A randomized trial to clarify the value of image fusion technology for aortic reconstruction

Rachel Clough

An ongoing randomized controlled trial funded by the UK National Institute for Health and Care Research (NIHR) seeks to illuminate the value of image fusion guidance technology for aortic endovascular repair.

In a process presentation at this year’s VEITH Symposium (November 14–18, New York, USA), Rachel Clough (King’s College London, London, UK) first outlined the problem at hand. While endovascular devices are available to treat complex aortic disease using a combination of branches and fenestrations, she said, challenges arise in positioning these devices in three-dimensional spaces.

“We currently use high-contrast, high-spatial-resolution computed tomography [computed tomography] angiography both to plan these procedures and to design these custom-made devices,” Clough said. Until recently, however, she noted that there was no “direct correlation” between these preoperative imaging data and intraoperative two-dimensional fluoroscopic images.

To remedy this, Clough detailed that a new technology—Cydar Maps (Cydar Medical) image fusion guide—was designed to accurately and in real-time automatically overlay preoperative CT, volume-imaged aortas onto intraoperative fluoroscopy data.

The presenter noted that Cydar Maps is now a cloud-based product that includes three phases – planning, navigation and review. The advantages of the cloud-based system, Clough relayed, include the fact that it is always updated, allows for remote scheduling and review of cases, and provides a platform for sharing data with other organizations or device companies.

Additionally, Clough said, the technology has the advantage of being able to aggregate data in an effort to develop data-driven clinical decision support. “During the planning, navigation and review phases, data is brought together and then analytics can be used to try to predict outcomes,” the presenter explained. She continued that a particular patient can be matched to similar previous patients, and not just necessarily at a single center, but across multiple centers, and then predictions of outcomes based on the use of a different type of device can be provided.

As for the data, Clough said the technology has been demonstrated in independent case-control series in both the UK and the US to result in reduced radiation and procedure times for both standard and complex endovascular repairs. In fenestrated cases, she added, it has also been shown to reduce the amount of iodine-containing contrast agent used. In addition, the presenter noted a permanent reduction in radiation exposure for the operator after only 10 cases.

However, integration into health systems will require additional data. “We have to demonstrate that [Cydar Maps] it provides similar operator benefit and similar or lower overall costs compared to comparators because the UK is a value-based healthcare system,” said Clough. She noted that the UK’s National Institute for Health and Care Excellence (NICE) has a digital evidence framework that requires a high-quality randomized trial for any technology intended to guide treatment.

Against this backdrop, Clough and Tom Carrell (creator of Cydar Maps) applied for funding to the NIHR for a randomized controlled trial to investigate the value of the technology. Funding was granted and the investigators subsequently organized a prospective, multicentre, randomized controlled, two-arm trial involving patients with abdominal aortic aneurysm (AAA) and a thoracoabdominal AAA trial at 10 UK sites.

“[The trial] is designed to capture real-world practice, so it is deliberately relatively simple,” comments Clough. “We screen patients in the MDT [multidisciplinary team meetings] or in the clinic and collecting routine clinical and CT data, as would be standard practice,” the presenter clarified. The quality of life questionnaire (10-question EQ5D) is actually the only additional item required for the trial.

Clough went on to say that patients will be randomized in a 1:1 ratio, with the goal of recruiting a total of 340 patients. Clinical, technical and cost-effectiveness data will be collected to evaluate the technology.

The presenter concluded with a progress report detailing that 213 patients – just over 60% of the required cases – had been enrolled so far. “We are pleased that overall the sites are recruiting patients well,” she noted, noting that about 80% of all eligible patients who are screened are recruited to the trial.

“Health technologies have the potential to drive efficiency and cost savings, but their value needs to be demonstrated,” Clough emphasized in his conclusion. “Cydar Maps has been shown to provide benefit compared to standard treatment in smaller trials for both complex and simple endovascular aortic repairs and we hope that this NIHR-funded trial will provide data of sufficient quality for submission to NICE for evaluation to understand the true value of this technology.”

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