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.

Comments
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, lansoprazole, etc) which is the most common medicine used to treat GERD has been available since about 1990 and there were very few comparisons of that drug with Nissen fundoplication. The largest randomized trial comparing the surgery and medicine has reported follow up of 12 years and shows that surgery is better at controlling GERD long term unless you increase the dose and frequency that you need to take the PPIs at which point the results are similar. At Swedish, we will be asking our patients who have undergone LINX implantation to participate in a long term follow up study to collect more data on the outcomes. In addition, since I direct the research activities for the Division of Thoracic Surgery, we will be looking to compare our LINX patients with our fundoplication patients.
12/21/2012 5:20:27 PM
Mike
If the Linx system was to break/fail who would have to pay to have it removed and a new one implanted? And if people suffer with acid reflux due to a hiatus hernia why can't they have just the muscle stitched up which in turn would cure the reflux?
12/21/2012 8:12:50 AM
Edward Gibson
Can you recommend scientific studies about the LINX procedure's effectiveness? There does not seem to be a lot out there. I have found one from 2010 that only analyzes 44 cases (with no control group, apparently). It also only covers a two year period (See Ann Surg. 2010 Nov;252(5):857-62). I wonder if there are studies also that provide a rigorous assessment of the LINX procedure's effectiveness versus the Nissen Fundoplication.
12/18/2012 2:03:53 PM
Brian E. Louie, MD
The management of a small sliding hernia is different for these two procedures.

In the TIF or trans-oral incisionless fundoplication, there is an attempt to reduce the hernia - meaning they try to push the stomach back into the abdomen but there is no attempt and no technical way to repair the hiatal hernia in this procedure.

In the LINX procedure, the hiatal hernia is assessed during surgery. If the hernia is around 3 cm is size we will repair it by placing sutures to close the gap from the hernia before we place the device. If the hernia is very small, the results of the research trial suggest that it is better to not repair the hernia and simply place the device.
12/12/2012 11:51:49 AM
joanne taravella
What kind of operation would they do to repair a small sliding hiatal hernia before the LINX or TIF precedures?
12/11/2012 10:44:28 PM
Brian E. Louie, MD
We would expect the same outcomes as a Nissen fundoplication when a LINX device is used for LPR. There has not been a study to determine if this is true since the procedure is new. However, if LPR (laryngopharyngeal reflux) is due to stomach contents being refluxed all the way up the esophagus then control of GERD by either method should produce similar results.
12/6/2012 10:34:25 PM
Nikhil
Is the linx an effective treatment for LPR suffers? Will it offer the same success rate as the nissen for LPR patients that have predominantly throat symptoms.
12/6/2012 11:25:50 AM
Brian E. Louie, MD
Considerable thought has gone into the potential long term damage from having the magnetic beads around the esophagus.

Many years ago a device for GERD call the Angelchik was implanted around the esophagus to control GERD. Unfortunately, it was large, bulky and stiff. It began to erode into the esophagus and it was eventually removed from the market. These occurred within a couple of years of placement. However, it did control reflux.

Something similar is the lap band which is used for weight loss surgery. This is much softer than the angelchik and is placed around the top of the stomach. But, it too does not open and is designed to be increasing closed around the esophagus to reduce the ability to eat. There have been erosions from this as well.

The LINX device is DIFFERENT than both of these. When it is placed around the esophagus it is done so as to be the same size as the outside of the esophagus. It should not in any way place pressure on the esophagus. It is also much small in size the either of the other devices. The dynamic nature of the magnets to open and close is also different and it is thought that this should reduce pressure when patients are swallowing. That being said, despite the research and understanding, it is theoretically possible for the device to erode into the esophagus. Fortunately, these has not been seen.
12/5/2012 5:43:55 PM
Edward Gibson
I was scheduled to have fundoplication surgery this month but postponed it while I explored the pros and cons of LINX. I have many questions, but let me start with this one: I know that we only have limited data on results over about 4 years, but has any thought been given to the long-term damage or effects to the esophagus from having these metal beads applying pressure and opening and closing on it multiple times day after day?
12/4/2012 7:35:59 PM
Noel
I had the linx procedure about 4 weeks ago. I do experience some pain mid sternum when swallowing and can usually feel when the band allows food to pass. I stopped ppi abruptly and on occasion wasn't sure if I was experiencing heartburn or something else. Maalox and Tums did not relieve it. I have not restricted my diet. I have to crush large pills and sometimes water will hang. It seams I have some things in common with my lap band friends. I have to take smaller bites, chew thoroughly and thus I get full on less food. My gastroenterologist's nurse says to give it more time... about 8 to 12 weeks. I remain hopeful that this is a good treatment.
11/24/2012 12:33:46 AM
Brian E. Louie, MD
Insurance approval whether it is medicare, medicaid or commercial is being carefully scrutinized by the insurers. Some have been accepting while others have not. It is best to see the surgeon and discuss whether you are a candidate for the procedure and then seek insurance approval.
9/24/2012 8:43:55 AM
Pete
What about medicare/medicaid patients?
9/21/2012 10:03:35 AM
Brian E. Louie, MD
At the current time, the 20 centers who are offering the LINX procedure across the country are following the same criteria for choosing patients who are ideally suited for the device. Unfortunately, that does not include patients who have had a prior Nissen fundoplication. I would encourage you to see your surgeon if you are having symptoms of GERD despite the Nissen fundoplication which is what I suspect based on your question. You may need to undergo repeat evaluation to determine if your symptoms are truly GERD or something else.
8/6/2012 8:51:47 AM
klemen
Hi, can i have LINX device, after Nissen fundoplication?
8/4/2012 2:14:57 PM
Brian E. Louie, MD
As far as we know, none of the patients who have received the LINX device has ever reported feeling the magnets. If a patient was going to sense anything it would be a subtle difference in swallowing liquids or food. To discuss whether you would be a candidate, you can speak with your primary care provider, or call our clinic at (206) 215-6800 to make an appointment.
7/23/2012 9:10:35 AM
Alfred Marton
With the Linx procedure is there sensation on the outside cover of the esophagus or can you feel the.linx magnets?
Thank you
I believe I am a prime candidate for this procedure
7/19/2012 12:20:47 AM
Brian E. Louie, MD
Hi Megan,

