Edwards Lifesciences shared data on long-term durability for its Resilia tissue at the 106th American Association for Thoracic Surgery Annual Meeting. The company presented 10-year results from the COMMENCE aortic trial including more than 500,000 patients worldwide who have been treated with Edwards’ surgical and transcatheter valves featuring RESILIA tissue.

At 10 years, COMMENCE trial data showed that patients treated with Edwards’ surgical valves featuring RESILIA tissue experienced:

• 97.9% freedom from structural valve deterioration (SVD)
• 97.8% freedom from reoperation due to SVD
• 98.6% freedom from non-structural valve dysfunction (other than PVL)
• Sustained hemodynamic performance, including stable gradients and effective orifice area over time

For patients, long-term durability matters because it can reduce the likelihood of repeat procedures over a lifetime, helping preserve quality of life as life expectancy increases, according to the company.

“These 10-year data from the COMMENCE trial suggest this tissue technology has the potential to change the way we think about durability in biological valves, including in younger patients,” said Lars G. Svensson, MD, PhD, chief of the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and professor of surgery at Cleveland Clinic. “What is striking is the low rate of structural valve deterioration and need for reoperation, even though the trial enrolled younger patients who historically face higher risks of valve deterioration, underscoring the importance of long-term evidence when physicians are making treatment decisions with their patients.”

The COMMENCE trial builds on the totality of Edwards’ clinical evidence, reinforcing the durability of outcomes supporting its surgical and transcatheter therapies, including large, randomized, FDA-approved studies such as the PARTNER series of trials. These trial series provide long-term patient outcomes on treatment with SAPIEN TAVR and SAVR, with 10 years of follow-up data. The new COMMENCE trial data build on that foundation with the latest evidence on the long-term durability of RESILIA tissue.

Edwards says the RESILIA tissue iss designed to enhance the durability of tissue valves by helping resist calcification, a leading cause of valve failure over time. The technology combines advanced calcium blocking processes with dry storage to support long-term valve performance.

“As patients live longer and expect to remain active, structural heart therapies must be designed with lifetime care in mind,” said Bernard Zovighian, Edwards’ CEO. “The COMMENCE 10-year study is the latest addition to our breadth of long-term data reflecting our commitment to advancing durable valve technologies through continuous evidence development, so Heart Teams and patients can make informed decisions over time.”

The COMMENCE aortic trial is an FDA-approved, pivotal, prospective, multicenter clinical study designed to evaluate the safety and effectiveness of a bioprosthetic valve with RESILIA tissue used in SAVR, with follow-up through 10 years.