Resilia tissue developed by Edwards Lifesciences associated with long-term durability
New 10-year results from the COMMENCE surgical aortic valve trial highlight the long-term durability and sustained performance of the Edwards Lifesciences Resilia tissue surgical valve. The data were presented at the 106th American Association for Thoracic Surgery (AATS) Annual Meeting in Chicago.
The most recent data show a 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 paravalvular leak) and a sustained hemodynamic performance, including stable gradients and effective orifice areas over time.
"What this affords really is for us to look at young patients because the number of bioprosthetic valve cases or utilization in the United States is continuing to go up exponentially because people just don't want to have a mechanical valve and they also don't want to be on anticoagulation. The advantage of this valve is, we can place it and they don't have to be anticoagulated. The sustainability that we have demonstrated at 10 years in the COMMENCE trial is really remarkable, and I am very excited about this as a surgeon," explained Kevin Accola, MD, a cardiac surgeon at Advent Health in Orlando, Florida, in a video interview with Cardiovascular Business.
With transcatheter aortic valve replacement (TAVR) now making up more than 80% of aortic valve replacements in the U.S. and younger patients not wanting to have surgery, there has been a larger emphasis on the improved durability associated with surgical valves. Surgeons often argue that younger patients should undergo surgery first to reduce the number of valve surgeries over their lifetime. TAVR valves, then, can be used later in life when patients are older and more frail.
Surgical valves are expected to function for about 10-15 years, where the expectation of TAVR valves is lower. However, few surgical valve trials have tracked patients out a decade or more, so this trial helps better inform decision making.
Edwards Lifesciences said the Resilia tissue used in the valve leaflets was 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. The trial is now showing the technology is leading to improved durability.
Edwards Lifesciences uses the same Resilia tissue leaflets for its Sapien TAVR valves. There is hope that the durability seen with the surgical valves will translate into extended service life with these devices as well. There were early concerns that TAVR valves would wear out more quickly due to the extreme folding stresses the tissue undergoes when it is crimped into a catheter for delivery, but those concerns have not yet been seen.
Long-term durability matters to patients because it reduces the likelihood of repeat procedures over a lifetime.
“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,” Lars Svensson, MD, PhD, chief of the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute and professor of surgery at Cleveland Clinic, said in an Edwards Lifesciences statement. “What is striking is the low rate of SVD 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.”
Edwards said more than 500,000 patients worldwide have now been treated with its surgical and transcatheter valves that feature the Resilia tissue.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]