Edwards Lifesciences announced on 19 October 2009 results from a new study that demonstrated excellent hemodynamic performance and the absence of any patient-prosthesis mismatch (PPM) in its Carpentier-Edwards Perimount Magna Ease aortic heart valve. The data were presented for the first time at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting, in Vienna, Austria.
PPM has been associated with a significant increase in the risk of overall mortality and cardiac events, and occurs when the replacement valve is too small for the patient’s anatomy. The Magna Ease valve, which was launched in Europe in 2007 and the United States in June of this year, was studied in 270 patients at University Hospital Bern, Switzerland.
“Patient-prosthesis mismatch is the most meaningful measure to evaluate hemodynamic performance and, in our study, the newest Edwards valve demonstrated it can be implanted without producing this effect,” said Thierry P Carrel, chief of the department of cardiovascular surgery at University Hospital Bern. “Follow-up at four months demonstrated no paravalvular leakage and low mean transvalvular gradients, which corresponds to good hemodynamic performance.”
The Magna Ease valve includes a low profile and smooth commissure posts to ease insertion through small incisions or small aortic roots. The research team at University Hospital Bern noted in an editorial that these new features allowed them to implant larger valves to optimise transvalvular flow.
Edwards also announced at EACTS that it is providing a grant to sponsor data collection beginning in 2010 to determine whether updates are needed for the European System for Cardiac Operative Risk Evaluation (EuroSCORE). EuroSCORE is the world’s most widely used cardiac surgical risk model, based on data from patients undergoing cardiac surgery in 1995.