IPAC date: 11 May 2017

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1 National Institute for Health and Care Excellence 973/2 Laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease Consultation ments table IPAC date: 11 May Consultee 1 Assoc Professor of Surgery Specialist Adviser ments 1.1 As the AUGIS nominated specialist advisor to NICE on the recently reviewed Linx Magnetic sphincter augmentation procedure for the treatment of gastro-oesophageal reflux I have some. I feel strongly that the extensive and careful published research on this procedure has quite clearly shown it to be a safe, effective and durable surgical treatment. The procedure is clearly associated with much fewer post operative side effects compared with standard surgery (fundoplication) and is a more patient acceptable therapy. This treatment is undoubtedly an advance in the surgical treatment of gastro-oesophageal reflux and I feel strongly that this should be given Level 1 IPAC support and should be a therapy available to Upper GI Surgeons. The mittee considered this comment but decided not to change the guidance. I would ask therefore that this initial decision be reviewed. 1 of 12

2 2 Consultee 2 Upper Gastrointestinal Surgeon 1.1 I write to comment on the draft guidance published by NICE on laparoscopic insertion of a magnetic titanium ring for gastrooesophageal reflux disease IPG10034/consultation/html-content I am a specialist upper gastrointestinal surgeon and was appointed to a substantive NHS consultant post in I have a special interest in the treatment of benign disease including gastro gastro-oesophageal reflux disease. I work as the lead of a multi-disciplinary team that diagnoses and treats patients with this condition. I have a high volume anti-reflux surgical practice regularly performing primary and revisional laparoscopic fundoplication. In addition over the last 5 years I have accumulated one of the largest series of LINX procedures in the UK; to date I have inserted 80 devices. The mittee considered this comment but decided not to change the guidance. I am disappointed that the draft guidance has not recognised the strength of the published evidence that was reviewed and just as importantly the context of current options for patients needing treatment for refractory GORD. While not intending to review the evidence I would like to make several based upon my personal experience. In particular I ask the committee to consider the evidence regarding what your reviewer called the current gold standard surgical treatment, namely laparoscopic fundoplication. Safety. The published data has clearly established the safety of the device over the medium term. This is consistent with my own series. Of 80 cases one patient requested removal of the device due to chest discomfort for which no specific cause was identified. This explant was performed without difficulty. It is now 10 years since the LINX device became available and over 7000 procedures performed. To date the most serious complication reported has been some erosion into the lumen of the oesophagus (20 according to the manufacturer, a rate of <0.3%). To my knowledge these patients have all been treated electively with no sequelae. So whilst the published data may 2 of 12

3 not extend to the long term, there are surgeons with experience of using the LINX device for 10 years and they do not report any concerns, in fact their usage of the device is increasing. Efficacy. The available data suggests that at five years approximately 85% of patients enjoy persistent good symptom control, quality of life and non-drug dependence. Failure tends to occur early and there appears to be only a small increase in patients with recurrent symptoms in years 2-5 following device implantation. Conversely follow up data on patients undergoing fundoplication suggests that there is a persistent attrition rate in effectiveness over time and that failure persists year on year. At ten years there is evidence of well over 50% of patients suffering recurrent symptoms. Re-operation. The incidence of re-operation following fundoplication is in the literature varies but has been reported to be as high as 30%. However, many specialist upper GI surgeons suspect that both revision and admission for complications is an under-estimated problem. Indications for revision include not only recurrent symptoms but dysphagia secondary to wrap migration, recurrent hiatus hernia and slipped wraps. This surgery can be difficult and complicated. The data published to date suggests a reoperation rate following LINX of ~3% which is relatively straight forward and still leaves open the option of fundoplication should the patient choose that course. Studies quantifying the economic cost of investigation and treatment of these failures has to my knowledge never been performed but is likely to be considerable. Side effects. Perhaps 20% of patients will suffer side effects following fundoplication. These include difficulty with belching and vomiting. These side effects can significantly affect quality of life. Consequently, following informed consent the number of patients choosing existing surgical options is declining. The published data suggests that these side-effects do not tend to effect LINX patients and this is certainly my experience. Indeed overall GERD-HRQL scores have fallen significantly in my series, consistent with published evidence. Since anti-reflux 3 of 12

4 ments surgery is primarily performed to improve quality of life these considerations should be paramount. I would be happy to share this data with you should you wish. Nature of evidence. Of course, it would be preferable if RCT data of LINX v Fundoplication were available and I m sure all clinicians involved in treatment decisions for these patients would prefer that this was the case. However, it is unlikely that a trial of this kind will ever be possible. To my knowledge there has been at least one attempt to create a protocol for recruitment of patients for an RCT but the difficulty has been that when the existing data, especially concerning side effects and duration of effectiveness is explained, patients expressed an unwillingness to enter the fundoplication arm. To my mind it is rather like the situation might have been when laparoscopic cholecystectomy was introduced. The benefits were clearly obvious over the existing open operation which was why widespread adoption occurred, despite the lack of evidence and relatively high rate of associated complications due to the learning curve at the time. Had NICE applied the same criteria as it is to LINX, it s conceivable that this would never have occurred as its equally hard to imagine patients electing to undergo a large sub-costal incision and weeks of convalescence over a minimally invasive operation. MRI. This was an issue until introduction of the 1.5 Tesla compatible device two years ago. 4 of 12

