ongoing discussion amongst surgeons who are placing the LINX device about whether the small hernias should be repaired. What we know is that reflux control seemed better in patients who did not have their hernias fixed presumably because the native tissues are still strong enough. Some have also wondered if the trouble swallowing after the surgery is related to the hernia repair since it seems that this symptom is more common in patients who have the hernia repaired.

If you are considering the LINX device, I would encourage you to discuss this with the surgeon who will be doing the surgery. My experience to date suggests that we should leave them alone if they are small and leave the native tissues alone so as not to disrupt what nature has given the patient.
3/1/2013 10:47:12 AM
dean
dr,

thanks for answering my earlier question, it's good of you to do that.


if the sliding hernia is relatively small and it isn't fixed, wouldn't that grow over time and hinder the integrity of the device?


thanks.
2/28/2013 6:31:33 PM
Brian E. Louie, MD
Hi Lori,

To discuss whether you would be a candidate for LINX, you can speak with your primary care provider, or call our clinic in the Greater Seattle area at (206) 215-6800 to make an appointment. If you are not in the Greater Seattle area, please visit www.linxforlife.com to find a LINX center near you.
2/25/2013 2:35:26 PM
lori
Can you refer me to a physician for a consultation for the LINX?
2/25/2013 10:55:51 AM
Brian E. Louie, MD
Ideally there is no hiatal hernia when we place a LINX. If a hiatal hernia is present it should be less than 3 cm in size.

A hernia this size does not always need to be repaired with LINX placement which is different than for Nissen. But, if it is repaired we expect it to be fixed forever. Hiatal hernias have been repaired multiple times but these are usually larger hernias that are 5 cm or greater.
2/22/2013 8:24:23 AM
dean
Dr,


i know there's no long term data on this, but how long do you think the hiatal hernia repair would last with the linx? and how many times can the hernia be redone?
2/21/2013 6:56:49 PM
Brian E. Louie, MD
Thanks for you comments and questions both on the LINX blog and on Dr. Schembre's Barrett's blog. You have asked a series of questions about GERD and Barrett's that are best discussed in person because of the complexities of the questions and situations.


I will say that the current guidelines for LINX placement do not include the use of the device in patients with Barrett's esophagus. However, we must remember that there is a wide variability in patients with Barrett's esophagus from patients who have disease detectable only on biopsy all the way to patients who have 10 cm or more of Barrett's. I think it there are two key components to your comments. First, symptoms of GERD are present despite the fact that you are taking Nexium. This would be a reason to consider surgery to better control reflux either with the LINX or a Nissen fundoplication. Second, the concern for recurrence of Barrett's and the risk of esophageal cancer. Fortunately, the risk of developing esophageal cancer remains very small for patients with small segments of Barrett's esophagus. While theoretically controlling your GERD better should reduce the chance of Barrett's recurring and thus cancer, there is no study that has been able to prove that fact.


If you wish to know more about whether LINX is appropriate for you to better manage incompletely controlled GERD symptoms then you may wish to be at seen at one of the LINX centers.
2/15/2013 4:43:01 PM
Flavia
Dr. Louie, I am a 40 year old female, with a history of GERD since I was 16. About 8 years ago I had an endoscopy that revealed Barrett's Esophagus (short segment) and was put on Nexium 40mg. Ever since I started taking Nexium my endoscopies have come back with no Barrett's. My symptoms are somewhat controlled on Nexium, but I fear all the potentially serious side effects of being on a PPI for the rest of my life. I have been having these endoscopies every 2 to 3 years. The last one showed a polyp in my stomach, which the doctor said was related to having been on Nexium for such a long time already. Needless to say my number one priority is not to get the Barrett's back let alone esophageal cancer, however I am nervous about getting atrophic gastritis that could lead to stomach cancer because of continuing to use Nexium indefinitely. I know there aren't any studies looking at Lynx in patients with a history of Barrett's, but would love to hear your take on my case. Thank you for your time!
2/11/2013 9:49:35 PM
Brian E. Louie, MD
As far as I know, no one has tried to implant the LINX device after a failed endoscopic procedure. When patients who have had an endoscopic procedure that has failed and are taken for Nissen fundoplication we have found either no scarring but have also found tremendous scarring which makes any procedure harder. Since there is more dissection to take apart the endoscopic procedure I would at this point convert it to a Nissen fundoplication. Perhaps with greater experience with the LINX we will try it in the future.
2/8/2013 4:17:29 PM
kapoo
Is linx successful after plicator endoscopic procedure.
2/8/2013 11:56:55 AM
Brian E. Louie, MD
Scott,

I'm sorry that you have had such a challenging time getting your GERD under control despite the multiple surgeries. Without knowing more about your current state and studies, it’s difficult to give you the best recommendation (and I am unable to provide direct medical advice online).

When your surgeon told you that he would no longer operate on you, I suspect he meant that revising the Nissen fundoplication for a 4th time is not reasonable. There are still options that could be entertained depending on your specific studies. You may wish to speak to the surgeon about alternatives to Nissen fundoplication or seek an additional opinion.

