The Reflux Centre was the first site in the UK to implant the LINX™ device and did so with exclusivity throughout 2011. Since launch there have been a number of important changes in respect of patient selection criteria. Here’s a brief summary:
- Patients with a hiatus hernia that is 3cm or smaller on endoscopy routinely have the procedure and enjoy good results.
- MRI testing – MRI is contraindicated but Torax Medical is exploring the potential for this to be permitted at lower level TESLA in the future.
- Laryngopharyngeal Reflux (LPR) – We are occasionally asked whether LINX™ is an effective treatment for LPR in the same way it is for conventional reflux disease/symptoms. The answer is yes and we have a number of successful LPR patients who are now symptom free and off medication (see patient IB below).
Update on Surgery Results
To date, our results are entirely consistent with the major trial results of Bonavina et al. In summary, most patients undergoing LINX™ implantation experience an immediate improvement and 6-12 months after surgery, 85% of patients report either complete resolution or major improvement in their symptoms of acid reflux.
For those on medication, our general policy is to gradually reduce the dose of medication over a maximum period of 3-months, and then stop.
The main side effect of the LINX™ procedure is a short period of dysphagia (difficulty swallowing) that tends to occur 2-3 weeks after surgery. It is not usually a major problem and, in the vast majority of cases, will have resolved after a maximum of 10-weeks. Most patients will experience at least some degree of dysphagia though, in itself, it isn’t anything to be concerned about. The exact cause is unclear but is probably related to a temporary change in the normal motility (contraction) of the oesophagus as it becomes accustomed to the LINX™ device.
To date no devices have been removed and there have been no cases of device migration or erosion. We are convinced that, in time, LINX™ will become the first choice surgical procedure for reflux patients whose symptoms cannot be managed through medication alone.
Pre-Operative Reflux Testing – What, Why and Where
Current guidelines require that we review gastroscopy, 24 hour pH and oesophageal manometry results before confirming a patient’s eligibility for LINX™. Most patients have had a gastroscopy but very few the pH or manometry. Here’s a brief explanation of what they are and why they’re needed.
Put simply, a gastroscopy is the procedure when a consultant gastroenterologist or surgeon puts a camera down into the oesophagus and stomach, through the mouth, in order to observe the condition of the tissue. A biopsy of the stomach and/or oesophagus will usually be taken as a routine part of the procedure. In addition, a test for Helicobacter Pylori will be carried out. The consultant will also be able to see a hiatus hernia or an area of Barrett’s oesophagus and pictures will usually be taken of any abnormal areas. A copy of the final report should be readily available through your GP or hospital consultant. In the majority of cases of reflux, the report will simply confirm the presence of oesophagitis (inflammation).
24 Hour pH Test
As the name implies, the 24 hour pH test is used to measure the acidity of the oesophagus over a 24-hour period. This is done by passing a fine probe through the nose into the oesophagus and leaving this in place for 24-hours. The test is done in the outpatient department and does not require an overnight stay in hospital. The probe sends information concerning changes in acidity to a special device which is usually worn around the waist. After removal of the device, the data are downloaded and analysed. There are a number of measures of acidity, the most important of which is the De Meester Score, which has a normal upper limit of 14.72. Anything above this is likely to be due to excess acid and a confirmation of reflux disease. Please note, however, that a normal De Meester score does not necessarily exclude reflux (though it certainly makes it less likely). If you have a high DeMeester Score and your symptoms are suggestive of reflux, there is a good chance that the LINX™ device will work for you.
Another way of measuring acidity is by means of a “Bravo” capsule, which is placed in the oesophagus and avoids the need to have a tube protruding from the nose for 24-hours. However, the Bravo system is not as widely available as the standard test and the information obtained offers no obvious advantage over the normal test.
