Welcome to MEDVIA’s new series on projects approved for funding in response to open calls. We are kicking off with the Elevate project, a collaboration among FEops cardiac imaging firm and two hospitals. The project will allow FEops’s product HEARTguide to grow users exponentially
It’s the challenge so many great innovations eventually face: Barriers to use. Regardless how useful, efficient or life-saving a medical technology is, if practitioners must jump through hoops in order to use it, they may soon abandon it. Worse yet, they may not have the tech required to even put it to use.
This is the problem facing Ghent-based cardiac imaging firm FEops. Its product is HEARTguide, which creates a 3D model of a patient’s heart. These are patients in need of a heart valve replacement or an occlusion of the left atrial appendage (LAA) – a procedure involving inserting a device to seal off this appendage from the heart.
“The function of this appendage is not very well understood,” explains Peter Mortier, CTO and co-founder of FEops. “But blood clots can travel from it to the rest of the body. People’s hearts vary greatly, just like hands and feet, so the medical devices to block off this appendage come in a lot of different sizes.”
The challenge for surgeons is to determine which size of device is best for which patient and then precisely where to fit it in the appendage to get the best results with the lowest risks. “And that’s where we help,” says Peter.
HEARTguide turns CT scans into a “digital twin”, which the FEops team analyzes to determine device size, placement and potential complications. It then provides insights to the surgeon. HEARTguide turns a one-size-fits-all approach to LAA closure into an individualized procedure, specific for every patient. The surgeon can even perform the procedure on the digital twin before performing it on the real-life patient.
“We do a full anatomical reconstruction,” explains Alessandra Bavo, project manager at FEops. “There are certain specifications that can guide the physician during the procedure. With imaging alone, they cannot see directly what they are doing, so they need specifications to position the device and to instruct them in exactly what to do.”
FEops tests different devices in the digital twin, “and surgeons can choose among the sizes we have designated for that heart,” continues Alessandra. She points to the analysis of one such 3D image. “Here it’s a choice among three sizes. So you really see how the device and the anatomy are interacting in each case.”
Preventing leaky valve
The same is true for heart valve replacements. “These valves prevent blood going back through the aorta to the heart, but if you don’t put them in a proper position or the anatomy is very challenging, you can get leakage,” says Peter. This is known as a leaky valve, or aortic regurgitation. “You really want to avoid that because leakage is associated with increased mortality.”
The procedure is often done by inserting a catheter into the upper leg or chest and inserting the valve through the catheter, known as Transcatheter Aortic Valve Implantation (TAVI). With HEARTguide, FEops predicts the risk of leakage, and, says Peter, “the surgeon can use that to determine the size or even to decide not to do a TAVI at all, but to do open heart surgery because TAVI would be too risky.”
HEARTguide is a revolutionary way to reduce risks for patients with heart disease, but Feops has run up against tech problems. So the company is partnering with two hospitals currently using HEARTguide – UZ Brussel and Ziekenhuis Oost-Limburg – for the Elevate project, funded by MEDVIA.
Sluggish data transfer
The first is a matter as simple as data transfer. The time it takes for surgeons to upload their CT scans and download the results from the HEARTguide platform can be a burden. And that’s only the beginning.
“When a patient comes to a hospital, all the data – including CT scans – are recorded in a central systeem,” explains Alessandra. Hospitals usually use a picture archiving and communication systems, or PACS. “The data is available only to that hospital and to certain physicians. A physician has to retrieve the scans and any other data from the PACS system, create a zip file and upload it to our platform.”
This requires more than one log-in, and – depending on the hospital – the doctor must be present in the hospital to get it done. The speed at which it all happens depends on the hospital’s internet connection.
“The whole work flow requires different log-ins to different systems,” says Alessandra. “It requires a local download to a machine and then another upload.” Sometimes this goes fairly smoothly, but a surgeon with three cases a day to send is going to be busy for at least 15 minutes – in the best-case scenario – just with data transfer.
The Elevate project involves establishing a direct connection between the hospital’s infrastructure and HEARTguide, turning two independent systems into one. Alessandra: “The doctor logs in to their account where the data is already stored and clicks ‘send to FEops’, and we receive it.”
From CT to ultrasound
The second problem that Elevate will solve is the type of images that can be sent. Currently, HEARTguide only works with CT scans, leaving out echocardiograms, or ultrasound imaging. Ultrasound makes up a majority of imaging used in hospitals around the world.
A full stack of ultrasound images is about 5Gb, and there are a host of other challenges compared to CT scans. “CT is standardized,” explains Peter. “Regardless of the brand of machine being used, the data is structured in the same way, according to international standards. With echo, every vendor has its own data format. On computers, for instance, you have jpg, tiff, png … it’s the same with ultrasound data.”
Currently, there are more than 100 hospitals worldwide using HEARTguide, but considering that up to three-quarters of hospitals use ultrasound rather than CT scans for heart patients, the potential for growth is enormous. FEops estimates that five full-time jobs will be needed for analysis of digital twins once the technology involved in the Elevate project is fully operational.
“MEDVIA offered us feedback on the abstract and the pitch sessions, which was extremely useful to define the direction of the full proposal,” says Alessandra. “It was very professional support that helped us get the project approved by VLAIO.” FEops is so satisfied with the application process that it has submitted a second application for funding from MEDVIA.
Elevate project in short:
Improve data transfer of FEops HEARTguide 3D planning technology and for both CT and ultrasound data
Consortium: FEops (Ghent); UZ Brussel (Brussels); Ziekenhuis Oost-Limburg (Genk)
Timeline: Result of first call for MEDVIA funding (2021.1), start date 01/01/2022, 12-month duration
Total project budget: €686,000
Funding provided by MEDVIA: €275,000
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Written by Lisa Bradshaw