'First-in-human' clinical trial of pioneering guidance in heart bypass surgery succeeded

The FAST TRACK CABG study, directed by the university's CORRIB Research Center for Advanced Imaging and Core Lab, allows cardiac surgeons to plan coronary artery bypass grafting (CABG) based solely on HeartFlow's non-invasive cardiac CT scan images. Running. Analyzing blood flow in a patient's coronary arteries using AI.

This research today european heart journal.

The key finding of this first-in-human study is that it has a 99.1% feasibility. This means that heart bypass surgery without invasive diagnostic catheterization is both feasible and safe due to the superior diagnostic accuracy of cardiac CT scans and AI-based blood flow. analysis.

This study was sponsored by the University of Galway and funded by GE Healthcare (Chicago, USA) and HeartFlow, Inc. (Redwood City, California, USA).

When comparing the safety and effectiveness of heart bypass surgery, this trial found similar results to a recent surgery group of patients who underwent conventional invasive angiography. This test involves inserting a catheter through an artery in the wrist or groin to access the affected artery and using a dye to examine it. Visualize the blockage.

Results from the FAST TRACK CABG trial suggest that a minimally invasive approach to heart bypass surgery offers safety and efficacy comparable to established methods. The research team noted that the safety issues inherent in invasive investigations can be replaced with non-invasive techniques using CT scan imaging and AI-powered blood flow analysis.

Trial chair Professor Patrick W. Seluis, established professor of interventional medicine and innovation at the University of Galway, said: “The results of this trial have the potential to simplify planning for patients undergoing heart bypass surgery. The central role played by this trial and its researchers is that the CORRIB Core Lab has enabled the University of Galway to be at the forefront of cardiovascular diagnosis, planning and treatment of coronary artery disease.”

The study was conducted at major cardiac care hospitals in Europe and the United States and involved 114 patients with severe blockages in multiple blood vessels that restricted blood flow to the heart.

The cardiac CT (Revolution CT, GE Healthcare) used in this study has special resolution and is non-invasive, comparable to or better than images traditionally obtained by directly injecting contrast into the arteries of the heart. Realize the image. catheter.

During the trial, high-resolution cardiovascular images and data analysis were performed by the CORRIB Core Lab team and shared via telemedicine with surgeons at the study hospital.

heart flow^TM The CT-derived Fractional Flow Reserve (FFRCT), which provides an AI-powered blood flow analysis, quantifies the extent to which narrowed vessels are inadequately supplying blood to the myocardium, allowing surgeons to This helped us clearly identify which blood vessel in the patient should be implanted with a bypass graft. .

Professor Serruys added: “FFRCT represents a revolutionary change in medicine, with the potential for surgeons to treat even the most complex cases of coronary artery disease using only non-invasive CT scans. “Interventional cardiologists could consider following their example,” he added. ”

Dr Yoshi Onuma, Professor of Interventional Cardiology and Medical Director of the CORRIB Research Center at the University of Galway, said: “Exploring the possibility of minimizing diagnostic catheterization procedures is important for several reasons. The insertion procedure is invasive and uncomfortable for the patient.” Although the risks associated with this procedure are minimal, they are not completely risk-free.

“It's important to know that this is the case,” said Dr. John Puskas of Mount Sinai Morningside, New York, and professor of cardiothoracic surgery at Emory University Hospital in midtown Atlanta, Georgia. “As the only North American surgeon enrolling many patients in this trial, I have a unique perspective. I guided my surgical team based solely on data from the latest generation non-invasive coronary CT scans. It can be concluded conclusively that diagnostic accuracy and precision are not compromised, nor is the quality of surgical planning or performance compromised.If you are familiar with this new imaging modality, There are several things that make it a better guide than invasive coronary angiography.”