Edwards Lifesciences has announced new eight-year data showing that patients receiving aortic surgical valves treated with its proprietary Resilia tissue technology have significantly improved long-term outcomes compared to those receiving non-Resilia tissue bioprosthetic valves.
Presented at the Heart Valve Society annual meeting (16–19 April, Cairo, Egypt), the study of 947 patients marks the first long-term, propensity-matched comparison between Resilia tissue and non-Resilia tissue surgical aortic valves.
The Resilia tissue data from the trial reported encouraging results through eight years, with low rates of structural valve deterioration (99.3% freedom from SVD in the Resilia tissue group versus 90.5% in the non-Resilia tissue group, p<0.0001) and freedom from reoperation due to SVD (99.2% in the Resilia tissue group versus 93.9% in the non-Resilia tissue group, p=0.0007).
Edwards developed the Resilia tissue technology more than two decades ago, and it is used in a wide range of Edwards’ surgical and transcatheter platforms, including the Inspiris Resilia aortic surgical valve, the Konect Resilia aortic surgical valve conduit, the Mitris Resilia mitral surgical valve and the Sapien 3 Ultra Resilia transcatheter aortic heart valve.
“These highly anticipated data provide strong clinical evidence of the excellent durability of Resilia tissue in surgical valves,” said Tsuyoshi Kaneko, John M Shoenberg chair of cardiovascular disease, chief of cardiac surgery at Washington University (St Louis, USA) and lead author of the study. “This level of performance is critical to reducing reinterventions and enabling more effective lifetime management for patients.”
“These data further validate the growing body of scientific evidence supporting the long-term durability, performance and significant patient benefits of our proprietary Resilia tissue,” said Wayne Markowitz, Edwards’ senior vice president, surgical structural heart.
To date, more than 450,000 patients worldwide have been treated with Edwards’ surgical or transcatheter aortic valve implantation (TAVI) valves with Resilia tissue.
“With patients of all ages living longer and demanding higher quality of life, the importance of lifetime management has never been greater,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “This significant advancement in tissue technology highlights Edwards’ dedication to pioneering unique innovations and improving patient outcomes.”
