A new approach to the guidance, planning and conduct of heart bypass surgery has been successfully tested on patients for the first time in a clinical trial coordinated by a research team at University of Galway.
The FAST TRACK CABG study, overseen by the University’s CORRIB Research Centre for Advanced Imaging and Core Lab, has seen heart surgeons plan and carry out coronary artery bypass grafting, based solely on non-invasive cardiac-CT scan images, with HeartFlow’s AI-powered blood flow analysis of the patient’s coronary arteries.
The key findings of this first-in-human study is the 99.1% feasibility, which means that heart bypass surgery without undergoing invasive diagnostic catheterisation is feasible and safe, driven by the good diagnostic accuracy of the cardiac CT scan and AI-powered blood flow analysis.
The trial was sponsored by University of Galway and funded by GE HealthCare (Chicago, USA) and HeartFlow, Inc. (Redwood City, California, USA).
In comparing the safety and effectiveness of heart bypass surgery, the trial had similar outcomes to recent surgical groups of patients who underwent conventional invasive angiogram investigations.
This involves inserting a catheter through an artery in the wrist or groin to access diseased arteries and using dye to visualise blockages.
The findings of the FAST TRACK CABG trial suggest that the less invasive approach to heart bypass surgery offers comparable safety and efficacy to established methods.
The research team noted that safety issues inherent to invasive investigation can be replaced by a non-invasive technique using CT scan imaging and AI-powered blood flow analysis.
Prof. Patrick W Serruys of University of Galway, said, “The results of this trial have the potential to simplify the planning for patients undergoing heart bypass surgery.”
“The trial and the central role played by the CORRIB Core Lab puts University of Galway on the frontline of cardiovascular diagnosis, planning and treatment of coronary artery disease.”
The study was carried out in leading cardiac care hospitals in Europe and the US and involved 114 patients who had severe blockages in multiple vessels, limiting blood flow to their hearts.
The cardiac CT used in this study has a special resolution that makes the non-invasive images as good or even better than the images traditionally obtained by a direct injection of contrast dye in the artery of the heart through a catheter.
During the trial, the analysis of high resolution cardiovascular imagery and data was carried out by the CORRIB Core Lab team and shared by telemedicine with surgeons in trial hospitals.
The HeartFlowTM Analysis, which provides AI-powered blood flow analysis, quantifies how poorly the narrowed vessel provides blood to the heart muscle, assisting the surgeon in clearly identifying which of the patient’s vessels should receive a bypass graft.
Professor Serruys added, “The potential for surgeons to address even the most intricate cases of coronary artery disease using only a non-invasive CT scan, and FFRCT represents a monumental shift in healthcare.”
“Following the example of the surgeon, interventional cardiologists could similarly consider circumventing traditional invasive cineangiography and instead rely solely on CT scans for procedural planning.”
“This approach not only alleviates the diagnostic burden in cath labs but also paves the way for transforming them into dedicated ‘interventional suites’- ultimately enhancing patient workflows.”
The pioneering research of the CORRIB Core Lab at University of Galway into cardiovascular diagnosis and coronary artery disease will be further investigated in a large scale randomised trial.
The research team is planning clinical trials which will involve more than 2,500 patients from 80 hospitals across Europe.
