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November NUI Galway coordinates “first in man” clinical trial of pioneering guidance for heart bypass surgery
NUI Galway coordinates “first in man” clinical trial of pioneering guidance for heart bypass surgery
Research and analysis team at CORRIB Core Lab puts University at the cutting edge of cardiovascular diagnosis and treatment of coronary artery disease
A new approach to the guidance, planning and conducting of heart bypass surgery is being tested on patients for the first time in a clinical trial coordinated by a high-level research team at NUI Galway.
The FAST TRACK CABG study, overseen by the University’s CORRIB Research Centre for Advanced Imaging and Core Lab, will see surgeons plan and carry out coronary artery bypass grafting (CABG), based solely on non-invasive CT images of the patient’s coronary arteries.
Trial chairman Professor Patrick W Serruys, Established Professor of Interventional Medicine and Innovation at NUI Galway, said: “The results of this trial have the potential to simplify the treatment for patients undergoing coronary artery bypass grafting.
“The trial and the central role played by the CORRIB Core Lab puts NUI Galway on the frontline of cardiovascular diagnosis and treatment of coronary artery disease.”
The trial is “first in man” as it demonstrates a way to perform medicine which has never been done before. It is being conducted across Europe on 114 patients who have severe blockages in multiple vessels which are limiting blood flow to the heart muscle.
The first patient underwent surgery at the end of September under Professor Giulio Pompilio in Centro Cardiologico Monzino, Italy. A 30-day follow-up CT, performed by Professor Daniele Andreini, confirmed the success and appropriateness of the surgical treatment.
Current convention in cardiovascular diagnosis and treatment sees heart patients undergo catheterisation procedure where an artery in the wrist or groin is punctured and a catheter is fed to the heart. Dye is then directly injected into the coronary artery to visualise blockages or narrowing of vessels using X-rays.
During the FAST TRACK trial, analysis of high-resolution cardiovascular imagery and data, obtained with modern high-resolution CT (Revolution CT, GE Healthcare), is carried out by the CORRIB Core Lab team. The location and severity of coronary artery blockages are assessed using CT scans after dye is put in a vein of the arm, without the need for invasive catheterisation. These images allow a functional assessment of blood flow impairment known as Fractional Flow Reserve derived from CT (FFRct, HeartFlow).
Deputy chairman of the trial Yoshi Onuma, Professor of Interventional Cardiology and medical director of CORRIB Research Centre, described it as a potential gamechanger for cardiac surgery.
“Researching the possibility of reducing diagnostic catheterization procedures is important for several reasons. Catheterization is invasive and it is unpleasant for the patient. It is also costly for the health service and while there is a minimal risk with the procedure it is not completely risk free,” Professor Onuma said.
“CT scan analysis, FFRct and guidance from the team in Galway is a world first in bypass surgery. It may become a gamechanger, altering the traditional relationship between GP, radiologist, cardiologist and cardio-thoracic surgeon for the benefit of the patient.”
Professor Tim O’Brien, Dean of NUI Galway’s College of Medicine, Nursing and Health Sciences and consultant endocrinologist at University Hospital Galway, said: “The potential impact of this trial will be significant from the perspective of a patient, but also service delivery. The combined benefits arising from a risk reduction to the patient and a less demanding and more cost-effective diagnosis of coronary artery disease present major enhancements in cardiovascular medicine and service delivery.”
The trial is co-chaired by Professor Serruys and Professor William Wijns, Science Foundation Ireland Professor of Interventional Cardiology at NUI Galway, both of whom are internationally renowned experts in interventional cardiology and cardiovascular disease.
The surgery is being carried out in three of Europe’s leading cardiac care hospitals - Centro Cardiologico Monzino near Milan, University hospital Brussels (UZB) and University hospital Jena, Germany.
Professor Serruys added: “If a surgeon can operate on the most complex cases of coronary artery disease with the sole guidance of a non-invasive CT scan and FFRct, it will mean a dramatic change in health care. Following the example of the surgeon, the interventional cardiologist should also not hesitate to skip the conventional invasive cineangiography, and plan their procedure based solely on a CT scan. That will unload the purely diagnostic workload of the cath lab as we know it today and enable them to upgrade the catheterization laboratory to a dedicated ‘interventional suite’, thereby improving the workflow of patients.”
The trial is sponsored by NUI Galway and funded by GE Healthcare (Chicago, USA) and HeartFlow, Inc. (Redwood City, California, USA).