Is LINX the way to go for GERD surgery? No.

This is half of a two-part debate — read the opposing argument.

For most individuals with gastroesophageal reflux, treatment with antisecretory medication yields excellent symptom relief. However, medical management fails in a subset of patients with more severe symptoms, and antireflux surgery should be considered. Traditionally the procedure of choice has been a 360° (Nissen) fundoplication. In most patients, this delivers a good long-term outcome, with effective reflux control and few side effects, and durability has now been confirmed at follow-up to 20 years. Unfortunately, a subset of approximately 10 to 15 percent are less than happy with their outcome following Nissen fundoplication, due to either recurrent reflux symptoms, or side effects such as dysphagia, bloating and flatulence.

When patients undergo a procedure for gastroesophageal reflux, they want their symptoms to be cured. They also do not want the treatment to generate a new problem which leaves them worse off than before their surgery. Some trade-offs, however, might be acceptable, and a certain level of less troublesome side effects might be a reasonable exchange for effective relief of reflux symptoms which adversely impact quality of life. The challenge for surgeons is to deliver an acceptable outcome for all patients considering surgery for reflux, and this has led to a focus on procedures that not only control reflux, but also minimize the risk and impact of the side effects which can follow Nissen fundoplication.

The quest to minimize side effects has followed divergent paths in different parts of the world. Many North American clinicians consider the words “fundoplication” and “Nissen” to be equivalent and interchangeable, and many surgeons have been reluctant to consider alternative fundoplication options which might reduce side effects. In other parts of the world, however, other fundoplication options have been pursued more vigorously. By the mid-1990s, surgeons in parts of Europe and Australia recognized that a significant subset of patients were not happy with their outcome following Nissen fundoplication, and this led to more formal evaluation of partial fundoplications as a strategy to reduce post-fundoplication side effects.

Partial fundoplications entail wrapping less than the full circumference of the esophagus by placing the gastric fundus either in front (anterior) or behind (posterior) the esophagus. These procedures were first described during the pre-1990s open surgery era, and laparoscopic variants were developed and described in the 1990s, with the aim of delivering a better overall outcome. Promising early results from case series were followed by the publication of randomized controlled trials in the 1990s and 2000s, and subsequent meta-analyses of these trials have confirmed effective reflux control and less side effects, compared to Nissen fundoplication.1 The promising early outcomes have now been confirmed at longer term follow-up of up to 10 to 20 years.2,3

There are some potential differences between the anterior and posterior partial fundoplication variants, with posterior partial fundoplications likely to achieve somewhat better reflux control, offset by less side effects following anterior partial fundoplication variants.4 An overview of all the randomized trial data suggests that there are trade-offs between reflux control versus side effects, across a fundoplication spectrum, ranging from Nissen to posterior to anterior partial variants. All of these procedures achieve high success rates, with 85 to 90 percent or more patients happy with their outcome at long-term follow-up, but with the anterior partial fundoplications doing better in terms of minimizing side effects.4 Importantly, construction of a partial fundoplication requires the same operating room equipment and the same surgical skill set that is required for Nissen fundoplication, and as a consequence, operating times and costs are virtually identical. For these reasons, partial fundoplications deliver an established antireflux procedure with proven good long-term outcomes which effectively address the issue of post-Nissen fundoplication side effects. This is the solution that many surgeons in Australia and Europe have pursued.

The LINX procedure seeks to address the same problem by also minimizing side effects while still delivering good reflux control. Enthusiasm for this procedure confirms that many North American surgeons have also recognised that Nissen fundoplication has not always delivered a satisfactory outcome. However, is LINX the best solution or even a logical solution to this problem?

Unlike a fundoplication, which creates a flap valve, the LINX procedure implants an expandable ring of magnetic beads around the distal esophagus, and this acts as a new sphincter. With a novel procedure such as LINX, which does not replicate the mechanism underpinning fundoplication, questions should be asked and answered before LINX is accepted into mainstream clinical practice. These include:

  1. Can LINX deliver a better outcome than the well-established alternatives which include partial fundoplication?
  2. Is the increased expense associated with implanting a novel device justified by an improved clinical outcome?
  3. Does LINX deliver acceptable long-term reflux control?
  4. Is LINX associated with any unacceptable complications and risks?

For LINX, these questions remain largely unanswered. Early objective outcome data following anterior and posterior partial fundoplication demonstrates normalization of esophageal acidification in more than 90 percent of patients. Early LINX data does not appear to match these outcomes.5 Long-term outcomes are known for both anterior and posterior partial fundoplication variants, with success rates of more than 85 percent at 10 to 20 years follow-up reported in randomized trials.1,2,3 The longevity of LINX will remain uncertain for at least another five to 10 years. LINX entails the placement of a foreign body around the lower esophagus. The history of devices placed around the gastroesophageal junction reveals that erosion of devices into the lumen of the esophagus is a significant risk, and reports of LINX erosion are now emerging.5

For now, surgeons and their patients seeking to reduce the risk of side effects following Nissen fundoplication are able to choose between a partial fundoplication or LINX. Compared to Nissen fundoplication, partial fundoplications have a proven better side effect profile and deliver good long-term reflux control and high levels of satisfaction in most patients.1,2,3,4 Uncertainty for LINX currently exists for long-term reflux control, and the long-term risk of device erosion. Furthermore, it is hard to see how LINX can deliver better reflux control than a partial fundoplication or deliver a cost-effective solution which offsets the additional expense of the implantable prosthesis. Arguably, LINX seeks to solve a problem that was solved many years ago in other parts of the world by modifying Nissen’s original procedure to a partial fundoplication. The onus is now on the proponents of LINX to demonstrate what has already been demonstrated for partial fundoplications: long-term efficacy, safety and cost utility, in well-designed prospective randomized controlled trials.

