Procyrion has announced the successful treatment of the first patients in the A PRIORI—Aortix therapy for perioperative reductIon of renal injury—pilot trial to evaluate the performance of its Aortix percutaneous mechanical circulatory support (pMCS) device in preventing acute kidney injury (AKI) during cardiac surgery.
The study will enrol up to 50 patients across four clinical sites in Australia: Royal Adelaide Hospital, Monash Health, Princess Alexandra Hospital, and Macquarie University.
“We are thrilled to be the first centre in the world to provide Aortix pump therapy during a cardiac surgery with the goal of reducing the risk of AKI,” said Stephen Worthley (Macquarie University Hospital, Sydney, Australia). “Patient history can help identify those with known risk factors for developing AKI and the Aortix pump has the potential to address major risk factors both during and after surgery by improving renal artery flow. The catheter-based pump was easy to deploy, operated in a location that did not interfere with the surgery, and greatly improved perfusion to the kidneys.”
During surgery, a reduction in systemic pressure can lower renal perfusion, increasing risk of AKI. Approximately one third of high-risk patients (defined as those with poor kidney function, heart failure, or diabetes or hypertension with complications) may develop AKI following a coronary artery bypass surgery (CABG) or heart valve surgery. Moderate AKI after cardiac surgery can lead to a fivefold increase in morbidity and mortality rates and double length of stay, hospital costs, and readmission rates.
The Aortix pump is placed in the descending thoracic aorta via a percutaneous catheter procedure at the beginning of the scheduled surgical procedure to directly increase perfusion to the kidneys while reducing cardiac energy requirements.