Interventional procedures
Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease (IPG431)
This novel procedure for gastro-oesophageal reflux disease (GORD) involves insertion of a ring of interlinked titanium beads, each weakly magnetic, around the gastro-oesophageal junction. The ring opens on swallowing and is then closed by magnetic force, with the aim of preventing reflux. The size of the ring is determined intraoperatively by use of a sizing tool. Claimed advantages over traditional antireflux surgery are less morbidity and preservation of the ability to belch and vomit.
The published evidence on efficacy was based on a single case series of 44 patients, which showed significant improvement in GORD scores as well as quality of life at one and two-year follow-up. Around 90% of patients no longer required proton pump inhibitors and measurements of oesophageal pH were significantly improved. The band required removal in 1 of the 44 patients because of dysphagia.
Bands were also removed for dysphagia in 2 of 100 patients (3%) in an unpublished case series. In that series, two further patients needed band removal to relieve vomiting. It reported painful swallowing in one other patient and unspecified pain in 24% of patients. Specialist advisors expressed concerns about the possibilities of perforation, erosion or displacement.
The committee considered the magnetic bead band to be an innovative concept that could be a useful addition to treatment options for refractory GORD if it is shown to be sufficiently safe and efficacious by further research and data collection. As part of its recommendation for use with ‘special arrangements’, it specified relevant outcome measures from further studies.
Laparoscopic gastric plication for the treatment of severe obesity (IPG432)
A claimed advantage of this procedure over other types of bariatric operation is that it is potentially reversible. It reduces the size of the stomach by plication of the gastric wall inwards along the greater curve and securing the fold using rows of continuous sutures. Variations include double or triple plication of the greater curve. Postoperatively, patients progress from fluids to semisolid food, avoiding intake of solid foods for about six weeks.
Case series of 100 and 135 patients reported mean excess weight loss of 60–65% at 2 years. Another series of 42 patients described 20% mean excess weight loss with no regaining of weight at 18 months. The series of 100 patients documented improvements of co-morbidities in a number of patients.
There were reports from these case series of single patients with jejunal necrosis due to mesenteric thrombosis, gastric obstruction due to fundal herniation and prepyloric perforation. There was also a small incidence (around 1%) of gastric leaks. A miscellany of other complications were reported, including intragastric seroma causing obstruction and persistent vomiting, which required further surgery; and prolonged nausea and vomiting, non-obstructive jaundice and hypocalcaemia, which were treated conservatively.
NICE recommended ‘special arrangements’ for the use of this procedure (only in specialist bariatric units) with submission of data on all patients to the National Bariatric Surgery Registry. Further research and comparison with other procedures would be useful.
Autologous blood injection for plantar fasciitis (IPG437) and for tendinopathy (IPG438)
Plantar fasciitis and tendinopathy (including tennis elbow, Achilles and patellar tendinopathy) are painful and disabling conditions that usually resolve over a period of several months. There is a variety of conservative treatments but local injection of steroids or extracorporeal shockwave lithotripsy are options when symptoms are persistent.
Autologous blood injection is claimed to promote healing through action of growth factors. Assessment of its effectiveness was complicated by the range of methods used. Either whole blood or platelet rich plasma may be injected (about 2–3 ml). ‘Dry needling’ (repeated passage of a needle into the tissues to disrupt fibres and induce bleeding) may be done beforehand. A ‘peppering’ technique may be employed, repeatedly inserting and slightly withdrawing the needle to inject in different positions. Ultrasonography guidance is sometimes used to guide injection. The procedure may be repeated if required.
For both plantar fasciitis and tendinopathies, there were a number for randomised controlled trials (RCTs) but not all of them were useful in assessing the efficacy of the procedure because of their choice of comparators. For example, the largest RCT (150 patients with tennis elbow) compared injection of autologous blood against platelet rich plasma (although, helpfully, this did suggest that use of autologous blood and platelet rich plasma may well be equivalent in any effect that they have).
The published trials gave inconsistent results. One RCT of 100 patients with tennis elbow compared platelet rich plasma with corticosteroid injections and showed >25% pain reduction without further intervention at two years in 76% and 43% respectively (p<0.0001). By contrast, an RCT comparing platelet rich plasma with a placebo in Achilles tendinopathy showed no significant differences and an RCT comparing injection of autologous blood, of corticosteroids or ‘peppering’ alone in plantar fasciitis also found no significant differences in outcomes. Other RCTs on plantar fasciitis showed similar results for autologous blood versus corticosteroids in 64 patients and better results for groups treated by steroids compared with autologous blood in a study of 100 patients. No serious adverse events were reported in any of the studies.
Plantar fasciitis and tendinopathies are very common conditions, and tend to be self-limiting so it is most important that any new treatments are well supported by good evidence. At present, that is not the case. NICE gave recommendations for use only with ‘special arrangements’ for all these conditions and encouraged more research, with appropriate comparators and outcome measures.
EXOGEN® ultrasonography bone healing system for long bone fractures with non-union or delayed healing
This is the first example of a new procedure evaluated for NICE interventional procedures guidance (IPG374) that has then led to assessment of the technology for medical technologies guidance (MTG12). In both cases, the guidance has been strongly supportive. The interventional procedures guidance published in 2010 recommended that low frequency pulsed ultrasonography was safe and effective in the treatment of non-union and delayed union of fractures. The manufacturer of EXOGEN® (Smith & Nephew, London, UK) subsequently notified the NICE Medical Technologies Evaluation Programme of its device.
The EXOGEN® system applies low frequency pulsed ultrasonography to the site of fractures. It consists of an operating unit designed to deliver a minimum number of treatments (over 5–6 months) and a transducer that is secured over the site of the fracture with a special strap. Treatments are administered for 20 minutes each day in the patient’s home.
The evidence was from observational studies but showed good healing rates with the use of EXOGEN® for non-union fractures (failure to heal after nine months). Between 62% and 100% healed, with the highest healing rates in fractures of the tibia (the most common bone to demonstrate non-union). The published evidence and expert advice supported the conclusion that many patients with non-union would avoid surgery, with its risk of complications. For non-union of long bone fractures, cost modelling estimated a saving of £1,164 per patient. The NICE medical technologies guidance recommended that EXOGEN® should be adopted for non-union fractures, based on these advantages both to patients and to the NHS.
The case for the advantages of EXOGEN® over current management for delayed healing (no radiological union after three months) was not so clear. There was considerable uncertainty about the rate of healing between three and nine months (it is very variable) and whether or not surgery would be required. Many patients might not need surgery. Cost modelling therefore showed a wide range of possible consequences, some that were cost saving but others in which EXOGEN® was more costly. It may be that further studies of the EXOGEN® device for delayed union will clarify the issues.
NICE interventional procedures guidance recommendations:
-
Use with normal arrangements for clinical governance, consent and audit
The evidence is sufficient to show that the procedure works well enough and is safe enough for surgeons to use as part of their normal practice, with the usual local policies for clinical governance, patient consent and audit.
-
Use with special arrangements for clinical governance, consent and audit
There is a greater need for permission, consent and follow-up due to uncertainties about the safety and/or efficacy of the procedure. This advice would also be given if there are known risks, which must be explained carefully to patients beforehand. It effectively means ‘tell your hospital, tell your patients and audit your results with special care’.
-
Use only in research
The procedure is considered to be experimental and/or particular uncertainties need to be resolved before more supportive guidance can be developed. The procedure should only be performed in the context of formal research studies, approved by a research ethics committee.
-
Do not use
The evidence suggests that the procedure is not effective and/or there are unacceptable safety risks.