5 3 Consultee 3 Consultant Upper GI Surgeon ments 1.1 I Recently came across your proposed recommendations re the Linx antireflux device, unchanged from your previous guidance some years back. I must say I am a little surprised. Since your initial guidance there have been a number of further scientific studies showing the effectiveness and safety of this device. In my own practice, this device has allowed me to operate on more patients and reduce length of stay therefore making this more cost effective in our NHS when treating GORD Patients surgically The mittee considered this comment but decided not to change the guidance. I was hoping for a more positive recommendation on the Linx thereby making it more readily available to all our NHS patients who suffer from medically refractory chronic GORD. 5 of 12

6 4 Consultee 4 Consultant Upper GI, OG & General Surgeon 1.1 I was disappointed to read the draft recommendations regarding the above Laparoscopic Magnetic Sphincter Augmentation (LMSA) procedure which still stipulates that this procedure should only be used with special arrangements, and is therefore unchanged from the previous issued advice from the committee. This is despite considerable published evidence which confirm the viability of LINX as a valid alternative to long term drug dependency or a fundoplication procedure. The inclusion criteria (hiatus hernia, Barrett s etc) have significantly broadened, and the rate of adverse events has declined substantially, as well as the ability to deal with these through shared global experience. The mittee considered this comment but decided not to change the guidance. I have been performing the LMSA procedure in XXXX since July 2012 and have now carried out nearly 80 operations. Our results have been excellent and thus far have had no adverse events or device removals. We recently presented our comprehensive 2-year follow-up data at the Association of Laparoscopic Surgeons Meeting in London, and this is being prepared for publication. Demand for our service is constantly rising, and patients are through their own research demanding this as the preferred option in their treatment. This draft guidance will unfortunately continue to limit the availability of LMSA on the NHS, as CCG and Hospital Administrators can justifiably block the development of this service quoting your recommendations. It will be extremely frustrating for patients in the UK suffering from chronic reflux to become aware that advanced, innovative and definitive management of their condition is lagging years behind their counterparts in Western Europe and the United States, and only readily available in this country in the private sector. I would urge your committee to review the latest evidence and reconsider your guidance to at least give clinicians in the UK the opportunity to offer LMSA to their long suffering reflux patients. Please do not hesitate to contact me if I can be of any further assistance. 6 of 12

7 5 Consultee 2 Upper Gastrointestinal Surgeon 6 Consultee 2 Upper Gastrointestinal Surgeon ments General GORD s impact on quality of life is too often under-estimated by health care professionals including surgeons; there is evidence that HRQL can be influenced negatively equivalent to conditions including depression and cardiac disease. It would in my view be a real missed opportunity to help people who s lives are blighted by their disease by not making the LINX device available to more NHS patients. General In assessing the LINX device the committee should consider the surgical alternative currently available, namely fundoplication. I would suggest that the evidence is that fundoplication can confer good results but these can be inconsistent and unpredictable even in experienced hands. The LOTUS study of Nissen v PPI insisted upon surgical standardisation of technique for a good reason- technique is very variable and outcomes likely to be too. Insertion of the LINX device is less disruptive of native anatomy and of significance surgical technique is easily reproducible; the steps involved are less variable and open to individual surgeon preference. In my experience outcomes are therefore more predictable and consistent. The risks of LINX appear to be well known and the side effects straightforward to manage. The mittee considered this comment but decided not to change the guidance. The IP programme does not assess the efficacy and safety of comparator interventions. 7 of 12

8 7 Consultee 6 Consultant Upper GI Surgeon 8 Consultee 5 Consultant upper GI surgeon ments General Interventional procedures guidance [IPG431] Published date: September 2012 XXXX is one of the NHS centres accredited to carry out this procedure. We have performed 72 LINX implants from Dec 2012 to April 2017 and have recently presented our preliminary results based on a postal survey of 54 patients. There were 2 intraoperative complications - 1 pneumothorax and one bleeding both dealt without any consequences. There was 1 readmission post op with abdominal collection drained radiologically. 83 % had improvement or complete resolution of heartburn, 85% improvement or resolution of regurgitation, 75% stopped PPI medication completely, 20% had more than 50% reduction in medication. Transient dysphagia (upto 3 months) occurred in 67% of patients. 2 patients had persistent dysphagia requiring reoperation whereby excessive scar (capsule) tissue around the device was excised laparoscopically. This lead to complete resolution of dysphagia in one patient and partial in the other. 2 patients have suffered from intermittent oesophageal spasmodic discomfort treated with medication. The overall satisfaction rate was 85% satisfied or highly satisfied, equivocal in 7%, and not satisfied in 7%. 87% would recommend the procedure to others with reflux disease. There have been no serious adverse events such as erosion and no devices have been removed so far. In our experience the procedure has been found to be safe and effective in the short to medium term. We are looking into the the cause and management of postoperative dysphagia in greater depth. General I have been using LINX in the NHS and privately for four years. I have implanted nearly 50 patients with minimal side effects and good efficacy my experience with the technique is positive. Thank you for your. Efficacy data that are unpublished or not peer reviewed are not normally selected for presentation to the mittee. This includes conference abstracts, which are not normally considered adequate to support decisions on efficacy. 8 of 12