An oesophageal manometry is carried out to confirm that the oesophagus is contracting normally and will be strong enough to push food through the LINX™ device. As with the pH test, manometry is carried out by passing a thin tube with a pressure sensor through the nose into the oesophagus. Once the probe is in place, the patient is asked to drink some liquid and pressure measurements can be taken at each of several levels over the entire length of the oesophagus. This usually takes 10-15 minutes at which point the probe and the tubing are removed. In the overwhelming majority of cases the pressure studies are normal, though there is often some weakness at the lower end at the level of the lower oesophageal sphincter (LOS) consistent with reflux disease.
Do I need all of these tests?
These diagnostic tests are all important in assessing how successful a LINX™ implantation is likely to but there are some cases where it isn’t necessary to have all three tests before proceeding with surgery. For example, if a patient has Barrett’s oesophagus we would not need a pH test to prove the presence of reflux disease. Each individual case will need to be assessed and managed accordingly.
In some cases you may be able to arrange to have these tests on the NHS, though this may incur a long delay. If you have private medical insurance, it’s likely the cost of these tests will be covered. Your first step is to contact the insurer then obtain the necessary referral letter from your GP.
If you are not insured and want to have the tests done privately, your consultant should be able to recommend a local doctor. We recommend the following centres:
|Dr Anthony Hobson PhD||Dr Joanne Barlow||Dr Theo Ngatchu|
Add: Dr Anthony Hobson, Princess Grace Hospital, Nottingham Place, London, W1U 5NY
Add : Spire Hospital, Russell Road, Whalley Range, Manchester, M16 8AJ
Add: Spire Parkway Hospital, 1, Damson Parkway, Solihull, West Midlands, B91 2PP
Private Medical Insurance
We are making progress towards having the LINX™ procedure recognised by private medical insurers. As you may be aware private medical insurers work by a common system of codes that govern the level of reimbursement per procedure type. LINX™ does not yet have a code and this is something we hope to change in the future. Nonetheless, most private medical insurers have now paid out for the LINX™ procedure, either in full or in part (see below). To our knowledge they have done so by coding the procedure as code G2331 – laparoscopic reflux procedure.
If you attempt to make a claim with any of these providers and have difficulty in getting them to recognise LINX™ you may want to refer them to us as we can give them named patients for whom they have already settled claims.
Anti-reflux Surgery Testimonials
The number of patients we are treating with the LINX™ procedure continues to increase and results are excellent. We are always grateful to patients who are prepared to give us a quotation to use in a newsletter or on the website. Here is a small sample of quotes from recent LINX™ patients.
”It is now 2 weeks since I had the LINX™ procedure and so far I’m doing really well. I have received excellent treatment, care and support from all the staff and medical team at The Reflux Centre. For the first time in years, I am able to sleep at night without being woken by the discomfort of reflux. I am delighted I went ahead with the procedure and would most definitely recommend it to others whose symptoms are not sufficiently controlled by medication. Many thanks for all your help in arranging the procedure for me and for your liaisons with my medical insurance company.”
Patient BG: Please see earlier notes about MRI and the developments made in this area since patient BG provided their feedback
“The LINX™ has helped a lot, and is a damn sight better than fundoplication. However, the MRI scan problem is not insignificant; it means there are a lot of potential conditions which cannot be adequately investigated without running the risk of reversing the polarity on the LINX™. I would gladly recommend the op to waiverers, but I could not, in conscience, offer any quotable endorsement without referring to this issue in any remarks I made.”
“The LINX™has very much helped me from day one – I have no GERD symptoms and I feel a lot better now that I can eat whatever I want. I am still getting a bit of dysphagia, but not as much now and I am not taking any medication at all for GERD. I feel in control, and I can now focus on other things without the constant worry of GERD and its symptoms. I’m very pleased I chose LINX™ and would recommend it to anyone with severe, life affecting symptoms as I had.”
“Before I had the LINX procedure I suffered from a sore throat and breathing problems for a number of years which greatly restricted my general lifestyle, but since the LINX I haven’t looked back as I’m medication free and my life is back to normal again”
If you would like to explore the possibility of having a LINX™ procedure, call our experienced team on 0845 128 0053. In most cases we will be able to advise whether you are eligible for a LINX™ procedure in that very first call.
Alternatively click the button right to see if you are eligible.