Disclosures: Dr. Watson is vice president of the International Society for Diseases of the Esophagus.


Dr. Lipham describes why LINX is the way to go.


References

1. Broeders J.A., Roks D.J., Jamieson G.G., Devitt P.G., Baigrie R.J., Watson D.I. Five-year outcome after laparoscopic anterior partial versus Nissen fundoplication: Four randomized trials. Ann Surg. 2012;255:637-642.
2. Kinsey-Trotman S.P., Devitt P.G., Bright T., Thompson S.K., Jamieson G.G., Watson D.I. Randomized trial of division versus non-division of short gastric vessels during Nissen fundoplication: 20-year outcomes. Ann Surg. 2018;268:228-232.
3. Mardani J., Lundell L., Engström C. Total or posterior partial fundoplication in the treatment of GERD: results of a randomized trial after 2 decades of follow-up. Ann Surg. 2011;253:875-8.
4. Amer M.A., Smith M.D., Khoo C.H., Herbison G.P., McCall J.L. Network meta-analysis of surgical management of gastro-oesophageal reflux disease in adults. Br J Surg. 2018;105:1398-1407.
5. Zadeh J., Andreoni A., Treitl D., Ben-David K. Spotlight on the Linx™ Reflux Management System for the treatment of gastroesophageal refluxdisease: evidence and research. Med Devices (Auckl). 2018;11:291-300.

13 comments

  • I had the fundiplication, and it was absolutely great……….until the stitches failed 5 years later.
    I then went in for a revision which included implanting the Linx. While the recovery was a bit longer, (probably 3 weeks until I felt “back to normal”); I feel great. I have been a year since the surgery, and all is well. Anyone may contact me with any questions.
    Keith

    • I am considering the LINX. Please share with me about your recovery and how things are for you now.

      • I had this done three years ago My linx procedure went very well as expected. My recovery took about three weeks. My only complaint is I cannot throw up if I have to. You have the reflux to throw up but it can’t come out it goes back down it is stopped by the lynx it makes you sick for the next 48 hours.

    • What was the total cost for all LINX surgery? Here in Russia it’s not available, only Nissen (Russian roulette in surgery world in my opinion), so I’am prepearing myself for a trip to Europe to get cure. Nothing can find in the web about cost. Thank you!

    • Thanks for sharing I’ve been on PPI for nearly 10 years and wish to get out of it as it is not a great solution as I had daily bouts of reflux. Diagnosed with Barrett’s esophagus I’m not a fan of fundoplication instead im keen on the Linx surgery. I’m 34 now, did your doctor advise on how long it might last until a replacement is needed. Does it also control the reflux well?

    • did you need any medications and do you eat any kind of food and any quantity as you like?

      i also heared that you should keep taking medicine after any kind of procedure ? if you did take for how long and when did you feel you are normal again !

    • Am considering the LINX surgery did your GERD go completely away and how bad is the recovery

    • Who did your surgery?

  • Hi Keith, Your response sounds very positive. I look forward to understand more about Linx. I have been on PPI for the past 10 years now. Eventually the PPI is not working for me after all these years. I was diagnosed with Barrett’s esophagus and so far I have been having an annual endoscopy to monitor it. I prefer to get a Linx surgery and have and end to PPI.

  • I am considering the LINX device too. But it seems hard to find surgeons that does it in quebec.

  • I had the lynx procedure 3 years ago. The recovery went well. The only problem I have is if you need to throw up you can’t it’s stopped by the lynx and goes back into your stomach causing upset for the next 24 hours.

  • I had the linx surgery June 25. Recovery has been a long road. I still am having a lot of passing gas and diarrhea .

  • I had a Linx device fitted in June 2018. I found swallowing very difficult for first three months. For a few months after that, I thought the operation had been successful but got intermittent pain in my chest, acid reflux and sore throat. I was back on gaviscon and have hardly had a day since without taking at least one. For the past 4 months I’ve had a sore throat, dysphagia, pain in sternum and back and nausea. A barium swallow showed I had regurgitation with the barium going back into my throat when lying down. As the radiologist pointed out to me, solid food as opposed to barium, must have the same result when standing.
    My surgeon has offered to do an endoscopy to stretch my oesophagus with a balloon. As the Linx was fitted to tighten an oesophagus that had lost its elasticity, I cannot see the point of stretching this. I just want it removed. I’m back to square one with symptoms and treatment so the Linx for me has been useless.

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