I can't speak to your case specifically, and encourage you to ask these questions to your health care provider. As a reminder, per our social media policy which you can find at www.swedish.org/socialmediapolicy, information via the blog is not intended to be medical advice and should not be considered medical advice, nor is it intended to replace consultation with a qualified physician or other health care provider.

As you can imagine with the LINX device being brand new there are not thousands of cases to draw experience from. However, it is not uncommon after both LINX and standard Nissen fundoplication to have symptoms that resemble "reflux". These symptoms are usually not reflux and usually relate to healing and other getting used to the new reflux barrier. The other possibility is that you came off of the PPIs too quickly and have experienced "rebound" acid production.

In my practice, we generally will restart the PPI's and then taper the patient off of the medication over a 3 to 4 week period of time. If the symptoms persistent, we will have the patient undergo pH testing to see if the symptom is related to acid reflux but we will wait until at least 4 months after surgery to make sure that surgical site has healed. In the vast majority of cases, the symptoms resolve and do not represent incomplete control of the GERD symptoms.

I would suggest that you discuss this with your surgeon to determine the best course of action in his or her opinion.
7/6/2012 2:41:32 PM
megan
Hi, I had linx five weeks ago and just as swallowing got better my reflux came back. Is this normal? I also quit ppis cold turkey.
7/6/2012 8:01:40 AM
Brian E. Louie, MD
Karen, since we just started the process of insurance approval at Swedish, we don't know which companies will be receptive to coverage. Across the country, we do know that patients have been approved and the procedure reimbursed, but there just isn't enough experience with insurance companies at the present time to give a clear answer. Our plan is to work with the patient and the patient's insurer to demonstrate why this procedure, even though it is new, is worthwhile undergoing over continued treatment with medication.
7/4/2012 10:50:48 AM
Karen
Are insurance companies covering the LINX system at Swedish? If so what are the companies?
7/3/2012 9:30:42 AM
Brian E. Louie, MD
Ann, the presence of a hiatal hernia is often associated with GERD. When patients undergo surgery for GERD and/or a hiatal hernia, the hiatal hernia is always repaired. In fact, we recently completed a research paper the concluded that hiatal hernia repair is very important in reconstructing the reflux barrier and achieving control of the patient's GERD.

When the LINX device is placed the hiatal hernia would be repaired at the same time. Patients with larger hiatal hernias, however, should undergo traditional repair. Assessment of hiatal hernia size to determine if it is suitable for the LINX procedure would be done during pre surgical testing .
6/29/2012 9:27:15 PM
Ann
Does this procedure help with Hiatle hernia
6/29/2012 2:12:55 PM
Brian E. Louie, MD
Several of the sites involved with LINX have just started to implant the devices. At Swedish, we have just started obtaining insurance approvals for several patients who are interested. We hope to implant our first at the end of July or early August.

For patients with chronic GERD, I always encourage them to discuss this with their physicians. It is true that esophageal cancer and GERD are related with patients who have experienced GERD symptoms on a daily basis for 20 years or more at highest risk. Concerning symptoms are trouble swallowing and food sticking. One of the more common stories I hear from esophageal cancer patients is that not only did they not talk to their doctor but that their symptoms of GERD got better all by themselves after 20 years of trouble. Chronic GERD rarely goes away on its own and this change should discussed with a specialist since its likely that the patient still has GERD but has no sensation of it and may have developed barretts esophagus, which is the precancerous condition.
6/29/2012 10:46:58 AM
Steve in Orlando
Hey really liked this post! Has there been any new news on this treatment in the last month? This has been a topic of concern for me as of late. I recently read about a study which discussed GERD's potential role in the development of esophageal cancer. Apparently, the number of cases has been on the rise, and the damage caused by GERD can increase your risk of developing this cancer. Given this information, I would not hesitate to be tested for GERD if I feel like I am experiencing any of these symptoms.
6/28/2012 8:45:00 AM
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Brian E. Louie, MD

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

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