9 9 Consultee 7 Patient ments General Having received your documentation re the Linx procedure becoming available/accessible on the NHS, AXA PPP etc., I would like to offer some details of my experiences of the procedure in question. I underwent the Linx procedure in October XXXX at XXXX in XXXX was my consultant surgeon. I had suffered with daily bouts of painful acid reflux over a period of several years, coupled with severe and almost constant painful laryngitis, none of which was cured or even very much improved with the accepted and widely recommended medication. I tried several different types of medication over that time with little to no improvement. The mittee very much welcomes hearing from patients who have undergone this procedure and considered your experience and views in their deliberations. Tests showed a hiatus hernia and singeing of the vocal chords, which was becoming pretty intolerable, especially at night time, although it was a continual daily issue for me. A little over two years on from the procedure, and I am delighted that I am cured of the Reflux/Hernia symptoms. The results have been very worthwhile and have improved my quality of life enormously. My acid reflux is no more, and my voice came back quite quickly after the op, although the constant long term acid reflux had taken it's toll. But there has been massive improvement, and in fact an almost complete cure. 9 of 12

10 ments Recovery from the procedure was not without it's challenges, although the actual operation went fairly smoothly. Recovery wise I found it rather difficult to eat for several weeks afterwards - it was quite painful and took time and perseverance to allow my oesophagus and stomach to accept food properly again - swallowing was temporarily difficult and painful. But this improved with small meals over a period of three to four weeks. I think I was one of the unlucky ones in that others I spoke to recovered more quickly than I. But the wait was worth it, and within a month I was able to eat a full and varied diet once more. After several months I no longer had any (or very few) problems, and although at first I was a little alarmed at the initial difficulty in eating and swallowing, as mentioned that did not last long. LINX was without doubt extremely beneficial to my condition, and has allowed me to live a normal life again. My condition had become fairly intolerable before undergoing the Linx procedure with XXXX. If you wish to contact me to receive further information please feel free to do so. 10 Consultee 8 Patient General My LINX was fitted in October I was also offered Nissan Fundoplication which was not an option for me as I would have found it overwhelming restrictive. Overall, I am extremely satisfied with the LINX. My recovery was slightly longer than expected but the majority of my symptoms have been completely resolved and I continue to improve. I would certainly recommend the LINX and hope you will consider approval to enable many more people to enjoy its benefits. The mittee very much welcomes hearing from patients who have undergone this procedure and considered your experience and views in their deliberations. 10 of 12

11 11 Consultee 9 Patient ments General Unfortunately I have only just received the asking for regarding the Linx operation in relation to the NHS and the deadline is 20th April. I requested this operation through XXXX via the NHS but payment was denied which I found both frustrating and discriminatory! I understood that the operation is available in the NHS in about 12 locations including XXXX but apparently not in XXXX my local hospital where XXXX operates from hence why I find it totally discriminatory based on my post code! The mittee very much welcomes hearing from patients who have undergone this procedure and considered your experience and views in their deliberations. I eventually paid for the Linx operation privately which cost 8,100 about the same as a Fundoplication operation! This was taken from my pension which i could not really afford to do but I felt I had no choice. I could not risk having the fundoplication operation as after extensive research I found that 35% of patients required further medication (Omeprazole etc )after 5 years and 63% required medication after 10 years hardly convincing figures that this was the best route for me as medication no longer had any affect on my condition. I subsequently have been told I suffer from Barretts disease so had to have an operation so I chose the Linx. The Linx operation went well and I believe that the acid level is much reduced. 11 of 12

12 12 Consultee 10 Patient ments General Could I say that it has been 6 months since I have had the Lynx procedure by XXXX, I had a very bad case of acid reflux, which resulted in Barrett's oesophagus. The Lynx procedure has been a new lease of life to me. I can now eat normally and sleep lying flat instead of elevated, I have no acid reflux at all. I can only say it's been a success. The mittee very much welcomes hearing from patients who have undergone this procedure and considered your experience and views in their deliberations. "ments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and to promote understanding of how recommendations are developed. The are published as a record of the submissions that NICE has received, and are not endorsed by NICE, its officers or advisory committees." 12 of 12

Interventional procedures guidance Published: 16 December 2015 nice.org.uk/guidance/ipg540

Electrical stimulation of the lower oesophageal sphincter for treating gastro-oesophageal reflux disease Interventional procedures guidance Published: 16 December 2015 nice.org.uk/guidance/ipg540 Your