If you wish to continue this discussion outside of the blog, please contact my office at 206-215-6800.
1/15/2013 2:23:22 PM
Robert
Dr. Louie and team implanted the LINX device in me on December 17th, 2012.
After normal post-op side effects lasting about a week, the LINX device is performing very well. I stopped PPIs after surgery and have had no reflux to report - I am able to sleep horizontally!
After four weeks I am able to swallow normally without any sensation of the device opening or closing and have not needed to restrict my diet in any way.
The miracles of modern Hi-Tech medicine!
Thank you Dr. Louie & Swedish.
1/15/2013 11:00:39 AM
Scott
I have had 3 Laparoscopic Nissen Fundoplication Surgeries. 1st March 2008, second August 2008. Third May 2010. The surgeries were all redone to correct a slipped Nisen wrap . I am still experiencing GERD symptoms. Since the last surgery I have had several Gastroscopy procedures, PH probe, Eso Motility studies.

Despite all of this I am still experiencing symptoms. I was told by the surgeon that he would no longer operate on me because of the buildup of scar tissue in my abdomen. The three surgeries were all done by the same surgeon.

I have been bounced around on different PPI medications. Currently I take Nexium 40mg twice daily and Ranitidine 300mg at bedtime.

The last Eso Motility I had done revealed some peristaltic problems.

I just am so frustrated that after 3 surgeries I continue to suffer from symptoms.

I am a 100 percent service connected disabled veteran. The VA GI Doctor seems quite puzzled with my case.

If anyone can offer some direction and info I would sur appreciate it.
1/15/2013 8:37:35 AM
Brian E. Louie, MD
I think the previous implants your gastroenterologist is referring to is the Angelchik which was used for GERD and the Lap Band which is used for weight loss surgery. These two devices have been reported to migrate or slip. However, they are very different than the LINX in terms of size, rigidity and placement. Neither of these devices is dynamic like the magnetics either and all of these characteristics can lead to migration.

Nevertheless, migration is something on everyone's mind including the FDA. This fact was so important that the FDA made the company show data on patients that were 4 and 5 years after the procedure so that they would have an idea if the device would migrate. So far, I am not aware of any migrations in the over 600 placed in the world. The other devices began to see migrations within the first year of placement.

The data on effectiveness is only out to 5 years, but it compares very favorably to the standard operation Nissen fundoplication. For some patients, whey want to see more data but the 9 patients we have placed a LINX in are very happy with their decision and there are another 6 who are awaiting surgery. Clearly, ongoing research to determine the long term meaning 10 years and beyond will be needed.
1/10/2013 8:04:48 AM
James
I'm in the process attempting to see if I qualify for your Linx system. Dr. Tice did your requested tests today and I think it went well. He suggested that some previous implants had problems with migration and were soon abandoned. Has the Linx device been in use long enough to establish it's effectiveness over time? Would I be aware of any allergy to the metals used? How many of these procedures have you done at this time?
I'm looking forward to meeting you and having this done.
1/9/2013 7:24:43 PM
Brian E. Louie, M.D.
Joanne,
We have been very impressed by the LINX device since were started using it this past fall and the results are very promising. I don't think we have had a patient who has wanted to decide between the transoral incisionless fundoplication (TIF) and the LINX.

We believe the LINX to be better but there is no research study that proves this statement. We are basing this statement on our knowledge of how each procedure is performed, how well it controls acid reflux as measured by a pH probe placed in the esophagus and the potential complications. The LINX augments the reflux sphincter 360 degrees, normalizes the acid level in the esophagus in over 80% of patients and has minimal complications. The TIF sphincter is NOT 360 degrees, normalizes acid in the esophagus in about 50% of patients and its major complications are perforation and bleeding.
1/2/2013 2:40:15 PM
Joanne taravella
The Linx precedure seems very promising,
Which surgury do the majority of people
have better results with the LINX or the TIF? surgury?
12/23/2012 7:34:10 PM
Brian E. Louie, MD
Edward,
As you can imagine when a new medical device becomes available, there are not hundreds of scientific studies nor is there much information on the web or elsewhere. The studies you have found represent some of the very early work done on the LINX system. The most recent paper is by Lipham et al and is in Surgical Endoscopy and it details the 4 yrs results of the LINX device and shows that patients who have had the device for 4 years continue to have control of their GERD symptoms, are off medications and without device complications. I am expecting that the results from a large mutli-institutional series will be published shortly in a very prominent journal. Data is continuing to be collected and analyzed but as you have wondered, a randomized trial comparing LINX to Nissen fundoplication has not been done as of yet. But, as more surgeons gain experience, that trial may be done in the near future. However, in the surgical management of GERD, one does not always require a trial to derive comparison although it would be ideal. The reason is that there are objective measures such as pH testing which allow for comparison of procedures and the ability to control GERD based on a pH test is very similar between the two procedures. If you want to take your reasoning one step further, the PPI (omeprazole, lansop