Edwards Lifesciences has announced new data from the COMMENCE aortic trial, demonstrating low rates of structural valve deterioration (SVD) in bioprosthetic aortic valves with the company’s innovative Resilia tissue.
The data, which represent the longest clinical follow-up for Edwards’ bioprosthetic surgical aortic valve with Resilia tissue with a mean follow-up of 7.7 years, were presented at the 103rd annual meeting of the American Association for Thoracic Surgery (AATS, 6–9 May, Los Angeles, USA).
Heart valves with Resilia tissue are designed to address calcification challenges of conventional tissue valves, and data from the COMMENCE aortic trial reported low rates of SVD (99.3% freedom from SVD), clinically stable gradients and freedom from reoperation (97.2%) through seven years.
“As bioprosthetic aortic valve replacement extends to younger and more active patients, valve durability is becoming increasingly important,” said Thomas Beaver (University of Florida College of Medicine, Gainesville, USA). “The seven-year data from the COMMENCE aortic trial demonstrates strong clinical outcomes and excellent durability in a study of younger patients with a mean age of 65.1 years.”
Current technologies utilising the tissue include the Inspiris Resilia aortic valve, the Konect Resilia aortic valved conduit, the Mitris Resilia mitral valve and the Sapien 3 Ultra Resilia transcatheter aortic heart valve. In addition to its anti-calcification properties,
The COMMENCE aortic trial is a prospective, non-randomised, multicentre, single-arm investigational device exemption (IDE) trial comprised of 689 patients at 27 clinical sites across the USA and Europe. The trial is evaluating the safety and effectiveness of Edwards’ bioprosthetic aortic valve with Resilia tissue in patients ages 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery. Long-term follow-up data were collected in a subset of these patients and will continue to be evaluated through 10 years.
