Advice
The technology
The technology
AcQMap (Acutus Medical) is an imaging and mapping system. It can be used to direct endocardial ablation treatment for stable and unstable arrhythmias, such as atrial fibrillation. It displays high-resolution 3D cardiac chamber reconstructions using ultrasound and cardiac electrical activity (measured using electrodes) as a propagation wavefront. 3D charge density maps can be overlaid on the cardiac chamber reconstruction.
The system can also be used with a novel algorithm, SuperMap, which is designed to be used to map stable or transient rhythms. It can distinguish between different morphologies and arrythmia cycle lengths in a single recording. The company claims that AcQMap can help identify arrhythmic regions of the heart, to guide targeted treatment with ablation, which cauterises or freezes areas of heart muscle.
The AcQMap System includes the AcQMap Console, which formats and transmits signals to the AcQMap Workstation for display and analysis using the AcQMap System Software. The AcQMap Workstation consists of a portable cart with a mounted desktop computer and USB keyboard and mouse for user input.
The AcQMap is used with an AcQMap 3D Imaging and Mapping Catheter. This catheter expands to form a 25 mm diameter spheroid cage and comprises 6 splines (arms), each of which houses 8 ultrasound transducers for anatomic reconstruction and 8 electrodes for recording biopotential signals. This catheter is inserted into the heart, through the AcQGuide Steerable Sheath, via a vein in the groin. The catheter allows non-contact mapping of the heart's electrical activity.
The AcQMap also needs an AcQMap Patient Electrode kit. This kit contains localisation dispersive electrodes, patient return electrodes, and body surface electrocardiogram (ECG) electrodes. The electrodes are placed on the body in designated locations based on colour coding and specific anatomical markers. They provide catheter-positioning information, a common reference between the person and AcQMap Console, and ECG monitoring information.
Patient patch connections are made directly to the front panel of the AcQMap Console along with the ECG cable. Ablation catheter and ablation generator connections are also made to the front panel, enabling signal acquisition by the AcQMap System.
Innovations
The company says that other 3D mapping systems are not able to collect global real-time activation data, which they believe are needed to effectively map atrial fibrillation. The device can remain in the heart during the ablation procedure to subsequently remap the arrythmia and look at the success of the ablation procedure. The SuperMap algorithm uses software that can identify multiple morphology and cycle length atrial tachycardias from a single moving non-contact recording. This technology could allow a more rapid and targeted approach to ablation therapy for atrial fibrillation and atrial tachycardia, reducing unnecessary ablation and so preserving atrial tissue.
Current care pathway
Atrial fibrillation can be treated with drugs including beta-blockers and rate-limiting calcium channel blockers. If drug treatment does not control symptoms or is unsuitable, people can be offered left atrial catheter ablation if they have paroxysmal atrial fibrillation; or left atrial catheter or surgical ablation for persistent atrial fibrillation. Mapping catheters can be inserted into the heart during the process to look at the electrical conduction and guide ablation.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
The AcQMap System is intended to treat cardiac arrhythmias, particularly atrial fibrillation or atrial tachycardia, that need endocardial catheter ablation. This would be done in a tertiary care setting by cardiologists with expertise in electrophysiology and ablation procedures.
The AcQMap System is contraindicated for some people, including those with:
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implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
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a permanent pacemaker or implantable cardioverter-defibrillator leads in the chamber being mapped
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hypercoagulopathy, or for whom anticoagulation therapy during an electrophysiology procedure is unsuitable
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active systemic infection
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inferior vena cava embolic protection filter devices.
Some or all of these contraindications would also be applicable to other invasive heart electrophysiology procedures.
Costs
Technology costs
The company estimates total costs per procedure of:
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£5,670 to £7,285 for atrial fibrillation
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£5,720 to £6,405 for right atrial tachycardia
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£5,690 to £6,585 for left atrial tachycardia.
This takes into account equipment not manufactured by the company including ablation catheters, decapolar coronary sinus catheters and irrigation tubing.
The AcQMap catheter, catheter sheath, and patient electrode kit cost £4,550 per procedure.
The AcQMap System also needs a single-use unipolar reference, which can be 1 of 2 options:
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AcQRef, another sheath featuring an integrated ring electrode at £150 to £252 (excluding VAT), or
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a fixed quadripolar catheter estimated at £60 to £90 (excluding VAT).
The AcQMap System, which includes a workstation, console and cabling, costs £260,000 (excluding VAT). The company says that the anticipated in-service lifetime is 7 to 10 years.
Resource consequences
The company says that the AcQMap System is currently used in 7 NHS sites in England, which are doing 1 to 8 cases a month. This technology would be used instead of other systems used to map or identify regions of the heart for ablation.
There is an upfront cost of buying the system, which includes the workstation and console needed to use the technology.
The company claims the technology will reduce the need for repeat procedures, leading to more efficient use of hospital resources including catheter lab time, general anaesthetic availability and disposable consumables used in each procedure.
The company provides free support for all procedures. It also provides a free 2‑day face-to-face training course, which covers system set up and use, map collection and data review. Attendees need to complete a logbook of 5 to 10 procedures before being signed off as proficient. Also included for free in the training are travel and accommodation, space rental, staff costs and hardware and disposables used.