COMMENCE findings reinforced Resilia’s long-term durability and sustained performance. Investigators presented data at the 106th American Association for Thoracic Surgery Annual Meeting in Chicago.
Irvine, California-based Edwards says COMMENCE provides 10-year data backing Resilia tissue in lifetime management for aortic stenosis (AS). To date, more than 500,000 patients worldwide have been treated with Edwards’ surgical and transcatheter systems that feature Resilia tissue.
Edwards designed its Resilia technology to extend valve durability. It utilizes bovine pericardial tissue treated with anti-calcification technology to serve as the platform for Edwards’ new class of valves. The calcium-blocking technology addresses structural valve deterioration, a primary cause of reintervention after valve replacement. Resilia features in valves like the Sapien M3 Ultra Resilia, Mitris Resilia mitral valve and more.
At 10 years, COMMENCE showed that patients treated with Edwards 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
According to Edwards, long-term durability can reduce the likelihood of repeat procedures over a lifetime. This helps to preserve quality of life as life expectancy increases.
Commentary from Edwards leadership and surgeons
“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.”
“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.”
