An ongoing UK National Institute for Health and Care Research (NIHR)-funded randomized controlled trial seeks to illuminate the value of an image fusion guidance technology for endovascular aortic repair.
In a presentation on the trial at this year’s VEITHsymposium (Nov. 14–18) in New York City, Rachel Clough, MD, a consultant vascular surgeon at King’s College London in London, England, first outlined the issue at hand. While endovascular devices are available to treat complex aortic disease using a combination of branches and fenestrations, she said, challenges arise when positioning these devices in three-dimensional spaces.
“We currently use high-contrast and high-spatial resolution CT [computed tomography] angiography to both plan these procedures and to design these custom-made devices,” Clough said. Until recently, however, she noted that there was “no direct link” between these preoperative image data and intraoperative two-dimensional fluoroscopy images.
To remedy this, Clough detailed that a new technology—Cydar Maps (Cydar Medical) image fusion guidance—was designed in order to accurately and in real time automatically overlay preoperative CT, volume-rendered aortas onto intraoperative fluoroscopy data.
The presenter noted that Cydar Maps is now a cloud-based product that incorporates three phases—planning, navigation and review. The benefits of a cloud-based system, Clough relayed, include the fact that it is always updated, enables remote planning and review of cases, and provides a platform for sharing data with other organisations or device companies.
Furthermore, Clough said, the technology has the benefit of being able to aggregate data in an effort to develop data-driven clinical decision support. “During the planning, navigation and review phases, the data are pooled and then analytics can be used to try to predict outcomes,” the presenter explained. She continued that a particular patient could be matched to similar previous patients, and not just necessarily in one centre, but across multiple centres, after which predictions of outcomes based on different device type usage could be provided.
Data-wise, Clough shared that the technology has been demonstrated in independent case-control series in both the UK and the USA to result in reduced radiation and procedure times in both standard and complex endovascular repair. In fenestrated cases, she added, it has also been shown to reduce the amount of iodinated contrast agent used. The presenter further noted a sustained reduction in radiation exposure for the operator after just 10 cases.
Integration into healthcare systems, however, will require further data. “We need to demonstrate that [Cydar Maps] provides similar operator benefit and similar or lower overall costs compared to comparators, as the UK is a value-based healthcare system,” Clough stated. She noted that the UK National Institute of Health and Care Excellence (NICE) has a digital evidence framework that requires a high-quality randomized trial for any technology designed to guide treatment.
Against this backdrop, Clough and Tom Carrell (co-creator of Cydar Maps) applied for funding to NIHR for a randomized controlled trial to investigate the technology’s value. The funding was granted, and the investigators subsequently set up a prospective, multicenter, two-arm randomized controlled trial recruiting patients with abdominal aortic aneurysm (AAA) and thoracoabdominal AAA trial in 10 sites across the UK.
“[The trial] is designed to capture real-world practice, so it is deliberately relatively simple,” Clough commented. “We screen patients at MDT [multidisciplinary team meetings] or in clinic and collect routine clinical data and CT imaging data, as would be usual practice,” the presenter elaborated. A quality-of-life questionnaire (the 10-question EQ5D) is really the only additional element needed for the trial.
Clough continued that patients will be randomized in a 1:1 fashion, with the aim being to recruit a total of 340 patients. Clinical, technical and cost-effectiveness data will be collected to evaluate the technology.
The presenter closed with a progress report, detailing that 213 patients—just over 60% of the cases required—have been enrolled so far. “We are pleased that, on the whole, sites are recruiting patients well,” she remarked, noting that around 80% of all eligible patients that are screened are being recruited to the trial.
“Health technology has the potential to drive efficiency and cost savings, but its value must be demonstrated,” Clough stressed in her conclusion. “Cydar Maps has been shown to provide benefit compared to standard treatment in smaller studies for both complex and simple endovascular aortic repair, and we hope this NIHR-funded trial will provide data of sufficient quality for submission to NICE for evaluation, to understand the true value of this technology.”