Advice
Expert comments
Expert comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
All 6 experts were familiar with the technology and 3 had used it before.
Level of innovation
All experts said that the technology is innovative because it allows non-contact mapping, instead of contact mapping, to treat arrhythmias. Three said it was faster than collecting contact data sequentially from multiple sites in the cardiac chamber. Four experts said that the ability to map the entire cardiac chamber simultaneously was particularly beneficial for unstable rhythms, such as atrial fibrillation, which have not been reliably mapped using standard technology. One expert noted that this type of global non-contact mapping can provide mechanistic information about the arrhythmia, which can help guide treatment.
Two experts said that this technology could replace, or be used alongside, standard care for atrial fibrillation ablation, depending on further evidence of its effectiveness. Two thought it would only be used alongside standard care. One expert said that AcQMap may become standard care for some people with persistent atrial fibrillation who are likely to have a poor outcome from pulmonary vein isolation alone.
Potential patient impact
Two experts said that AcQMap-guided ablation could be more effective than current treatment for persistent atrial fibrillation, and reduce the number of ablation procedures needed. However, they said that evidence is needed from randomised controlled trials to prove its effectiveness compared with standard care. One expert noted that people with very complex atrial arrhythmias may benefit more from using this specific technology than anyone with atrial fibrillation, but further evidence is needed to show this. One commented that, for more challenging atrial fibrillation (such as persistent atrial fibrillation, or atrial fibrillation that has recurred after previous pulmonary vein isolation ablation), the AcQMap System offers a greater chance of a successful ablation procedure than current standard care. The expert also noted that for atrial tachycardias, particularly those that are non-sustained or with multiple foci, the technology offers the chance of faster procedures with a higher success rate. Another expert thought that this device gives the opportunity to treat non-sustained atrial tachycardias that cannot be mapped with other systems, and identify possible sites for atrial fibrillation initiation and perpetuation.
One expert commented that AcQMap could allow more personalised treatments and reduce procedure time. Three noted that the technology can improve success rates and reduce the need for further procedures. This could mean less scar tissue and a better clinical outcome. One expert suggested fewer heart failures could mean fewer hospitalisations and deaths. They also said that, if there was less atrial fibrillation refractory to rhythm control measures, that could also lead to fewer hospitalisations.
Potential system impact
Five experts said that if the technology is effective, it could lead to less ablated tissue, fewer redo procedures and potentially quicker procedures. One said that if fewer procedures were needed, the technology could be cost saving. However, another expert said the cost case depends on whether randomised controlled trial or registry data show that the technology improves procedural success and reduces the need for further medical treatment. Two said that the technology would cost more than standard care using electro-anatomical mapping systems because extra consumable equipment is needed, including the AcQMap mapping catheter. One expert thought the technology could be cost neutral in the future. Five experts thought that only limited changes to facilities were needed to adopt the technology and that it could be adopted in any department currently doing ablation for complex cardiac arrhythmias. The only change needed was to purchase the core equipment and the consumables. Four experts said that training is needed. Two of these said that, because the technology is similar to existing technology, experienced cardiac electrophysiologists would have a relatively short learning curve. Three experts mentioned that support from experienced users for the first cases is beneficial. Two said that the company provides ongoing technical support.
General comments
Four experts said that the adverse events seen in the AcQMap data so far are similar to what would be expected for other catheter ablation procedures. Five noted the current lack of randomised controlled trial data comparing the technology to standard care. However, 1 expert said that most technologies in this field are assessed using single-arm studies. One said that longer-term outcome data are also needed.