Specialist commentator comments
Comments on this technology were invited from clinical specialists working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
All the commentators were familiar with the technology, and 2 out of 4 had used Danis stent before.
Three of the commentators considered Danis stent novel in its concept or application. However, 1 commentator highlighted that it is not a new technology and the insertion technique compared with standard care (balloon tamponade) is similar. The innovative aspects identified were that Danis stent allows oral intake and can be left in place for a longer period than a balloon tamponade, potentially allowing stabilisation for definitive treatment. One commentator noted that Danis stent does not cause complete oesophageal obstruction, which reduces the risk of oropharyngeal aspiration and patients do not need intubation in an intensive care unit (ICU) for airway protection (which they would need for balloon tamponade). Danis stent was identified as having a novel delivery system, with accurate stent placement, reducing risk of stent misplacement and oesophageal balloon inflation with subsequent possible oesophageal rupture. This has been a recognised complication of balloon tamponade. The use of a removal stent was identified as a novel design but has been available for some years for clinical use. Hemospray foram and histoacryl glue were identified as competing technologies by 1 commentator. None of the other commentators were aware of any competing technologies.
Potential patient benefits identified by commentators included quickly stopping bleeding, increased time to stabilise the patient before more definitive treatment and the ability to maintain oral nutrition. One commentator noted that the technology is associated with improved bleeding control and fewer adverse events compared with the Sengstaken-Blakemore tube, but that the mortality and length of ICU or hospital stay was similar. One commentator also said that the stent avoids the need for compulsory tracheal intubation and reduces the risk of oropharyngeal aspiration and pneumonia. A lower risk of oesophageal perforation compared with balloon tamponade was also mentioned by commentators. Patients with severe and refractory oesophageal variceal bleeding, including those with rebleeding from banding-induced ulcers, were identified by commentators as people who would benefit from Danis stent. Patients presenting to non-specialist centres or small district hospitals that may not have access to definitive treatment (such as transjugular intrahepatic portosystemic shunt [TIPS]) or specialist liver services were also identified by some of the commentators. One of the commentators noted that the stent would allow emergency haemostasis and allow the patient to be transferred to a specialist unit. The same commentator noted, however, that these non-specialist centres are likely to have the lowest access to Danis stent and the skills needed to do the procedure.
Potential system benefits identified by commentators included: faster time to haemostasis, a reduction in number of endoscopies, less ICU beds and fewer infective complications, such as pneumonia. Identification of patients for whom more definitive treatment would be suitable was another benefit highlighted. Another commentator noted that the longer stability period for patients would allow clinicians to optimise resuscitation and plan next steps. One commentator concluded that Danis stent could cost more than current standard of care, including the need for both fluoroscopy-guided removal and a specific removal device. Other commentators specified that the upfront cost of Danis stent would be greater, but 2 of them agreed that overall costs could be reduced because of a reduction in ventilator-dependent ICU care and complications. The remaining commentator said that it was difficult to clarify the costs because these patients are very ill and will often still need intensive care and subsequent interventions. Three commentators suggested that Danis stent would replace the current treatment option of balloon tamponade. Another commentator suggested both techniques would co-exist to be used depending on clinical context, but Danis stent could replace radiological treatments such as TIPS when its use is contraindicated.
Commentators agreed that regular product-specific training on how to use the device would be needed for healthcare professionals. Operators of the device are likely to be gastroenterologists, but radiologists could also be trained. One commentator said that inserting Danis stent is more complicated than inserting a Sengstaken-Blakemore tube, and that screening is usually needed to remove the stent. The only safety concerns raised related to inadequate training which could increase complications with use. The eligible population was estimated to be 100 patients per year in the UK by 1 commentator, with another commentator suggesting an average UK unit may have 4 refractory cases needing Danis stent per year. Based on experience from their trusts or hospitals, 1 commentator said that 3 people have treatment with Sengstaken-Blakemore tube each year, while the remaining commentator said that 10 people out of a local population of 700,000 people would be eligible for Danis stent. Adoption issues identified included cost of device and removal system and need of repeated training for gastroenterologists. One commentator highlighted that randomised controlled trials would be helpful to understand the rate of stent migration and ulceration with Danis stent as well as mortality but noted that this is a very challenging area in which to undertake clinical studies.